Pricing Implications of Subcutaneous Reformulations Following Intravenous Launches: A Multicountry Analysis
Author(s)
Brett Gardiner, MPhil, Rosie Brady, Phd, Jona Hoxha, MPhil.
Access Infinity, London, United Kingdom.
Access Infinity, London, United Kingdom.
OBJECTIVES: Indication-based price erosion is a well-established practice, but less is known about how the price of an original formulation influences the pricing of its reformulated version within the same patient population. This study investigates the pricing dynamics of reformulations, specifically subcutaneous (SC) versions introduced following intravenous (IV) formulations.
METHODS: We analysed launch list pricing trends for branded drugs first launched in an IV formulation and subsequently reformulated as SC versions between January 2010 and June 2024. Drug pricing data were sourced from national databases including ANVISA (Brazil), CDA-AMC (Canada), NRDL (China), AMELI-BdMIt (France), Lauer Taxe (Germany), Gazzetta (Italy), NHI (Japan), Bot Plus (Spain), and NHS (England). The analysis focused on comparing the launch price of SC formulations with their IV counterparts at the time of SC launch, evaluated both on a cost of treatment (CoT) and cost per milligram basis.
RESULTS: None of the reformulations analysed achieved a price premium on a CoT basis, even when supported by claims of improved efficacy, safety, or patient convenience. Most SC reformulations launched after IV versions achieved CoT price parity. Notably, in cases where monthly SC and IV costs appeared to diverge, the IV formulation was weight- or body surface area-based, making monthly treatment costs highly sensitive to weight assumptions and drug wastage. For instance, in one oncology product, varying the weight assumption by 5 kg shifted the perceived 14% SC price premium to parity.
CONCLUSIONS: Health technology assessment (HTA) submissions and reimbursement negotiations must consider country-specific assumptions for patient weight and dosing. While CoT parity is common for SC reformulations, differences in dosing regimens can result in significant price variation on a per-milligram basis. Strategic selection of assumptions during pricing negotiations may support achieving a list—and potentially net—price premium for reformulated products.
METHODS: We analysed launch list pricing trends for branded drugs first launched in an IV formulation and subsequently reformulated as SC versions between January 2010 and June 2024. Drug pricing data were sourced from national databases including ANVISA (Brazil), CDA-AMC (Canada), NRDL (China), AMELI-BdMIt (France), Lauer Taxe (Germany), Gazzetta (Italy), NHI (Japan), Bot Plus (Spain), and NHS (England). The analysis focused on comparing the launch price of SC formulations with their IV counterparts at the time of SC launch, evaluated both on a cost of treatment (CoT) and cost per milligram basis.
RESULTS: None of the reformulations analysed achieved a price premium on a CoT basis, even when supported by claims of improved efficacy, safety, or patient convenience. Most SC reformulations launched after IV versions achieved CoT price parity. Notably, in cases where monthly SC and IV costs appeared to diverge, the IV formulation was weight- or body surface area-based, making monthly treatment costs highly sensitive to weight assumptions and drug wastage. For instance, in one oncology product, varying the weight assumption by 5 kg shifted the perceived 14% SC price premium to parity.
CONCLUSIONS: Health technology assessment (HTA) submissions and reimbursement negotiations must consider country-specific assumptions for patient weight and dosing. While CoT parity is common for SC reformulations, differences in dosing regimens can result in significant price variation on a per-milligram basis. Strategic selection of assumptions during pricing negotiations may support achieving a list—and potentially net—price premium for reformulated products.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE616
Topic
Economic Evaluation