The United States of America (USA) represents the most significant global healthcare market for pharma, medtech and biotech companies – with a population of approximately 332 million people. The US is considered the innovation friendliest healthcare system for pricing and reimbursement in the world. Manufacturers benefit from free pricing but there are certain price control and reimbursement formulary tools used by payers that must be highlighted. Our agency Justin Stindt Consultants is specialized in Market Access in the United States and can help you navigate the US Market Access.
Market Access United States of America – Essential to access the world’s largest market for pharma, biotech and medtech firms
The United States is widely regarded as having one of the friendliest healthcare systems when it comes to pricing and reimbursement. In this system, pharmaceutical products, medical devices and health apps enjoy free pricing with prices often surpassing the prices seen in Europe. However, it is important to emphasize that payers employ specific price control mechanisms and formulary management tools to regulate these costs.
Unlike many other countries that implement price controls to regulate drug prices, the US adopts a fully decentralized approach to pricing and reimbursement. This implies that there are no price controls or centralized entities at the federal level regulating drug pricing, which grants manufacturers more independence in determining the prices of their medications.
Exploring the Dynamics of Drug Pricing and Reimbursement in the US: Key Players and Strategies
In the USA, the pricing and reimbursement landscape is characterized by direct negotiations between manufacturers and entities and organizations such as:
- Government programs (such as Medicare and Medicaid) and pharmacy benefit managers (PBMs).
For more information visit our Navigating Pricing and Reimbursement in the US: Opportunities and Challenges page. - Integrated delivery networks (IDNs): IDNs are organizations that provide a wide range of healthcare services, including primary care, specialty care, and hospital care. IDNs often have their own pharmacies and can use their scale and bargaining power to negotiate lower drug prices from manufacturers.
- Specialty pharmacy managers (SPMs) and radiology benefit managers (RBMs): SPMs and RBMs are third-party administrators that help health insurers manage their specialty pharmacy and radiology benefits, respectively. SPMs and RBMs can also use their scale and bargaining power to negotiate lower drug prices from manufacturers.
- Managed care organizations (MCOs): MCOs are health insurance companies that use managed care techniques to control costs and improve quality of care. MCOs use a variety of tools to manage costs, including:
- Step edits: Step edits require patients to try lower-cost drugs before they can be prescribed higher-cost drugs.
- Prior authorization: Prior authorization requires patients to get approval from their MCO before they can fill a prescription for certain drugs.
- Quantity limits: Quantity limits restrict e.g. the number of pills that a patient can fill for a prescription.
- NDC block: National drug code (NDC) block prevents patients from filling certain prescriptions at certain pharmacies
The Institute for Clinical and Economic Review (ICER) plays a significant role in drug pricing assessments in the United States. As an independent watchdog, ICER’s evaluations carry considerable weight, shaping payer decisions. Payers also often request an Academy of Managed Care Pharmacy (AMCP) dossier to inform their assessment.
For more information visit our P&R dossiers – US page.
Assessing the Impact of the Inflation Reduction Act on Pharma and Biotech Industries: Challenges and Adaptations for Market Access in the US
One of the recent developments in the healthcare landscape is the Inflation Reduction Act (IRA) of 2022. The IRA is a major piece of legislation that will have a significant impact on the pharmaceutical, medtech and biotech industries in the United States. The IRA will allow the government to negotiate prices for a subset of high-cost drugs covered by Medicare and will require pharma companies to rebate the amount by which they raise prices above inflation for drugs covered by Medicare. These provisions are expected to have a negative impact on pharma companies, particularly those with a high concentration of high-Medicare-spend products in their portfolio. This act introduces measures to curb price increases and intends to emphasize transparency in drug pricing but has been criticized by industry to undermine the market based economic principles underlying the healthcare industry and to create barriers for future investment in R&D. Understanding and adapting to these changes is crucial for successful Market Access in the USA.
Justin Stindt Consultants is your agency to support you with Market Access in America
Justin Stindt Consultants is your consulting firm with experts who have extensive experience in Market Access in the US.
As a service provider, our consultancy has helped many clients with engaging the American authorities and payer organizations to devise pricing and reimbursement strategies and develop AMCP dossiers. Our consultants also support price and contracting negotiations.
For medical devices and digital health apps, our agency supports dossiers and negotiations. Many of our consulting firm’s clients have found the US to be the place to start for Market Access and decided to enlist our agency as partner of choice given our experience in the American market.
Contact our experts today to learn how our agency can tailor our services to meet your unique needs to enable Market Access in the USA.
Market Access services for Pharma and Biotech in US
Case studies for USA market
- Support entire USA Market Access process
- ATU Feasibility Assessment
- HAS early dialogue meeting
