loading page

Free of charge medicine schemes in the NHS. A local and regional Drug and Therapeutic Committees (DTC) experience.
  • +2
  • Simon O'Callaghan,
  • Robin Ferner,
  • Andrew Barron,
  • Katherine Saxby,
  • Reecha Sofat (CURRENTLY UNAVAILABLE)
Simon O'Callaghan
University College London Hospitals NHS Foundation Trust
Author Profile
Robin Ferner
City Hospital
Author Profile
Andrew Barron
University College London Hospitals NHS Foundation Trust
Author Profile
Katherine Saxby
University College London Hospitals NHS Foundation Trust
Author Profile
Reecha Sofat (CURRENTLY UNAVAILABLE)
University College London
Author Profile

Abstract

Introduction: Free-of-charge (FoC) medicine schemes are increasingly available and allow access to investigational treatments outside clinical trials or in advance of licensing or NHS commissioning. Methods: We retrospectively reviewed FoC medicine schemes evaluated between 2013 and 2019 by a single NHS trust and a regional drug and therapeutics committee (DTC). The details of each locally reviewed FoC scheme, and any nationally available MHRA Early Access to Medicines Scheme (MHRA EAMS) in the same period, were recorded and categorised. Results: Most FoC schemes (95%) allowed access to medicines intended to address an unmet clinical need. Over 7 years, 90% were company-FoC schemes and 10% were MHRA EAMS that were locally reviewed. Phase 3 clinical trial data were available for 44% of FoC schemes; 37% had phase 2 data; and 19% were supported only by phase 1, retrospective observational studies, or pre-clinical data. Utilisation of company-FoC schemes increased on average by 50% per year, while MHRA EAMS showed little growth. Conclusion: Company-FoC medicine schemes are increasingly common. This may indicate a preference for pharmaceutical companies to independently co-ordinate schemes. Motivations for company-FoC schemes remain unclear and many provide access to treatments that are yet to be evaluated in appropriately conducted clinical trials, and whose efficacy and risk of harm remain uncertain. There is no standardisation of this practice and there is no regulatory oversight. Moreover, no standardised data collection framework is in place that could demonstrate the utility of such programmes in addressing unmet clinical need or allow generation of further evidence.

Peer review status:ACCEPTED

05 Jul 2021Submitted to British Journal of Clinical Pharmacology
08 Jul 2021Submission Checks Completed
08 Jul 2021Assigned to Editor
11 Jul 2021Reviewer(s) Assigned
06 Aug 2021Review(s) Completed, Editorial Evaluation Pending
09 Aug 2021Editorial Decision: Revise Minor
31 Aug 20211st Revision Received
01 Sep 2021Submission Checks Completed
01 Sep 2021Assigned to Editor
01 Sep 2021Review(s) Completed, Editorial Evaluation Pending
09 Sep 2021Editorial Decision: Revise Minor
14 Sep 20212nd Revision Received
15 Sep 2021Submission Checks Completed
15 Sep 2021Assigned to Editor
15 Sep 2021Review(s) Completed, Editorial Evaluation Pending
16 Sep 2021Editorial Decision: Accept