Children in Scotland with attention-deficit hyperactivity disorder (ADHD) have gained access to a new treatment option after regulators agreed to fund Shire's Elvanse on the National Health Service.
The Scottish Medicines Consortium (SMC) has accepted for use Elvanse (lisdexamfetamine dimesylate) as part of a comprehensive treatment programme for the condition in children aged six years and older, when response to previous methylphenidate treatment is inadequate.
The decision was based on data from a multicenter, randomised, double-blind, controlled study in children and adolescents with ADHD, which showed that treatment with the drug was linked with a shorter time to first response compared with a non-stimulant, centrally-acting sympathomimetic agent.
In addition, a greater proportion of Elvanse-treated patients achieved improvements in symptom scores and functioning than those treated with the active comparator, the agency noted.
According to Shire, research suggests that 37,000 children and young people are affected by ADHD in Scotland, and yet only 4,539 Scottish children with a diagnosis of ADHD are currently estimated to be in contact with specialist services.
“Every child has specific and individual needs when it comes to treatment, so the decision made by the SMC is great news as it will help provide a broader range of options to help people with ADHD manage their individual needs effectively,” commented David Coghill, Child and Adolescent Psychiatrist, University of Dundee.
The first stimulant prodrug in Europe for the treatment of ADHD, Elvanse won UK marketing authorisation in February of this year.
Elsewhere, the SMC also issued green lights for Astellas' Betmiga (mirabegron) as a treatment for overactive bladder syndrome, and Novartis' Lucentis (ranibizumab) for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion in adults.
On the down side, the news was not so good for Pfizer after the use of Xalkori (crizotinib) within NHS Scotland for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) was turned down.
While a Phase III clinical study in this subset of patients significantly increased progression-free survival compared with standard chemotherapy, the company's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC, the group said, explaining its decision.
The National Institute for Health and Care Excellence (NICE) also turned down the drug's use in draft guidance last month.