35569 - Cancer: Drugs (Answered)

Danny Kinahan
To ask the Secretary of State for Health, what recent discussions he has had with the National Institute for Health and Care Excellence on granting that Institute the power to be able to approve cancer drugs for use off-license.

George Freeman

Clinicians can prescribe any treatment, including an unlicensed product or a product not licensed for a particular indication, which they consider the best available medicine to meet the individual clinical needs of their patient, subject to their primary care organisation agreeing to fund this treatment.

The National Institute for Health and Care Excellence (NICE) already produces Evidence Summaries which critically review the best available evidence for significant uses of unlicensed or off-label medicines. They help commissioners and clinicians to make evidence-based prioritisation, treatment and funding decisions where there are no clinically-appropriate licensed alternatives.

Ensuring that patients get timely access to any new treatment, including off-label medicines in new indications, is complex and the Department is committed to working with stakeholders including NICE, the Medicines and Healthcare products Regulatory Agency, the General Medical Council, patient and professional groups, and charities to co-ordinate activities and set plans in place that will make this easier. This includes work to look at more systematic inclusion of off-label uses of drugs in the British National Formulary and development of case studies looking at re-purposed medicines and their pathways from research results into clinical practice.

Alongside these, the Access to Medical Treatments (Innovation) Act 2016 will, in due course, provide the National Health Service with a newly created database which will provide a mechanism for collecting and sharing information on innovative treatments including off-label drugs and medicines in development. Now that the Act has received Royal Assent the work to implement its provisions can begin.