Access To New Drugs After The Introduction Of The 2011 Reimbursement Act In Poland

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pharmaceutical companies may decide to withdraw their innovative drugs from the market. All withdrawals from the German market since 2011 were analysed with regards to the additional benefit granted by G-BA and recommendation status in clinical guidelines.  Methods: Withdrawals from the German pharmaceutical market that completed a benefit assessment between January 2011 and June 2016 were identified and categorised into opt-out decisions (prior to completion of first price negotiation) and supply termination (during or after further price negotiations). Respective medicines were reviewed with regards to recommendation status in clinical guidelines and G-BA’s benefit decision.  Results: Of 139 medications, 10 opt-outs and 12 supply terminations were identified. Twenty-one (95%) thereof received a ‘no benefit’ rating. Of the 12 terminations, 9 (75%) underwent the arbitration procedure. Most frequently (9 of 22), withdrawals concerned metabolic disorders. At the time of the benefit assessment, 19% of the withdrawn medicines were recommended specifically and 62% by therapeutic class in ≥ 1 relevant therapeutic guideline per indication.  Conclusions: A ‘no benefit rating’ suggests that, based on available data, the new medicine does not provide additional benefit to patients. Yet, some of those medications are recommended in clinical guidelines. Our analysis indicates that new medicines with a ‘no benefit’ rating might still provide additional value to patients and health care systems which are not captured within the early benefit assessment. PHP157 General Practitioners Awareness On Medicines Cost And Financing In Bosnia And Herzegovina Catic T1, Martinovic I2, Avdagic L3 Economics and Outcomes Research, Sarajevo, Bosnia, 2Bosnalijek JSC, Sarajevo, Bosnia and Herzegovina, 3Faculty of Economics, Sarajevo, Bosnia and Herzegovina

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Objectives: Public pharmaceutical spending in Bosnia and Herzegovina (BH) is constantly growing. Health Insurance Funds (HIF) are financing drugs prescribed in primary health care settings through reimbursement lists under the price that is set by governments. Reimbursed drugs are prescribed by general practitioners (GP) and often they are marked as “gate keepers” for rational drug utilization and drug budget control. Since there is no formal education in health economics and pharmacoeconomics in BH we have studied GPs awareness on cost of medicines and knowledge on reimbursement and pharmacoeconomics approaches in BH.  Methods: We have developed and conducted survey consisted of sixteen questions/statements related to prices and cost of medicines, reimbursement system and pharmacoeconomics knowledge. Five-level Liker scale was used to measure respondents level of agreement/disagreement. Survey was distributed to 450 GPs in four major cities in BH. Descriptive statistics was used to evaluate responses.  Results: Response rate was 99,0%. Majority of respondents were females (73,3%) and 47,3% are 30-40 years old. Majority of respondents are aware that generic drugs have lower prices and 56,5% discuss prices with patients prior to prescription. Even significant number of GPs agree that majority of patients need could be satisfied by drugs included into reimbursement lists, 39,1% disagree. Drugs wit price lower that 1,5EUR should not be reimbursed, and copayment should not exceed 2,5 EUR. GPs consider that members of Reimbursement board are not enough qualified. Even do majority of respondents show understanding of pharmacoeconomics concepts, 71,3% claim need for additional education in this field.  Conclusions: Our study showed that GPs are regularly follow up reimbursement list updates being aware on drug prices. In order to improve rational drug prescribing they are interested in additional education in pharmacoeconomcis. PHP158 Access To New Drugs After The Introduction Of The 2011 Reimbursement Act In Poland Zaremba A, Iwanczuk T, Tatara T, Misiak J, Krakowian P, Wysoczanski W Agency for Health Technology Assessment and Tariff System in Poland (AOTMiT), Warsaw, Poland

Objectives: The new reimbursement law that came into force in Poland in 2012 listed amongst its goals better access to new, more effective treatments for Polish patients. The purpose of this study is to analyze the dynamics of including new drugs into the reimbursement lists (that are published every 2 months) since the introduction of the new law and to evaluate the impact of the Reimbursement Act on access to new drugs.  Methods: All reimbursement lists (25) published since the introduction of the new reimbursement law and enumerating newly enlisted drugs were analyzed and active substances appearing on the list for the first time were extracted. Products containing the same active substance were calculated as one new active substance available (also in case of introducing an innovative pharmaceutical form). Drugs combinations were calculated as a new active substance even if one of the active ingredients had already been previously available. Foodstuffs intended for particular nutritional purposes and medical devices were excluded. Graphs illustrating new active substances inclusion into the particular reimbursement lists were generated.  Results: Over the 4 and a half year of the new reimbursement law functioning over 250 new active substances have been introduced into public funding. There are no clear increasing or decreasing trends discernible. The number of new active substances introduced varies widely between lists. Relatively, the largest number of new active substances became available in 2014.  Conclusions: The new reimbursement law led to inclusion into reimbursement lists of a significant number of new active substances. It constitutes an apparent change in comparison to the past, when few active substances had been introduced over decades. The new active substances are usually dedicated though to narrow subpopulations of particularly needy patients. PHP159 Implementation Of The Insurance Programs For Catastrophic Diseases In China: A Qualitative Study MAO W, Chen W Fudan University, Shanghai, China

