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      <abstractText>OBJECTIVE: This article introduces an Evidence Framework for Off-Patent Pharmaceutical Review (EFOR), which establishes value-based criteria in a template that manufacturers use to provide evidence showing how their products meet those criteria. Health authorities in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to support policy decisions, including pricing, reimbursement, formulary listing, and drug procurement. METHODS: A literature search found no multi-criteria evidence framework for evaluating OPPs in emerging markets. An International Outcomes Research Board (IORB) of academia and industry experts conducted extensive research, meetings, and workshops to define high-priority criteria to incorporate into an evidence-based health technology assessment (HTA) tool using the multi-criteria decision analysis (MCDA) technique. The resulting framework was further tailored for country-specific needs in workshops in three emerging countries (Kazakhstan, Vietnam, and Indonesia). RESULTS: The IORB defined nine criteria four categories (Product, Manufacturing, Service, and Value Assessment), which OPP manufacturers can use to provide evidence for reimbursement and health policy decision making. Then the IORB developed the EFOR as a base case document, which can be adapted and used as a template by health authorities in emerging countries. CONCLUSIONS: Emerging countries have a significant need for an HTA tool that balances affordability with accurate evidence showing the value differentiation of OPPs. The value attributes in this setting often are different from those in developed markets, which emphasize new products and have high regulation and manufacturing standards. The EFOR is an easy-to-use, adaptable framework that emerging countries can use to increase the consistency, transparency, and effectiveness of drug decision making. The open source EFOR is available as Supplemental Materials.</abstractText>
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            Department of Health Policy and Health Economics, Eötvös Loránd University (ELTE), Budapest, Hungary            
            Department of Health Policy, Hanoi University of Public Health, Hanoi, Viet Nam            
            Center for Health Economics and Policy Studies (CHEPS), Faculty of Public Health, Universitas Indonesia, Depok, Indonesia            
            Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan            
            Department of Health Economics, Hanoi Medical University, Hanoi, Viet Nam            
            Department of Clinical Pharmacy, University of Colorado, Aurora, CO, United States            
            Department of Health Services Organization and Management, National School of Public Health, Athens, Greece            
            Department of Pharmacotherapy, University of Utah, Salt Lake City, UT, United States            
            Abbott Established Pharmaceutical Division, Abbott, Basel, Switzerland            
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Syreon Research Institute, Budapest, Hungary            
            Department of Health Policy and Health Economics, Eötvös Loránd University (ELTE), Budapest, Hungary            
            Department of Health Policy, Hanoi University of Public Health, Hanoi, Viet Nam            
            Center for Health Economics and Policy Studies (CHEPS), Faculty of Public Health, Universitas Indonesia, Depok, Indonesia            
            Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan            
            Department of Health Economics, Hanoi Medical University, Hanoi, Viet Nam            
            Department of Clinical Pharmacy, University of Colorado, Aurora, CO, United States            
            Department of Health Services Organization and Management, National School of Public Health, Athens, Greece            
            Department of Pharmacotherapy, University of Utah, Salt Lake City, UT, United States            
            Abbott Established Pharmaceutical Division, Abbott, Basel, Switzerland            
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	&lt;pre class=&quot;comment&quot; style=&quot;margin-top: 0; margin-bottom: 0;&quot;&gt;&lt;u&gt;Megjegyzés&lt;/u&gt;: Syreon Research Institute, Budapest, Hungary            
