Oscar Apretude (cabotegravir extended-release injectable suspension) (PG158) Form

Pre-Exposure Prophylaxis (PrEP)

Pre-Exposure Prophylaxis (PrEP) is the use of anti-retroviral medications to prevent the acquisition of HIV. When taken consistently and correctly, PrEP can reduce the risk of HIV acquisition by over 99%. PrEP is not 100% effective and does not protect against other sexually transmitted infections (STIs). Therefore, condom use and frequent STI testing should be recommended

PrEP is recommended for people who are at risk of acquiring HIV, particularly those who have multiple sexual partners, use injection drugs, have a partner with HIV, or engage in condomless sex. PrEP is also recommended for people who are HIV-negative and are planning to become pregnant with an HIV-positive partner. The need for PrEP should be patient-driven, and offered to all patients who could benefit from its use.

The U.S. Preventive Services Task Force (USPSTF) recommends that clinicians offer pre-exposure prophylaxis (PrEP) with effective antiretroviral therapy to individuals who are at high risk of HIV acquisition. This is a Grade A recommendation, indicating that the USPSTF believes there is a high certainty of substantial benefit from using PrEP in these populations.¹

• The specific drugs recommended for PrEP can vary based on the individual's health situation and the most current research.

Historically, the combination of emtricitabine and tenofovir has been commonly used for PrEP.

Apretude (cabotegravir extended-release injectable suspension), for intramuscular use is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating Apretude (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.

• Cabotegravir is a human immunodeficiency virus type-1 (HIV-1) integrase strand transfer inhibitor (INSTI). It is available as oral tablets and an extended-release injection.
• The oral tablets are approved for use in combination with rilpivirine for short-term treatment (as a lead-in to assess tolerability of cabotegravir before administering extended-release cabotegravir; rilpivirine injection or as a replacement for a missed injection) of HIV-1 infection in adults and children 12 years and older weighing at least 35 kg who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
• The extended-release injection is approved for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and children 12 years and older who weigh at least 35 kg and are at high risk; it is the first injectable treatment for HIV-1 PrEP. The oral tablets may also be used short-term for PrEP as a lead-in to assess tolerability of cabotegravir before giving the extended-release injection or as a replacement for a missed injection. Cabotegravir injection may be especially appropriate for patients with significant renal disease, those who have had difficulty with adherent use of oral PrEP,and those who prefer injections every 2 months to an oral PrEP dosing schedule.
• The FDA-approved package labeling contains a Black Box Warning regarding risk of drug resistance with use of cabotegravir extended-release injection for PrEP in undiagnosed HIV-1 infection; individuals must be tested for HIV-infection prior to therapy initiation and with each subsequent injection.

Definitions

• Human Immunodeficiency Virus (HIV) is a virus that attacks the immune system, leaving the body vulnerable to infections and diseases. It is primarily spread through sexual contact, sharing of needles or other injection equipment, or from mother to child during pregnancy, childbirth, or breastfeeding.²
• Antiretroviral Therapy (ART) is the treatment for HIV that involves taking a combination of medications that work to suppress the virus and prevent it from replicating in the body. ART is not a cure for HIV, but it can significantly reduce the amount of virus in the body, slow the progression of the disease, and improve the immune system's function.
• Pre-Exposure Prophylaxis (PrEP) is the use of anti-retroviral medications to prevent the acquisition of HIV.
• Acquired Immune Deficiency Syndrome (AIDS) is an outdated term that was previously used to describe advanced HIV disease and the loss immune function required to fight certain infections.

Medical Necessity Criteria for Initial Authorization

The Plan considers Apretude (cabotegravir) medically necessary when ALL the following criteria are met:

1. The member is at least 12 years of age and weighing at least 35 kg (77 lbs) or greater; AND
2. Is being prescribed for pre-exposure prophylaxis (PrEP) for members meeting ONE of the following criteria:
   • to reduce the risk of sexually acquired HIV-1 (i.e., those with an HIV-positive sexual partner, recent sexually transmitted infection, multiple sex partners, history of inconsistent or no condom use, commercial sex work or transactional sex, in high-prevalence area or network); or
   • injection drug users at substantial risk of HIV acquisition (i.e., those with an HIV-positive injecting partner and those sharing injection equipment or who recently received drug treatment but are currently injecting); AND
3. The member is documented to be HIV-1-negative; AND
4. The member is unable to use, or has a documented clinical rationale indicating they are not an appropriate candidate (e.g., history of non-adherence to once-daily oral PrEP regimen, baseline renal dysfunction or at risk for developing renal impairment, osteoporosis, low bone mineral density, or at risk of developing low bone mineral density) for emtricitabine and tenofovir disoproxil fumarate (Truvada).

If the above prior authorization criteria is met, Apretude (cabotegravir) will be approved for 12 months.³

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if BOTH of the following are met:

1. the member still meets the applicable initial criteria; AND
2. recent chart documentation (within the last 3 months) shows the member has experienced therapeutic response to the requested medication as evidenced by a documented negative HIV test.

Experimental or Investigational / Not Medically Necessary

Apretude (cabotegravir) for any other indication or use is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.