Overview of Proposed Rule Changes to “Safe Harbor” Regulation

February 27, 2019   |   By Brian Duffant

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)…


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…


March 24, 2018 | Lopamudra Das, Brian Duffant, Courtney Coles

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 –…


US Market Access – Key Considerations in a Changing Environment

November 1, 2017   |   By Brian Duffant

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.


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…


Medicare Part D Direct & Indirect Remuneration

September 1, 2017   |   By Brian Duffant

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,…