Strategies to Increase Hepatitis C Treatment Within ADAPs

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Strategies to Increase Hepatitis C Treatment Within ADAPs Amanda Bowes National Alliance of State & Territorial AIDS Directors (NASTAD)

Disclosures Presenter(s) has no financial interest to disclose.

Learning Objectives At the conclusion of this activity, the participant will be able to: 1. Participants will learn why HIV/HCV coinfection is an important health care and public health issue to address. 2. Participants will learn how the Ryan White HIV/AIDS Program is addressing HIV/HCV coinfection. 3. Participants will be able to identify strategies to reduce barriers to HCV treatment among people living with HIV, including AIDS Drug Assistance Programs.

Agenda Introduction and Pertinent HRSA Policy ADAP Formulary Coverage for Hepatitis C (HCV) Treatment Key Findings: NASTAD Consultation NASTAD HIV/HCV Co-Infection Resources Q&A 4

HRSA Policy: ADAP Formulary The Ryan White HIV/AIDS Program Section 2616(c)(6) of the Public Health Service Act contains language that places the following requirements on ADAP formularies: Must include at least one drug from each class of HIV antiretroviral medications. ADAP funds may only be used to purchase medications approved by the Food and Drug Administration (FDA) or devices needed to administer them. They must be consistent with the Department of Health and Human Services (HHS) Adolescent and Adult HIV/AIDS Treatment Guidelines. All treatments and ancillary devices covered by the ADAP formulary, as well as all ADAP-funded services must be equitably available to all eligible/enrolled individuals within a given jurisdiction. 5

ADAP Formulary Coverage of HCV DAA Medications (2016) VT NH AK WA OR NV CA ID AZ UT MT WY CO NM ND SD NE KS OK TX MN WI IA MO AR LA IL MS NY MI PA OH IN WV VA KY NC TN SC GA AL ME CT NJ DE MD DC MA RI FL HI HCV DAA Medication(s) included HCV DAA Medication(s) NOT included 6

Request for Information (RFI) Produced as part of NASTAD s cooperative agreement with the Health Resources and Services Administration (HRSA). NASTAD asked states that have added one or more of the DAA HCV treatments to complete an online request for information (RFI). 17 of 20 eligible ADAPs responded. 7

ADAP Formulary - HCV DAAs DAA HCV Medication Full-Pay ADAP-Funded Prescription Insurance daclatasvir (Daklinza) 10 9 dasabuvir, ombitasvir / paritaprevir / ritonavir (Viekira Pak) 15 12 elbasvir and grazoprevir (Zepatier) 9 9 ledipasvir and sofosbuvir (Harvoni) 16 13 ombitasvir, paritaprevir and ritonavir (Technivie) 10 9 simeprevir (Olysio) 9 11 sofosbuvir (Sovaldi) 15 13 8

Policies and Restrictions ADAPs may have additional policies that are used to determine clients eligibility to receive coverage for a DAA HCV medication. These policies may be determined by the ADAP directly or may be the result of either statewide policy or individual private insurance plan restrictions. 9

Policies and Restrictions Continued ADAP FORMULARY COVERAGE POLICIES POLICY FULL-PAY RX ADAP-FUNDED INSURANCE Cap or maximum number of prescriptions/expenditures per client 0 0 Cap or maximum number of clients to receive prescriptions or total expenditures 4 0 Cap or maximum number of clients N/A 1 Fibrosis score restriction or prioritization (e.g., F3 or F4) 2 1 Prior authorization 10 4 Proof of denial by other payer (e.g., Medicaid) 6 0 Sobriety requirement 2 1 Specialist provider supervision requirement (e.g., hepatologist) 1 1 No restrictions, open access 2 8 10

Utilization Full Pay Rx 324 clients received a prescription for DAA HCV medication(s) via the ADAP full-pay prescription program as of May 1, 2016. Six ADAPs can report the cure rate among their clients to receive a prescription; 105 clients have been reported cured. 11

Utilization ADAP-Funded Insurance 283 clients received a prescription for DAA HCV medication(s) via the ADAP-funded insurance program as of May 1, 2016. Four ADAPs can report the cure rate among their clients to receive a prescription; 40 clients have been reported cured. 12

NASTAD Consultation: Background This consultation was funded via NASTAD s cooperative agreement with HRSA. Topics covered include: Reasons ADAPs are seeing low utilization among their co-infected clients Methods to encourage ADAPs to add these medications to their formularies, while still maintaining fiscal solvency 13

Key Findings - System-Level Barriers: Low rates of HCV confirmatory testing and follow-up post-hcv antibody screening No nationally coordinated HCV surveillance activities 14

Key Findings - ADAP-Level Barriers: Engagement with providers Communicating the role of ADAP in the provision of HCV treatment Data regarding clients HCV status Very restrictive/varying Medicaid prior authorization requirements Manufacturer patient assistance programs restrict access from payer denials 15

Key Findings - Provider-Level Barriers: Patient assistance programs (PAPs) and costsharing assistance programs (CAPs) Provider unfamiliarity with ADAP (e.g., hepatologists) Payer restrictions and administrative burden (e.g., Medicaid, private insurance) Provider capacity to treat HIV/HCV coinfection 16

HIV/HCV Co-infection Resources National ADAP Monitoring Project Annual Report National ADAP Formulary Database Technical assistance via HRSA Cooperative Agreement HIV/HCV ad hoc work group and other peer exchange ADAP Crisis Task Force 17