ModifiedArizona Complete HealthPolicy AZ.CP.PMN.05

Rifapentine (Priftin) coverage and PA criteria

Defines medical necessity, prior authorization, dosing, and coverage criteria for rifapentine (Priftin) for treatment of active pulmonary tuberculosis and latent tuberculosis infection for Arizona Complete Health members.

Policy Summary

PayerArizona Complete Health

PolicyRifapentine (Priftin) coverage and PA criteria

Policy CodePolicy AZ.CP.PMN.05

Change TypeCoverage criteria revised and addedoff-label guidance updated

Effective Date01.20.2020

Next Review Date

Key ActionSubmit prior authorization with documentation of regimen, dosing, and CD4 when applicable to demonstrate member meets approval criteria.

SourceLink

POLICY UPDATE CHANGES

For active pulmonary TB added requirements for optional 4 month daily Priftin regimen prescribed in combination with isoniazid, moxifloxacin, and pyrazinamide as well as maximum dosing requirements; added option for HIV-positive use requiring CD4 count ≥ 100 cells/mm3.

For latent TB modified isoniazid trial duration from 9 to 6 months per CDC and WHO treatment guidelines.

For latent TB added bypass for isoniazid redirection and optional alternative dosing up to 600 mg/day for a 4 week regimen per NIH/CDC HIV guidelines.

Removed reference to retired policy AZ.CP.PMN.53 Off-Label Use policy and added AHCCCS FFS Prior Authorization Guideline - Coverage of Off-Label Non-FDA Approved Indications.

Removed reference to Care1st Health plan and logos.

2indications listed (active TB, LTBI)

12 wksstandard LTBI treatment duration

6 moactive TB initial approval duration

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150 mgtablet strength

≥100CD4 threshold (HIV option)

4 mooptional 4-month regimen

Coverage Criteria for Rifapentine (Priftin)

Initial Therapy — Active Pulmonary Tuberculosis

Covered when ALL of the following are met:

Active Pulmonary Tuberculosis Initial Approval: 1. Diagnosis of TB; 2. Age ≥ 12 years; 3. Prescribed in consultation with an infectious disease specialist, pulmonologist, or TB treatment expert; 4. Prescribed in combination with one or more anti-tuberculosis drugs (e.g., isoniazid, rifampin, pyrazinamide, ethambutol); 5. If request is for the 4-month daily Priftin regimen, prescribed in combination with isoniazid, moxifloxacin, and pyrazinamide (off-label); 6. Failure of a 4-week trial of rifampin unless contraindicated, medically justified, or clinically significant adverse effects are experienced; 7. Member is not pregnant; 8. If member is HIV-positive, BOTH: (a) request is for the 4-month daily Priftin regimen (off-label) and (b) recent (within 30 days) CD4 count ≥ 100 cells/mm3; 9. Dose does not exceed one of the following: (a) For 6-month regimen: induction 600 mg twice weekly for 2 months AND continuation 600 mg once weekly for 4 months; OR (b) For 4-month regimen (off-label): 1,200 mg per day for 119 doses.

Initial Therapy — Latent Tuberculosis Infection

Covered when ALL of the following are met:

Latent Tuberculosis Infection Initial Approval: 1. Diagnosis of LTBI; 2. Age ≥ 2 years; 3. Member is not pregnant; 4. Failure of a 4-week trial of rifampin unless contraindicated, medically justified, or clinically significant adverse effects are experienced; 5. One of the following: (a) failure of >6-month trial of isoniazid at maximally indicated doses OR (b) member has HIV and is prescribed antiretroviral therapy; 6. Prescribed in combination with isoniazid; 7. Dose does not exceed either: (a) 900 mg (6 tablets) per week OR (b) for member with HIV, 600 mg (4 tablets) per day for 4 weeks.

Continuation Therapy — Active Pulmonary Tuberculosis

For continuation or renewal, ALL must be met:

Active Pulmonary Tuberculosis Continuation: 1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; 2. Member has not received up to 6 months of therapy; 3. Prescribed in combination with one or more anti-tuberculosis drugs (e.g., isoniazid, rifampin, pyrazinamide, ethambutol); 4. If request is for the 4-month daily Priftin regimen, prescribed in combination with isoniazid, moxifloxacin, and pyrazinamide (off-label); 5. If request is for a dose increase, new dose does not exceed specified limits: induction 600 mg twice weekly for 2 months; continuation 600 mg once weekly for 4 months; or for 4-month regimen (off-label) 1,200 mg per day for 119 doses.

Continuation Therapy — LTBI

For continuation or renewal, ALL must be met:

Latent Tuberculosis Infection Continuation: 1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; 2. Member has not yet received 12 weeks of therapy; 3. Prescribed in combination with isoniazid; 4. Dose does not exceed 900 mg weekly (6 tablets/week).

