Scotland backs five new drugs at July meeting

Five new medicines have been added to the list of prescribable medicines on the NHS in Scotland, although two cancer drugs and a blood-thinner did not make the cut.

The latest crop of approvals by cost-effectiveness watchdog the Scottish Medicines Consortium (SMC) includes treatments for thyroid cancer, Crohn's disease, pulmonary atrial hypertension and blood clots, as well as a novel antibiotic for pneumonia.

Bayer's Nexavar (sorafenib) was given the go-ahead for NHS use as a treatment for an extremely rare type of cancer called differentiated thyroid carcinoma (DTC) and was one of two new drugs that were accepted under Scotland's PACE (Patient and Clinician Engagement) process, which aims to improve patient access to new medicines for the treatment of end-of-life and very rare conditions.

DTC can cause difficulties with breathing and swallowing and, with no alternative treatment options currently available, "sorafenib can be life-changing and possibly even life-saving," said the SMC.

Also cleared under the PACE process was Bayer's first-in-class pulmonary arterial hypertension (PAH) therapy Adempas (riociguat), which provides another treatment option and may help to improve the quality of life of patients with the disease, according to the SMC.

PAH is a disease where narrowing of the blood vessels leads to increased pressure in the main artery to the lungs, making physical activity of any kind difficult. Adempas was cleared by the EMA in March 2014 and brought in €89 million in sales last year.

Takeda got a green light from the SMC for Entyvio (vedolizumab), which was approved in the EU as an alternative to tumour necrosis factor (TNF) inhibitors for the treatment of moderate-to-severe Crohn's disease and ulcerative colitis (UC) last year.

Entyvio may have fewer side effects than TNF inhibitors in Crohn's disease, according to the Scottish agency, which approved the drug for the treatment of adult patients who have not responded to treatment with the other drug class. The top-selling TNF inhibitor – and in fact the biggest pharmaceutical product in the world – is AbbVie's $13 billion-a-year Humira (adalimumab).

Leo Pharmaceuticals' Innohep (tinzaparin) was also given the nod by the SMC to treat venous thrombo-embolism, which includes blood clots in the legs and the lungs, as was Basilea Pharmaceuticals' new antibiotic Zevtera (ceftobiprole) for the treatment of hospital-acquired pneumonia.

Nexavar has not yet been reviewed for DTC by England's National Institute for Health and Care Excellence (NICE), which has yet to deliver guidance on Adempas for PAH, Zevtera and Innohep. NICE has, however, backed Entyvio for both Crohn's and UC.

Three rejections

There was bad news from the SMC for AstraZeneca, whose Lynparza (olaparib) was rejected as a treatment for advanced ovarian cancer, following the lead of NICE which took the same line on the drug in June and prompted a debate over what has been described as deadlock over access to cancer drugs in the UK.

"The committee felt there were a number of uncertainties around the overall survival benefits of olaparib and that the health benefits may not justify the cost to NHS Scotland," said the SMC.

The SMC also said it was also unable to recommend Pierre Fabre's Javlor (vinflunine) for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract, even though there is a lack of effective therapies for this type of cancer, with no new treatments for bladder cancer reaching the market in 30 years. The SMC said there were weaknesses around the overall costs in relation to health benefits.

It also rejected use of Bayer's novel oral anticoagulant Xarelto (rivaroxaban) for preventing blood clots in patients with acute coronary syndrome (ACS), arguing that the drug did not offer value for money compared with other therapies on the market. NICE backed Xarelto use in ACS in guidance finalised in March.