Artikkel

Mapping the United States pricing and reimbursement journey

  • Casper Paardekooper

  • David Ringger, PHD

The disparate pricing and reimbursement (P&R) landscape in the United States (U.S.) poses significant challenges for biopharmaceutical companies new to the market. Despite the fragmented payer environment, the U.S. remains the largest global pharmaceutical market, accounting for around 45% of global pharmaceutical sales.1  The country’s large and diverse patient population of more than 300 million people has vital portfolio-level implications for any global pharmaceutical company. To tap into this important market, manufacturers need to understand the challenges and payer dynamics, stay on top of changing policies, and carefully strategize their commercialization plan, taking into consideration the likely patient population and how that will impact reimbursement. 

A complex, multi-faceted landscape

Unlike the largely single-payer European markets, the U.S. payer environment is a fragmented system spanning Medicare, Medicaid, and commercial plans, including pharmacy benefit managers (PBMs), integrated delivery networks, specialty pharmacies, and complex distribution channels.

From a Medicare perspective, companies face a dichotomous structure of Medicare Fee for Service (FFS) – sometimes referred to as “traditional Medicare,” which fragments healthcare coverage, payment, and reimbursement by site of care – vs Medicare Advantage, which operates under Medicare guidelines but is managed by commercial companies.
For Medicare FFS, outpatient products often fall under Part B and incorporate rebates based on the list price called the average sales price (ASP).2 Medicare Part A includes hospital inpatient coverage for products under the Medicare Severity Diagnosis Related Group (MS-DRG)3 bundled payment.

Part D products, which are generally self-administered, are paid based on the list price and contracted rates with pharmacies without rebates included.4 Of note, the Inflation Reduction Act introduced Medicare-manufacturer price negotiation for the top utilized Medicare products under Part B and Part D.

Medicaid is administered by the states, with each state setting its own fee schedule, which, in our experience, is typically 30% to 40% lower than Medicare. There is a mandatory rebate for Medicaid, and there are often supplemental rebates, which are not incorporated into the reimbursement price.5

The commercial landscape spans a diverse network of plans, where reimbursement is based on list prices, along with contracted rates with healthcare professionals and pharmacies. This complex environment requires a nuanced understanding of changing dynamics, such as major PBM reforms6 that will reshape the compensation structure and the vertical integration of PBMs, specialty pharmacies, and retail pharmacies.7

Unravelling the market challenges

For non-U.S. biopharmaceutical companies, navigating the complex payer dynamic can be overwhelming. 

Many manufacturers that are unaccustomed to the U.S. market may not understand that the price of the product is separate from the reimbursement that pharmacies, healthcare providers, and hospitals receive. That amount will depend on the payers, the contracts in place, or the overall payment system. With more than 1,000 commercial payers,8 and each with potentially different ways of covering the product and managing access, the landscape is further complicated and increasingly heterogeneous.

The patient support component is another factor non-U.S. companies may overlook. Even when drugs are covered by the payers, patients face out-of-pocket costs that have been increasing over time.9 Having patient support programs, including copay assistance programs, can improve access for patients who otherwise may not be able to afford the therapy, particularly when it comes to many newer, costly treatments, such as cell and gene therapies.  

Global companies must also navigate a rapidly shifting geopolitical landscape, with tariffs and Most-Favored-Nation (MFN) pricing initiatives creating further P&R uncertainties. Companies will need to stay on top of a variety of current and emerging programs that could further weigh on P&R, including:

  • The GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) model, which uses manufacturer-reported average prices from 8 economically comparable countries, will impact Medicaid products.10
  • GLOBE (Global Benchmark for Efficient Drug Pricing), which is a proposed mandatory model for certain Medicare Part B drugs.11
  • GUARD (Guarding U.S. Medicare Against Rising Drug Costs) (GUARD), which will need to be factored in for certain Medicare Part D drugs.12

Frequent P&R missteps from non-U.S. manufacturers

Biopharmaceutical companies from outside the U.S. often don’t understand the regulations and requirements for getting products paid for by Medicare and Medicaid, such as being listed on the Federal Supply Schedule, participation in the 340B Program, and the Medicare Drug Rebate Program, which requires manufacturer collaboration among various public health entities and can, at times, require a physical presence in the U.S.13

An over-reliance on the list price vs net price after discounts and rebates is a common misunderstanding among non-U.S. manufacturers. There can also often be uncertainty about how best to price a therapy, for example, whether to price a product low to increase access or price it higher and offer rebates. 
There is also a tendency to leave engagement with the payers too late in the process and assume that the evidence about the product speaks for itself, or fail to provide more direct product education to specific channels. 

Building a strategic roadmap for P&R success

Any biopharmaceutical company entering the U.S. marketplace will need to navigate a complex network of patients, providers and payers. The following 5-step strategic roadmap can be leveraged to help non-U.S. manufacturers successfully commercialize their products in the complex U.S. marketplace:

Step 1

Determine who will use the product, which sites of care to target and whether they are equipped to handle a particular therapy, and how the product will be coded so that it is billable. Integrated Delivery Networks and Centers of Excellence can be crucial to the success of specialized therapies, but they have complex and diverse needs, which can be difficult for non-U.S. manufacturers to navigate.  

