Watch 03: July 2022
The HIV/HCV Co-Infection Watch is a project of the Community Access National Network (CANN) designed to research, monitor and report on HIV and Hepatitis C (HCV) co-infection in the United States. The July 2022 Watch includes timely updates herein. To read the project disclaimer and/or methodology, CLICK HERE.
1. FINDINGS
The following is a summary of the key findings for July 2022:
AIDS Drug Assistance Programs:
There are 56 State and Territorial AIDS Drug Assistance Programs (ADAPs) in the United States, 48 of which offer some form of coverage for Hepatitis C (HCV) treatment. Of those programs, 46 have expanded their HCV coverage to include the Direct-Acting Antiviral (DAA) regimens that serve as the current Standard of Care (SOC) for Hepatitis C treatment. Two (2) programs offer only Basic Coverage and 8 programs offer No Coverage. Two (2) programs cover only a single Direct-Acting Antiviral. Three (3) territories – American Samoa, Marshall Islands, and Northern Mariana Islands – are not accounted for in this data. A state-by-state Drug Formulary breakdown of coverage is included in the July 2022 Updates, with accompanying drug-specific maps in Figures 1 – 10.
Medicaid Programs:
There are 59 State and Territorial Medicaid programs in the United States, and data is represented for all fifty (50) states and the District of Columbia. As of October 01, 2016, all 50 states and the District of Columbia offer Expanded Coverage. A state-by-state PDL breakdown of coverage is included in the July 2022 Updates, with accompanying drug-specific maps in Figures 11 – 20.
Harm Reduction Programs:
Every State and Territory in the United States currently provides funding for low-income people living with substance abuse issues to enter state-funded rehabilitation services (National Center for Biotechnology Information, n.d.). Forty-four (44) States, the District of Columbia and three (3) Territories currently have Syringe Services Programs (SSPs) in place, regardless of the legality. Fifty (50) States and the District of Columbia have expanded access to Naloxone to avert opioid drug overdoses. Fifty (50) States and the District of Columbia have Good Samaritan laws or statutes that provide some level of protection for those rendering emergency services during drug overdoses. Forty-seven (47) States, the District of Columbia, and Guam make reporting to Prescription Drug Monitoring Programs (PDMPs) mandatory, requiring physicians and/or pharmacists to report prescriptions written or filled to a state agency for monitoring. Fifty (50) States and the District of Columbia have Opioid-Specific Doctor Shopping Laws preventing patients from attempting to receive multiple prescriptions from numerous physicians, and/or from withholding information in order to receive prescriptions. Forty-five (45) states and the District of Columbia mandate a Physical Exam Requirement in order for patients to receive a prescription for opioid drugs. Thirty-Five (35) states have in place an ID Requirement mandating that people filling opioid prescriptions present a state-issued ID prior to receiving their prescription. Forty-five (45) states and the District of Columbia require prescribing physicians to attend mandatory and continuing opioid prescribing education sessions. Forty-seven (47) states and the District of Columbia have Medicaid doctor/pharmacy Lock-In programs that require patients to receive prescriptions from a single physician and/or fill prescriptions from a single pharmacy. A state-by-state program breakdown is included in the July 2022 Updates, with accompanying drug-specific maps in Figures 21-29.
2. AIDS DRUG ASSISTANCE PROGRAMS (ADAPs) & HCV THERAPIES
Of the 56 respective State and Territorial ADAPs, only 8 (KS, KY, OH, UT, VT, GU, PW, VI) do not offer any coverage for HCV drug therapies. States whose formularies are not available on the state-run website have been checked against the most recent National Alliance of State and Territorial AIDS Directors (NASTAD) formulary database (last updated January 1, 2022). The data presented are current as of July 20, 2022.
July 2022 Updates:
Basic Coverage
States with Basic HCV Medications Coverage: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, LA, ME, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OK, OR, PA, RI, SC, SD, TN, VA, WA, WV, WI, WY, D.C.
States without Basic HCV Medications Coverage: ID, KS, KY, MS, OH, TX, UT, VT
Territories with Basic HCV Medications Coverage: P.R.
Sovaldi
States with Sovaldi Coverage: AZ, CA, CO, GA, HI, IL, IN, IA, LA, ME, MD, MA, MN, NE, NV, NH, NJ, NM, ND, OK, OR, PA, SD, VA, WA, WI, WY, D.C.
States without Sovaldi Coverage: AL, AK, AR, CT, DE, FL, ID, KS, KY, MI, MS, MO, MT, NY, NC, OH, RI, SC, TN, TX, UT, VT, WV
Territories with Sovaldi Coverage: P.R.
Harvoni
States with Harvoni Coverage: AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NC, ND, OK, OR, PA, SD, TN, VA, WA, WI, WY, D.C.
