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NICE’s fast-track catapults Skyrizi into market

Watchdog also gives direction on comparing rival treatments


NICE has published a final recommendation for AbbVie and Boehringer Ingelheim’s Skyrizi today, completing a fast-track process which will see the new 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 and also cuts the standard 90 day implementation period down to 30 days.

This means the NHS across England has a month from today to make preparations for prescribing of Skyrizi to begin.

All told, that means Skyrizi (risankizumab), 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.

The NICE approval means Skyrizi is recommended for severe psoriasis treatment in adults who have failed conventional systemic therapies.

The recommendation puts Skyrizi into an already highly competitive field in psoriasis, but it has an advantage in being administered only every 12 weeks, compared to once every four weeks for many established treatments.

The fast-track approval is great news for Boehringer and AbbVie – the latter has seen its UK revenues from Humira (adalimumab) plummet since late 2018. This is because NHS England is overseeing a rapid switch to biosimilar versions of the blockbuster wherever possible which is used across a number of indications, including psoriasis.

While biosimilars will dampen demand for Skyrizi, NICE’s appraisal has also given it a helping hand in regard to value comparisons with many of its branded rivals.

NICE noted in its final appraisal in June that clinical trials shows Skyrizi 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 Skyrizi 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 Skyrizi 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 Skyrizi 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.

Dr Alice Butler, UK medical director, AbbVie confirmed last month that Skyrizi’s NICE fast-track appraisal would make it the fastest ever market access approval for any psoriasis biologic treatment.

SVB Leerink analyst Geoffrey Porges predicts $3bn in peak sales for AbbVie's Skyrizi, with its success dependent on how it will fare not just in psoriasis but the other hotly-contested inflammation and immunology indications as well, such as Crohn’s and ulcerative colitis.

Skyrizi is not the end of AbbVie's ambitions in the field – it also has a new oral JAK inhibitor upadacitinib, which has just gained FDA approval for moderate-to-severe arthritis.

Article by
Andrew McConaghie

21st August 2019

From: Marketing



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