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UK, Germany back routine use of J&J’s Tremfya

The IL-23 inhibitor is currently being assessed in other EU countries

J&J

Johnson & Johnson’s new psoriasis therapy Tremfya has cleared two critical hurdles as it rolls out in European markets, with the UK and German cost-effectiveness watchdogs saying its cost reflects its benefits.

The National Institute for Health and Care Excellence (NICE) for England and Wales, the Scottish Medicines Consortium (SMC) and Germany’s Federal Joint Committee (G-BA) are the first health technology assessment authorities in Europe to back the first-in-class interleukin-23 inhibitor, which was approved in the EU last November for moderate to severe plaque psoriasis.

NICE and the SMC have approved National Health Service (NHS) funding for Tremfya (guselkumab) - which has a list price in the UK of £2,200 per pre-filled syringe but is being offered at an undisclosed discount. Meanwhile the G-BA has published its decision stating that guselkumab offered “substantial additional therapeutic benefits” compared to comparator drugs, which J&J says is “the first time a biologic treatment for psoriasis has been awarded this level of benefit”.

Further assessments of Tremfya are currently underway in a number of other countries in the EU, with decisions anticipated later in the year, according to the drugmaker.

Tremfya (guselkumab) is a follow-up to J&J’s IL-23/IL-12 inhibitor Stelara (ustekinumab) that rakes in blockbuster revenues but is facing the threat of competition from newer psoriasis therapies such as Novartis’ fast-growing IL-17 inhibitor Cosentyx (secukinumab), which EvaluatePharma expects to become a $4.6bn product by 2022.

Stelara was a $4bn product for J&J’s Janssen Pharma unit last year, but has seen the first glimmers of weakness with sales declining slightly in the first quarter of the year versus the last three months of 2017. J&J is hoping that Tremfya will help it defend the lucrative franchise as competition gets more intense.

“The swift decision by two of Europe’s key HTA bodies reflects the positive results demonstrated in clinical studies of guselkumab for the treatment of moderate to severe plaque psoriasis,” said Jaime Oliver, medical lead for Janssen Immunology, EMEA.

“Providing a new therapeutic option may help to alleviate some of the physical and emotional burden of this disease. We are therefore working hard to ensure that eligible patients in Europe can access guselkumab as quickly as possible,” he added.

J&J is facing the threat of direct competition to Tremfya, however, as rival AbbVie’s IL-23 inhibitor risankizumab which - according to some analysts - might have an edge in terms of clinical activity and dosing.

Add in additional IL-17 inhibitors for Eli Lilly and Valeant and the market for biologics for psoriasis is looking increasingly crowded, and a lot will depend on which of the new drugs wins the battle to become the go-to alternative to TNF inhibitors such as AbbVie’s Humira (adalimumab), which have dominated the market for years.

Article by
Phil Taylor

14th June 2018

From: Regulatory

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