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Setting priorities for the adoption of health technologies on a national level — the Israeli experience
Health Policy 54 (2000) 169 – 185 www.elsevier.com/locate/healthpol
Setting priorities for the adoption of health technologies on a national level — the Israeli experience Segev Shani a, Miriam Ines Siebzehner a, Osnat Luxenburg a, Joshua Shemer a,b,* a Israeli Center for Technology Assessment in Health Care, The Gertner Institute for Epidemiology and Health Policy Research, Tel Hashomer, Israel b Sackler School of Medicine, Tel A6i6 Uni6ersity, Tel A6i6, Israel
Received 11 January 2000; accepted 9 July 2000
Abstract The rapid development of new and expensive health technologies together with the limited resources available for the health care system, makes priority setting or rationing inevitable. The Israeli Health Insurance Law, enacted in 1995, determined a basic list of health services to be provided to all residents by public funding. Although the Israeli health care system has reached a high standard of medical care as expressed by parameters such as long life expectancy and low infant mortality, the social and professional demand for new and expensive health technologies is increasing. Towards the fiscal year of 1999, the Medical Technologies Administration of the Ministry of Health recommended a list of new technologies to be added to the list of health services. The Ministry of Finance allocated that year US$ 35 million for this purpose, while a rough assessment found that there are new important technologies to be added at a cost of more than US$ 350 million. The Medical Technologies Administration took a systematic approach of health technology assessment — ad-hoc teams were established for evaluating clinical safety, efficacy and effectiveness, conducting needs assessment and cost-effectiveness descriptions. Assessment of the data was based on evidence-based medicine. A set of criteria was determined in order to enable the prioritizing of the assessed new technologies. This procedure led to a list of technologies
* Corresponding author. Present address: Israeli Centre for Technology Assessment in Health Care, The Gertner Institute for Epidemiology and Health Policy Research, Tel Hashomer, 5261, Israel. Tel.: + 972-3-5303278; fax: + 972-3-6354136. E-mail address: [email protected] (J. Shemer). 0168-8510/00/$ - see front matter © 2000 Elsevier Science Ireland Ltd. All rights reserved. PII: S 0 1 6 8 - 8 5 1 0 ( 0 0 ) 0 0 1 0 9 - 3
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suggested for inclusion. The Minister of Health appointed a public committee whose purpose was to decide the technologies to be added to the list of health services. The committee, made up of representatives from the government, the sick-funds and the public, had to evaluate each technology, based on the analysis submitted to the committee, taking into consideration clinical, economic, social, ethical and legal aspects according to predefined criteria. The thorough work of the Medical Technologies Administration enabled the committee to adopt its recommended list with minor changes within a limited timeframe. In conclusion, we propose a practical and pragmatic model for the inclusion of new health technologies at a national level, based on health technology assessment and explicit priority setting. © 2000 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Health technology assessment; Health care decision-making; Priority setting; Rationing
1. Introduction In general, the health of Israelis compares favorably with that of residents of other developed countries. In 1996, the average infant mortality was 6.3 for every 1000 live births, similar to the average for countries whose GNP per capita is high. Life expectancy at birth is 75.9 years for men — ranking third among all high-income countries, and 80.1 years for women — somewhat lower than the average for high-income countries [1]. Israel’s healthcare system is considered to be one of the leading healthcare systems among western-world countries, as can be concluded from the broad spectrum of sophisticated health technologies publicly funded, including organ transplants, in-vitro fertilization, high-tech imaging techniques, and the latest developed pharmaceuticals. Although the Israeli healthcare system has reached a high standard of medical care as expressed by the parameters mentioned above, the social and professional demand for new and expensive technologies to be provided by the government is increasing continuously. Simultaneously, the inherent scarcity of resources for health services is increasing in Israel, like in other western countries, on account of the aging population and the rapid development of new and expensive health technologies. In 1985, the Israeli national health expenditure was 5.6% of GNP while in 1998, it reached 8.4% [2]. The impressive increase in the availability of health technologies (drugs, devices, medical and surgical procedures) presents society in general and the healthcare community in particular, with some difficult dilemmas concerning the need and ability to implement these technologies. In 1995, as part of a major reform in the Israeli healthcare system, the National Health Insurance Law was enacted, thus making health insurance both compulsory and universal [3]. The law determined a basic list of health services to which all residents are entitled, and states that the government is responsible for funding those health services. Moreover, the law specifies that all health services included in the list of health services will be of reasonable quality within the framework of the funding sources available [4]. The National List of Health Services was defined as the 1994 formulary of Israel’s largest Sick-Fund. This list included drugs, devices, techniques and procedures used by health care professionals to deliver medical care
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to individuals. The annual cost (in 1999) of providing all services included in the National List of Health Services (NLHS) for the entire Israeli population (about 6 million people) was about US$ 4 billion. All services included in this list must be available for every single patient through every single Sick-Fund. According to paragraph 8 of the National Health Insurance Law, ‘‘The Minister of Health may, by order, make changes in the List of Health Services, provided that he shall make no change that derogates from the basket or that increases its cost.’’ Furthermore, ‘‘No service shall be added to the basket of health services at no cost or for a payment lower than its cost unless a source of funding, or a source that has become available due to cancellation of a service or increased efficiency, is found therefor’’ [4]. Since all Sick-Funds are in deficit, one cannot expect the addition of new services due to increased efficiency. Hence, the NLHS can be updated only by additional allocation of funds from the Ministry of Finance. The Ministry of Health estimated that the cost of providing health services should be increased by a health technology factor of 2 – 4% each year due to the aging population and the emergence of new health technologies. Despite this fact, for three consecutive years, between January 1995 and December 1997, the NLHS was not updated, since no financial resources were allocated by the Ministry of Finance for this purpose. The only exception was the inclusion of beta-interferon for the treatment of Multiple Sclerosis in the NLHS in 1996, following Legal Proceedings. The Pharmaceutical Administration at the Ministry of Health identified the emerging problem of deciding which new drugs should be added to the NLHS and set up a screening mechanism. Every six months, all new registered drugs in that time period were screened for breakthrough products. Breakthrough products were defined as drugs with significant clinical efficacy compared with current therapies for the same disease state, or drugs which were indicated for the treatment of diseases for which no drug therapy was available at that time. That procedure led to a list of drugs considered for inclusion in the NLHS, ranked according to their cost and clinical importance [5]. In December 1997, after a considerable public outcry, the Ministry of Finance allocated US$ 35 million for updating the NLHS, although according to the health technology factor, the estimated annual cost for updating the NLHS should have been US$ 80 – 160 million. The existence of the proposed list helped the Ministry of Health to decide which new drugs will be added to the NLHS. However, the experience learnt in this first update was that updating the NLHS is a very complicated issue, that should address other health technologies apart from drugs, and should be carried out on a formal periodical basis. The Medical Technologies Administration at the Israeli Ministry of Health, which was established in 1998, was appointed to be responsible for updating and managing the NLHS. Towards the fiscal year of 1999, The Medical Technologies Administration was requested to assess a list of new technologies to be included in the NLHS estimated at a cost of more than US$ 350 million. The Ministry of Finance allocated only US$ 35 million for the update of the NLHS in 1999, an amount that is ten times smaller than the estimated amount needed.
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Hence, the objective of the Medical Technologies Administration was to develop and implement a mechanism for updating the NLHS, based on priority setting for the inclusion of new medical technologies in the NLHS according to their assessment.
2. Health Technology Assessment The astounding advances in health technologies have been a cardinal cause of the increase in national health expenditures. As new technologies are developed and replace old ones, a mechanism is needed, which can prevent the use of those of unproven effectiveness, and regulate the use of others, which although proven effective and safe, are extremely expensive. Only in this manner will it be possible to contain costs while sustaining high standards of treatment. The Office of Technology Assessment defined Health Technology Assessment as a form of research, analysis and evaluation that attempts to examine the various impacts of a particular technology on the individual and society for its safety, efficacy, effectiveness and cost-effectiveness, and its social, economic and ethical implications both in absolute and comparative terms, and to identify those areas requiring further research and evaluation [6]. In the EUR-ASSESS report, Health Technology Assessment is defined as the analysis of the implications of a health technology that is intended to influence decision making and existing policies. Health Technology Assessment should help demonstrate problems and potentials and the way to handle them, by a systematic interdisciplinary process based on scientific evidence and other types of information [7]. For these purposes, the Medical Technologies Administration took a systematic approach of Health Technology Assessment, based on the model suggested by Shemer and Siebzehner [8]. According to this model, Health Technology Assessment is a multidisciplinary approach based on a comprehensive process, which includes the evaluation of evidence-based clinical, epidemiological and economic aspects. Optimal utilization of financial resources allocated to health care can be achieved by combining the scientific aspects mentioned above with social, political, ethical and legal considerations. Furthermore, Health Technology Assessment helps decision-makers set up priorities in an era of limited resources.
