Question to the Department of Health and Social Care:

To ask Her Majesty’s Government how patients' interests are able to be represented if a company chooses not to appeal decisions of NHS England to exclude certain drugs from the approved list in the Cancer Drugs Fund.

NHS England’s Cancer Drugs Fund (CDF) Standard Operating Procedure (SOP) outlines that applications to include candidate drugs/indications for inclusion in the national CDF list can only be made directly for potential cohorts of patients by the pharmaceutical industry and/or clinicians.

There are two different routes for applicants to challenge the decisions of the national Cancer Drugs Fund panel – either by making a complaint to the Chair of the panel and/or by requesting a formal review (often referred to as an ‘appeal’).

The complaints process outlined within the CDF SOP, indicates that a complaint can be made by either the manufacturer or a clinician where there is dissatisfaction with the outcome (either inclusion or exclusion of a drug) in respect of the national CDF list. A complaint must be made by a written letter to the chair of the panel outlining the reasons for the complaint.

A formal review, which is undertaken by NHS England’s Cancer and Blood Programme of Care Board, can only be requested by the original applicants to the CDF where the application has been unsuccessful.

With regard to the decisions announced by NHS England on 12 January 2015, all complaints or requests for a formal review must be submitted by 9 February 2015.

NHS England’s CDF Standard Operating Procedure document is available at:

www.england.nhs.uk/wp-content/uploads/2014/11/sop-cdf-1114.pdf

Clinicians will continue to be able to apply for individual patients to receive drugs not on the national CDF list on an exceptional basis.

Patients have the right to make a complaint using the National Health Service complaints process and, under this process, complainants have 12 months in which to lodge their complaint. This is separate to the CDF complaints process referenced above, which can only be accessed by CDF applicants and clinicians. Details of the NHS complaints process can be found at:

www.nhs.uk/choiceintheNHS/Rightsandpledges/complaints/Pages/NHScomplaints.aspx