We interviewed a medical director from a major US health insurer to gain insight into potential changes in reimbursement and prior authorization (PA) for the PCSK9 inhibitors after presentation of Praluent's ODYSSEY trial results at the 2018 ACC conference and a concurrent announcement from sponsors Regeneron/Sanofi that, in exchange for reduced barriers from insurers, they plan to negotiate net prices down into a cost-effective range based on a new ICER analysis of high-risk patients.

Topics discussed include:

• Impact of the December 2017 US label change for competitor Repatha (AMGN) for its own cardiovascular indication, as well as LDL-C lowering for primary prevention, for both commercial and Medicare plans
• Views on the ODYSSEY results, including benefit primarily in those with LDL-C of at least 100mg/dl and the mortality benefit seen
• Net price levels for moving the PCSK9 inhibitors off specialty tiering (and how that could differ for commercial plans), for most insurers to change PA to physician attestation only, and for removing PA
• Views on physician attestation versus chart documentation for PA among insurers
• Medicare MAXIMUS independent reviews and star ratings
• Whether there are differences in how they view Praluent and Repatha
• Potential impact of changes to clinical guidelines
• Potential impact and reimbursement of ETC-1002 (bempedoic acid; ESPR), along with types of step therapy

For the views of a regional health insurer, please see additional material in our 2018 post-ACC report.

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