Prostate cancer drug rejected for use on the NHS

A drug that can extend the lives of some men with prostate cancer is not approved by the NHS.

In a draft guideline, the National Institute for Health and Care Excellence (Nice) said the evidence on olaparib (also called Lynparza) was uncertain and that it would not be a meaningful use of NHS funds.

According to Nice, the list price of the drug is £ 2,317.50 per pack of 56 tablets (14 day supply), with the cost of an average treatment being £ 37,491.

AstraZeneca, which makes the tablets, has a private commercial agreement that provides the NHS with olaparib at a discount.

In his guidelines for England and Wales, Nice said the drug should not be used on men with hormone-relapsed prostate cancer with BRCA1 or BRCA2 mutations that has spread to other parts of the body.

People who had already received treatment with the hormone therapy abiraterone or enzalutamide were studied.

The current treatment for prostate cancer that has spread and no longer responds to hormone therapy is chemotherapy with docetaxel, cabazitaxel, or radium-223 dichloride.

Nice said the evidence from clinical trials shows that people who take olaparib have more time before their disease gets worse and live longer overall than people who are re-treated with abiraterone or enzalutamide.

However, it is said that retreatment with abiraterone or enzalutamide is not considered effective and is not a standard treatment in the NHS.

Nice also said it was uncertain how effective olaparib would be compared to docetaxel, cabazitaxel, or radium-223 dichloride as there was no evidence to directly compare the drugs.

An indirect comparison suggests that olaparib extends the life expectancy of people who received docetaxel compared to cabazitaxel, but that too is uncertain, the watchdog said.

The Institute of Cancer Research (ICR) in London, whose scientists were the first to demonstrate that PARP inhibitors such as olaparib could be particularly effective in BRCA-mutated cancers, said it was disappointed with the news.

The results of the 2019 PROfound study showed that men with prostate cancer who had certain defective genes lived an average of 7.4 months before their cancer progressed, compared with 3.6 months for those who received enzalutamide and abiraterone.

Johann De Bono, Professor of Experimental Cancer Medicine at the ICR and head of the PROfound study, said: “Olaparib is a precision drug that can prolong life for men with some mutations in their tumors while avoiding the side effects of chemotherapy.

“I was delighted when olaparib was approved for NHS patients in Scotland earlier this year – and it is disappointing that this decision means that their colleagues in England and Wales will miss out on such a valuable new treatment option.

“It is an example of the barriers to providing innovative medicines at prices the NHS can afford and will result in postcode prescriptions across the UK.”

ICR Chairman Professor Kristian Helin said: “This is a disappointing decision that is denying men with advanced prostate cancer in England and Wales personalized treatment that could enable them to live longer and healthier lives.

“I urge Nice and the manufacturer to come back to the table and try to find an agreement on a way to make olaparib available at a reasonable price.

“We also need to address the systemic problems we face in providing NHS patients with access to innovative cancer drugs at reasonable prices.

“The NHS needs to be more flexible in pricing drugs from one indication to the next to ensure that new drugs reach more patients, and drug companies in return have to be willing to offer discounts if drugs don’t work as promised.”

Nice executive director Professor Gillian Leng said the body is disappointed in not being able to recommend olaparib to these men.

She added, “However, the company’s own economic model has shown that the drug does not provide enough benefits to justify the asking price.

“We will continue to work with the company to try to address the issues highlighted by the committee.”

It is estimated that around 100 people with hormone-relapsed prostate cancer would have been eligible for treatment with olaparib.

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