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Novartis’ Jakavi turned down by NICE for blood cancer

UK cost-effectiveness watchdog concerned about 'uncertainties' in data in draft guidance

Novartis

Novartis received a blow today when its new treatment for blood cancer Jakavi was turned for use within the UK's NHS by the country's healthcare cost watchdog.

The National Institute for Health and Clinical Excellence (NICE) said in draft guidance it was unable to recommend Jakavi (ruxolitinib) for use in the treatment of the symptoms associated with the rare condition myelofibrosis as it had uncertainties about the data provided by Novartis.

The drug was approved by the European Commission in August last year to treat disease-related splenomegaly (enlarged spleen) or symptoms, such as itching and fatigue, in adults with various forms of myelofibrosis.

NICE agreed that Jakavi was able to offer improvements in these areas, and that these improvements would be of benefit to patients, but the cost effectiveness body also decided the way Novartis had calculated how much survival benefit Jakavi offered to patients was flawed.

The price per quality-adjusted life year (QALY) gained was a particular sticking point for NICE, with the independent committee assigned to assess Jakavi stating that due to limitations in Novartis' economic model, along with related uncertainties about the incremental cost-effectiveness ratio (ICER), the price per QALY gained was more likely to be £149,000 than the £74,000 presented by Novartis.

NICE generally does not recommend drugs that cost more than £30,000 per QALY.

Myelofibrosis is a type of haematological (blood) cancer. It is a rare condition, with around 0.4 cases per 100,000 each year in the UK, in which bone marrow is less able to make blood cells. To compensate for this, other organs in the body, including the liver and the spleen, begin to produce them. But as the spleen does this it grows in size, causing splenomegaly.

“Myelofibrosis and splenomegaly can be extremely debilitating, with symptoms such as severe itching and fatigue,” said Professor Carole Longson, Health Technology Evaluation Centre director at NICE.

“It is disappointing not to be able to recommend this new treatment in our preliminary recommendations, but in order to do this we have to be sure that the treatment is both clinically and cost effective, because money has to be diverted from elsewhere in the health service to pay for it.”

This draft guidance is now up for consultation until March 2013 with final guidance expected to be published in June 2013.

Jakavi currently costs about £43,200 per patient per year and one possibility for Novartis to change NICE's mind on the drug would be to reduce its cost under a patient access scheme.

Novartis has already agreed such schemes with the Department of Health for Lucentis, Tarceva, Tasigna and Gilenya.

13th February 2013

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