NICE consults on a new treatment for chronic myeloid leukaemia
NICE, the healthcare guidance body, has issued new preliminary draft guidance that does not recommend bosutinib (Bosulif, Pfizer) for previously treated chronic myeloid leukaemia.
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. The median age at diagnosis is 60 years. Bosutinib is licenced for the treatment of CML in those for whom imatinib, nilotinib and dasatinib are not appropriate1.Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: "NICE has already recommended two drugs, imatinib and nilotinib, for treating different stages of CML, and it is disappointing not to be able to add a third. But NHS resources are limited and NICE has to decide what treatments represent best value to the patient as well as to the NHS.
"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. This meant that the independent Appraisal Committee could not recommend them as an appropriate use of NHS resources in the first draft recommendations."
Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country. This draft guidance does not mean that people currently taking bosutinib will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.
Notes to Editors
Explanation of terms
1. Bosutinib is not recommend for treating Philadelphia chromosome positive CML, that is, for adults with chronic, accelerated or blast phase CML previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
The Committee considered the marketing authorisation for bosutinib and concluded that, within this marketing authorisation, bosutinib was likely to be predominantly used third line or later in clinical practice.
About the guidance
2. The draft guidance will be available from Tuesday 16 July 2013. Embargoed copies of the draft guidance are available from the NICE press office on request.
3. In April 2012 NICE published guidance (technology appraisal guidance) recommending imatinib and nilotinib for the first line treatment of CML. Dasatinib was not recommended.
4. In January 2012 NICE published guidance (technology appraisal guidance 241) recommending nilotinib as a possible treatment for some people with CML. High dose imatinib and dasatinib were not recommended.
5. It was not possible to make a robust estimate of survival with bosutinib.
6. The manufacturer submitted data from a clinical trial called Study 200, the trial was a single-arm study in which only a small proportion of people met the licensed indication for bosutinib. The Committee concluded that the quality of the available data for the comparators was limited and that there was great uncertainty around how comparable the data were to Study 200. It also concluded that although there were indicative data on the survival of patients receiving bosutinib and the comparator treatments the relative treatment effect between bosutinib and the comparators was subject to uncertainty.
7. The Committee considered the most plausible cost per QALY for the chronic phase population to be above £43,000 and £49,000, depending on the degree to which bosutinib in clinical practice would be used beyond the treatment durations of Study 200 and that the ICER may reach £135,000 per QALY gained if people continue to take bosutinib until they progress to the next phase of CML. Similarly, the ICERs for the accelerated and blast phase populations are at least £65,000 and £89,000 per QALY gained respectively.
8. Bosutinib is available in two pack sizes: 500 mg x 28 tablets (£3,436.67) and 100 mg x 28 tablets (£859.17), with an average cost of £122.74 for 500mg/day (all costs exclude VAT). The annual cost of bosutinib at this dose is £44,799. A Patient Access Scheme is available for bosutinib.
9. Committee concluded that, even if the ICERs had been at an acceptable level, bosutinib does not meet all of the criteria in order to take the supplementary advice on life extending treatments into account.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).
Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.
Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.
To find out more about what we do, visit our website: www.nice.org.uk and follow us on Twitter: @NICEComms.