Prep toolkit ebrief3 v05 final

Accessing PrEP

The Centers for Disease Control and Prevention (CDC) has estimated that approximately 1.2 million individuals in the United States (US) have a substantial risk of contracting human immunodeficiency virus (HIV) and could benefit from pre-exposure prophylaxis (PrEP) as an HIV prevention strategy. Given the high number of individuals who could potentially benefit from this strategy, being prepared to help patients navigate the costs associated with PrEP—which include medication and doctor/clinic visits—can make PrEP implementation more manageable.

Finding a PrEP Provider Many groups who are actively involved in efforts to promote HIV prevention and treatment services have begun to compile resources to help interested individuals locate medical providers who are knowledgeable about PrEP for HIV prevention. For example, in late 2016, Emory University launched a PrEP-locator Web site (https://preplocator.org) that features a directory of US-based PrEP providers. This resource allows individuals to search for providers by zip code, city, and/or state. It also allows individuals to search for clinicians who offer PrEP to uninsured patients and clinicians who offer PrEP access assistance.

Paying for PrEP Two types of costs are associated with PrEP:  The cost of the medication used in PrEP  The cost of the doctor/clinic visits associated with the laboratory tests that are performed before PrEP is prescribed and during routine follow-up visits after it is started (cost varies by insurance status) Several payment-assistance programs have been developed to help support individuals on PrEP who have limited insurance coverage or who are uninsured.

Insured Patients Most private insurance providers cover medication costs related to PrEP, but some insurance plans may require prior authorization. If you are having difficulty getting insurance programs to cover PrEP, make sure the coding being used matches the CDC’s recommended coding: (www.cdc.gov/hiv/pdf/prepprovidersupplement2014.pdf).

If a patient is covered by Medicaid, all medical costs related to PrEP should be covered. If you experience difficulty getting PrEP covered for your patient, contact a legal advocate to discuss how to best address the problem.

If your patient is insured but still needs extra financial support to help cover out-of-pocket PrEP costs, several programs can be of assistance:  Public health clinics/federally qualified health centers (FQHCs)—These clinics usually offer sliding-scale fees and can be a great way to help patients offset the costs of PrEP. Find local FQHCs at https://findahealthcenter.hrsa.gov/.  Gilead Advancing Access co-pay card—Gilead offers insured individuals support in the form of a co-pay card that covers up to $3,600 per calendar year for co-pays, deductibles, and co-insurance. There are no income restrictions set for this program, and consumers may reapply as needed. This program does require proof of US residence and is not available to patients enrolled in a state- or federally funded prescription drug program (ie Medicare Part D, Medicare Part D prescription coverage gap, Medicaid, or VA) (www.cdc.gov/hiv/pdf/prepprovidersupplement2014.pdf).  Patient Advocate Foundation (PAF) co-pay relief (CPR)—PAF CPR supports up to $7,500 per year for co-pays only, is based on taxable income, and allows participants to reapply as needed. To be eligible, patients must supply proof of US residence, and their income must fall below 400% of the federal poverty level (FPL). More information on the program can be found at www.copays.org.  Patient Access Network (PAN) Foundation—As of July 18, 2016, PAN has stopped accepting new applications, but it may be worth checking back on their site occasionally to see whether they have started accepting new applications again (www.panfoundation.org).

This program offers a maximum of $7,500 per year for co-pays, deductibles, and coinsurance. US citizenship is not a requirement of this program, and patients can reapply as needed. Patient income must fall below 400% or 500% of the FPL, depending on fundspecific guidelines, and the amount allotted is based on the patient’s taxable income.

Uninsured Patients For patients who are uninsured, interested in PrEP, and US citizens, the first place to start is the government insurance marketplace When looking for the best insurance plan, it is recommended that patients avoid the Bronze plans, as they generally have higher costs. Gold and Platinum plans offer better coverage, but they are more expensive.

Individuals who have an income below 138% of the FPL (< $16,242) in a state with Medicaid expansion should be eligible for Medicaid. If the state does not have Medicaid expansion, such individuals may still qualify based on income, household size, disability, and family status.

Medicaid covers all costs associated with PrEP, so enrolling in this program might be the best option for patients who meet these criteria.

For individuals with an income above 138% of the FPL or who are ineligible for Medicaid for other reasons, Gilead offers a Medication Assistance Program that uninsured patients can use to help cover the cost of PrEP . To apply for this program, several pieces of information must be provided by the patient and prescriber.

PAGE 2

Additional Ways to Reduce the Financial Burden The fees associated with clinic visits that are required as a part of on-treatment monitoring (ie, copay for the visit and HIV, STI, and pregnancy testing) may be cost prohibitive for some patients who are interested in or using PrEP. If these costs are not covered by an insurance plan or other payment-assistance program, using a FQHC or community health center with sliding-scale fees can lessen the financial burden.

Required Forms Although each of these payment-assistance programs may require different pieces of paperwork, some standard documents may be of assistance. These include, but are not limited to:  Program application form  Copy of insurance card  Proof of income (2 most recent pay stubs, most recent W-2 form, or Federal Income Tax Form 1040)  Unemployment benefits award letter  Prescriber information including NPI# and Tax ID#  Statement of medical necessity  HIPAA authorization (eg, https://www.caring.com/forms/hipaa-release-form/free-hipaarelease-form.pdf)  Prescription form

References Calabrese SK, Magnus M, Mayer KH, et al. Putting PrEP into practice: lessons learned from early-adopting U.S. providers’ firsthand experiences providing HIV pre-exposure prophylaxis and associated care. PLoS One. 2016;11(6):e0157324.

Centers for Disease Control and Prevention (CDC). Daily pill can prevent HIV. www.cdc.gov/vitalsigns/hivprep/. Accessed November 3, 2016.

Centers for Disease Control and Prevention (CDC). Paying for PrEP. www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-paying-for-prep.pdf. Accessed November 3, 2016.

US Public Health Service. PrEP for the prevention of HIV infection in the United States - 2014. www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf. Accessed November 3, 2016.

US Public Health Service. PrEP for the prevention of HIV infection in the United States - 2014: clinical providers’ supplement. www.cdc.gov/hiv/pdf/prepprovidersupplement2014.pdf. Accessed November 3, 2016.

Conniff J, Evensen A. Preexposure prophylaxis (PrEP) for HIV prevention: the primary care perspective. J Am Board Fam Med. 2016;29(1):143151.

Juusola JL, Brandeau ML, Owens DK, Bendavid E. The cost-effectiveness of preexposure prophylaxis for HIV prevention in the United States in men who have sex with men. Ann Intern Med. 2012;156(8):541-550.

Project Informed. Getting PrEPPED. www.projectinform.org/pdf/PrEP_Flow_Chart.pdf. Accessed November 3, 2016.

This activity was developed by Med-IQ in collaboration with HealthHIV, Pozitively Healthy, and the National Coalition for LGBT Health.

The information provided through this activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a physician relative to diagnostic and treatment options of a specific patient’s medical condition.

Supported by an educational grant from Gilead Sciences, Inc. © 2016 Med-IQ. All rights reserved.

PAGE 3