NICE publishes draft guidance on two prostate cancer treatments
pharmafile | December 11, 2015 | News story | Medical Communications, Research and Development, Sales and Marketing | Astellas, Janssen, NICE, Xtandi, Zytiga, prostate cancer
NICE has issued final draft guidance recommending Astellas Pharma’s Xtandi (enzalutamide) in prostate cancer prior to chemotherapy, but not Janssen’s Zytiga (abiraterone).
The regulator specifically approved Xtandi for prostate cancer which has spread in people whose first treatment has failed, who have no or mild symptoms, and for whom chemotherapy is not yet clinically indicated. Zytagi was rejected for the same indication.
The Appraisal Committee concluded that Xtandi is a well-tolerated treatment that delays chemotherapy (which it recognised as being valuable to patients) and improves survival. It considered the drug to be cost-effective, while the opposite was true for Zytiga, despite Janssen offering 20% discounts to NICE, as well as free treatment for patients after the first 10 months.
The Committee said that that while Zytiga is also a well-tolerated treatment, which delays chemotherapy, it was “not convinced that the uncertain evidence for the long-term benefit of abiraterone justified accepting estimates of cost-effectiveness that were significantly above what it would normally consider acceptable.”
Sir Andrew Dillon, NICE chief executive, said the evidence submitted was “uncertain in terms of the extent of the quality of life and survival benefit,” adding: “Its current cost does not appear to justify its advantages, to patients, over current standard treatment.”
Janssen said it was extremely disappointed with a decision which would deny men in England routine access to a medicine that can delay disease progression and prolong life. It noted that Zytiga is already routine available before chemotherapy in over 100 countries worldwide, including Scotland, and that NICE considers the drug cost-effective for use after chemotherapy- an indication in which it is already approved.
The only way in which eligible men in England and Wales will now be ensured routine access to Zytiga earlier in their disease is via the Cancer Drugs Fund- where Janssen says it is the second most commonly-requested drug. However, with the Fund due to end in March 2016 and its future still uncertain, Janssen asserts that a NICE approval is the only guarantee of access.
Mark Hicken, managing director, Janssen UK & Ireland, rejected NICE’s evaluation of Zytiga’s benefits, saying: “There is high demand for abiraterone in England, so it is extremely disappointing that yet again patients may not be routinely entitled to earlier access to a treatment on the NHS that can extend survival. We disagree with NICE that the evidence we submitted was uncertain. Our trial, one of the largest and longest in prostate cancer, clearly demonstrates long-term survival and quality of life benefits for patients which are also recognised by the clinical community.
“Abiraterone is an important option for patients who cannot or who do not want to undergo chemotherapy. It is in everybody’s interest to have a range of treatment options for men with advanced prostate cancer and we will continue to collaborate with NICE and NHS England to explore ways to secure routine and early access for eligible patients in England.
He continued: “This latest decision only serves to heighten our concern about patient access to many other innovative cancer medicines that are likely to be available in other countries around the world. England already lags behind the rest of Europe in the access and uptake of new cancer medicines and the recently published consultation on the Cancer Drugs Fund signals greater restrictions in the future and not the improvements that patients deserve. This is a very worrying time.”
Heather Blake, director of Support and Influencing at Prostate Cancer UK, comments: “Today’s announcement approving earlier use of enzalutamide in England and Wales is a huge victory for men. It shows that when manufacturers finally get their act together and demonstrate clinical benefit at a price the NHS can afford – men can get access to treatments. By contrast, it is baffling that after years of negotiation, abiraterone’s manufacturer still hasn’t convinced NICE of its worth as an earlier treatment, which is at odds with what has been agreed for men in Scotland. It is a decision NICE and abiraterone’s manufacturer must step up efforts to change over the coming weeks.
“We can’t carry on with a system that spends more than a year haggling over drugs that could benefit men immediately. We’ve long been calling for wholesale reform of the way cancer drugs are appraised that provides a better deal for patients. Now a proposal is finally on the table, we won’t rest until we know it will result in a more streamlined, financially sustainable, fast track process that men and their families so desperately need. Men with advanced prostate cancer do not have time to wait around.”
Consultees may appeal both decisions until a final verdict is made, and the Committee will consider all comments.
Joel Levy
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