To ask Her Majesty's Government how NHS England formulates approval criteria for drugs already approved by the National Institute for Health and Clinical Excellence; and how it involves (1) patients, and (2) clinicians in this process.
To ask Her Majesty's Government how many Individual Funding Requests have been submitted to the NHS for the treatment of blood cancer; and of those, how many requests were (1) successful, and (2) unsuccessful.
To ask Her Majesty's Government (1) what evidence NHS England considered, (2) which clinicians it consulted, and (3) which patient groups it consulted when deciding that ibrutinib should not be prescribed to people with chronic lymphocytic leukaemia who have been in remission for more than three years.
NHS England has advised that it develops treatment criteria for cancer and other high cost drugs to support implementation of National Institute for Health and Care Excellence (NICE) guidance and to ensure approved treatments are available as intended, with access funded consistently across the country. These criteria are developed by relevant expert clinical advisers, drawn from NHS England’s 42 Clinical Reference Groups (CRGs). These CRGs have been established to support clinical commissioning across the entire specialised commissioning portfolio.
In the case of NICE Technology Appraisal TA429 for ibrutinib in previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation, NICE issued the following statement on 8 June 2018:
“Given the evidence that was considered by the NICE appraisal committee, we consider it reasonable for the guidance to be read as referring to those patients considered unsuitable for retreatment. Because unsuitability for retreatment is not defined in the guidance, we consider it appropriate for NHS England, as the commissioner, to take clinical advice in order to do so.”
NHS England took clinical advice in setting the specific treatment criteria linked to this appraisal and we are advised that the criteria were derived from the main study that had underpinned the NICE guidance and are consistent with guidance issued by the European Society for Medical Oncology last updated in June 2017. Between January 2017 and May 2018, nearly 1,000 patients were registered to receive treatment with ibrutinib in this indication. This is in line with NICE’s estimates that 700 adults per year would be eligible for treatment as a result of its guidance.
However, NHS England has further advised that it is more than willing to receive and review by the end of July, any further evidence that patients and clinicians wish to submit on this matter. The evidence will first be considered by NHS England’s Chemotherapy CRG, with advice and recommendations from this group then being submitted to the National Medical Director, Professor Steve Powis, for consideration.
During 2017/18, 1,193 Individual Funding Requests were considered by NHS England. An analysis of how may related to treatments for blood cancer has not been conducted.