When the Food and Drug Administration approved the pancreatic cancer pill Rasonque on Aug. 26, the drugmaker's free early access program closed. For some patients who had not yet enrolled, insurance coverage was not ready to take its place.
Kelsey Solano, a critical care nurse in Washington state, was finishing paperwork to enroll her husband, Juan, in Revolution Medicines' expanded access program for daraxonrasib, the drug's generic name, when the approval came through. Juan has metastatic pancreatic cancer. "He was considered an urgent request because his clinical status was really starting to change," she told STAT, which reported the family's experience on Sept. 8.
Her insurer, Aetna, told her the drug had not yet been added to the databases that pharmacies and insurers use. The list price is nearly $40,000 a month, too much to pay at once, so she raised her credit limit and paid $9,286.67 for a seven-day supply. A GoFundMe page was also updated to ask for help.
The family's situation has since changed. CVS Health, which owns Aetna, told STAT it approved coverage through its formulary exceptions process within hours of receiving a request from one of Juan's doctors on Sept. 3. The next day, the family learned the drug would be covered for at least one year. After STAT contacted Revolution Medicines and Solano asked for her case to be escalated, the company's patient support program also agreed to provide a 30-day supply.
For people with metastatic pancreatic cancer, even a short delay matters. According to STAT, Juan had been off treatment for about a week before he started the drug.
The Mechanics Behind the Delay
Solano and cancer experts told STAT that the problem is built into the system. Regulatory approval triggers the closure of early access programs, often called compassionate use, but commercial insurance coverage often is not available for weeks or months while payers complete the technical steps needed to cover a new medicine.
Those steps begin with assigning the drug a national drug code and adding it to drug databases. Payer and pharmacy systems then pull in those updates so plans can make coverage decisions and process claims. Experts told STAT the process can take several weeks.
The problem was not limited to one insurer. Arturo Loaiza-Bonilla, a hematologist-oncologist at St. Luke's University Health Network in Pennsylvania, told STAT that a Medicare patient of his was initially denied Part D coverage for reasons he described as nonclinical. After he posted the denial letter on social media, the patient's pharmacy benefit manager, OptumRx, approved the prior authorization. He said other patients at St. Luke's were still waiting for answers.
The FDA's approval notice covers adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. The agency said it delivered the approval months ahead of schedule. A faster review moved the approval date up, but it did not speed up insurers' systems.
MedicalDaily previously reported that approval replaced a case-by-case expanded access route with a therapy oncologists can prescribe. The new reporting shows that for some patients, the replacement did not arrive in time.
The Patients Most Exposed
Not every patient faces this problem. "It's people [who are] on the waitlist for the expanded access program and hadn't yet been approved, or anyone new who wants the drug," Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network, told STAT.
Patients whose disease is progressing quickly have the least time to wait. Medicare Part D enrollees can face similar delays while plans add a new drug, as the St. Luke's case shows.
The shift also reaches beyond large cancer centers. Before approval, MedicalDaily reported that the drug was reaching community oncology practices, not only major academic centers. Patients treated at those practices now depend on the same commercial coverage process as everyone else.
Steps Patients and Caregivers Can Take Now
Nobody should stop or change prescribed cancer treatment based on this report. The useful steps are administrative, and they work best when started early.
Ask the oncology practice to submit a prior authorization request as soon as the prescription is written. If the plan has not yet added the drug to its list of covered medicines, ask whether a formulary exception request is possible. CVS Health told STAT that eligible Aetna members can apply through that process while an outside committee reviews the drug for formal coverage.
Revolution Medicines runs a support program called (ON)PATH. The company told STAT the program is designed to help patients move to commercial coverage after approval and to help uninsured or underinsured patients get the drug for free. Solano was initially told that help required a pending prior authorization request, so filing that request quickly may matter.
If a denial arrives, request the written reason and file an appeal. Plans generally must offer a faster appeal when waiting could seriously harm a patient's health. Independent charitable foundations and hospital financial assistance programs are separate options that a practice can pursue at the same time.
The Open Questions and the Trial Behind the Urgency
Several things remain unknown. There is no public count of how many patients have been caught in this gap, and no published measure of how long coverage typically takes for this drug. STAT's reporting describes individual experiences rather than a national rate. Fleshman told STAT that advocates and policymakers need to find ways to make the process smoother for patients.
The trial results explain why the wait matters. The approval was based on RASolute 302, a randomized, open-label trial in which 500 patients whose disease had progressed after one prior line of therapy received either daraxonrasib or standard chemotherapy chosen by their physician. In the overall trial population, median overall survival was 13.2 months with daraxonrasib and 6.7 months with chemotherapy. Those are medians across a trial population, not a promise to any individual patient, and they apply to previously treated metastatic disease.
The drug also carries warnings, including skin and soft tissue toxicity, mouth sores, diarrhea, tears in the stomach or intestinal wall, lung inflammation, and harm to a developing fetus. Patients taking it should report new or worsening symptoms to their care team promptly.
MedicalDaily will continue to follow coverage decisions and any policy efforts to close the gap between approval and insurance coverage.
Key Questions Answered
What happened? STAT reported that some patients seeking the newly approved pancreatic cancer drug Rasonque faced delays because the manufacturer's early access program closed at FDA approval before some insurers were ready to cover the drug.
Why does approval end free access? Expanded access is a pathway for investigational drugs. Once a drug is approved, it is prescribed and paid for through normal channels, so the program closes.
How long does the gap last? There is no published figure for this drug. Experts told STAT that coverage can take weeks or months, depending on the plan.
Did the family in the report get coverage? Yes. Aetna approved coverage through a formulary exception after a request on Sept. 3, and the manufacturer later agreed to provide a 30-day supply.
Who is most affected? Patients who were on the expanded access waitlist at approval, new patients seeking the drug, and people whose disease is progressing quickly.
What can a family do first? Ask the oncology practice to submit prior authorization or a formulary exception request right away, ask about the (ON)PATH support program, and appeal any denial in writing.
Does this change treatment guidance? No. Nobody should delay, stop, or change cancer treatment because of a coverage dispute. Treatment decisions belong with the treating oncologist.
