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NICE backtracks on Biogen's multiple sclerosis drug Zinbryta

Recommends the treatment after new cost effectiveness and a discount provided

Biogen building

Biogen's new multiple sclerosis (MS) therapy should be available to NHS patients in England within three months after NICE reversed an earlier appraisal decision.

The cost-effectiveness regulator has published a final determination on Zinbryta (daclizumab) giving the go-ahead for the drug to be used routinely for patients with the relapsing/remitting form of the disease if they have failed to respond to first-line treatment with Sanofi's Lemtrada (alemtuzumab) or have rapidly evolving severe MS.

NICE turned down Zinbryta in draft guidance issued last October, criticising the analysis submitted by Biogen of the cost effectiveness of daclizumab compared with other disease-modifying treatments. It faced an immediate backlash from patient groups, including the MS Trust, which said it was "frustrating that, yet again, access to an effective new treatment will be further delayed by the NICE appraisal process".

Now, the charity says it is pleased by the change of heart, which comes after Biogen offered an undisclosed discount on Zinbryta's list price of £1,596.67 per 150mg pre-filled syringe and additional cost effectiveness analysis.

MS Trust’s CEO Pam Macfarlane said the green light "further expands the range of disease modifying drugs by offering a different dosing schedule, a different mode of action and a different profile of benefits and risks compared to existing disease modifying drugs".

Zinbryta is dosed once a month - less frequently than other MS drugs such as Biogen's own Plegridy and Avonex - and is formulated as a subcutaneous injection that can be administered by the patient at home. It was originally developed by AbbVie and Biogen, and the latter has marketing rights in Europe.

Terry O'Regan, managing director of Biogen UK and Ireland, said the company was “thrilled” with the decision, as "in this patient group there was a particular need for more treatment options".

"Daclizumab's unique mode of action, together with its convenient once-monthly dosing, offers patients an effective treatment choice against MS, whilst re-balancing the immune system. We look forward to making daclizumab available to eligible patients via the NHS in the coming months," he added.

Zinbryta is also being considered for use by the NHS in Scotland, and the Scottish Medicines Consortium (SMC) is due to publish its decision on April 10.

Article by
Phil Taylor

17th March 2017

From: Regulatory

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