Rasonque FDA Approval Traps Patients in Coverage Limbo — SkimNews
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- Revolution Medicines' expanded access program for Rasonque closed immediately upon FDA approval last month, stranding patients like Juan Solano who were mid-application despite the drug being shown to nearly double median overall survival.
- Aetna told Solano that coverage review for the newly approved drug 'may take several months,' and CVS Health (which owns Aetna) said an external committee would review daraxonrasib for 'formal formulary inclusion' — leaving patients with no clear path during the transition.
- Revolution Medicines' (ON)PATH patient support program requires a pending insurer prior authorization request, but Aetna told Solano it couldn't create one because the drug wasn't yet in its system, producing a catch-22 that blocked free-drug assistance.
- Arturo Loaiza-Bonilla, a hematologist-oncologist at St. Luke's University Health Network, had a Medicare patient denied coverage with a letter stating the FDA-approved drug 'is not properly listed with the Food and Drug Administration and does not meet the regulatory requirements' for Part D — a denial reversed only after he posted it on X.
- Kelsey Solano logged 61 phone calls in 48 hours to find a commercial pathway, ultimately paying $9,286.67 out of pocket for a 7-day supply of Rasonque at its roughly $40,000-per-month list price after raising her credit limit.
- PanCAN president Julie Fleshman confirmed her organization has 'heard from some patients who are caught in this transition,' and Loaiza-Bonilla argued payers should have been ready after the drug earned a standing ovation at the ASCO plenary in June.
- Experts told STAT the delay is structural: post-approval, a national drug code must be assigned, uploaded to drug databases, and ingested by payer systems — a process that routinely takes weeks before claims can be processed.
Why it matters: Patients with months to live can't bridge a weeks-to-months coverage gap. Revolution's (ON)PATH support requires a pending insurer authorization — a chicken-and-egg problem when Aetna said reviewing Rasonque could take 'several months.' Solano paid $9,286.67 for a 7-day supply while waiting, exposing how a drug shown to nearly double survival is functionally unreachable at launch.
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