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AbbVie’s Skyrizi gets rapid ‘yes’ from NICE

New fast-track appraisal a boon for companies

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AbbVie and Boehringer Ingelheim’s new psoriasis treatment Skyrizi has gained fast-track recommendation from NICE, coming less than three months after its European marketing approval.

The positive Final Appraisal Document (FAD) means Skyrizi (risankizumab) is recommended for severe psoriasis treatment in adults who have failed conventional systemic therapies.

The recommendation means that the NHS in England will make Skyrizi available from August, putting it into an already highly competitive field in psoriasis.

Skyrizi is a new entrant to the IL-23 inhibitor class, but has an advantage in being administered only every 12 weeks, compared to once every four weeks for established treatments.

NICE notes in its final appraisal that clinical trials shows Skyrizi is more effective than AbbVie’s now off-patent Humira (adalimumab) and J&J’s IL-12/IL-23 inhibitor Stelara (ustekinumab).

It adds that indirect comparisons suggest Skyrizi is likely to provide similar health benefits compared with J&J’s IL-23 inhibitor Tremfya (guselkumab) (which gained NICE recommendation a year ago) and better PASI (Psoriasis Area and Severity Index) response rates compared with many other biologicals.

The recommendation is great news for AbbVie, as it looks to replace a small percentage of the millions in revenue lost to biosimilar versions of Humira, which arrived in Europe late last year.

In 2017/18, Humira was by far the biggest drug cost for the NHS in England, at £495 million, 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%.

This reflects a global picture, with Stelara expected to maintain its lead among the newer agents, Evaluate expecting its sales to global annual sales to rise to $7.79bn by 2024 from $5.29bn last year.

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.

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.

However the final guidance does give one final direction to help clinicians and 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 Skyrizi, Cosentyx (secukinumab) and Eli 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.

AbbVie welcomed NICE’s decision, and said it had worked closely with NICE for its drug to be considered through the fast track appraisal process.  

“Risankizumab’s availability on the NHS will represent the fastest time between marketing authorisation and reimbursement of any biologic treatment for psoriasis,” commented Dr Alice Butler, UK medical director, AbbVie.

Skyrizi is not the end of AbbVie's ambitions in the field - it also has a new oral JAK inhibitor upadacitinib in its late-stage pipeline, which recently proved its superiority to Humira in a head-to-head trial.

Article by
Andrew McConaghie

14th July 2019

From: Regulatory

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