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.


Systematic Review of Signs and Symptoms Associated with HSCT-TMA

Our colleagues recently participated in the first systematic literature review and meta-analysis on the signs and symptoms associated with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The recent open access publication published in Transplantation and Cellular Therapy provides a robust synthesis of currently available evidence. The findings will improve our understanding of HSCT-TMA, a complex […]

A Model to Estimate Cytokine Release Syndrome and Neurological Event Management Costs Associated With CAR T-Cell Therapy

With the marketplace flush with Chimeric antigen receptor (CAR) T-cell therapies to treat relapsed/refractory large B-cell lymphoma (LBCL), one of the key clinical and economic differentiators may be the risk of cytokine release syndrome (CRS) and neurological events (NE).  Our recent publication aimed to focus solely on this key feature of treatment with the aim […]

Real-world assessment: effectiveness and safety of extended-release calcifediol and other vitamin D therapies for secondary hyperparathyroidism in CKD patients

A recent publication by our colleagues uses real world data to demonstrate the real world effectiveness of a recently approved therapy while maintaining safe outcomes. Extended-release calcifediol (ERC), active vitamin D hormones and analogs (AVD) and nutritional vitamin D (NVD) are commonly used therapies for treating secondary hyperparathyroidism (SHPT) in adults with stage 3–4 chronic […]

Breast, Colorectal, Lung, Prostate, and Cervical Cancer Screening Prevalence in a Large Commercial and Medicare Advantage Plan, 2008–2020

Our colleagues recently published a large-scale analysis to comprehensively assess breast, colorectal, cervical, lung, and prostate cancer screening rates and trends in the US over time among individuals for whom screening is recommended by the United States Preventive Services Task Force (USPSTF). Cancer screening rates remain suboptimal and efforts to increase uptake seemed stalled. Future […]

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 [...]