June 2017 decisions news release

The Scottish Medicines Consortium (SMC), which reviews newly licensed medicines, has today published advice accepting four new medicines for routine use by NHSScotland.

Nivolumab (Opdivo) was accepted following consideration through SMC’s Patient and Clinician Engagement (PACE) process, for medicines used at the end of life and for very rare conditions. Nivolumab is used to treat advanced renal (kidney) cancer, a terminal condition with poor prognosis. Through the PACE meeting, patient groups and clinicians highlighted that there are limited treatment options for advanced renal cancer and patients often have to stop work at a relatively early stage due to the disease itself and side effects from current treatments. Nivolumab offers the opportunity of increased overall survival and improved quality of life for patients. It is also better tolerated than other current treatments.

Cabozantinib (Cabometyx) was also accepted for the treatment of advanced renal cancer following consideration through PACE. In the PACE meeting, patient groups and clinicians spoke of how cabozantinib can increase the time until the disease progresses and extend overall survival. As an oral treatment, it also reduces the number of hospital visits patients have to make to receive treatment.

The SMC Committee also accepted obeticholic acid (Ocaliva) through the PACE process. Obeticholic acid is used to treat a liver disease known as primary biliary cholangitis in patients who fail to respond adequately to existing treatments. PACE participants highlighted that this group of patients face a decline in liver function and decreasing quality of life. Obeticholic acid may delay progression of the disease.

Also accepted was aprepitant (Emend), which is used in combination with other medicines to prevent nausea and vomiting caused by moderately emetogenic chemotherapy in children aged 6 months to 17 years.

The committee was unable to accept pertuzumab (Perjeta) for the treatment of HER2- positive metastatic breast cancer. Pertuzumab is used in combination with two other medicines, trastuzumab and docetaxel, which are already used to treat patients at this stage of the disease. Following consideration through PACE, the committee did not recommend pertuzumab as in spite of the benefits it offered the costs were too high and would not have been a good use of NHS resources.

Dr Alan MacDonald, chairman of the SMC, said:

“The committee is pleased to be able to accept four new medicines for routine use by NHS Scotland."

“We know from the evidence given by patient groups at our PACE meeting for nivolumab and cabozantinib that these two medicines will be valuable additions to the treatment currently available for patients with terminal renal cancer."

“For those with liver disease, the routine availability of obeticholic acid will also be welcomed, while aprepitant is a helpful additional treatment option for the prevention of nausea and vomiting caused by chemotherapy."

“Unfortunately the committee was unable to accept pertuzumab for routine use. While there was strong support for the medicine from patients and clinicians and we applied as much flexibility as we could through the PACE process, having considered all the evidence the committee did not consider that the addition of pertuzumab would be a good use of limited NHS resources for treating HER2-positive metastatic breast cancer compared with the use of trastuzumab and docetaxel alone. Pertuzumab is a very expensive medicine."

“We know this decision will be disappointing to patients and their families as we understand how devastating breast cancer can be. However, when we make our decisions we have to take account of the needs of all patients who require treatment by NHSScotland, not just those who would benefit from the medicine under consideration.”