Scottish cost regulators are allowing routine use of a combination of Bristol-Myers Squibb's Opdivo and Yervoy for first-line treatment of patients with advanced melanoma on the National Health Service.
The endorsement was based on data from the Phase III Checkmate-067 study - which also underpinned EU approval of the Opdivo (nivolumab)/Yervoy (ipilimumab) regimen in May - showing a median progression-free survival of 11.5 months versus 6.9 months for Opdivo and 2.9 months for Yervoy.
On the downside, the SMC also issued guidance which will deny Scottish NHS patients with previously treated advanced kidney cancer the option of treatment with Opdivo.
The submission for kidney cancer included data from a pivotal Phase III trial showing that patients who received the drug as a second-line treatment lived an average of 5.4 months longer than those treated with a current standard therapy (everolimus), BMS said. But the SMC took the position that the the firm's justification of the treatment's cost in relation to its health benefits was not sufficient and that it failed to present a sufficiently robust economic analysis to gain acceptance.
Elsewhere, AstraZeneca's Lynparza (olaparib) was accepted to treat a rare type of incurable ovarian cancer, after having been considered through the SMC's Patient and Clinician Engagement (PACE) process, which is used for medicines that treat end of life and very rare conditions.
Specifically, the drug can be used for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Lynparza is the first maintenance treatment for ovarian cancer, delaying time to chemotherapy and potentially offering increased survival benefits and, as an oral treatment, also reduces the number of hospital visits for women, the SMC noted.
Gilead's Epclusa (sofosbuvir/velpatasvir) can now be funded on NHS Scotland to combat a particular type of hepatitis C, genotype 3, the most difficult strain to treat.
The therapy is a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF/VEL; approved as Sovaldi) and the pan-genotypic NS5A inhibitor velpatasvir, and the first all-oral, single tablet regimen cleared for the treatment of adults with genotype 1-6 chronic HCV.
As an oral treatment, fewer hospital visits are needed with less disruption to daily life. It has a more tolerable side effect profile than some other treatment options and, in addition, it offers the opportunity of a cure in a shorter treatment period.
Amicus' Galafold (migalastat) has been endorsed as a treatment for the rare, inherited condition Fabry disease.
Current treatment is through enzyme replacement therapy, administered via intravenous infusion, which can affect patients' work and social life. Galafold is a self-administered oral, small molecule drug, which can help patients better manage their condition while improving their ability to carry on with day to day life, the regulator noted.
Also accepted was Kora Healthcare's Fluomizin (dequalinium) for the treatment of bacterial vaginosis, a condition in which the balance of bacteria inside the vagina becomes disrupted, usually causing an abnormal discharge.
On the downside, the SMC rejected Biogen Idec's Fampyra (fampridine) for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability.
The Committee was unable to recommend the drug because the overall health benefits of the medicine were not sufficient to justify its cost to the NHS, the cost watchdog explained.