Our Approach to Pricing, Access and Affordability

WHY WE DO WHAT WE DO

Amgen’s mission is to serve patients. Every day, we work to discover, develop and deliver breakthrough medicines that make a difference to patients’ lives and address some of society’s most serious diseases, including cancer, cardiovascular disease, inflammation and osteoporosis.

Healthcare systems are facing unprecedented challenges, such as increasing prevalence of chronic diseases, health disparities and constrained budgets, while access to and cost of medication is a concern for many patients.

At Amgen, we believe that innovative medicines are the best hope for patients in the fight against serious disease. To realize the full value of our medicines and for the patients who need them most, Amgen is delivering integrated patient access and health system solutions. 

Mark (right) is a Kyprolis^® patient

DELIVERING PATIENT ACCESS AND HEALTH SYSTEM SOLUTIONS

We’re helping to evolve the health ecosystem by actively engaging with and leveraging the strengths of governments, manufacturers, academics, payers, digital health companies, and practitioners. Together, we are working to co-create solutions that transform health systems by not only treating disease after it strikes, but also helping to predict and prevent disease before it occurs. We are also advocating for policies that would help make medicines more affordable and accessible for patients.

Amgen is delivering integrated patient access and health system solutions across three pillars and eight “Amgen Solutions.” Click on each pillar below to learn more about what we’re doing.

Explore Amgen's access and system solutions further:

• Access Approaches, Collaborations, and Lower Cost Treatment Options
• Transformative Treatments, Approaches, and Technology
• Shaping the Future of Healthcare

THE BURDEN OF DISEASE DICTATES INNOVATION

The growing burden of disease not only takes an enormous human toll, but also creates a huge financial burden on society. Innovation is necessary now, more than ever, to prevent taking a step backward in the progress of human health. For many diseases, better, more effective therapies are needed—key examples are cancer, cardiovascular disease, inflammation and osteoporosis.

COVID-19 has highlighted the importance of the prevention and treatment of chronic conditions—such as heart disease and obesity—in reducing the harm attributed to widespread disease outbreaks. The pandemic has also demonstrated how disruptions in care can impede delivery of timely medical attention for urgent and, in many cases, preventable conditions. Read more here about how the pandemic has underscored the need to continue investing in innovation that helps us predict and prevent chronic diseases.

For more information on how Amgen is supporting patients and communities during the pandemic, visit our COVID-19 Information Center. 

RISK OF NOT INNOVATING

About 659,000 people in the United States die from heart disease each year—that's 1 in every 4 deaths.¹  The total costs of cardiovascular disease in the United States are expected to reach $1.1 trillion by 2035.² A study published in 2019 looked at where we might go from here and presents a very stark choice.

Historical data and chart adapted from Ortendahl JD, Diamant AL, Toth PP, Cherepanov D, Harmon AL, Broder MS. Protecting the gains: What changes are needed to prevent a reversal of the downward cardiovascular disease mortality trend? Clinical Cardiology. 2019;42:47-55.

As this chart shows, if innovation stagnates, the cardiovascular (CV) mortality rate in the U.S. is predicted to significantly increase. However, if innovations are widely adopted and new innovations come along behind them, the CV mortality rate could be significantly reduced, building on the remarkable gains of the past 50 years. It is important to remember that these lines on this chart represent people's lives—that is what’s at stake here.

There is a tremendous opportunity—and an urgent need—to bend the curve of cardiovascular disease, cancer, osteoporosis and the many other serious diseases that affect tens of millions of people around the world. Our aspiration is to be a leader advancing innovative medicines that bend the curve on the rising burden of disease to benefit patients, society and other stakeholders.

IN THE NEWS

"We've accelerated growth by securing broad access and reimbursement at an affordable out-of-pocket cost for commercial and Medicare patients. We continue to work with payers and pharmacy benefit managers to make it easier for health care professionals to complete prior authorizations and ensure that a prescription written is a prescription filled," shared Executive Vice President of Global Commercial Operations, Murdo Gordon, during our 2022 Virtual Business Review. Read more here.

If scientists can deliver vaccines for COVID-19 in under a year, why does it normally take a decade or more to develop other types of medicines? Long timelines are not an inherent feature of drug development but a problem that can be solved through innovation. Read how Amgen is responding to this challenge.

David Reese, Executive Vice President of Research & Development

Read more from our head of U.S. Value & Access, Jen Norton, on findings from Amgen's latest Biosimilar Trends Report, which demonstrates that competition supported by biosimilars has the potential to provide cost savings for public and commercial payers.

While the current healthcare model is focused on treating and curing serious illnesses like cancer, heart disease and osteoporosis, Amgen is advocating for a different approach: one aimed at predicting who is at risk and helping to prevent the impact of serious diseases from occurring. Read why the company champions this approach from Amgen's chief medical officer, Dr. Darryl Sleep.

PRICING DECISIONS IMPACTING OUR PRODUCT PORTFOLIO

Since 2018, the average net price for Amgen medicines has declined and, for 2022, we expect a trend towards a mid-to high single digit decline in net price across our global portfolio of products as compared to 2021. The average list price increase across Amgen’s entire U.S. portfolio of products is in line with inflation and key pricing indices.

Learn more about Amgen’s Approach to Responsible Pricing.

OVERSIGHT OF OUR APPROACH TO PRICING, ACCESS AND AFFORDABILITY OF MEDICINES

The Corporate Responsibility and Compliance Committee of our Board of Directors receives regular updates regarding our approach to pricing, access and affordability of our medicines, as well as on the activities of our Amgen Safety Net Foundation and other philanthropic activities that provide access to our medicines across the globe. 

OUR COMPLIANCE WITH DRUG PRICING LAWS

One of our core Company values is “Be Ethical,” and part of being ethical is being compliant. At Amgen, compliance is adhering to the laws and regulations that govern what we do, including those that govern healthcare pricing and reimbursement.

Forward-Looking Statements

This material contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla^® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this material and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology and to integrate the operations of companies or to support the products or technology we have acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.