JAMA Netw Open. 2026 Mar 2;9(3):e262201. doi: 10.1001/jamanetworkopen.2026.2201.
ABSTRACT
IMPORTANCE: Biologic manufacturer copay coupon programs reduce patient out-of-pocket spending but may undermine biosimilar competition. Whether biologic manufacturers deploy coupons strategically to facilitate shifting patients to reformulated drugs to extend market exclusivity (ie, product hopping), remains unclear.
OBJECTIVE: To examine coupon use and coupon value for biologics line extensions whose originators are at risk of biosimilar competition.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from national prescription drug claims from the IQVIA Formulary Impact Analyzer, October 1, 2017, through September 30, 2019, including 43 088 commercially insured patients with 382 550 claims across 47 biologic products. Analyses were conducted February to September 2025.
EXPOSURES: Candidate product hop status interacted with the time since originator approval (≥12 vs <12 years). Candidate product hops were defined as biologic line extensions approved between 2017 and 2019; comparators were biologics with earlier approval.
MAIN OUTCOME AND MEASURES: The primary outcome was manufacturer coupon use. Secondary outcomes included coupon amount, share of patient costs covered by coupons, and postbuydown out-of-pocket spending. Linear probability models with product line random effects estimated associations among candidate hop status, time since originator approval (≥12 vs <12 years), and coupon outcomes.
RESULTS: Among 43 088 patients (22 113 [51.3%] female; mean [SD] age, 47.6 [15.2] years), coupon use for candidate hops increased relative to comparators as originators approached 12 years since approval (change, 19.0 [95% CI, 1.7-36.4] percentage points; P = .03). For products with older originators, coupons for candidate hops offset 38.8 (95% CI, 28.0 to 49.7) percentage points more of patient cost-sharing than comparators (P < .001), and postbuydown costs were $124 (95% CI, -$183 to -$65) lower (P < .001). Candidate hops accounted for 11 122 of 382 550 claims (2.9%).
CONCLUSIONS AND RELEVANCE: In this cross-sectional study, manufacturer coupon use for candidate hop biologics diverged from comparators as originators neared exclusivity loss, suggesting coupons may facilitate product hopping. Regulators should consider monitoring coupon programs during biologic exclusivity transitions.
PMID:41848732 | DOI:10.1001/jamanetworkopen.2026.2201
