The Impact of Recent Generic Drug Price Policies on Pharmaceutical Innovation: A Theoretical Rationale and Proposal of a Method Supporting Innovation in Areas of Unmet Medical Need

New discoveries are a critical priority for the pharmaceutical industry. However, the use of fixed incremental cost-effectiveness (ICER) thresholds for health technology assessment (HTA) may compromise incentives to innovate and affect future treatment options. This paper highlights the impact of ge...

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Main Authors: Pierre-Alexandre Dionne, Farzad Ali, Mendel Grobler
Format: Article
Language:English
Published: Columbia Data Analytics, LLC 2016-10-01
Series:Journal of Health Economics and Outcomes Research
Online Access:https://doi.org/10.36469/9838
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author Pierre-Alexandre Dionne
Farzad Ali
Mendel Grobler
author_facet Pierre-Alexandre Dionne
Farzad Ali
Mendel Grobler
author_sort Pierre-Alexandre Dionne
collection DOAJ
description New discoveries are a critical priority for the pharmaceutical industry. However, the use of fixed incremental cost-effectiveness (ICER) thresholds for health technology assessment (HTA) may compromise incentives to innovate and affect future treatment options. This paper highlights the impact of generic drug price policies on pharmaceutical innovation in the context of fixed ICER thresholds and proposes a new consideration for the cost-effectiveness analysis (CEA). There is a direct causal relationship between HTA and the market price of a drug; in jurisdictions where HTA agencies apply fixed ICER thresholds as an important reimbursement listing criterion, the incremental cost of a new drug is expected to be proportional to its incremental benefit over the comparator. However, the comparator price is subject to market forces or sudden policies and may change markedly affecting the cost-effectiveness assessment (e.g. where the comparator patent has expired). Since recent generic price regulations increased the price gap between drugs’ generic and patented versions, it is harder to achieve a sufficient level of incremental benefits in order to offset incremental prices of new treatments. Consequently, even promising drugs may have challenges to show attractive ICERs and research and development (R&D) investments may become unattractive in certain disease area. In order to promote innovation in therapeutic fields with unmet medical needs, a compromise would be to include the comparator’s patented price in the CEA instead of the generic drug. By identifying the relevant disease areas, decision makers and HTA authorities could therefore convey the importance of investing in these therapeutic areas to manufacturers.
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spelling doaj-art-3cf9115105de42aa9a59c9d921823c6e2025-02-10T16:12:28ZengColumbia Data Analytics, LLCJournal of Health Economics and Outcomes Research2327-22362016-10-0131The Impact of Recent Generic Drug Price Policies on Pharmaceutical Innovation: A Theoretical Rationale and Proposal of a Method Supporting Innovation in Areas of Unmet Medical NeedPierre-Alexandre DionneFarzad AliMendel GroblerNew discoveries are a critical priority for the pharmaceutical industry. However, the use of fixed incremental cost-effectiveness (ICER) thresholds for health technology assessment (HTA) may compromise incentives to innovate and affect future treatment options. This paper highlights the impact of generic drug price policies on pharmaceutical innovation in the context of fixed ICER thresholds and proposes a new consideration for the cost-effectiveness analysis (CEA). There is a direct causal relationship between HTA and the market price of a drug; in jurisdictions where HTA agencies apply fixed ICER thresholds as an important reimbursement listing criterion, the incremental cost of a new drug is expected to be proportional to its incremental benefit over the comparator. However, the comparator price is subject to market forces or sudden policies and may change markedly affecting the cost-effectiveness assessment (e.g. where the comparator patent has expired). Since recent generic price regulations increased the price gap between drugs’ generic and patented versions, it is harder to achieve a sufficient level of incremental benefits in order to offset incremental prices of new treatments. Consequently, even promising drugs may have challenges to show attractive ICERs and research and development (R&D) investments may become unattractive in certain disease area. In order to promote innovation in therapeutic fields with unmet medical needs, a compromise would be to include the comparator’s patented price in the CEA instead of the generic drug. By identifying the relevant disease areas, decision makers and HTA authorities could therefore convey the importance of investing in these therapeutic areas to manufacturers.https://doi.org/10.36469/9838
spellingShingle Pierre-Alexandre Dionne
Farzad Ali
Mendel Grobler
The Impact of Recent Generic Drug Price Policies on Pharmaceutical Innovation: A Theoretical Rationale and Proposal of a Method Supporting Innovation in Areas of Unmet Medical Need
Journal of Health Economics and Outcomes Research
title The Impact of Recent Generic Drug Price Policies on Pharmaceutical Innovation: A Theoretical Rationale and Proposal of a Method Supporting Innovation in Areas of Unmet Medical Need
title_full The Impact of Recent Generic Drug Price Policies on Pharmaceutical Innovation: A Theoretical Rationale and Proposal of a Method Supporting Innovation in Areas of Unmet Medical Need
title_fullStr The Impact of Recent Generic Drug Price Policies on Pharmaceutical Innovation: A Theoretical Rationale and Proposal of a Method Supporting Innovation in Areas of Unmet Medical Need
title_full_unstemmed The Impact of Recent Generic Drug Price Policies on Pharmaceutical Innovation: A Theoretical Rationale and Proposal of a Method Supporting Innovation in Areas of Unmet Medical Need
title_short The Impact of Recent Generic Drug Price Policies on Pharmaceutical Innovation: A Theoretical Rationale and Proposal of a Method Supporting Innovation in Areas of Unmet Medical Need
title_sort impact of recent generic drug price policies on pharmaceutical innovation a theoretical rationale and proposal of a method supporting innovation in areas of unmet medical need
url https://doi.org/10.36469/9838
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