States without Harvoni Coverage: AL, AK, KS, KY, MO, MT, NY, OH, RI, SC, TX, UT, VT, WV
Territories with Harvoni Coverage: P.R.
Zepatier
States with Zepatier Coverage: AL, AZ, AR, CA, CO, FL, GA, HI, IL, IA, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OR, PA, SD, VA, WA, WV, WI, WY, D.C.
States without Zepatier Coverage: AK, CT, DE, ID, IN, KS, KY, MO, MT, OH, OK, RI, SC, TN, TX, UT, VT
Territories with Zepatier Coverage: P.R.
Epclusa
States with Epclusa Coverage: AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, NE, NY, NV, NH, NJ, NM, ND, OR, PA, SD, TN, TX, VA, WA, WI, WY
States without Epclusa Coverage: AL, AK, DE, KS, KY, MT, NC, OH, OK, RI, SC, UT, VT, WV, D.C.
Territories with Epclusa Coverage: P.R.
Vosevi
States with Vosevi Coverage: CA, CT, FL, HI, ID, IL, IN, IA, LA, MD, MA, MN, NE, NV, NH, NJ, NM, ND, OR, SD, TN, WA, WY
States without Vosevi Coverage: AL, AK, AZ, AR, CO, DE, GA, KS, KY, ME, MI, MS, MO, MT, NY, NC, OH, OK, PA, RI, SC, TX, UT, VT, VA, WV, WI, D.C.
Territories with Vosevi Coverage: P.R.
Mavyret
States with Mavyret Coverage: AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OR, PA, SD, TN, VA, WA, WV, WI, WY, D.C.
States without Mavyret Coverage: AK, DE, KS, KY, OH, OK, RI, SC, TX, UT, VT
Territories with Mavyret Coverage: P.R.
Pegasys
States with Pegasys Coverage: AL, CA, CO, CT, DE, HI, IL, IA, LA, ME, MD, MA, MI, MN, NE, NV, NH, NJ, NM, NC, ND, OR, PA, RI, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.
States without Pegasys Coverage: AK, AZ, AR, FL, GA, ID, IN, KS, KY, MS, MO, MT, NY, OH, OK, SC, TN, TX, UT, VT, VA
Territories with Pegasys Coverage: None/Unknown
Harvoni (generic)
States with Harvoni (generic) Coverage: AZ, AR, CA, CO, CT, FL, IL, IA, ME, MD, MA, MN, MS, NE, NV, NH, NJ, NM, NC, ND, OK, OR, PA, SD, TN, WA, WI, WY, D.C.
States without Harvoni (generic)Coverage: AL, AK, DE, GA, HI, ID, IN, KS, KY, LA, MI, MO, MT, NY, OH, RI, SC, TX, UT, VT, VA, WV
Territories with Harvoni (generic) Coverage: P.R.
Epclusa (generic)
States with Epclusa (generic) Coverage: AZ, AR, CA, CO, CT, FL, IL, IN, IA, ME, MD, MA, MN, MS, MO, NE, NV, NH, NJ, NM, ND, OR, PA, SD, TN, WA, WI, WY, D.C.
States without Epclusa (generic) Coverage: AL, AK, DE, GA, HI, ID, KS, KY, LA, MI, MT, NY, NC, OH, OK, RI, SC, TX, UT, VT, VA, WV
Territories with Epclusa (generic) Coverage: P.R.
July 2022 Notes:
States with Open Formularies: IL, IA, MA, MN, NE, NH, NJ, NM, ND, OH, OR, WA, WY
N.B. – Although Ohio is listed by NASTAD as having an open formulary, both NASTAD’s ADAP Formulary Database and Ohio’s ADAP website indicates that the state does not offer any treatment for HCV.
N.B. – Although North Dakota has adopted an open formulary, they provide only co-pay and deductible assistance for HCV medications.
N.B. – Wyoming's ADAP Open Formulary document, the following disclaimer related to HCV is made: Hepatitis C treatment medications (i.e. Harvoni, Sovaldi, Ribavirin, Zepatier, Epclusa) must be prior authorized. To be eligible, clients must have applied for prior authorization from their insurance plan and the WY ADAP Hepatitis C Treatment checklist must be completed and signed by the provider and client.
Colorado offers five coverage options – Standard ADAP, HIV Medical Assistance Program (HMAP), Bridging the Gap Colorado (BTGC), HIV Insurance Assistance Program (HIAP), and Supplemental Wrap Around Program (SWAP). ‘Yes’ indications in Figure 1. for Colorado denote that at least one of these programs offers coverage for each respective drug. The Standard ADAP Formulary covers medications only if funds are available to do so.
Louisiana’s ADAP (Louisiana Health Access Program – LA HAP) offers two coverage options – Uninsured (Louisiana Drug Assistance Program – L-DAP) and Insured (Health Insurance Program – HIP). HIP pays for the cost of treatment only if the client’s primary insurance covers the drug under its formulary.
