Three new medicines have been cleared for use by NHS Scotland by cost regulator the Scottish Medicines Consortium (SMC), bringing patients new options for breast cancer, fungal infection and warts.
Novartis’ Afinitor (everolimus) has been accepted as a treatment for advanced breast cancer, giving patients who no longer respond to hormone therapy a new option besides chemotherapy.
The decision marks a u-turn from the SMC’s earlier rejection of the drug back in October last year, and comes after patient groups and clinicians highlighted that the drug can delay the need for chemotherapy by up to six months, as well as a patient access scheme to enhance its cost-effectiveness.
“Being able to provide Scottish patients, with this type of advanced breast cancer, a targeted treatment option is welcome news for them and their families,” noted David Cameron, Professor of Oncology at Edinburgh University.
Elsewhere, Basilea’s Cresemba (isavuconazole) is in for the treatment of aspergillosis and mucormycosis, fungal infections which can attack the brain and lungs of patients with weakened immune systems. PACE participants described how these infections carry a significant mortality rate as well as causing severe shortness of breath and chronic fatigue, and the drug offers another treatment option for these patients, the SMC noted.
A Phase III, randomised, double-blind, non-inferiority study demonstrated that, in the treatment of invasive aspergillosis, isavuconazole was non-inferior to a triazole antifungal for all-cause mortality through day 42, and had a similar overall response at the end of treatment.
Also accepted was Kora Healthcare’s Catephen (camellia sinensis) ointment for the treatment of genital and perianal warts.
According to the SMC there is currently an unmet need for an effective, licensed, well-tolerated treatment for this condition, but the regulator has restricted its use to patients not suitable or unresponsive to podophyllotoxin.
On the downside, the Committee was unable to accept PTC Therapeutics’ Translarna (ataluren) for Duchenne Muscular Dystrophy, “as there was too much uncertainty about the overall clinical benefits it might bring in relation to its cost”, despite “powerful” testimonies from patient groups and clinicians. However, the firm has indicated its intention to re-submit the drug, the SMC said.
Also ousted was Alexion Pharma’s Soliris (eculizumab) for Paroxysmal Nocturnal Haemoglobinuria (PNH), a rare genetic disease in which red blood cells break apart prematurely, causing blood clots and bone marrow dysfunction.
The Committee was unable to support the drug’s use “as the overall health benefits of the medicine meant it would not justify the cost to the NHS”.