Fast-track status completed for AbbVie and BI’s psoriasis treatment Risankizumab

NICE published a final recommendation for AbbVie and Boehringer Ingelheim’s Risankizumab today, completing fast-track process that sees the psoriasis treatment gain market access in record time.

The drug is one of the first treatments to go through NICE’s fast-track appraisal system, which accelerates the review process, whilst also cutting the standard 90-day implementation period down to 30 days.

This means the NHS across England has a month from today to prepare for prescribing of Risankizumab.

This will mean that the treatment, an IL-23 inhibitor, has gained market access in England in less than five months after its European marketing approval on 30 April.

This is even faster than J&J’s rival IL-23 inhibitor Tremfya, which was the first psoriasis treatment to use the fast-track appraisal (FTA) route last year, and which gained full market access eight months after its European approval in November 2017.

NICE noted in its final appraisal in June that clinical trials shows Risankizumab is more effective than AbbVie’s Humira (adalimumab) and J&J’s IL-12/IL-23 inhibitor Stelara (ustekinumab). It added that indirect comparisons suggest Risankizumab is likely to provide similar health benefits compared with Tremfya (guselkumab) and better PASI (Psoriasis Area and Severity Index) response rates compared with many other biologicals.

In 2017/18, Humira was by far the biggest drug cost for the NHS in England, at £495m, but will record steep decline this financial year. Of the newer agents, Stelara was the most prescribed, with expenditure at £32m for the period, up 25%.

NICE says in cost terms, it is ‘appropriate’ to compare Risankizumab with Tremfya, and says the total costs associated with the newly-recommended drug are similar to or lower than those of Tremfya – however confidential price agreements for both agents means it can’t publicly disclose what these levels are.

The final guidance does give one final direction to help local health economies decide on which of the new agents to prescribe.It says that if patients and clinicians consider Risankizumab to be one of a range of suitable treatments, including Cosentyx (secukinumab) and Lilly’s Talz (ixekizumab), then the least expensive should be chosen, once administration costs, dosage, price per dose and commercial arrangements are taken into account.

Source: PMLive