On the heels of highly anticipated cardiovascular outcomes data for PCSK9 med Repatha, Amgen has signed a money-back guarantee with Harvard Pilgrim. Adverse reactions:The most common adverse reactions (>5% of Repatha-treated patients and more common than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repathadosing was not modified or interrupted on this basis. Unless otherwise noted, Amgen is providing this information as of the date of this news release 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. Harvard ID (8 digits) * Student Name * Amount Requested * (no commas) Term * Are you enrolled in Direct Deposit? As with all therapeutic proteins, there is a potential for immunogenicity with Repatha. If you have not yet signed up for Direct Deposit, please go to the SAO website (http://sfs.harvard.edu/student-accounts). Amgen has announced from the World Medical Innovation Forum focused on cardiovascular disease that Harvard Pilgrim, a health services company providing healthcare coverage for nearly 2.7 million customers in the northeast region of the US, has signed an outcomes-based refund contract with Amgen for Repatha (evolocumab). Amgen or others could identify safety, side effects or manufacturing problems with its products after they are on the market. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between it and the U.S. government, Amgen could become subject to significant sanctions. *Information contained in this database is either primary-source verified or self-reported by the physician, and is validated every 36 months during recredentialing (with the exception of Medical group affiliation, which is determined by contractual arrangement). The contract provides Harvard Pilgrim with a rebate for the cost of Repatha for an eligible patient who has a heart attack or stroke while on Repatha. "That Amgen is willing to go at financial risk for patients with elevated LDL-C levels who are adherent to Repatha and suffer cardiovascular events shows that they are willing to stand by their data, and that sends a strong positive message to health plans, prescribing physicians and patients," said Michael Sherman, Harvard Pilgrim's chief medical officer. The discovery of significant problems with a product similar to one ofAmgen'sproducts that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. That Amgenreached an agreement with Harvard Pilgrim first is not surprising. Founded by doctors about 50 years ago, Harvard Pilgrim Health Care provides health plans and services to more than 3 million customers, primarily in New England (Massachusetts, Maine, New Hampshire, and Connecticut) but offer national plans for group insurance as well. HPI (Health Plans, Inc.) is a leading national third-party administrator (TPA) of customized self-funded health plans serving employers and brokers. Adverse reactions from a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Furthermore, Amgen'sresearch, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. 9 Detox: Most rehabilitation programs begin with a detoxification phase. "We expect payers will start changing utilization management criteria and processes over the coming months.". Forward-Looking StatementsThis news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. Amgen'sbusiness may be impacted by government investigations, litigation and product liability claims. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including 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 and other such estimates and results. Were not ready for it, Psychedelic magic mushroom drug may ease some depression, Extremely satisfying: Scientists insight powers new RSV vaccine for infants. The safety and effectiveness of Repathahave not been established in pediatric patients with primary hyperlipidemia or HeFH. Here you can submit batch claim files, verify patient eligibility, send/receive specialty referrals, submit authorization requests, and more. Some conditions apply: a patient must have taken Repathaproperly for at least six months before a cardiac event for Amgento refund the insurer the cost of treatment. 1996-2022 Amgen Inc. All Rights Reserved. Box 699183 Quincy, MA 02269-9183 Passport Connect Mail to the address on the back of the member's ID card Health Plans Inc. "We are focused on reducing barriers and improving processes to make it easier for a physician to prescribe Repatha and for patients to get access to this important therapy," Amgen'sTony Hooper, head of commercial operations, said on an earnings call last month. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Harvard Pilgrim Refines the Utilization Management Criteria to Help High-Risk Cardiovascular Patients Access Repatha First-of-its-Kind Contract Will Demonstrate Value to Harvard Pilgrim Plans for Cardiovascular Patients THOUSAND OAKS, Calif. , May 2, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today HPHConnect is Harvard Pilgrim's highly acclaimed Web-based transaction service for our commercial plans. In early August 2012, some U.S. employers with fully insured employee health benefit plans received a medical loss ratio (MLR) rebate. Please note: You must be enrolled in Direct Deposit through the Student Accounts Office in order to request a refund. Amgen'sefforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. 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 its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. In addition, sales ofAmgen'sproducts 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. