What is PrEP and how is it prescribed?
PrEP refers to the use of an antiretroviral medication prescribed to prevent HIV infection. It is used by people who do not have HIV infection but who may be exposed to HIV through sex and/or use of injection drugs. When taken as prescribed, PrEP is highly effective at preventing HIV, but does not protect against other sexually transmitted infections. PrEP may be used along with condoms, use of sterile injection equipment, and/or other risk reduction tools as part of a comprehensive approach to prevention.
There are currently two forms of PrEP: a once-daily pill and an injectable medication.
- Once-daily pill: Emtricitabine (F) 200mg combined with tenofovir disoproxil fumarate (TDF) 300mg (F/TDF brand name Truvada®), or Emtricitabine (F) 200mg combined with alafenamide (TAF) 25mg (F/TAF brand name Descovy®) are taken orally on a daily basis.
- Injection: Cabotegravir (CAB) 600mg (brand name Apretude®) is a long-acting injectable form of PrEP. Injections are administered by healthcare providers at two-month intervals.
These medications are approved to prevent HIV among adults and adolescents weighing 77lbs or more.
- Daily oral PrEP with F/TDF is approved to prevent HIV infection for people at risk due to sexual exposure and/or injection drug use. F/TDF is not recommended for patients with chronic kidney disease and an eGFR of < 60 mL/min/1.73m2.
- Daily oral PrEP with F/TAF is approved to prevent HIV infection among people at risk through sex. F/TAF has not been studied for HIV prevention for people assigned female at birth or others who could get HIV through receptive vaginal sex. F/TAF is safe for people with chronic kidney disease and an eGFR of 30 - 60 mL/min/1.73m2, but is not recommended for people with an eGFR < 30 mL/min/1.73m2.
- Injectable PrEP with CAB is approved to prevent HIV infection among people at risk because of sexual exposure.
The US Preventive Services Task Force has given oral PrEP a grade A recommendation. This grade indicates that their review found high certainty that the net benefit of this service is substantial.
The Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021Update – A Clinical Practice Guideline presents the evidence-base for PrEP, and provides guidance to clinicians to assist them to identify indications for prescription of PrEP, to select appropriate laboratory tests and other diagnostic procedures to obtain prior to starting PrEP, dosing strategies and considerations to prescribe PrEP, and guidance on clinical and laboratory monitoring and support patients prescribed PrEP.
While current guidelines for clinicians outlines off-label prescribing of PrEP, this approach is not approved by the US Food and Drug Administration, nor is it recommended by CDC.
Which patients can most benefit from PrEP?
HIV-negative people who are at high risk of exposure to HIV can use PrEP. It is an especially helpful tool for individuals who identify with the following groups or experiences:
- Men who have sex with other men
- Transgender women who have sex with men
- People who have sex with or share injection drug equipment with a partner who is HIV positive
- People who share needles, syringes or other drug injection equipment
- People who have been diagnosed with an STI in the past 6 months, especially gonorrhea or syphilis among heterosexually active adults, and gonorrhea, syphilis or chlamydia among men who have sex with men
- People who have had anal or vaginal sex in the past six months and have not consistently used a condom
- People who have been prescribed multiple courses of HIV post-exposure prophylaxis (PEP)
- Anyone requesting PrEP regardless of disclosed sources of risk
Who can prescribe PrEP?
PrEP can be prescribed by any practitioner licensed to prescribe medications. PrEP can be prescribed by primary care providers. There is no requirement that prescribers specialize in HIV or infectious diseases.
How can I help my patients pay for PrEP?
The US Preventive Services Task Force has given oral PrEP a grade A recommendation. Therefore, PrEP is usually covered as a preventive service by health insurers without patient cost-sharing. This extends to ancillary services including testing for HIV, hepatitis B and C, creatinine clearance, STIs, and adherence counseling/support. A Pre-Exposure Prophylaxis (PrEP), Post-Exposure Prophylaxis (PEP), and Other HIV Prevention Strategies: Billing and Coding Guide, published by NASTAD, describes procedure and diagnosis codes accepted by both public and private insurers, along with specific requirements for some billing codes, for PrEP and other prevention services. Updated ICD-10-CM Official Guidelines for Coding and Reporting from the Centers for Medicare and Medicaid Services (CMS) include coding specific to HIV PrEP. Providers may assign code Z29.81 (Encounter for HIV pre-exposure prophylaxis) when the patient encounter is for administration of pre-exposure prophylaxis medication. Using correct coding can help to optimize a client’s insurance.
For patients who do not have health insurance or who have other challenges in paying for PrEP services, there are programs to help with the cost of the medicine and the cost of deductibles or co-pays. For more information about paying for PrEP, or for help enrolling in health insurance coverage, contact the Massachusetts PrEP Drug Assistance Program (PrEPDAP) at (617) 502-1767.
If your patient is on someone else’s insurance policy, like a spouse or parent, it may be possible to keep billing information associated with HIV testing private. Learn about privacy in billing and find tools that can help your patient keep health information private.
For more information about health insurance coverage of HIV PrEP in Massachusetts, please refer to "Frequently Asked Questions: Accessing Pre-exposure Prophylaxis" prepared by the Center for Health Law and Policy Innovation at Harvard Law School.
Where can I get more information to help me prescribe PrEP?
CDC has published a toolkit, The Clinical Providers’ Supplement for PrEP which contains tools for clinicians and other health care providers including patient/provider checklists; patient information sheets; and provider information sheets. Also available from the CDC is a Clinicians Quick Guide to prescribing PrEP.
The National Clinician Consultation Center runs a PrEPline for clinicians to obtain clinical consultation on HIV PrEP prescribing. You can contact them at (855) 448-7737 (855-HIV-PREP) from 9am to 8pm ET, Monday through Friday.
CDC has published resources for health care professionals including current PrEP treatment guidelines, information on clinical trials, and educational resources for healthcare professionals.
Where can I get educational materials for my patients?
PrEP materials for clients such as brochures and wallet cards are available at no cost to you on the Massachusetts Health Promotion Clearinghouse.
For more information about PrEP and PEP and other prevention options for men who have sex with men, check out Care that Fits You.
DPH publishes a list and PrEP locator tool of clinical sites in the Commonwealth that have DPH-contracted PrEP programs