Scottish Medicines Consortium approves six new drugs


Patients with psoriasis, advanced melanoma, chronic myelogenous leukaemia, urinary tract infections, schizophrenia, and those in need of emergency surgery or experiencing life-threatening bleeding now have access to new treatment options in NHS Scotland.

The SMC endorsed LEO pharmaceuticals’ Enstilar cutaneous foam, a fixed combination of calcipotriol 50 mg/g and betamethasone 0.5 mg/g as topical treatment of psoriasis vulgaris in adult patients.Following a full submission assessed

Following a full submission assessed under the end of life and ultra-orphan medicine process, Novartis’ Mekinist was approved in combination with dabrafenib as first-line treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The SMC’s advice was dependent on the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower. Though Mekinist is license as monotheraoy, SMC did not recommend the medicine for monotherapy use.

In another full submission, Bristol-Myers Squibb’s Sprycel was recommended for adult patients with (1) newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia in the chronic phase, and (2) chronic, accelerated or blast phase chronic myelogenous leukaemia with resistance or intolerance to prior therapy including imatinib mesilate. Similar to Mekinist, SMC advice was based on continuous availability of the Patient Access Scheme in NHS Scotland.

Profile Pharma’s Monuril was endorsed for (1) acute lower uncomplicated urinary tract infections, caused by pathogens sensitive to fosfomycin in adult and adolescent females, and (2) as prophylaxis in diagnostic and surgical transurethral procedures.

The Janssen Cilag’s three-monthly maintenance injection Trevicta was approved for adult patients with schizophrenia who are clinically stable on one-monthly paliperidone palmitate injectable product.

Lastly, Boehringer Ingelheim’ s Praxbind, a specific reversal agent for dabigatran was recommended for adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

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