Georgia’s ADAP notes the following: “Georgia ADAP Hepatitis C Program is currently on HOLD until future funding is available. Please utilize Patient Assistance Programs (PAP’s) for Hepatitis C medications.”
Texas ADAP’s coverage of HCV medications is limited to Epclusa (brand).
3. MEDICAID PROGRAMS & HCV THERAPIES
All 50 states and the District of Columbia continue to offer some form of HCV coverage. All 50 states and the District of Columbia have expanded their Preferred Drug Lists to include at least one HCV Direct Acting Agent (DAA).
July 2022 Updates:
Basic Coverage
States with Basic HCV Medications Coverage: AZ, AK, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, D.C.
States without Basic HCV Medications Coverage: AL, ID, KS, MO, OK, SC, VA, WY
Sovaldi
States with Sovaldi Coverage: AR, CA, CO, DE, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.
States without Sovaldi Coverage: AL, AK, AZ, CT, FL, NM, OR, SC, VA
Harvoni
States with Harvoni Coverage: AL, AR, CA, CO, DE, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.
States without Harvoni Coverage: AK, AZ, CT, FL, NM, OR, SC, VA
Zepatier
States with Zepatier Coverage: AL, AR, CA, CO, DE, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.
States without Zepatier Coverage: AK, AZ, CT, FL, NM, OK, OR, SC, VA
Epclusa
States with Epclusa Coverage: AL, AR, CA, CO, GA, HI, IL, IN, IA, KS, KY, LA, MA, ME, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OR, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.
States without Epclusa Coverage: AK, AZ, CT, DE, FL, ID, MD, NE, OH, OK, SC, VA
Vosevi
States with Vosevi Coverage: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, WV, WI, WY, D.C.
States without Vosevi Coverage: AL, AK, AZ, NM, OK, VA
Mavyret
States with Mavyret Coverage: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.
Pegasys
States with Pegasys Coverage: AK, AZ, CA, CT DE, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, RI, SD, TN, TX, VT, WA, WV, WI, D.C.
States without Pegasys Coverage: AL, AR, CO, ID, KS, MO, ND, OK, SC, UT, VA, WY
Harvoni (generic)
States with Harvoni (generic) Coverage: AL, AR, CA, CO, DE, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, PA, RI, SD, TN, TX, UT, VT, WA, WV, WI, D.C.
States without Harvoni (generic) Coverage: AK, AZ, CT, FL, KS, NM, OR, SC, VA, WY
Epclusa (generic)
States with Epclusa (generic) Coverage: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.
States without Epclusa (generic) Coverage: AK, ID, ME, OK
July 2022 Notes:
The follow states’ Medicaid programs offer multiple coverage plans for their respective Medicaid clients. The plan highlighted in bold typeface represents the most comprehensive plan with the most drugs covered in the respective state:
Hawaii – (1.) Advantage Plus; (2.) QUEST Integration
New Jersey – (1.) Aetna; (2.) AmeriGroup NJ; (3.) Horizon NJ Health; (4.) UnitedHealthcare of New Jersey; (5.) WellCare
New Mexico – (1.) BlueCross BlueShield of New Mexico; (2.) Presbyterian Centennial Care; (3) Western Sky Community Care
Kentucky has a Unified Medicaid Formulary
Louisiana has a Unified Medicaid Formulary
Ohio – Ohio has a Unified Medicaid Formulary that applies to all MCOs
Connecticut has added Epclusa (generic) to its Medicaid PDL.
Maryland has removed Epclusa (brand) from its Medicaid PDL.
Virginia Medicaid has reduced its HCV coverage to only Mavyret and Epclusa (generic).
Washington Medicaid has returned basic HCV medications to its formulary.
Idaho Medicaid has removed coverage of basic HCV medications.
As of July 25th, 2022, Florida’s Medicaid program notes the following “The Preferred Drug List is currently under construction. A new PDL will be posted here soon representing changes from the June 24, 2022 P&T Committee meeting.”
No data is has been made available by the Medicaid programs in the U.S. Territories.
