Coverage of subcutaneous versus intravenous oncology therapies by US commercial health plans.

Abstract

1554 Background: Several widely used intravenous (IV) oncology therapies have recently been reformulated for subcutaneous (SC) administration. Compared with IV infusions, SC formulations reduce administration time and chair use, improve patient convenience, and enable more flexible sites of care. At the same time, SC formulations may alter established reimbursement and contracting arrangements, including shifts away from buy-and-bill payment, changes in site-of-care management, and differences in how net costs are realized by payers. We examined how US commercial health plans prioritize SC formulations relative to IV formulations in their drug coverage policies. Methods: We used the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) Database to identify US commercial health plans with coverage policies for both SC and IV formulations of oncology therapies. SPEC includes detailed treatment access criteria from 17 large US commercial health plans. Coverage policies were current as of December 2025. The unit of analysis was a plan-drug combination, e.g., UnitedHealthcare’s policies for trastuzumab. Coverage was classified as IV preferred , on par , or SC preferred , depending on if one formulation is required before another. Results: We identified 86 coverage policies across 6 oncology therapies. One payer excluded the SC formulation from coverage in two instances, thereby denying enrollees access to the therapy. Among the remaining 84 policies, 8 (9.5%) were classified as IV preferred and 76 (90.5%) as on par ; no policies classified the SC formulation as preferred (Table 1). Coverage varied across therapies, with the frequency of IV-preferred coverage among payers covering both formulations ranging from 0% to 21%. Among the 76 on-par policies, 55 (72.4%) allowed patients to initiate treatment with either the IV or SC formulation without prior treatment requirements. In contrast, 21 (27.6%) required patients to first try and fail an alternative therapy before coverage for either formulation was granted. These step-therapy requirements were more common for older therapies with available biosimilars, and the required prior therapy was most often a biosimilar of the reference product. Conclusions: Across six oncology therapies, most US commercial plans covered SC and IV formulations on par, with a minority preferring IV and none preferring SC. Preferences varied by product, and access restrictions mainly reflected step-therapy requirements for older therapies with available biosimilars. Overview of coverage for intravenous (IV) and subcutaneous (SC) formulations. Drug # Payers Covering IV & SC Formulations SC Only Preferred Coverage Parity(SC vs IV) IV Only Preferred Drug A 16 0 14 (87.5%) 2 (12.5%) Drug B 15 0 14 (93%) 1 (7%) Drug C 15 0 14 (93%) 1 (7%) Drug D 15 0 15 (100%) 0 (0%) Drug E 14 0 11 (79%) 3 (21%) Drug F 9 0 8 (89%) 1 (11%) Total 84 0 76 (90.5%) 8 (9.5%)