- Email: [email protected]
HEALTH PLAN COVERAGE FOR MEDICAL DEVICES AND THE USE OF ELECTRONIC MEDICAL RECORD SYSTEMS
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treatment of early invasive breast cancer. In committee meetings on 27 August 2014 and 26 August 2015 further information on the clinical effectiveness data was requested. In their last update on 06 November 2015 the committee decided that further work by NICE would be required before it could issue a recommendation to the NHS. Conclusions: Intrabeam is available for routine use in many countries. Intrabeam, replaces a course of at least 15 (up to 30) postoperative radiotherapy sessions. This could greatly reduce the health care resource burden and enhance the quality of life. Until NICE publishes its final guidance, decisions on whether or not to fund specific treatments are the responsibility of local National Health Service bodies. Incorporation of patients’ perspective with economic/social/ethical dimensions is essential in the evidence synthesis for multi-criteria decision process. PMD63 ASSESSMENT OF DIAGNOSTIC TOOLS USED TO IDENTIFY PATIENTS WITH CHRONIC NEUROPATHIC PAIN: A SYSTEMATIC REVIEW Lopez-Cabra C 1, Reyes J M 2, Prieto V A 2 del Rosario, Bogota, Colombia, 2Pfizer SAS, Bogota, Colombia .
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1Universidad
Objectives: To identify and assess the diagnostic accuracy of screening tools used to detect chronic neuropathic pain (NeP) in patients with chronic diseases compared with the reference standard of clinical judgment. Methods: We performed a systematic review of the literature to identify and evaluate the discriminant characteristics of screening questionnaires chronic NeP in patients with a comparative clinical assessment. The search was performed on MEDLINE, EMBASE, Cochrane library, and LILACS databases. Cohort studies, diagnostic tests accuracy studies, cross-sectional studies and randomized clinical trials (RCT) were included. Study selection and data extraction were accomplished by two independent researchers. A qualitative analysis was included comparing the sensitivity, specificity and receiver operator characteristics (ROC) across the various screening tools. Quantitative analyses were not conducted due to the high heterogeneity of the published studies. Results: We included 23 studies: 16 diagnostic, 5 cohort, 1 cross-sectional and 1 RCT. Seven questionnaires were identified: Douleur Neuropathique en 4 Questions (DN4), Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), ID-Pain, painDETECT, the self-report version of LANSS (S-LANSS), Standardized Evaluation of Pain (SteP) and the Neuropathic Pain Questionnaire (NPQ). The screening tools most frequently researched regarding validation and reliability across different languages were DN4 and LANSS. The DN4 reported higher sensitivity than LANSS; 61%-100% vs. 22% to 89%, respectively. Specificity was similar between the DN4 and LANSS; 73%-97% vs. 74%-100%, respectively. The ROC of DN4 was higher for the LANSS compared with DN4; 0.89 (standard deviation or SD 0.71 to 0.99) vs. 0.99 (0.73 to 0.96), respectively. Overall, the DN4 reported better diagnostic accuracy compared to the other six screening tools. Conclusions: A systematic review of the literature identified the DN4 as the most studied screening tool with robust discriminant characteristics to detect chronic NeP. PMD64 EFFICACY OF THE MICA ANTIBODY FOR TRANSPLANT PATIENTS Mo J National Evidence-based Healthcare Collaborating Agency, SEOUL, South Korea .
Objectives: MICA antibody identification is a test performed on transplant patients to check for the presence of donor-specific MICA for the purpose of predicting the incidence of organ rejection among transplant patients. The purpose of this assessment was to evaluate the effectiveness. Methods: The literature search was performed using 8domestic research databases and 3core databases. A total of 9papers that remained. Each of the stages from literature search to application of selection criteria and data extraction was independently by 2researcher. The SIGN was used for the quality assessment. Results: There were 5studies reporting on the medical results of kidney transplant patients. 2of the studies reported no significant differences in the graft survival rate and incidence of organ rejection(p= .67). However, 3studies reported a low graft survival rate and a significantly lower incidence of organ rejection in MICA(-)patients compared to the MICA (+)patients. There were 3studies reporting of heart transplant patients. 2studies reported an incidence of organ rejection of 23.1~62.5% and 1study reported a 5~10year graft survival rate of 94.7%(p= ns). There was one study reporting of lung transplant patients. The incidence of organ rejection was reported to be 42.0%(p= ns). Conclusions: MICA Identification lacked clinical effectiveness for the following reasons: i)there were no significant differences in the graft survival rate and incidence of organ rejection; ii)it is difficult to determine whether the different results for the graft survival rate and incidence of organ rejection reported; iii)the results cannot be generalized as it is probable that they will change in case of including all the patients fitting the description; iv)kidney transplantation is presently performed even if the results of the histocompatibility test of the donor and the patient do not conform to each other; v)heart and lung transplantations are performed based on anatomical compatibility without a histocompatibility test. PMD65 NURSE-LED CARE FOR PATIENTS WITH RHEUMATOID ARTHRITIS: A SYSTEMATIC REVIEW Lopatina E 1, Garner S 1, Marshall D A 2 of Calgary, Calgary, AB, Canada, 2and Director, Health Technology Assessment, Alberta Bone and Joint Health Institute, Calgary, AB, Canada .
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using the narrative analysis approach. Results: 17 publications met the inclusion criteria (8 randomized controlled trials, 1 case-controlled trial, 6 qualitative and 2 economic evaluation studies of moderate to high quality), which represented 10 studies. Disease activity was the most common measure of effectiveness with NLC being superior (n= 3) or equal (n= 3) to comparator. Acceptability was assessed in 6 studies; patients were more (n= 4) or equally (n= 1) satisfied with NLC compared to single-provider care and less satisfied compared to team care (n= 1). NLC was found to be safe (n= 2), with no difference in blood tests and disease activity. With regard to efficiency, mixed data on cost of NLC was reported with NLC being equivalent or less costly than traditional models (n= 3). Quantitative measures of accessibility and appropriateness were not found. Although in qualitative studies patients found NLC provided improved continuity of care (n= 3) and education and support (n= 4). Conclusions: NLC for RA patients is effective, acceptable, and safe. More information regarding accessibility, appropriateness and efficiency of this model, including its cost-effectiveness and the impact on patient flow, is needed.
