CurrentExecutive Office of Health and Human ServicesPolicy N/A

General Approval Criteria — Hepatitis C medications (ADAP formulary)

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Prior authorization requirements and approval criteria for Hepatitis C direct-acting antiviral and related medications on the Rhode Island ADAP formulary, affecting prescribers and ADAP beneficiaries seeking HCV treatment.

Policy Summary

PayerExecutive Office of Health and Human Services

PolicyGeneral Approval Criteria — Hepatitis C medications (ADAP formulary)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 25, 2017

Next Review DateN/A

Key ActionSubmit a fully completed ADAP pre-authorization (PA) form and ensure quantitative HCV viral load is within 90 days of the PA request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

28-daydispensing increment

90 daysviral load recency

6 monthsabuse-free / monitored

Preferred Providerprescriber requirement

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Prescriber qualifications: Requesting physician must be a gastroenterologist, hepatologist, or infectious disease specialist. Physicians with clinical expertise in HCV care may be considered; interested physicians must submit and await approval of the EOHHS Preferred Provider Application. Physician Assistants and Nurse Practitioners employed by and co-located with a physician on the Preferred Provider List may request Preferred Provider status by submitting the Preferred Provider Application and awaiting approval.

Preferred Provider Application available on the EOHHS ADAP pharmacy webpage.

Documentation: A fully completed ADAP pre-authorization (PA) form must be submitted. A quantitative HCV viral load result must be documented and be within 90 days of the PA request.viral load within 90 days

PA form located on the EOHHS ADAP pharmacy webpage.

Monitoring for substance use: Patients with current or past significant alcohol or intravenous drug abuse must be actively participating in a clinician‑monitored treatment program or be abuse‑free for a minimum of 6 months. Treatment and monitoring may be documented and maintained in the treating clinician's office, including by attestation.6 months

Patient Contract is intended as an assessment and not an eligibility screen for denial.

Patient agreement: Patient must have a signed 'Patient Contract' indicating willingness to comply with treatment and monitoring; the contract must be retained in the provider's clinical record but is not required to be submitted with the PA request.

Sample contract available on the EOHHS ADAP pharmacy webpage.

Formulary and regimen restrictions: Approval is limited to ADAP formulary medications for a full course of treatment, dispensed in 28‑day increments, and limited to FDA‑approved indications and regimens. EOHHS will periodically review randomly selected, de‑identified prior authorizations for consistent application and may request post‑treatment patient‑specific clinical information.28‑day dispensing increments

Non‑FDA indications are not approved under this policy.

Approval for Hepatitis C medications on the Rhode Island ADAP formulary is limited to FDA‑approved indications and regimens. Prior authorization approvals are issued for a full course of treatment with medication dispensed in 28‑day increments. Non‑FDA indications or regimens are not approved under this policy.

Formulary and Coding Information

Formulary HCV medications and strengthsNDC | mixedCovered

simeprevir 150mg	Olysio
sofosbuvir 400mg	Sovaldi
ledipasvir/sofosbuvir 90mg/400mg	Harvoni
ombitasvir/paritaprevir/ritonavir & dasabuvir (various strengths)	Viekira Pak / Viekira XR
daclatasvir 30mg/60mg/90mg	Daklinza
ombitasvir/paritaprevir/ritonavir (various strengths)	Technivie
elbasvir/grazoprevir 50mg/100mg	Zepatier
sofosbuvir/velpatasvir 400mg/100mg	Epclusa
sofosbuvir/velpatasvir/voxilaprevir 400mg/100mg/100mg	Vosevi
glecaprevir/pibrentasvir 300mg/120mg	Mavyret

Quantitative HCV viral load — timing requirement

Required recency for quantitative HCV RNAQuantitative HCV viral load result must be documented within 90 days of the PA request.

Where to submit resultInclude the quantitative viral load on the fully completed ADAP pre-authorization (PA) form located on the EOHHS ADAP pharmacy webpage.

Consequence of missing timingPA requests must be completed in their entirety; viral load older than 90 days may render the PA incomplete and subject to denial.

Relation to documentation requirementsThe quantitative viral load requirement is part of the Documentation section of the General Approval Criteria and must accompany the PA request.

Provider Actions and Requirements

Prior Authorization

Prior authorization required; approvals for full course with 28‑day dispensing

Prior authorization is required for all ADAP formulary HCV medications. Approvals are issued for a full course of treatment and medications are dispensed in 28-day increments.

PA required before dispensing any formulary DAA or protease inhibitor listed on the ADAP formulary.
Approved courses will be dispensed in 28-day increments.

Step Therapy

Limit approval to FDA‑approved regimens; EOHHS oversight reviews

Approval is limited to FDA‑approved indications and regimens; EOHHS will periodically review randomly selected, de‑identified prior authorizations to ensure consistent application of the policy.

Prescribed regimen must match an FDA‑approved indication/regimen.
EOHHS may request post‑treatment clinical information and will perform random reviews of PAs for consistency.

Documentation Required

Submit ADAP PA form and retain signed Patient Contract

Submit a fully completed ADAP pre‑authorization (PA) form located on the EOHHS ADAP pharmacy webpage and maintain a signed 'Patient Contract' in the patient's clinical record; the contract does not need to be submitted with the PA.

PA form is available on the EOHHS website (ADAP pharmacy page).
Signed Patient Contract must be kept in the provider's documentation but is not required to accompany the PA submission.

Documentation Required

Provide quantitative HCV viral load within 90 days

Include a quantitative HCV viral load result obtained within 90 days of the PA request as part of the documentation submitted with the PA.

