Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs-Reference-Cited by-同舟云学术

Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs

Published:2018-11-08 Issue:3 Volume:105 Page:684-691
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Vreman Rick A.¹²,Bouvy Jacoline C.³,Bloem Lourens T.¹⁴,Hövels Anke M.¹,Mantel‐Teeuwisse Aukje K.¹,Leufkens Hubert G.M.¹,Goettsch Wim G.¹²

Affiliation:

1. Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences (UIPS) Utrecht University Utrecht The Netherlands

2. The National Healthcare Institute (ZIN) Diemen The Netherlands

3. National Institute for Health and Care Excellence (NICE) London UK

4. Dutch Medicines Evaluation Board (MEB) Utrecht The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1251

Reference33 articles.

1. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma

2. From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients

3. Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No. 726/2004 of the European Parliament and of the Council. Official Journal of the European Union (2006).

4. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU

5. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

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