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1University
Objectives: Nurse-led care (NLC) is an alternate model of care where nurses take on primary responsibilities for part of patients follow-up and/or management. We assessed the impact of NLC for RA patients on quality of care compared to traditional models of care according to multiple quality dimensions. Methods: We searched Ovid MEDLINE, EMBASE, and CINAHL from 1950 to January 2015. Studies were included if they met the following criteria: English language; original data from an original study; adult patients with RA, nurses took on primary responsibility for follow-up and/or management; reported data on one or more dimensions of quality as defined by the Alberta Health Quality Matrix (effectiveness, acceptability, efficiency, accessibility, appropriateness and safety). Data were synthesized
PMD66 HEARING RESTORATION, QUALITY OF LIFE, AND SAFETY OUTCOMES IN BONECONDUCTION DEVICES FOR PATIENTS WITH CONDUCTIVE OR MIXED HEARING LOSS OR SINGLE-SIDE DEAFNESS Battaglia S , Annoni E Medtronic International Trading Sàrl, Tolochenaz, Switzerland .
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Objectives: To provide a comprehensive literature review on the various boneconduction devices (BCDs) available, including bone-anchored hearing aids (BAHAs). Methods: A comprehensive search strategy was defined to perform a literature review of the data available to date on the different types of marketed BCDs for hearing rehabilitation in patients presenting with conductive hearing loss (CHL), mixed hearing loss (MHL), or single-side deafness (SSD). A search was conducted on December 22nd, 2015 on the PubMed, EMBASE and Google Scholar databases. Search criteria included patients presenting with CHL, MHL or SSD, and implanted with percutaneous (pBCI) or transcutaneous (tBCI) bone conduction implants. Non-systematic reviews, case reports and clinical studies on < 5 patients were excluded. The literature analysis specifically examined the type of implantation (pBCI vs. tBCI), the principle of operation (active device, i.e. direct drive to the skull bone vs. passive device, i.e. skin drive), or by indication. Results: 1,223 potentially relevant publications were identified; on full review, 95 studies met eligibility criteria. Hearing restoration, QoL and patient-reported outcomes measures have been increasingly documented for each technology in recent years. While the tBCIs seemed to be associated with a lower rate of skin complications than pBCIs, all the other parameters (clinical outcomes and QoL) seemed to be similarly distributed across all devices. The available data are still insufficient and the measurements’ sensitivities do not allow for a robust comparison between the different types of implants. Conclusions: The evidence base to support any differentiation between ‘passive’ and ‘active’ implants is insufficient, and direct comparison data is scarce. Future clinical studies and case reports should continue to investigate the clinical efficacy and safety outcomes related to the use of these devices, so as to provide physicians a more refined patient selection rationale and evidence-based practice pathways according to each device’s characteristics. PMD67 BEYOND BUDGET SILOS: BUDGET IMPACT ANALYSIS OF TRANSARTERIAL RADIOEMBOLIZATION WITH YTTRIUM-90 GLASS MICROSPHERES FOR HEPATOCELLULAR CARCINOMA FROM A HOSPITAL PERSPECTIVE Hubert M M 1, Karellis A 1, Sherman M 2, Gill S 3, Beecroft R 4, Sampalis J S 5 1JSS Medical Research, Saint-Laurent, QC, Canada, 2Toronto General Hospital, Toronto, ON, Canada, 3BC Cancer Agency, Vancouver, BC, Canada, 4Mount Sinai Hospital, Toronto, ON, Canada, 5JSS Medical Research Inc., St-Laurent, QC, Canada .
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Objectives: Budget silos can hinder reimbursement when a healthcare investment from one department incurs savings in another. For patients with hepatocellular carcinoma (HCC) at intermediate (BCLC-B stage) or advanced (BCLC-C) stages, transarterial radio-embolization (TARE) has the potential to improve survival, a favorable safety profile and successful outcomes in patients with portal vein thrombosis (PVT). Given its outpatient administration, low number of treatments and low toxicity relative to conventional transarterial chemoembolization (cTACE), TARE may be associated with overall decreased hospital resource use. A budget impact analysis (BIA) was undertaken from a Canadian hospital perspective. Methods: The epidemiological BIA included costs of drug and device acquisition and key cost drivers of administration (inpatient, outpatient or self-administered) and management of adverse events (AEs). In intermediate HCC, TARE with yttrium-90 glass microspheres was compared to TACE, an inpatient procedure, including cTACE and drug-eluting beads TACE (DEB-TACE). In advanced HCC, with or without PVT, TARE was compared to self-administered sorafenib. The Ontario Case Costing Initiative database, published literature and expert opinion were utilized. AE management was based on published rates for TARE, cTACE, DEB-TACE and sorafenib. Results: For a Canadian hospital managing 200 HCC patients annually, reimbursing TARE incurred savings of approximately $37,000, $55,000 and $75,000 in years 1, 2 and 3, respectively. In year 3, it includes incremental costs of $207,000 for device acquisition, savings of $281,000 for administration and savings of $1,000 in AE management. Sixty-six percent of HCC patients were deemed eligible, of which 8, 13 and 17 patients were anticipated to undergo TARE in years 1, 2 and 3, respectively. Conclusions: TARE is associated with cost savings and decreased hospital resource use, which enhance the ability of the hospital to manage scarce resources. Decisions made from one department’s perspective alone may therefore underestimate the true value for the hospital. PMD68 HEALTH PLAN COVERAGE FOR MEDICAL DEVICES AND THE USE OF ELECTRONIC MEDICAL RECORD SYSTEMS Brook R A 1, Sax M J 2, Carlisle J A 3, Smeeding J E 4 1The JeSTARx Group, Newfoundland, NJ, USA, 2The TPG-NPRT, Glastonbury, CT, USA, 3The Pharmacy Group, Glastonbury, CT, USA, 4The JeSTARx Group, Dallas, TX, USA .