*Medicaid coverage excludes patients from most drug manufacturer patient assistance programs (PAPs)
4. VETERANS PROGRAMS & HCV THERAPIES
The Veteran's Administration (VA) currently offers coverage for all HCV drugs. This is according to the most recent VA National Formulary, dated May 2021 (U.S. Dept. of V.A., 2021a). The VA Treatment Considerations and Choice of Regimen for HCV-Mono-Infected and HIV/HCV Co-Infected Patients, dated March 2021 (U.S. Dept. of V.A., 2021b) lists the following therapies as preferred treatments:
Abbreviations:
- CTP – Child-Turcotte-Pugh (score used to assess severity of cirrhosis)
- IU/mL – International Units Per Milliliter
- PEG-IFN/IFN – Peginterferon/Interferon
- RAS – Resistance-associated substitutions
Genotype 1:
Treatment-naïve without or with cirrhosis (CTP A):
Pangenotypic regimens
Mavyret: 3 tablets orally daily with food for 8 weeks; may consider 12 weeks in patients with poor prognostic factors
Epclusa: 1 tablet orally daily for 12 weeks
Non-pangenotypic regimens:
Zepatier: 1 tablet orally daily for 12 weeks if GT1a without baseline NS5A RAS or GT1b
Harvoni: 1 tablet orally daily
If HCV-noninfected, non-cirrhotic, and HCV RNA baseline <6 million IU/mL: 8 weeks
If cirrhotic, baseline HCV RNA ≥6 million IU/mL, HIV/HCV-co-infected, or African American: 12 weeks
Consider adding ribavirin in CTP A patients
Treatment-naïve with decompensated cirrhosis (CTP B or C):
Harvoni: 1 tablet orally daily + ribavirin (600 mg/day and increase by 200 mg/day every 2 weeks only as tolerated) for 12 weeks
Epclusa: 1 tablet orally daily + ribavirin (1000 mg/day - <75kg – or 1,200 mg daily - ≥75kg – orally daily in 2 divided doses with food) for 12 weeks; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb).
Treatment-experienced (NS5A- and SOF-naïve [e.g., failed PEG-IFN/RBV ± NS3/4A PI]) without or with cirrhosis (CTP A)
Pangenotypic regimens:
Mavyret: 3 tablets orally daily with food
If PEG-IFN/RBV-experienced: 8 weeks if non-cirrhotic or 12 weeks if cirrhotic
If NS3/4A PI + PEG-IFN/RBV-experienced: 12 weeks
Vosevi: 1 tablet orally daily for 12 weeks
Non-pangenotypic regimens
Zepatier: 1 tablet orally daily for 12 weeks if GT1b, or if failed only PEG-IFN/RBV and GT1a without baseline NS5A RAS
Harvoni: 1 tablet orally daily for 12 weeks
Treatment-experienced (NS5A-naïve and SOF-experienced) without or with cirrhosis (CTP A)
Mavyret: 3 tablets orally daily with food
If PEG-IFN/RBV + Sovaldi-experienced: 8 weeks if non-cirrhotic or 12 weeks if cirrhotic
If Olysio + Sovaldi-experienced: 12 weeks
Epclusa: 1 tablet orally daily for 12 weeks if GT1b
Vosevi: 1 tablet orally daily with food for 12 weeks if GT1a
Treatment-experienced (prior NS5A-containing regimen) without or with cirrhosis (CTP A)
Mavyret: 3 tablets orally daily with food for 16 weeks if failed only an NS5A inhibitor without NS3/4A PI (e.g., Harvoni)
Vosevi: 1 tablet orally daily with food for 12 weeks
Treatment-experienced with decompensated cirrhosis (CTP B or C)
Epclusa: 1 tablet orally daily + RBV; start at lower RBV doses as clinically indicated (e.g., baseline Hgb);
If NS5A-naïve: 12 weeks
If NS5A-experienced: 24 weeks; NOT FDA approved for 24 weeks
Genotype 2:
Treatment-naïve or treatment-experienced (PEG-IFN/IFN ± RBV or Sovaldi + RBV ± PEG-IFN) without or with cirrhosis (CTP A)
Mavyret: 3 tablets orally daily with food for 8 weeks; 12 weeks if CTP A and treatment-experienced or in patients with poor prognostic factors
Epclusa: 1 tablet orally daily for 12 weeks
Treatment-experienced (NS5A-experienced) without or with cirrhosis (CTP A)
Vosevi: 1 tablet orally daily with food for 12 weeks
Treatment-naïve or treatment-experienced patients with decompensated cirrhosis (CTP B or CTP C)
Epclusa: 1 tablet orally daily + ribavirin; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)
If NS5A-naïve: 12 weeks
If NS5A-experienced: 24 weeks
Genotype 3:
Treatment-naïve without cirrhosis or with cirrhosis (CTP A)
Mavyret: 3 tablets orally daily with food for 8 weeks; may consider 12 weeks if cirrhotic or in patients with poor prognostic factors
Epclusa: 1 tablet orally daily for 12 weeks
If CTP A, test for NS5A RAS
Add ribavirin if Y93H RAS present
Treatment-experienced (PEG-IFN ± RBV or Sovaldi + RBV ± PEG-IFN) without or with cirrhosis (CTP A)
Mavyret: 3 tablets orally daily with food for 16 weeks
Treatment-experienced (NS5A-experienced) without or with cirrhosis (CTP A)
Vosevi: 1 tablet orally daily with food for 12 weeks
If CTP A, consider adding ribavirin (no supporting data)
Treatment-naïve or treatment-experienced with decompensated cirrhosis (CTP B or CTP C)
Epclusa: 1 tablet orally daily + ribavirin; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)
If NS5A-naïve: 12 weeks
