NICE Draft Recommendation Rejects Pfizer’s Bosulif

It is looking unlikely that Pfizer’s Bosulif (also known as Bosutinib) will be made available on the NHS, after cost regulator, NICE, released preliminary draft guidance rejecting the drug’s use in patients with chronic myeloid leukaemia (CML).

Bosulif has already been approved in Europe as well as the US for use after treatment with one or more tyrosine kinase inhibitor, i.e. Novartis’ Gleevec and Tasigna or Bristol-Myers Squibb’s Sprycel.

However, while admitting that there is evidence to suggest that Bosulif is clinically effective for the treatment of CML, Sir Andrew Dillon, chief executive at NICE, noted that “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.”

According to the National Institute for Health and Care Excellence (NICE)’s independent Appraisal Committee, the most credible cost per QALY for the chronic phase population overshot £43,000 and £49,000, depending on the amount that 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, failing to fall within adequate cost thresholds.

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

“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,” Sir Andrew Dillon concluded.

Stakeholders will now have the chance to try to alter the regulatory body’s position prior to the final decision.


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