Early Patient Access to Medicines: Health Technology Assessment Bodies Need to Catch Up with New Marketing Authorization Methods

Lada Leyens, Angela Brand

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

National and international medicines agencies have developed innovative methods to expedite promising new medicines to the market and facilitate early patient access. Some of these approval pathways are the conditional approval and the adaptive pathways by the European Medicines Agency (EMA); the Promising Innovative Medicine (PIM) designation and the Early Access to Medicines Scheme (EAMS) by the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as the Fast Track, Breakthrough or Accelerated Approval methods by the Food and Drug Administration (FDA). However, at least in Europe, these methods cannot achieve the goal of improving timely access for patients to new medicines on their own; the reimbursement process also has to become adaptive and flexible. In the past 2 years, the effective access (national patient access) to newly approved oncology drugs ranged from 1 to 30 months, with an extremely high variability between European countries. The goal of early patient access in Europe can only be achieved if the national health technology assessment bodies, such as NICE (ENG), HAS (FR), G-BA (DE) or AIFA (IT), provide harmonized, transparent, flexible, conditional and adaptive methods that adopt the level of evidence accepted by the medicines agencies. The efforts from medicines agencies are welcome but will be in vain if health technology assessments do not follow with similar initiatives, and the European 'postcode' lottery will continue.

Original languageEnglish
Pages (from-to)187-191
Number of pages5
JournalPublic Health Genomics
Volume19
Issue number3
DOIs
Publication statusPublished - 01-06-2016

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Biomedical Technology Assessment
Marketing
Medicine
International Agencies
United States Food and Drug Administration
Delivery of Health Care
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Public Health, Environmental and Occupational Health
  • Genetics(clinical)

Cite this

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Early Patient Access to Medicines : Health Technology Assessment Bodies Need to Catch Up with New Marketing Authorization Methods. / Leyens, Lada; Brand, Angela.

In: Public Health Genomics, Vol. 19, No. 3, 01.06.2016, p. 187-191.

Research output: Contribution to journalArticle

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