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As stated in the proposed rule, we believe the proposed policy is consistent with policies finalized in the CY 2018 PFS rulemaking, as the proposal would allow CMS to calculate an operationally reasonable payment limit using positive manufacturer's ASP data for highly similar products in limited instances, but also not group biosimilars with a shared reference product in a single billing and payment code

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A population pharmacokinetic and pharmacodynamic modelling approach to support the clinical development of RBP-6000, a new, subcutaneously injectable, long-acting, sustained-release formulation of buprenorphine, for the treatment of opioid dependence

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