CurrentCignaPolicy N/A

Drug Quantity Management Policy — Oral COVID-19 Antivirals (Paxlovid, Lagevrio)

Defines drug quantity management limits and one-time override criteria for Paxlovid (nirmatrelvir/ritonavir) and Lagevrio (molnupiravir) for Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyDrug Quantity Management Policy — Oral COVID-19 Antivirals (Paxlovid, Lagevrio)

Policy CodePolicy N/A

Change TypeRevised override timing requirement

Effective DateN/A

Next Review DateSep 11, 2024

Key ActionRequest a one-time second-course override only when the patient has a repeat COVID-19 diagnosis and at least 30 days have elapsed since completion of the initial course.

SourceLink

POLICY UPDATE CHANGES

Override criteria were updated to require at least 30 days to have elapsed since completion of the initial course of treatment; previously required 90 days.

30Max Paxlovid (30-tablet carton) per 180 days

20Max Paxlovid (20-tablet carton) per 180 days

40Max Lagevrio per 180 days

5 daysRecommended treatment duration

>=30d

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Coverage Criteria

Quantity limits and one-time override criteria

Covered as medically necessary when drug quantity limits are met; one-time override for a second course may be approved when ALL of the following are met:

Paxlovid second course override

Repeat diagnosis: Patient has a repeat diagnosis of COVID-19 (a second diagnosis unrelated to the initial diagnosis)N/A
supporting note
Timing: At least 30 days have elapsed since completion of the initial course of Paxlovid>= 30 days
must be counted from completion of initial course

Lagevrio second course override

Repeat diagnosis: Patient has a repeat diagnosis of COVID-19 (a second diagnosis unrelated to the initial diagnosis)N/A
supporting note
Timing: At least 30 days have elapsed since completion of the initial course of Lagevrio>= 30 days
must be counted from completion of initial course

Default quantity limits: Maximum quantities per 180 days: Paxlovid 30-tablet carton = 30 tablets; Paxlovid 20-tablet carton = 20 tablets; Lagevrio = 40 capsulesper 180 days

Any request exceeding these limits requires meeting override criteria

Lagevrio (molnupiravir) is authorized under its EUA for treatment of mild-to-moderate COVID-19 only in adults at high risk for progression. It is not authorized for use in patients < 18 years of age, is not authorized for initiation of treatment in patients hospitalized due to COVID-19, and is not authorized for pre-exposure or post-exposure prophylaxis. Additionally, therapy with Lagevrio is limited to a maximum of 5 consecutive days per course of treatment.

Paxlovid (nirmatrelvir co-packaged with ritonavir) is not approved for pre-exposure or post-exposure prophylaxis for prevention of COVID-19; its authorization and approval are for treatment of mild-to-moderate COVID-19 in adults at high risk of progression, not for prophylactic use.

Coverage is contingent on the Drug Quantity Management limits. Any request for a quantity that exceeds the listed maximums per 180 days (Paxlovid 30-tablet carton = 30 tablets; Paxlovid 20-tablet carton = 20 tablets; Lagevrio = 40 capsules) is considered not medically necessary unless the specific one-time override criteria for a second course are met.

Coding

Document does not list specific billing codesmixed

N/A	No CPT/HCPCS/ICD codes listed in document

inv-06: Treatment timing and retreatment interval

Initiation windowTreatment with Paxlovid or Lagevrio should be initiated as soon as possible and within 5 days of symptom onset.

Retreatment intervalAt least 30 days must have elapsed since completion of the initial course before approving a second course (override).

Course completionCompletion of the full 5-day treatment course is recommended to maximize viral clearance.

Provider Actions & Requirements

Billing Rule

Quantity limits and override requirements

Paxlovid and Lagevrio are subject to Drug Quantity Limits. If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the stated criteria; exceptions require a one-time override as described below. All approvals are provided for the duration noted and will be reviewed by a clinician (nurse or pharmacist).

