NHS England (NHSE) has lifted restrictions on provision of Imbruvica (ibrutinib) after a successful campaign from patient groups over its interpretation of NICE guidelines.
NICE approved the drug for chronic lymphocytic leukaemia (CLL) in January 2017 for suitable patients, but NHSE restricted its use to patients who had already received chemotherapy, but had relapsed within 3 years.
These limitations have come in for criticism from both patient groups such as the CLL Support Association (CLLSA) and Leukaemia Care, as well as experts including senior haematologists. CLLSA highlighted that NHSE is required to fund all medicines approved by NICE, and along with Leukaemia Care described these restrictions as “arbitrary”, while Henry Smith MP insisted that it was unacceptable for NHSE to be “reinterpreting” NICE guidance. The case has received additional attention as a result of reporting by Sean O’Neill from The Times, who has been personally affected by these restrictions.
The Chair of NHSE’s Chemotherapy Clinical Reference Group has now written to NHSE’s National Medical Director Professor Stephen Powis recommending that the restrictions be lifted on the grounds of new evidence being available in support of the case. Powis has now confirmed that in light of this recommendation, he expects the restrictions to be lifted within weeks.
As a result of the questions raised by the case, NICE has issued a comment, clarifying that the wording of its guidance stipulated a recommendation only for “suitable patients”, and “because unsuitability for treatment 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.”