Patient groups and academics have urged the National Institute for Health and Care Excellence and Johnson & Johnson unit Janssen to get back to the table following the former’s rejection of Zytiga as a treatment for prostate cancer before chemotherapy.  

In final draft guidance NICE has not recommended Zytiga (abiraterone) for prostate cancer in people who received hormone therapy but whose disease has spread, who have few symptoms and when chemotherapy would not yet have been given. The drug is already backed by the cost watchdog for treatment after docetaxel containing chemotherapy.

Sir Andrew Dillon, NICE chief executive, said “we know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way. However, the manufacturer’s own economic model demonstrated that the drug does not offer enough benefit to justify its price”.

Not clear how much drug extends life

NICE goes on to say that although data from one trial indicated that, when compared with placebo, Zytiga could delay the progression of the disease, it was not clear how much the therapy, which is available through the Cancer Drug Fund, actually extended life. It also argues that the health economic model presented by Janssen “was particularly complex and the committee felt that this has made it difficult for the evidence review group (ERG) to validate and critique the model”.

Cost per Quality Adjusted Life Year (QALY) estimated both by Janssen (£46,700 per QALY gained) and the ERG “fell substantially above the range normally considered cost effective”, NICE noted, that is £20,000 -£30,000. Zytiga costs £2,930 for 120 tablets and Janssen agreed a patient access scheme two years ago with the Department of Health which involves a single confidential discount.

Janssen to appeal

Unsurprisingly, Janssen said it is “extremely disappointed” and intends to appeal. The company noted that the reduced cost has also been offered for Zytiga before chemotherapy, saying that the decision means men with prostate cancer, whose treatment with androgen deprivation therapy is failing, will be denied the opportunity to delay or avoid chemotherapy.
Peter Barnes, medical director at Janssen, said that NICE’s decision “if it stands, will leave thousands of men in England in the advanced stages of prostate cancer with no option but to accept chemotherapy”. He added that “these men will eventually be able to receive abiraterone on the NHS after chemotherapy anyway”, noting that it is “the second most requested medicine through the CDF and so the support for this treatment from doctors and patients is clear”.

The stand-off between NICE and Janssen has caused consternation among patients. Prostate Cancer UK noted that at the end of June, former health minister Paul Burstow urged the DoH to intervene in the NICE process and call off the proposed restriction on pre-chemotherapy use.

‘Kick in the teeth’ for patients
Owen Sharp, the charity’s chief executive, said: “It’s a fiasco. This decision is a kick in the teeth for men with advanced prostate cancer. For many this presented a vital opportunity for extra time with loved ones and a chance to delay chemotherapy and the debilitating side effects which come with it”.   
He added that “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”. Mr Sharp said that”once again men in England will have to take their chances with the CDF, with men in Wales and Northern Ireland left with nowhere to turn”.
He concluded by saying “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 [and] we urge Janssen and NICE to get their act together and do whatever is necessary to get abiraterone pre-chemotherapy across the line without delay”.

‘Plainly illogical’
Paul Workman, interim chief executive of the Institute of Cancer Research (where Zytiga was discovered), urged NICE and Janssen to “explore every option for making abiraterone available to these men at a price that is affordable for the NHS”. He added 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”.

Prof Workman went on to say that “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”. He added 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”.

Prof Workman said it is also concerning that “the willingness of the CDF 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”.