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Objectives: Medical devices are used to treat different conditions, are reviewed by the FDA, and potentially paid for by insurers/payors. For some payors medical devices payments are mandated through specific benefit. To manage their plans/ practices, many organizations use Electronic Medical Record systems [EMRs]. To understand the review and coverage of medical devices; and the adoption/funding of EMRs. Methods: Managed care (MC) medical+pharmacy directors [MDs+PDs] completed an online-interactive survey of: advisor+plan information; medical device coverage/reviews; and EMR adoption/use. Results: Respondents were mostly MDs (54.6%) and worked for health plans (83.6%). The plans were local= 39.6%, National= 35.4%, and regional= 25.0%; Plans could cover multiple member-types: commercial= 91.3%, Medicaid= 89.1%, Medicare MA-PDP= 91.3% and Medicare PDPonly= 76.1%. The majority were involved with medical device reviews (66% versus 86% for pharmaceutical reviews). AMCP-dossiers for medical devices were not required by 76.6% of plans and only 4.4% used AMCP-dossiers in their reviews. In their reviews medical devices were compared with: standards of care (63.8%), other medical devices only (23.4%) or pharmaceuticals (12.8%). Respondent involvement in medical device reviews were: all cases= 66%, based on a cost-threshold= 10.6%, under the medical plan due to Medicare regulations= 4.3% and not-involved= 19.1%. EMRs were used for billing (30.2% of plans); ePrescribing (27.9%); and lab tests (21.4%). Among the plans that require EMRs: 31.6% previously acquired; EMRs were provided at no cost (31.6%) and 5.3% at a cost; 21.0% didn’t specify funding; and other sources funded (10.6%). ACA funding had already been received (27.9% of plans) and 2.3% planned to receive funding through the ACA; 69.8% didn’t know. Conclusions: The environment for P&T Committee decision making in managed care is undergoing a series of changes. Health plan medical and pharmacy directors, who commonly serve as P&T Committee members, have distinct opinions as to how to alter the process to adapt to these influences as they review medical devices and implement EMRs. PMD69 RE-USE OF SINGLE USE MEDICAL DEVICES: PERCEPTIONS AMONG LATIN AMERICAN HEALTH CARE PROFESSIONALS Gilardino R E 1, Cabra H A 2, Couso A 1, Zanela O O 2, Nemocon C 3 1Johnson & Johnson MD, Buenos Aires, Argentina, 2Johnson & Johnson Medical, México DF, Mexico, 3Johnson & Johnson MD Colombia, Bogota, Colombia .
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Background: The re-use (re-u) of medical devices (MDs) is increasing its adoption among Latin America (LATAM) due to the attractiveness of generating potential savings in the short term. Most MDs are designed to be single-use (SUD); however, it could be re-used if are reprocessed (a practice that guarantees the device’s integrity, functionality and safety), but this not being available in LATAM. While regionally there are limited regulations and published evidence on re-u, re-sterilization (with physical or chemical agents) is a current practice, without clear understanding on the potential adverse events (AE) and the impact on Patient Safety (PS). Objectives: Assess and quantify Central Sterile Supply Department (CSSD) professionals’ perspectives on re-u of MDs in LATAM, while identifying key trends and improvement areas. Methods: During an educational event held on August 2015th we provided an specific survey to 25 CSSD members to collect feedback about re-u of MDs. Device type (T) and frequency (N) , existence of regulations, users perspectives on PS, malfunctioning of the MDs, gender (G), age (A), years of experience (YE) and country of residence (CR) were included. Results are shown as mean and percentage (%). Results: 20 surveys (80%) were answered. 60% of responders were female, with A: 41 and YE: 17. While 35% indicated re-u is not allowed in their countries (Chile, Puerto Rico, Panama, Brazil, and Mexico), the overall N of re-u was 3, being trocars, ultrasonic energy shears and staplers/cutters the most common. 90% of respondents believed that PS may be compromised in terms of infections (90%) and bleeding (75%), leading to increased resource utilization, particularly length of stay. Conclusions: Despite considerations on AE & PS, re-u is still common in LATAM. Implementation and improvement of PS surveillance mechanisms would be beneficial to avoid AEs in current conditions. PMD70 HEALTH TECHNOLOGY ASSESSMENT OF COMPLEMENTARY DIAGNOSTICS: ISSUES, OPTIONS, AND OPPORTUNITIES Mestre-Ferrandiz J 1, Garrison L P 2, Zamora B 1 1Office of Health Economics, London, UK, 2University of Washington, Seattle, WA, USA .
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Objectives: Our aim was to produce a white paper that identifies key issues facing the HTA of complementary diagnostics in Europe, defines options for addressing challenges and barriers, and recommends approaches for dealing with them. Methods: (1) Systematic literature review on different value frameworks and specific valuations for complementary diagnostics. (2) Analyses of health economic evaluations of three complementary diagnostics presented by the HTA agencies of England (National Institute of Health and Care Excellence, NICE) and France (Haute Autorité de Santé, HAS), where available. Results: We distinguish among seven elements of value for complementary diagnostics which are independent and additive and that should be considered aggregated at societal level. Three are included in the traditional cost-effectiveness analysis conducted as part of HTA (life years gained; improvements in patient quality of life; cost savings within the healthcare system (also called “cost-offsets”)). The fourth is “productivity”. We identified three other potential sources of value in healthcare technologies that are also relevant to complementary diagnostics: reduction in uncertainty (value of knowing/planning value); option value/value of hope; and scientific spillovers. Conclusions: The full value that complementary diagnostics can bring to patient care is underappreciated in healthcare systems around the world. By identifying those unique elements of value related to information, we aim not only to increase appreciation but also to provide a basis for evaluating and valuing their impact. As these healthcare systems evolve to more accountability for outcomes and to value-based reimbursement, the framework described here should provide a sounder basis for the HTA of complementary diagnostics as well as for appropriate reimbursement and rewards for innovation.
