Three new medicines have been issued a green light by cost regulators for use on NHS Scotland, offering new treatment options to patients for breast cancer, prostate cancer and heart failure.

The Scottish Medicines Consortium has now accepted for use Eisai’s Halaven (eribulin) for the treatment of advanced breast cancer in those patients who have already received a number of treatments.

Halavan was considered under the SMC’s PACE (Patient and Clinician Engagement) process, during which patient groups and clinicians highlighted that the drug may give patients two to three months additional survival.

Novartis’ Entresto (sacubitril/valsartan) was endorsed to treat chronic heart failure in patients with reduced ejection fraction, a life-threatening and debilitating condition that can have a major impact on quality of life. 

The drug is widely considered a breakthrough treatment as it is the first to show a significant benefit over mortality benefit over an ACE-inhibitor; with data from the 8,442 patient PARADIGM-HF demonstrating that it cut cardiovascular deaths by 20% versus enalapril, as well as heart failure hospitalisations and all-cause mortality by 21% and 16%, respectively.

There was also good news for patients with prostate cancer after earlier use of Astellas’ Xtandi (enzalutamide) was accepted following consideration by an Independent Review Panel convened by the SMC. 

The drug was previously recommended by the SMC for use in patients who have already received chemotherapy, but is now also approved for use at a much earlier stage in the treatment pathway, when chemotherapy is not yet clinically indicated. 

Xtandi “offers this patient group a significant improvement in survival and quality of life and provides a further treatment option in the pre-chemotherapy setting,” the cost watchdog said. 


On the downside, Roche’s Perjeta (pertuzumab) has been turned down for the routine treatment of early stage breast cancer before surgery, because of uncertainty around the overall survival benefit it may bring.

Roche argues that the decision means that women in Scotland “will be denied a treatment which allows reduction of large tumours to a size that is operable, therefore potentially enabling breast conservation surgery instead of mastectomies”.

Similarly, Bristol-Myers Squibb’s Opdivo (nivolumab) was rejected for advanced skin cancer, 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, the cost regulator noted.

“Immunotherapies such as nivolumab have been shown to improve significantly survival in metastatic melanoma and also are generally well tolerated, so the decision to withhold funding is disappointing”, said Marianne Nicolson, Consultant Medical Oncologist.

“We appreciate these decisions will be disappointing for patients and would welcome resubmissions addressing the points raised,” said SMC chairman Jonathan Fox.