Addressing Barriers to PCSK9 Inhibitor Access in the Community Pharmacy

This article was sponsored by Amgen Inc.

Please see full Prescribing Information for Repatha^® (evolocumab).

In a Presidential Advisory Call to Action issued by the American Heart Association, failure to use advanced and specialized therapies, such as proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, was noted as a missed opportunity in the treatment of cardiovascular (CV) disease.¹ Barriers to treatment with PCSK9 inhibitors, including prior authorization requirements and high out-of-pocket costs, may limit patient access.² Insurance approval can be delayed, and several appeals and resubmissions may be needed; however, even after obtaining approval, patients may not pick up their prescriptions from the pharmacy, mainly because of the high out-of-pocket costs.²

IMPROVING AFFORDABILITY OF AND ACCESS TO REPATHA^®

Resources and Support for Pharmacists

Improving affordability of and access to medication is an important consideration in addressing patient barriers to CV treatment.¹ Regarding affordability, Repatha^® (evolocumab), a PCSK9 inhibitor, is now available at a lower list price of $5850 per year, which is a 60% reduction from the original list price. This reduction in list price may result in lower patient co-pays.³

For new and refill prescriptions, pharmacists can select the Repatha^® product with the lower list price, which is designated by a specific National Drug Code (NDC) starting with 72511. Availability will depend on insurance plan determinations of coverage, and if the product is not covered, the original list price NDC should be used.

• Repatha^® is available as a 140-mg/mL injection administered subcutaneously every 2 weeks in either a⁴: Single-use prefilled syringe (NDC for lower-priced option, 72511-0750-01; original NDC, 55513-0750-01) Single-use prefilled SureClick^® autoinjector (NDC for lower-priced option, 72511-0760-02; original NDC, 55513-0760-02)
• Repatha^® is available as a once-monthly 420-mg/3.5 mL subcutaneous injection using the single-use Pushtronex^® system (on-body infusor with prefilled cartridge) (NDC for lower-priced option, 72511-0770-01; original NDC, 55513-0770-01).

With the lower list price and anticipated shift to community pharmacy dispensing, pharmacists can help improve access to treatment by familiarizing themselves with the tools needed to process Repatha^® prescriptions. Resources to help pharmacists facilitate the dispensing of Repatha^® and increase patient access are available at www.RepathaHCP.com, including information regarding product selection, insurance coverage, patient support programs, and financial assistance. To assist with the prior authorization process, pharmacists may use CoverMyMeds^®, a free resource that offers a streamlined process for submitting prior authorization requests electronically.

INDICATIONS

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

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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).

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Homozygous Familial Hypercholesterolemia: Repatha^® is indicated as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.

The safety and effectiveness of Repatha^® have not been established in pediatric patients with HoFH who are younger than 13 years old or in pediatric patients with primary hyperlipidemia or HeFH.

IMPORTANT SAFETY INFORMATION

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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^®.

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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.

Please see additional Important Safety Information throughout.

Resources and Support for Patients

With RepathaReady^®, eligible patients have access to a suite of support services to help them start and remain adherent to their treatment, including Repatha^® co-pay support programs, injection support from nurses, free delivery of needle disposal containers, a medication reminder program, informational emails, and coverage information. RepathaReady^® insurance specialists are available to provide information on financial assistance programs for Repatha^®, including:

• The Repatha^® Copay Card, which can help lower patient out-of-pocket costs for eligible commercially insured patients
• Independent charitable patient assistance programs to help minimize prescription out-of-pocket costs for eligible Medicare Part D patients with limited income and resource limits
• The Amgen Safety Net Foundation, which can help patients with financial need, who are uninsured or underinsured, gain access to Amgen medications, including Repatha^®

ROLE OF THE PHARMACIST

In addition to providing patients with information regarding financial assistance programs to improve affordability and helping improve access to medications by assisting with the insurance approval process and prior authorization requirements, pharmacists have an important opportunity to provide patients and their caregivers with Repatha^® injection support at each visit to the pharmacy. Patient education and injection support may also support adherence to Repatha^®. In a study of patients who received training from a health care professional on how to self-administer Repatha^® with the Pushtronex^® system (on-body infusor with prefilled cartridge) and SureClick^® autoinjector, 95% of patients successfully administered at home with either device and reported full-dose administrations of Repatha^® at Weeks 4 and 8. Patients used the Pushtronex^® system or three autoinjectors for the once monthly regimen.⁵

By ensuring patients have access to their medications and providing education and training on advanced treatments, pharmacists can help patients attain their treatment goals and optimize their health outcomes.

IMPORTANT SAFETY INFORMATION

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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%).

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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.

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Adverse Reactions in Homozygous Familial Hypercholesterolemia (HoFH): The adverse reactions that occurred in at least two patients treated with Repatha^® and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis.

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

Please see full Prescribing Information and Patient Product Information.

REFERENCES

1. McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease. A presidential advisory from the American Heart Association. Circulation. 2019;139(9):e44-e54.

2. Navar AM, Taylor B, Mulder H, et al. Association of prior authorization and out-of-pocket costs with patient access to PCSK9 inhibitor therapy. JAMA Cardiol. 2017;2(11):1217-1225.

3. Amgen. Amgen makes Repatha^® (evolocumab) available in the US at a 60 percent reduced list price. News release; October 24, 2018.

4. Repatha^® (evolocumab) prescribing information, Amgen.

5. Dent R, Joshi R, Stephen Djedjos C, et al. Evolocumab lowers LDL-C safely and effectively when self-administered in the at-home setting. Springerplus. 2016;5:300.

USA-145-81710 12/19