Three new medicines have been granted approval by cost regulators for use on NHS Scotland. The new treatments will offer options to patients for breast cancer, prostate cancer and heart failure.

The Scottish Medicines Consortium has now accepted use of 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.

The SMC also accepted Novartis’ Entresto (sacubitril/valsartan) 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.

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

Astellas’ Xtandi (enzalutamide) was also accepted for the treatment of patients with prostate cancer after earlier use of 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 has now been approved for use at a much earlier stage within treatment, 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.

Rejections

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

Roche argues that the decision means 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,” stated SMC chairman Jonathan Fox.

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