PMD71 IMPACT OF THE INTRODUCTION OF NEWER LONG ACTING REVERSIBLE CONTRACEPTIVE (LARC) METHODS ON LARC USE IN A COMMERCIALLY INSURED POPULATION Law A 1, Pilon D 2, Lynen R 1, Laliberté F 3, Gozalo L 3, Lefebvre P 2, Duh M S 4 1Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA, 2Groupe d’analyse, Ltée, Montreal, QC, Canada, 3Groupe d’analyse, Ltée, Montréal, QC, Canada, 4Analysis Group, Inc., Boston, MA, USA .
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Objectives: To assess the impact of the introduction of newer LARC methods on LARC use relative to all contraceptive users. Methods: Using a US insurance claims database (01/1999-03/2014), we studied women using LARC or short acting reversible contraceptive (SARC) methods. The proportion of women using LARC relative to all contraceptives (LARC+SARC) was reported yearly. Four time periods corresponding with the approval of a new LARC method, that is, Jan2001 (new intrauterine device [IUD]), Jul2006 (new implant), and Jan2013 (new IUD), were identified. Generalized estimating equation models were utilized to identify the impact of time periods and patient characteristics on the use of LARC over SARC methods. Results: A total of 1,040,978 women met inclusion criteria. LARC use increased yearly from 0.6% (1999) to 16.6% (2013) among all contraceptive users. Time periods associated with the introduction of a newer LARC method were significant predictors of LARC use; women in 2006-2012 and 2013-2014 were respectively 3.7-fold (95%CI: 3.57-3.74) and 6.6-fold (95%CI: 6.43-6.80) more likely to use LARC over SARC relative to women in 2001-2006. The increase in LARC use was especially pronounced in young women. Compared to women aged 18 to 24 in 2001-2006, women aged 18 to 24 in 2006-2012 and in 2013-2014 were respectively 6.4-fold (95%CI: 5.91-6.86) and 14.7-fold (95%CI: 13.59-15.89) more likely to use LARC over SARC method. Conclusions: This broadly representative commercial claim-based study showed that the proportion of women using LARC increased over time and that the introduction of newer LARC methods corresponded with significant increases in overall LARC use. PMD72 THE IMPACT OF POSITIVE AIRWAY PRESSURE TREATMENT ON HEALTH CARE UTILIZATION AMONG PATIENTS WITH OBSTRUCTIVE SLEEP APNEA Niu X , Parente A , Hunsberger J C Avalere Health - An Inovalon Company, Bowie, MD, USA .
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Objectives: To evaluate the impact of positive airway pressure (PAP) treatment on healthcare utilization among patients with obstructive sleep apnea (OSA). Methods: This retrospective-cohort study was conducted using a large nationally representative administrative claims database. Patients were included in the study if they: (1) were ≥ 65 years; (2) had a polysomnography (PSG) diagnostic test between 2008 and 2013; (3) had ≥ 2 medical claims with OSA diagnosis (ICD9-CM code 327.23) within 1 year after the first PSG test; (4) were newly treated (index) or never treated with PAP after OSA diagnosis; and (5) were continuously enrolled in a plan with medical benefits for 12 months prior and 24 months after the index date. Patients were excluded if they: (1) had claims indicating the use of PAP device, PAP-related supplies, or PAP management prior to the first PSG diagnostic test date; or (2) had a diagnosis of other primary respiratory conditions at baseline. Multivariate logistic regression and negative binomial models were estimated to examine the impact of PAP treatment on all-cause hospitalizations, sleep apnearelated hospitalizations and emergency room (ER) visits. Results: A total of 24,420 patients (mean age: 72.0±5.1; 58% males) were identified, of which 89% used PAP. Mean Charlson score was not significantly different between patients with PAP and those without PAP (1.44±1.33 vs. 1.46±1.36, p= 0.88). After controlling for potential confounders, patients with PAP were less likely to have an all-cause hospitalization than those without PAP (OR= 0.90, 95% CI: 0.82-0.98, p= 0.02). Considering frequency, those with PAP had significantly fewer all-cause hospitalizations (RR= 0.86, 95 CI: 0.80-0.93, p< 0.01), sleep apnea-related hospitalizations (RR= 0.86, 95 CI: 0.77-0.97, p= 0.01), and ER visits (RR= 0.90, 95 CI: 0.85-0.96, p< 0.01). Conclusions: This study provides new evidence that the use of PAP devices decreases the risk of hospitalizations and ER visits in elderly patients with OSA. PMD73 OUT-OF-POCKET PAYMENTS FOR PATIENTS WITH LYMPHEDEMA IN FRANCE: A DISTRIBUTIONAL ANALYSIS Mercier G 1, Pastor J Z 1, Clement V 2, Quere I 1 Montpellier, Montpellier, France, 2Universite de Montpellier, Montpellier, France .