Approval duration: Up to 12 weeks of total treatment

Other Indications / Off-Label

Other Indications: Coverage for diagnoses not specifically listed requires referral to the AHCCCS FFS Prior Authorization Guideline – Coverage of Off-Label Non-FDA Approved Indications and documentation of efficacy and safety per that guideline; alternatively, coverage may be approved if the member is currently receiving the medication via the benefit and documentation supports a positive response to therapy.

Approval duration: Duration of request or 12 (6 for specialty) months (whichever is less)

Modified coverage criteria (summarized)

Policy modifications relevant to coverage criteria include:

Active pulmonary TB optional regimen: Optional 4-month daily Priftin regimen prescribed in combination with isoniazid, moxifloxacin, and pyrazinamide; maximum dosing requirements apply4 months

HIV-positive option requires CD4 >= 100 cells/mm3

Latent TB isoniazid trial duration: Modified isoniazid trial duration from 9 to 6 months per CDC and WHO guidelines6 months

Added bypass for isoniazid redirection and optional alternative dosing up to 600 mg/day for a 4-week regimen per NIH/CDC HIV guidelines

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use guidance (see AHCCCS FFS Prior Authorization Guideline — Coverage of Off‑Label Non‑FDA Approved Indications).

When state Medicaid coverage provisions conflict with the coverage statements in this clinical policy, state Medicaid coverage provisions take precedence. Providers should follow the state Medicaid manual for any coverage rules that differ from this policy.

Priftin (rifapentine) must not be used as monotherapy in either the initial or continuation phases of active antituberculous treatment. Additionally, once‑weekly use of Priftin in the continuation phase combined with isoniazid in HIV‑infected patients with active TB is not recommended due to higher rates of treatment failure and relapse with rifampin‑resistant organisms. Active TB should be ruled out before using rifapentine-containing regimens for latent infection, and rifapentine for LTBI must be used in combination with isoniazid as specified.

This portion of the document does not include any explicit statements labeling specific indications as “not medically necessary.”

Product Availability, Dosing, and Coding

Product AvailabilityNDC|formulation

150 mg

Tablet: 150 mg

Age and dosing thresholds (table summary)

Age thresholdsActive pulmonary TB: age ≥ 12 years; LTBI: age ≥ 2 years

6-month regimen dosing limits (active TB)Induction: 600 mg twice weekly for 2 months; Continuation: 600 mg (4 tablets) once weekly for 4 months; maximum single dose listed as 900 mg

4-month off‑label regimen dosing (active TB)1,200 mg (8 tablets) per day for 119 doses when prescribed with isoniazid, moxifloxacin, and pyrazinamide

LTBI standard regimen dosingRifapentine plus isoniazid once-weekly for 12 weeks (directly observed therapy or self‑administration); weekly maximum 900 mg (6 tablets)

LTBI alternative short course (HIV) dosingWeight-based daily rifapentine for 4 weeks with isoniazid 300 mg and pyridoxine: <35 kg = 300 mg/day; 35–45 kg = 450 mg/day; >45 kg = 600 mg/day (maximum 600 mg/day)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Must Specify Regimen and Eligibility

Prior authorization is required. Requests must specify the exact Priftin regimen (e.g., 6-month regimen with induction/continuation dosing or the 4-month daily off‑label regimen) and the specific combination agent(s) to be used (for example, isoniazid, rifampin, pyrazinamide, ethambutol, moxifloxacin). The prior authorization should indicate whether the request is for active pulmonary TB or latent TB and the intended approval duration.

Specify regimen (6‑month weekly regimen or 4‑month daily regimen) and all concomitant anti‑tuberculosis agents used
Indicate indication: Active pulmonary TB vs Latent TB
Include requested approval duration (e.g., 6 months)

Documentation Required

Documentation of Regimen‑Specific Criteria Required

Provide supporting documentation demonstrating that the member meets regimen‑specific criteria. Acceptable documentation includes office/consult notes, treatment plan, recent laboratory results (including CD4 count when applicable), pregnancy test results for persons of childbearing potential, prior medication trial documentation, and consultation notes from an infectious disease specialist, pulmonologist, or public health TB expert. Documentation must clearly show rationale for any deviations from standard trials (e.g., contraindication to rifampin or isoniazid).

Background on Rifapentine and Indications

Rifapentine is a rifamycin antimycobacterial agent used as part of combination regimens for tuberculosis. It functions within the rifamycin class and is indicated for use in combination with other anti‑tuberculosis drugs — for latent TB typically in combination with isoniazid as a once‑weekly 12‑week regimen, and for active pulmonary TB as specified in combination regimens. Important clinical limitations include that rifapentine should not be used as monotherapy, active TB must be excluded prior to LTBI treatment, and certain regimens are not recommended in HIV‑infected patients because of higher failure/relapse rates.

