Cost regulators for the National Health Service in Scotland have OK'd the use of Roche's MabThera (rituximab) to treat two potentially life-threatening illnesses, GPA and MPA.
The move gives patients access to the first licensed medicine for these autoimmune diseases, which until now have been treated off-label with chemotherapy drugs.
GPA (active granulomatosis with polyangiitis) and MPA (microscopic polyangiitis) affect around 13,000 patients in the UK and, if left untreated, can cause the blood vessels to become inflamed and die, potentially leading to organ failure and death.
According to Roche, treatment with MabThera provided effective induction of complete remission at six months in 64% of patients compared to 53% with current standard of care cyclophosphamide.
The Scottish Medicines Consortium has agreed that the drug is both clinically and cost effective, but has restricted its use to patients who have relapsed following treatment with cyclophosphamide or who are intolerant to/unable to receive cyclophosphamide.
The news was also good for Otsuka's Abilify (aripiprazole), which was granted access to Scotland's NHS for treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
The SMC noted that the drug demonstrated superior efficacy to placebo in reducing manic symptoms at four weeks, but its endorsement is dependent on the restriction that initiation and management of treatment is under the supervision of a child/adolescent psychiatrist.
Janssen-Cilag's Intelence (etravirine) was also accepted by the cost regulator, for use in combination with a boosted protease inhibitor and other antiretroviral medicinal products to treat HIV-1 infection in antiretroviral treatment-experienced paediatric patients from six years to under 18 years of age.
It did, however, stipulate that the drug is prescribed under the supervision of specialists in paediatric HIV.
Elsewhere, Sanofi-Aventis' Lyxumia (lixisenatide) was given a green light for the treatment of adults with type 2 diabetes mellitus to help control blood sugar in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, are not effective.
Its use in Scotland has, however, been restricted to patients for whom a glucagon-like protein-1 (GLP-1) agonist is appropriate, as an alternative to existing GLP-1 agonists.
Merck Sharp and Dohme's Isentress (raltegravir) was accepted for use on NHS Scotland in combination with other anti-retrovirals to treat HIV-1 in adolescents and children aged two to 17 years.
The SMC has narrowed its use to patients who are unable to take or are resistant to non-nucleoside reverse transcriptase inhibitors or protease inhibitors, and ordered that the drug should be prescribed under the supervision of paediatric HIV specialists.
Also making it in were: Gilead's Viread, for certain adults and children aged six-12 years with HIV-1 infection, as well as patients with Hepatitis B infection; Pfizer's Sayana Press (medroxyprogesterone acetate injection),cleared for long-term female contraception; Norgine's Targaxan (rifaximin), to reduce recurrence of episodes of overt hepatic encephalopathy (HE) in patients over 18 years of age; and Chiesi's Peyona (caffeine citrate), which won favour for the treatment of primary apnoea of premature newborns.
On the downside, Thrombogenics' Jetrea (ocriplasmin) was turned away by the cost regulator as a treatment for vitreomacular traction.
According to the SMC, two randomised, controlled double-masked studies showed that significantly more patients treated with Jetrea than placebo achieved resolution of vitreomacular traction, which may correlate with improved visual acuity.
However, the submitting company did not present a sufficiently robust economic case to gain acceptance, it said.
The drug, which is being marketed by Novartis unit Alcon, was approved by SMC sister body the National Institute for Health and Care Excellence as a cost-effective option for the condition just last month.