3. The proposed mechanism to updating the NLHS The different stages of the proposed mechanism for the 1999 update of the NLHS are shown in Table 1. Briefly, the whole process can be described as follows. Ad-hoc teams were established for evaluating clinical safety, efficacy and effectiveness, conducting needs assessment and cost-effectiveness descriptions. A set of criteria was determined in order to enable the prioritizing of the assessed new technologies. The Minister of Health appointed a public committee made up of representatives from the government, the sick-funds and the public. The committee
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Table 1 The process of the 1999 NLHS update 1 2 3 4 5 6 7
Call for proposals Quick assessment and screening Data collection and initial evaluation Comprehensive evaluation Priority setting Decision-making Government approval and legislation
had to evaluate each technology, based on the analysis performed by the Medical Technologies Administration, and decide which technologies will be added to the List of Health Services. The rest of this section will describe thoroughly the different stages of the update process.
3.1. Call for proposals In March 1998, a letter was sent to all Sick-Funds directors, hospital directors, chairpersons of the National Councils, the Israeli medical Association and Health Ministry units asking them to suggest to the Medical Technologies Administration new technologies to be included in the NLHS. The letter also specified which data should be included in the application for the proposed technologies (as shown in Table 2). The first announcement was followed in May by a second one, citing August 1 as the deadline for submitting proposals. External applications from patient interest groups, politicians and pharmaceutical companies, who became aware of the call for proposals, were accepted as well. In parallel, in-house screening of the National Drug Registry was conducted in search of breakthrough drugs. These measures have led to the creation of a list, containing about 100 health technologies, proposed for inclusion in the 1999 update of the NLHS.
Table 2 Data requested in the call for proposals 1 2 3 4 5
Technical description of the technology (name, manufacturer, indications, way of administration, dosage, etc.) Evidence for the safety, efficacy and effectiveness of the technology Existing treatment alternatives and the added value of the suggested technology compared with these alternatives Number of patients suffering from the disease-state and the estimated number of patients who will be treated with the suggested technology The cost of treating the patients with existing treatment alternatives versus the cost of treating them with the suggested technology
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3.2. Quick assessment and screening Since the list of candidates contained about 100 medical technologies, and a comprehensive evaluation could not be conducted for all the technologies, due to the limited number of available personnel and time constraints, a quick assessment and screening was performed firstly by the Medical Technology Administration, in cooperation with the Israeli Center for Technology Assessment in Health Care. In the assessment, different criteria were used for drugs and for other technologies. In Israel, drugs intended for marketing must go through a rigorous registration process. In order to get marketing approval, the drug should prove its safety, efficacy and quality. Hence, only drugs registered in Israel were recognized as eligible candidates for the NLHS update. On the other hand, as in any other developed country, medical procedures are not controlled by any defined regulatory mechanism, and therefore, they should be dealt otherwise. The proposed technologies (excluding drugs) were divided into four groups, following a quick assessment according to the data submitted in the proposals, 1. new technologies, which did not previously exist; 2. existing technologies for new indications; 3. new technologies requiring large investments in infrastructure or disposable equipment; 4. technologies that improve professional standards without causing a major change in the quality of the treatment. Within the framework of the allocated budget, it was decided that only the first two categories would be considered for the 1999 update. After this screening process, the list was narrowed to 84 proposed technologies, 69 of which were drugs.
3.3. Data collection and initial e6aluation Ad-hoc multidisciplinary teams were appointed to complete and correct the submitted data, and subsequently, to evaluate the proposed technologies. Assessment of the data was based on evidence-based medicine. The issues dealt by the teams were assessing clinical safety, efficacy, and effectiveness, conducting economic evaluation and assessing the populations’ needs. The sources of data used for performing the evaluation were local and international literature, the Health Ministry’s databases, experts’ opinions and the original proposals. Costs were obtained from the Health Ministry’s databases, the manufacturer of the relevant technology, hospitals and the sick-funds. The clinical, epidemiological and economic evaluations were performed simultaneously, although the clinical evaluation was of the most importance. Especially in the case of medical procedures, the clinical evaluation was conducted in order to make sure that the proposed technology is safe and efficient. For some procedures, it was found that the procedure is still experimental, clinical trials are still being conducted, there is no sufficient evidence in the international literature or the local setting for its use, or that there is no sufficient expertise in performing this procedure in Israel.
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The major role of the clinical evaluation was to assess the clinical importance of the suggested technology in comparison to existing treatments for the indicated disease-state. The evaluation was based on the most updated available data, focussing on evidence-based data including post-marketing effectiveness data. Furthermore, commonly used treatment regimens, frequent and significant adverse events and alternative treatments were identified. Special attention was given to the issue of identifying specific patient groups that will benefit mostly from the use of the technology, in case treatment of all the indicated patient population would not be possible. The epidemiological evaluation included a description of the disease-state needed to be treated including its incidence and prevalence, mortality and morbidity data from abroad and from Israel, where available. The number of patients to be treated was estimated based on data from practicing physicians, pharmaceutical companies, sick-funds and epidemiological databases, when available. Another important parameter, which usually was unattainable, was the current use of the technology in Israel before its inclusion in the NLHS. The economic evaluation taken, was a cost-effectiveness description, which was performed in order to calculate the overall cost of including the technology in the NLHS. The overall cost was calculated by multiplying the cost of an annual patient treatment with the technology, by the number of patients estimated to use it each year. The cost of an annual patient treatment was based on the cost of the common treatment regimen of the proposed technology, minus the cost of an annual treatment with the currently available treatment in the NLHS for the same indication. Since the addition of a new technology to the NLHS is permanent (unless it will be excluded in the future), the number of patients who will use the technology was estimated as the number of maximal potential users after the technology was disseminated completely and accepted in the healthcare system. However, for a small number of technologies, cost-benefit analysis/cost-effectiveness analysis were conducted. Moreover, in cases where the economic benefit from using the new technology was obvious and immediate (during the first year of its use), the amount that could be saved was deducted from the annual treatment cost of the technology.
3.4. Comprehensi6e e6aluation The completed evaluations performed by the ad-hoc teams were passed to the Medical Technology Forum for a comprehensive evaluation. The Medical Technology Forum was chaired by the Director of the Medical Technology Administration and was made up of the medical management of the Ministry of Health, senior officials in the Medical Technology Administration, and senior researchers from the Israeli Center for Technology Assessment in Health Care. The comprehensive evaluation aggregated all data from the different evaluations and came out with a complete technology evaluation ready for the priority setting. Key issues in the comprehensive evaluation were,
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1. scope of the problem — assessed by the use of indices for prevalence and incidence of the disease-state; 2. the disease’s burden on the health system in terms of mortality, morbidity, use of health services and/or functional disability; 3. the existing alternatives to treat the disease, including prevention, diagnosis, treatment and rehabilitation; 4. the cost of the disease according to the resources allocated to deal with it and the costs of alternative treatments; 5. clinical and economic characteristics of the new treatment. First of all, an initial filtering process was taken in order to identify all beneficial technologies. The few technologies that have been found to lack sufficient data in order to prove efficacy or safety received a ‘no-go’ recommendation from the Forum. After the forum considered the issues mentioned above, a three-page summary of the data for each technology was compiled. The summary consisted of three parts, 1. clinical — detailing commonly used treatment regimens, mechanism of action, common and serious side effects, comparison to alternative treatments and place in therapy; 2. epidemiological — incidence and prevalence of the disease, the estimated target population (number of patients expected to be treated); 3. economic — evaluation of the annual cost of treating the patient with existing therapies and immediate savings from the use of the suggested technology. Each summary was concluded by a recommendation on the appropriate indication and the specific patient population for the technology, in case it differed from the original proposal (limitations of use), and its annual price tag. 3.5. Priority setting This procedure led to a recommended list of technologies, which had to be prioritized by the Medical Technology Forum. Each technology presented was placed in three major groups, with all technologies being graded on a scale from 1 to 10, group A — high priority technologies (graded 8–10); group B — intermediate priority technologies (graded 4–7); group C — low priority technologies (graded 1–3). Two other groups were added; ‘no-go’ technologies, for which safety and efficacy were not proven, and hence were recommended by the Forum to be excluded from the list of candidates. The other group consisted of technologies identified as bearing no additional cost compared with existing technologies in the NLHS (at times even as saving money), and the Forum recommended on their inclusion, no matter what their priority was determined to be. The reasons for this recommendation were, 1. to enlarge the treatment possibilities for the practicing physician; and 2. to increase competition between the manufacturers of these technologies and, thus, causing reductions in their prices which will, eventually, decrease the national health expenditure.