Paxlovid: Maximum quantity per 180 days = one 30-tablet carton (30 tablets) or one 20-tablet carton (20 tablets).
Lagevrio: Maximum quantity per 180 days = 40 capsules (one bottle).

Note

Timing requirement

Treatment with Paxlovid or Lagevrio should be initiated as soon as possible after diagnosis and within 5 days of symptom onset. Completion of the full 5-day treatment course is recommended; if a patient is hospitalized after starting treatment, the full 5-day course may be completed at the provider's discretion.

Background

Lagevrio is a nucleoside analogue that inhibits SARS‑CoV‑2 replication via viral mutagenesis. It was issued an Emergency Use Authorization for treatment of mild-to-moderate COVID-19 in adults at high risk for progression when alternative FDA‑authorized or approved treatments are not accessible or clinically appropriate. The EUA includes explicit use limitations: adults only, not for initiation after hospitalization for COVID-19, not for prophylaxis, and restricted to a maximum 5-day treatment course.

Definitions

inv-12: Lagevrio (molnupiravir)

Product and formLagevrio (molnupiravir) — 200 mg capsules (bottles of 40 capsules).

Authorized populationEmergency Use Authorization for adults (not authorized for use in patients < 18 years of age).

Limitations of useNot authorized for initiation of treatment in patients hospitalized due to COVID-19; not authorized for pre- or post-exposure prophylaxis.

Maximum durationNot authorized for use longer than 5 consecutive days (maximum 5-day course).

inv-13: Paxlovid (nirmatrelvir + ritonavir)

Product and componentsPaxlovid — nirmatrelvir tablets co-packaged with ritonavir tablets (must be co-administered).

Initial Therapy Criteria

Initial dosing and timing

Recommended dosing and timing for initial therapy

Paxlovid dosing: 300 mg nirmatrelvir with 100 mg ritonavir twice daily for 5 days; dose adjustment to 150 mg nirmatrelvir with 100 mg ritonavir BID for moderate renal impairment; not recommended in severe renal impairment5 days treatment

Nirmatrelvir must be co-administered with ritonavir

Lagevrio dosing: 800 mg (four 200 mg capsules) every 12 hours for 5 days5 days treatment

Not authorized for patients < 18 years

Timing of initiation: Treatment should be initiated as soon as possible after diagnosis and within 5 days of symptom onset; complete the full 5-day course

Step Therapy / Override Requirements

Step	Requirement	Timing/Threshold
Second-course override (Paxlovid)	Approve a one-time override for a second course (one 30-tablet carton or one 20-tablet carton) when the patient has a repeat diagnosis of COVID-19 (a second diagnosis unrelated to the initial diagnosis treated with Paxlovid).	>= 30 days since completion of the initial course of Paxlovid
Second-course override (Lagevrio)	Approve a one-time override for a second course (40 capsules) when the patient has a repeat diagnosis of COVID-19 (a second diagnosis unrelated to the initial diagnosis treated with Lagevrio).	>= 30 days since completion of the initial course of Lagevrio

Quantity Limits

inv-16: Paxlovid (30-tablet carton) maximum per 180 days

DrugPaxlovid (30-tablet carton).

Maximum quantity per 180 days30 tablets (1 carton of 5 blister cards).

Unit definition30-tablet carton contains five daily-dose blister cards (each card contains four nirmatrelvir 150 mg tablets and two ritonavir 100 mg tablets).

inv-17: Paxlovid (20-tablet carton) maximum per 180 days

DrugPaxlovid (20-tablet carton).

Maximum quantity per 180 days20 tablets (1 carton of 5 blister cards).

Unit definition

Site of Care

Note

Home initiation: start ASAP within 5 days; hospitalization after start may still allow completion

Oral outpatient therapy should be initiated as soon as possible and within 5 days of symptom onset; if the patient is hospitalized after starting treatment, completing the 5-day course may still be permitted per clinician discretion.

Start treatment promptly in the home/outpatient setting within 5 days of symptom onset.
Hospitalization after treatment initiation does not automatically preclude completion of the prescribed 5-day course.