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US pricing watchdog to review bowel disease, cystic fibrosis therapies

The Institute for Clinical and Economic Review will assess the clinical effectiveness and value of therapies for ulcerative colitis, an inflammatory bowel disease, and genetic disorder cystic fibrosis in two separate reports.

The U.S. pricing watchdog, known as ICER, will assess already marketed ulcerative colitis drugs, including Pfizer Inc.'s Inflectra and Xeljanz, Johnson & Johnson's Remicade and Simponi, and AbbVie Inc.'s Humira. ICER will also evaluate Takeda Pharmaceutical Co. Ltd.'s Entyvio and J&J's Stelara, both of which are under review for U.S. Food and Drug Administration approval.

According to ICER's Sept. 6 release, the watchdog will accept input from interested stakeholders until Sept. 24 and publish a draft scoping document detailing ICER's planned assessment Sept. 27. ICER's full report will be discussed in June 2020 at the California Technology Assessment Forum, where an independent evidence review panel will vote on the report's findings.

Ulcerative colitis results in inflammation in the digestive tract.

ICER also plans to further examine FDA-approved cystic fibrosis drugs Symdeko, Orkambi and Kalydeco, all marketed by Vertex Pharmaceuticals Inc. ICER reviewed the medicines in a June 2018 final report that determined that Vertex needed to significantly reduce prices for all three drugs to make them cost-effective.

Vertex's experimental cystic fibrosis treatment, a combination therapy of elexacaftor, tezacaftor and ivacaftor, also will be assessed, ICER said in its Sept. 6 release. ICER is accepting public comments until Sept. 25, and the draft scoping document will be released Sept. 30. ICER's findings will be discussed at an April 2020 California Technology Assessment Forum meeting.

Cystic fibrosis is a rare inherited disorder characterized by the buildup of sticky mucus in the lungs and digestive system, causing severe damage to the affected organs.