The Compass

Let’s go on a walk together

The Compass is the place for us to share our thoughts and opinions about market access, health economics, and policy issues.


Medicare Part D Direct & Indirect Remuneration

Payers who offer Medicare Part D plans may receive additional compensation after the point-of-sale. These funds are known as Direct & Indirect Remuneration (DIR), and account for growing levels of disparity between Part D gross and net drug costs. As DIR is primarily composed of manufacturer rebates on select drugs, the way rebates are allocated [...]

Overview of Proposed Rule Changes to “Safe Harbor” Regulation

Health and Human Services (HHS) is proposing to eliminate safe harbor protection for manufacturer reductions in price on prescription pharmaceutical products to Medicare Part D plans, PBM’s, and Medicaid Managed Care Organizations. In conjunction with this amendment, HHS is proposing new safe harbor protections which would protect manufacturer point-of-sale (POS) reductions in price on prescription [...]

CAR-T Commercial Market Access Brief – A Review of Initial Brand Access at Select US Payers

Chimeric Antigen Receptor T-cell (CAR-T) therapies represent a breakthrough in cancer care due to the significant clinical response induced in patients who do not respond to currently available treatments. In 2017, two CAR-T therapies were approved by the FDA – KYMRIAH™ (Novartis) was approved for use in children with acute lymphoblastic leukemia in August and [...]

A Snapshot of the Conclusions on Long-term Value of Healthcare Treatments Conducted by the Institute for Clinical and Economic Review Group

The Institute for Clinical and Economic Review, a non-profit institute evaluates the cost-effectiveness of drugs, medical devices, medical procedures, and diagnostics. The Institute for Clinical and Economic Review has published multiple assessments of healthcare technologies which provide a volume of evidence to better understand the quantitative conclusions by each evaluation relative to all evaluations undertaken [...]

US Market Access – Key Considerations in a Changing Environment

Many life science manufacturers employ a payer size and control strategy in the US market. While this continues to be viable model, changes in formulary and benefit design result in local-level access variation. This suggests that alternative strategic approaches are important to consider when manufacturers engage in market access planning. Key Findings The employer shift [...]

Emerging Barriers to Launch Access – the Impact of New Drug Coverage Policies

New drug coverage policies provide guidance around a payer’s coverage of new drugs in the time period between FDA approval and P&T committee review. As these policies proliferate, manufacturers may find initial new drug launch access to be more limited than anticipated. Key Findings Commercial and Medicare Part D payers have implemented new drug coverage [...]