Monday, 21 March 2016

Zytiga (abiraterone) approved

Thousands of prostate cancer patients in England and Wales will no doubt welcome news that cost-regulators have changed their minds on whether to release NHS funding for Janssen’s Zytiga pre-chemotherapy, now endorsing the drug as a cost-effective option.

Back in December the National Institute for Health and Care Excellence turned down Zytiga (abiraterone) for patients for whom chemotherapy is not yet indicated after initial evidence submitted by Janssen failed to demonstrate quality of life and long-term survival.

But during the consultation period the drugmaker submitted extra data from a large group of patients given Zytiga at this stage in the treatment pathway in the US, which showed that 14% were still taking the drug after 4.4 years. 

The appraisal committee expressed some concerns about whether these results could be generalised to the UK, but they recognised that the new data supported the case for some patients taking Zytiga for long periods of time. As such, the committee has now issued final guidance concluding that the drug is indeed a cost-effective use of NHS resources.

“I am very pleased that the new evidence submitted has meant we are able to recommend abiraterone,” said Carole Longson, Director of the Centre for Health Technology Evaluation at NICE. “There are few treatments available for patients at this stage of prostate cancer so this is very good news.”

Paul Workman, chief executive of The Institute of Cancer Research, London, which discovered the drug, has welcomed the news: “This is a big victory for men in England with prostate cancer, and means they will finally catch up with the US, Europe and indeed Scotland in being able to access abiraterone earlier in the course of treatment”.

System overhaul
“The answer today is the right one, but I would urge NICE to implement the planned overhaul of its drug appraisal processes as soon as possible to avoid repeated delays in getting the best, most innovative treatments to patients. It’s been more than three years since NICE first started evaluating use of abiraterone pre chemotherapy, and it’s very frustrating that it has taken that long for NICE and the drug’s manufacturer to find a way of making it available cost-effectively.”

Mark Hicken, managing director of Janssen UK & Ireland, said: “We have worked tirelessly for several years to ensure abiraterone, a UK-discovered medicine, which demonstrates long term survival and quality of life benefits for patients, is made widely available for men who cannot have or do not want chemotherapy and are delighted that this is now possible for them”.

But he also stressed that “the length of time taken to gain approval in the UK demonstrates a clear need for reform of the way NICE appraises innovative cancer medicines,” and that Janssen is “concerned that the CDF changes recently approved by NICE and NHS England will only exacerbate these problems, resulting in even greater restrictions for cancer patients in England”.

Zytiga is also approved by NICE for routine use after chemotherapy in patients with metastatic prostate cancer.

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