NHS: Biologics Benefit Children With Plaque Psoriasis, But Cost-Effectiveness Uncertain

A recent Health Technology Assessment (HTA) report by the United Kingdom’s National Institute for Health and Care Excellence (NICE) concludes that adalimumab, etanercept, and ustekinumab all improve the symptoms of psoriasis in children and young people in the short term, but because there is such a limited body of evidence on the use of these drugs in children, the effects of biologic therapies later in patients’ lives are unclear, and the cost-effectiveness of these medications requires further study.

NICE researchers, led by Ana Duarte, MD, investigated health-related quality of life (QOL) gains associated with treatment, as well as the number of hospitalizations in children and young people with plaque psoriasis who were using 1 of the 3 biologics approved for use by the United Kingdom’s National Health Service (NHS) for that indication. They found that biological treatments appear to offer some benefits, but may not be cost-effective for the management of psoriasis in children and young people at the willingness-to-pay threshold of £30,000 (approximately $39,735) per quality-adjusted life-year unless an assumption is made that the consequences of biologic treatment long-term in children are the same as those in adults.

The cost-effectiveness analysis considered 3 separate populations:

1. Children and young people aged 4 to 17 years, with adalimumab as the only licensed intervention for the treatment of severe plaque psoriasis in patients inadequately controlled by, or intolerant to, topical therapy and phototherapies—that is, as an alternative to systemic therapies.
2. Children and young people aged 6 to 11 years, with adalimumab and etanercept used for the treatment of severe plaque psoriasis in patients inadequately controlled by, or intolerant to, systemic therapies or phototherapies.
3. Children and young people aged 12 to 17 years, with adalimumab, etanercept, and ustekinumab used for the treatment of severe plaque psoriasis in patients inadequately controlled by, or intolerant to, systemic therapies or phototherapies.

The report concluded the following:

• Etanercept and ustekinumab, used within their licensed indications, lead to significantly greater improvements in psoriasis symptoms than placebo at 12 weeks, and QOL benefits are also observed. Although these effects appear to persist beyond 12 weeks, their magnitude and persistence is less certain.
• Adalimumab at the licensed dose leads to significantly greater improvements in psoriasis symptoms than does methotrexate for some, but not all, measures at 16 weeks. Observed QOL benefits are inconsistent across different measures.
• There is a lack of comparative evidence for using these biologics in very young children.
• There is little evidence of short-term adverse events, with the exception of a non-significantly higher observed rate of infections, among participants receiving etanercept.
• The majority of incremental cost-effectiveness ratios for the use of biologics in children and young people are in excess of NICE’s usual cost-effectiveness threshold, and are reduced significantly only when figures for the management of psoriasis in adults are adopted.

Finally, the authors advise continued collection of data through registries of biological therapies for individuals aged under 18 years. These data will allow researchers to better understand safety, patterns of treatment switching, impact on comorbidities, and long-term withdrawal rates for these therapies. The uncertainty surrounding the effectiveness of biological treatments in children and young people could be substantially reduced through adequately powered randomized clinical trials, which are currently lacking.