Asembia 2024: Advancing Medication Access

Presenters:

• Dinesh Kabaleeswaran, Senior Vice President, Consulting and Advisory Services, MMIT Network
• Jennifer Klarer, Partner, The Dedham Group

Summary: What was discussed

This session discussed the growing use of real-world data (RWD) and AI in addressing medication access barriers. The presenters highlighted the impact of increasing coverage restrictions, patient costs and government regulations on the pharma industry. All of the stats shared in this session recap are derived from their market research, which was based on the perspectives of 309 stakeholders from various levels and functions within pharma and biotech. The findings highlight some of the key medication access concerns within the industry.

Key takeaways

• Pharma companies are increasingly using real-world data (RWD) to assess and improve patient access. Kabaleeswaran and Klarer highlighted their recent market research that found 71% of participants reported RWD as being “very integrated in access decision-making,” while 73% reported usage beyond market access.^{[0]Dinesh Kabaleeswaran, Jennifer Klarer, May 1, 2024, Asembia Specialty Pharmacy Summit, From Pipeline to Patient: Understanding Barriers to Access in 2024 and Beyond.} As insurance coverage and affordability challenges grow, pharma companies are using RWD to help overcome barriers.
• Kabaleeswaran and Klarer also highlighted the growing focus on AI as a strategic driver of industry innovation. In fact, their research found 71% of pharma decision-makers are incorporating AI into their access strategy, and nearly all plan to use it in future strategies.^{[0]Dinesh Kabaleeswaran, Jennifer Klarer, May 1, 2024, Asembia Specialty Pharmacy Summit, From Pipeline to Patient: Understanding Barriers to Access in 2024 and Beyond.} AI has already shown significant potential in streamlining workflows, sharing knowledge, analyzing disease landscapes, conducting health economics and outcome research, and identifying commercial opportunities.
• Pharma companies are making significant investments in improving patient access. The presentation shared that 84% of decision makers plan to increase their spending on access in the next five years, with particular focus on finding innovative ways to extract value and develop novel technologies that may support patient access, like RWD and AI. They also shared that pre-launch planning is also evolving, noting that 42% of decision makers report shifting planning earlier to address challenges such as increased competition, product complexity and coverage restrictions.^{[0]Dinesh Kabaleeswaran, Jennifer Klarer, May 1, 2024, Asembia Specialty Pharmacy Summit, From Pipeline to Patient: Understanding Barriers to Access in 2024 and Beyond.}

The industry call to action

RWD and AI have emerged as powerful tools in helping to improve medication access within the pharma industry, and ultimately improving patient outcomes.^{[0]Dinesh Kabaleeswaran, Jennifer Klarer, May 1, 2024, Asembia Specialty Pharmacy Summit, From Pipeline to Patient: Understanding Barriers to Access in 2024 and Beyond.} The presenters suggested the industry work to integrate these technologies into access decision-making processes and leverage the capabilities of these technologies to inform strategies and stay ahead in an increasingly competitive landscape.

Presenters:

• Karen Silverblatt, Vice President, Business Development, Pharmacy, Inovalon
• Christie Teigland, Vice President, Research Science & Advanced Analytics, Inovalon
• Boris Vabson, Research Faculty, Harvard Medical School

Summary: What was discussed

This session focused on the impact of social drivers of health (SDOH) on health outcomes and medication adherence, emphasizing the need to address SDOH to promote health equity. They discussed the relationship between medication adherence in the Medicare population and SDOH.