Definitions and Product Details

LTBI (latent tuberculosis infection)

DefinitionLatent tuberculosis infection (LTBI) — infection with Mycobacterium tuberculosis without clinical evidence of active TB disease; members with LTBI may be considered for rifapentine in combination with isoniazid per policy criteria

Typical regimen lengthStandard rifapentine + isoniazid regimen: once‑weekly for 12 weeks

RequirementActive TB must be ruled out prior to LTBI treatment per policy guidance

INH (isoniazid)

TermINH = isoniazid

Use with rifapentineIsoniazid is prescribed in combination with rifapentine for LTBI regimens described in the policy

Policy Summary

PayerArizona Complete Health

PolicyRifapentine (Priftin) coverage and PA criteria

Policy CodePolicy AZ.CP.PMN.05

Change TypeCoverage criteria revised and addedoff-label guidance updated

Effective Date01.20.2020

Next Review Date

Key ActionSubmit prior authorization with documentation of regimen, dosing, and CD4 when applicable to demonstrate member meets approval criteria.

SourceLink

On This Page

HIV-specific CD4 threshold

CD4 count thresholdFor HIV-positive members to be eligible for the 4‑month daily Priftin regimen, recent (within 30 days) CD4 count must be ≥ 100 cells/mm3

ContextCD4 requirement applies only when the 4‑month daily (off‑label) regimen is requested for HIV‑positive members

DocumentationRecent CD4 result should be submitted with prior authorization request to support eligibility

Office chart notes and treatment plan
Relevant labs (e.g., recent CD4 within 30 days for HIV‑positive members)
Pregnancy test results when applicable
Documentation of prior drug trials and reasons for failure or intolerance
Consultation notes from TB expert or public health authority

Step Therapy

Step Therapy / Prior Trials

Step therapy requirements must be documented in the prior authorization. For many indications, members must have failed a 4‑week trial of rifampin unless rifampin is contraindicated, medically unjustified, or caused clinically significant adverse effects. For latent TB, documentation of failure of a >6‑month trial of isoniazid at maximally indicated doses is required unless an approved bypass applies (see CDC/WHO alignment and HIV exceptions).

Failure of 4‑week rifampin trial required unless contraindicated
For LTBI, failure of >6 months of isoniazid at maximally indicated doses required unless bypass applies
If bypassing isoniazid trial, include clinical justification per guidelines

Step Therapy

Step Therapy Alignment with CDC/WHO Guidance

Step therapy and trial duration requirements are aligned with CDC and WHO guidance. Per updated recommendations: for LTBI the isoniazid trial duration was modified to >6 months; options exist to bypass standard trials in specific circumstances (for example, HIV‑positive members on antiretroviral therapy or when isoniazid is contraindicated). For active pulmonary TB, the policy includes an optional 4‑month daily Priftin regimen (off‑label) when prescribed in combination with isoniazid, moxifloxacin, and pyrazinamide, and for HIV‑positive members this regimen requires recent CD4 ≥ 100 cells/mm3. Include guideline references in the submission when applicable.

LTBI: isoniazid trial modified to >6 months per CDC/WHO
Bypass options allowed (e.g., HIV on ART, contraindication to isoniazid) with documentation
Active TB: 4‑month daily regimen allowed only with specified combination and CD4 ≥ 100 cells/mm3 for HIV‑positive members

Documentation Required

Supporting Documentation to Submit with Prior Authorization Requests

Provider must submit complete supporting documentation with the prior authorization demonstrating the member has met all approval criteria. Examples of acceptable documentation include office chart notes, laboratory results, imaging reports if relevant, medication administration records, and specialist consultation notes. Ensure documentation addresses age requirements, pregnancy status, prior trial details (drug, dose, duration, and reason for failure), and any HIV‑specific requirements such as recent CD4.

Office notes and treatment plan showing diagnosis and age
Pregnancy status documentation for persons of childbearing potential
Prior medication trials with dates, doses, and reason for discontinuation
Recent CD4 count (within 30 days) for HIV‑positive members when applicable
Specialist consultation notes (infectious disease, pulmonology, or public health TB expert)

Note

Medicaid Precedence

For Medicaid members, state Medicaid coverage provisions take precedence if they conflict with this clinical policy. Refer to the state Medicaid manual for any applicable coverage provisions.

Dosing referenceIsoniazid dosing referenced in policy: adults receive isoniazid 15 mg/kg (900 mg maximum); children 2–11 years 25 mg/kg (900 mg maximum)

Priftin (rifapentine) product details

Brand namePriftin (brand name for rifapentine)

Product form and strengthTablet: 150 mg

Prescribing information referencePriftin Prescribing Information. Sanofi‑Aventis U.S. LLC; July 2021 (referenced in policy)

Pediatric weight-based dosing examplesExamples in policy: 10–14 kg = 300 mg (2 tablets); 14.1–25 kg = 450 mg (3 tablets); 25.1–32 kg = 600 mg (4 tablets); 32.1–50 kg = 750 mg (5 tablets); >50 kg = 900 mg (6 tablets)