With the rise in US health care spending from $3.49 trillion in 2017 to $3.65 trillion in 2018 (a 4.6% increase), there is no surprise that scrutiny continues regarding the price tags on healthcare services and pharmaceutical products. With these price tags in mind, Health Technology Assessments (HTA) have become more prominent in US payer’s toolbox for coverage and reimbursement decisions. An HTA refers to the systematic research process and evaluation that examines evidence of the long- and short-term consequences of a medical treatment or healthcare delivery innovation. In ex-US, there are national bodies that utilize HTAs for healthcare coverage decisions, managing consumption, and determining pricing.
Although the U.S. currently lacks a national HTA program to guide coverage and pricing decisions, there are several agencies that undertake HTAs such as the Patient-Centered Outcomes Research Institute (PCORI), Agency of Healthcare Research and Quality (AHRQ), Medicare Evidence Development & Coverage Advisory Committee (MedCAC), and Institute for Clinical and Economic Review (ICER). ICER, in particular, was put on center stage with the introduction of high cost, novel, direct-acting antiviral agents for Hepatitis C that continue to influence drug pricing, formulary, and payer coverage decisions. Additionally, ICER has gained technology assets to support indirect comparisons and facilitate more capacity for assessments of new products and innovation.
As I reflect on our current healthcare environment shifting from fee for service to value-based care, I am excited as to how real world data, predictive analytics, clinical impact, quality of life, and an understanding of total healthcare cost has transcended talking points into a reality for innovative contracting. This excitement, however, is tempered with the concern that ICER is increasing their capacity for assessments bringing concerns on assumptions and methodological uncertainties resulting in avoidable curtailed access or a predefined undervaluation not reflective of the treatment’s real-world value and performance. With these concerns, it becomes paramount for biotech and biopharma to leverage their real world and value access roadmap to encompass the necessary elements to inform and engage payers to set a stage to demonstrate success. The value and access roadmap development starts in Phase 2 of clinical research ensuring that variables for the real world inclusive of patient experience, pathways, competing therapies, impacting technology, and healthcare utilization are accounted for in both the clinical and economic studies. These actions will inform strategy and provide collateral to address uncertainties and failure points in ICER assessments thereby driving a stronger market entry. Additionally, it is critical to prepare for post-commercial real-world studies that lend to a framework that serves as functional bridge for life cycle management.
For expert solutions focused on addressing evolving threats in the market contact Sapere Health Solutions.
1. National Health Expenditures 2018 Highlights. Accessed at: https://www.cms.gov/files/document/highlights.pdf
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