If NS5A-experienced: 24 weeks
Genotype 4:
Treatment-naïve without or with cirrhosis (CTP A)
Pangenotypic regimens
Mavyret: 3 tablets orally daily with food for 8 weeks; may consider 12 weeks in patients with poor prognostic factors
Epclusa: 1 tablet orally daily for 12 weeks
Non-pangenotypic regimens
Zepatier: 1 tablet orally daily for 12 weeks
Harvoni: 1 tablet orally daily for 12 weeks
Treatment-naïve with decompensated cirrhosis (CTP B or C)
Pangenotypic regimen
Epclusa: 1 tablet orally daily + RBV for 12 weeks; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)
Non-pangenotypic regimen:
Harvoni: 1 tablet orally daily + ribavirin (600 mg/day and increase by 200 mg/day every 2 weeks only as tolerated) for 12 weeks
Treatment-experienced (Sovaldi-experienced and NS5A-naïve) without or with cirrhosis (CTP A)
Mavyret: 3 tablets orally daily with food for 8 weeks if NS3/4A PI-naïve without cirrhosis, and 12 weeks if NS3/4A PI-experienced or CTP A
Epclusa: 1 tablet orally daily + ribavirin for 12 weeks; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)
Treatment-experienced (NS5A-experienced) without or with cirrhosis (CTP A)
Vosevi: 1 tablet orally daily with food for 12 weeks
Treatment-experienced with decompensated cirrhosis (CTP B or CTP C)
Epclusa: 1 tablet orally daily + ribavirin; start at lower ribavirin doses as clinically indicated (e.g., baseline Hgb)
If NS5A-naïve: 12 weeks
If NS5A-experienced: 24 weeks; NOT FDA approved for 24 weeks
5. PATIENT ASSISTANCE PROGRAMS
The drug manufacturers and various national nonprofit organizations offer a variation of patient assistance programs (PAPs) to assist patients in accessing treatments. They include:
Support Path (Gilead Sciences):
Financial Assistance
Provides Co-Pay Coupons for Sovaldi, Harvoni, Harvoni (Generic), Epclusa, Epclusa (Generic), and Vosevi
Co-Pay Coupons cover out-of-pocket costs up to 25% of the catalog price of a 12-week regimen (3 bottles/packages) of Sovaldi, Harvoni, Harvoni (Generic), Epclusa, Epclusa (Generic), or Vosevi
Excludes patients enrolled in Medicare Part D or Medicaid
Insurance Support
Researches and verifies patient’s benefits, and gives information they need about coverage options and policies
Explain Prior Authorization process and works with HCV Specialist’s office so they can submit PA forms to a patient’s insurance company
May be able to provide assistance with appeals process
Website: http://www.mysupportpath.com/
AbbVie Mavyret Co-Pay Savings Card:
Financial Assistance
Patient may be eligible to pay as little as $5
Excludes patients enrolled in Medicare Part D, Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs)
NeedyMeds:
NeedyMeds Drug Discount Card
Designed to lower cost of prescription medications by up to 80% at participating pharmacies
Price finder tool for the drug discount card
No eligibility requirements
CANNOT be used in combination with government healthcare programs, but CAN be used IN PLACE of program
CANNOT be combined with other offers
Website: http://ow.ly/fEJo309cJ7Z
The Assistance Fund:
Status: WAITLISTED
Requires provider referral
Copay assistance
Eligibility Criteria:
US citizen or permanent resident
Diagnosed with the disease for which you are applying
Prescribed an FDA-approved treatment for the disease
Have prescription coverage for the prescribed treatment
Meet financial eligibility criteria based upon household income and size
Patient Advocate Foundation Co-Pay Relief:
Status: CLOSED
Maximum award of $15,000
Eligibility Requirements:
Patient must be insured, and insurance must cover prescribed medication
Confirmed HCV diagnosis
Reside and receive treatment in the U.S.
Income falls below 400% of FPL with consideration of the Cost of Living Index (COLI) and the number in the household
Patient Access Network (PAN) Foundation:
Status: OPEN
Co-Pay Assistance with a maximum award of $6,000
Patients may apply for a second grant during their eligibility period subject to availability of funding
Eligibility Requirements:
Must be being treated for HCV
Have insurance that covers HCV prescribed medication
Medication must be listed on PAN’s list of covered medications: https://www.panfoundation.org/index.php/en/patients/medications-covered
Income falls below 500% of FPL
Residing and receiving treatment in the U.S. (citizenship NOT required)
Website: https://www.panfoundation.org/index.php/en/patients/assistance-programs/hepatitis-c
HealthWell Foundation:
Status: OPEN
Co-Pay Assistance with a maximum award of $30,000
Minimum Co-Pay Reimbursement Amount: None
Minimum Premium Reimbursement Amount: None
Eligibility Requirements:
Must be being treated for HCV
Have insurance that covers HCV prescribed medication
Income falls below 500% of FPL
Receiving treatment in the U.S.
