SMC accepts three medicines for use in NHS Scotland; rejects two

Posted: 7 March 2016 | | No comments yet

The Scottish Medicines Consortium (SMC) has accepted three new medicines for routine use in NHS Scotland.

Eisai’s Halaven (Eribulin) for advanced breast cancer, Novartis’ Entresto (sacubitril/valsartan) for chronic heart failure and Astellas’ Xtandi (enzalutamide) for prostate cancer were all accepted.

The SMC Committee was unable to accept Bristol-Myers Squibb’s Opdivo (nivolumab) for melanoma and Roche’s Perjeta (pertuzumab) 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.

Commenting on the announcement, 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.”

Nivolumab and pertuzumab not recommended

Following consideration under the PACE process, the Committee was unable to recommend pertuzumab for the routine treatment of early stage breast cancer before surgery due to concerns about uncertainty around  the overall survival benefit it may bring. 

Commenting on the partuzumab announcement, Richard Erwin, General Manager, Roche Products, said: “Roche is extremely disappointed that the SMC has decided not to fund Perjeta for patients with early-stage breast cancer. We are committed to working in collaboration with both the SMC and the Scottish Government to ensure that all eligible patients in Scotland can access Perjeta and other innovative medicines now and in the future.” 

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 said: “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.”