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Table 3 Guiding criteria for the prioritization of the suggested technologies Life saving technology with full recovery The potential of the technology to prevent mortality/morbidity The number of patients to benefit from the use of technology The financial burden on society and the individual patient New technology for mild diseases, for which no treatment alternative exists New technology for serious diseases, for which no treatment alternative exists Technology which brings to an increase in longevity as well as quality of life Benefit of reducing morbidity versus the benefit of improving quality of life Technology of which the net gain to the health care system or to society is higher than its cost in a short/long term perspective Mutual assistance for publicly funding a very expensive technology (of proven efficacy) to the individual, yet of reasonable cost of society
Priorities were determined according to established guiding criteria (as shown in Table 3), which include the effect of the suggested technologies on mortality, morbidity, longevity and quality of life, existence of alternative treatments, the number of possible patients to benefit from the technology, the cost of the technology and its affordability both by society and by the individual patient. No scoring method was used for the criteria mentioned above. Each Forum member was aware of the criteria for setting priorities, read the final evaluation for each technology and decided on the recommended priority. The priority of the technology was agreed by all members and was not calculated as the average of the grades given by the members. The Forum acted as a consensus committee (Delphi model) — all decisions were made unanimously [9]. The entire process led to a final list of recommended technologies for inclusion in the NLHS, ranked according to priorities. The list containing summaries of the evaluation conducted for each technology, its ranking and the justifications for it were published as a position paper in a formal book that was presented to the Ministry of Health’s senior management and to the National Advisory Committee members.
3.6. Decision-making The Minister of Health appointed a public National Advisory Committee as a decision-making body for the 1999 update of the NLHS. The public committee included senior officials at the Ministry of Health, officials from the Ministry of Finance, Sick-Fund directors and public representatives (most of whom had no medical background). The committee numbered 14 members, of which more than a third were public representatives. The Director-General of the Ministry of Health was appointed as the committee’s chairman. The choice of the committee members was designed purposely to make sure that decisions would be based on national considerations and not on individual organization’s preferences, and that the public/patients’ perspective will be heard, as well as the perspective of healthcare professionals.
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The first meeting of the committee was held in the presence of the Minister of Health, and the committee members received a full explanation as to the professional work performed by the Medical Technology Administration and the committee’s role. The recommendations of the Medical Technology Forum were presented to the committee members. At the committees’ meetings, each technology was presented by the Forum’s chairman, and was followed by a discussion. About 70% of the Forum’s recommendations were accepted, and the committee focused on the remaining 30%, taking into account the criteria for priority setting (Table 3). The committee held several discussions, and concluded its work by recommending by consensus, which technologies should be added to the NLHS in the 1999 update and for which indications, according to the budget allocated by the Ministry of Finance for the fiscal year of 1999. Each technology was added to the NHLS with limitations on its use, which varied from giving only specialist physicians the authority to prescribe the drug to a set of clinical guidelines according to which treatment should be given. The reason for these limitations was to ensure the rational and cost-effective use of these technologies.
3.7. Go6ernment appro6al and legislation The National Advisory Committee gave the Minister of Health a recommended list of 44 drugs and six other technologies for inclusion in the NLHS. Details of the complete process are given for the involved authorities and their function in Fig. 1, and for the classification of the suggested technologies in Fig. 2. The Minister of
Fig. 1. The involved authorities and their function in the 1999 NLHS update, according to the Health Technology Assessment model [8].
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Fig. 2. Classification of the suggested technologies throughout the process.
Health adopted the committee’s recommendations and presented it for the government’s approval. The government’s approval was a binding legislation, announced in public. In March 1999, the NLHS was updated formally, by the addition of 44 drugs and six other technologies at an annual cost of US$ 35 million (general description of these technologies can be found in Table 4).
4. International perspective Drummond has stated that the ultimate goal of health technology assessment is to improve resource allocation, and hence it was pointless if decision-makers would not know how to use the data. Therefore, the two major challenges to developing a policy based on health technology assessment are; (a) costs and benefits data need to be produced in a timely fashion; (b) secondly, technology assessment cannot be isolated from the general healthcare policy and the decision-makers [10].
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A review of attempts to establish priorities in health services in international publications in different countries reveals a consensus that decisions concerning the allocation of resources should be made by a systematic and controlled process. Most models used by different bodies throughout the world for decision-making concerning public health, are still in the initial, even experimental phase. Decisionmaking models in the public sector must be detailed and allow total transparency and be able to withstand scientific and public criticism [11]. In the Netherlands, the 1997 Dunning Commission recommended steps such as technology assessment, cost benefit analysis, and public debates that would permit the establishment of priorities [12]. The most known example of priority setting is the ‘Oregon experiment’ in which an explicit system of limiting the number of medical treatments was established [13]. The basic criteria for prioritization were clinical effectiveness and cost-effectiveness, and the proposed list of treatments was suggested to the public for prioritization. The priorities set by the public led to a list in which treatment for thumb sucking and acute headaches received higher ranking than treatment for AIDS and cystic fibrosis [14]. Hence, the suggested list was modified several times and the priority criteria were abandoned almost totally. In New Zealand, as part of the 1992 healthcare reform, a list of core health services to be funded publicly was established. Four fundamental principles were used for defining those core health services — benefit, value for money, fair use of public money (accessibility and equity) and communities’ values [15]. The Swedish Parliamentary Priorities Commission defined three criteria for priority setting; (A) human dignity which implies that all human beings are equally valuable, (B) need and solidarity which implies that resources should be concentrated where needs are greatest and that special attention should be given to the needs of the weakest, (C) cost-efficiency which implies that one should aim for the reasonable relation between cost and effect, measured in terms of improved quality of life [16]. In the United Kingdom, the National Institute of Clinical Excellence (NICE) was established to appraise the clinical benefits and the costs of healthcare interventions, and to reach a judgement on whether on balance, these interventions can be recommended as a cost-effective use of the available resources. In reaching this judgement, NICE should consider the degree of clinical need of the patients, the broad balance of benefits and costs, and the effective use of available resources [17].
