Scotland says yes to Shire's Elvanse but no to Pfizer's Xalkori
This article was originally published in Scrip
The Scottish Medicines Consortium, Scotland's health technology appraisal body, has okayed Shire's attention deficit/hyperactivity disorder (ADHD) drug Elvanse/Vyvanse (lisdexamfetamine dimesylate) for use on the Scottish National Health Service. However, Pfizer's lung cancer Xalkori (crizotinib) failed to make the grade.
The SMC said Elvanse could be used on the Scottish NHS as part of a comprehensive treatment program for ADHD in children aged over six years when response to methylphenidate treatment has not been adequate.
In December, Elvanse (known as Vyvanse in the US) won EU approval through the decentralised procedure, led by the UK regulator, the MHRA (scripintelligence.com, 20 December 2012). Already available in the US and Canada, the drug reached blockbuster status in February having brought in $1.03 billion (scripintelligence.com, 14 February 2013).
Scottish sales are unlikely to have much of an impact on the drug's international trajectory, but the SMC's decision is a positive sign that other payers in Europe will want to fund the drug.
According to Shire, 546 patients are eligible for treatment, with some 11% are likely to get treatment with the drug in the first year it is available.This will increase to 61% by the fifth year. Shire predicts authorities will spend around £54, 000 on the drug in the first year, rising to £298,000 in year five. However, the firm expects Elvanse to be cost neutral as it displaces other products. Lilly's Strattera (atomoxetine) and Celltech's Dexedrine (dexamfetamine) are also used to treat ADHD in the UK. NICE, the HTA institute for England and Wales, has not appraised the drug.
Pfizer, however, did not impress with Xalkori for treating adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer. The firm failed to both submit a robust enough economic analysis and to justify the drug's benefits in relation to its costs, said the SMC. Xalkori costs £13,129 per course of treatment, while comparators docetaxel and pemetrexed cost £4,092 and £ 5,760 respectively. Pfizer had estimated that 84 patients stood to receive treatment, with 80% receiving the drug in the first year and 90% in the fifth. The firm predicted that authorities would spend £3.07m on the product in year one and £3.42m in year five.
Xalkori fared no better south of the border. NICE turned the drug down in March (scripintelligence.com, 27 March 2013)