Website: https://www.healthwellfoundation.org/fund/hepatitis-c/
6. HARM REDUCTION PROGRAMS
Harm Reduction, as it relates to opioid abuse and HCV, are measures designed to serve as preventive or monitoring efforts in combating opioid prescription drug and heroin abuse, and as an effect, helping to prevent the spread of HCV and HIV. The Co-Infection Watch covers the following measures: Syringe Exchange, Expanded Naloxone Access, Good Samaritan Laws, Mandatory PDMP Reporting, Doctor Shopping Laws, Physical Exam Requirements, ID Requirements for Purchase, Required or Recommended Prescriber Education, and Lock-In Programs (Editor’s Note: Program descriptions provided herein).
July 2022 Updates:
Syringe Exchange
Syringe Services Programs (SSPs) exist to provide injection drug users (or those whose prescriptions require injection) with clean syringes and/or in exchange for used ones. (N.b. – states listed as "at least one SSP…” indicate only that a Syringe Services Program (SSP) exists within the state, regardless of the legality of SSPs under state law).
States with Syringe Exchange: AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, D.C.
States without Syringe Exchange: AL, KS, MS, NE, SD, WY
Territories with Syringe Exchange: Puerto Rico, U.S. Virgin Islands
Expanded Naloxone
Naloxone is a drug used to counteract the effects of opioid overdoses. Expanded Access refers to one of more of the following conditions: Naloxone purchase without a prescription; availability to schools, hospitals, and emergency response units for use in the event of an overdose.
States with Expanded Naloxone: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.
States without Expanded Naloxone: None
Territories with Expanded Naloxone: Unknown
Good Samaritan Laws
Good Samaritan Laws are laws that are designed to protect emergency services personnel, public or private employees, and/or citizens from being held legally liable for any negative healthcare outcomes as a result of providing "reasonable measures" of emergent care.
States with Samaritan Laws: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.
States without Samaritan Laws: None
Territories with Samaritan Laws: Unknown
Mandatory PDMP Reporting
Prescription Drug Monitoring Programs (PDMPs) are programs established by state and/or federal law that requires prescribing physicians and the fulfilling pharmacies to report to a state agency one or more of the following data points: Patient Names; Specific Drug(s) Prescribed; Prescription Dosage; Date; Time; Form of State-Issued ID.
States with PDMP Reporting: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.
States without PDMP Reporting: MO, MT, SD
Territories with PDMP Reporting: Guam
Doctor Shopping Laws
Doctor Shopping Laws are those laws designed to prevent patients from seeking one or more of the same prescription from multiple doctors through the use of subterfuge, falsifying identity, or any other deceptive means. While federal law prohibits Doctor Shopping, most states also include provisions that prohibit patients from seeking a new prescription if another physician has denied a similar prescription within a certain period of time.
States with Doctor Shopping Laws: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.
States without Doctor Shopping Laws: None
Territories with Doctor Shopping Laws: None
Physical Exam Required
Physical Exam Requirements are those that mandate that the prescribing physician perform a physical examination on a patient before providing a prescription for a controlled substance to determine if the prescription is medically necessary.
States with Physical Exam Required: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, ME, MI, MN, MO, MS, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, UT, VA, VT, WA, WV, WY, D.C.
States without Physical Exam Required: KS, MT, OR, SD, WI
Territories with Physical Exam Required: None
I.D. Required for Purchase of Opioid Prescription
Federal law requires anyone purchase a controlled substance to provide a state-issued identification (“I.D.”) in order to fill the prescription. Mandatory ID requirements go further and require that this information be recorded and stored in an effort to prevent the same patient from obtaining multiple or repeated prescriptions in a given period of time.
States with I.D. Required: AZ, CA, CT, DE, FL, GA, HI, ID, IL, IN, KY, LA, ME, MA, MI, MS, MN, MT, NE, NV, NJ, NM, NY, NC, ND, OK, OR, SC, TN, TX, VT, VA, WV, WI, WY
States without I.D. Required: AL, AK, AR, CO, IA, KS, MD, MO, NH, OH, PA, RI, SD, UT, WA, D.C.
Territories with I.D. Required: Unknown
Prescriber Education Required/Recommended
States that require/do not require that prescribing physicians undergo special training related to safer prescribing and utilization practices.
States with Prescriber Education Required: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.