5. The Israeli perspective Israel, like every other western-world country has to deal with the adoption of new health technologies in an era of limited resources. The model presented in this article depicts a process of explicit priority setting based on health technology assessment including clinical and economic evaluations, and involves social, legal, ethical and political considerations. The importance of priority setting is that both health professionals and the public will accept it. In this paragraph, we will address
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Table 4 The 1999 update of the National Health Services list of reimbursed services Technology name Drugs Abacavir, Combivir™, Didanosine, Zalcitabine Alfuzosine, Doxazosin Mesylate, Terazosin HCl
Altretamine
Anagrelide Anastrozole, Formestane, Letrozole Atorvastatin, Cerivastatin, Fluvastatin, Lovastatin, Pravastatin
Bicalutamide Dexrazoxane Diacerein Dornase alfa
Dorzolamide HCl Epoprostenol sodium
Eptacog alfa
Flutamide
Gabapentin, lamotrigine, topiramate
Glipizide
Goserelin acetate Insulin Lispro
Mycophenolate mofetil
Indication
Antiretroviral combination therapy for Human Immunodeficiency Virus (HIV) infected adults and children. Treatment of benign prostatic hypertrophy Palliative treatment of ovarian cancer following first-time therapy with a cisplatin and/or alkylating agent based combination Treatment of patients with Essential Thrombocythemia Treatment of advanced breast cancer Reduction of elevated total cholesterol and LDL-cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia or combined hyperlipidaemia Treatment of advanced prostate cancer Prevention of cardiotoxicity in women with breast cancer receiving doxorubicin Symptomatic treatment of osteoarthritis Management of cystic fibrosis, not for patients under 5 years of age or with FVCB40% Treatment of elevated intraocular pressure Treatment of primary pulmonary hypertension in NYHA Class III and Class IV patients Serious bleeding events and surgery in patients with inhibitors to coagulation factors (FVIII or FIX) Indicated for use in combination with LHRH agonistic analogues for the treatment of metastatic prostatic carcinoma (stage d2) As adjunctive therapy in the treatment of partial seizures with or without secondary generalization in adults with epilepsy Adjunct to diet for the control of hyperglycemia in patients with non-insulin dependent diabetes mellitus (type II) Prostate cancer suitable for hormonal manipulation Treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis Prophylaxis of rejection reactions in renal allograft recipients. Should be used concomitantly with cyclosporin and corticosteroids
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Table 4 (Continued) Technology name
Indication
Pamidronate disodium
Treatment of bone metastases and multiple myeloma, and tumor induced hypercalcemia Treatment of symptoms and prevention of relapse of obsessive-compulsive disorder (OCD), and panic disorder with or without agoraphobia Adjunct to Levodopa/Carbidopa in management of Parkinson’s disease in patients with on-off phenomena Indicated in combination with interferon alpha-2b for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalization of ALT at the end of treatment) to interferon alpha therapy but who have subsequently relapsed Treatment of patients with amylotrophic lateral sclerosis (ALS) First line therapy for schizophrenia in children up to the age of 18 years (already included as second line therapy for schizophrenia) Treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-Hodgkin’s lymphoma Treatment of idiopathic Parkinson’s disease Treatment of metastatic islet cell carcinoma of the pancreas Prevention of graft rejection following transplantation of liver or kidney. Treatment of liver or kidney allograft rejection in patients previously having received other immunosuppressive agents Treatment of metastatic carcinoma of the ovary after failure of initial or subsequent therapy Treatment of non-small cell lung cancer, and advanced breast cancer
Paroxetine
Pergolide mesylate
Ribavirn
Riluzole Risperidone
Rituximab
Ropinirole Streptozocin Tacrolimus
Topotecan
Vinorelbine Technologies Cochlear implants Child development services Spinal cord stimulation Laparoscopic gastroscopy for morbid obesity Left ventricular assist device (LVAD) Dental treatments for oncology patients
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two key issues in this process — transparency and the involvement of the public, and the crucial importance of evidence-based medicine in the evaluation process.
5.1. Transparency and the in6ol6ement of the public It is accepted widely that the public should participate in the priority-setting process. The question is how to make the public a participant and if it is possible at all [18]. From the day the National Health Insurance Law was implemented (in 1995), until 1997 the NLHS became an important public issue, and the first update in 1997 was due to a major public outcry through the mass media. Lobbying new technologies has become a trend; either pharmaceutical companies or patient interest groups ask politicians for their support or use the media to publicize the technology and their cause. Numerous discussions have been held in different committees of the Israeli parliament on new technologies. The Minister of Health announced the establishment of the National Advisory Committee including the names of all members. One-fourth (25%) of the committee’s members were public representatives with no medical background. All lobbying efforts aimed at the Minister of Health were rejected for the reason that only the public committee is responsible for updating the NLHS. The committee with its public representatives represented a neutral body with national consideration and no prejudice. Hence, politicians, the public and the media accepted the sovereignty of the committee.
5.2. The importance of e6idence-based medicine in the process According to Sacket et al. [19], Evidence based medicine is ‘‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research’’. The term evidence-based medicine is mostly used theoretically — an insurer considering the adoption of a new medical technology should take into account its safety, efficacy, effectiveness and epidemiological data like morbidity, mortality, number of patients, etc. Practically however, there is a need to assess the utilization of currently available treatment alternatives, the need for the suggested technology, and the number of patients who will be treated with the technology after it is added to the NLHS. One should also take into consideration the dissemination of the technology in the market, including those patients who, clinically, do not need the new technology, but will still be treated with it. Furthermore, even when the collected data concerning costs and outcomes is optimal, the available limited budget makes priority setting necessary. Hence, preparation of the technical report for each technology according to evidencebased data is crucial, yet it is not sufficient for priority setting since all the technologies were proven already to be based on clinical evidence and as such compete with each other on their priorities.
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6. Future developments Although the suggested process was accepted widely by the public in Israel, and is compatible with other prevailing models in developed countries, we believe that the process can be improved further. First of all, we would like the process to be more transparent to the public. Hence, the call for proposals should be publicized well in the media, so that every resident will be able to submit an application. Public participation in priority setting is important and we would like to encourage the public debate on the importance of emerging new technologies through the media, the parliament and specific discussion groups. The Medical Technologies Administration should improve its assessment process into a well-known rigorous mechanism that will enable a full economic evaluation for each new technology, considering its positioning among competing treatments. Frequent reassessment of previous decisions according to new clinical or economic data is important to have a dynamic and efficient process. As part of the reassessment, the basic list of health services determined in the law should be screened according to evidence-based data, and the exclusion of technologies included in the NLHS that did not meet the criteria should be considered.
7. Summary Setting priorities is a complex process; it involves making painful decisions, that should be accepted socially by both health professionals who have to implement them and the public affected by them. Updating the NLHS is an example of decision making in the process of determining, executing and assessing public policy, showing how to use health technology assessment in priority setting on a national level. According to our estimation, the rapid development of new health technologies requires an increase of the annual budget allocated for providing health services by a factor of 2 – 4%. In western-world countries with public funding for the healthcare system, the supply of health technologies is greater than the resources available to fund them, which makes priority setting inevitable. Health Technology Assessment is vital for optimizing the use of health technologies within the workframe of the available resources. The process of updating the NLHS can be described as a transparent public process, composed of an initial phase of data evaluation performed by professional teams, and continued by priority setting and decisionmaking by a public committee. The public committee included government policy makers and healthcare professionals together with public representatives. The balance between the different committee members enabled achieving decisions by consensus, with public acceptance. Unlike the 1997 update of the NLHS, which was described as being explicitly implicit [20], the 1999 update is an explicit process trying to blend healthcare professionals with lay participation. The process was accepted widely in Israel by government officials, healthcare professionals, politicians, and the courts.
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In comparison to the international perspective, the model described in this article incorporates health technology assessment as the ultimate tool for setting priorities. Collectively, the criteria used in our model for prioritization are similar to those suggested elsewhere, and public participation was also part of the decision-making process. Hence, the model suggested in this article offers a unique solution based on the local characteristics of the Israeli healthcare system.