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Objectives: To summarize the implementation progresses, challenges and trends of the Insurance Programs for Catastrophic Diseases (IPCD) in China.  Methods: Policy document review and key informant interviews have been conducted in 8 Provinces.  Results: IPCD was promoted by the State Council to cover Urban Resident Basic Medical Insurance (URBMI) and New Rural Cooperative Medical Scheme (NCMS) enrollees but Urban Employee Basic Medical Insurance(UEBMI) enrollees are also covered in some cities. Financial contribution rate, benefits package and operation of IPCDs vary among different cities and have close associations with local Basic Medical Insurance schemes (BMI). IPCD serves as an extension of BMI in two perspectives: the premium of IPCD is directly transferred from BMI fund and IPCD provides further reimbursement on the copayment after the reimbursement by BMI with a certain deductible, copayment rate and ceiling of payment. At least one city’s IPCD covers medications not included by provincial BMI reimbursable list. The majority of IPCD are operated by commercial insurance companies (CIC) under guidance of local BMI agency. Net loss, reputation and market share are the key indicators for the competitive bidding among CIC. In the early establishment of IPCD, BMI agencies share the responsibility with CIC if IPCD underwent deficit since the change of health services utilization is not predictable after introduction of IPCD due to lack of baseline observation. The partnership with CIC brings additional human resources to supervise health services provision, which benefits not only IPCD but also BMI. However, BMI agencies’ concern on the security of BMI enrollees’ information become major barrier for sharing information with CIC.  Conclusions: IPCD relieves financial burden of patients by providing further reimbursement but its benefits package remains limited to BMI reimbursable list. CIC play an important role in supervising health services provision yet their specialties on actuarial services or risk control is under-developed. PHP160 Pharmaceutical Reimbursement Of Innovative Medicinal Products In Belgium Van Wilder P, Bormans V SMART&BI, Zaventem, Belgium

Objectives: The aim of this study was to investigate the reimbursement submissions of innovative medicines and analyze the consistency between the advice of the Commission for Reimbursement of Medicines (CRM) and the decision of the competent Minister.  Methods: Data for submissions in the period 2010-2014 were extracted from the MORSE -report from the National Institute for Health and Disability Insurance (NIHDI)1. Products claiming added therapeutic value (class 1) or orphan medicinal products (OMP) were considered as innovative. The CRM’s advice was grouped into 3 categories: ‘positive’ (P), ‘negative’ (N) or ‘no proposition’ (NP, if no valid CRM proposition was voted). The Minister’s decision on reimbursement was coded as ‘positive’ (P) or ‘negative’ (N). Statistical analyses were executed in SPSS Statistics 22. [1] http://www.riziv.fgov.be/SiteCollectionDocuments/rapportmorse-2014.pdf  Results: There were 72 class1 and 30 OMP – submissions: the median annual number was respectively 12 and 6.5. The percentages of CRM-advices being P, N or NP were respectively 29%, 42% and 29% for class1 and 57%, 27% and 17% for OMP (p <  0.05, chi-square =  6.88). There were 72 class1 and 32 OMP – decisions taken by the Minister. The percentage of decisions being P were 79% for class1 and 75% for OMP (NS, chi-square =  0.22). Agreement between the CRM’s proposition (P and N only) and the Minister’s decision was achieved in respectively 65% and 85% of class1 and OMP submissions. Disagreement occurred for 20 negative CRM propositions and 2 positive ones (p <  0.001, McNemar test).  Conclusions: Overall the CRM advised positively for reimbursing innovation in <  40% of submissions with OMPs being advised positively about twice as much than class1 products. The Minister reimburses innovative products in >  75% of cases; disagreement with the CRM reflects mainly the decidision to reimburse products which were negatively advised by the CRM. PHP161 Linear, Flat And Mixed Pricing Structures As Negotiation Quantities Of New Medicinal Products In Context Of Amnog In Germany: A Comparison At Market Launch And Post Price Negotiations Bot D, Campion M, Ecker T Ecker + Ecker GmbH, Hamburg, Germany

Objectives: Within the framework of AMNOG price negotiations between pharmaceutical manufacturers and SHI (National Association of Statutory Health Insurance Funds), a relevant quantity for both parties is the pricing structure of the reimbursed price after negotiations. While the SHI generally favors a linear pricing structure (price increases with dose), the choice of pricing structure by manufacturers between flat pricing (identical price for different doses), linear pricing or a combination of the two (“mixed pricing”) depends on different parameters such as indication, expected physicians’ prescription behavior or conditions of parallel trade issues due to the European reference pricing. The objective of this study is to assess if manufacturers could maintain their favored pricing structure for new pharmaceuticals at market launch in Germany after price negotiations.  Methods: Analysis is based on all price negotiations concluded until June 2016 in which manufacturers entered into either with a linear, a flat or a mixed pricing structure. Negotiations were excluded in this analysis if the respective drug was available only in one dose or if the drug has been withdrawn from the market before negotiation started. Afterwards, the selected negotiations were analyzed by comparing initial ex-factory prices of all packages for each drug at market launch and final prices after negotiations.  Results: 47 relevant negotiations were identified. Manufacturers could maintain their favored pricing model in 38 negotiations (linear pricing= 17, flat pricing= 18, mixed pricing= 3) while pricing structures switched in 9 negotiations (linear to flat pricing= 1, linear to mixed pricing= 1, flat to linear pricing= 6, flat to mixed pricing= 1).  Conclusions: In price