HIV Pre-Exposure Prophylaxis (PrEP) Medical Necessity Determination

Patient Eligibility Criteria

• The American College of Physicians recommends that PrEP is medically indicated for patients who are confirmed HIV-negative and meet criteria for being at risk of HIV acquisition, with a negative HIV test immediately prior to PrEP initiation using combined HIV antibody and antigen testing 1
• The Centers for Disease Control and Prevention (CDC) guidelines state that PrEP is absolutely contraindicated if HIV status is positive or unknown, and patients must have a creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula) for Truvada 1, 3
• The CDC also recommends hepatitis B surface antigen testing completed for all patients prior to initiating PrEP 1, 3, 2

Risk Stratification for Medical Necessity

• The CDC guidelines indicate that PrEP is medically necessary if the patient meets any of the following criteria: HIV-seronegative partner of an HIV-infected person who is not consistently virally suppressed 1, 5
• The CDC also recommends PrEP for members of a population with HIV incidence ≥2% per year 1, 6
• Men who have sex with men (MSM) with recent bacterial sexually transmitted infections or high-risk sexual behavior are also eligible for PrEP 1, 4
• Heterosexually active adults in HIV-discordant relationships are also considered at risk and eligible for PrEP 3

Medication Selection Algorithm

• The CDC recommends Truvada (TDF/FTC) as the first-line option for men who have sex with men (MSM) or transgender women, with an alternative option of Descovy (TAF/FTC) for patients with creatinine clearance 30-60 mL/min, osteopenia or osteoporosis, or age >50 years with renal risk factors 1, 4, 6
• For cisgender women or transgender men at risk through vaginal exposure, Truvada (TDF/FTC) is the only approved and effective option 5, 4

Ongoing Monitoring Requirements

• The CDC guidelines recommend ongoing monitoring every 3 months, including combined HIV antibody and antigen testing, three-site STI screening, syphilis testing, pregnancy testing for individuals of childbearing potential, and assessment of adherence and risk behaviors 1, 2, 4, 6
• Every 6-12 months, patients should undergo serum creatinine and estimated glomerular filtration rate monitoring, with more frequent renal monitoring required for patients >50 years, taking hypertension/diabetes medications, or baseline eGFR <90 mL/min 1, 2, 4

Critical Contraindications

• The CDC guidelines state that PrEP prescriptions should not exceed 90 days without interval HIV testing, and patients with positive or unknown HIV status, creatinine clearance <60 mL/min for Truvada, or creatinine clearance <30 mL/min for Descovy are not eligible for PrEP 2, 5, 6, 4