Reimbursement Realities: Billing for Subcutaneous

EP: 1.The Shifting to Subcutaneous Oncology: Recent FDA Approvals

EP: 2.Subcutaneous Value: Efficiency and Access

EP: 3.Workflow Wins: Scheduling and Pharmacy Impact

EP: 4.IV vs Subcutaneous: Clinical Considerations

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EP: 5.Reimbursement Realities: Billing for Subcutaneous

EP: 6.Implementing Subcutaneous Without Disruption

Incorporating SubQ formulations into a clinical formulary involves a series of careful evaluations by pharmacy and therapeutics committees. These decisions start with confirming that the SubQ and intravenous (IV) versions are clinically equivalent in efficacy and safety. It's also crucial to understand the scope of indications, as SubQ versions may not always carry the same approvals as their IV counterparts. Committees also assess whether SubQ administration makes practical sense within a given care plan—particularly when combined with other IV treatments—since giving both concurrently might require multiple injections and diminish efficiency.

Adverse event profiles also guide decision-making. For example, SubQ versions of medications known to cause infusion-related reactions—such as daratumumab—are typically fast-tracked for inclusion due to better tolerability and simpler administration. More nuanced cases demand deeper analysis, with input from both clinical and pharmacy teams to identify the most appropriate patient populations for these formulations. This ensures the SubQ product fits into existing workflows and offers tangible benefits without introducing unnecessary complexity.

Reimbursement presents another layer of consideration. When a new SubQ drug is released, it may lack an established J-code or formal reimbursement pathway, which introduces financial risk—particularly for community oncology practices that must front the cost. Reimbursement delays can stretch to 6 months or more. To mitigate this, practices often engage with manufacturers to negotiate extended product dating and other protections. Pricing also plays a key role. Ideally, SubQ and IV versions should be cost-equivalent to prevent payers from favoring one purely for economic reasons. However, challenges arise with fixed-dose SubQ drugs, which can appear more expensive than weight-based IV versions for lighter patients. This complexity underscores the need for collaboration among providers, payers, and pharmaceutical companies to ensure that patient care—not cost alone—drives treatment decisions.