It is looking unlikely that Janssen’s Zytiga plus androgen deprivation therapy (ADT) and prednisone/prednisolone will become routinely available on the NHS as a first-line treatment for patients with high-risk hormone-sensitive metastatic prostate cancer.

The National Institute for Health and Care Excellence has published draft guidelines rejecting the therapy in this setting, after concluding that the company’s economic model “did not accurately reflect the treatment pathway” for these patients.

It noted that data comparing the clinical effectiveness of Zytiga (abiraterone) plus ADT with current standard treatment (docetaxel plus ADT) “has not been fully explored” and so there is “no plausible cost-effectiveness estimate” comparing the two.

Zytiga is currently approved for use on the NHS before chemotherapy but only after patients have received standard hormone therapy. Last year European regulators cleared its use as a first-line treatment for advanced prostate cancer, alongside hormone therapy.

Janssen said it is disappointed with NICE’s position, noting that if it becomes final “up to 4,400 men with this particularly aggressive form of prostate cancer will be unable to access the treatment until their disease has progressed”.

Also, around half of these patients who are unable to tolerate conventional docetaxel chemotherapy “will be left with no life-prolonging treatment option at this early, but crucial stage in the treatment pathway,” the firm added, stressing that Zytiga “is the only licensed treatment for mHSPC that can delay chemotherapy and disease progression, prolong overall survival and maintain patients’ quality of life.”

“We firmly believe that the clinical effectiveness demonstrated in the multinational, Phase 3 LATITUDE study, means that abiraterone plus ADT should be made available routinely to NHS patients that need it, and we will continue to work closely with NICE to make this happen,” said Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen UK.

Also expressing disappointment at the decision, the Institute for Cancer Research, London, which discovered abiraterone, is now calling “for urgent discussions around the data supporting the drug’s effectiveness earlier in treatment and its price, and is urging a review of the decision within a year as new trial data become available”.

“Abiraterone has been a game changer for treatment of prostate cancer – extending the lives of men with the disease, and crucially sparing them the side-effects of conventional chemotherapy,” said the ICR’s chief executive Professor Paul Workman.

“We hope the manufacturer will be able to provide the data NICE needs as soon as possible so that the drug can be made available earlier in treatment. I’d also urge both parties to get together to discuss the price of abiraterone, as it is essential that those men who might benefit from earlier access to the drug do not miss out on the grounds of cost.”

Prostate cancer is the most common cancer in men in the UK, with 1 in 8 men affected by the condition in their lifetime.