PrEP Financing: Considerations for Scale up Amy Killelea, JD Senior Director, Health Systems & Policy NASTAD
PrEP Pricing, Access, and Sustainability 2
PrEP Pipeline: At-a-Glance Route of Product Status Administration TDF/FTC Brand-name drug approved 2012; Single generic competitor in September 2020; multiple generic competitors March 2021 Oral TAF/FTC FDA approval in October 2019 RAL/3TC Phase IV Cabotegravir Phase III Long-acting Dapivirine Phase III/FDA review (ring); 3-month ring and rectal gel in development Tenofovir Ring Phase I Dapivirine or tenofovir + Phase I levonorgestrel Tenofovir, TAF/EVG, IQP- Vaginal/rectal Pre-clinical – Phase I 0528, Griffithsin, PC-1005, inserts, enemas, DS-003 tablets 3
USPSTF Final Grade A Recommendation Population Recommendation Grade Persons at high The USPSTF recommends that clinicians offer A risk of HIV pre-exposure prophylaxis (PrEP) with effective acquisition antiretroviral therapy to persons who are at high risk of HIV acquisition § ACA mandates that private insurance plans and Medicaid expansion programs cover preventive services with a USPSTF A or B rating at at no cost § Plans must adopt in the plan year that begins at least one year following the final USPSTF recommendation (for PrEP that means Ja January 2021 for most plans and Medicaid) 4
USPSTF Challenge: Formulary § What USPSTF says: o Once-daily oral treatment with combined tenofovir disoproxil fumarate and emtricitabine o Tenofovir disoproxil fumarate alone can be considered as an alternative regimen for high-risk heterosexually active men and women and persons who inject drugs o Silent on utilization management § Questions o Are plans required to cover TAF-based regimens without cost sharing? o Federal regulation allows plans to use “reasonable medical management” for USPSTF recommended A and B services. What does that look like for PrEP? 5
USPSTF Challenge: Clinic and Lab Services § What USPSTF says: HIV, STI, and liver function testing “generally recommended” at initiation and periodically while a person is on PrEP § Questions o Do plans have to cover all of the CDC recommended clinic and lab tests without cost sharing? o If CDC recommendations are updated, will plans have to update practices accordingly? 6
Next Steps for USPSTF Implementation § Potential CMS/CCIIO and CMS/CMCS guidance to private insurance plans and state Medicaid agencies about appropriate implementation § Potential state insurance regulator bulletins and guidance to plans (e.g., NY Department of Insurance Bulletin on non-discriminatory practices for PrEP coverage) § Provider and consumer education is critical to ensure that USPSTF and CDC guidelines are being followed and to ensure consumers know about new cost- sharing protections 7
Financing Models for PrEP: A Patchwork of Funding and Delivery Mechanisms… Drug Access PrEP Clinical Visits & Counseling and Lab Costs Linkage Uninsured Manufacturer Patient PrEP DAPs (state funded) PrEP DAPs (state funded) Assistance Program CDC prevention funds to CDC prevention grants PrEP Drug Assistance pay for HIV/STD testing Community Health Programs or “PrEP DAPs” Community Health Centers; Family Planning (state funded) Centers; Family Planning Clinics; STD Clinics using Community Health Clinics; STD Clinics using 340B savings Centers; Family Planning 340B savings Clinics; STD Clinics using 340B savings Ready, Set, PrEP Insured Covered by payers; co- Largely covered, but with Not well covered by pay assistance through patient co-pays public or private manufacturer assistance insurance PrEP DAPs (state funded) program 8
EtHE: Ready, Set, PrEP § In December 2019, HHS launched Ready, Set, PrEP , a nationwide program to provide Truvada or Descovy at no cost to eligible participants § To qualify, recipients must: o Lack prescription drug coverage o Be tested for HIV with a negative result o Have a prescription for PrEP § Once a PrEP patient has the necessary prescription, they can visit GetYourPrEP.com or call 855-447-8410 to enroll § CVS Health, Walgreens, and Rite Aid will begin distributing the medication in March. Between now and March 30, 2020, patients will be able to access PrEP medications through a network of participating pharmacies 9
EtHE: CDC Implementation NOFO § Released January 21, 2020 with new flexibility for PrEP services in the eligible jurisdictions, including for: o Increased provider training o PrEP adherence and persistence services o Lab services o Novel engagement strategies, including mobile units o Tele-PrEP models o Limited personnel costs related to provision of PrEP medication, if coupled with other supportive services Note: PrEP medication and most clinical care may not be funded with CDC dollars 10
PrEP Medication Pricing Changes Descovy ($56) Truvada ($56) Multi TDF/FTC Single TDF/FTC Generics ($6)* Generic ($50)* Commercial Plans Commercial Plans Commercial Plans Stat. required Medicaid/340B (~$43.50) Stat. required Medicaid/340B (~$37.00) Commercial Plans Voluntary 340B Stat. required (~$15.00) Medicaid/340B (~$15.00) *Forecasted *Forecasted 11
Considerations Moving Forward § Do we need to rethink our current PrEP models in light of changes to the PrEP medication landscape? § How do we make sure that PrEP is getting to the right places and people, while also designing a cost- effective delivery model? Are those two priorities in tension? § How should community and providers respond to formulary designs that preference certain forms of PrEP over others based on cost? 12
Contact/Resources § Amy Killelea, NASTAD (akillelea@nastad.org) § NASTAD PrEP Resources – https://www.nastad.org/prepcost- resources/additional-resources § PrEPcost.org – NASTAD’s online plan assessment tool for PrEP § AIDSVu PrEP Mapping – https://aidsvu.org/prep/ § CDC PrEP Guidelines – https://www.cdc.gov/hiv/risk/prep/index.html 13
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