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NICE backtracks on Novartis Farydak decision

Published on 04/12/15 at 09:35am
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NICE has reversed its earlier decision to reject the Novartis drug Farydak as an NHS treatment for people with multiple myeloma.

The body issued positive guidance for the use of Farydak (panobinostat) in treating myeloma patients in England and Wales who have received at least two prior treatments.

Having been approved by the European Commission in September, in combination with Velcade (bortezomib) and dexamethasone, NICE then originally ruled out its use on the NHS.

The decision was criticised by the manufacturer and by patient support groups, including Myeloma UK. They argued that – following cuts to the Cancer Drugs Fund – rejecting Farydak would have meant that patients with multiply myeloma would have been unable to access licensed therapies if they fail to respond to standard-of-care therapies.  

However the U-turn means that Farydak is recommended, in combination with Velcade and dexamethasone, for “adult patients with relapsed and/or refractory multiple myeloma, who have received at least two prior regimens including bortezomib and an immunomodulatory agent.”

NICE’s reverse came after Novartis agreed to provide a discount through a patient access scheme. Novartis had earlier spoken of its hope that the decision could be reversed, after NICE made “constructive comments which indicate an open-minded view.” Farydak is the first drug in its class, called histone deacetylase (HDAC) inhibitors, to be approved in Europe, and costs £776 per 20 milligram tablet.

Novartis says in a statement: "This recommendation is a clear recognition that panobinostat represents an important treatment option within the management of multiple myeloma as well as a cost effective use of NHS resources. This decision is also a reflection of the ongoing commitment of Novartis to achieve positive outcomes in such reviews through constructive dialogue with NICE."

This recommendation is a clear recognition that panobinostat represents an importanttreatment option within the management of multiple myeloma as well as a costeffective use of NHS resources.This decision is also a reflection of the ongoing commitment of Novartis to achievepositive outcomes in such reviews through constructive dialogue with NICE.

Myeloma UK welcomed the decision, saying “it offers myeloma patients in England and Wales a new treatment option.”

Chief executive Eric Low says: “This is a very encouraging outcome. In a time of such uncertainty for patients with regard to access to cancer treatments in England, it is good to see important new treatments for myeloma being approved by NICE.

“I applaud the efforts and willingness of everybody involved, especially the NICE Appraisal Committee and Novartis, in working together to reverse the draft ‘no’ and to deliver such a positive outcome for myeloma patients. It goes to show the power stakeholders have when they work together and it’s something that needs to happen on a more regular basis.”

Lilian Anekwe

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