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Injectable PrEP Frequently Asked Questions – Access and Financing

The information in these FAQs provides general guidance and reflects what is currently understood about Cabotegravir-LA (Apretude) access and financing.

Craig Pulsipher, APLA Health, and Christina Espegren, CDPH, provided guidance with these FAQs.

1. How do uninsured people access CAB-LA?
ViiV Connect offers a patient assistance program to cover the cost of Apretude® (CAB-LA). To qualify, people must reside in the United States, District of Columbia, or Puerto Rico; earn <5x Federal Poverty Level ($67,950 for an individual in 2022); and meet one of the following criteria:

  • Have no prescription drug coverage, or
  • Have a Medicare Part B, Medicare Part D, or Medicare Advantage Plan, and have spent at least $600 or more on out-of-pocket prescription expenses during the current calendar year, or
  • Have a private health plan limited to generic-only coverage, outpatient use only, or therapeutic class exclusion (non-coverage) of a drug.

Visit https://www.viivconnect.com/for-providers/patient-enrollment/ for information and enrollment.

The State of California offers assistance with copays and out-of-pocket costs to people enrolled in the PrEP-AP program. See FAQ #9, “Does California PrEP-AP cover CAB-LA?,” below.

2. Can insured people receive assistance with out-of-pocket costs?
ViiV Connect offers copay assistance of up to $7500/year (2022) for Apretude®. Visit https://www.viivconnect.com/for-providers/viivconnect-programs/ for information.

California PrEP-AP offers assistance with associated out-of-pocket care costs (office visits, lab fees). See FAQ #9, “Does California PrEP-AP cover CAB-LA?,” below.

3. For insured people, what is the difference between Apretude® classification as a pharmaceutical benefit versus a medical benefit?
Unlike oral PrEP medications, CAB-LA can be covered under the medical benefit, the pharmacy benefit, or both. Most health plans will cover Apretude® as a medical benefit because it needs to be administered in a clinical setting. There may be different cost sharing depending how Apretude® is covered. For example, drugs covered as a medical benefit often require a flat co-insurance rate (e.g., 20% of the total cost of the medication) after the deductible has been met.
4. Can insurers require a prior authorization (PA) or letter of medical necessity for CAB-LA? Can insurers deny coverage?

The answers to these questions are complicated. Commercial or private insurance policies may be regulated or governed at the state or federal level and, thus, vary significantly by insurer and state. Providers/navigators may need to work with their patients and their patients’ insurers to secure coverage, which can sometimes require a significant time investment. In some cases, each injection may need to be approved by the insurer. In other words, an insurer may approve the first injection but deny subsequent injections. Additionally, coverage for HIV RNA testing (recommended at each injection visit) may vary.

In California, Senate Bill 159 generally prohibits health plans from requiring prior authorization or step therapy for patients to access PrEP (including CAB-LA). PrEP drugs also cannot be designated as “non-formulary”. If a health plan is not in compliance with Senate Bill 159, patients are strongly encouraged to submit a complaint to the Department of Managed Health Care.

Download more information on access and financing in California.

5. How does the USPSTF Grade A recommendation for PrEP impact Apretude® cost sharing?

In June 2019, the U.S. Preventive Services Task Force (USPSTF) issued a grade A recommendation for PrEP. Because of patient protections under the Affordable Care Act (ACA), most private health plans are now required to cover both PrEP medication and related clinical services such as provider visits and labs without cost sharing.

In California, state regulators issued guidance following the USPSTF recommendation indicating that, for health plans regulated at the state level, all PrEP medications (including Apretude®) must be covered without cost sharing. If a health plan is not in compliance with the USPSTF recommendation, patients are strongly encouraged to submit a complaint to the Department of Managed Health Care. 

Unfortunately, federal guidance implementing the USPSTF recommendation currently does not mention Apretude®. Because CAB-LA is not discussed in either the current USPSTF recommendation or federal guidance, it is possible that plans regulated at the federal level will apply cost sharing to Apretude®. There is likely to be variation in coverage and cost-sharing for Apretude® across insurers.

6. How do patients/providers receive CAB-LA medication?
Uninsured patients enrolled in ViiV Connect Patient Assistance Program: medication will be shipped via 2-day delivery from the ViiV specialty pharmacy to the provider. Providers/navigators should coordinate with ViiV Connect to arrange delivery.

