Cancer specialists have expressed disappointment at a decision by the National Institute for Health and Care Excellence (NICE) not to recommend a targeted drug that can delay progression of a type of prostate cancer.
In draft guidance, NICE rejected olaparib (Lynparza, AstraZeneca) as a treatment option for hormone-relapsed metastatic prostate cancer with BRCA1/2 mutations.
The list price of the poly-ADP-ribose polymerase (PARP) inhibitor, at £37,491 for an average cost of treatment, meant it was not cost effective to recommend for routine NHS use, the medicines regulator said.
The Institute of Cancer Research (ICR) said the decision by NICE put patients in England and Wales at a disadvantage to those in Scotland where the regulator had approved olaparib for men with the same condition under a patient access scheme.
Prof Kristian Helin, ICR chief executive, said: "I urge NICE and the manufacturer to come back to the table and try to find agreement on a way to make olaparib available at an agreeable price."
Encouraging Clinical Evidence
Results from the PROfound trial, published in 2020 in The New England Journal of Medicine, suggested that progression-free survival for patients with prostate cancers who had faulty BRCA2, BRCA1, or ATM genes was significantly longer in the olaparib group than in a control group who received either enzalutamide or abiraterone.
Median survival in the Olaparib cohort was 7.4 months, compared with 3.6 months in the control group.
Retreatment with abiraterone or enzalutamide is not considered effective for men with this type of prostate cancer, and is not standard care in the NHS, NICE said.
Current treatment for metastatic hormone-relapsed prostate cancer is chemotherapy with docetaxel, cabazitaxel, or radium‑223 dichloride.
NICE acknowledged that while an indirect comparison suggested that in men previously treated with docetaxel, olaparib increased survival compared with cabazitaxel, there were no evidence directly comparing them.
Consultation Period
Prof Gillian Leng CBE, NICE chief executive, said: "We know how important it is for people with this type of prostate cancer to have more treatment options that can help them live longer and enable them to maintain or improve their quality of life, as well as delay chemotherapy and its associated side effects.
"We're therefore disappointed not to be able to recommend olaparib for use in this way. However, the company's own economic model demonstrated that the drug does not offer enough benefit to justify the price it is asking.
"We’ll continue working with the company to try and address the issues highlighted by the committee."
Johann De Bono, professor of experimental cancer medicine at the ICR, who leads the PROfound trial, said: "Olaparib is a precision drug that can extend life for men with some mutations in their tumours while sparing them the side effects of chemotherapy.
"I was delighted when olaparib was approved for NHS patients in Scotland earlier this year – and it's disappointing that this decision means their counterparts in England and Wales will miss out on such a valuable new treatment option.
"It’s an example of the barriers that exist to making innovative drugs available at prices that the NHS can afford and is going to result in postcode prescribing across the UK."
The list price of olaparib is £2317.50 for a pack of 56 tablets covering 14 days of treatment. A confidential discount has been agreed by the manufacturer to make make olaparib available to the NHS.
It is estimated that around 100 men would be eligible for treatment with Olaparib if it was to be approved by NICE.
Consultation on the draft guidance closes on 31 January.
