NICE has made an interim decision in its draft guidance not to recommend olaparib^​ for ovarian cancer patients with BRCA gene mutations.

According to NICE: "The evidence provided shows that the price that the NHS is being asked to pay for olaparib is too high for the benefit it may provide to patients, so the preliminary guidance does not recommend it."

This draft guidance is now open for public consultation: NICE has not yet published final guidance to the NHS.

Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: “Olaparib slows the progression of the disease for patients with some forms of ovarian cancer but the evidence that it can extend life is uncertain. Because patients are already living longer than two years with conventional treatment, we weren’t able to apply the flexibility we can sometimes use when we appraise cancer drugs.”

He continued: “The cost to the NHS of using this new drug isn’t consistent with the benefits that patients for whom it works will gain and so we were disappointed not to be able to recommend it in this draft guidance.”

Ovarian cancer is the fifth most common cancer in women.

Epithelial ovarian cancer, which affects the surface layers of the ovary, is the most common type, and is similar to fallopian tube and peritoneal cancer. 

People who have BRCA 1 or 2 gene mutations may have an increased risk of ovarian cancer. 

For many people, their cancer will return within 2 years of finishing treatment, requiring further drug therapy.

The news has been met with much disappointment.

Professor Peter Johnson, Cancer Research UK’s chief clinician, said: “NICE’s provisional decision not to recommend olaparib for the small number of women with ovarian cancer and mutations in the BRCA gene is hard to understand. This is a great example of personalised medicine which offers a new treatment for a type of cancer where we have made little progress in the last decade and where there is a clear need for different approaches.

“The NHS can’t afford to ignore important innovations like this while our ovarian cancer survival rates lag behind the rest of the developed world. We hope that the manufacturer and NICE can work together quickly to reach an agreement which allows the drug to be made available when NICE issues its final guidance.”

Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, which carried out 20 years of research underpinning the development of olaparib, said:

“We are very disappointed that women will not have access to this innovative drug through the NHS. The evidence of olaparib’s benefit in women with BRCA positive ovarian tumours is very clear, and this frustrating delay will prevent around 450 women each year from being able to access a beneficial treatment.

“This decision highlights how the current system of drug evaluation and pricing needs reform – in particular to reward the development of innovative drugs that address unmet need in cancer treatment, and which have additional, further potential.

“Olaparib, a PARP inhibitor, is the first cancer drug to be approved that is directed against an inherited genetic mutation. Its development was underpinned by research carried out by scientists at The Institute of Cancer Research, London, and represents a real scientific breakthrough.

“We are pleased that NICE considered earlier phase II trial data as part of this appraisal, as opposed to waiting for the results of larger phase III trials which may take many years. But we’d like to see NICE going further and having the flexibility to approve drugs before overall survival data are available. In return, we’d like to see pharmaceutical companies playing their part – for example by cutting the initial prices of drugs during this period, with prices rising later as benefits are shown in more patients. Such a flexible approach to licensing would allow patients to benefit earlier, reward innovation and at the same time be affordable.

“Larger clinical trials are ongoing, and we are confident in the longer term that drugs like olaparib will become available for subgroups of women with ovarian cancer – and ultimately patients with other cancers too.

“We are especially disappointed because this innovative medicine is based on breakthrough scientific research in UK that involved a creative partnership between academia, biotech and pharma and also with funders.”

Source: Cancer Research UK, ICR and NICE