Health economics and outcomes research (HEOR) demand has grown alongside utilization of real-world data (RWD) in healthcare decision-making. Sectors influenced and impacted by use of HEOR evidence include pharmaceutical companies (manufacturers and distributors), healthcare institutions, payers, and government agencies. HEOR professionals hold vast knowledge in economic science and recent clinical studies and seek to improve…
Drug manufacturers offer voluntary discounts off list prices, known as drug rebates, but these are more complex than discounts for other healthcare products. This complexity arises from the various stakeholders involved and the types of rebates available. Formulary Placement Drug Rebate The primary recipients of rebates are commercial payers, including health insurance companies and pharmacy…
Transitional pass-through payments (TPTs) are a valuable tool for manufacturers looking to maximize market access and product adoption in the early stages of a product’s life cycle. By securing pass-through status, companies can accelerate market entry, support a strong pricing strategy, and gather essential real-world data to inform longer-term reimbursement strategies. This mechanism helps lay…
How Is the FDA Using PROs? The FDA has identified PROs1, also known as patient-generated health data (PGHD), as a focus area for regulatory science, given limitations with data collected in a controlled clinical setting, that patients are the experts in living with their condition, and therefore the FDA increasingly seeks to understand how patients…
When a new drug or technology enters the market following FDA approval, Medicare may approve or deny coverage on a claim-by-claim basis and beneficiaries may face coverage restrictions until a national or local coverage determination is made. National coverage determinations and local coverage determinations are key decisions on whether a particular medical service, procedure, or…
A chart review, also referred to as a chart abstraction or medical record review, is a specific method of RWD collection commonly used to gain insights in healthcare research. Chart reviews involve systematically reviewing the medical records, or charts, of a patient population to gather information on a specific clinical issue, treatment, or outcome. Chart…
Critical to ensuring market access success for your product or technology, global value dossiers and AMCP dossiers are utilized to communicate product value with an eye to the unique access and reimbursement influencers within the market. Your product’s GVD or AMCP dossier should be started early in development and updated frequently with new clinical evidence…
A Delphi panel is a group of experts who provide opinions on a particular topic through a series of surveys administered in rounds. The expert group is a Delphi panel, while the methodology used to survey these experts is the Delphi method. The Delphi method utilizes a specific set of scientific methodologies to achieve expert…