Key takeaways

• Teigland shared that, "If you don’t address social drivers of health, you are not going to achieve good outcomes for a big percentage of the population." As SDOH and environmental factors impact up to 80% of health outcomes.^{[0]World Health Organization, Social determinants of health.}
• Centers for Medicare & Medicaid Services (CMS) is incentivizing Medicare Advantage plans to address social risk gaps by introducing the Health Equity Index in their Star Ratings Program, which goes into effect in 2027.^{[0]First Report Managed Care, How Medicare Advantage Plans Can Prepare for the CMS Health Equity Index, Feb. 13, 2024.} It will initially focus on three social risk factors: dual eligibility for Medicaid, low-income subsidy and disabled status.^{[0]First Report Managed Care, How Medicare Advantage Plans Can Prepare for the CMS Health Equity Index, Feb. 13, 2024.} But Teigland stressed the need to better understand other SDOH to help tackle disparities and promote health equity.
• Accessing accurate real-world data on patients' SDOH remains a significant challenge in identifying those at the highest risk of poor outcomes and effectively allocating resources.^{[0]Karen Silverblatt, Christie Teigland, Boris Vabson, May 1, 2024, Asembia Specialty Pharmacy Summit, Exploring Data-Driven Solutions to Improve Medication Access, Adherence, and Outcomes.} Additionally, finding effective ways to communicate with patients and address these barriers becomes the next crucial step in the journey towards equitable healthcare.
• Pharmacists are playing an increasingly important role in patient care management. A recent CoverMyMeds patient survey found 80% of patients have visited their pharmacy for clinical reasons other than, or in addition to, picking up their prescriptions.^{[0]CoverMyMeds, Patient Survey, 2022} Leveraging this frequent interaction, pharmacists can play a critical role in identifying SDOH factors for the patients they serve and utilizing this knowledge to help patients overcome access and adherence barriers, ultimately leading to improved patient outcomes.

The industry call to action

Drive meaningful change and create a more equitable healthcare system by:

• Harnessing real-world data on patients' SDOH to identify disparities and allocate resources effectively.
• Empowering pharmacists to play a critical role in patient care management by leveraging their frequent interactions and knowledge of SDOH.
• Implementing targeted interventions that address specific barriers to medication access and adherence, improving patient outcomes and promoting health equity.

Presenters:

• Nick Meza, Partner, Quarles & Brady LLP
• Ann Fritsche, Managing Senior Counsel, Biologics
• Leah Tinney, Managing Senior Counsel, CoverMyMeds

Summary: What was discussed

Panelists discussed the challenges faced by specialty pharmacies in delivering advanced therapies while facing complex regulatory barriers. They highlighted several examples of states evolving regulations, including heightened scrutiny from state boards of pharmacy on temperature controls and off-site and remote dispensing programs for gene therapy products. Additionally, the panelists discussed the regulatory hurdles involved in implementing specialty pharmacy-supported clinical trial operations.

Key takeaways

Specialty pharmacies face the challenge of adhering to state and federal regulations for community and mail-order pharmacies. They must also meet the unique needs of patients with complex medical conditions, all while embracing technology and adapting to a constantly evolving regulatory environment.

A growing number of states are implementing regulations that could hinder specialty pharmacies and their ability to use technology and innovation.

• Boards of Pharmacy in Miss., N.Y., Calif. and Ky. have faced opposition for strict shared services rules (including central fill), but advocacy efforts are moving proposals to more business-friendly regulations.^{[0]Nick Meza, Ann Fritsche, Leah Tinney, May 1, 2024, Asembia Specialty Pharmacy Summit, What’s Around the Corner? Navigating the Future Regulatory Landscape of Specialty Pharmacy.}
• Some states require individual pharmacists involved in shared prescription processing to hold a license in their state, causing a financial burden for nationally dispensing pharmacies.^{[0]Nick Meza, Ann Fritsche, Leah Tinney, May 1, 2024, Asembia Specialty Pharmacy Summit, What’s Around the Corner? Navigating the Future Regulatory Landscape of Specialty Pharmacy.}
• Several state Boards of Pharmacy, including Ariz., Ky., Okla. and Texas, are considering or have approved temperature monitoring requirements for dispensing pharmacies during shipment to patients.^{[0]Nick Meza, Ann Fritsche, Leah Tinney, May 1, 2024, Asembia Specialty Pharmacy Summit, What’s Around the Corner? Navigating the Future Regulatory Landscape of Specialty Pharmacy.}
• Specialty pharmacies face challenges in dispensing cell and gene therapies due to the need for immediate shipping and long distances between manufacturers and pharmacies.^{[0]Nick Meza, Ann Fritsche, Leah Tinney, May 1, 2024, Asembia Specialty Pharmacy Summit, What’s Around the Corner? Navigating the Future Regulatory Landscape of Specialty Pharmacy.} The panel shared that the industry needs to address this issue proactively to prevent restrictive regulations or legislation.

The industry call to action

The panelists encouraged the industry to stay informed and continue advocacy efforts, as they said the public outcry from the industry has been our best and most effective defense against challenging regulations. Otherwise, specialty pharmacies may be hindered in their ability to provide necessary medications to patients in states with restrictive legislation.