States without Prescriber Education Required: KS, MO, MT, ND, SD
Territories with Prescriber Education Required: Unknown
Medicaid Lock-In Program
Lock-In Programs are laws requiring that patients either receive prescriptions from only one physician and/or fill prescriptions from only one pharmacy.
States with Medicaid Lock-In Program: AL, AK, AZ, AR, CA, CO, CT, DE, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, D.C.
States without Medicaid Lock-In Program: FL, HI, SD
Territories with Medicaid Lock-In Program: Unknown
7. COVID-19 IMPACT ON HIV & HCV
The Community Access National Network’s blog began 2021 by assessing COVID-19’s impact on HIV, HCV, and Substance-Use Disorder. We've subsequently followed-up by asking, COVID-19: How Far We’ve Come & How Far We Have to Go? We continue to monitor developments in light of the ongoing COVID-19 pandemic and its impacts on public health.
Additional Resources and Relevant Issues:
Declaration of Public Health Emergency Renewed - On July 15, 2022, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra renewed the existing declaration of a public health emergency (PHE) due to COVID-19. The previous declaration was set to expire in October 2022. To review some potential changes when the PHE ends, click here.
2020 HIV Surveillance Report Proves Earlier COVID-19 Concerns - In May 2022, CANN reviewed the U.S. Centers for Disease Control and Prevention’s (CDC) 2020 surveillance report. The annual report confirmed what many advocates suspected would occur as a result of the COVID-19 pandemic: activities related to HIV testing, linkage to care, and retention in care took a dramatic downturn during 2020. What this means for the future of the HIV epidemic in the United States is unclear but many advocates remain concerned that years of gains have been lost due to decades of disinvestment in public health.
A Collision of Pandemics: HIV and COVID-19 - An assessment in The Lancet reviews the cooccurring pandemics of HIV and COVID-19, under the lens of how people living with HIV faired with COVID-19, given the exceptional number of publications with contradictory findings. The analysis reviewed the findings of almost 200,000 COVID-19 patients, with 19,955 who were living with HIV and 180,524 who were not. The authors concluded that both HIV and the higher likelihood of PLWHA to have at least one comorbidity increased the likelihood of poorer COVID-19 outcomes. The authors state a desire to continue this analysis in an ongoing basis.
HIV Care Fell in Black Communities During COVID. Here’s How Congress Can Get It Back on Track. - While advocates have successfully lobbied Congress to expand HIV-related funding in the past, the programs those funds go towards are often broad in design, not necessarily reaching the communities most in need. The Hill explores the dynamics of the relationship between broad HIV-public policy, existing gaps in mandatory sex education and lack of standardized sex education, and where private industry has failed to engage racial and ethnic communities, leading to and maintaining the health disparities plaguing the nation.
HIV and COVID-19 - What We’ve Learned - In a Podcast hosted by the Infectious Disease Society of America, health care and public health professionals discuss both the specific clinical considerations for people living with HIV experiencing a COVID-19 infection and the broader impacts of the COVID-19 pandemic on the HIV community and efforts to end the HIV epidemic.
People with HIV Face Higher Risk of Breakthrough COVID, Study Says - Forbes covers a study in JAMA Network Open that argues people living with HIV should be a high priority group for COVID-19 booster shots because of a 28% higher risk of contracting breakthrough COVID-19 than their peers. Researchers found no link between viral suppression and breakthrough COVID-19, however, younger people living with HIV were more likely to experience a breakthrough than older people living with HIV. This may be reflective of poor public health messaging, access to boosters, and/or risk assessments of the age cohorts.
Assessing the HIV Community’s Needs and Concerns About Long COVID - POZ Magazine reviews a survey of people living with HIV about their concerns regarding “long COVID”. The survey revealed both patients and providers felt like they lacked adequate information and resources to navigate long COVID and the mental health burdens, especially the risk of retraumatizing survivors of the AIDS Crisis, were extraordinary. As has been the case all along, many participants emphasized leveraging the knowledge of HIV to combat the COVID-19 pandemic.
KHN: Different Takes: The Future of COVID is Not Promising; Is it Time to Start Masking Again - Kaiser Health News reviews three articles discussing the 2022 summer COVID-19 surge, the emergence of yet another variant with a propensity of even more infectiousness, and the need to engage in easy to access preventative tools like masks. If COVID-19 is here to stay, exactly how bad does that look?
8. LATEST NEWS
Renewal of Determination That a Public Health Emergency Exists - On June 30, 2022, the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra renewed the ongoing declaration of public health emergency regarding the opioid crisis. The declaration is the latest in extensions regarding the opioid crisis, originating in October 2017.
