With the Inflation Reduction Act (IRA) now in place, the Enhanced Oncology Model (EOM) implementing changes, and the second round of applications for participation now open, a panel of experts in patient-centered oncology care® The conference discussed improving access to cancer care, the impact on innovation, and creating value in cancer care.
Ryan Hamshild, PharmD, MS, MBA, CPEL, vice president of pharmacy at Emory Healthcare and Winship Cancer Institute, moderated the discussion, which included:
- Zahra Mahmujafari, PharmD, MBA, BCOP, FHOPA, Clinical Pharmacy Manager, Department of Hematological Malignancies and Cellular Therapy, University of Kansas Cancer Center
- Bruce Wilson, Vice President, U.S. Oncology Care and Access, AstraZeneca
- Derek Athey, senior vice president, government strategy and federal accounts, Lilly USA
- Samuel Stolpe, PharmD, MPH, Director of Healthcare Quality Strategy, Johnson & Johnson Innovative Medicines
Derek Athey
Image courtesy of Lily USA
The discussion began with the hottest topic: how the IRA will affect the timeline for new drugs. Asay argued that the law will cut the value of small molecule drugs in half because they will only have nine years of exclusivity before negotiations, or what is called “pricing,” take effect. By comparison, biologics have 13 years of exclusivity. While several drugs that have undergone Medicare Fair Price (MFP) negotiations have gained new indications after being selected for the list, Asay believes that will no longer happen.
“I think you’re going to see them actually shortening the timeline and trying to get the indications as close together as possible,” he explained. That may be good for patients, but it comes with risks. Starting a drug as a third-line treatment, avoiding risk, and taking time to progress to an earlier line of treatment is going to be more difficult going forward.
Bruce Wilson
Image courtesy of AstraZeneca
Wilson added that companies are being put in the position to decide whether they should launch an asset in a smaller indication or hold off until a larger one. Manufacturers will look at the net present value opportunity to determine whether that first indication is worth launching.
“Now, we’re targeting a small population. [and] I am now trying to help my patients until there are bigger signs. [the drug] “You start a clinical trial for the larger indication, and then you start both indications at the same time,” Wilson says, “and the smaller population just loses out.”
Zahra Mahmood Jafari, PharmD, MBA, BCOP, FHOPA
Image courtesy of University of Kansas Cancer Center
Mahmujafari agreed that not being eligible for smaller patient populations will likely negatively impact patient outcomes in the short term, but will also impact clinicians who now have to do a lot of administrative work for that patient population.
Athey said while MFP has been getting a lot of attention when it comes to IRAs, the bigger change is the benefit design that will take effect Jan. 1. The design changes will eliminate the donut hole, set a $2,000 out-of-pocket cap and introduce “smoothing” to spread out out-of-pocket costs so that the entire out-of-pocket bill isn’t incurred in January.
“I think this has huge implications for oncology,” he said.[It’s] This is truly a game changer for patients and for affordability.”
One unknown is how negotiated drugs will be written onto prescriptions. The IRA says negotiated drugs are On Because the formulary doesn’t specify that these drugs should be prioritized, plans will likely use them in negotiations with others in their class, Athey noted.
Medication regimen management is important in oncology because health care providers sometimes want to try the latest and best treatments as soon as possible, even if they don’t line up with the medication regimen or aren’t the best option for the patient, Mahmujafari said.
Sam Stolpe, PharmD
Image courtesy of Johnson & Johnson
IRAs also overlap with EOMs for oncology providers, as patients enter the catastrophic phase, with Medicare’s total cost-of-care contributions shifting from 80% to 20% starting Jan. 1, 2025. Stolpe said this will ultimately lower the average cost of Part D drugs, with a big impact on certain cancer subtypes. But infused drugs will remain the same, so disparities related to the cost of infused drugs will widen, he said.
“What concerns me about this is that this is completely disconnected from clinical reality, and there are already so many issues associated with EOM,” Stolpe said.
Wilson added that while EOM’s predecessor oncology care model was somewhat innovative, EOM simply figured out how to get oncologists to do more work for less. He believes the model is trying to get the right thing done by reducing disparities in care, but the approach needs to be adjusted.
But Stolpe is optimistic because he feels there are good ideas out there on how to revise the EOM, including comments from CMS. There has been discussion, especially in oncology, about redefining what counts as value. In the Affordable Care Act, value is defined as keeping costs constant while improving quality, or lowering costs while keeping quality constant.
“But it’s easy to imagine scenarios where expensive, high-value therapies provide enormous value, and cancer treatment is one of those scenarios that calls for exactly that,” he said.
Additionally, continuing shortages pose a challenge for patient access. Wilson said, “The U.S. has done a really good job of taking costs out of the generic drug market,” but that means generic drug manufacturers may only have one or two facilities to produce critical treatments, which creates risks. All it takes is a problem with one manufacturer to create a shortage.
“I can’t emphasize enough the impact that drug shortages have when you have to have very difficult ethical conversations with multidisciplinary medical teams about who gets treatment and who doesn’t,” Mahmujafari said, “and with parents who have children with curable diseases.”
