Amgen Response in Support of the 2018 AHA/ACC Cholesterol Clinical Practice Guidelines

Updated Guidelines Now Clearly Recommend a PCSK9 Inhibitor Like Repatha® (evolocumab) For Very High-Risk Patients

Amgen appreciates the work of the American College of Cardiology, the American Heart Association and their collaborators on the 2018 ACC/AHA Cholesterol Clinical Practice Guidelines. We are pleased the updated guidelines recognize the importance of significantly lowering cholesterol to lower cardiovascular risk.

We are encouraged that the updated guidelines recognize that lower is better when it comes to LDL-C, and for the first time recommend the use of PCSK9 inhibitors. Specifically, the guidelines define two distinct patient populations for whom PCSK9 inhibitors can be appropriate – patients on maximal LDL-C lowering therapy above 70 mg/dL who are at very high risk for Atherosclerotic Cardiovascular Disease (ASCVD) and patients with severe hypercholesterolemia. Further, the guidelines define a clear LDL-C threshold for action, which is 70 mg/dL for patients at very high risk of ASCVD.

In October, Amgen made Repatha® (evolocumab) available at a substantially lower list price of $5,850 in order to make Repatha affordable for patients in line with other metabolic and key cardiovascular therapies*. We understand that due to the timing of this change, the lower list price for Repatha was not used to inform the value recommendations in the guidelines. We are encouraged that the guidelines embrace the positive impact a price reduction and a focus on very high-risk patients would have on the economic value of PCSK9 inhibitors. We are highly confident that with the new list price, Repatha is now even more cost effective. We look forward to working with experts to conduct further analyses to confirm the improved cost effectiveness of Repatha for very high-risk patients at the lower list price.

Amgen is committed to being part of a sustainable, long-term solution for ensuring that patients have access to the medicines they need. As a healthcare community, we all now need to take appropriate steps to make sure patients can access the high value treatments their physicians are prescribing. We remain committed to partnering with all relevant stakeholders as additional independent, peer-reviewed analyses are evaluated. We firmly believe we can reduce cardiovascular risk for more patients with established cardiovascular disease when we go #LowerTogether.

* Jardiance®, Invokana®, Entresto®, Corlanor®, Xarelto® and Eliquis®. Based on per script price based on wholesale acquisition cost (WAC) from AnalySource. https://www.analysource.com accessed on October 15, 2018. Repatha® does not have the same indications, safety, or effectiveness as these therapies.

INDICATIONS

  • Prevention of Cardiovascular Events: In adults with established cardiovascular disease, Repatha® (evolocumab) is indicated to reduce the risk of myocardial infarction, stroke, and coronary revascularization.

  • Primary Hyperlipidemia (including Heterozygous Familial Hypercholesterolemia): Repatha® is indicated as an adjunct to diet, alone or in combination with other lipid‑lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia to reduce low‑density lipoprotein cholesterol (LDL‑C).

IMPORTANT SAFETY INFORMATION

  • Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

  • Allergic Reactions: Hypersensitivity reactions (e.g. angioedema, rash, urticaria) have been reported in patients treated with Repatha®, including some that led to discontinuation of therapy. 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.

  • Adverse Reactions in Primary Hyperlipidemia (including HeFH): The most common adverse reactions (>5% of patients treated with Repatha® and occurring more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site 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. The most common injection site reactions were erythema, pain, and bruising.

    Allergic reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

  • Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and occurring more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

    Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients assigned to Repatha® compared with 7.7% in those assigned to placebo.

  • Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.

Please see full Prescribing Information.