Asembia 2024: Shaping Pipeline Trends

Presenter: Doug Long, Vice President Industry Relations, IQVIA

Summary: What was discussed

One of this morning’s featured presentations, Long delivered an insightful analysis on pharmaceutical market trends. In his data-packed slides, Long highlighted the profound impact of GLP-1s on the industry, foreseeing continued growth. He emphasized the dominance of specialty drugs in the market, particularly in oncology, immunology and HIV, while highlighting growth in traditional drugs for diabetes and respiratory conditions. He also explored challenges facing the industry, such as drug shortages, escalating prices within the supply chain affecting drug pricing and some of the hurdles faced by generics manufacturers.

Key takeaways

• Long shared slides from IQVIA that covered notable medication trends in 2023, including the growing use of immunology treatments, rising use of novel obesity drugs, antibiotic use and rising antimicrobial resistance, drug shortages impacting patient care, and changing patterns of contraceptive use.^{[0]IQVIA Institute, March 2024. Report: The Use of Medicines in the U.S. 2024: Usage and Spending Trends; and Outlook to 2028: IQVIA Institute for Human Data Science, Feb. 2024.}
• The top five therapy areas by defined daily doses in 2023 were hypertension (0.3% growth over 2022), lipid regulators (11.4% growth), mental health (0.4% growth), antidiabetics (9.3% growth) and gastrointestinal (11.0% growth).^{[0]IQVIA National Sales Perspective, Dec. 2023: IQVIA Institute, March 2024, as shared in slide at Long’s presentation at Asembia’s 2024 Specialty Pharmacy Summit.}
• There have been eight new launches through Feb. 2024, with immunology leading as the top therapy area so far in 2024, accounting for 38% of new product launches.^{[0]IQVIA U.S. Launch Landscape Tracker, Feb. 2024}
• GLP-1s, which Long refers to as "tsunamis," have been a game changer for the industry and he expects them to continue growing due to high obesity rates in the U.S. and their expansion into other indications.
• Specialty drugs have become a dominant force in the market, accounting for more than half of drug expenditures in 2022.^{[0]American Journal of Managed Care, An Overview of Health Care and Pharmaceutical Trends, 2023-2024, April 19, 2024.} Notably, immunology (451%), oncology (349%), and HIV (206%) have seen substantial growth since 2012.^{[0]American Journal of Managed Care, An Overview of Health Care and Pharmaceutical Trends, 2023-2024, April 19, 2024.} While traditional drugs have seen growth in diabetes (223%) and respiratory (140%).^{[0]American Journal of Managed Care, An Overview of Health Care and Pharmaceutical Trends, 2023-2024, April 19, 2024.}
• Biosimilars and generics will play an important role in offsetting the rising costs of specialty drugs.^{[0]American Journal of Managed Care, An Overview of Health Care and Pharmaceutical Trends, 2023-2024, April 19, 2024.} However, generic manufacturers are facing a challenging environment, given dropping generic drug prices and increased competition.^{[0]American Journal of Managed Care, An Overview of Health Care and Pharmaceutical Trends, 2023-2024, April 19, 2024.} While biosimilars have seen a growing number of FDA approvals, there is still a need to expand the pipeline.^{[0]American Journal of Managed Care, An Overview of Health Care and Pharmaceutical Trends, 2023-2024, April 19, 2024.}
• Drug shortage reached a record high in the first quarter of this year.^{[0]CNN, Drug shortages reach record high in US, April 12, 2024.}
• Rising prices throughout the supply chain, from shipping to gas to raw materials, continue to drive up drug prices.

The industry call to action

Continued investment in research and development is important for exploring the broader impact of GLP-1s on new indications, driving innovation and reinvigorating preventative care. Additionally, the further development of biosimilars and refinement of generics is important to support medication affordability and improve access.

Presenter: Jon Mahrt, President, PBM and Chief Operating Officer, Optum Rx

Summary: What was discussed

“Unaffordable innovation is useless.” That’s the assertion Mahrt shared in this session, covering the challenges presented by both current drug trends and those on the horizon.

The popularity of GLP-1s is shaping trends in the pipeline, which is full of exciting, yet potentially costly treatments. According to Mahrt, the continuing innovation of therapy development needs to be matched by innovation in the way we help patients access safe, effective and affordable medicines.

