NICE changes tack on NHS use of BMS' myelofibrosis drug Inrebic

After turning down routine NHS funding of Bristol-Myers Squibb's Inrebic for bone marrow disorder myelofibrosis earlier this year, NICE now says the drug can be made available via the Cancer Drugs Fund.

The health technology assessment (HTA) agency has recommended Inrebic (fedratinib) for treating disease-related splenomegaly (enlarged spleen) or other symptoms in myelofibrosis in patients previously treated with Novartis' Jakavi (ruxolitinib).

The decision makes Inrebic an alternative to chemotherapy, radiation therapy, splenectomy or red blood cell transfusions in myelofibrosis patients who no longer respond to Jakavi treatment.

Inrebic has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) with a wider label for myelofibrosis, including people untreated with Jakavi, but BMS proposed the more restricted label during the NICE appraisal process.

Approval via the CDF means that the drug will be made available to NHS patients in England and Wales on an interim basis while additional clinical data on overall survival and treatment duration are collected.

"As the first treatment to be made available for people with myelofibrosis in a number of years, the community has been eagerly awaiting this decision," said Jonathan Mathias and Nona Baker, co-chairs of the MPN Voice patient organisation.

"It is vital that eligible myelofibrosis patients have access to new treatments that can help to minimise the symptoms of the condition, which is why today's decision is so important to the myelofibrosis community."

Many people diagnosed with myelofibrosis experience debilitating symptoms including fatigue, itching, weight loss, night sweats, fever and bone pain, and splenomegaly that can have a detrimental impact on quality of life.

Around 300 people are diagnosed with myelofibrosis in the UK annually, and around 1,600 are living with the condition, according to BMS. Myelofibrosis can affect people at any age, but it is most often diagnosed in people in their early 70s. Between 10% and 20% of people with myelofibrosis can go on to develop acute myeloid leukaemia.

Inrebic was originally developed by US biotech TargeGen before being acquired by Sanofi, Impact Biosciences, and then Celgene over the course of several years. BMS inherited the drug – which has an annual peak sales estimate of around $400 million – when it bought Celgene for $74 billion.