To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 19 December 2018 to Question 201214 on Rare Diseases: Drugs, on how many occasions NICE has made a conditional recommendation for a rare disease treatment that do not qualify for conditional recommendation through the cancer drugs fund; and what criteria NICE uses to determine whether such treatments are eligible for conditional recommendations.
The National Institute for Health and Care Excellence (NICE) is able to take into account the commercial terms offered by a manufacturer during a NICE appraisal through a mechanism known as a commercial access agreement. On two occasions NICE has issued optimised recommendations to make rare disease medicines routinely available for the appropriate group of National Health Service patients that are conditional on it being supplied in accordance with the terms of the commercial access arrangements. These were Sorafenib, for advanced hepatocellular carcinoma, and ibrutinib for relapsed or refractory mantle cell lymphoma.
This is different from the process of a conditional recommendation for use within the Cancer Drugs Fund (CDF) for oncology drugs, where there is significant remaining clinical uncertainty which needs more investigation through data collection. In these cases funding is provided from the CDF for a time-limited period to allow patient access whilst this data is collected, before guidance is then reviewed again for routine commissioning.
NICE does not have any particular criteria to determine whether treatments are eligible for conditional recommendations. However, the process guide for patient access schemes and commercial access agreements and the CDF can be found at the following link: