Cost regulators for NHS Scotland have given children with Crohn's disease routine access to AbbVie's Humira, marking the first of the UK nations to accept the drug's use in this setting.
The Scottish Medicines Consortium (SMC) has approved Humira's use for the treatment of severely active Crohn’s disease in paediatric patients aged six to 17 years of age, but only in those who failed to respond or are intolerant to conventional therapy, including nutrition therapy, corticosteroids and immunomodulator.
“For patients in Scotland who do not respond to standard therapies, this new treatment option addresses a significant unmet need by offering another treatment option and the flexibility of out of hospital injectable administration, usually by patients or their parents,” said Dr Richard Russell, Consultant Paediatric Gastroenterologist, Royal Hospital for Sick Children, Glasgow.
Humira has also been accepted for use in combination with methotrexate for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged two to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.
Elsewhere, the news was not so good for Novartis' breast cancer drug Afinitor (everolimus) or Sanofi's colorectal cancer drug Zaltrap (aflibercept).
Following in the footsteps of sister body the National Institute for Health and Care Excellence, the SMC felt that while adding Afinitor to exemestane treatment significantly increased progression free survival in postmenopausal women with advanced disease, a sufficiently robust economic analysis was not presented to warrant its routine use on the NHS.
A patient access scheme (PAS) was submitted by the company under which the first pack of the medicine would be provided free of charge. However, even taking the PAS into account, the SMC estimated the cost per quality adjusted life year (QALY) against exemestane alone to be £28,912 (£32,417 without the PAS).
With regard to Zaltrap, the SMC conceded that adding the drug to a particular chemotherapy regimen (FOLFORI) did indeed result in significantly longer overall survival in patients with metastatic colorectal cancer resistant an oxaliplatin-containing regimen, but it considered the effect to be of "relatively modest clinical benefit".
Sanofi also put forward a PAS offering a discount on the list price of its medicine, but the cost per QALY still came in at around £36,294.
The SMC concluded that it failed to present a sufficiently robust economic analysis or to justify the treatment’s cost in relation to its health benefits.