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SMC approves Amgen orphan drug for use in NHS Scotland

Also accepts AbbVie's former orphan drug Duodopa, but rejects Sanofi's Jevtana

Scottish Medicines Consortium (SMC) 

The Scottish Medicines Consortium (SMC) has accepted Amgen's orphan drug Blincyto (blinatumomab) for routine use in NHS Scotland.

The health technology assessment body also approved AbbVie's drug/device combination Duodopa (co-careldopa) for advanced Parkinson's disease.

Both treatments were accepted after being considered under the SMC's Patient and Clinician Engagement process (PACE) for medicines that treat end of life and very rare conditions.

Duodopa is a gel that is administered directly into the gut via a surgically-inserted pump and tube, providing symptom control for the small number of patients with Parkinson's disease for which it is suitable.

The drug formerly had orphan status, but was withdrawn from the Community Register of designated orphan medicinal products in November 2015.

The SMC was criticised by patient groups last December when it initially rejected the treatment, but this time around the views of sufferers and their clinicians swung a positive verdict.

AbbVie will, however, have to provide the drug under a patient access scheme to improve Duodopa's cost-effectiveness score.

Professor Jonathan Fox, chairman of the SMC, said: “I am pleased we were able to accept these new medicines for routine use in NHS Scotland. From the powerful testimony we heard from patients and clinicians about co-careldopa, we know this decision will be welcomed by patients and carers alike.

“Blinatumomab, which is a further treatment option for acute lymphoblastic leukaemia, and can provide a bridge to bone marrow transplant for some patients, is also to be welcomed.”

Amgen's Blincyto was accepted as a treatment of acute lymphoblastic leukaemia (ALL), a rare and aggressive form of leukaemia, provided the company offers an agreed patient access scheme to improve its cost-effectiveness.

However, after putting Sanofi's Jevtana (cabazitexel) chemotherapy through the PACE process the SMC decided it was unable to recommend it - in contrast with the advanced prostate cancer treatment's recommendation by NICE.

In its ruling on Jevtana the SMC said: “The submitting company did not present a sufficiently robust economic analysis and in addition their justification of the treatment's cost in relation to its benefits was not sufficient to gain acceptance by SMC.”

Following a meeting between Sanofi and the SMC the pharma company has signalled its intention to re-submit Jevtana for approval in the future.

Article by
Dominic Tyer

16th June 2016

From: Regulatory



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