Coverage and Pricing Recommendations of the French National Health Authority for Innovative Drugs: A Retrospective Analysis From 2014 to 2020

Kergall, Pauline; Autin, Erwan; Guillon, Marlène; Clément, Valérie

doi:10.1016/j.jval.2021.06.013

Cited by 3 publications

(1 citation statement)

References 28 publications

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“…The proposed procedure could serve as a pillar for the characterization of the relationship between the CAB and the incremental health gain quantified in the cost-effectiveness analysis. A recently published article about HAS's system (21) found convergence between the independent clinical and economic appraisal processes: the CAV rating is positively associated with the disease severity, the quality-adjusted life-year gain provided by the drug, and the validation of the incremental cost-utility ratio in the Economic Opinion. A similar validation process could be performed in the case of our framework in the future.…”

Section: Discussionmentioning

confidence: 99%

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

Dóczy¹,

Sódar²,

Hölgyesi

et al. 2022

Int J Technol Assess Health Care

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Objectives The reimbursement process for innovative health technologies in Hungary lacks any formalized assessment of clinical added benefit (CAB). The aim of this research is to present the development, retrospective testing, and implementation of a local assessment framework for determining the CAB of cancer treatments at the Department of Health Technology Assessment of the National Institute of Pharmacy and Nutrition in Hungary. Methods The assessment framework was drafted after screening existing methods and a retrospective comparison of local reimbursement dossiers to that of German and French methods. The Magnitude of Clinical Benefit Scale of the European Society for Medical Oncology was chosen to rate the extent of CAB in oncology, as part of a conclusion complemented by the assessment of endpoint relevance and the quality of evidence. Several rounds of retrospective assessments have been conducted involving all clinical assessors, iterated with semistructured discussions to consolidate divergence between assessors. External stakeholders were consulted to provide feedback on the framework. Results Retrospective assessments resulted in average more than 75 percent concordance between assessors on each element of the conclusion. Input from ten stakeholders was also incorporated; stakeholders were generally supportive, and they mostly commented on the concept, the elements of the framework, and its implementation. Conclusions The procedure is suitable for routine use in the decision-making process to describe the CAB of antineoplastic technologies in Hungary. Further extension of the framework is required to cover more disease areas for structured and comparable conclusions on CAB of innovative health technologies.

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Section: Discussionmentioning

confidence: 99%

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

Dóczy¹,

Sódar²,

Hölgyesi

et al. 2022

Int J Technol Assess Health Care

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Reimbursement and pricing for innovative drugs in France: identifying criteria to inform decision-making

2021

PharmacoEcon Outcomes News

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High drug prices are not justified by industry’s spending on research and development

Angelis

Polyakov

Wouters

et al. 2023

BMJ

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Concerns over the prices of new medicines have been growing over the past decade. In the US, estimated net prices of newly launched prescription drugs increased from a median of around $1400 a year (£1200; €1300) in 2008 to over $150 000 a year in 2021. 1 Onasemnogene abeparvovec (Zolgensma), a gene therapy approved by the US Food and Drug Administration in 2019 for spinal muscular atrophy, was at the time of approval the most expensive drug ever, with a price of over $2m for a single dose treatment. 2 Several more recent drugs for rare diseases are priced even higher, 3 with a gene therapy for haemophilia B approved by the FDA in November 2022 costing $3.5m per dose. 4 But even old and common drugs have seen inexplicable price increases: in the US, the list price of some insulin products increased more than twofold from 2007 to 2018, 5 while a US government report identified 1216 products that had seen prices rise above inflation

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Coverage and Pricing Recommendations of the French National Health Authority for Innovative Drugs: A Retrospective Analysis From 2014 to 2020

Cited by 3 publications

References 28 publications

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

Development, testing, and implementation of a new procedure to assess the clinical added benefit of pharmaceuticals

Reimbursement and pricing for innovative drugs in France: identifying criteria to inform decision-making

High drug prices are not justified by industry’s spending on research and development

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