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FDA Updates to JAK Inhibitors: How Are Payers Reacting, and What Do Pharma Companies Need to Know?


After the FDA called for additional warning labels on anti-inflammatory drugs known as JAK inhibitors this September, pharma companies in the immunology space have been waiting with bated breath to see how payers will react to this news. Will insurers start requiring step-edits or prior authorization? Will payers alter their management strategies for rheumatoid arthritis and ulcerative colitis? What will potential restrictions mean for newly diagnosed patients or those who are seeing success with JAK inhibitors? What will the impact be to pipeline agents?

To understand the impact of this news and address unanswered questions like these, MMIT conducted a quick-turnaround Rapid Response survey and held a webcast with current P&T committee members at different managed care organizations to glean insight into payers’ reactions and potential changes to the management of JAK inhibitors. The survey, which was fielded in mid-September to 19 payers covering more than 130 million lives, found that while the majority (83%) were moderately to severely concerned by the FDA’s updated safety warnings, major changes are unlikely. Only 10% anticipate an immediate re-review of JAK inhibitors, whereas 71% reported that they will wait to re-review the agents until the normal review cycle.

The webcast, which consisted of seven P&T committee members and three specialists, covered topics related to the impact on manufacturers of JAK inhibitors and their non-JAK competitors, as well as pipeline agents in these indications. The committee discussed scenarios in which manufacturers of JAK inhibitors may face additional restrictions and expect pipeline JAK inhibitors to be treated similarly.

So what does this mean for manufacturers in the immunology space? Pharma companies with JAK inhibitors in their current or future pipeline should largely stay the course, although some payers recommended that manufacturers be prepared to increase transparency and communication of safety data to physicians and patients. According to one payer, manufacturers should “provide data that reviews safety and total cost of care.” Others suggested that they “demonstrate clinically significant safety differences among the JAKs” and asked that companies “be responsive to our team if they reach out for additional safety information for your product.”

While many questions remain, pharma companies can use this opportunity to put physicians’ and patients’ minds at ease with safety data that’s robust and easily accessible. Those who do are likely to find themselves ahead of the pack.

For the full results from our survey and webcast, including insight into the impact on contracting and takeaways for non-JAK-inhibitor manufacturers, connect with us to purchase MMIT’s Rapid Response report and video recording of the meeting.

By Carley Peyser and Julie Bays

© 2024 MMIT


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