Old CDF drug not recommended in initial NICE guidance due to lack of evidence
pharmafile | August 10, 2016 | News story | Research and Development, Sales and Marketing | Adcetris, Cancer Drugs Fund, NICE, Takeda, hodgkin's lymphoma
The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Takeda’s Adectris (brentuximab vedotin), despite its presence on the Cancer Drugs Fund (CDF) list.
Adcetris was indicated on the CDF for the treatment of refractory systemic anaplastic lymphoma, and the treatment of relapsed or refractory CD30+ Hodgkin’s lymphoma, but it had not yet been appraised by NICE.
It was recently approved in additional early indications by the European Medicines Agency and yielded a five year survival rate of 41% in patients with relapsed or refractory Hodgkin’s lymphoma following autologous stem cell transplantation. Its data showing median overall survival rate of 40.5 months and progression-free survival rate of 9.3 months was called “interesting and provocative” by Professor Karl Peggs from University College London.
Despite this data, an independent NICE committee judged the evidence around the drug’s clinical effectiveness to be “immature and limited”, and that treatment with the drug would not constitute a cost effective use of NHS resources.
Treatment with the drug can cost between £69,000 and £87,000 per patient per course. The committee also pointed to the small number who could potentially benefit from the treatment, approximately 50-60 per year.
Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE, says: “We recognise that people with this type of Hodgkin’s lymphoma are difficult to treat, but there is not enough convincing evidence on brentuximab vedotin’s clinical and cost effectiveness to recommend its use within the NHS as representing value for money.
“We understand that this preliminary decision will be disappointing to patients who could be eligible for treatment. But we need to make sure that the drugs and treatments we look at will benefit patients and be a cost effective use of NHS resources.”
Takeda issued a statement strongly opposing the decision. They highlight the availability of Adcetris in Scotland and Wales after the Scottish Medicines Consortium the All Wales Medicines Strategy Group approved the drug, as well as many other European countries having wide access to it.
Jon Neal, business unit director – oncology at Takeda UK, says: “Brentuximab vedotin has been a game changer in the management of relapsed or refractory Hodgkin lymphoma and is the only licensed medicine in this setting. This is a rare disease that often affects young people and due to the high level of unmet need, brentuximab vedotin was granted a license on unprecedented Phase II trial results. This poses a challenge to the NICE methodology which penalises the absence of Phase III data which is often the case for rarer cancer medicines.
“Despite the committee’s conclusion that this is not a relevant population for routine care in England, Takeda stands firm that there is a clear unmet need especially in high-risk patients who might not be eligible for a subsequent allogeneic transplant.”
Sean Murray
Related Content
Digital mental health technologies – a valuable tool in supporting people with depression and anxiety
The potential benefits of digital mental health technology for managing depression, anxiety and stress, together …
Von Willebrand disease – increasing awareness and access to vital care
Pharmafile talks to Anthea Cherednichenko, Vice President Franchise Head Haematology and Transplant at Takeda about …
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