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1CHU
Objectives: Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. Our aim was to analyze the distributive effects of OOPP for lymphedema patients in France. Methods: A prospective, multicenter study was conducted in France in 2014 on patients with lymphedema (the LYMPHORAC study). Household ability to pay was specified by net income and OOPP were assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements were considered. We combined concentration curves and concentration indices to assess the distributive effects. Results: We included 103 patients, the average age being 56 years. The average OOPP for outpatient care over 6 months was 183 Euros (SD: 191) out of which 80% due to prescription compression devices. OOPP represented a higher share of income in the poorer quintile as compared to the richer one (p< 0.01). OOPP had a regressive effect on income distribution with a concentration index equal to 0.13 after reimbursement by the mandatory health insurance scheme and equal to 0.14 after complementary reimbursement by the voluntary schemes. 21% of patients declared having forgone lymphedema medical care because of cost during the study. Conclusions: Even in a health care system organized and financed to warrant equity, OOPP have a regressive distributive effect in patients with lymphedema, mainly because of
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treatment of early invasive breast cancer. In committee meetings on 27 August 2014 and 26 August 2015 further information on the clinical effectiveness data was requested. In their last update on 06 November 2015 the committee decided that further work by NICE would be required before it could issue a recommendation to the NHS. Conclusions: Intrabeam is available for routine use in many countries. Intrabeam, replaces a course of at least 15 (up to 30) postoperative radiotherapy sessions. This could greatly reduce the health care resource burden and enhance the quality of life. Until NICE publishes its final guidance, decisions on whether or not to fund specific treatments are the responsibility of local National Health Service bodies. Incorporation of patients’ perspective with economic/social/ethical dimensions is essential in the evidence synthesis for multi-criteria decision process. PMD63 ASSESSMENT OF DIAGNOSTIC TOOLS USED TO IDENTIFY PATIENTS WITH CHRONIC NEUROPATHIC PAIN: A SYSTEMATIC REVIEW Lopez-Cabra C 1, Reyes J M 2, Prieto V A 2 del Rosario, Bogota, Colombia, 2Pfizer SAS, Bogota, Colombia .
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1Universidad
Objectives: To identify and assess the diagnostic accuracy of screening tools used to detect chronic neuropathic pain (NeP) in patients with chronic diseases compared with the reference standard of clinical judgment. Methods: We performed a systematic review of the literature to identify and evaluate the discriminant characteristics of screening questionnaires chronic NeP in patients with a comparative clinical assessment. The search was performed on MEDLINE, EMBASE, Cochrane library, and LILACS databases. Cohort studies, diagnostic tests accuracy studies, cross-sectional studies and randomized clinical trials (RCT) were included. Study selection and data extraction were accomplished by two independent researchers. A qualitative analysis was included comparing the sensitivity, specificity and receiver operator characteristics (ROC) across the various screening tools. Quantitative analyses were not conducted due to the high heterogeneity of the published studies. Results: We included 23 studies: 16 diagnostic, 5 cohort, 1 cross-sectional and 1 RCT. Seven questionnaires were identified: Douleur Neuropathique en 4 Questions (DN4), Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), ID-Pain, painDETECT, the self-report version of LANSS (S-LANSS), Standardized Evaluation of Pain (SteP) and the Neuropathic Pain Questionnaire (NPQ). The screening tools most frequently researched regarding validation and reliability across different languages were DN4 and LANSS. The DN4 reported higher sensitivity than LANSS; 61%-100% vs. 22% to 89%, respectively. Specificity was similar between the DN4 and LANSS; 73%-97% vs. 74%-100%, respectively. The ROC of DN4 was higher for the LANSS compared with DN4; 0.89 (standard deviation or SD 0.71 to 0.99) vs. 0.99 (0.73 to 0.96), respectively. Overall, the DN4 reported better diagnostic accuracy compared to the other six screening tools. Conclusions: A systematic review of the literature identified the DN4 as the most studied screening tool with robust discriminant characteristics to detect chronic NeP. PMD64 EFFICACY OF THE MICA ANTIBODY FOR TRANSPLANT PATIENTS Mo J National Evidence-based Healthcare Collaborating Agency, SEOUL, South Korea .
Objectives: MICA antibody identification is a test performed on transplant patients to check for the presence of donor-specific MICA for the purpose of predicting the incidence of organ rejection among transplant patients. The purpose of this assessment was to evaluate the effectiveness. Methods: The literature search was performed using 8domestic research databases and 3core databases. A total of 9papers that remained. Each of the stages from literature search to application of selection criteria and data extraction was independently by 2researcher. The SIGN was used for the quality assessment. Results: There were 5studies reporting on the medical results of kidney transplant patients. 2of the studies reported no significant differences in the graft survival rate and incidence of organ rejection(p= .67). However, 3studies reported a low graft survival rate and a significantly lower incidence of organ rejection in MICA(-)patients compared to the MICA (+)patients. There were 3studies reporting of heart transplant patients. 2studies reported an incidence of organ rejection of 23.1~62.5% and 1study reported a 5~10year graft survival rate of 94.7%(p= ns). There was one study reporting of lung transplant patients. The incidence of organ rejection was reported to be 42.0%(p= ns). Conclusions: MICA Identification lacked clinical effectiveness for the following reasons: i)there were no significant differences in the graft survival rate and incidence of organ rejection; ii)it is difficult to determine whether the different results for the graft survival rate and incidence of organ rejection reported; iii)the results cannot be generalized as it is probable that they will change in case of including all the patients fitting the description; iv)kidney transplantation is presently performed even if the results of the histocompatibility test of the donor and the patient do not conform to each other; v)heart and lung transplantations are performed based on anatomical compatibility without a histocompatibility test. PMD65 NURSE-LED CARE FOR PATIENTS WITH RHEUMATOID ARTHRITIS: A SYSTEMATIC REVIEW Lopatina E 1, Garner S 1, Marshall D A 2 of Calgary, Calgary, AB, Canada, 2and Director, Health Technology Assessment, Alberta Bone and Joint Health Institute, Calgary, AB, Canada .
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using the narrative analysis approach. Results: 17 publications met the inclusion criteria (8 randomized controlled trials, 1 case-controlled trial, 6 qualitative and 2 economic evaluation studies of moderate to high quality), which represented 10 studies. Disease activity was the most common measure of effectiveness with NLC being superior (n= 3) or equal (n= 3) to comparator. Acceptability was assessed in 6 studies; patients were more (n= 4) or equally (n= 1) satisfied with NLC compared to single-provider care and less satisfied compared to team care (n= 1). NLC was found to be safe (n= 2), with no difference in blood tests and disease activity. With regard to efficiency, mixed data on cost of NLC was reported with NLC being equivalent or less costly than traditional models (n= 3). Quantitative measures of accessibility and appropriateness were not found. Although in qualitative studies patients found NLC provided improved continuity of care (n= 3) and education and support (n= 4). Conclusions: NLC for RA patients is effective, acceptable, and safe. More information regarding accessibility, appropriateness and efficiency of this model, including its cost-effectiveness and the impact on patient flow, is needed.
