This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

CLINICAL RATIONALE

The Affordable Care Act (ACA) requires a member-friendly mechanism for waiving the cost share for an alternative recommended product deemed medically necessary by the provider when a health care provider considers the $0 covered product is inappropriate for an individual. Prime Therapeutics offers a standard coverage exception/cost share waiver policy that is applied across all ACA categories.

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf

Statin ACA Prevention Copay Waiver Criteria

OBJECTIVE

The intent of the ACA Prevention Copay Waiver Criteria is to help ensure the copay waiver, when applicable based on the member’s benefit, is applied to the appropriate population as described by the United States Preventative Services Task Force (USPSTF).  The USPSTF recommendation requires the calculation of Atherosclerotic Cardiovascular Disease (ASCVD) risk.  The calculation requires inputting the patient’s sex, age, race, high density lipoprotein (HDL) cholesterol, total cholesterol, blood pressure, whether the patient has diabetes, whether the patient is under treatment for hypertension, and whether the patient is an active smoker.¹

1. American College of Cardiology and American Heart Association’s Atherosclerotic Cardiovascular Disease (ASCVD) calculator. Available at: https://tools.acc.org/ASCVD-Risk-Estimator/ Accessed on 7/27/2023.

CRITERIA FOR APPROVAL

The requested statin will be approved when ALL of the following are met:

1. The requested statin is covered under the pharmacy benefit or has been approved through the coverage exception process

AND

2. The prescriber has provided information stating that the requested statin is medically necessary

AND

3. The requested statin is for use in the primary prevention of cardiovascular disease (CVD)

AND

4. The patient is 40-75 years of age (inclusive)

AND

5. The patient has at least one of the following risk factors:
   1. Dyslipidemia
   2. Diabetes
   3. Hypertension
   4. Smoking

AND

6. The patient has a calculated 10-year risk of a cardiovascular event of 10% or greater per the American College of Cardiology and American Heart Association’s Atherosclerotic Cardiovascular Disease (ASCVD) calculator

Length of Approval: 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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