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. In that context, Amgen announced it would offer refunds in certain cases to payers willing to lower coverage restrictions a bet on the strength of Repatha's data. thousand oaks, calif., may 2, 2017 /prnewswire/ -- amgen (nasdaq: amgn) today announced from the world medical innovation forum focused on cardiovascular disease that harvard pilgrim, a health. The New England-based insurer has worked with Amgenin the past, inking value-based payment deals for both Repatha and the drugmaker's blockbuster anti-inflammatory drug Enbrel (etanercept). A biotechnology pioneer since 1980,Amgenhas grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. "As an organization, we are looking to pay for interventions that demonstrate value and are effective in treating serious illnesses, such as cardiovascular disease," said Michael Sherman, chief medical officer, Harvard Pilgrim. Final approval rates were more palatable, but still high: 73% on commercial plans and 39% for Medicare. That Amgenreached an agreement with Harvard Pilgrim first is not surprising. But, as recent setbacks have shown, researchers and drugmakers still face major challenges. Harvard Pilgrim and its family of companies provide health benefit plans, programs and services to more than 3 million customers in New England and beyond. For complete details on options available from Harvard Pilgrim or to enroll call us at 1-866-843-3186, TTY/TDD users call: 711, Oct. 1 - Mar. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen hopes to reach similar deals with other payers as well. How much is covered and exactly what services you can access will depend on your insurance plan, your personal situation, and your addiction history. Sales of Repathawere only $49 million in the first quarter, up from a year ago but $9 million less than in the fourth quarter of last year. Revenue: $1 to $5 billion (USD) Competitors: Unknown Harvard Pilgrim Health Care is a leading not-for-profit health services company that serves as a guide to better health for its members in Massachusetts, New Hampshire, Maine, Connecticut and beyond. Applications in other countries are pending. The most common adverse reaction that led to Repathatreatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repathaand placebo, respectively). Harvard Pilgrim is providing $30 million in premium credits to all its fully-insured employer groups The insurer will provide an additional $6 million in financial support to independent primary care physicians and community health centers. Musculoskeletal adverse reactions were reported in 14.3% of Repatha-treated patients and 12.8% of placebo-treated patients. We identify the drivers of healthcare cost using advanced analytics. All Plans renew automatically. To date, utilization management practices on the part of payers have largely stymied initial attempts to fill prescriptions for either Repathaor Sanofiand Regeneron'scompeting Praluent (alirocumab). Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. Cancellation Policy: If a member wishes to cancel his/her membership, the member may do so at least 30 days prior to membership expiration date. * "Amgen is committed to combating cardiovascular disease, one of the largest public health concerns in the world, and our value-based partnership with Harvard Pilgrim further demonstrates our confidence in the significant value that Repatha can bring to patients, payers and society," said Joshua J. Ofman, M.D., MSHS, senior vice president of Global Value, Access and Policy at Amgen. "That Amgen is willing to go at financial risk for patients with elevated LDL-C levels who are adherent to Repatha and suffer cardiovascular events shows that they are willing to stand by their data, and that sends a strong positive message to health plans, prescribing physicians and patients.". Amgen, looking to jumpstart sales of its slow-growing heart med Repatha (evolocumab), has signed a deal with the insurer Harvard Pilgrim to fully refund the drug's cost if a patient is hospitalized with either a heart attack or stroke. Despite high initial sales expectations for the PCSK9 inhibitor, Repatha has so far failed to gain traction on the market, earning only $141 million in revenue last year. If you are located in the European Union, Iceland, Liechtenstein or Norway (the European Economic Area), please click here for additional information about ways that certain Harvard University Schools, Centers, units and controlled entities, including this one, may collect, use, and share information about you. Business Incorporated: 2/11/1969. This contract builds on Amgen's ongoing work with Harvard Pilgrim to find new and innovative ways to partner that enable Amgen to share in mutually beneficial endeavors to deliver the highest value to the healthcare system and society, and help ensure patients are able to access the medicines they need. Still have questions? Further, some raw materials, medical devices and component parts for Amgen'sproducts are supplied by sole third-party suppliers. Harvard Pilgrim ID Number Last Name First Name Date of Birth (mm/dd/yyyy) Harvard Pilgrim ID Number Last Name First Name Date of Birth (mm/dd/yyyy) Section C - Fitness Facility Information (List all health club and facility memberships that you and/or your dependent(s) are submitting for reimbursement spanning the qualifying four months.) Repathais approved in more than 40 countries, including the U.S.,Japan,Canadaand in all 28 countries that are members of theEuropean Union. Susan Morse, Executive Editor For eligible Harvard Pilgrim members. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The New England-based insurer has worked with Amgenin the past, By signing up to receive our newsletter, you agree to our, Amgen's Repatha shows CV benefit, but falls short of expectations, Back-to-back gene therapy approvals give Bluebird shot at survival, String of gene therapy deals spurs cautious optimism on Wall Street, Alkermes, continuing transformation, plans to split in two, Lilly sales of new diabetes drug accelerate on rising patient demand, Surface Oncology to lay off 20% of staff in restructuring, A New Standard of Care: The Benefits of Continuous Temperature Monitoring and Early Fever Detection, The latest developments on the gene therapy frontier, This is biologys century. Initially active in Massachusetts . Please note: What is the difference between Harvard College and Harvard University? The proportions of patients who discontinued treatment due to local injection site reactions in Repatha-treated patients and placebo-treated patients were 0.1% and 0%, respectively. Side by side, we know we can push past the status quo and deliver even more to the diverse communities we serve: more innovation, more access, more support, and better health. The adverse reactions that occurred in at least 2 (6.1%) Repatha-treated patients and more frequently than in placebo-treated patients, included upper respiratory tract infection (9.1% versus 6.3%), influenza (9.1% versus 0%), gastroenteritis (6.1% versus 0%), and nasopharyngitis (6.1% versus 0%). Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. What is a "liberal arts & sciences" education? Dive Brief: Amgen, looking to jumpstart sales of its slow-growing heart med Repatha (evolocumab), has signed a deal with the insurer Harvard Pilgrim to fully refund the drug's cost if a patient is hospitalized with either a heart attack or stroke. Can I get a waiver? Homozygous Familial Hypercholesterolemia (HoFH):In 49 patients with homozygous familial hypercholesterolemia studied in a 12-week, double-blind, randomized, placebo-controlled trial, 33 patients received 420 mg of Repathasubcutaneously once monthly. In a Tuesday email sent to insurance brokers and other stakeholders, Harvard Pilgrim said its parent company, Point32Health "has made the difficult decision to withdraw" the company's fully. As an integrated program, Harvard Pilgrim provides health coverage as well as negotiating drug contracts, making tracking of prescriptions and patient events more straightforward than with an insurer that relies on a pharmacy benefit manager. Harvard Pilgrim Student Resources Refer to the Student Resources Since 2007, the Foundation's focus has been on childhood obesity prevention and healthy food access for low income communities and older adults. Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. Welcome to the online Refund Request Form. WELLESLEY, Mass., June 9, 2020 /PRNewswire/ -- Harvard Pilgrim Health Care today announced that it will extend its existing policy that waives member cost-sharing for COVID-19 treatment at in . Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Harvard Pilgrim Health Care and Tufts Health Plan have combined. With Harvard Pilgrim MyConnect, you can connect with your care team who will guide you through your benefit coverage, coordinate your care, help you with claim inquiries, connect you with a lifestyle coach, give you access to a curated library of health care resources and so . AboutAmgenAmgenis committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. For all products unless noted below: Harvard Pilgrim Health Care P.O. Allergic reactions:Hypersensitivity reactions (e.g. Amgen'sstock price may be volatile and may be affected by a number of events. Medicare is a federal health insurance program that's made up of several different parts. Harvard Pilgrim was founded by doctors nearly 50 years ago and now serves more than 3 million customers. Facility. In return, Harvard Pilgrim will relax some of its utilization restrictions on coverage for high-risk patients. Please contact Amgen Medinfo at 800-77-AMGEN(800-772-6436) or 844-REPATHA (844-737-2842) regarding Repathaavailability or find more information, including full Prescribing Information, atwww.amgen.comandwww.Repatha.com. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. Reset My Password. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve. 1 The provider network includes more than 80,000 doctors and other . and N.H. Press Release March 18, 2020 Foundation also allows current grantees flexibility to help those affected by the coronavirus Press Release Due to a system upgrade, you will need to complete a few simple steps to reset your password. Click Here. An agreement between Amgen and Harvard Pilgrim guaranteeing a refund for the cost of Repatha (evolocumab) if a health plan member is hospitalized with a myocardial infarction or stroke after receiving the drug for six months or more. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repathaand placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%). WELLESLEY, Mass., Sept. 16, 2020 /PRNewswire/ -- Harvard Pilgrim Health Care announced today that it has signed a multi-year partnership with The Boston Red Sox as its . U.S. Repatha IndicationRepathais indicated as an adjunct to diet and: The effect of Repathaon cardiovascular morbidity and mortality has not been determined. Amgen'sresults may be affected by its 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 its products and global economic conditions. Amgenfocuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. More news. Neurocognitive events were reported in less than or equal to 0.2% in Repatha-treated and placebo-treated patients. The Harvard Pilgrim Health Care Foundation was founded in 1980 by the Harvard Community Health Plan as the corporate philanthropy of the not-for-profit health plan. "That seems like a bad deal, especially if I'm dead," said David Mitchell, president of Patients for Affordable Drugs . In addition, Amgen'sbusiness may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Power & Associates ranking. 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