UK patients with myeloma have been dealt yet another blow after cost regulators issued a preliminary rejection for the use of Novartis’ Farydak by the National Health Service in England and Wales.
The National Institute for Health and Care Excellence is currently appraising the drug’s use in combination with Janssen's Velcade (bortezomib) and dexamethasone to fight the condition in patients who have already received at least two prior therapies.
Farydak (panobinostat) is the first cancer medicine to target enzymes known as histone deacetylases, offering a novel mechanism of action different from other MM treatments on the market.
Clinical data underpinning the drug's European approval earlier this month show that it can boost progression-free survival; patients receiving the Farydak regimen saw a delay in their disease progression of about 7.8 months more than those given Velcade/dexamethasone alone.
NICE said its independent review committee heard from the clinical and patient experts that the drug may provide an additional treatment option for patients because of its different mode of action when compared with existing treatments, but did not consider it a step-change in treatment.
Also, the Committee concluded that Farydak failed to meet the short life expectancy, extension to life criteria, and that it was not possible to determine the most plausible incremental cost effectiveness ratio for the drug, “because the appropriate analyses had not been presented”.
News of the preliminary rejection will be particularly concerning to patients given that recent cuts to England’s Cancer Drugs Fund included multiple myeloma treatments Celgene's Revlimid (lenalidomide) and Imnovid (pomalidomide), leaving patients with no alternative options if they fail to respond to standard therapies.
Novartis said it is disappointed with the decision, but that it will continue to “work closely” with NICE to achieve a positive final outcome for patients.
“With nearly half of multiple myeloma patients currently not expected to survive past five years, this is a wholly unacceptable situation that is indicative of the wider issues surrounding the assessment of, and access to, cancer medicines in England,” the Swiss drug giant said in a statement.