A drug which can extend the lives of some men with prostate cancer will not be approved for use on the NHS.
In final guidance which rubber-stamps an earlier decision, the National Institute for Health and Care Excellence (Nice) said olaparib (also called Lynparza) is not a good use of NHS money at its current price.
The Institute of Cancer Research (ICR) in London, whose scientists worked on a clinical trial of the drug, said the decision means men will miss out on a highly innovative treatment.
The ICR said it 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”, arguing that this testing should already be happening as part of NHS care.
In its guidance, Nice said the drug should not be used for men with hormone-relapsed prostate cancer with BRCA1 or BRCA2 mutations which has spread to other parts of the body.
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 Johann De Bono, Institute of Cancer Research
While clinical trial evidence shows that people taking the drug have more time before their cancer gets worse, and live longer overall, than people having a further round of treatment with abiraterone or enzalutamide, Nice said this “re-treatment” is not standard care in the NHS.
It added: “Further indirect comparisons with some existing treatments also show that olaparib may increase how long people live. However, the results are uncertain.”
It said that, while the drug does meet the criteria for life-extending end-of-life treatment, it cannot be approved at its current price.
Olaparib, which is made by AstraZeneca and given as a tablet, is a type of targeted drug called a PARP inhibitor. These prevent cancer cells from repairing.
The ICR said Nice has considered the cost of 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 already be carried out for “any prostate cancer”.
The ICR said biomarker testing to personalise treatments 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.
Johann De Bono, professor of experimental cancer medicine at the ICR and leader of the PROfound trial into the drug, 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.”
The drug is currently approved in Scotland.
We are extremely disappointed by today’s decision, which will deny hundreds of men in England, Wales and Northern Ireland access to an innovative, life-extending treatment— Dr Matthew Hobbs, Prostate Cancer UK
ICR chief executive Professor Kristian Helin said: “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 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.”
Dr Matthew Hobbs, director of research at Prostate Cancer UK, said: “We are extremely disappointed by today’s decision, which will deny hundreds of men in England, Wales and Northern Ireland access to an innovative, life-extending treatment, just months after it was approved in Scotland.
“No man should miss out on additional time with his loved ones because of where he lives.
“We urge all parties to come back to the table and work together more flexibly to find a solution that will change this decision.”
