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    Responsibility

    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 and cardiovascular disease. 

    Our mission requires that we engage with the many stakeholders in the healthcare system to tackle concerns over the cost of prescription drugs while also maintaining systemic incentives for innovation so that we can continue to attack serious diseases. Our vision for our Company’s role in society over the longer-term is as an agent for change as we strive to “bend the curve” on the rising burden of disease for patients, healthcare systems and other stakeholders.

    Mark (right) is a Kyprolis® patient

    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—two key examples are cancer and cardiovascular disease.

    Sources:  1. Centers for Disease Control and Prevention. FastStats; Deaths: Leading Causes for 2016.  Accessed July 17, 2017.  2. Murphy KM, et al. J Political Econ. 2006;114(5):871-904.  3. From 1997-2007 Seabury SA, et al. Forum for Health Economics & Policy. 2015; 19(1):141-156.  4. Benjamin E, et al. Circulation. 2017;135:e1-e458.  5.  Masana L, et al. J Clin Lipidol doi: 10.1016/j.jacl.2017.12.018. LDL-C = low-density lipoprotein cholesterol.   6. Raymond C. et al. Clev Clin J Med. 2014;81:11-19.  7. Cholesterol Treatment Trialists’ (CTT) Collaboration. Lancet. 2010;376:1670-1681. Cardiovascular events include coronary death and non-fatal heart attack, stroke and coronary revascularization.

    RISK OF NOT INNOVATING

    In 2016 (the last year for which we have data), cardiovascular disease claimed more than 840,000 U.S. lives and, for 2019, was projected to cost around $600 billion in the U.S. A recent study looked at where we might go from here and presents a very stark choice.

    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.

    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.

    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.

    HERE’S WHAT WE ARE DOING TODAY TO IMPROVE ACCESS AND AFFORDABILITY

    In the current environment, we are striving to develop approaches to address immediate needs. Innovation provides value to patients who are able to lead longer and healthier lives, reduces burden on families and caregivers, and reduces healthcare and societal costs. However, the value of our innovation cannot be realized if patients cannot afford or access our medicines.

     

    Pricing Decisions Impacting Our U.S. Portfolio


    In 2018:
    • We continued to offer rebates and discounts in exchange for appropriate patient access to our medicines, and our overall net selling price of our medicines declined. In 2018, our sales growth came from unit (or volume-driven) growth, and we believe future sales growth will also be volume-driven.
    • We made Repatha® available in the U.S. at 60% less than the original list price to help lower out-of-pocket costs, particularly for seniors on Medicare.

    "Every 40 seconds, someone in America has a heart attack or stroke, making cardiovascular disease one of the country's most significant health challenges…. Repatha can help to address this significant public health issue, which is why we are working hard to improve patient affordability by lowering Repatha's list price." – Murdo Gordon, executive vice president of Global Commercial Operations, Amgen.

    Bob is a Repatha® patient

    • We priced Aimovig®, our new medicine for migraine, with the goal of ensuring access for the appropriate patient population. We’ve also priced Aimovig® below the specialty threshold to ensure that patients’ out-of-pocket costs are manageable. Additionally, to help patients with affordable access, we have created the Aimovig Ally™ product support program, which helps patients navigate insurance coverage and identify potential access resources for those who are uninsured or underinsured. 

    “Aimovig is the first drug that was specifically developed for migraine sufferers. We are excited about doing everything we can to make sure patients have access to it and have a good experience using the drug." – Robert A. Bradway, chairman and chief executive officer, Amgen.

    Migraine patient Kayleen (right) with Amgen scientist Cen Xu (left), who led the team that discovered and developed Aimovig®

    • We have actively partnered with payers on contracts where we share risk and accountability for health outcomes, to work to ensure that patients can access medicines they need. Across the U.S., we've signed more than 30 of these contracts. This approach gives insurers confidence that the money they spend on our medicines will prevent other, longer-term health costs and provides innovative biotechnology companies like Amgen an incentive to develop more effective therapies.