References [1] World development indicators — 1998, World Bank, Washington, DC, 1998. [2] Statistical abstract of Israel — 1998, Israel Central Bureau of Statistics, Jerusalem, 1999. [3] Shalev C, Chinitz D. In search of equity, universality and comprehensiveness: health reform and managed competition in Israel. Dalhousie Law Journal 1997;20:553 – 82. [4] National Health Insurance Law, State of Israel, 1994. [5] Shani S, Klang SH, Haran B, Shemer J. Updating the national list of reimbursed drugs in an era of limited resources. Pharmacy World Science 1999;21:A13. [6] Development of medical technology: opportunities for assessment, Office of Technology Assessment, Washington, DC, 1976. [7] Banta D. Introduction to the EUR-ASSESS report. International Journal of Technology Assessment in Health Care 1997;13:133–43. [8] Shemer J, Siebzehner MI. Health technology policy in Israel at a time of healthcare reform. In: Shemer J, Schersten T, editors. Technology Assessment in Healthcare — From Theory to Practice. Jerusalem: Gefen, 1995. [9] Fink A, Kosecoff J, Chassin M, Brook RH. Consensus methods: characteristics and guidelines for use. American Journal of Public Health 1984;74:979 – 83. [10] Drummond MF. Health technology policy and health services research. In: Drummond MF, Maynard A, editors. Purchasing and Providing Cost-Effective Healthcare. New York: Churchill Livingstone, 1993. [11] Perry S, Gardner E, Thamer M. The status of health technology assessment worldwide — results of an international survey. International Journal of Technology Assessment in Health Care 1997;13:81–98. [12] Ham C, Locock L. International approaches to priority setting in health care. Handbook Series 25. Health Services Management Center, University of Birmingham, 1998. [13] Kitzhaber JA. Priority setting in an era of limits: the Oregon experience. In: BMJ: Rationing in Action. London: BMJ Publishing Group, 1993. [14] Tengs T. An evaluation of Oregon’s Medicaid rationing algorithms. Health Economics 1996;5:171 – 81. [15] Jones L. The Core Services Committee. The core debater 3. Wellington, New Zealand, 1994. [16] Swedish Parliamentary Priorities Commission, Priorities in Health Care: Ethics, economy, implementation, Ministry of Health and Social Affairs, Stockholm, 1995. [17] National Institute of Clinical Excellence, http://www.nice.org.uk/appraisals [18] Donovan J, Coast J. Public participation in priority setting: commitment or illusion. In: Coast J, Donnovan J, Frankel S, editors. Priority Setting: The Healthcare Debate. Chichester: Wiley, 1996. [19] Sackett DL, Richardson WS, Rosenberg W, Haynes BR. Evidence-Based Medicine: How to Practice and Teach EBM. New York: Churchill-Livingstone, 1997. [20] Chinitz D, Shalev C, Galai N, Israeli A. Israel basket of health services: the importance of being explicitly implicit. British Medical Journal 1998;317:1005– 7.
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Setting priorities for the adoption of health technologies on a national level — the Israeli experience Segev Shani a, Miriam Ines Siebzehner a, Osnat Luxenburg a, Joshua Shemer a,b,* a Israeli Center for Technology Assessment in Health Care, The Gertner Institute for Epidemiology and Health Policy Research, Tel Hashomer, Israel b Sackler School of Medicine, Tel A6i6 Uni6ersity, Tel A6i6, Israel
Received 11 January 2000; accepted 9 July 2000
Abstract The rapid development of new and expensive health technologies together with the limited resources available for the health care system, makes priority setting or rationing inevitable. The Israeli Health Insurance Law, enacted in 1995, determined a basic list of health services to be provided to all residents by public funding. Although the Israeli health care system has reached a high standard of medical care as expressed by parameters such as long life expectancy and low infant mortality, the social and professional demand for new and expensive health technologies is increasing. Towards the fiscal year of 1999, the Medical Technologies Administration of the Ministry of Health recommended a list of new technologies to be added to the list of health services. The Ministry of Finance allocated that year US$ 35 million for this purpose, while a rough assessment found that there are new important technologies to be added at a cost of more than US$ 350 million. The Medical Technologies Administration took a systematic approach of health technology assessment — ad-hoc teams were established for evaluating clinical safety, efficacy and effectiveness, conducting needs assessment and cost-effectiveness descriptions. Assessment of the data was based on evidence-based medicine. A set of criteria was determined in order to enable the prioritizing of the assessed new technologies. This procedure led to a list of technologies
* Corresponding author. Present address: Israeli Centre for Technology Assessment in Health Care, The Gertner Institute for Epidemiology and Health Policy Research, Tel Hashomer, 5261, Israel. Tel.: + 972-3-5303278; fax: + 972-3-6354136. E-mail address: [email protected] (J. Shemer). 0168-8510/00/$ - see front matter © 2000 Elsevier Science Ireland Ltd. All rights reserved. PII: S 0 1 6 8 - 8 5 1 0 ( 0 0 ) 0 0 1 0 9 - 3
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suggested for inclusion. The Minister of Health appointed a public committee whose purpose was to decide the technologies to be added to the list of health services. The committee, made up of representatives from the government, the sick-funds and the public, had to evaluate each technology, based on the analysis submitted to the committee, taking into consideration clinical, economic, social, ethical and legal aspects according to predefined criteria. The thorough work of the Medical Technologies Administration enabled the committee to adopt its recommended list with minor changes within a limited timeframe. In conclusion, we propose a practical and pragmatic model for the inclusion of new health technologies at a national level, based on health technology assessment and explicit priority setting. © 2000 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Health technology assessment; Health care decision-making; Priority setting; Rationing
1. Introduction In general, the health of Israelis compares favorably with that of residents of other developed countries. In 1996, the average infant mortality was 6.3 for every 1000 live births, similar to the average for countries whose GNP per capita is high. Life expectancy at birth is 75.9 years for men — ranking third among all high-income countries, and 80.1 years for women — somewhat lower than the average for high-income countries [1]. Israel’s healthcare system is considered to be one of the leading healthcare systems among western-world countries, as can be concluded from the broad spectrum of sophisticated health technologies publicly funded, including organ transplants, in-vitro fertilization, high-tech imaging techniques, and the latest developed pharmaceuticals. Although the Israeli healthcare system has reached a high standard of medical care as expressed by the parameters mentioned above, the social and professional demand for new and expensive technologies to be provided by the government is increasing continuously. Simultaneously, the inherent scarcity of resources for health services is increasing in Israel, like in other western countries, on account of the aging population and the rapid development of new and expensive health technologies. In 1985, the Israeli national health expenditure was 5.6% of GNP while in 1998, it reached 8.4% [2]. The impressive increase in the availability of health technologies (drugs, devices, medical and surgical procedures) presents society in general and the healthcare community in particular, with some difficult dilemmas concerning the need and ability to implement these technologies. In 1995, as part of a major reform in the Israeli healthcare system, the National Health Insurance Law was enacted, thus making health insurance both compulsory and universal [3]. The law determined a basic list of health services to which all residents are entitled, and states that the government is responsible for funding those health services. Moreover, the law specifies that all health services included in the list of health services will be of reasonable quality within the framework of the funding sources available [4]. The National List of Health Services was defined as the 1994 formulary of Israel’s largest Sick-Fund. This list included drugs, devices, techniques and procedures used by health care professionals to deliver medical care
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to individuals. The annual cost (in 1999) of providing all services included in the National List of Health Services (NLHS) for the entire Israeli population (about 6 million people) was about US$ 4 billion. All services included in this list must be available for every single patient through every single Sick-Fund. According to paragraph 8 of the National Health Insurance Law, ‘‘The Minister of Health may, by order, make changes in the List of Health Services, provided that he shall make no change that derogates from the basket or that increases its cost.’’ Furthermore, ‘‘No service shall be added to the basket of health services at no cost or for a payment lower than its cost unless a source of funding, or a source that has become available due to cancellation of a service or increased efficiency, is found therefor’’ [4]. Since all Sick-Funds are in deficit, one cannot expect the addition of new services due to increased efficiency. Hence, the NLHS can be updated only by additional allocation of funds from the Ministry of Finance. The Ministry of Health estimated that the cost of providing health services should be increased by a health technology factor of 2 – 4% each year due to the aging population and the emergence of new health technologies. Despite this fact, for three consecutive years, between January 1995 and December 1997, the NLHS was not updated, since no financial resources were allocated by the Ministry of Finance for this purpose. The only exception was the inclusion of beta-interferon for the treatment of Multiple Sclerosis in the NLHS in 1996, following Legal Proceedings. The Pharmaceutical Administration at the Ministry of Health identified the emerging problem of deciding which new drugs should be added to the NLHS and set up a screening mechanism. Every six months, all new registered drugs in that time period were screened for breakthrough products. Breakthrough products were defined as drugs with significant clinical efficacy compared with current therapies for the same disease state, or drugs which were indicated for the treatment of diseases for which no drug therapy was available at that time. That procedure led to a list of drugs considered for inclusion in the NLHS, ranked according to their cost and clinical importance [5]. In December 1997, after a considerable public outcry, the Ministry of Finance allocated US$ 35 million for updating the NLHS, although according to the health technology factor, the estimated annual cost for updating the NLHS should have been US$ 80 – 160 million. The existence of the proposed list helped the Ministry of Health to decide which new drugs will be added to the NLHS. However, the experience learnt in this first update was that updating the NLHS is a very complicated issue, that should address other health technologies apart from drugs, and should be carried out on a formal periodical basis. The Medical Technologies Administration at the Israeli Ministry of Health, which was established in 1998, was appointed to be responsible for updating and managing the NLHS. Towards the fiscal year of 1999, The Medical Technologies Administration was requested to assess a list of new technologies to be included in the NLHS estimated at a cost of more than US$ 350 million. The Ministry of Finance allocated only US$ 35 million for the update of the NLHS in 1999, an amount that is ten times smaller than the estimated amount needed.