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1University
Objectives: Nurse-led care (NLC) is an alternate model of care where nurses take on primary responsibilities for part of patients follow-up and/or management. We assessed the impact of NLC for RA patients on quality of care compared to traditional models of care according to multiple quality dimensions. Methods: We searched Ovid MEDLINE, EMBASE, and CINAHL from 1950 to January 2015. Studies were included if they met the following criteria: English language; original data from an original study; adult patients with RA, nurses took on primary responsibility for follow-up and/or management; reported data on one or more dimensions of quality as defined by the Alberta Health Quality Matrix (effectiveness, acceptability, efficiency, accessibility, appropriateness and safety). Data were synthesized
PMD66 HEARING RESTORATION, QUALITY OF LIFE, AND SAFETY OUTCOMES IN BONECONDUCTION DEVICES FOR PATIENTS WITH CONDUCTIVE OR MIXED HEARING LOSS OR SINGLE-SIDE DEAFNESS Battaglia S , Annoni E Medtronic International Trading Sàrl, Tolochenaz, Switzerland .
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Objectives: To provide a comprehensive literature review on the various boneconduction devices (BCDs) available, including bone-anchored hearing aids (BAHAs). Methods: A comprehensive search strategy was defined to perform a literature review of the data available to date on the different types of marketed BCDs for hearing rehabilitation in patients presenting with conductive hearing loss (CHL), mixed hearing loss (MHL), or single-side deafness (SSD). A search was conducted on December 22nd, 2015 on the PubMed, EMBASE and Google Scholar databases. Search criteria included patients presenting with CHL, MHL or SSD, and implanted with percutaneous (pBCI) or transcutaneous (tBCI) bone conduction implants. Non-systematic reviews, case reports and clinical studies on < 5 patients were excluded. The literature analysis specifically examined the type of implantation (pBCI vs. tBCI), the principle of operation (active device, i.e. direct drive to the skull bone vs. passive device, i.e. skin drive), or by indication. Results: 1,223 potentially relevant publications were identified; on full review, 95 studies met eligibility criteria. Hearing restoration, QoL and patient-reported outcomes measures have been increasingly documented for each technology in recent years. While the tBCIs seemed to be associated with a lower rate of skin complications than pBCIs, all the other parameters (clinical outcomes and QoL) seemed to be similarly distributed across all devices. The available data are still insufficient and the measurements’ sensitivities do not allow for a robust comparison between the different types of implants. Conclusions: The evidence base to support any differentiation between ‘passive’ and ‘active’ implants is insufficient, and direct comparison data is scarce. Future clinical studies and case reports should continue to investigate the clinical efficacy and safety outcomes related to the use of these devices, so as to provide physicians a more refined patient selection rationale and evidence-based practice pathways according to each device’s characteristics. PMD67 BEYOND BUDGET SILOS: BUDGET IMPACT ANALYSIS OF TRANSARTERIAL RADIOEMBOLIZATION WITH YTTRIUM-90 GLASS MICROSPHERES FOR HEPATOCELLULAR CARCINOMA FROM A HOSPITAL PERSPECTIVE Hubert M M 1, Karellis A 1, Sherman M 2, Gill S 3, Beecroft R 4, Sampalis J S 5 1JSS Medical Research, Saint-Laurent, QC, Canada, 2Toronto General Hospital, Toronto, ON, Canada, 3BC Cancer Agency, Vancouver, BC, Canada, 4Mount Sinai Hospital, Toronto, ON, Canada, 5JSS Medical Research Inc., St-Laurent, QC, Canada .
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Objectives: Budget silos can hinder reimbursement when a healthcare investment from one department incurs savings in another. For patients with hepatocellular carcinoma (HCC) at intermediate (BCLC-B stage) or advanced (BCLC-C) stages, transarterial radio-embolization (TARE) has the potential to improve survival, a favorable safety profile and successful outcomes in patients with portal vein thrombosis (PVT). Given its outpatient administration, low number of treatments and low toxicity relative to conventional transarterial chemoembolization (cTACE), TARE may be associated with overall decreased hospital resource use. A budget impact analysis (BIA) was undertaken from a Canadian hospital perspective. Methods: The epidemiological BIA included costs of drug and device acquisition and key cost drivers of administration (inpatient, outpatient or self-administered) and management of adverse events (AEs). In intermediate HCC, TARE with yttrium-90 glass microspheres was compared to TACE, an inpatient procedure, including cTACE and drug-eluting beads TACE (DEB-TACE). In advanced HCC, with or without PVT, TARE was compared to self-administered sorafenib. The Ontario Case Costing Initiative database, published literature and expert opinion were utilized. AE management was based on published rates for TARE, cTACE, DEB-TACE and sorafenib. Results: For a Canadian hospital managing 200 HCC patients annually, reimbursing TARE incurred savings of approximately $37,000, $55,000 and $75,000 in years 1, 2 and 3, respectively. In year 3, it includes incremental costs of $207,000 for device acquisition, savings of $281,000 for administration and savings of $1,000 in AE management. Sixty-six percent of HCC patients were deemed eligible, of which 8, 13 and 17 patients were anticipated to undergo TARE in years 1, 2 and 3, respectively. Conclusions: TARE is associated with cost savings and decreased hospital resource use, which enhance the ability of the hospital to manage scarce resources. Decisions made from one department’s perspective alone may therefore underestimate the true value for the hospital. PMD68 HEALTH PLAN COVERAGE FOR MEDICAL DEVICES AND THE USE OF ELECTRONIC MEDICAL RECORD SYSTEMS Brook R A 1, Sax M J 2, Carlisle J A 3, Smeeding J E 4 1The JeSTARx Group, Newfoundland, NJ, USA, 2The TPG-NPRT, Glastonbury, CT, USA, 3The Pharmacy Group, Glastonbury, CT, USA, 4The JeSTARx Group, Dallas, TX, USA .
