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ph-91225

Anti-COVID19 Quantity Limit Program Summary

Policy Number: PH-91225

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, SourceRx-Performance, and Health Insurance Marketplace formularies

POLICY REVIEW CYCLE

Effective Date	Date of Origin
10-01-2025	11-16-2023

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Lagevrio™ (molnupiravir) Capsule	Emergency Use Authorization (EUA) for the treatment of mild-to-moderate COVID-19 in adults: Who are at high risk for progression to severe COVID-19, including hospitalization or death, and for Whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate Limitations of Authorized Use: Lagevrio is not authorized for use in patients less than 18 years of age Lagevrio is not authorized for initiation of treatment in patients requiring hospitalization due to COVID-19. Benefit of treatment with Lagevrio has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19 Lagevrio is not authorized for use longer than 5 consecutive days Lagevrio is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19 Lagevrio may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which Lagevrio belongs (i.e., anti-infectives). Lagevrio is not approved for any use, including for use for the treatment of COVID-19. Prior to initiating treatment with Lagevrio, carefully consider the known and potential risks and benefits, use in specific populations, and nonclinical toxicology. Lagevrio is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Lagevrio under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.		1
Paxlovid™ (nirmatreivir/ritonavir) Tablet	Treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death Limitations of Use: Paxlovid is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19 Paxlovid is approved through an Emergency Use Authorization (EUA) for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death Limitations of Authorized Use: Paxlovid is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19. Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. Paxlovid may also be prescribed for an individual patient by a state-licensed pharmacist for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, in accordance with the FDA-approved Prescribing Information or authorized labeling, as applicable, under the following conditions: Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply: Sufficient information is not available to assess renal and hepatic function. Sufficient information is not available to assess for a potential drug interaction. Modification of other medications is needed due to a potential drug interaction. Paxlovid is not an appropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible. Paxlovid is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Paxlovid under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.		2,6

Agent(s)

FDA Indication(s)

Notes

Ref#

Lagevrio™

(molnupiravir)

Capsule

Emergency Use Authorization (EUA) for the treatment of mild-to-moderate COVID-19 in adults:

Who are at high risk for progression to severe COVID-19, including hospitalization or death, and for
Whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate

Limitations of Authorized Use:

Lagevrio is not authorized for use in patients less than 18 years of age
Lagevrio is not authorized for initiation of treatment in patients requiring hospitalization due to COVID-19. Benefit of treatment with Lagevrio has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19
Lagevrio is not authorized for use longer than 5 consecutive days
Lagevrio is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19
Lagevrio may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which Lagevrio belongs (i.e., anti-infectives).
Lagevrio is not approved for any use, including for use for the treatment of COVID-19.
Prior to initiating treatment with Lagevrio, carefully consider the known and potential risks and benefits, use in specific populations, and nonclinical toxicology.
Lagevrio is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Lagevrio under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Paxlovid™

(nirmatreivir/ritonavir)

Tablet

Treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death

Limitations of Use:

Paxlovid is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19

Paxlovid is approved through an Emergency Use Authorization (EUA) for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death

Limitations of Authorized Use:

Paxlovid is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
Paxlovid may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.
Paxlovid may also be prescribed for an individual patient by a state-licensed pharmacist for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, in accordance with the FDA-approved Prescribing Information or authorized labeling, as applicable, under the following conditions:
- Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function
- Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.
The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
- Sufficient information is not available to assess renal and hepatic function.
- Sufficient information is not available to assess for a potential drug interaction.
- Modification of other medications is needed due to a potential drug interaction.
Paxlovid is not an appropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
Paxlovid is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Paxlovid under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

2,6

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

COVID-19

Data currently indicates that prior infection with COVID-19 does provide some protection from reinfection. Some studies find that prior infection reduces the risk of infection by 80-85% for 6-7 months.(3,4) In 2021, studies initially suggested natural immunity could protect against reinfection for 8 to 12 months, however, real-world cases have contradicted this with reinfection occurring within 3 to 6 months.(5)

Safety

Molnupiravir has no FDA labeled contraindications for use based on the limited available data on the emergency use molnupiravir authorized under the EUA.(1)

