Industry experts gathered at the Patient-Centered Oncology Care® meeting to discuss the profound impacts of recent healthcare policy changes on cancer care innovation and accessibility. The implementation of the Inflation Reduction Act (IRA) and the Enhancing Oncology Model (EOM) are creating ripple effects throughout the oncology landscape.
Impact on Drug Development Timelines
Derek Asay, senior vice president at Lilly USA, highlighted how the IRA's Medicare price negotiation provisions are fundamentally altering drug development strategies. The law creates a significant disparity between small molecules, which receive 9 years of pricing exclusivity, and biologics, which get 13 years before negotiations begin.
"I think what we'll see is you're really trying to truncate that timeline, of really putting those indications close together," Asay explained. This compression could accelerate patient access to new indications but also increases development risks.
Bruce Wilson from AstraZeneca emphasized a concerning trend: companies may delay launching drugs for smaller patient populations to protect their pricing position for larger indications. "Instead of launching in a small population [and] helping those patients until that bigger indication comes, now I have to hold [the drug] for the larger indication," Wilson noted.
Medicare Benefit Design Changes
A major positive development from the IRA is the transformation of Medicare's benefit design. Starting January 2024, the program will:
- Eliminate the coverage gap ("donut hole")
- Cap out-of-pocket costs at $2,000
- Implement cost smoothing throughout the year
These changes are expected to significantly improve treatment affordability for cancer patients, though questions remain about how negotiated drugs will be positioned on formularies.
Challenges in the Enhancing Oncology Model
The intersection of the IRA with the EOM presents new complexities for oncology providers. Samuel Stolpe of Johnson & Johnson Innovative Medicine pointed out that while Part D drug costs will decrease as Medicare's catastrophic phase coverage shifts, infused agent costs will remain stable, potentially exacerbating treatment disparities.
Drug Shortage Crisis
Access challenges persist due to ongoing drug shortages, particularly in the generic market. Dr. Zahra Mahmoudjafari from the University of Kansas Cancer Center described the devastating impact: "I cannot stress the ramifications of a drug shortage when you are having to have really difficult, ethical conversations with your multidisciplinary care team as to who gets treatment, who does not."
Experts attribute these shortages to the consolidation of generic manufacturing facilities, where a single facility disruption can trigger nationwide supply issues.
Redefining Value in Cancer Care
The discussion highlighted the need to reconsider how value is defined in oncology. Traditional definitions focused on cost containment may not adequately capture the benefits of innovative cancer therapies. Stakeholders emphasized the importance of recognizing that high-cost treatments can deliver substantial value through improved patient outcomes.