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A309
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
Objectives: Medical devices are used to treat different conditions, are reviewed by the FDA, and potentially paid for by insurers/payors. For some payors medical devices payments are mandated through specific benefit. To manage their plans/ practices, many organizations use Electronic Medical Record systems [EMRs]. To understand the review and coverage of medical devices; and the adoption/funding of EMRs. Methods: Managed care (MC) medical+pharmacy directors [MDs+PDs] completed an online-interactive survey of: advisor+plan information; medical device coverage/reviews; and EMR adoption/use. Results: Respondents were mostly MDs (54.6%) and worked for health plans (83.6%). The plans were local= 39.6%, National= 35.4%, and regional= 25.0%; Plans could cover multiple member-types: commercial= 91.3%, Medicaid= 89.1%, Medicare MA-PDP= 91.3% and Medicare PDPonly= 76.1%. The majority were involved with medical device reviews (66% versus 86% for pharmaceutical reviews). AMCP-dossiers for medical devices were not required by 76.6% of plans and only 4.4% used AMCP-dossiers in their reviews. In their reviews medical devices were compared with: standards of care (63.8%), other medical devices only (23.4%) or pharmaceuticals (12.8%). Respondent involvement in medical device reviews were: all cases= 66%, based on a cost-threshold= 10.6%, under the medical plan due to Medicare regulations= 4.3% and not-involved= 19.1%. EMRs were used for billing (30.2% of plans); ePrescribing (27.9%); and lab tests (21.4%). Among the plans that require EMRs: 31.6% previously acquired; EMRs were provided at no cost (31.6%) and 5.3% at a cost; 21.0% didn’t specify funding; and other sources funded (10.6%). ACA funding had already been received (27.9% of plans) and 2.3% planned to receive funding through the ACA; 69.8% didn’t know. Conclusions: The environment for P&T Committee decision making in managed care is undergoing a series of changes. Health plan medical and pharmacy directors, who commonly serve as P&T Committee members, have distinct opinions as to how to alter the process to adapt to these influences as they review medical devices and implement EMRs. PMD69 RE-USE OF SINGLE USE MEDICAL DEVICES: PERCEPTIONS AMONG LATIN AMERICAN HEALTH CARE PROFESSIONALS Gilardino R E 1, Cabra H A 2, Couso A 1, Zanela O O 2, Nemocon C 3 1Johnson & Johnson MD, Buenos Aires, Argentina, 2Johnson & Johnson Medical, México DF, Mexico, 3Johnson & Johnson MD Colombia, Bogota, Colombia .
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Background: The re-use (re-u) of medical devices (MDs) is increasing its adoption among Latin America (LATAM) due to the attractiveness of generating potential savings in the short term. Most MDs are designed to be single-use (SUD); however, it could be re-used if are reprocessed (a practice that guarantees the device’s integrity, functionality and safety), but this not being available in LATAM. While regionally there are limited regulations and published evidence on re-u, re-sterilization (with physical or chemical agents) is a current practice, without clear understanding on the potential adverse events (AE) and the impact on Patient Safety (PS). Objectives: Assess and quantify Central Sterile Supply Department (CSSD) professionals’ perspectives on re-u of MDs in LATAM, while identifying key trends and improvement areas. Methods: During an educational event held on August 2015th we provided an specific survey to 25 CSSD members to collect feedback about re-u of MDs. Device type (T) and frequency (N) , existence of regulations, users perspectives on PS, malfunctioning of the MDs, gender (G), age (A), years of experience (YE) and country of residence (CR) were included. Results are shown as mean and percentage (%). Results: 20 surveys (80%) were answered. 60% of responders were female, with A: 41 and YE: 17. While 35% indicated re-u is not allowed in their countries (Chile, Puerto Rico, Panama, Brazil, and Mexico), the overall N of re-u was 3, being trocars, ultrasonic energy shears and staplers/cutters the most common. 90% of respondents believed that PS may be compromised in terms of infections (90%) and bleeding (75%), leading to increased resource utilization, particularly length of stay. Conclusions: Despite considerations on AE & PS, re-u is still common in LATAM. Implementation and improvement of PS surveillance mechanisms would be beneficial to avoid AEs in current conditions. PMD70 HEALTH TECHNOLOGY ASSESSMENT OF COMPLEMENTARY DIAGNOSTICS: ISSUES, OPTIONS, AND OPPORTUNITIES Mestre-Ferrandiz J 1, Garrison L P 2, Zamora B 1 1Office of Health Economics, London, UK, 2University of Washington, Seattle, WA, USA .
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Objectives: Our aim was to produce a white paper that identifies key issues facing the HTA of complementary diagnostics in Europe, defines options for addressing challenges and barriers, and recommends approaches for dealing with them. Methods: (1) Systematic literature review on different value frameworks and specific valuations for complementary diagnostics. (2) Analyses of health economic evaluations of three complementary diagnostics presented by the HTA agencies of England (National Institute of Health and Care Excellence, NICE) and France (Haute Autorité de Santé, HAS), where available. Results: We distinguish among seven elements of value for complementary diagnostics which are independent and additive and that should be considered aggregated at societal level. Three are included in the traditional cost-effectiveness analysis conducted as part of HTA (life years gained; improvements in patient quality of life; cost savings within the healthcare system (also called “cost-offsets”)). The fourth is “productivity”. We identified three other potential sources of value in healthcare technologies that are also relevant to complementary diagnostics: reduction in uncertainty (value of knowing/planning value); option value/value of hope; and scientific spillovers. Conclusions: The full value that complementary diagnostics can bring to patient care is underappreciated in healthcare systems around the world. By identifying those unique elements of value related to information, we aim not only to increase appreciation but also to provide a basis for evaluating and valuing their impact. As these healthcare systems evolve to more accountability for outcomes and to value-based reimbursement, the framework described here should provide a sounder basis for the HTA of complementary diagnostics as well as for appropriate reimbursement and rewards for innovation.