Nirmatrelvir tablets; ritonavir tablets is contraindicated in the following:(2,6)

History of clinically significant hypersensitivity reactions to the active ingredients (nirmatrelvir or ritonavir) or any other components
Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions
Co-administration with potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance

Nirmatrelvir tablets; ritonavir tablets has a boxed warning:(2,6)

Paxlovid includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certain concomitant medications, resulting in potentially severe, life-threatening, or fatal events
Prior to prescribing Paxlovid:
- Review all medication taken by the patient to assess potential drug-drug interactions with strong CYP3A inhibitor like Paxlovid
- Determine if concomitant medications require and dose adjustment, interruption, and/or additional monitoring
Consider the benefit of Paxlovid treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed

REFERENCES

Number	Reference
1	U.S. Food and Drug Administration. Fact Sheet for Healthcare Providers: Emergency Use Authorization for Lagevrio (Molnupiravir) Capsules. 2024. https://www.merck.com/eua/molnupiravir-hcp-fact-sheet.pdf
2	Paxlovid Fact Sheet for Healthcare Providers: Emergency Use Authorization for Paxlovid. Pfizer Labs. February 2025. https://labeling.pfizer.com/ShowLabeling.aspx?id=16474&format=pdf.
3	Hall VJ, Foulkes S, Charlett A, et al. SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN). Lancet. 2021;397(10283):1459. Epub 2021 Apr 9.
4	Hansen CH, Michlmayr D, Gubbels SM, et al. Assessment of protection against reinfection with SARS-CoV-2 among 4 million PCR-tested individuals in Denmark in 2020: a population-level observational study. The Lancet. 2021;397(10280):1204. Epub 2021 Mar 17.
5	Gomez-Gonzales W, Chihuantito-Abal LA, Gamarra-Bustillos C, et al. Risk factors contributing to reinfection by SARS-COV-2: A systematic review. Advances in Respiratory Medicine. 2023;91(6):560-570. doi:10.3390/arm91060041
6	Paxlovid prescribing information. Pfizer Laboratories Division of Pfizer Inc. February 2025.

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

Lagevrio	Molnupiravir Cap	200 MG	40	Capsules	30	DAYS
Paxlovid	nirmatrelvir tab	6 x 150 MG & 5 x 100MG	11	Tablets	30	DAYS
Paxlovid	Nirmatrelvir Tab	10 x 150 MG & 10 x 100MG	20	Tablets	30	DAYS
Paxlovid	Nirmatrelvir Tab	20 x 150 MG & 10 x 100MG	30	Tablets	30	DAYS

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
Lagevrio	Molnupiravir Cap	200 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Paxlovid	nirmatrelvir tab	6 x 150 MG & 5 x 100MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Paxlovid	Nirmatrelvir Tab	20 x 150 MG & 10 x 100MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance
Paxlovid	Nirmatrelvir Tab	10 x 150 MG & 10 x 100MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Quantity Limit for the Target Agent(s) will be approved when ALL of the following are met: The patient is using the requested agent for a COVID-19 reinfection AND The patient’s age is within FDA labeling OR Emergency Use Authorization (EUA) for the requested indication for the requested agent AND The requested agent is NOT being used to extend treatment beyond the maximum FDA labeling OR EUA treatment regimen for the requested indication AND The patient will NOT be using the requested agent in combination with another agent in this program for the requested indication AND The requested quantity (dose) does NOT exceed the maximum FDA labeling OR EUA dosing for the requested indication Length of Approval: 1 additional course of therapy for 1 month

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ALL of the following are met:

The patient is using the requested agent for a COVID-19 reinfection AND
The patient’s age is within FDA labeling OR Emergency Use Authorization (EUA) for the requested indication for the requested agent AND
The requested agent is NOT being used to extend treatment beyond the maximum FDA labeling OR EUA treatment regimen for the requested indication AND
The patient will NOT be using the requested agent in combination with another agent in this program for the requested indication AND
The requested quantity (dose) does NOT exceed the maximum FDA labeling OR EUA dosing for the requested indication

Length of Approval: 1 additional course of therapy for 1 month

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.