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November 2016 decisions news release

Five new medicines accepted for routine use in Scotland. 

The Scottish Medicines Consortium (SMC) has today (Monday 7 November) published advice accepting five new medicines for routine use in NHS Scotland. 

Olaparib (Lynparza) was accepted to treat a rare type of incurable ovarian cancer. It was 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. Through PACE, patient groups and clinicians highlighted that patients tend to be younger women who may have significant family and work commitments. This diagnosis is often made at an advanced stage and there are currently no other treatment options available. Olaparib is the first maintenance treatment for ovarian cancer, delaying time to chemotherapy and potentially offering increased survival benefits. As an oral treatment, it also reduces the number of hospital visits for women. 

Nivolumab (Opdivo) was accepted via PACE for the treatment of advanced melanoma (a form of skin cancer) in combination with another medicine, ipilimumab. PACE participants spoke of melanoma affecting a disproportionate number of young adults who may have a key role in caring for children or elderly parents. Using nivolumab in combination with ipilimumab offers an increased response rate compared to using either medicine alone. 

Sofosbuvir/velpatasvir (Epclusa) is used to treat a particular type of hepatitis C, genotype 3, which is the most difficult strain of hepatitis C to treat. 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. 

Migalastat (Galafold) is used to treat Fabry disease, a very rare, inherited metabolic condition. In Fabry disease, the enzyme alpha-galactosidase, which breaks down waste materials in cells, is missing or deficient, leading to symptoms including progressive cardiac disease, renal disease and renal failure. Current treatment is through enzyme replacement therapy which is administered via intravenous infusion, which can affect patients’ work and social life. Migalastat is a self-administered oral treatment which can help patients better manage their condition while improving their ability to carry on with day to day life. 

Also accepted was dequalinium (Fluomizin) for the treatment of bacterial vaginosis, a condition in which the balance of bacteria inside the vagina becomes disrupted, usually causing an abnormal discharge.

The Committee was unable to accept nivolumab (Opdivo) for the treatment of advanced renal (kidney) cancer. The Committee did not recommend the medicine as it was not satisfied that the company’s evidence on the benefits of the medicine was strong enough to justify its cost to the NHS.

Also not recommended was fampridine (Fampyra) for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability. The Committee was unable to recommend fampridine because the overall health benefits of the medicine were not sufficient to justify its cost to the NHS. 

Professor Jonathan Fox, chairman of the SMC, said:

“The Committee is pleased to be able to accept these five medicines for routine use in NHS Scotland. As the first maintenance treatment for ovarian cancer, olaparib is an important development, and we know from the evidence given by patients and clinicians through our PACE process that it will be welcomed. 

“The increased response rate seen in patients given nivolumab in combination with ipilimumab for the treatment of advanced melanoma will be beneficial to patients. 

“Eradicating hepatitis C is a key commitment for both Scottish Government and the World Health Organisation, so new medicines for this condition, particularly the hard to treat genotype 3 variant, are always useful.

“Migalastat, an oral treatment for Fabry disease, will be a convenient option for some patients.”

“Unfortunately, the Committee was not able to accept nivolumab for renal cancer as it was not satisfied by the evidence of benefits in relation to its cost. This meant nivolumab was not considered to be a good use of NHS resources. For fampridine, the overall health benefits offered by the medicine did not justify its cost.”