Viral load test date must be no more than 90 days before the PA request.

Denial Risk

Complete all required PA form fields or risk denial

Complete the PA request in its entirety; missing or incomplete information may lead to denial.

PA requests must be fully completed per the ADAP PA form instructions.
Incomplete submissions or missing required documentation can result in denial of the request.

Background

Hepatitis C is a leading cause of chronic liver disease and is associated with significant morbidity, including liver failure, need for transplantation, and death. This policy applies to direct‑acting antiviral (DAA) agents on the Rhode Island ADAP formulary and governs prior authorization, dispensing, and oversight to ensure treatment is provided according to FDA‑approved regimens and monitored appropriately. EOHHS will periodically review randomly selected prior authorizations for consistency and may request post‑treatment clinical information as part of quality oversight.

Definitions

inv-11: DAA — Direct-acting antiviral agents; note about FDA boxed warning for HBV reactivation

DefinitionDirect-acting antiviral (DAA) agents: antiviral medications indicated for treatment of Hepatitis C.

FDA boxed warningSince October 4, 2016, DAA labels include an FDA Boxed Warning regarding risk of Hepatitis B (HBV) reactivation.

Reference for detailsDetailed information available from FDA: http://www.fda.gov/Drugs/DrugSafety/ucm522932.htm.

inv-12: Preferred Provider — Prescriber requirements and accepted specialties for approval

Approved prescriber specialtiesRequesting physician must be a gastroenterologist, hepatologist, or infectious disease (ID) specialist.

Mid-level cliniciansPhysician Assistants and Nurse Practitioners employed by and co-located with a Preferred Provider physician may request Preferred Provider status after submitting the application.

How to applyInterested clinicians must submit the Preferred Provider Application available on the EOHHS website (pharmacy page under ADAP) and await approval before submitting medication PA requests.

Policy Summary

PayerExecutive Office of Health and Human Services

PolicyGeneral Approval Criteria — Hepatitis C medications (ADAP formulary)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 25, 2017

Next Review DateN/A

Key ActionSubmit a fully completed ADAP pre-authorization (PA) form and ensure quantitative HCV viral load is within 90 days of the PA request.

SourceLink

On This Page

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General Approval Criteria — Hepatitis C medications (ADAP formulary)

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Preferred Provider Application available on the EOHHS ADAP pharmacy webpage.

PA form located on the EOHHS ADAP pharmacy webpage.

Patient Contract is intended as an assessment and not an eligibility screen for denial.

Sample contract available on the EOHHS ADAP pharmacy webpage.

Non‑FDA indications are not approved under this policy.

Formulary and Coding Information

Formulary HCV medications and strengthsNDC | mixedCovered

simeprevir 150mg	Olysio
sofosbuvir 400mg	Sovaldi
ledipasvir/sofosbuvir 90mg/400mg	Harvoni
ombitasvir/paritaprevir/ritonavir & dasabuvir (various strengths)	Viekira Pak / Viekira XR
daclatasvir 30mg/60mg/90mg	Daklinza
ombitasvir/paritaprevir/ritonavir (various strengths)	Technivie
elbasvir/grazoprevir 50mg/100mg	Zepatier
sofosbuvir/velpatasvir 400mg/100mg	Epclusa
sofosbuvir/velpatasvir/voxilaprevir 400mg/100mg/100mg	Vosevi
glecaprevir/pibrentasvir 300mg/120mg	Mavyret

Quantitative HCV viral load — timing requirement

Required recency for quantitative HCV RNAQuantitative HCV viral load result must be documented within 90 days of the PA request.

Where to submit resultInclude the quantitative viral load on the fully completed ADAP pre-authorization (PA) form located on the EOHHS ADAP pharmacy webpage.

Consequence of missing timingPA requests must be completed in their entirety; viral load older than 90 days may render the PA incomplete and subject to denial.

Relation to documentation requirementsThe quantitative viral load requirement is part of the Documentation section of the General Approval Criteria and must accompany the PA request.

Provider Actions and Requirements

Prior Authorization

Prior authorization required; approvals for full course with 28‑day dispensing

Prior authorization is required for all ADAP formulary HCV medications. Approvals are issued for a full course of treatment and medications are dispensed in 28-day increments.

PA required before dispensing any formulary DAA or protease inhibitor listed on the ADAP formulary.
Approved courses will be dispensed in 28-day increments.

Step Therapy

Limit approval to FDA‑approved regimens; EOHHS oversight reviews

Approval is limited to FDA‑approved indications and regimens; EOHHS will periodically review randomly selected, de‑identified prior authorizations to ensure consistent application of the policy.

Prescribed regimen must match an FDA‑approved indication/regimen.
EOHHS may request post‑treatment clinical information and will perform random reviews of PAs for consistency.

Documentation Required

Submit ADAP PA form and retain signed Patient Contract

PA form is available on the EOHHS website (ADAP pharmacy page).
Signed Patient Contract must be kept in the provider's documentation but is not required to accompany the PA submission.

Documentation Required

Provide quantitative HCV viral load within 90 days

Include a quantitative HCV viral load result obtained within 90 days of the PA request as part of the documentation submitted with the PA.

Viral load test date must be no more than 90 days before the PA request.

Denial Risk

Complete all required PA form fields or risk denial

Complete the PA request in its entirety; missing or incomplete information may lead to denial.

PA requests must be fully completed per the ADAP PA form instructions.
Incomplete submissions or missing required documentation can result in denial of the request.