New challenges to medicare beneficiary access to mAbs

Area of Science:

• Biotechnology
• Pharmacoeconomics
• Health Policy

Background:

• Monoclonal antibodies (mAbs) are critical therapeutics with significant clinical success and expanding indications.
• High costs and lack of generic pathways present unique economic challenges for mAbs.

Purpose of the Study:

• To enumerate mAb approvals, indications, and off-label uses.
• To assess payer formulary management of mAbs.
• To identify challenges to Medicare beneficiary access to mAbs.

Main Methods:

• Literature review and primary data collection.
• Enumeration of original approvals, supplemental indications, and off-label uses.
• Assessment of payer coverage and reimbursement conditions for mAbs.

Main Results:

• The FDA approved 22 mAbs and 30 supplemental indications.
• 46 off-label use citations were identified in pharmaceutical compendia.
• Significant variation in coverage and reimbursement exists across Medicare Part B and Part D plans.

Conclusions:

• Four major challenges impact mAb stakeholders: administrative price controls, coverage variation, shift to self-administration, and comparative effectiveness.
• Systematic use of "coverage with evidence development" is proposed to address these challenges optimally.