The latest batch of decisions by the Scottish Medicines Consortium has seen Lundbeck's Selincro approved for use by NHS Scotland to treat patients with alcohol dependence.
Selincro (nalmefene) is a unique dual-acting opioid system modulator that acts on the brain’s motivational system, which is dysregulated in patients with alcohol dependence, and was approved for use in the UK back in May.
Now, the Scottish cost regulator has endorsed the once-daily pill to cut of alcohol consumption in alcohol-dependent adults who have a high drinking risk level, without physical withdrawal symptoms and who do not require immediate detoxification.
But the drug should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption, and should only be given to patients who continue to be at high risk of drinking two weeks after initial assessment, the SMC stressed.
The decision was based on findings from a post hoc analysis of two pivotal Phase III studies representing the licensed population, which showed that the Selincro significantly reduced alcohol intake compared with placebo, measured as a reduction in heavy drinking days and total alcohol consumption over a six-month period.
Annual treatment with the drug is expected to cost around £550.
The regulator also accepted for use Allergan's Botox (botulinum toxin A) for the management of urinary incontinence in adult patients with neurogenic detrusor overactivity due to spinal cord injury or multiple sclerosis.
Botox, which costs £276 per treatment, should however only be used in those not adequately managed with anticholinergics, and patients should be already catheterising or willing and able to catheterise if required.
Two Phase III, double-blind, placebo-controlled studies, in which all patients received best supportive care, showed that botulinum toxin type A was "significantly superior to placebo" in reducing weekly urinary incontinence episodes, the SMC said, explaining its decision.
Allergan's Ganfort (bimatoprost plus timolol) eye drops also gained approved (albeit for restricted use) for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to standard treatments.
The SMC has stipulated that the drug should only be used in patients who have proven sensitivity to preservatives.
Also through the NHS Scotland door were: Pfizer's Xalkori (crizotinib) for adults with previously treated anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (rejected by NICE in August); ProStrakan's Sancuso (granisetron) patches for preventing nausea and vomiting associated with chemotherapy, where oral anti-emetic administration is complicated by factors making swallowing difficult; and Orphan Europe's Carbaglu (carglumic acid) for the treatment of hyperammonaemia .
On the down side, the SMC rejected: Novartis' Glivec (imatinib) for paediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia (on the absence of a submission); Roche's Perjeta (pertuzumab) for HER2-positive metastatic or locally recurrent unresectable breast cancer (insufficiently robust economic case); and Roche's Erivedge (vismodegib) for metastatic or locally advanced basal cell carcinoma (no submission).