November 2015 decisions news release
The Scottish Medicines Consortium (SMC) has announced today that four new medicines have been accepted for routine use by NHSScotland.
Pembrolizumab (Keytruda) is a new medicine that is indicated for the treatment of advanced skin cancer (melanoma) in adults. It was accepted for use in patients who have not been previously treated with ipilimumab (another medicine used to treat skin cancer). Through the SMC’s Patient and Clinician Engagement (PACE) process, which aims to improve patient access to new medicines for the treatment of end of life and very rare conditions, patient groups highlighted that melanoma affects a disproportionate number of young adults and that current treatment options are limited. Pembrolizumab may delay the progression of skin cancer and also has different side effects to existing medicines, increasing the range of potential options for patients who may be unable to tolerate other treatments.
The committee also considered a submission for pembrolizumab in patients with skin cancer who have been previously treated with ipilimumab. The committee was unable to accept pembrolizumab for use at this stage of treatment due to uncertainty around the extent of clinical effectiveness the medicine may have for this patient group.
Bevacizumab (Avastin) was accepted following a resubmission for use in combination with chemotherapy as an initial treatment for patients with advanced ovarian cancer. In the PACE meeting, patient groups and clinicians spoke of the lack of treatment options for patients, highlighting that no other new medicines had been developed in the past 10 years for use at this stage of the condition.
The committee also accepted edoxaban (Lixiana), an oral anticoagulant (a medicine that prevents blood clots forming) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism. Patient group submissions stated that edoxaban offers an alternative treatment option which could benefit patients and their families as it required fewer hospital visits than some other similar medicines.
Edoxaban was also accepted for the prevention of stroke in patients with atrial fibrillation (a kind of irregularity of the heart beat). Patient group submissions highlighted that the once a day dose of edoxaban could be an advantage for some patients.
Professor Jonathan Fox, chair of SMC, said:
“I am pleased the committee has been able to accept these new medicines. Treatment options for ovarian cancer and advanced melanoma in particular are quite limited at present, so it is particularly pleasing to be able to accept both bevacizumab for ovarian cancer and pembrolizumab for advanced melanoma in patients not yet treated with ipilimumab. We know from the testimonies given by patient groups through both the PACE process and patient group submissions that patients and clinicians will welcome these medicines being made routinely available in NHSScotland.
“Unfortunately we were unable to recommend pembrolizumab for routine use in patients who have already received treatment with ipilimumab as there were uncertainties around the extent of clinical effectiveness of using the medicine at this stage of the treatment pathway.”