Key takeaways

• Mahrt said, "this year, we’re expecting 2% of U.S. Gross Domestic Product (GDP) will be spent on prescription drugs." And continued that the problem is "somewhat unique to this country. Drug list prices in the U.S. are over 2.5 times higher than peer countries."^{[0]Jon Mahrt, April 30, 2024, Asembia’s Specialty Pharmacy Summit, “Addressing Cost & Accessibility for Innovative Medicines - GLP-1s and Beyond}
• He highlighted a seven-year trend of more than 20 orphan disease drugs entering the market each year, providing hope to patients with rare disease. He noted this trend is expected to continue, with 18% of prescription drug sales in the U.S. for treatment of rare or orphan diseases.^{[0]Jon Mahrt, April 30, 2024, Asembia’s Specialty Pharmacy Summit, “Addressing Cost & Accessibility for Innovative Medicines - GLP-1s and Beyond}
• There are new indications in the pipeline that could expand the usage of GLP-1s to areas such as sleep apnea, chronic kidney disease, MASH (metabolic dysfunction-associated steatohepatitis), heart failure and Alzheimer’s Disease.^{[0]Jon Mahrt, April 30, 2024, Asembia’s Specialty Pharmacy Summit, “Addressing Cost & Accessibility for Innovative Medicines - GLP-1s and Beyond} With the expected expansion of GLP-1s into other indications,^{[0]Drug Discovery & Development, Will GLP-1 drugs transition from obesity and diabetes to diverse clinical indications?, Oct. 19, 2023.} the affordability question will continue to be present.
• 83% of Americans say the cost of prescription drugs is unreasonable. Additionally, 89% of employers believe that specialty drug spending is becoming a "top threat" to employer-provided benefits.^{[0]Jon Mahrt, April 30, 2024, Asembia’s Specialty Pharmacy Summit, “Addressing Cost & Accessibility for Innovative Medicines - GLP-1s and Beyond}
• According to Mahrt, addressing the historical lack of transparency in how drug pricing works is one of the biggest obstacles that needs to be tackled. Increasing transparency into how drug prices are negotiated and how formulary decisions are made can help increase trust and help improve access to therapy.
• When it comes to GLP-1s, and future blockbuster therapies, increasing transparency is key to lowering the list price.

The industry call to action

Mahrt stressed the need to find a path that nurtures innovation while ensuring drugs are attainable for those who need them. He underlined the importance of cooperation to improve access, affordability and value – identifying three specific areas of focus: lowering drug pricing, collaborating on the right therapies and clinical solutions, and partnering with pharma on value-based arrangements.

Presenters:

• Sarah Butler, Chief Commercial Officer, ADVI Health
• Hillary Cavanaugh, Director, Federal and State Policy, ADVI Health
• C. Lyn Fitzgerald, Vice President of Sales, Ontada
• Lindsay Greenleaf, Vice President and Solution Leader, Federal and State Policy, ADVI Health

Summary: What was discussed

Healthcare is typically a hot issue in election years with the potential to result in significant policy changes. With the implementation of the Inflation Reduction Act (IRA) drawing near, this panel explored the future of this landmark legislation, the impact of its drug pricing provisions and other policy issues shaping the landscape of drug coverage, including the war on cancer.

Key takeaways

• While the long-term impact of the IRA remains uncertain, the panel highlighted the crucial need for pharma companies to be prepared for negotiations. They shared the importance of building a team that develops rigorous evidence generation strategies, with a focus on factors such as speed to market and patient adherence.
• Companies will need to demonstrate value and differentiation, which is where real-world evidence becomes critical for showcasing efficacy, effectiveness, safety, value, diversity, and adherence data and insights. Oncology has the potential for a greater impact, given the large proportion of patients.
• Significant progress has been made in improving cancer outcomes, and the industry possesses the necessary power, technology and opportunities to generate the data and insights required to support ongoing innovation. This includes optimizing trial design, expediting the launch of drugs in a more efficient manner, and providing education to instill confidence in patients.
• There are some policy exceptions for rare disease therapies; however, the panel shared that there are not many rare disease therapies that meet the requirements outlined in the IRA legislation.^{[0]Sarah Butler, Hillary Cavanaugh, C. Lyn Fitzgerald, Lindsay Greenleaf, April 30, 2024, 2024 Election Policy Issues and the Patient Journey Ripple Effect: IRA, The War on Cancer, and More}
• Now more than ever, community oncology needs consolidation and care needs to be close to home for patients.

The industry call to action

The panelists emphasized the importance of the industry working together. Costs are a widespread concern that demand effective solutions. In addition to the IRA, there are – and will be more – efforts aimed at curbing escalating costs. Innovation in areas such as trial design, evidence generation, patient adherence and value is crucial to improve outcomes.