AstraZeneca’s New 340B Replenishment Policy: An Unexpected Yet Welcome Change
In a rare but welcome move in the 340B landscape, AstraZeneca recently announced a shift in its replenishment policy for its breast cancer drug, Truqap (capiversatib). This update, which was published on the Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs website, comes as AstraZeneca prepares to discontinue the 160mg bottle dosage by the end of 2024. For 340B covered entities, the change brings relief and flexibility at a time when inventory management for high-cost drugs can be challenging.
Let’s unpack what AstraZeneca’s announcement means for 340B providers and why this approach could signal a more collaborative future between drug manufacturers and covered entities.
AstraZeneca’s Shift: Replenishment Flexibility Amid Dosage Discontinuations
Beginning January 1, 2025, AstraZeneca will discontinue the 160mg bottle dosage of Truqap, replacing it with a 160mg blister pack wallet. For 340B covered entities, the good news is that these entities will be allowed to count accumulations of the 160mg blister pack form toward their replenishment quotas for the discontinued 160mg bottle. Additionally, AstraZeneca has confirmed that both bottle and blister pack formats of the 200mg dosage will remain available, and these dosages are interchangeable for replenishment purposes.
In effect, this change eases the transition from one packaging format to another and ensures that covered entities can continue to access their needed drug supplies. AstraZeneca’s proactive stance on this shift comes as a welcome surprise, as it provides covered entities with the flexibility to manage and replace inventories without interruption.
Why This Change Matters for 340B Covered Entities
AstraZeneca’s approach is significant in the context of 340B’s unique inventory replenishment requirements. Under the 340B Program, covered entities can purchase drugs at a reduced price to serve low-income and uninsured patients but managing high-cost specialty drugs—especially those with strict handling or dosage requirements—has become increasingly complex.
Some of the key benefits this update offers to 340B covered entities include:
Seamless Inventory Management: Transitioning from one dosage form to another, such as from bottles to blister packs, can create logistical challenges. By allowing 340B entities to count accumulations of blister packs toward bottle replenishment, AstraZeneca ensures that healthcare providers can maintain continuity of care for patients without having to worry about replenishment discrepancies.
Flexibility in High-Cost Drug Management: Specialty cancer drugs are often expensive and limited in availability, making any disruption to dosage forms a challenge for 340B entities that rely on discounted drug access. AstraZeneca’s announcement provides much-needed flexibility by letting covered entities use blister packs to fulfill demand, alleviating the administrative burden that could come with changing inventory.
Reduced Risk of Stock-Outs: Breast cancer treatments are time-sensitive, and the 340B community cannot afford interruptions in drug availability. By clarifying that accumulations of the blister pack form can be counted toward replenishment, AstraZeneca has helped prevent potential shortages of Truqap. This proactive approach minimizes the risk of stock-outs, ensuring that patients can continue receiving their treatment without delay.
AstraZeneca’s Decision: A Model for Manufacturer-340B Relations?
The 340B landscape has been turbulent in recent years, with mounting restrictions on drug discounts, escalating compliance requirements, and shifting relationships between covered entities and pharmaceutical manufacturers. In this environment, AstraZeneca’s decision to ease the transition in packaging forms stands out as a collaborative move that balances both the company’s needs and the 340B Program’s mission.
While the company has made headlines in the past for imposing limitations on 340B discounts, this recent action demonstrates a willingness to work with covered entities in a way that benefits both parties. AstraZeneca’s approach to the Truqap dosage transition is a reminder that, with the right approach, manufacturers can address business needs while still supporting covered entities’ ability to serve vulnerable populations.
What Could This Mean for the Future of 340B?
The 340B Program’s long-term success depends on a balanced partnership between manufacturers and covered entities. While the program has faced increasing scrutiny from pharmaceutical companies concerned about potential misuse, AstraZeneca’s recent flexibility shows that there are ways to adjust pricing, packaging, or policies without undermining the program’s intent. It sets a precedent for a more flexible approach in cases where 340B covered entities need support in managing their inventories for life-saving medications.
A Rare Adjustment
AstraZeneca’s adjustment to Truqap’s packaging and replenishment policy represents an unexpected but positive change for 340B covered entities. By allowing interchangeable replenishment across dosage forms, AstraZeneca has demonstrated a rare level of consideration for the operational realities of hospitals and clinics that rely on the 340B Program.
This move could hopefully encourage other manufacturers to consider the benefits of proactive, flexible policies that acknowledge the needs of both patients and providers in the 340B ecosystem. As 340B covered entities continue to face challenges in inventory management, AstraZeneca’s approach serves as a welcome example of how the industry can align with the program’s mission of expanding access to critical medications for those most in need.
Navigating Requirements and Other Complexities
Rx|X developed its training, curriculum, and consulting to empower CEs nationwide to navigate changes within the 340B ecosystem, such as those stemming from the AstraZeneca’s decision.
“Rx|X is here to offer hands-on support on all aspects related to 340B, including changing AstraZeneca regulations,” said Rx|X co-founder Dr. Madeline Wallack. “We’ve also developed a new tool, Avanti 340B, for CEs to keep their internal operations proactive amidst policy changes impacting their 340B operations.”
Additionally, Rx|X’s Next Level site facilitates up-to-date information on the hottest 340B industry topics, including research papers, articles, and informational videos. It’s an invitation-only site that gives our clients vital and comprehensive 340B information.
“We designed Next Level to be an elite 340B information hub for our clients,” said Dr. Wallack. “The hub leverages various forms of media on 340B-related topics.”
Rx|X also plans to roll out webinars on the AstraZeneca decision and more. Follow us on LinkedIn to stay posted on upcoming dates.