On Aug. 26, the FDA approved daraxonrasib, brand name Rasonque, for adults with advanced pancreatic cancer that has stopped responding to chemotherapy.
The approval came three months after a landmark study found the drug extended progression-free survival by a median of 8.5 months, kicking off a wave of patient interest that had health system leaders preparing for access hurdles well before the drug reached the market.
At the time, Rosario Ligresti, MD, director of pancreas center at Hackensack (N.J.) Meridian Health’s Hackensack University Medical Center, told Becker’s the cancer center was experiencing a substantial interest in this new drug as it “represents the most significant change and success in pancreatic cancer chemotherapy in 20 years.”
Now that daraxonrasib has cleared the FDA, health systems face the work of turning that preparation into actual prescriptions.
Becker’s asked five oncology leaders what needs to happen at the health system level to quickly get daraxonrasib to pancreatic cancer patients.
Editor’s note: Responses have been lightly edited for clarity and length.
Olatunji Alese, MD. Director of Gastrointestinal Oncology at Winship Cancer Institute of Emory University (Atlanta): The rate-limiting steps for newly approved oral cancer therapies are usually specialty pharmacy onboarding and payer prior-authorization turnaround. Clinical readiness tends to move faster than the reimbursement process, and one would expect an off-cycle P&T review to add daraxonrasib to the formulary. Hopefully, a robust manufacturer patient assistance program will also be set up for uninsured and underinsured patients. Lastly, clinical education for the various layers of healthcare providers will be very important.
Peter Hosein, MD. Associate Director for Clinical Research at the Pancreatic Cancer Research Institute at Sylvester Comprehensive Cancer Center, part of the University of Miami Health System: The manufacturer has announced a distribution system for the drug via either of two specialty pharmacies in the U.S. (Onco360 and Biologics). Individual hospital-based specialty pharmacies will not be involved. Many institutions have an oral chemotherapy team that need to quickly become familiar with the ordering process for the drug. The manufacturer has also established a patient support program called OnPath that will provide assistance for patients to get started. They are offering a free 30-day supply of the medication to patients in case of insurance delays. They have also indicated that their patient assistance program will only help those who are getting the prescription on-label, in other words, for the FDA-approved indication. One challenge that we have faced already is that many insurance providers have not made a coverage determination yet, but that is expected to happen soon.
Jimmy Hwang, MD. Chief of GI Medical Oncology at Atrium Health Levine Cancer Institute, part of Advocate Health (Charlotte, N.C.): For most patients, the critical next step is ensuring reliable and timely access to the drug as demand increases in the U.S. As this treatment moves from approval into broader clinical use, coordination among the manufacturer and its ability to meet the demand will be essential to helping appropriate patients begin therapy as quickly as possible.
At Advocate Health, our role is to make sure our physicians and prescribing providers are aware that daraxonrasib is available and have the information they need to understand which patients may be most appropriate for treatment. Because RASolute 302 was highly anticipated and the approval has been widely disseminated, broad awareness of the drug is likely not the primary challenge. The more important work is ensuring providers are comfortable identifying appropriate patients, prescribing the drug thoughtfully and managing potential side effects so patients can receive the best possible benefit from therapy. Here at the Atrium Health Levine Cancer Institute, which is part of Advocate Health, we support that through our own education series for physicians, disease specialty section meetings, pharmacists and nurses. Also, the FDA approved the use of daraxonrasib in a broader population than RASolute 302 proved benefit for, so prescribing the drug appropriately is important. Clinical pathways will be important to helping understand that. We have developed, maintained and updated our own pathways over the past decade, but more commonly used ones include the National Comprehensive Cancer Network guidelines, or commercially available guidelines.
Daniel King, MD, PhD. Director of Research and Development for the Center for Genomic Medicine at Northwell Health Cancer Institute (New Hyde Park, N.Y.): Health systems must determine the best strategy for patients to access the drug through the commercial route, which for the time being is by way of two specialty pharmacies. Many systems built order sets to facilitate the expanded access program and are now repurposing these order sets to source the drug from commercial supply. There has been an influx of appointments for GI oncology providers throughout the system to manage the interest from patients to hear more about the drug and find a path toward access.
Sasha Watson, PharmD. Medical Oncology Clinical Pharmacist at Sylvester Comprehensive Cancer Center, part of the University of Miami Health System: This will be a big help to our patients since we know that dispensing specialty medications within our own pharmacy is associated with fewer treatment delays and higher patient satisfaction. We are grateful for the opportunity to provide free drug supply when needed and other financial assistance programs since this is a frequent burden our patients face. We are committed to avoiding any gaps in treatment as we transition patients from the Expanded Access Program to commercial supply. The turnaround time from a new FDA approval to drug in hand for patients is typically at least a month or so due to manufacturing and insurance coverage delays.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