            Department of Health Policy and Health Economics, Eötvös Loránd University (ELTE), Budapest, Hungary            
            Department of Health Policy, Hanoi University of Public Health, Hanoi, Viet Nam            
            Center for Health Economics and Policy Studies (CHEPS), Faculty of Public Health, Universitas Indon...&lt;/pre&gt;

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      <abstractText>BackgroundOff-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited. OPPs are comprised of off-patent originals, branded generics and unbranded generics; nonetheless, these products are not identical and often there are differences in their equivalence, manufacturing quality standards and reliability of supply. This necessitates reconsideration of the lowest price policy objective in pharmaceutical decision making. The aim of this study was to develop a Multi-Criteria Decision Analysis (MCDA) framework through a pilot workshop to inform the national procurement of OPPs in Indonesia.MethodsAn initial list of potentially relevant criteria was identified based on previous work and a literature review. In a 2-day pilot policy workshop, twenty local experts representing different stakeholder groups and decision-making bodies selected the final criteria, approved the scoring function for each criterion, and assigned weights to each criterion.ResultsAn MCDA framework was proposed for OPP drug decision making in developing countries, which included price and 8 non-price criteria. Based on the pilot policy workshop 6+1 criteria were considered relevant for Indonesia: pharmaceutical price (40% weight), manufacturing quality (18.8%), equivalence with the reference product (12.2%), product stability and drug formulation (12.2%), reliability of drug supply (8.4%), real world clinical or economic outcomes, such as adherence or non-drug costs (4.2%) and pharmacovigilance (3.6%).ConclusionsAccording to the pilot policy workshop, other criteria apart from price need to be strengthened in the tendering process. The introduction of additional criteria for OPP procurement in an MCDA framework creates incentives for manufacturers to invest into improved manufacturing standards, equivalence proof, product quality, reliability of supply or even additional real-world data collection, which ultimately may result in more health gain for the society.</abstractText>
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&lt;div class=&quot;title&quot;&gt;&lt;a href=&quot;/gui2/?mode=browse&amp;params=publication;30557183&quot; target=&quot;_blank&quot;&gt;Development of multi-criteria decision analysis (MCDA) framework for off-patent pharmaceuticals - an application on improving tender decision making in Indonesia&lt;/a&gt;&lt;/div&gt;    &lt;div&gt;		&lt;span class=&quot;journal-title&quot;&gt;BMC HEALTH SERVICES RESEARCH&lt;/span&gt;

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FTO PsziTB [1901-]&amp;nbsp;&amp;nbsp;&amp;nbsp;A&lt;/div&gt; &lt;div class=&quot;journal-subject&quot;&gt;Demográfiai Osztályközi Állandó Bizottság IXGJO DEM [1901-]&amp;nbsp;&amp;nbsp;&amp;nbsp;A hazai&lt;/div&gt; &lt;/div&gt;&lt;/OnlyViewableByAuthor&gt; &lt;div class=&quot;publication-citation&quot; style=&quot;margin-left: 0.5cm;&quot;&gt; &lt;span title=&quot;Nyilvános idézőközlemények összesen, említések nélkül&quot; class=&quot;citingPub-count&quot;&gt;Nyilvános idéző összesen: 4&lt;/span&gt; | Független: 4 | Függő: 0 | Nem jelölt: 0 | WoS jelölt: 4 | Scopus jelölt:&amp;nbsp;4 | WoS/Scopus jelölt:&amp;nbsp;4 | DOI jelölt:&amp;nbsp;4 &lt;/div&gt;  &lt;div class=&quot;mtid&quot;&gt;&lt;span class=&quot;long-pub-mtid&quot;&gt;Közlemény: 1835872&lt;/span&gt; | &lt;span class=&quot;status-data status-VALIDATED&quot;&gt; Egyeztetett &lt;/span&gt; &lt;span class=&quot;oldId&quot;&gt;Régi azonosító: 1835872&lt;/span&gt; | Forrás | &lt;span class=&quot;type-subtype&quot;&gt;Folyóiratcikk ( Összefoglaló cikk ) &lt;/span&gt; | &lt;span class=&quot;pub-category&quot;&gt;Tudományos&lt;/span&gt; | &lt;span class=&quot;publication-sourceOfData&quot;&gt;MEDLINE&lt;/span&gt; &lt;/div&gt; &lt;div class=&quot;lastModified&quot;&gt;Utolsó módosítás: 2022.02.23. 19:06 Tichy Rita (SE_KK_Admin5_TR, admin) &lt;/div&gt; &lt;/div&gt;&lt;/div&gt;</template2>
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