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Valeant, J&J psoriasis drugs slated for updated price group review

With new plaque psoriasis options on the market from Valeant Pharmaceuticals International Inc. and Johnson & Johnson's Janssen unit, and more on the way, the Institute for Clinical and Economic Review will update last year's review of the drug class.

Plaque psoriasis, the most common form of the autoimmune skin disorder, has typically been treated in its milder form with topical creams and UV radiation. However, more recently, injectable biologics have become an area of high interest for severely affected patients. Seven of these therapies were reviewed by the independent price advisory group in 2016, and the update will consider new evidence related to any of them that could impact cost-effectiveness analyses.

Joining the seven will be two recently approved drugs and two that are expecting approval decisions in 2018. Valeant Pharmaceuticals' Siliq was approved for the U.S. market in February, followed by Johnson & Johnson's Tremfya in July. Siliq has a black box warning on suicidal ideations, which analysts have said could limit its market. At the same time, the company has billed its $3,500-per-injection list price as a low-cost alternative to rivals.

Tremfya, on the other hand, is forecast to be one of the top 20 sellers by 2020, according to market intelligence firm Evaluate.

ICER said that UCB SA's Cimzia, which is currently used to treat rheumatoid arthritis, psoriatic arthritis and Crohn's disease, should have a U.S. Food and Drug Administration decision on plaque psoriasis by mid-2018, around when the ICER's meeting on its findings will take place. Merck & Co. Inc. and India-based Sun Pharmaceutical Industries Ltd. also have a candidate, tildrakizumab, that is up for an FDA decision in March 2018.

The seven drugs previously reviewed that could have cost-effectiveness changes in the new report include AbbVie Inc.'s Humira, Amgen Inc.'s Enbrel, J&J's Remicade and Stelara, Novartis AG's Cosentyx, Eli Lilly and Co.'s Taltz, and one pill, Celgene Corp.'s Otezla.

AbbVie and Boehringer Ingelheim GmbH's risankizumab, which recently completed a positive phase 3 trial, will not be included in the review as an approval decision is not expected until 2019, an ICER spokesperson said.

ICER will not consider biosimilars if they do not have psoriasis-specific evidence available. Humira biosimilars such as Pfizer Inc.'s Inflectra, Celltrion Pharm Inc.'s Remsima and Renflexis from Merck and Samsung Bioepis Co. Ltd. generally have switch studies showing they are bioequivalent to Remicade, which ICER said will not count.

As the institute previously announced, it will also review the upcoming class of new migraine drugs known as CGRP blockers. These include Amgen and Novartis' erenumab, Teva Pharmaceutical Industries Ltd.'s fremanezumab and Eli Lilly's galcanezumab, which have all been submitted to the FDA for review.

The draft scoping documents are both open for public comment until Dec. 22, after which ICER said it will release its draft assessment of the drugs in early January 2018.