Novartis has criticised the current state of drug access in the UK after its melanoma combination of Tafinlar and Mekinist launched in the country, but is still unavailable to patients while the Cancer Drugs Fund (CDF) is closed to new medicines.
NICE guidance on the treatment – which is the first targeted combination treatment for melanoma in the UK – is not expected until the second half of 2016. While Novartis was hoping that the CDF could fund the drug while it awaited full approval, NHS England announced in July that no new medicines will be listed through the CDF until at least April, when a revamped Fund is expected to begin.
“While the CDF was not sustainable, it was the only mechanism by which new cancer medicines could get funding between launch and an appraisal by NICE,” said Margaret Dean, general manager, Novartis Oncology UK and Ireland. “It is unfortunate that the CDF is closed to all new cancer medicines – with no transition mechanism in place. What this means for Tafinlar and Mekinist is that no patients can benefit from July 2015 until April 2016 at the earliest and patients are falling through the gap.”
Several drugs were dropped from the CDF last year as the Fund came under increasing financial pressure from skyrocketing prices for new cancer medicines. A National Audit Office investigation concluded that although it has improved access it is ‘not sustainable’.
Consultations for a revamped CDF are proposing that it becomes a ‘managed access’ fund to give early access to those drugs which appear promising but which have uncertain evidence bases. All new cancer drugs would receive a clear ‘yes’ (baseline commissioning), ‘maybe’ (CDF funding for time limited period), or ‘no’ funding decision within 90 days of market authorisation.
The Tafinlar (dabrafenib) and Mekinist (trametinib) combo is a precision treatment that targets patients with a BRAF V600 mutation. Approximately half of all melanoma cases have a BRAF mutation, which can be determined by genetic testing of the tumour.