Patients asked to accept unlicensed treatment to save money
Sep 21, 2018
The High Court has today ruled it is lawful for CCGs in North East England to introduce a Policy that encourages the use of a medicine not licensed to treat wet age-related macular degeneration (“wAMD”), as a preferred option, purely for financial reasons, despite licensed medicines being available.
Novartis is deeply disappointed in this decision and remains of the opinion that the Policy undermines the well-established legal and regulatory framework that is there to protect both patients’ safety and to ensure health care professionals can prescribe with confidence. It is a system the public can trust and it should not be put in jeopardy purely to save money. It is the role of the regulatory authorities – the MHRA (The Medicines and Healthcare products Regulatory Agency) and EMA (European Medicines Agency) – to determine if medicines do more good than harm. We believe the decision undermines the role of these regulatory bodies to determine which medicines meet this minimum standard before being made available to the public.
This is a bad day for patients, doctors and the NHS. This ruling threatens to jeopardize a world-leading system that has protected patients for many years by ensuring medicines have been tested rigorously and carefully scrutinized for delivering value.
This CCG Policy also places an unfair burden on patients, doctors and the NHS.
A burden on patients - Patients will now be asked to consider an unlicensed treatment solely to help save the NHS money and we believe this is unprecedented and unethical.
A burden on already over-stretched doctors - It is doctors who will carry the additional burden of having complex discussions with patients and their carers about using an unlicensed medicine and the challenges of ensuring informed consent.
A burden on hospitals - Hospitals will be responsible for implementing this Policy, but it is not clear how this can be done legally.
Novartis fully understands the challenges that the NHS faces, which include capacity challenges due to increasing patient numbers. However the use of this unlicensed treatment for wAMD may exacerbate this capacity issue, as clinical trial data indicates that on average more frequent injections will be required.1
If this Policy is implemented, patients will be asked to choose between bevacizumab, a cancer drug that is unlicensed for injection in to the eye, and licensed medicines that have had a rigorous analysis of their clinical efficacy, safety and quality, performed by the regulatory authorities, specifically for intravitreal use.
This is not the right solution and we believe this is not in the interest of patients. Therefore we are exploring all options available, including appealing the decision, in an effort to ensure that patients living with wAMD can continue to be offered treatment with licensed medicines that NICE has determined are clinically effective and provide value for money.2,3
Berg K et al. Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to the LUCAS protocol: Ophthalmology 2014;1–7
NICE guideline [TA155] Macular degeneration (age-related) - ranibizumab and pegaptanib: July 2013
NICE guideline [TA294] Aflibercept solution for injection for treating wet age‑related macular degeneration: July 2013
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