PrEP Financing & Sustainability PrEP ECHO Hub, Session Four Edwin Corbin-Gutierrez NASTAD

Disclosure Successful Completion: Contact hours will be prorated according to documented attendance. To receive contact hours, participants must complete and submit the on-line evaluation/request for credit form. CNE and CME certificates will be emailed approximately 4 weeks after completion of the evaluation/request for credit form. Commercial Support/Sponsorship: There is no commercial support for this training. Non-Endorsement of Products: The University of Missouri-Kansas City School of Nursing and Health Studies, and the ANCC do not approve or endorse any commercial products associated with this activity. Moderator will read this verbatim.

Disclosure Conflict of Interest: In accordance with continuing education guidelines, the speakers and planning committee members have disclosed commercial interests/financial relationships with companies whose products or services may be discussed during this program. Speakers: Edwin Corbin-Gutierrez has no personal conflicts of interest to report. . Planning Committee: Katherine Atcheson, Angela Bolen, Sharon Colbert and Shelby Webb have nothing to disclose. Jacki Witt serves on the advisory panel for Afaxys (Resolved). Acknowledgment of Funding: This presentation was supported by Grant # 1 FPTPA006029-01-00 from the United States Department of Health and Human Services (HHS), Office of the Assistant Secretary of Health (OASH), Office of Population Affairs (OPA). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of HHS, OASH, or OPA. Moderator will read this verbatim.

Accreditation Statements   Continuing Medical Education This Live series activity, PrEP in Family Planning Project ECHO, from 08/07/2019- 09/18/2019, has been reviewed and is acceptable for credit by the American Academy of Family Physicians. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Approved for 1 AAFP (1 Elective) credits. Continuing Nursing Education The University of Missouri-Kansas City School of Nursing and Health Studies is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. Each live webinar offers up to 1.0 contact hour for nurses. Moderator will read this verbatim.

Objectives After attending this session, participants should be able to: Explain the process for access to pre-exposure prophylaxis (PrEP) for uninsured and underinsured patients Discuss leveraging the 340B program and other issues when considering maintenance and sustainability of a PrEP program

Topics Covered PrEP access for uninsured and underinsured patients PrEP coverage and cost landscape Copay and patient assistance programs Insurance navigation considerations for PrEP Coverage and billing for preventive services Sustainability and other considerations when leveraging the 340B program for PrEP PrEP pipeline and 340B savings Coverage policies impacting PrEP access and affordability

Payment and Delivery Barriers to PrEP Without 340B discount, the drug cost is prohibitively expensive for many public health programs High co-payments/co-insurance for a specialty-tier medication High Cost CDC funds may not be used for PrEP medication (policy) Ryan White HIV/AIDS Program cannot pay for the medication (statutorily) Clinical expertise necessary for appropriate PrEP access Payment & Delivery Conundrum 17 states have still not expanded Medicaid Medicaid Expansion Source: Smith DK et. al. JAIDS 76.5 (2017)

PrEP Components and Costs Cash Price* Medication (emtricitabine and tenofovir disoproxil fumarate) brand name Truvada® (single source) is only FDA-approved medication for PrEP currently) ~$1,700/month (Wholesale Acquisition Cost, no discount) Lab costs** (at PrEP initiation and every three months) Baseline HIV test HBV tests (at initiation only) Metabolic panel/creatine test Gonorrhea and Chlamydia screening Syphilis screening ~$188 to $486 Physician visit (at initiation and every three months) ~$60 to $170 per visit * Above costs are estimates, the cash price of services varies significantly depending on geography and provider. Many providers provide lab and clinical services to uninsured patients at a reduced, sliding fee scale rate. ** Providers should refer to the CDC PrEP Clinical Guidelines for specific lab recommendations based on patient risk and other factors.

