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The commenter reasoned that separate bundled payments for each product are needed under the Medicare OTP benefit because Sublocade and Brixadi are clinically different due to several factors, including that the medications are not interchangeable, they have pharmacokinetic differences (for example, 2.46 ng/mL trough concentration for Sublocade 100mg versus 2.0 ng/mL for Brixadi 96mg), differences in minimum time between monthly dosing (26 days for Sublocade versus 28 days for monthly Brixadi), and differences in buprenorphine half-lives (19-26 days for Sublocade versus 43-60 days for Brixadi)

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The bacteriostatic water preservative provides adequate antimicrobial protection for the 30-day use window