NICE rejects prostate cancer drug due to cost of genetic testing

The National Institute of Health and Care Excellence (NICE) has confirmed its decision not to recommend olaparib for previously treated metastatic prostate cancer in patients with BRCA gene mutations.

The Institute of Cancer Research (ICR) has called the decision ‘disappointing’ and ‘frustrating’. It means that men in England and Wales with prostate cancer will miss out on a treatment option which is available in Scotland.

The drug has also been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat some breast cancer patients, though the decision from NICE on this indication is still awaited.

A “penalty for innovation”

NICE has judged olaparib too expensive partly because of the cost of genetic testing to tailor the drug for patients. However, these tests are already included on the NHS testing directory and the ICR believes that “double counting” the costs is acting as a “penalty for innovation”.

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.

The PROfound trial, led by researchers at the ICR and The Royal Marsden NHS Foundation Trust, showed that in men with faulty DNA repair genes olaparib blocked prostate cancer growth more effectively than modern hormone treatments.

Biomarker testing “should be routine”

A biomarker test for BRCA mutations is required before treatment with olaparib. NICE has considered this test as part of the cost of the drug, even though the National Genomic test directory states that BRCA testing should be carried out for ‘any prostate cancer’.

The ICR argues biomarker testing to personalise treatment should become a routine part of cancer care. It is now urging NICE to work with the manufacturer to make olaparib available.

Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said: “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 reaching patients on the NHS.”

MHRA approval for breast cancer

On a more positive note, olaparib been approved by the MHRA to treat patients with high-risk, early-stage breast cancer and inherited faults in their BRCA1 or BRCA2 genes.

The drug offers women diagnosed with early-stage, inherited breast cancer an additional treatment that can help prevent their cancer recurring and improve their survival.

The approval grants marketing authorisation for the use of olaparib in the UK. However, an appraisal by NICE is currently under way with a decision expected by early 2023.

Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at the ICR and King’s College London, said: “Olaparib offers the first treatment that exploits the specific biology of this inherited type of breast cancer to reduce the risk of cancer returning and improve survival in women diagnosed with early-stage disease. I am hopeful it will become a new standard of care.”


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