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      Prezzo e rimborso dei farmaci in caso di estensione delle indicazioni: i risultati di una survey sui soci di ISPOR Italy Rome Chapter

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      1 , 2
      Global & Regional Health Technology Assessment
      AboutScience
      Indication, Italy, Medicines, Pricing

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          Price and reimbursement of medicines when new indications are approved: the results of a survey on ISPOR Italy Rome Chapter members

          Multi-indication pricing models for medicines and some international impact evidence are available in the literature. Data on the Italian context are more limited. This paper illustrates the results of a study aimed at gathering the opinion on this topic of experts, members of the ISPOR Italy Rome Chapter.

          The opinion was collected through a structured questionnaire, validated by two potential responders, and administered online in the period October/July 2022.

          There were 45 responders (20% of the members); 67% of responders work in pharmaceutical companies and 13% in consultancy firms. The remainder belongs to regulators/payers and universities.

          The survey highlighted a preference for (i) non-automatic models, as automatic approaches are mainly based on price cuts/discount increases in relation to an increase in volumes, (ii) an “indication-based-pricing” model (where prices are differentiated by indication through discounts/risk sharing agreements), since it is more consistent with a value-based approach, even if more complex to manage, (iii) a mix of discounts/agreements according to existing evidence.

          The opinion collected is consistent with the opinions available in the literature, but not consistent with the Italian trend, where, compared to the past, a blended approach is prevailing. A blended pricing envisages a renegotiation of the single price for all indications, essentially based on a change in the discount. Our hope is that in the future the experts’ opinion will be taken into consideration and that a targeted indication-based-pricing will be adopted again.

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          Most cited references11

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          The Use of Risk-Sharing Contracts in Healthcare: Theoretical and Empirical Assessments

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            Value and Price of Multi-indication Cancer Drugs in the USA, Germany, France, England, Canada, Australia, and Scotland

            Purpose Oncology drugs are often approved for multiple indications, for which their clinical benefit varies. Aligning a single price to this differing value remains a challenge. This study examines the clinical and economic value, price, and reimbursement of multi-indication cancer drugs across seven countries, representing different approaches to value assessment, pricing, and coverage decisions: the USA, Germany, France, England, Canada, Australia, and Scotland. Methods Twenty-five multi-indication cancer drugs across 100 indications were identified with US Food and Drug Administration (FDA) approval between 2009 and 2019. For each indication data on Health Technology Assessment (HTA) recommendations, disease prevalence, and drug prices were obtained. Quality-adjusted life years (QALYs) gained, disease prevalence, list prices, and HTA outcomes were then compared across indications and regions. Results First approved indications provide a higher clinical benefit whilst targeting a smaller patient group than indication extensions. Quality-adjusted life year gains were higher for first (0.99, 95% CI 0.05–3.25) compared to second (0.51, 95% CI 0.02–1.63, p < 0.001) and third (0.58, 95% CI 0.05–2.07, p < 0.01) approved indications. Disease prevalence per 100,000 inhabitants was 20.7 (95% CI 0.2–63.3) for first compared to 27.1 (95% CI 1.5–109.6, p = 0.907) for second and 128.3 (95% CI 3.1–720.1, p < 0.001) for third approved indications. With each approved indication drug prices declined in Germany and France, remained constant in the UK, Canada, and Australia, whilst they increased in the USA. Negative HTA outcomes, clinical restrictions, and managed entry agreements (MEAs) were more frequently observed for indication extensions. Conclusions Results suggest that indication development is prioritised according to clinical value and disease prevalence. Countries employ different mechanisms to account for each indication’s differential benefit, e.g., weighted-average prices (Germany, France, Australia), differential discounts (England, Scotland), clinical restrictions, and MEAs (England, Scotland, Australia, Canada). Value-based indication-specific pricing can help to align the benefit and price for multi-indication cancer drugs. Supplementary Information The online version contains supplementary material available at 10.1007/s40258-022-00737-w.
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              Price Models for Multi-indication Drugs: A Systematic Review.

              Marketing of new and existing drugs with new indications used alone or in combination is increasing.
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                Author and article information

                Journal
                Glob Reg Health Technol Assess
                Glob Reg Health Technol Assess
                GRHTA
                Global & Regional Health Technology Assessment
                AboutScience
                2284-2403
                2283-5733
                02 May 2023
                Jan-Dec 2023
                : 10 ,2023
                : 40-45
                Affiliations
                [1 ] Alta Scuola di Economia e Management dei Sistemi Sanitari, Università Cattolica del Sacro Cuore, Roma - Italy
                [2 ] Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale, Novara - Italy
                Author notes
                Indirizzo per la corrispondenza: Dipartimento di Scienze del Farmaco Università del Piemonte Orientale Largo Guido Donegani 2 28100 Novara - Italy claudio.jommi@ 123456uniupo.it
                Article
                10.33393/grhta.2023.2562
                10158496
                d83b0a6c-f7ac-4b5a-b059-72c518b104b0

                Global & Regional Health Technology Assessment - www.aboutscience.eu/grhta

                © 2023 The Authors. This article is published by AboutScience and licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). Commercial use is not permitted and is subject to Publisher’s permissions. Full information is available at www.aboutscience.eu

                History
                : 15 January 2023
                : 25 April 2023
                Categories
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                indication,italy,medicines,pricing
                indication, italy, medicines, pricing

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