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

Human Immunodeficiency Virus (HIV) Infection: Pre-exposure Prophylaxis (PrEP) 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).

CRITERIA FOR APPROVAL

The requested HIV infection pre-exposure prophylaxis (PrEP) agent will be approved when ALL of the following are met:

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

AND

2. The requested agent is being used for PrEP

AND

3. The prescriber has provided information stating that the requested PrEP agent is medically necessary compared to other available PrEP agents

AND

4. ONE of the following:
   1. The requested PrEP agent is ONE of the following:
      1. Tenofovir disoproxil fumarate and emtricitabine combination ingredient agent

OR

1. 1. 2. Tenofovir disoproxil fumarate single ingredient agent

OR

1. 1. 3. Tenofovir alafenamide and emtricitabine combination ingredient agent

OR

1. 2. The prescriber has provided information stating that a tenofovir disoproxil fumarate and emtricitabine combination ingredient agent, tenofovir disoproxil fumarate single ingredient agent, or tenofovir alafenamide and emtricitabine combination ingredient agent is contraindicated, likely to be less effective, or cause an adverse reaction or other harm for the patient

AND

5. The patient is at high risk of HIV infection

AND

6. The patient has recently tested negative for HIV

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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