Patient Assistance Program Clinical Visits & Labs Health Insurance Income Eligibility Gilead Patient Assistance Program Not covered Uninsured 500% FPL Details on eligibility and enrollment: www.nastad.org/prepcost

Co-pay Assistance Programs Medication Copay Max Clinical Visits & Labs Health Insurance Income Eligibility Gilead Advancing Access Copay $7,200/yr Not covered Private health plans Any income Patient Advocate Foundation $7,500/yr Plans covering Truvada 400% FPL Patient Access Network Foundation $8,000/yr Covered (limited) Medicare 500% FPL Details on eligibility and enrollment: www.nastad.org/prepcost

State PrEP Assistance Programs

Health Insurance Navigation PrEPcost.org: a health insurance assessment tool for Marketplace plans in all 50 states and DC developed by NASTAD Purpose: Help PrEP Navigators compare the best health coverage options for clients Integrated formulary search function Tax subsidies applied PrEP-related monthly out-of-pocket cost estimate Compare coverage and costs Connect with enrollment assistance

Comparing Health Plans Out-of-pocket costs Co-pay assistance programs Lab tests covered as a preventive service First-dollar coverage Cost spikes

PrEP Pipeline Product Administration Status TAF/FTC Oral Application for expedited FDA approval submitted TDF/FTC (generic) Generic available Sep. 2020 (exclusive) Three generic manufacturers expected Sep. 2021 CAB LA Injectable Phase III (primary results estimated Mar. 2022) Providers need to anticipate a different PrEP medication landscape in the next 1-2 years (e.g. generic PreP, long-acting injection) Generic TDF/FTC: Teva Pharmaceuticals will make a generic version of Truvada available in the U.S. by the end of September 2020 We don’t expect much of a price reduction at that point given that it is an exclusivity agreement The availability of a generic equivalent may begin to impact health plan formularies for 2021 plans Two additional generic manufacturers are expected to enter the market in September 2021 Competition once additional generic manufacturers enter is expected to drive down the price of the medication significantly TAF/FTC: Gilead submitted an expedited approval application for FDA approval in May At CROI this year, Gilead presented results from their DISCOVER trial pointing to its non-inferiority and decrease in adverse events for renal function and bone density loss Approval of the TAF formulation is expected this Fall With generic TDF/FTC becoming available in September 2020, Gilead’s market strategy will be to encourage patients and providers to move to Descovy as soon as it is approved; expect to see incentives in the form of voluntary rebates and by expanding their assistance programs Cabotegravir, long-acting: Strand-transfer integrase inhibitor being developed for HIV treatment and prevention Formulated as a long-acting injectable nanosuspension for intramuscular (IM) administration (every 8 weeks) May ameliorate suboptimal adherence, address pill fatigue, protect of health privacy (reduce HIV risk and Px-related stigma) Additional payer and delivery mechanism considerations for coverage of an injectable

PrEP Medication Pricing Changes Commercial Plans Commercial Plans Truvada ($58) Descovy ($58) URA (23.1%) Inflation Penalty (14%) Medicaid (~$37.00) URA (23.1%) + Inflation Penalty (~50%) Commercial Plans Medicaid (~$14.00) TDF/FTC ($4.00)

USPSTF Draft Grade A Recommendation Population Recommendation Grade Persons at high risk of HIV acquisition The USPSTF recommends that clinicians offer pre-exposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition A ACA mandates that private insurance plans and Medicaid expansion programs cover preventive services with a USPSTF A or B rating at no cost Plans must adopt in the plan year that begins at least one year following the final USPSTF recommendation USPSTF recommendation includes HIV, hepatitis, and STI testing at initiation and every three months as well as follow-up provider appointment every three months, all of which should be covered without cost sharing Potential for use of management strategies in discriminatory ways (e.g. prior authorization)

Resources Discussed NASTAD PrEP Resources: CDC PrEP Guidelines: www.PrEPcost.org Assistance programs: www.nastad.org/prepcost Billing coding guide: http://bit.ly/1N8VXNz CDC PrEP Guidelines: www.cdc.gov/hiv/risk/prep/index.html