Janssen statement in response to the NICE Final Appraisal Determination (FAD) on the use of Zytiga® (abiraterone acetate) prior to chemotherapy
Janssen is extremely disappointed with the NICE Final Appraisal Determination (FAD) 1 published today (August 15) which does not recommend the use of Zytiga® (abiraterone acetate) for the treatment of metastatic castration resistant prostate cancer, before chemotherapy. The company intends to appeal this decision.
NICE has rejected abiraterone before chemotherapy on the basis that it does not meet end of life criteria* and is therefore not cost effective.
The NICE decision comes despite abiraterone already being approved by NICE as cost effective for use after chemotherapy. Abiraterone is available to the NHS at a reduced cost, which was agreed under a patient access scheme two years ago, and this has also been offered to the NHS for the treatment of men with abiraterone before chemotherapy.
This decision means that men with prostate cancer, whose treatment with androgen deprivation therapy (ADT) is failing, will be denied the opportunity to delay or avoid chemotherapy through the use of abiraterone prescribed routinely on the NHS at this stage of their disease.Dr Peter Barnes, Medical Director at Janssen said:
"We are very disappointed with this decision which, if it stands, 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. These men will eventually be able to receive abiraterone on the NHS after chemotherapy anyway, but will be denied the option of taking it earlier on in their illness."
"Abiraterone is the second most requested medicine through the Cancer Drugs Fund and so the support for this treatment from doctors and patients is clear."
This medicine was discovered in the UK and its use around the world represents a major success story for the life science industry in this country.
The Institute of Cancer Research (ICR) statement: NICE rejection of abiraterone before chemotherapy in advanced prostate cancer
Commenting on today's rejection of abiraterone before chemotherapy in final draft guidance from NICE, Professor Paul Workman, Interim Chief Executive of The Institute of Cancer Research, London, said:
"We're very disappointed that men with prostate cancer will miss out on the chance to have abiraterone much earlier in their course of treatment as a consequence of this decision. There is clear evidence that use of abiraterone before chemotherapy is beneficial for patients, and gives them longer, healthier lives. 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.
"Abiraterone, which was discovered at The Institute of Cancer Research, is now used as standard after chemotherapy, where it was found to be cost-effective under NICE's own end-of-life criteria. 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. 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.
"Abiraterone maintains patients in a better state of health during the course of treatment than chemotherapy, and the increases in median survival it offers include much larger benefits for life expectancy in some men. Now men will have to wait until they are in the final stage of their lives before they can access this treatment, and men who are too frail to receive chemotherapy face not being able to receive abiraterone at all.
"It is critical that patients are able to benefit from innovative new treatments that make use of the latest genetic and molecular advances in cancer. We believe that the current NICE system for drug appraisals takes too little account of how innovative a treatment is, and we worry that the new rules under consideration could make this situation even worse. It is likely that many modern targeted therapies will be more effective in patients when used earlier in treatment or in combinations, but it will be impossible to provide treatment in these ways if innovative drugs first fail to clear the hurdle of NICE approval.
"It is also concerning that the willingness of the Cancer Drugs Fund to cover the full cost of some new treatments in England may be damaging the ability for drugs to be approved and made available across the UK, or to secure long-term access to these treatments once the Fund comes to an end."