The Institute of Cancer Research, London, has expressed disappointment that NICE has confirmed its decision not to recommend olaparib for previously treated, hormone-relapsed metastatic prostate cancer.

NICE’s decision, means that men in England and Wales with prostate cancer will miss out on a highly innovative treatment option. It puts the NHS in England and Wales out of step with Scotland, where olaparib was approved last year for the treatment of prostate cancers with faulty DNA repair genes, like BRCA1 or BRCA2, which have not responded to prior treatment with the hormone therapies enzalutamide or abiraterone.

The Institute of Cancer Research (ICR) is especially concerned that olaparib appears to have been judged too expensive in part because of the cost of genetic testing to tailor the drug for patients. Tests for BRCA1 and BRCA2 are already included on the NHS testing directory – and the ICR believes that ‘double counting’ the costs is acting as a penalty for innovation.

Earlier this year, NICE issued draft guidance rejecting the use of olaparib on the NHS for patients with advanced prostate cancer and mutations in DNA repair genes. NICE’s final decision to reject olaparib will lead to a postcode lottery across the UK – with men in Scotland being able to access olaparib, but those in England and Wales facing the prospect of missing out.

Olaparib, which was initially developed to treat women with ovarian and breast cancer, is part of a family of drugs called PARP inhibitors that target and kill cancer cells with faulty DNA repair machinery.

Findings from the PROfound trial, led by researchers at the ICR and The Royal Marsden NHS Foundation Trust, showed that giving olaparib to men with tumours with faulty DNA repair genes blocked prostate cancer growth more effectively than the modern hormone treatments enzalutamide and abiraterone – it improved survival and delayed disease progression.

The findings led to olaparib being licensed in the US and Europe for the treatment of some men with advanced prostate cancer. But NICE has judged that the drug is not sufficiently cost-effective to be used on the NHS – apparently in part because of the cost of the accompanying genetic testing.

Before starting treatment with olaparib, men need to get their tumours tested for BRCA mutations, using a ‘biomarker’ test, to ensure they are likely to benefit.

NICE has considered this genetic testing as part of the cost of the drug, even though the National Genomic test directory, which specifies which genomic tests are commissioned by the NHS in England, states that BRCA testing should be carried out for ‘any prostate cancer.

The ICR believes biomarker testing to personalise treatment should become a routine part of cancer care – and that the costs should not be included when assessing whether a new treatment is cost-effective.

The ICR is now urging NICE to work with the manufacturer to make olaparib available – including by showing flexibility on the cost of genetic testing.

Professor Johann De Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and leader of the PROfound trial, said:

“Olaparib works by targeting cancer’s Achilles heel – it is a more effective and personalised treatment option for men with certain mutations in their tumours. I am disappointed and frustrated by NICE’s decision, which will lead to marked differences across the UK in accessing olaparib for prostate cancer.”

Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said:

“This disappointing decision means men with advanced prostate cancer in England and Wales who could benefit from olaparib will miss out on a treatment that could help them live longer and better. I would urge NICE and the drug’s manufacturer to immediately return to the negotiating table and work towards an agreement that can make olaparib available on the NHS at an acceptable price.

“In the longer term, the Government and the pharmaceutical industry need to work together to remove the systemic barriers that can prevent innovative new treatments like olaparib from reaching patients on the NHS. In particular, setting the cost of genetic tests against this drug when those tests are already recommended on the NHS seems to be double counting, and is acting as a penalty to innovation.”

Source: ICR