HHS Announces Notice of Proposed Rulemaking: Section 1557 of the ACA - On July 25, 2022, the U.S. Department of Health and Human Services (HHS) announced a long-awaited “notice of proposed rulemaking” for the Affordable Care Act’s non-discrimination provision, known as Section 1557. The notice outlines the Biden Administration’s aims with a new Final Rule, speaking explicitly on the issues of gender affirming care, abortion access, formulary designs, and more. Section 1557 has been volleyed back and forth in courts since the Obama administration issued a Final Rule in 2016. This iteration will be the first since the Supreme Court’s ruling in Bostock, which HHS relies upon heavily.
Conservatives Take a New Swing at the Affordable Care Act - POLITICO covers the issues at the heart of a case pending before Judge Reed O’Connor in Texas. Kelley represents the situation of - you guessed it, dentists (among others) - who wish to be able to discriminate against people accessing PrEP and contraceptives by attacking the very structures of the ACA that mandate these services as “preventative”. The effort is indeed another politically driven swipe at dismantling the ACA.
Allen County (Ind.) HIV Spike Due to Increased Contact, Testing - Allen County, Indiana, is seeing a surge in new HIV diagnoses with diagnoses for the year already surpassing last year’s total. The local department says this wasn’t entirely unexpected and does not attribute the spike to having any relationship to a surge in overdose deaths and a higher percentage than normal being attributed to heterosexual sexual contact. Rather, the health department states the driving issue of these new HIV diagnoses is because of a relaxation of COVID precautions and more testing.
The HIV/AIDS Battle is a Global Health Fight That We Can Win - In an opinion piece in Forbes, CEO of One Campaign, Gayle Smith, argues that despite the losses incurred due to the COVID-19 pandemic, HIV/AIDS can be defeated globally, if we have the will to do so. Recounting a past when public health threats brought politicians together and a need to replenish global funding as politicians look away from the ongoing fight against HIV/AIDS, Smith argues now - with the tools to succeed in sight - is not the time to abandon our neighbors in this global fight. We “urgently need a victory”.
Monkeypox: Not Enough Vaccine Available, One in Ten May End Up in Hospital - AIDS Map assesses the threat of Monkeypox, who is experiencing infections, containment strategies, and vaccine efforts as the virus makes its presence known in non-endemic countries worldwide. Reviewing previous outbreaks, while one in ten people were hospitalized, most of those were for isolation and observation purposes, with only 3 out of 3506 patients being admitted into intensive care units. While this doesn’t present an immediate threat of mortality, short and long term impacts of yet another infectious disease outbreak, largely affecting MSM, does pose a significant public health threat.
Stay Informed About AIDS 2022 with Daily Updates from HIV.gov - Staff from HIV.gov will be attending the International AIDS Conference in Montreal, Canada in July. This is the first in-person event since 2019. Representing a global brain trust with regard to HIV, AIDS, and associated health impacts, this blog outlines what to expect from the United State’s government attendees.
Resurgence of Meningococcal Disease Among MSM Causes Alarm - ADAP Advocacy Association’s blog reviews a disturbing return of meningitis among MSM. The outbreak has been raging since March, appearing to originate in Florida. Because meningitis is easily transmitted between people by way of coughing or kissing and can escalate quickly into a fatal illness within a matter of days. The blog aims to raise awareness of the signs and symptoms of a meningitis infection and encourage vaccination.
As Biden fights Overdoses, Harm Reduction Groups Face Local Opposition - Despite the American Rescue Plan’s inclusion of $30 million to support harm reduction programs, local organizations are struggling to find support in state legislatures, often operating in a legal grey area or outright working against the laws of their state. One example is how about half of states still maintain paraphernalia laws which would encompass fentanyl test strips, others hold no carve out for syringe exchange programs. In San Francisco, some residents maintain outdated and moralistic views that these harm reduction services promote drug use. In order to effectively implement harm reduction strategies, well-intentioned but misaligned state laws and stigma must be addressed.
988: national Suicide Prevention Lifeline Launches New 3-Digit Number - After much lobbying, the National Suicide Prevention Lifeline now only requires a 3-digit dial: 988. The code is available across the United States, in an effort to streamline access to mental health crisis intervention. Some of the hope in the program is to reduce reliance on police intervention and to help people needing help connect with a qualified counselor and other resources. Advocates fear, though, a mandate for “crisis intervention teams”, which may include police, putting people at risk of violence. Administrators are concerned the need may outstrip the resources allocated to run the hotline.
New Federal Implementation plan for Viral Hepatitis National Strategic Plan - In May, the U.S. Department of Health & Human Services (HHS) released the Viral Hepatitis Federal Implementation Plan outlining federal commitments to elimination viral hepatitis in the United States by 2030. The implementation plan is the tool by which the Viral Hepatitis National Strategic Plan is activated. Recognizing viral hepatitis is a syndemic to STIs, HIV, substance use, and mental health, HHS prioritizes integrated strategies to successfully address all of these public health concerns concurrently.