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EDMUND G. BROWN JR.
Governor

State of Californiaā€”Health and Human Services Agency
California Department of Public Health


ADAP MM 2021-16
October 19, 2021


TO:
ADAP ENROLLMENT WORKERS

SUBJECT:
IMPLEMENTATION PLAN: PHASE ONE FOR CABENUVA ACCESS


ā€‹ADAP MM 2021-16: IMPLEMENTATION PLAN: PHASE ONE FOR CABENUVA ACCESS


The purpose of this management memorandum is to inform enrollment workers of the implementation plan (phase one) being pursued by OA for access to Cabenuva.

Overview
On January 21, 2021, the U.S. Food and Drug Administration (FDA) approved Cabenuva (cabotegravir extended release injectable suspension; rilpivirine extended release injectable suspension) and Vocabria (cabotegravir tablets). Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen of adults who have achieved viral suppression (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
A recommended oral lead-in of Vocabria and Edurant (rilpivirine) should be used prior to the initiation of Cabenuva to assess the tolerability of cabotegravir and rilpivirine before commencing injections of the extended release suspensions. Vocabria tablets are not commercially available and must be obtained from the manufacturer (who will provide a free one-month supply of oral lead-in tablets) or from the specialty pharmacy TheraCom. For more details review the ā€œPreparing for Long-Acting Antiretroviral Treatment (PDF)ā€ document, prepared by the HIV Medicine Association.
  • The recommended dosage of Vocabria is 30 mg in combination with Edurant 25 mg. Administer Vocabria and Edurant orally once daily with a meal for approximately 1 month (at least 28 days)*.
* Please refer to the Cabenuva package insert (PDF) for the most up to date information on dosing. Different oral lead-in protocols and different dosing intervals are still be evaluated in clinical trials.

Cabenuva must be administered by a healthcare professional. A complete dose of Cabenuva requires two intramuscular (IM) injections: one cabotegravir injection and one rilpivirine injection. The two intramuscular (IM) injections should be administered at separate gluteal injection sites (on opposite sides or 2 cm apart) during the same visit.

In addition to covering the cost of medications, the Health Resources and Services Administration (HRSA) released a letter in December 2019 stating Ryan White HIV/AIDS Program Part B AIDS Drug Assistance Programs can cover any costs related to medical office visits for the medication administration.
Implementation Plan

Phase I
ADAP access to Cabenuva will be implemented in three phases. Phase one will cover the medication or co-pay cost for Cabenuva. In phase one, ADAP will not cover the administration cost associated with Cabenuva injections for ADAP clients with or without insurance coverage. For uninsured clients, Ryan White funded clinics may use the Outpatient/Ambulatory Health Services category to cover the costs associated Cabenuva administration. In order for ADAP to cover the medication cost for Cabenuva, the client must have active ADAP eligibility and have the prescription filled at a pharmacy within the Magellan Network.

ADAP clients with private insurance are encouraged to visit a provider within their insurance network to limit the cost for the administration of Cabenuva. ADAP clients enrolled in ADAPā€™s Insurance Assistance Programs (OA-HIPP, EB-HIPP or MDPP programs) can access Cabenuva and the insurance assistance program can assist with reimbursement for medical out of pocket (MOOP) costs. The client/provider would need to submit a MOOP claim form along with supporting documentation (including Explanation of Benefits) to Pool Administrators Inc. (PAI) for processing. PAI handles MOOP reimbursement for clients enrolled in our insurance assistance programs and can assist the client/provider in submitting documentation. Once PAI confirms the client/provider has provided the necessary documentation, PAI will process reimbursement for the MOOP and remit payment to the provider. The provider is responsible for reimbursing or crediting the client for the MOOP.
Phase one is effective as of the date of this memo.

Phase II & III
ADAP is currently working with its contractors Magellan Rx and PAI to implement phases II and III, which will cover the administration cost for Cabenuva for all ADAP clients when billed as a pharmacy benefit or a medical benefit. A subsequent management memorandum will be sent out detailing phases two and three once available.

Please contact your OA Advisor if you have any questions regarding the information provided in this memo.

Thank you,

Electronic signature of Chris Unzueta

Chris Unzueta
Operations Eligibility Section Chief
Office of AIDS
California Department of Public Health
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