Pharmacy Prior Authorization Criteria

Cabotegravir Containing Agents - PA, NF

Indications for Prior Authorization

Cabenuva (cabotegravir and rilpivirine) Injection

• For diagnosis of Treatment of HIV-1 Infection
  Indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (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.

Vocabria (cabotegravir) Tablet

• For diagnosis of Treatment of HIV-1 Infection
  Indicated in combination with EDURANT (rilpivirine) for short-term treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 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. Vocabria may be used as:

  1) Oral lead-in to assess the tolerability of cabotegravir prior to administration of Cabenuva extended-release injectable suspension for HIV-1 treatment.

  2) Oral therapy for patients who will miss planned injection dosing with Cabenuva for HIV-1 treatment.

• For diagnosis of HIV-1 Pre-Exposure Prophylaxis
  Indicated in at-risk adults and adolescents weighing at least 35 kg for short-term pre exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Vocabria may be used as:

  1) Oral lead-in to assess the tolerability of cabotegravir prior to administration of Apretude extended-release injectable suspension for HIV-1 PrEP.

  2) Oral therapy for patients who will miss planned injection dosing with Apretude for HIV-1 PrEP.

Criteria

Vocabria*, Cabenuva*

*If patient meets criteria above, please approve both Vocabria and Cabenuva at GPI list “CABOTEGRPA”.

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Treatment of HIV-1 Infection

• All of the following:
• Diagnosis of HIV-1 infection
AND
• Patient is 12 years of age or older
AND
• Patient's weight is greater than or equal to 35 kg
AND
• Patient is currently virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable, uninterrupted antiretroviral regimen for at least 6 months
AND
• Patient has no history of treatment failure or known/suspected resistance to either cabotegravir or rilpivirine
AND
• Provider attests that patient would benefit from long-acting injectable therapy over standard oral regimens
AND
• Prescribed by or in consultation with a clinician with HIV expertise
OR
• For continuation of prior therapy

Vocabria*, Cabenuva*

*If patient meets criteria above, please approve both Vocabria and Cabenuva at GPI list “CABOTEGRPA”.

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Treatment of HIV-1 Infection

• All of the following:
• Diagnosis of HIV-1 infection
AND
• Patient is 12 years of age or older
AND
• Patient's weight is greater than or equal to 35 kg
AND
• Patient is currently virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable, uninterrupted antiretroviral regimen for at least 6 months
AND
• Patient has no history of treatment failure or known/suspected resistance to either cabotegravir or rilpivirine
AND
• Provider attests that patient would benefit from long-acting injectable therapy over standard oral regimens
AND
• Prescribed by or in consultation with a clinician with HIV expertise
OR
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 70-day gap in therapy [A]

Vocabria**

**If patient meets criteria above, please approve Vocabria at GPI list “APRETUDEPA”

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of HIV-1 Pre-Exposure Prophylaxis

• Requested drug is being used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection
AND
• Patient's weight is greater than or equal to 35 kg
AND
• Documentation of both of the following U.S. Food and Drug (FDA)-approved test prior to use of Vocabria:
• Negative HIV-1 antigen/antibody test
• Negative HIV-1 RNA assay
AND
• One of the following:
• Trial of, contraindication or intolerance to generic emtricitabine-tenofovir disoproxil fumarate 200/300mg
OR
• Provider attests to both of the following:
• Patient would benefit from long-acting injectable therapy over standard oral regimens
• Patient would be adherent to testing and dosing schedule

Vocabria**

**If patient meets criteria above, please approve Vocabria at GPI list “APRETUDEPA”

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of HIV-1 Pre-Exposure Prophylaxis

• Requested drug is being used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection
AND
• Patient's weight is greater than or equal to 35 kg
AND
• Submission of medical records (e.g., chart notes) confirming documentation of both the following U.S. Food and Drug (FDA)-approved test prior to use of Vocabria:
• Negative HIV-1 antigen/antibody test
• Negative HIV-1 RNA assay
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
• Trial of, contraindication or intolerance to generic emtricitabine-tenofovir disoproxil fumarate 200/300mg
OR
• Both of the following:
• Patient would benefit from long-acting injectable therapy over standard oral regimens
• Patient would be adherent to testing and dosing schedule

P & T Revisions

2024-12-06, 2024-09-16, 2024-02-22, 2023-03-15, 2022-12-02, 2022-09-08, 2022-05-04, 2022-03-17, 2021-10-08, 2021-04-07, 2021-03-17

References

1. Cabenuva Prescribing Information. ViiV Healthcare Company. Research Triangle Park, NC. December 2023.
2. Vocabria Prescribing Information. ViiV Healthcare Company. Research Triangle Park, NC. December 2023.

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End Notes

1. Continuation of therapy for Cabenuva and Vocabria in NF criteria will allow for a 70-day gap to account for the 2-month dosing schedule +/- 7 days. [1]

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Revision History

• 2024-12-06: Updated to remove Apretude from guideline.
• 2024-09-16: Updated spelling error in indication section .
• 2024-02-22: 2024 Annual Review. No clinical changes. Updated references.
• 2023-03-15: Annual review - no changes.
• 2022-12-02: Per PA team feedback, updated T/F requirement of generic Truvada for PrEP to include verbiage "Trial of" for additional clarity. Also removed "provider attests" for NF section as we already require submission of MR.
• 2022-09-08: Updated COT for Cabenuva NF criteria. Modified NF criteria for Apretude and added NF criteria for reauth as well.
• 2022-05-04: Added age and weight criteria for cabenuva/vocabria. Updated background and references.
• 2022-03-17: Update GL to include new indication for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection, added NF section for PrEP, added Apretude PA/NF criteria to GL, updated background information along with GL name.
• 2021-10-08: Update to include EHB formulary. Guideline update to include non-formulary criteria.
• 2021-04-07: Update criteria to clarify patient should be virologically suppressed on a stable, uninterrupted ARV regimen for at least 6 months and that provider attests to benefit of injectable therapy over oral regimen
• 2021-03-17: New program.

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