When we last reported on this subject, in December 2016, there were concerns about the restrictions NHS England (NHSE) had placed on the access of patients to NICE-approved drug combinations, specifically:
- The targeted therapy combination of dabrafenib + trametinib, suitable for patients with a BRAF mutation; and
- The immunotherapy combination of ipilimumab + nivolumab, which is also appropriate for many patients.
The restrictions applied to patients with brain metastases and to those who had previously been involved in clinical trials, and would have adversely affected patients currently on trials as well as the ability to conduct trials in the future.
We are pleased to report that these restrictions have now been removed. This follows concerns raised by the Melanoma Specialist Advisory Group, which was set up by NHSE at the end of last year to establish and oversee national melanoma systemic therapy algorithms. Melanoma clinicians led by Dr Pippa Corrie (Chair of the NCRI Skin Clinical Studies Group and a Trustee of Melanoma Focus) served on this Group.
Their concerns centred on the ‘Blueteq Criteria’ that govern patient eligibility for combination therapies; in particular, melanoma specialist oncologists felt them to be too restrictive and not reflecting NICE guidance or the emerging clinical evidence base. NHSE accepted these concerns and worked with the Group to revise the criteria.
The revised criteria, effective from 13 March 2017, are summarised below (changes underlined):
Dabrafenib + Trametinib
Ipilimumab + Nivolumab
- CDF criteria may be amended to permit access for patients recruited to NIHR portfolio clinical trials, following request by the Chief Investigator.
- Approval has been given to recruit patients to the INTERIM portfolio trial comparing intermittent versus continuous dosing of dabrafenib + trametinib.
Professor Paul Lorigan
Chairman, Melanoma Focus
14 March 2017