March 2016 decisions news release
The Scottish Medicines Consortium (SMC) has today published advice accepting three new medicines for routine use in NHSScotland.
Eribulin (Halaven) for advanced breast cancer, sacubitril/valsartan (Entresto) for chronic heart failure and enzalutamide (Xtandi) for prostate cancer were all accepted. The SMC Committee was unable to accept nivolumab (Opdivo) for melanoma (skin cancer) and pertuzumab (Perjeta) for treatment of early stage breast cancer in patients before they receive surgery.
Eribulin was accepted for the treatment of advanced breast cancer in those patients who have already received a number of treatments. Eribulin was considered under the SMC’s PACE (Patient and Clinician Engagement) process. During the PACE meeting, patient groups and clinicians highlighted that eribulin may give patients two to three months additional survival which is extremely valuable in the context of limited remaining months.
Sacubitril/valsartan is used to treat chronic heart failure, a common long-term, life-threatening and debilitating condition that can have a major impact on quality of life. A patient group submission from Chest, Heart and Stroke Scotland stated that sacubitril/valsartan has the potential to prevent early death and also reduce hospital admissions. Sacubitril/valsartan offers a further treatment option for patients suffering from this condition.
Enzalutamide (Xtandi) was also accepted following consideration by an Independent Review Panel (IRP) convened by SMC. SMC has previously accepted enzalutamide for use in patients who have already received chemotherapy. This submission related to the medicine’s use at an early stage in the treatment pathway for prostate cancer before chemotherapy. Enzalutamide offers this patient group a significant improvement in survival and quality of life and provides a further treatment option in the pre-chemotherapy setting.
Following consideration under the PACE process, the committee was unable to recommend pertuzumab (Perjeta) for the routine treatment of early stage breast cancer before surgery. Despite the added flexibility PACE gives to the decision making process, the committee was unable to recommend pertuzumab due to concerns about uncertainty around the overall survival benefit it may bring.
Nivolumab, which is used to treat advanced skin cancer, was also considered under the PACE process. The committee was unable to recommend nivolumab as the uncertainty around the long term benefits of the medicine for this patient group meant it was not considered to be a good use of NHS resources.
Professor Jonathan Fox, chairman of SMC said:
“I am pleased we were able to accept these new medicines for routine use in NHSScotland. We know from the powerful inputs we received from patient groups that our advice on medicines for advanced breast cancer, chronic heart failure and prostate cancer will be welcomed.
“Unfortunately, the committee was not able to recommend pertuzumab for early stage breast cancer in the pre-surgery setting or nivolumab for advanced melanoma. Uncertainties in the evidence for both these medicines meant the committee was concerned they may not represent a good use of NHS resources. We appreciate these decisions will be disappointing for patients and would welcome resubmissions addressing the points raised.”