    For 2019:
    • We said in January 2019 that we expect a mid-single-digit decline in net price across our portfolio in 2019 compared to 2018 due to rebates and discounts negotiated with payers, providers and others in the drug distribution chain to ensure patients continue to have access to our medicines. In July 2019, we said that for the rest of 2019 we continue to expect lower net price across our portfolio compared with 2018. For many Amgen medicines, there have been no list price increases in 2019. 

    Net Price = the actual amount that the manufacturer recoups from selling its product, once fees, discounts and rebates to various stakeholders—including wholesalers, payers, Pharmacy Benefit Managers (PBMs)—are taken out.

    List Price = the price a manufacturer establishes for a product. In most basic terms, it is the original selling price before discounts and rebates are applied.

    GIVING PATIENTS ACCESS TO OUR MEDICINES

    Providing assistance for eligible patients who need support affording their medicines:

    • The Amgen Safety Net Foundation provides access to Amgen medicines at no cost to qualifying patients in the U.S. who have a financial need and are uninsured or have an insurance plan that excludes the prescribed Amgen medicine.

    Since 2008, the Amgen Safety Net Foundation has provided nearly $5.5 billion worth of Amgen medicines to help hundreds of thousands of qualifying patients gain access to their therapy in the U.S.

    Providing medicines for cancer patients in need in developing countries:

    • In 2018, $93 million worth of Amgen cancer treatments and supportive care medicines were donated throughout 18 developing countries at zero cost, thanks to a joint initiative between Amgen and Direct Relief. 

    “Direct Relief is deeply appreciative to Amgen for its leadership and initiative in providing critical treatments to underserved cancer patients globally…. Cancer patients who would otherwise not be able to access many important therapies will be able to receive these advanced biologic medicines.” – Thomas Tighe, president and chief executive officer, Direct Relief.

    Michael is an Amgen Safety Net Foundation beneficiary

    BIOSIMILARS OFFER MORE AFFORDABLE OPTIONS

    Our expertise and reputation as a leader in biomanufacturing for nearly four decades has steered us toward developing high-quality biosimilars, designed to serve more patients with more affordable treatment options. High-quality, reliably supplied biosimilars offer lower-cost options to treat serious diseases such as inflammatory disease and certain types of cancer. We launched our first two biosimilars, AMGEVITA™ and KANJINTI™, in Europe in 2018 and are developing additional biosimilars to treat other diseases across the globe. 

    Amgen Biosimilars Portfolio and Pipeline

    Product/Molecule Name

    Originator Worldwide 2018 Sales*

    Status

    Therapeutic Area

    AMJEVITA™?

    HUMIRA® ~ $20B

    Launched**

    Inflammation

    KANJINTI™

    Herceptin® ~ $7B

    Launched

    Oncology

    MVASI™

    Avastin® ~ $7B

    Launched

    Oncology

    ABP 710

    REMICADE® ~ $6B

    Submitted∞

    Inflammation

    ABP 798

    RITUXAN® ~ $7B

    Phase 3

    Hematology / Oncology & Inflammation

    ABP 959

    Soliris® ~ $4B

    Phase 3 commencing

    Hematology / Oncology

    ABP 494

    ERBITUX® ~ $1B

    Process development

    Oncology

    Molecules #8-#10

    ~ $15B

    Process development

    --

    Total

    ~ $68B+

     

    *Per EvaluatePharma (February 12, 2019): numbers may not add due to rounding.  ?Approved in Europe as AMGEVITA™; **Launched in EU, U.S. launch expected in 2023; ∞Submitted in U.S.

    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 during the year 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 estimates of future prices, disease impacts and costs 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 Amgen and the U.S. government, we could become subject to significant sanctions. 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. 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 new indications for existing products 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 acquire other companies or products and to integrate the operations of companies 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.


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