PMD71 IMPACT OF THE INTRODUCTION OF NEWER LONG ACTING REVERSIBLE CONTRACEPTIVE (LARC) METHODS ON LARC USE IN A COMMERCIALLY INSURED POPULATION Law A 1, Pilon D 2, Lynen R 1, Laliberté F 3, Gozalo L 3, Lefebvre P 2, Duh M S 4 1Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA, 2Groupe d’analyse, Ltée, Montreal, QC, Canada, 3Groupe d’analyse, Ltée, Montréal, QC, Canada, 4Analysis Group, Inc., Boston, MA, USA .
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Objectives: To assess the impact of the introduction of newer LARC methods on LARC use relative to all contraceptive users. Methods: Using a US insurance claims database (01/1999-03/2014), we studied women using LARC or short acting reversible contraceptive (SARC) methods. The proportion of women using LARC relative to all contraceptives (LARC+SARC) was reported yearly. Four time periods corresponding with the approval of a new LARC method, that is, Jan2001 (new intrauterine device [IUD]), Jul2006 (new implant), and Jan2013 (new IUD), were identified. Generalized estimating equation models were utilized to identify the impact of time periods and patient characteristics on the use of LARC over SARC methods. Results: A total of 1,040,978 women met inclusion criteria. LARC use increased yearly from 0.6% (1999) to 16.6% (2013) among all contraceptive users. Time periods associated with the introduction of a newer LARC method were significant predictors of LARC use; women in 2006-2012 and 2013-2014 were respectively 3.7-fold (95%CI: 3.57-3.74) and 6.6-fold (95%CI: 6.43-6.80) more likely to use LARC over SARC relative to women in 2001-2006. The increase in LARC use was especially pronounced in young women. Compared to women aged 18 to 24 in 2001-2006, women aged 18 to 24 in 2006-2012 and in 2013-2014 were respectively 6.4-fold (95%CI: 5.91-6.86) and 14.7-fold (95%CI: 13.59-15.89) more likely to use LARC over SARC method. Conclusions: This broadly representative commercial claim-based study showed that the proportion of women using LARC increased over time and that the introduction of newer LARC methods corresponded with significant increases in overall LARC use. PMD72 THE IMPACT OF POSITIVE AIRWAY PRESSURE TREATMENT ON HEALTH CARE UTILIZATION AMONG PATIENTS WITH OBSTRUCTIVE SLEEP APNEA Niu X , Parente A , Hunsberger J C Avalere Health - An Inovalon Company, Bowie, MD, USA .
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Objectives: To evaluate the impact of positive airway pressure (PAP) treatment on healthcare utilization among patients with obstructive sleep apnea (OSA). Methods: This retrospective-cohort study was conducted using a large nationally representative administrative claims database. Patients were included in the study if they: (1) were ≥ 65 years; (2) had a polysomnography (PSG) diagnostic test between 2008 and 2013; (3) had ≥ 2 medical claims with OSA diagnosis (ICD9-CM code 327.23) within 1 year after the first PSG test; (4) were newly treated (index) or never treated with PAP after OSA diagnosis; and (5) were continuously enrolled in a plan with medical benefits for 12 months prior and 24 months after the index date. Patients were excluded if they: (1) had claims indicating the use of PAP device, PAP-related supplies, or PAP management prior to the first PSG diagnostic test date; or (2) had a diagnosis of other primary respiratory conditions at baseline. Multivariate logistic regression and negative binomial models were estimated to examine the impact of PAP treatment on all-cause hospitalizations, sleep apnearelated hospitalizations and emergency room (ER) visits. Results: A total of 24,420 patients (mean age: 72.0±5.1; 58% males) were identified, of which 89% used PAP. Mean Charlson score was not significantly different between patients with PAP and those without PAP (1.44±1.33 vs. 1.46±1.36, p= 0.88). After controlling for potential confounders, patients with PAP were less likely to have an all-cause hospitalization than those without PAP (OR= 0.90, 95% CI: 0.82-0.98, p= 0.02). Considering frequency, those with PAP had significantly fewer all-cause hospitalizations (RR= 0.86, 95 CI: 0.80-0.93, p< 0.01), sleep apnea-related hospitalizations (RR= 0.86, 95 CI: 0.77-0.97, p= 0.01), and ER visits (RR= 0.90, 95 CI: 0.85-0.96, p< 0.01). Conclusions: This study provides new evidence that the use of PAP devices decreases the risk of hospitalizations and ER visits in elderly patients with OSA. PMD73 OUT-OF-POCKET PAYMENTS FOR PATIENTS WITH LYMPHEDEMA IN FRANCE: A DISTRIBUTIONAL ANALYSIS Mercier G 1, Pastor J Z 1, Clement V 2, Quere I 1 Montpellier, Montpellier, France, 2Universite de Montpellier, Montpellier, France .
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1CHU
Objectives: Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. Our aim was to analyze the distributive effects of OOPP for lymphedema patients in France. Methods: A prospective, multicenter study was conducted in France in 2014 on patients with lymphedema (the LYMPHORAC study). Household ability to pay was specified by net income and OOPP were assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements were considered. We combined concentration curves and concentration indices to assess the distributive effects. Results: We included 103 patients, the average age being 56 years. The average OOPP for outpatient care over 6 months was 183 Euros (SD: 191) out of which 80% due to prescription compression devices. OOPP represented a higher share of income in the poorer quintile as compared to the richer one (p< 0.01). OOPP had a regressive effect on income distribution with a concentration index equal to 0.13 after reimbursement by the mandatory health insurance scheme and equal to 0.14 after complementary reimbursement by the voluntary schemes. 21% of patients declared having forgone lymphedema medical care because of cost during the study. Conclusions: Even in a health care system organized and financed to warrant equity, OOPP have a regressive distributive effect in patients with lymphedema, mainly because of