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EDMUND G. BROWN JR.
Governor

State of California—Health and Human Services Agency
California Department of Public Health


ADAP MM 2023-23
December 22, 2023


TO:
PrEP-AP Clinical Providers and PrEP-AP Enrollment Workers

SUBJECT:
Addition of Long Acting Injectable Cabotergravir (Apretude) to the PrEP-AP Formulary for Clients with Confidentiality Concerns and Minors

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​ADAP MM 202-23: Addition of Long Acting Injectable Cabotergravir (Apretude) to the PrEP-AP Formulary for Clients with Confidentiality Concerns and Minors


Overview

The purpose of this management memorandum is to notify PrEP-AP Clinical Providers and Enrollment Workers of the approach for the coverage of Apretude for PrEP-AP clients.

​PrEP-AP Coverage of Apretude

Effective December 21, 2023, cabotegravir 200 mg/mL extended-release injectable suspension (Apretude), the first long-acting injectable PrEP has been added to the PrEP-AP Formulary for PrEP-AP clients with confidentiality concerns that prevent them from using insurance they have through a parent, guardian, spouse, or registered domestic partner and for minor PrEP-AP clients (ages 12-17). PrEP-AP Clinical Providers must complete and submit a PrEP-AP Long-acting Injectable Cabotegravir Request Form (PDF) before ordering medications for these clients.

Additionally, PrEP-AP clients with insurance, including Medicare with Part D or Medicare Advantage Plans can receive wrap-around coverage for Apretude after they have exhausted coverage available from insurance and the pharmaceutical assistance program.

ViiV Healthcare, the manufacturers of Apretude, support two ViiVConnect Pharmaceutical Assistance Programs for Apretude – the Patient Assistance Program and Apretude Savings Program that can be utilized by PrEP-AP uninsured and insured clients respectively.

​PrEP-AP Coverage of Apretud​e by Client Type

The PrEP-AP Long-Acting Injectable PrEP Coverage Flowchart provides a graphic representation of the information detailed below.

Clients will receive PrEP-AP benefits as described below:

​Uninsured Clien​ts

Uninsured PrEP-AP clients prescribed Apretude must enroll in the ViiVConnect Patient Assistance Program to access medications. ViiVConnect will coordinate with a specialty pharmacy to mail the medication directly to the provider's office for administration to the client.

​Insured Clien​​ts

Apretude should be fully covered by most comprehensive healthcare insurance plans as a preventative service. Apretude coverage may be a pharmacy benefit or a medical benefit depending on the plan.*

If the client's health plan partially covers Apretude while imposing cost sharing, the client must apply to the ViiVConnect Apretude Savings Program to cover up to $7,500 annually for Apretude co-pays and deductibles. PrEP-AP will cover the remaining cost of Apretude if the ViiVConnect Apretude Savings Program benefit is exhausted.

​If the client's health plan does not cover Apretude** they are eligible to enroll in the ViiVConnect Patient Assistance Program for assistance with the full cost of medications.

*For more information on acquiring Apretude for insured clients, see the ViiVConnect Apretude Acquisition Guide (PDF).

**The client must have a private insurance plan with generic-only coverage, outpatient use only, or therapeutic class exclusion (non-coverage) of drug to be eligible for ViiVConnect's Patient Assistance Program.

​Clients with Confidentiality Concerns & Minor C​​lients

PrEP-AP will cover the full cost of Apretude for clients who are enrolled in PrEP-AP as 1) clients with confidentiality concerns that prevent them from using health insurance they have through a parent, guardian, spouse, or domestic partner, or 2) minor clients (ages 12-17). The PrEP-AP Clinical Provider prescribing Apretude must fill out the PrEP-AP Long-acting Injectable Cabotegravir Request Form attached to this memorandum, and available on the Magellan Rx website. This form must be completed and returned to Magellan Rx by fax at 1-800-424-5927 before the medication can be ordered.

PrEP-AP covers Apretude as a pharmacy benefit. Prescriptions for Apretude must be filled through a pharmacy in the Magellan Rx pharmacy network and given to the provider for administration to the client. This may require special coordination with an onsite or local pharmacy. Alternatively, the prescription can be filled through a pharmacy in both the Apretude pharmacy network (PDF) and the Magellan Rx pharmacy network – the pharmacy can mail the medication directly to the provider's office for administration to the client.

​Medicare Clien​​ts

PrEP-AP will cover the cost of Apretude co-pays for clients with Medicare Part D drug coverage or Medicare Advantage Plans.

The prescription can be filled through a pharmacy in both the client's Medicare plan network and the Magellan Rx pharmacy network and provided directly to the provider's office for administration to the client.

​PrEP-AP Long-acting Injectable Cabotegravir Request Form

The PrEP-AP Long-acting Injectable Cabotegravir Request Form must be completed and submitted to Magellan Rx by fax at 1-800-424-5927 for PrEP-AP clients with confidentiality concerns and PrEP-AP minor clients prescribed Apretude. Once this form has been submitted to Magellan Rx and processed, the medication will be covered for the client. The form collects information on prior PrEP use and reason for long-acting injectable preference.

​PrEP-AP Coverage of Related Medical Services

The PrEP-AP Allowable PrEP Related Medical Services​​​ page lists medical services covered under PrEP-AP. It includes allowable CPT and HCPCS codes for medical services that are necessary for the provision of Apretude, such as office visits, laboratory tests, and injection administration.

​PrEP-AP Formulary

The PrEP-AP Formulary has been updated to reflect the addition of Apretude.

If you have any questions regarding the addition of this medication to the PrEP-AP formulary, please contact PrEP-AP Support at PrEP.Support@cdph.ca.gov.

Thank you,

Joseph Lagrama Signature 

Joseph Lagrama
ADAP Branch Chief
California Department of Public Health