he Institute of Cancer Research and Prostate Cancer UK are both urging NICE and Janssen to ‘get their act together’ over the watchdog’s rejection of a new prostate cancer medicine.
Zytiga (abiraterone) is already recommended by NICE for patients at the end-of-life after they have received chemotherapy, as it can potentially give them a longer survival time.
But in new final draft guidance issued today, the drug pricing watchdog says it is not cost-effective to offer the drug before these patients have been given chemotherapy.
Specifically, NICE has not recommended Janssen’s medicine in prostate cancer patients that received hormone therapy, but whose disease has spread and have few symptoms when chemotherapy would not yet have been given.
NICE blames Janssen’s data for the decision, saying it “was not clear by how much” Zytiga actually extended life when compared with placebo, and could only delay the progression of the disease, not increase overall survival.
The body also says it has a ‘number of concerns’ with the way Janssen calculated the drug’s cost-effectiveness, but NICE says what was clear is that the drug is “not cost-effective at its current price”.
Zytiga costs £2,930 for 120 tablets and is given in a single dose of 1g per day, taken as four 250mg tablets. Janssen has agreed a patient access scheme with NICE, which lowers the overall cost of the drug.
Owen Sharp who is the chief executive of Prostate Cancer UK, did not mix his words: “It’s a fiasco,” he says. “This decision is a kick in the teeth for men with advanced prostate cancer.”
He goes on: “An inflexible NICE process plus the drug company’s inability to produce all the requested data has led to this being just the latest in a string of hugely disappointing rulings on prostate cancer drugs.
“The current system is flawed. It is not fit for purpose and it is the very people it is supposed to serve who are bearing the brunt. This decision is unjust and it needs to be overturned so that men in desperate need can receive the most effective drugs, wherever they live.”
He says that he is now urging Janssen and NICE to ‘get their act together’ and do “whatever is necessary to get [Zytiga] pre-chemotherapy across the line without delay”.
Professor Paul Workman, interim chief executive of The Institute of Cancer Research in London, which discovered Zytiga and helped develop it, says he too is ‘very disappointed’ in the rejection.
He went on to say that it is “plainly illogical that NICE did not have the flexibility to assess use of abiraterone before chemotherapy under the same end-of-life criteria, simply because men were here surviving for longer than the two-year cut-off”.
He adds: “It is an unintended, and quite bizarre, consequence of the current rules for appraisals that patients have to wait until their life expectancy drops before they can access beneficial drugs on the NHS.”
Prof Workman concludes: “We urge NICE and the drug’s manufacturer to get back to the table, and explore every option for making abiraterone available to these men at a price that is affordable for the NHS.”
In a statement sent to Pharmafile Janssen says it is also ‘extremely disappointed’ in the decision, with Dr Peter Barnes, the firm’s medical director, saying the decision will “leave thousands of men in England in the advanced stages of prostate cancer with no option but to accept chemotherapy – which they may not necessarily need or want yet – before being eligible to receive abiraterone routinely on the NHS”.
The firm will be appealing the decision.
Cancer Drugs Fund
The drug is currently available via the government’s Cancer Drugs Fund which injects nearly £1 billion over a six-year period into the NHS to pay for medicines not recommended by NICE, or under appraisal.
But this Fund is due to stop from April 2016, and there is currently no political promise in place to have it extended. The General Election also falls in May 2015, meaning a new government – with a new health mandate – could also have very different plans for the CDF.
Cancer charities and pharma firms are urging the government to create a longer term solution, with many now saying that NICE should be reformed to allow them the remit to pass more oncology medicines through its process.
In a strongly worded statement Roche said: “NICE’s rejection of Kadcyla demonstrates quite simply that their current system is broken, not fit for purpose and in need of a complete overhaul when it comes to advanced cancer.”
The ABPI (of which Roche is not a member) made a similar statement, saying that NICE “needs to reform its processes to ensure cancer medicines can go through routine commissioning”.
Ben Adams .