Scotland says no to Afinitor but approves six other drugs

Patients in Scotland will not be eligible for routine treatment with Novartis’ breast cancer therapy Afinitor, in common with their counterparts in the rest of the UK.

The Scottish Medicines Consortium (SMC) said it was unable to recommend Afinitor (everolimus) for routine use in advanced breast cancer patients by NHS Scotland ‘due to uncertainties surrounding the overall clinical benefit the medicine would provide for patients at the end of their lives’.

Despite assertions being made that the drug has the ability to delay chemotherapy during the SMC’s Patient and Clinician Engagement (PACE) process – in which it listens to the views of doctors and patients to gain extra insight above and beyond the company submission – the SMC was unswayed. The agency said it still had doubts that the drug, which costs around £36,000 per year, would be an effective use of NHS resources.

The National Institute for Health and Care Excellence (NICE) delivered a similar verdict on Afinitor for patients in England and Wales in the summer, and the drug is also among those culled from the Cancer Drugs Fund (CDF).

Afinitor is approved to treat post-menopausal women with hormone receptor-positive breast cancer, in other words tumours whose growth is driven by the hormone oestrogen, but who test negative for HER2.

Novartis maintains that Afinitor is the first new therapy licensed in 15 years in this patient group, pointing to clinical evidence that it can delay chemotherapy for up to six months, which, it says, is a clinically meaningful benefit for patients.

The company said it was disappointed by the SMC’s decision but was hoping to resubmit the drug after ‘continued constructive communication’ with the agency.

The SMC gave its blessing to six other drugs, however, including Roche’s Herceptin (trastuzumab), which it cleared for a rare form of stomach cancer involving HER2-postive tumours cells, an indication that has also been backed by NICE.

Specifically, the drug got the go-ahead for use in combination with capecitabine or fluorouracil and cisplatin for HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction (GEJ) in previously-untreated patients.

There was a volte-face on Janssen’s prostate cancer Zytiga (abiraterone acetate), with the SMC reversing its earlier stance and endorsing use of the drug for use before chemotherapy. The drug is prescribable under NHS Scotland for post-chemotherapy patients but the SMC rejected its use in the pre-chemotherapy setting earlier this year.

The SMC also backed another prostate cancer therapy – Bayer’s radiopharmaceutical Xofigo (radium 223) – which is indicated for the treatment of men whose malignancy has spread to the bones and has been shown to improve survival in trials and can also reduce the risk of spinal cord compression and fractures.

Boehringer Ingelheim got a positive recommendation for its idiopathic pulmonary fibrosis (IPF) therapy Ofev (nintedanib), on the grounds that it works differently to the only other approved drug for this progressive lung disease, Roche’s Esbriet (pirfenidone). It therefore provides an alternative treatment approach to Esbriet, which was backed by the SMC in 2013.

The SMC also backed funding for Novo Nordisk’s recently-approved combination insulin/GLP-1 agonist product Xultophy (degludec/liraglutide) for type 2 diabetes and Santen’s Ikervis (ciclosporin) eye drops for the eye disease severe keratitis.

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