Scotland accepts HIV drug Rezolsta, rejects cancer drug Xtandi

HIV treatment Rezolsta is one of three new drugs accepted for use by the Scottish Medicines Consortium (SMC).

Accepted alongside Janssen’s Rezolsta were Merck Sharp & Dohme’s novel antibiotic Sivextro (tedizolid phosphate) and Boehringer Ingelheim’s (BI) Spiriva (tiotropium) for a new use in asthma.

However two other drugs were rejected: Astellas’ prostate cancer treatment Xtandi (enzalutamide) in use before chemotherapy and Eisai’s Halaven (eribulin) for advanced breast cancer.

Dr Alan MacDonald, vice chairman of SMC, said: “We are pleased to be able to accept these three medicines for use in NHS Scotland. Tackling antibiotic resistance and HIV are high on the agenda for Scotland, and severe asthma is also a significant concern. We hope these medicines will be of benefit to patients.”

Janssen’s Rezolsta combines protease inhibitor darunavir (Janssen’s Prezista) and boosting agent cobicistat (Gilead’s Tybost) in a single daily dose. The drug was launched in the UK in December, and offers convenience and an alternative for patients unable to tolerate the side effects of other treatments.

The Spiriva approval is good news for BI, being the first in its class to be approved in combination with other treatments for patients with ‘severe, persistent and poorly-controlled’ asthma.

Merck will also be pleased with the thumbs up for Sivextro, which was launched in June in the UK.

Developed by antibiotics specialist Cubist before it was acquired by Merck, (Merck Sharp & Dohme in the UK) the drug is the first new oral antibiotic in its class for 15 years.

The drug’s oral formulation could help patients leave hospital earlier, which is likely to improve outcomes for patients and hospital costs. The SMC stipulated that effective antibiotic stewardship was needed to ensure the drug was used only when necessary. It accepted Sivextro for use in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain Gram-positive bacteria, including MRSA.

No to cancer drugs, despite Patient and Clinician Engagement

The news wasn’t so good for Astellas and Eisai, which saw their respective cancer drugs Xtandi and Halaven rejected. This was despite the Patient and Clinician Engagement (PACE) process, in which the SMC listens to the views of doctors and patients to gain extra insight above and beyond the company submission.

Dr Alan MacDonald, vice chairman of SMC, said it was disappointing not to be able to recommend the drugs, despite the PACE progress and ‘applying as much flexibility as we could’.

He added: “We realise these decisions will disappoint patients and clinicians alike, but SMC has to consider clinical and cost effectiveness in making its decisions.”

In the case of Halaven, the SMC said there was uncertainty around the benefits Halaven would bring to patients at the end of their lives – trials have shown it can add around two months of survival, but is also associated with sometimes severe side effects. The decision is in contrast to a Cancer Drugs Fund (CDF) ruling in England in July, although this decision was only reached after an appeal against de-listing by Eisai.

The decision on Xtandi mirrors a draft NICE ruling from June in the same setting, in men with metastatic prostate cancer who have relapsed on hormone treatment, but have not yet received chemotherapy.

The SMC agreed with NICE in ruling that the trial data was not robust enough to prove its value in these patients. The NICE decision has been criticised, but has yet to be finalised. Xtandi is still available to these patients in England via the CDF.

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