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Hence, the objective of the Medical Technologies Administration was to develop and implement a mechanism for updating the NLHS, based on priority setting for the inclusion of new medical technologies in the NLHS according to their assessment.
2. Health Technology Assessment The astounding advances in health technologies have been a cardinal cause of the increase in national health expenditures. As new technologies are developed and replace old ones, a mechanism is needed, which can prevent the use of those of unproven effectiveness, and regulate the use of others, which although proven effective and safe, are extremely expensive. Only in this manner will it be possible to contain costs while sustaining high standards of treatment. The Office of Technology Assessment defined Health Technology Assessment as a form of research, analysis and evaluation that attempts to examine the various impacts of a particular technology on the individual and society for its safety, efficacy, effectiveness and cost-effectiveness, and its social, economic and ethical implications both in absolute and comparative terms, and to identify those areas requiring further research and evaluation [6]. In the EUR-ASSESS report, Health Technology Assessment is defined as the analysis of the implications of a health technology that is intended to influence decision making and existing policies. Health Technology Assessment should help demonstrate problems and potentials and the way to handle them, by a systematic interdisciplinary process based on scientific evidence and other types of information [7]. For these purposes, the Medical Technologies Administration took a systematic approach of Health Technology Assessment, based on the model suggested by Shemer and Siebzehner [8]. According to this model, Health Technology Assessment is a multidisciplinary approach based on a comprehensive process, which includes the evaluation of evidence-based clinical, epidemiological and economic aspects. Optimal utilization of financial resources allocated to health care can be achieved by combining the scientific aspects mentioned above with social, political, ethical and legal considerations. Furthermore, Health Technology Assessment helps decision-makers set up priorities in an era of limited resources.
3. The proposed mechanism to updating the NLHS The different stages of the proposed mechanism for the 1999 update of the NLHS are shown in Table 1. Briefly, the whole process can be described as follows. Ad-hoc teams were established for evaluating clinical safety, efficacy and effectiveness, conducting needs assessment and cost-effectiveness descriptions. A set of criteria was determined in order to enable the prioritizing of the assessed new technologies. The Minister of Health appointed a public committee made up of representatives from the government, the sick-funds and the public. The committee
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Table 1 The process of the 1999 NLHS update 1 2 3 4 5 6 7
Call for proposals Quick assessment and screening Data collection and initial evaluation Comprehensive evaluation Priority setting Decision-making Government approval and legislation
had to evaluate each technology, based on the analysis performed by the Medical Technologies Administration, and decide which technologies will be added to the List of Health Services. The rest of this section will describe thoroughly the different stages of the update process.
3.1. Call for proposals In March 1998, a letter was sent to all Sick-Funds directors, hospital directors, chairpersons of the National Councils, the Israeli medical Association and Health Ministry units asking them to suggest to the Medical Technologies Administration new technologies to be included in the NLHS. The letter also specified which data should be included in the application for the proposed technologies (as shown in Table 2). The first announcement was followed in May by a second one, citing August 1 as the deadline for submitting proposals. External applications from patient interest groups, politicians and pharmaceutical companies, who became aware of the call for proposals, were accepted as well. In parallel, in-house screening of the National Drug Registry was conducted in search of breakthrough drugs. These measures have led to the creation of a list, containing about 100 health technologies, proposed for inclusion in the 1999 update of the NLHS.
Table 2 Data requested in the call for proposals 1 2 3 4 5
Technical description of the technology (name, manufacturer, indications, way of administration, dosage, etc.) Evidence for the safety, efficacy and effectiveness of the technology Existing treatment alternatives and the added value of the suggested technology compared with these alternatives Number of patients suffering from the disease-state and the estimated number of patients who will be treated with the suggested technology The cost of treating the patients with existing treatment alternatives versus the cost of treating them with the suggested technology
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3.2. Quick assessment and screening Since the list of candidates contained about 100 medical technologies, and a comprehensive evaluation could not be conducted for all the technologies, due to the limited number of available personnel and time constraints, a quick assessment and screening was performed firstly by the Medical Technology Administration, in cooperation with the Israeli Center for Technology Assessment in Health Care. In the assessment, different criteria were used for drugs and for other technologies. In Israel, drugs intended for marketing must go through a rigorous registration process. In order to get marketing approval, the drug should prove its safety, efficacy and quality. Hence, only drugs registered in Israel were recognized as eligible candidates for the NLHS update. On the other hand, as in any other developed country, medical procedures are not controlled by any defined regulatory mechanism, and therefore, they should be dealt otherwise. The proposed technologies (excluding drugs) were divided into four groups, following a quick assessment according to the data submitted in the proposals, 1. new technologies, which did not previously exist; 2. existing technologies for new indications; 3. new technologies requiring large investments in infrastructure or disposable equipment; 4. technologies that improve professional standards without causing a major change in the quality of the treatment. Within the framework of the allocated budget, it was decided that only the first two categories would be considered for the 1999 update. After this screening process, the list was narrowed to 84 proposed technologies, 69 of which were drugs.
3.3. Data collection and initial e6aluation Ad-hoc multidisciplinary teams were appointed to complete and correct the submitted data, and subsequently, to evaluate the proposed technologies. Assessment of the data was based on evidence-based medicine. The issues dealt by the teams were assessing clinical safety, efficacy, and effectiveness, conducting economic evaluation and assessing the populations’ needs. The sources of data used for performing the evaluation were local and international literature, the Health Ministry’s databases, experts’ opinions and the original proposals. Costs were obtained from the Health Ministry’s databases, the manufacturer of the relevant technology, hospitals and the sick-funds. The clinical, epidemiological and economic evaluations were performed simultaneously, although the clinical evaluation was of the most importance. Especially in the case of medical procedures, the clinical evaluation was conducted in order to make sure that the proposed technology is safe and efficient. For some procedures, it was found that the procedure is still experimental, clinical trials are still being conducted, there is no sufficient evidence in the international literature or the local setting for its use, or that there is no sufficient expertise in performing this procedure in Israel.
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The major role of the clinical evaluation was to assess the clinical importance of the suggested technology in comparison to existing treatments for the indicated disease-state. The evaluation was based on the most updated available data, focussing on evidence-based data including post-marketing effectiveness data. Furthermore, commonly used treatment regimens, frequent and significant adverse events and alternative treatments were identified. Special attention was given to the issue of identifying specific patient groups that will benefit mostly from the use of the technology, in case treatment of all the indicated patient population would not be possible. The epidemiological evaluation included a description of the disease-state needed to be treated including its incidence and prevalence, mortality and morbidity data from abroad and from Israel, where available. The number of patients to be treated was estimated based on data from practicing physicians, pharmaceutical companies, sick-funds and epidemiological databases, when available. Another important parameter, which usually was unattainable, was the current use of the technology in Israel before its inclusion in the NLHS. The economic evaluation taken, was a cost-effectiveness description, which was performed in order to calculate the overall cost of including the technology in the NLHS. The overall cost was calculated by multiplying the cost of an annual patient treatment with the technology, by the number of patients estimated to use it each year. The cost of an annual patient treatment was based on the cost of the common treatment regimen of the proposed technology, minus the cost of an annual treatment with the currently available treatment in the NLHS for the same indication. Since the addition of a new technology to the NLHS is permanent (unless it will be excluded in the future), the number of patients who will use the technology was estimated as the number of maximal potential users after the technology was disseminated completely and accepted in the healthcare system. However, for a small number of technologies, cost-benefit analysis/cost-effectiveness analysis were conducted. Moreover, in cases where the economic benefit from using the new technology was obvious and immediate (during the first year of its use), the amount that could be saved was deducted from the annual treatment cost of the technology.