Insured patients: medication will be shipped from the specialty pharmacy or distributor to the provider. The procedures for ordering and the time for receipt vary by insurer/pharmacy. Apretude® is generally obtained by providers through “buy-and-bill”, or “white bagging”. Learn more about these options below. Providers/navigators will likely have to monitor this process closely to ensure that the medication arrives at the provider’s location in time for the patient’s injection.

7. Does California Medicaid (Medi-Cal) cover CAB-LA?

Medi-Cal covers CAB-LA medication and related care without cost-sharing or prior authorization (Treatment Authorization Request “TAR”). Apretude® was added to Medi-Cal’s Contract Drug List on May 1, 2022. Apretude® can be billed to Medi-Cal Rx as a pharmacy claim or to the Managed Care Plan if it is billed as a medical claim.

People who are eligible but not enrolled in modified adjusted gross income (MAGI) Medi-Cal can receive a 30-day temporary access period to PrEP-AP assistance. Medi-Cal Accelerated Enrollment gives temporary Medi-Cal coverage at the time of a person’s application to MAGI Medi-Cal until a determination has been made. If a patient is denied standard or MAGI Medi-Cal, they can be fully enrolled in PrEP-AP. See FAQ #9, “Does California PrEP-AP cover CAB-LA?,” below.

8. Does Medicare cover CAB-LA?

Currently Medicare coverage of Apretude® is limited. Apretude® is expected to be covered under Medicare Part B with zero cost sharing following a favorable “National Coverage Determination” (NCD) and updated USPSTF recommendation. Some Medicare Advantage plans that include prescription drug coverage (Part D) may opt to cover it as a pharmacy benefit.

California PrEP-AP offers assistance with associated out-of-pocket care costs (office visits, lab fees). See FAQ #9, “Does California PrEP-AP cover CAB-LA?,” below.

9. Does California PrEP-AP cover CAB-LA?

PrEP-AP provides assistance to insured and uninsured people for out-of-pocket costs incurred in receiving CAB-LA, but will not cover the cost of the medication itself. To be eligible for PrEP-AP, applicants must be at least 18 years old (CAB-LA has not been FDA approved for minors) and California residents; earn <5x Federal Poverty Level ($67,950 for an individual in 2022); not be covered by Medi-Cal, and have a negative HIV test result within the six months prior to the application. After enrolling in PrEP-AP:

  • Uninsured clients must co-enroll in ViiVConnect Patient Assistance Program
  • Insured clients must co-enroll in ViiVConnect Copay Assistance Program

PrEP-AP enrollment takes place at a designated PrEP-AP Enrollment Site. To receive coverage for out-of-pocket expenses, uninsured individuals must receive their CAB-LA from a PrEP-AP Clinical Provider. Insured clients must see a provider in their health plan’s network. The provider will bill PrEP-AP for reimbursement of costs not covered by the patient’s insurance. PrEP-AP can only reimburse providers and does not reimburse individuals directly. People who are eligible but not enrolled in standard Medi-Cal can receive a 30-day temporary access period to PrEP-AP assistance and an extension in temporary PrEP-AP access until the Medi-Cal determination is made.

Between Medi-Cal’s Accelerated Enrollment policy (see FAQ #6, “Does California Medicaid (Medi-Cal) cover CAB-LA?,” above) and PrEP-AP, including its temporary access period, most people who don’t have private insurance coverage should be able to receive assistance with out-of-pocket costs

Visit: https://www.cdph.ca.gov/Programs/CID/DOA/Pages/OA_adap_resources_prepAP.aspx# for information.

10. What is the difference between “buy-and bill” and “white bagging”?

Under buy-and-bill, a provider purchases Apretude® from a specialty distributor and maintains an inventory of the drug on site to minimize potential missed doses due to problems related to shipping or insurance coverage. Following administration of the injection, the provider submits a reimbursement claim to the patient’s health plan.

Under white bagging, provider submits prescription for Apretude® to a specialty pharmacy within ViiV’s specialty pharmacy network. The specialty pharmacy processes the claim and ships the product to the provider. Once Apretude® is received by the provider, it can only be administered to the patient who was prescribed the drug.