Step 2

Understand how payers will evaluate the products from a coverage and payment perspective. This will require manufacturers to carry out primary and secondary market research on the payer landscape, including conducting data analysis and gathering insights from key opinion leaders and stakeholders to support strategic decision-making. Consider developing budget impact models that can be customized for different payers and demonstrated in the field.

Step 3

Understand the expectations from a patient support perspective and conduct a cost analysis to help quantify the manufacturer’s potential exposure. Could the patient population for the product benefit from guidance throughout the process – from the time the prescription is written to fulfilling it and beyond – or would they simply need support from a copay program? Is there a huge uninsured patient population that will require free-goods support to remain adherent? It is recommended to pair a patient support benchmarking assessment with an exposure (cost) analysis to estimate the total expected cost of the program to the manufacturer under various utilization scenarios.

Step 4

Develop a comprehensive evidence package to support the product’s value proposition for the payer. Define the product’s clinical differentiation supported by data from clinical trials, additional studies, or real-world data. Different disease states will have different expectations, depending on how crowded the therapeutic area is or whether the product addresses an unmet need. Recognize that Food and Drug Administration (FDA) approval data is the baseline, and payers will expect more data to demonstrate the product’s value attributes; for example, using reports generated by the Institute for Clinical and Economic Review (ICER). Begin in-depth information exchange with payers before marketing approval, then provide payers with the comprehensive value proposition after approval. 

Step 5

Engage stakeholders and build credibility with key opinion leaders and physicians who will prescribe the product as soon as the target product profile has been established to pressure test any potential data gaps. These stakeholders will vary from product to product. 

  • If it is an oral or self-administered therapy, the primary driver is payers. 
  • If a product is physician-administered in the outpatient setting, the product is often purchased in anticipation of administration to a patient, then reimbursed following administration. Physicians and hospitals, therefore, need to ensure the reimbursement is adequate for the price paid. Stakeholders include physicians and hospital decision-makers, including pharmacists, group purchasing organizations, and payers. 
  • If the product is administered in a hospital during an inpatient stay, the product is reimbursed based on its Diagnosis-Related Group (DRG). If the drug price exceeds the DRG amount, the manufacturer will need to consider other hospital decision-makers, such as group purchasing organizations, pharmacy directors, and hospital reimbursement directors. 

Meeting the U.S. P&R moment

Developing a strong P&R roadmap begins with a clear understanding of the product and the patient journey. It depends on being able to uncover gaps and loopholes in the evidence package that payers are likely to question. 

A manufacturer can have a great product, but if they don’t understand the U.S. healthcare system and complex nuances of the reimbursement landscape, they will struggle to get payers to support the product or physicians to prescribe it. While it is important to engage with key opinion leaders and physicians to determine if they will prescribe the product, asking payers how they will cover and reimburse the product, as well as any restrictions they may place on that reimbursement, is key to successfully commercializing a product in the U.S.

Manufacturers will also need to be vigilant when it comes to geopolitical developments. Understand how MFN policies and related initiatives may impact how public health entities – Medicare and Medicaid – and commercial payers reimburse products. 

A best practice approach is to work with a trusted partner that has the breadth and depth of knowledge and expertise to address the complexities of the U.S. healthcare system, as well as the myriad of P&R issues manufacturers will face. 
*Kildene fortsetter nedenfor

About the authors:

Casper Paardekooper is Head of Pricing, Policy and Stakeholder Engagement, Europe at Cencora. Prior to this role, he has been responsible for the Life Sciences practice and the Value, Access & Policy Center of Excellence at strategic consultancy Vintura, for more than 10 years, where he focused on access policy, market access strategy, value demonstration and value-based healthcare in Europe. Casper is a trusted advisor to many large biopharma companies and brings more than 15 years of experience as strategy consultant in life sciences and healthcare.

David Ringger, PhD, is a Director of the Global Market Access and Pricing team at Cencora. With over 12 years of experience in market access, pricing, and health economics across various therapeutic areas and product types, Dr. Ringger brings a wealth of experience and knowledge to his role. He oversees a team focused on formulating evidence-generation plans, developing pricing and reimbursement strategies, and supporting stakeholder engagements. The team collaborates closely with Cencora’s local market access teams to ensure that the global strategies are rooted in local realities.


Ansvarserklæring:
Informasjonen i denne artikkelen utgjør ikke juridisk rådgivning. Cencora, Inc. oppfordrer leserne på det sterkeste til å gjennomgå tilgjengelig informasjon relatert til emnene som diskuteres og stole på sin egen erfaring og ekspertise når de tar beslutninger relatert til dette.
 


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Sources


1. Business Market Insights. US Pharmaceutical Market – Historic data: 2020–2021. https://www.businessmarketinsights.com/reports/us-pharmaceutical-market 
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10. Centers for Medicare & Medicaid Services. GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) model. Page last modified: 23 December 2025. Accessed 29 December 2025. https://www.cms.gov/priorities/innovation/innovation-models/generous 
11. Centers for Medicare & Medicaid Services. GLOBE (Global Benchmark for Efficient Drug Pricing) model. Page last modified: 29 December 2025. Accessed 29 December 2025. https://www.cms.gov/priorities/innovation/innovation-models/globe    
12. Centers for Medicare & Medicaid Services. GUARD (Guarding U.S. Medicare Against Rising Drug Costs) model. Page last modified: 29 December 2025. Accessed 29 December 2025. https://www.cms.gov/priorities/innovation/innovation-models/guard 
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