3.4. Comprehensi6e e6aluation The completed evaluations performed by the ad-hoc teams were passed to the Medical Technology Forum for a comprehensive evaluation. The Medical Technology Forum was chaired by the Director of the Medical Technology Administration and was made up of the medical management of the Ministry of Health, senior officials in the Medical Technology Administration, and senior researchers from the Israeli Center for Technology Assessment in Health Care. The comprehensive evaluation aggregated all data from the different evaluations and came out with a complete technology evaluation ready for the priority setting. Key issues in the comprehensive evaluation were,
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1. scope of the problem — assessed by the use of indices for prevalence and incidence of the disease-state; 2. the disease’s burden on the health system in terms of mortality, morbidity, use of health services and/or functional disability; 3. the existing alternatives to treat the disease, including prevention, diagnosis, treatment and rehabilitation; 4. the cost of the disease according to the resources allocated to deal with it and the costs of alternative treatments; 5. clinical and economic characteristics of the new treatment. First of all, an initial filtering process was taken in order to identify all beneficial technologies. The few technologies that have been found to lack sufficient data in order to prove efficacy or safety received a ‘no-go’ recommendation from the Forum. After the forum considered the issues mentioned above, a three-page summary of the data for each technology was compiled. The summary consisted of three parts, 1. clinical — detailing commonly used treatment regimens, mechanism of action, common and serious side effects, comparison to alternative treatments and place in therapy; 2. epidemiological — incidence and prevalence of the disease, the estimated target population (number of patients expected to be treated); 3. economic — evaluation of the annual cost of treating the patient with existing therapies and immediate savings from the use of the suggested technology. Each summary was concluded by a recommendation on the appropriate indication and the specific patient population for the technology, in case it differed from the original proposal (limitations of use), and its annual price tag. 3.5. Priority setting This procedure led to a recommended list of technologies, which had to be prioritized by the Medical Technology Forum. Each technology presented was placed in three major groups, with all technologies being graded on a scale from 1 to 10, group A — high priority technologies (graded 8–10); group B — intermediate priority technologies (graded 4–7); group C — low priority technologies (graded 1–3). Two other groups were added; ‘no-go’ technologies, for which safety and efficacy were not proven, and hence were recommended by the Forum to be excluded from the list of candidates. The other group consisted of technologies identified as bearing no additional cost compared with existing technologies in the NLHS (at times even as saving money), and the Forum recommended on their inclusion, no matter what their priority was determined to be. The reasons for this recommendation were, 1. to enlarge the treatment possibilities for the practicing physician; and 2. to increase competition between the manufacturers of these technologies and, thus, causing reductions in their prices which will, eventually, decrease the national health expenditure.
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Table 3 Guiding criteria for the prioritization of the suggested technologies Life saving technology with full recovery The potential of the technology to prevent mortality/morbidity The number of patients to benefit from the use of technology The financial burden on society and the individual patient New technology for mild diseases, for which no treatment alternative exists New technology for serious diseases, for which no treatment alternative exists Technology which brings to an increase in longevity as well as quality of life Benefit of reducing morbidity versus the benefit of improving quality of life Technology of which the net gain to the health care system or to society is higher than its cost in a short/long term perspective Mutual assistance for publicly funding a very expensive technology (of proven efficacy) to the individual, yet of reasonable cost of society
Priorities were determined according to established guiding criteria (as shown in Table 3), which include the effect of the suggested technologies on mortality, morbidity, longevity and quality of life, existence of alternative treatments, the number of possible patients to benefit from the technology, the cost of the technology and its affordability both by society and by the individual patient. No scoring method was used for the criteria mentioned above. Each Forum member was aware of the criteria for setting priorities, read the final evaluation for each technology and decided on the recommended priority. The priority of the technology was agreed by all members and was not calculated as the average of the grades given by the members. The Forum acted as a consensus committee (Delphi model) — all decisions were made unanimously [9]. The entire process led to a final list of recommended technologies for inclusion in the NLHS, ranked according to priorities. The list containing summaries of the evaluation conducted for each technology, its ranking and the justifications for it were published as a position paper in a formal book that was presented to the Ministry of Health’s senior management and to the National Advisory Committee members.
3.6. Decision-making The Minister of Health appointed a public National Advisory Committee as a decision-making body for the 1999 update of the NLHS. The public committee included senior officials at the Ministry of Health, officials from the Ministry of Finance, Sick-Fund directors and public representatives (most of whom had no medical background). The committee numbered 14 members, of which more than a third were public representatives. The Director-General of the Ministry of Health was appointed as the committee’s chairman. The choice of the committee members was designed purposely to make sure that decisions would be based on national considerations and not on individual organization’s preferences, and that the public/patients’ perspective will be heard, as well as the perspective of healthcare professionals.
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The first meeting of the committee was held in the presence of the Minister of Health, and the committee members received a full explanation as to the professional work performed by the Medical Technology Administration and the committee’s role. The recommendations of the Medical Technology Forum were presented to the committee members. At the committees’ meetings, each technology was presented by the Forum’s chairman, and was followed by a discussion. About 70% of the Forum’s recommendations were accepted, and the committee focused on the remaining 30%, taking into account the criteria for priority setting (Table 3). The committee held several discussions, and concluded its work by recommending by consensus, which technologies should be added to the NLHS in the 1999 update and for which indications, according to the budget allocated by the Ministry of Finance for the fiscal year of 1999. Each technology was added to the NHLS with limitations on its use, which varied from giving only specialist physicians the authority to prescribe the drug to a set of clinical guidelines according to which treatment should be given. The reason for these limitations was to ensure the rational and cost-effective use of these technologies.
3.7. Go6ernment appro6al and legislation The National Advisory Committee gave the Minister of Health a recommended list of 44 drugs and six other technologies for inclusion in the NLHS. Details of the complete process are given for the involved authorities and their function in Fig. 1, and for the classification of the suggested technologies in Fig. 2. The Minister of
Fig. 1. The involved authorities and their function in the 1999 NLHS update, according to the Health Technology Assessment model [8].
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Fig. 2. Classification of the suggested technologies throughout the process.
Health adopted the committee’s recommendations and presented it for the government’s approval. The government’s approval was a binding legislation, announced in public. In March 1999, the NLHS was updated formally, by the addition of 44 drugs and six other technologies at an annual cost of US$ 35 million (general description of these technologies can be found in Table 4).
4. International perspective Drummond has stated that the ultimate goal of health technology assessment is to improve resource allocation, and hence it was pointless if decision-makers would not know how to use the data. Therefore, the two major challenges to developing a policy based on health technology assessment are; (a) costs and benefits data need to be produced in a timely fashion; (b) secondly, technology assessment cannot be isolated from the general healthcare policy and the decision-makers [10].
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A review of attempts to establish priorities in health services in international publications in different countries reveals a consensus that decisions concerning the allocation of resources should be made by a systematic and controlled process. Most models used by different bodies throughout the world for decision-making concerning public health, are still in the initial, even experimental phase. Decisionmaking models in the public sector must be detailed and allow total transparency and be able to withstand scientific and public criticism [11]. In the Netherlands, the 1997 Dunning Commission recommended steps such as technology assessment, cost benefit analysis, and public debates that would permit the establishment of priorities [12]. The most known example of priority setting is the ‘Oregon experiment’ in which an explicit system of limiting the number of medical treatments was established [13]. The basic criteria for prioritization were clinical effectiveness and cost-effectiveness, and the proposed list of treatments was suggested to the public for prioritization. The priorities set by the public led to a list in which treatment for thumb sucking and acute headaches received higher ranking than treatment for AIDS and cystic fibrosis [14]. Hence, the suggested list was modified several times and the priority criteria were abandoned almost totally. In New Zealand, as part of the 1992 healthcare reform, a list of core health services to be funded publicly was established. Four fundamental principles were used for defining those core health services — benefit, value for money, fair use of public money (accessibility and equity) and communities’ values [15]. The Swedish Parliamentary Priorities Commission defined three criteria for priority setting; (A) human dignity which implies that all human beings are equally valuable, (B) need and solidarity which implies that resources should be concentrated where needs are greatest and that special attention should be given to the needs of the weakest, (C) cost-efficiency which implies that one should aim for the reasonable relation between cost and effect, measured in terms of improved quality of life [16]. In the United Kingdom, the National Institute of Clinical Excellence (NICE) was established to appraise the clinical benefits and the costs of healthcare interventions, and to reach a judgement on whether on balance, these interventions can be recommended as a cost-effective use of the available resources. In reaching this judgement, NICE should consider the degree of clinical need of the patients, the broad balance of benefits and costs, and the effective use of available resources [17].
