Humana spells out its conditional Exondys 51 coverage policy — strings attached

Humana’s decision to cover Sarepta’s $SRPT controversial Duchenne muscular dystrophy drug Exondys 51 (eteplirsen) comes with some thick strings attached to it.

In a new coverage policy posted at the big insurer, Humana says that it will only provide coverage for the $300,000-plus therapy provided patients are still ambulatory, continue to prove that they remain able to walk and meet the criteria for patients who may benefit from an Exon 51-skipping drug.

Under conditions for coverage, Humana notes: “The member remains ambulatory (e.g. able to walk with assistance, not wheelchair dependent).”

Translation: Any patient who continues to deteriorate to the point that they require a wheelchair will no longer be covered.

That policy coverage decision follows Anthem’s verdict that it won’t cover the drug because in their view it remains experimental, even though the FDA has approved it for marketing. Other big insurers have said that they will cover it, but have not yet posted their conditions.

Janet Woodcock

Janet Woodcock

Janet Woodcock’s decision to overrule the pointed objections of the review team as well as senior-level colleagues — widely celebrated in the DMD community that fought for this drug — continues to draw heavy criticism in some circles. Earlier this week two FDA policy experts fretted over the “worrisome model” that the agency had endorsed in backing eteplirsen for an approval, urging a fresh look at how similar drugs backed by patient advocates ahead of convincing data should be handled in the future, including a suggestion to make them available without allowing a profit. Inside the FDA, meanwhile, John Jenkins has been eager to suggest that that Sarepta was a once-off, with all the same traditional demands on efficacy and safety data still in place.

That controversy is now spilling over into the payer community, and some clearly don’t like the idea of covering a drug that some believe remains experimental, regardless of the FDA’s decision.

Jefferies’ Gena Wang, who bet against an approval, says she wasn’t surprised by the decision. And more such conditional policies may appear. Her note included:

Recall we had previously noted that payers ranked evidence of clinical benefit higher than FDA approval status and independent analysis would be likely required. Humana’s decision to limit coverage within ambulatory pts is also in-line with our expectations of additional restrictions based on clinical trial demographics (ambulatory pts with baseline age 7-10). Furthermore, the 6 month initial approval period and the requirement for pts to remain ambulatory for continual treatment, also echo the feedback we received from payers on possible continuous monitoring of drug efficacy. Among other large payers, Aetna plans to conduct a full clinical review (according to Reuters), United (via our communication with a spokesperson) have noted their interest in covering the drug with a prior authorization (details undisclosed) and Cigna has confirmed interest in providing coverage (via email to Bloomberg). Express Scripts also has plans to conduct a full clinical review but details are unknown.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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