Novartis MS pill heads stream of SMC approvals

by | 13th Oct 2014 | News

Scottish patients with a severe form of relapsing remitting multiple sclerosis will become the first in the UK to get routine access to Novartis’ once daily pill Gilenya (fingolimod).

Scottish patients with a severe form of relapsing remitting multiple sclerosis will become the first in the UK to get routine access to Novartis’ once daily pill Gilenya (fingolimod).

The Scottish Medicines Consortium has become the first UK body to endorse an oral, first-line treatment for rapidly evolving severe relapsing remitting MS on the National health Service, giving patients access to a drug which has been shown to cut the risk of relapses by 67% compared to placebo.

The National Institute for Health and Care Excellence (NICE) is planning to review Gilenya alongside a range of other MS treatments next year, leaving the decision on whether patients in England have NHS access in local hands for now.

Elsewhere, there was also good news for patients with venous thrombosis after the cost regulator expanded the use of Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) to treat and prevent blood clots in the legs and lungs.

Pradaxa is already approved for use on the NHS in Scotland to prevent venous thromboembolism after elective total hip or knee replacement surgery and for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation. But its use will also be funded for treating deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as preventing their reoccurrence.

Staying with Boehringer, and Jardiance (empagliflozin) has made it through the door as add on combination therapy to improve blood glucose levels in adults with type II diabetes, alongside other glucose-lowering medicines when these, together with diet and exercise, do not provide adequate control.

Again highlighting the postcode lottery of care, NICE said in August that it is “minded not to recommend” the drug and has asked Boehringer to provide with more information to help prove its cost-effectiveness compared to already available treatments.

Takeda’s diabetes offerings Vipidia (alogliptin) and Vipdomet (alogliptin plus metformin combo) have also been accepted for restricted use in Scotland, for improving glycaemic control in type II adult diabetics.

Also getting the green light were: Janssen-Cilag’s Olysio (simeprevir) in combination with other medicines to treat chronic hepatitis C in adults; Takeda’s Adcetris (brentuximab) for certain patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL); Astellas’ Qutenza (capsaicin) for peripheral neuropathic pain in non-diabetic adults; Ferring’s Mysodelle (misoprostol) for labour induction in women with an unfavourable cervix; MSD’s Noxafil (posaconazole) for a stream of fungal infections in adults; Media Pharmaceuticals Dymista (azelastine/fluticasone propionate nasal spray) for moderate to severe seasonal and perennial allergic rhinitis; and Sunovion’s Latuda (lurasidone) for the treatment of schizophrenia in certain adults aged 18 years and over.

On the down side, patients with advanced breast cancer will be disappointed by news that, like NICE, the SMC has rejected funding for Roche’s Kadcyla (rastuzumab emtansine) as “its cost in relation to its health benefits was not sufficient to gain acceptance”. The drug is estimated to cost around £90,000 per patient as per its list price, but is available to patients in England through the Cancer Drugs Fund, in a further show of cross border differences in care.

MSD’s Simponi (golimumab) was also ousted as a treatment for moderately to severely active ulcerative colitis, because the company failed to submit a sufficiently robust economic analysis, while Galderma’s Pliaglis (tetracaine/lidocaine) was not recommended simply because there was no submission from the firm.

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