Under the original proposed formulary change, adult patients currently taking the reference infliximab would be switched to the biosimilar.
Excellus BlueCross BlueShield (BCBS) announced in January 2018 that it would switch its formulary coverage for adult Crohn disease and ulcerative colitis treatment from the reference infliximab (Remicade, sold by Janssen) to biosimilar infliximab (Inflectra, sold by Pfizer).
Under the original proposed formulary change, adult patients currently taking the reference infliximab would be switched to the biosimilar.
According to Excellus BCBS’ Pharmacy Management Drug Policy, this change would only apply to adult patients due to the reference infliximab product being the only one with an FDA-approved indication for the treatment of pediatric ulcerative colitis. The pediatric ulcerative colitis indication is protected by orphan exclusivity through September of this year.
However, a month after receiving some pushback from patients, Excellus made a second announcement that, after further consideration, it had modified the criteria requirements for prescribing the biosimilar in place of the reference product.
The updated proposal mandates that for adult patients enrolled in its commercial, exchange, Medicaid managed care, and Child Health Plus plans who are newly initiating infliximab therapy, the biosimilar is the preferred drug. In the instance that the biosimilar is ineffective for the patient, the request for medical necessity review is allowed for an alternate therapy.
However, a nonmedical switch no longer applies to members who are currently prescribed the reference product, who may continue with the reference therapy, though Excellus does encourage prescribers to consider switching patients.
Around the time of the updated formulary change, Mona Chitre, PharmD, chief pharmacy officer and vice president of medical operations and health innovations at Excellus, wrote an editorial published in the Oneida Daily Dispatch that discussed the lack of competition among US drug makers.
“Per capita healthcare spending in many industrialized nations is less than it is here in the United States, but in many cases, those countries have healthcare outcomes that are similar to ours. Contributing to this parity in quality but disparity in spending is the lack of approved biosimilar medications to compete here with high-priced, brand-name biologics,” said Chitre.
Chitre writes that the average annual cost of reference infliximab in the United States is $28,000 per patient. In fact, over the past 5 years, Johnson & Johnson, the developer of the reference, raised the price by 57% with many of those years seeing 2 price increases.
Lower-cost infliximab biosimilars have been available in Europe since 2013, 2 of which are FDA-approved: Inflectra and Renflexis (sold by Merck).
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