Things are not looking good for Pfizer's Bosulif on the NHS, after cost regulators said they were minded not to approve its use in patients with a certain form of leukaemia.

The National Institute for Health and Care Excellence has issued preliminary draft guidance rejecting Bosulif (bosutinib) for previously treated patients with chronic myeloid leukaemia (CML).

The drug has been approved in both Europe and the US for use after treatment with one or more tyrosine kinase inhibitor i.e. Novartis' Gleevec (imatinib) and Tasigna (nilotinib) or Bristol-Myers Squibb's Sprycel (dasatinib).

But while conceding that there is evidence to suggest that the drug is clinically effective for the treatment of CML, "limitations in the evidence provided by the manufacturer meant that the actual benefit compared to other treatments in terms of the estimated effect on overall survival was unclear", said NICE chief executive Sir Andrew Dillon, explaining the decision. 

According to NICE's independent Appraisal Committee, the most plausible cost per QALY for the chronic phase population overshot £43,000 and £49,000, depending on the degree to which bosutinib would be used in clinical practice beyond that shown in clinical trials.

Similarly, the ICERs for the accelerated and blast phase patient populations are at least £65,000 and £89,000 per QALY gained, respectively, failing to fall within acceptable cost thresholds.

Even if cost ratios had been at an acceptable level, the drug does not meet all of the criteria in order to take the supplementary advice on life extending treatments into account, NICE said.

“CML is a chronic condition, meaning the drugs will be used for a long period of time and even with the proposed patient access scheme, which reduces the overall cost of treatment, bosutinib doesn’t offer enough benefit to justify its price," Dillon concluded.

However, these are just preliminary recommendations and stakeholders will now have the opportunity to try to change the Institute's position.