Preparing for Long-Acting Antiretroviral Treatment

The first long-acting antiretroviral product for HIV treatment is expected to be available soon in the U.S. Cabenuva® will be a co-packaged product containing cabotegravir and rilpivirine and is manufactured by ViiV Healthcare. Cabenuva will be delivered via monthly injections that generally will need to be administered in a clinical setting. This novel maintenance therapy option may help to improve adherence and reduce stigma for some patients but will require pharmacy and/or clinical delivery system and administrative adjustments for clinics and providers.

This document highlights delivery system, staffing and administrative issues for clinics and clinicians to consider in preparing to provide patients access to this novel treatment modality. Following approval of Cabenuva by the Food and Drug Administration, please refer to the product package insert for clinical guidance.

Clinical Considerations

Patients will need to be virally suppressed on an oral regimen prior to
A 30-day oral lead-in dose of cabotegravir plus Edurant (rilpivirine) will be required (two tablets once daily). Co-packaged oral cabotegravir plus rilpivirine is expected to be available via a limited distribution
The Cabenuva loading dose requires two 3 mL IM injections (600 mg cabotegravir plus 900 mg rilpivirine).
Maintenance dosing, involving two 2 mL IM injections (400 mg cabotegravir plus 600 mg rilpivirine), will be required every four weeks (+/– 1 week).
Administration every eight weeks, involving two 3 mL IM injections, is currently being evaluated in the ATLAS-2M clinical trial, with a supplemental New Drug Application expected to be filed by the manufacturer in early
Cold-chain storage or a temperature-controlled supply chain will be Cabenuva will need to be brought to room temperature before administration.
The recommended injection procedure is intramuscular administration using the Z-track method in the gluteus medius, and generally will require administration in a clinic or possibly a pharmacy in a private space.

Delivery System Issues

Clinics will need to assess available clinic space and develop staffing plans to accommodate more frequent office visits for some
State regulations or a clinic or institution’s internal policies may determine who can administrator the Nurses or other staff who may able to administer the injection will require training.
More intensive patient reminder systems will likely be needed to ensure patients do not miss a monthly

Healthcare Coverage

Due to Cabenuva’s administration in a clinical setting, health insurers are likely to cover it as a medical benefit rather than a pharmacy benefit, which will affect how clinics obtain and bill for the Patients’ out-of-pocket and how they access co-pay assistance to help cover their out of pocket costs also will be determined by how the medication is covered.
Drugs covered under the health insurer’s medical benefit may require a flat co-insurance rate (e.g., 20%) of the cost of the
The Centers for Medicare and Medicaid Services (CMS) may designate Cabenuva as covered under Medicare Part B or Part D (the prescription drug benefit). If CMS does not make a determination, then it may be covered under Medicare B or Medicare Part
Medicaid coverage policies will be determined on a state-by-state

Procurement and Purchasing

Drugs administered by a clinician, particularly those with cold-chain requirements, are generally not purchased directly by an outpatient They are typically procured through one of the options below, and the method may be determined by the third-party payer.
- Buy-and-bill: Provider or clinic purchases the drug/biologic product from a wholesaler or distributor and bills the primary third-party payer. Provider or clinics assume liability for the cost of the drug under this model. Buy-and-bill is typical of drugs or biologics covered as a medical benefit.
- White bagging: Provider submits prescription to specialty pharmacy; specialty pharmacy processes the claim and ships product to the provider for administration. White bagging may be typical of drugs or biologics covered as a pharmacy benefit. White bagging may also be an option for drugs or biologics covered as a medical benefit.
- Brown bagging: Specialty pharmacy processes the claim and the patient picks it up and takes it to the provider for administration. Brown bagging is not expected to be an option for Cabenuva.

Temperature-controlled storage will be needed for
Separate buy-and-bill and white-bag inventories will need to be maintainted. Cabenuva is expected to be available via buy-and-bill and white-bag mechanisms from a variety of specialty pharmacies and specialty distributors.

Ryan White HIV/AIDS Program Assistance

Check with your state AIDS Drug Assistance Program regarding coverage of Cabenuva and the assistance that may be NASTAD maintains a directory of ADAP staff.
The HIV/AIDS Bureau issued guidance in December 2019 recommending that AIDS Drug Assistance programs add long-acting ARV products to their formularies when they become available. HAB also has determined that the costs of ARV product administration and/or office visits directly associated with provider administration of ARVs are allowable costs under the ADAP service category. In addition, ADAPs may cover medical co-payment associated with the administration of Cabenuva for patients with health insurance.

Cost-Sharing and Patient Assistance for the Uninsured

Details on the cost sharing and patient assistance that will be available from ViiV Healthcare has not been released. This document will be updated when it comes.

The information in this resource was compiled by the National Alliance of State and Territorial AIDS Directors and the HIV Medicine Association. Please email questions or comments to Tim Horn with NASTAD at thorn@nastad.org or Andrea Weddle with HIVMA at aweddle@hivma.org.