艾昆纬-患者服务和市场准入季度顾问-2023年第一季度（英）-2023.3-12页_1mb

Patient Services and Market Access Quarterly Advisor Q1 2023

Market Access Overview

• Key Trends: The biopharmaceutical industry faces ongoing challenges including margin pressures, evolving payer controls, and regulatory changes.
• Inflation Reduction Act (IRA): Introduced measures like free vaccines, $35/month insulin caps, and Medicare price negotiations despite delayed full implementation.
• Market Dynamics: Disruptions driven by emerging models (e.g., Cost Plus Drugs) and increasing payer restrictions, exacerbated by the IRA.

Key Challenges and Developments

1. Pricing and Value Demonstration

• IRA Impact: Uncertainty surrounds negotiated Medicare prices and rebates; manufacturers must prepare for cost-sharing adjustments.
• Value Assessment: CMS will evaluate drug value through pharmacoeconomic analyses; debate continues over defining "value."

2. Innovation Pipeline

• Breakthroughs: Advances in Alzheimer’s, gene therapy, and vaccines face market barriers due to high costs.
• Launch Considerations: Manufacturers must align clinical positioning with market access strategies early in development.

3. Payer Controls and Restrictions

• Formulary Growth: Unique exclusions average over 600; oncology and specialty drugs increasingly targeted.
• Binding Tools: Payers may use triaging or coverage determinations (NCDs/CEDs), complicating product access.

4. Alternative Access Channels

• Patient Disruption: Rise of pharmacy discount cards and cost containment solutions challenging traditional insurance-based access.
• New Models: Examples include Cost Plus Drugs, offering transparent pricing and affordable generics.

5. Biosimilar Competition

• Humira Biosimilars: Entering market; competition focuses on pricing, contracting, and payer coverage varies.

6. Deductible Accumulators and Copay Maximizers

• Exposure: Strategies extract value from support programs; patient wallets bear increasing costs.
• Cost Impact: Estimated $5B in 2022; manufacturers face budget strain from delayed support.

7. 340B Program Challenges

• Marginal Mitigation: Channel expansion complicates margin forecasting and payer negotiations.
• IRA Effects: Interactions with inflation discounts and regulatory ambiguity persist.

8. Health Equity and Access Disparities

• Policy Initiatives: Addressing health deserts and disparities through equity-focused market access strategies.
• Industry Response: Manufacturers investing in patient support; programs aiming to bridge gap from symptom to treatment.

9. Modern Launch Practices

• Patient Support: Aggressive programs offset delayed formulary inclusion; continued launch price debates due to inflation.
• Margin Pressures: High pricing (e.g., >$200,000/year) and regulatory constraints require robust evidence-based strategies.

Disruptors and New Entrants

• Cost Plus Drugs: Revolutionary pricing model with low markup and transparency, projected to save Medicare billions.
• Market Response: IQVIA advisors suggest partnerships with disruptors to enhance payer strategy and patient access.

Next Steps: IQVIA Initiatives

• Market Access Master Class: Year-long webinar series covering legislation and strategic issues.
• Thought Leadership: Commitment to informing strategy and providing nuanced content through analyses.

Contact & Events

• Asembia 2023 Summit: Inquiries for partnership discussions and speaker participation with Scott Brzygot.

Note: This summary highlights key sections from the detailed quarterly advisor report, with a focus on market access trends, regulatory developments, and strategic implications.