CurrentCentenePolicy CP PMN.288

Nirmatrelvir and Ritonavir (Paxlovid) coverage

Defines medical necessity and coverage criteria for Paxlovid (co-packaged nirmatrelvir and ritonavir) for treatment of mild-to-moderate COVID-19 in members at high risk for progression; applies to Centene-affiliated health plans and lines of business listed in the policy.

Policy Summary

PayerCentene

PolicyNirmatrelvir and Ritonavir (Paxlovid) coverage

Policy CodePolicy CP PMN.288

Change TypeNo material change

Effective DateSep 1, 2023

Next Review Date

Key ActionSubmit prior authorization with documentation showing COVID-19 diagnosis, age, risk factor(s), symptom onset within 5 days, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 daysApproval duration

≤5 daysSymptom window

≥18 yrsMinimum age

600 mg / 200 mgMax daily dose

Coverage Criteria for Nirmatrelvir and Ritonavir (Paxlovid)

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Initial Approval Criteria: 1) Diagnosis of COVID-19.

Age: 2) Age ≥ 18 years.

Risk factors: 3) Member has ≥1 risk factor for progression to severe COVID-19 (see Appendix D).

Symptom onset: 4) Onset of COVID-19 symptoms (e.g., cough, fever, diarrhea, sore throat) is within 5 days of request.

No retreatment for rebound/long-COVID: 5) Request is not for a second course of Paxlovid to treat continuing or recurrent symptoms after an initial course (e.g., rebound symptoms, long‑COVID, post‑acute sequelae of SARS‑CoV‑2).

Dose limits and duration: 6) Proposed dosing does not exceed 600 mg nirmatrelvir plus 200 mg ritonavir per day for a maximum of 5 days (standard regimen: 300 mg nirmatrelvir with 100 mg ritonavir twice daily for 5 days).

Approval duration: 5 days

Requests for pre-exposure or post-exposure prophylaxis for prevention of COVID-19 are not authorized under this policy. Likewise, non–FDA-approved indications are not covered by this policy unless the provider supplies sufficient documentation of efficacy and safety and the use is permitted per the applicable off‑label use policy (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

The policy references several conditions in the literature and prescribing information but does not establish explicit coverage exceptions for them within this document. These listed conditions include active cancer, HIV, dementia, tuberculosis, and substance use disorders; clinical relevance and any special considerations for these diagnoses should be evaluated against the FDA prescribing information and applicable clinical guidance cited in the references.

Provider Responsibilities, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must obtain prior authorization and submit documentation that all approval criteria are met, including diagnosis of COVID-19, member age, presence of CDC-listed risk factors for progression to severe disease, symptom onset timing, dosing limits, and that a second course is not being requested for persistent/rebound symptoms. Approval duration is up to 5 days when criteria are met.

Approval duration: 5 days
Dose limit: does not exceed 600 mg nirmatrelvir with 200 mg ritonavir per day for 5 days

Note

Prior Authorization and Policy History

This policy includes a documented history of policy creation and P&T reviews. Key actions: policy created 06.06.23 (P&T 08.23); removal of criterion to exhaust U.S. government supplies and addition of patient assistance program information (01.26.24); annual reviews in 3Q 2024 and 3Q 2025 with updates to CDC risk factors and references. Providers should reference the clinical policy history when needed.

Policy created 06.06.23; P&T Approval Date 08.23
Removed requirement to exhaust U.S. government supplies (01.26.24)
3Q 2024 & 3Q 2025 annual reviews: updated CDC risk factors

Denial Risk

Denial Triggers

Requests for uses that are non–FDA approved and not supported by the off-label use policies, and requests for pre‑exposure or post‑exposure prophylaxis for prevention of COVID‑19, will not be authorized under this policy.

Non‑FDA indications not addressed by this policy — require off‑label policy evidence: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)
Pre‑exposure prophylaxis requests — not authorized
Post‑exposure prophylaxis requests — not authorized

Documentation Required

Required Documentation

Providers must submit supporting documentation with the prior authorization request — for example, office chart notes, laboratory results, and other clinical information demonstrating that the member meets all approval criteria (diagnosis, age, risk factors, symptom onset within 5 days, dosing).

Include office notes, labs, and clinical documentation showing symptom onset date and CDC risk factors
Documentation must show prescribed dose and that a second course is not being requested due to rebound or long‑COVID

Note

Formulary / Off‑Label Routing

If the requested use, diagnosis, age, or dosing is not addressed by this policy, follow formulary/non‑formulary or off‑label routing: for formulary or PDL items refer to the relevant line‑of‑business coverage/no‑coverage policy; for non‑formulary items refer to the non‑formulary policy; for off‑label uses refer to the off‑label use policy listed by line of business.

Formulary/no‑coverage policies: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid)
Non‑formulary policies: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid)
Off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

Step Therapy

No Step Therapy Requirements

There are no step therapy requirements specified in this policy for authorization of nirmatrelvir/ritonavir; approval is based on meeting the clinical criteria outlined in the policy rather than completion of prior therapies.

No step therapy required

Key Definitions and Guideline References

Definition — co-packaged nirmatrelvir and ritonavir (Paxlovid)

TermCo-packaged nirmatrelvir and ritonavir (Paxlovid)

DescriptionNirmatrelvir: SARS-CoV-2 main protease (Mpro/3CLpro) inhibitor; Ritonavir: HIV protease inhibitor and CYP3A inhibitor used to boost nirmatrelvir.

FDA-approved indicationTreatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe disease (including hospitalization or death).

Limitation of useNot approved for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

COVID-19 Treatment Guidelines — NIH guidance cited as primary source

SourceCOVID-19 Treatment Guidelines Panel, National Institutes of Health

AccessAvailable at: https://www.covid19treatmentguidelines.nih.gov/

Most recent update cited in policyLast updated February 29, 2024 (as cited).

Role in policyReferenced as a primary source for treatment recommendations for outpatient COVID-19 management.

IDSA guidelines — Infectious Diseases Society of America guidance cited

OrganizationInfectious Diseases Society of America (IDSA)

Guideline referenceBhimraj A, Falck-Ytter Y, Kim AY et al. IDSA guidelines on the treatment and management of patients with COVID-19 (Clinical Infectious Diseases).

Most recent update cited in policyLast updated June 4, 2025 (accessed June 5, 2025).

Role in policyCited as a supporting guideline informing treatment and management recommendations for COVID-19 in the policy references.

Background on Paxlovid and Clinical Context

Paxlovid is a co‑packaged oral combination of nirmatrelvir (a SARS‑CoV‑2 main protease inhibitor) and ritonavir (a CYP3A inhibitor used to boost nirmatrelvir concentrations). It is indicated for treatment of mild‑to‑moderate COVID‑19 in adults at high risk for progression to severe disease and is supplied as co‑packaged tablets of nirmatrelvir 150 mg with ritonavir 100 mg.