Rifapentine (Priftin) coverage and PA criteria
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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.
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.
Coverage Criteria for Rifapentine (Priftin)
Initial Therapy — Active Pulmonary Tuberculosis
Covered when ALL of the following are met:
Initial Therapy — Latent Tuberculosis Infection
Covered when ALL of the following are met:
Continuation Therapy — Active Pulmonary Tuberculosis
For continuation or renewal, ALL must be met:
Continuation Therapy — LTBI
For continuation or renewal, ALL must be met:
Approval duration: Up to 12 weeks of total treatment
Other Indications / Off-Label
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:
HIV-positive option requires CD4 >= 100 cells/mm3
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
| 150 mg | Tablet: 150 mg |
Prior Authorization, Documentation, and Step Therapy
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 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).
- 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 / 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 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
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)
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.
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
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