Medicare spending and use of subcutaneous biologic formulations with hyaluronidase

Area of Science:

• Pharmacoeconomics
• Drug Delivery Systems
• Biotechnology

Background:

• Intravenous biologic drugs are increasingly reformulated with hyaluronidase for subcutaneous administration.
• This shift offers patient convenience and reduces infusion reactions.
• However, it can lead to increased healthcare spending, particularly if biosimilar competition is delayed.

Purpose of the Study:

• To analyze the impact of hyaluronidase-enabled subcutaneous biologic drug delivery on Medicare spending.
• To assess the relationship between the introduction of hyaluronidase versions and the timing of biosimilar competition.
• To inform policy regarding "hyaluronidase hopping" and its effect on drug pricing and market access.

Main Methods:

• Analysis of Medicare spending data for biologic drugs with and without hyaluronidase formulations as of December 2024.
• Comparison of spending shares for hyaluronidase versions across different drugs, considering the presence of biosimilar competition for original intravenous versions.
• Review of drug approval and biosimilar entry timelines.

Main Results:

• As of December 2024, at least 9 biologics had investigational or approved hyaluronidase versions.
• Medicare spending on these drugs was $10.3 billion in 2022.
• For four analyzed drugs, hyaluronidase versions accounted for 5%-83% of Medicare spending, with higher shares for drugs lacking early biosimilar competition (e.g., pertuzumab-trastuzumab, daratumumab).

Conclusions:

• Subcutaneous hyaluronidase formulations present a trade-off between patient benefits and potential increases in drug costs.
• The delay in biosimilar competition for original intravenous versions can significantly inflate spending on newer subcutaneous formulations.
• Policymakers must address strategies like "hyaluronidase hopping" to prevent artificial delays in biosimilar entry and protect Medicare's price negotiation capabilities.