5. The Israeli perspective Israel, like every other western-world country has to deal with the adoption of new health technologies in an era of limited resources. The model presented in this article depicts a process of explicit priority setting based on health technology assessment including clinical and economic evaluations, and involves social, legal, ethical and political considerations. The importance of priority setting is that both health professionals and the public will accept it. In this paragraph, we will address
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Table 4 The 1999 update of the National Health Services list of reimbursed services Technology name Drugs Abacavir, Combivir™, Didanosine, Zalcitabine Alfuzosine, Doxazosin Mesylate, Terazosin HCl
Altretamine
Anagrelide Anastrozole, Formestane, Letrozole Atorvastatin, Cerivastatin, Fluvastatin, Lovastatin, Pravastatin
Bicalutamide Dexrazoxane Diacerein Dornase alfa
Dorzolamide HCl Epoprostenol sodium
Eptacog alfa
Flutamide
Gabapentin, lamotrigine, topiramate
Glipizide
Goserelin acetate Insulin Lispro
Mycophenolate mofetil
Indication
Antiretroviral combination therapy for Human Immunodeficiency Virus (HIV) infected adults and children. Treatment of benign prostatic hypertrophy Palliative treatment of ovarian cancer following first-time therapy with a cisplatin and/or alkylating agent based combination Treatment of patients with Essential Thrombocythemia Treatment of advanced breast cancer Reduction of elevated total cholesterol and LDL-cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia or combined hyperlipidaemia Treatment of advanced prostate cancer Prevention of cardiotoxicity in women with breast cancer receiving doxorubicin Symptomatic treatment of osteoarthritis Management of cystic fibrosis, not for patients under 5 years of age or with FVCB40% Treatment of elevated intraocular pressure Treatment of primary pulmonary hypertension in NYHA Class III and Class IV patients Serious bleeding events and surgery in patients with inhibitors to coagulation factors (FVIII or FIX) Indicated for use in combination with LHRH agonistic analogues for the treatment of metastatic prostatic carcinoma (stage d2) As adjunctive therapy in the treatment of partial seizures with or without secondary generalization in adults with epilepsy Adjunct to diet for the control of hyperglycemia in patients with non-insulin dependent diabetes mellitus (type II) Prostate cancer suitable for hormonal manipulation Treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis Prophylaxis of rejection reactions in renal allograft recipients. Should be used concomitantly with cyclosporin and corticosteroids
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Table 4 (Continued) Technology name
Indication
Pamidronate disodium
Treatment of bone metastases and multiple myeloma, and tumor induced hypercalcemia Treatment of symptoms and prevention of relapse of obsessive-compulsive disorder (OCD), and panic disorder with or without agoraphobia Adjunct to Levodopa/Carbidopa in management of Parkinson’s disease in patients with on-off phenomena Indicated in combination with interferon alpha-2b for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalization of ALT at the end of treatment) to interferon alpha therapy but who have subsequently relapsed Treatment of patients with amylotrophic lateral sclerosis (ALS) First line therapy for schizophrenia in children up to the age of 18 years (already included as second line therapy for schizophrenia) Treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-Hodgkin’s lymphoma Treatment of idiopathic Parkinson’s disease Treatment of metastatic islet cell carcinoma of the pancreas Prevention of graft rejection following transplantation of liver or kidney. Treatment of liver or kidney allograft rejection in patients previously having received other immunosuppressive agents Treatment of metastatic carcinoma of the ovary after failure of initial or subsequent therapy Treatment of non-small cell lung cancer, and advanced breast cancer
Paroxetine
Pergolide mesylate
Ribavirn
Riluzole Risperidone
Rituximab
Ropinirole Streptozocin Tacrolimus
Topotecan
Vinorelbine Technologies Cochlear implants Child development services Spinal cord stimulation Laparoscopic gastroscopy for morbid obesity Left ventricular assist device (LVAD) Dental treatments for oncology patients
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two key issues in this process — transparency and the involvement of the public, and the crucial importance of evidence-based medicine in the evaluation process.
5.1. Transparency and the in6ol6ement of the public It is accepted widely that the public should participate in the priority-setting process. The question is how to make the public a participant and if it is possible at all [18]. From the day the National Health Insurance Law was implemented (in 1995), until 1997 the NLHS became an important public issue, and the first update in 1997 was due to a major public outcry through the mass media. Lobbying new technologies has become a trend; either pharmaceutical companies or patient interest groups ask politicians for their support or use the media to publicize the technology and their cause. Numerous discussions have been held in different committees of the Israeli parliament on new technologies. The Minister of Health announced the establishment of the National Advisory Committee including the names of all members. One-fourth (25%) of the committee’s members were public representatives with no medical background. All lobbying efforts aimed at the Minister of Health were rejected for the reason that only the public committee is responsible for updating the NLHS. The committee with its public representatives represented a neutral body with national consideration and no prejudice. Hence, politicians, the public and the media accepted the sovereignty of the committee.
5.2. The importance of e6idence-based medicine in the process According to Sacket et al. [19], Evidence based medicine is ‘‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research’’. The term evidence-based medicine is mostly used theoretically — an insurer considering the adoption of a new medical technology should take into account its safety, efficacy, effectiveness and epidemiological data like morbidity, mortality, number of patients, etc. Practically however, there is a need to assess the utilization of currently available treatment alternatives, the need for the suggested technology, and the number of patients who will be treated with the technology after it is added to the NLHS. One should also take into consideration the dissemination of the technology in the market, including those patients who, clinically, do not need the new technology, but will still be treated with it. Furthermore, even when the collected data concerning costs and outcomes is optimal, the available limited budget makes priority setting necessary. Hence, preparation of the technical report for each technology according to evidencebased data is crucial, yet it is not sufficient for priority setting since all the technologies were proven already to be based on clinical evidence and as such compete with each other on their priorities.
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6. Future developments Although the suggested process was accepted widely by the public in Israel, and is compatible with other prevailing models in developed countries, we believe that the process can be improved further. First of all, we would like the process to be more transparent to the public. Hence, the call for proposals should be publicized well in the media, so that every resident will be able to submit an application. Public participation in priority setting is important and we would like to encourage the public debate on the importance of emerging new technologies through the media, the parliament and specific discussion groups. The Medical Technologies Administration should improve its assessment process into a well-known rigorous mechanism that will enable a full economic evaluation for each new technology, considering its positioning among competing treatments. Frequent reassessment of previous decisions according to new clinical or economic data is important to have a dynamic and efficient process. As part of the reassessment, the basic list of health services determined in the law should be screened according to evidence-based data, and the exclusion of technologies included in the NLHS that did not meet the criteria should be considered.
7. Summary Setting priorities is a complex process; it involves making painful decisions, that should be accepted socially by both health professionals who have to implement them and the public affected by them. Updating the NLHS is an example of decision making in the process of determining, executing and assessing public policy, showing how to use health technology assessment in priority setting on a national level. According to our estimation, the rapid development of new health technologies requires an increase of the annual budget allocated for providing health services by a factor of 2 – 4%. In western-world countries with public funding for the healthcare system, the supply of health technologies is greater than the resources available to fund them, which makes priority setting inevitable. Health Technology Assessment is vital for optimizing the use of health technologies within the workframe of the available resources. The process of updating the NLHS can be described as a transparent public process, composed of an initial phase of data evaluation performed by professional teams, and continued by priority setting and decisionmaking by a public committee. The public committee included government policy makers and healthcare professionals together with public representatives. The balance between the different committee members enabled achieving decisions by consensus, with public acceptance. Unlike the 1997 update of the NLHS, which was described as being explicitly implicit [20], the 1999 update is an explicit process trying to blend healthcare professionals with lay participation. The process was accepted widely in Israel by government officials, healthcare professionals, politicians, and the courts.
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In comparison to the international perspective, the model described in this article incorporates health technology assessment as the ultimate tool for setting priorities. Collectively, the criteria used in our model for prioritization are similar to those suggested elsewhere, and public participation was also part of the decision-making process. Hence, the model suggested in this article offers a unique solution based on the local characteristics of the Israeli healthcare system.
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