Generating comparative evidence on new drugs and devices before approval.

Naci, Huseyin; Salcher-Konrad, Maximilian; Kesselheim, Aaron S; Wieseler, Beate; Rochaix, Lise; Redberg, Rita F; Salanti, Georgia; Jackson, Emily; Garner, Sarah; Stroup, T Scott; Cipriani, Andrea (2020). Generating comparative evidence on new drugs and devices before approval. Lancet, 395(10228), pp. 986-997. Elsevier 10.1016/S0140-6736(19)33178-2

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Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment options at the time of regulatory approval in Europe and the USA. Even when active-comparator trials exist, they might not produce meaningful data to inform decisions in clinical practice and health policy. The uncertainty associated with the paucity of well designed active-comparator trials has been compounded by legal and regulatory changes in Europe and the USA that have created a complex mix of expedited programmes aimed at facilitating faster access to new drugs. Comparative evidence generation is even sparser for medical devices. Some have argued that the current process for regulatory approval needs to generate more evidence that is useful for patients, clinicians, and payers in health-care systems. We propose a set of five key principles relevant to the European Medicines Agency, European medical device regulatory agencies, US Food and Drug Administration, as well as payers, that we believe will provide the necessary incentives for pharmaceutical and device companies to generate comparative data on drugs and devices and assure timely availability of evidence that is useful for decision making. First, labelling should routinely inform patients and clinicians whether comparative data exist on new products. Second, regulators should be more selective in their use of programmes that facilitate drug and device approvals on the basis of incomplete benefit and harm data. Third, regulators should encourage the conduct of randomised trials with active comparators. Fourth, regulators should use prospectively designed network meta-analyses based on existing and future randomised trials. Last, payers should use their policy levers and negotiating power to incentivise the generation of comparative evidence on new and existing drugs and devices, for example, by explicitly considering proven added benefit in pricing and payment decisions.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)

UniBE Contributor:

Salanti, Georgia

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0140-6736

Publisher:

Elsevier

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

07 Apr 2020 17:18

Last Modified:

14 Apr 2020 08:09

Publisher DOI:

10.1016/S0140-6736(19)33178-2

PubMed ID:

32199486

BORIS DOI:

10.7892/boris.142738

URI:

https://boris.unibe.ch/id/eprint/142738

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