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NICE rejects Pfizer blood cancer drug

pharmafile | July 16, 2013 | News story | Sales and Marketing BMS, CML, NICE, Pfizer, bosulif 

NICE is not recommending Pfizer’s blood cancer drug Bosulif due to uncertainties over its cost effectiveness and survival benefit.

In new draft guidance NICE said that Bosulif (bosutinib) is not recommend for treating Philadelphia chromosome positive chronic myeloid leukaemia (CML) for adults with chronic, accelerated or blast phase CML previously treated with one or more tyrosine kinase inhibitors.

It is also not recommended for patients where Novartis’s Glivec (imatinib) and Tasigna (nilotinib), or Bristol-Myers Squibb’s Sprycel (dasatinib), are not considered appropriate treatment options.

This comes despite Pfizer offering a patient access scheme for the drug which cuts the overall cost of the treatment, although the size of the discount remains confidential.

NICE currently recommends Novartis’ Glivec and Tasigna for treating different stages of CML. It does not, however, recommend BMS’s Sprycel due to cost issues.

NICE’s expert committee said it considered the marketing authorisation for the drug and concluded that Bosulif was likely to be predominantly used third line or later in clinical practice, i.e., after use with Tasigna and Glivec.

Sir Andrew Dillon, NICE’s chief executive, 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.

“Although there is evidence to suggest that bosutinib was considered 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.”

The guidance is now out for public consultation, where anyone can offer their comments on NICE’s preliminary verdict on the drug.

High cost

The annual cost of Bosulif at its recommend dose is £44,799 – although the patient access scheme will lower this overall cost.

NICE said the most likely QALY for the chronic phase population would be above £43,000 and £49,000. It added that it could be as high as £135,000 per QALY gained, if people continue to take the drug until they progress to the next phase of CML.

NICE does not usually recommend a medicine if it is higher than £30,000 per QALY. It does, however, have the option to go above this if a drug meets the ‘end of life’ criteria, but Pfizer’s treatment was not considered a candidate for this exemption.

Chronic myeloid leukaemia (CML) is a cancer of the myeloid cells. It develops slowly, over the course of many years and it is estimated that about 560 people are diagnosed in the UK each year, with median age at diagnosis being 60 years.

Ben Adams

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