The decision by Novartis to cut the price to the NHS of its chronic myeloid leukaemia drug Tasigna (nilotinib) means that the National Institute for Health and Clinical Excellence can now recommend it, says the Institute.
In new draft guidance, NICE recommends the use of Tasigna for the treatment of the chronic and accelerated phases of CML that is resistant or intolerant to standard-dose Glivec (imatinib), also made by Novartis.
However, the new draft guidance does not recommend Bristol-Myers Squibb's Sprycel (dasatinib) for CML that is resistant or intolerant to standard-dose Glivec, nor does it back high-dose Glivec for CML that is resistant to the standard dose of the drug.
NICE's independent Appraisal Committee had heard from clinical specialists that, in practice, Tasigna and Sprycel are equally effective in treating both Glivec-intolerant and Glivec-resistant disease and would be preferred over high-dose Glivec for CML that is resistant to high-dose Glivec, said the Institute.
"Both treatments are expensive and cost over £30,000 per patient per year - CML is also a chronic condition, meaning the drugs will be used for a long period of time," added Professor Carole Longson, director of NICE's health technology evaluation centre.
However, during consultation on draft recommendations, Novartis agreed to provide Tasigna to the NHS at a discounted price, and this enabled the Committee to recommend its use.
Discount remains confidential
The firm has requested that the size of the discount remains confidential, says NICE, also noting that Novartis has recently increased Glivec's price, which means the cost per patient is now over £40,000 per year for the high dose of 800mg.
CML is a very rare condition which affects around 560 people in the UK each year, and the Committee agreed it was clear that Tasigna, Sprycel and high-dose Glivec provided clinical benefit for people with the Glivec-resistant form of the disease. However, the panel also felt that the lack of an evidence base meant that the benefit's magnitude was uncertain.
The draft guidance is now with consultees, who have the opportunity to appeal against it.