To ask the Secretary of State for Health, on how many occasions in each of the last five years the NHS (a) requested and (b) was granted exemption from its legal requirement to fund drugs and treatments within three months of technology appraisal guidance issued by NICE; and for which drugs and treatments each of those exemptions was sought; what the reasons were for each such request; what the outcome was of each such request; and what the new timescale for the funding requirement was on each occasion where the request was granted.
21 November 2016
The National Institute for Health and Care Excellence (NICE) has advised that there have been two occasions since 2013 on which NHS England has requested an extension to the three month timescale for the funding requirement, and there has been one occasion since 2013 in which an extension to the three month timescale for the funding requirement has been agreed.
The two requests for an extension relate to sofosbuvir for treating chronic hepatitis C (TA330) and simeprevir in combination with peginterferon alfa and ribavirin for treating genotypes 1 and 4 chronic hepatitis C (TA331).
NHS England requested an extension to the implementation period for sofosbuvir to allow them time to put the staff and resources in place to plan and deliver the hepatitis C service, including the provision of a national database and dashboard to monitor and support individual care. The request was granted following a further public consultation on changes to the timescale for the funding requirement. The implementation period was extended to 31 July 2015 (an additional two months over the usual time for implementation as the guidance was published in February 2015).
NHS England also sought an extension to the implementation period for simeprevir in order to be consistent with the requested extension for sofosbuvir. This was on the basis that further therapies for hepatitis C would become available in the foreseeable future, and the NHS would wish to see their comparative cost effectiveness assessed before selecting one particular option for hundreds of millions of pounds of new public investment.
The request for an extension to the implementation period for simeprevir was subsequently withdrawn by NHS England following the development of an interim policy document for the use of this technology, for introduction in early 2015.
Prior to April 2013, different mechanisms were in place for the funding requirement, and there were no requests for extensions to the period within which funding must be made available for NICE recommended drugs between 2011 and 2013.