PrEP Financing: Considerations for Scale up Amy Killelea, JD - - PowerPoint PPT Presentation

PrEP Financing: Considerations for Scale up

Amy Killelea, JD Senior Director, Health Systems & Policy NASTAD

2

PrEP Pricing, Access, and Sustainability

PrEP Pipeline: At-a-Glance

Product Route of Administration Status TDF/FTC Oral Brand-name drug approved 2012; Single generic competitor in September 2020; multiple generic competitors March 2021 TAF/FTC FDA approval in October 2019 RAL/3TC Phase IV Cabotegravir Long-acting Phase III Dapivirine Ring Phase III/FDA review (ring); 3-month ring and rectal gel in development Tenofovir Phase I Dapivirine or tenofovir + levonorgestrel Phase I Tenofovir, TAF/EVG, IQP- 0528, Griffithsin, PC-1005, DS-003 Vaginal/rectal inserts, enemas, tablets Pre-clinical – Phase I

3

USPSTF Final Grade A Recommendation

§ 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

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

USPSTF Challenge: Formulary

§ What USPSTF says:

• Once-daily oral treatment with combined tenofovir disoproxil

fumarate and emtricitabine

• Tenofovir disoproxil fumarate alone can be considered as an

alternative regimen for high-risk heterosexually active men and women and persons who inject drugs

• Silent on utilization management

§ Questions

• Are plans required to cover TAF-based regimens without cost

sharing?

• 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

• Do plans have to cover all of the CDC recommended clinic and

lab tests without cost sharing?

• 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…

8

Drug Access PrEP Clinical Visits & Lab Costs Counseling and Linkage

Uninsured Manufacturer Patient Assistance Program PrEP Drug Assistance Programs or “PrEP DAPs” (state funded) Community Health Centers; Family Planning Clinics; STD Clinics using 340B savings Ready, Set, PrEP PrEP DAPs (state funded) CDC prevention funds to pay for HIV/STD testing Community Health Centers; Family Planning Clinics; STD Clinics using 340B savings PrEP DAPs (state funded) CDC prevention grants Community Health Centers; Family Planning Clinics; STD Clinics using 340B savings Insured Covered by payers; co- pay assistance through manufacturer assistance program Largely covered, but with patient co-pays PrEP DAPs (state funded) Not well covered by public or private insurance

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:

• Lack prescription drug coverage
• Be tested for HIV with a negative result
• 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:

• Increased provider training
• PrEP adherence and persistence services
• Lab services
• Novel engagement strategies, including mobile units
• Tele-PrEP models
• 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

11

Truvada ($56)

• Stat. required

Medicaid/340B (~$15.00) Commercial Plans

Descovy ($56)

• Stat. required

Medicaid/340B (~$37.00) Commercial Plans Commercial Plans

PrEP Medication Pricing Changes

Voluntary 340B (~$15.00)

Single TDF/FTC Generic ($50)*

• Stat. required

Medicaid/340B (~$43.50) Commercial Plans

Multi TDF/FTC Generics ($6)* *Forecasted *Forecasted

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