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ph-1225

Anti-COVID19 Quantity Limit Program Summary

Policy Number: PH-1225

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

POLICY REVIEW CYCLE

Effective Date	Date of Origin
10-01-2024	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: Not authorized for use in patients less than 18 years of age 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 Not authorized for use longer than 5 consecutive days Not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19		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 initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19 Paxlovid is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19 Paxlovid is not authorized for use longer than 5 consecutive days		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:

Not authorized for use in patients less than 18 years of age
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
Not authorized for use longer than 5 consecutive days
Not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19

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 initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
Paxlovid is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19
Paxlovid is not authorized for use longer than 5 consecutive days

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) Others find that reinfections are rare events and that persons there is minimal risk of reinfection for at least 8 months after the primary infection.(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: 1) Review all medication taken by the patient to assess potential drug-drug interactions with strong CYP3A inhibitor like Paxlovid and 2) 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	Lagevrio Fact Sheet for Healthcare Providers: Emergency Use Authorization for Lagevrio. Merck Sharp & Dohme LLC. October 2023.
2	Paxlovid Fact Sheet for Healthcare Providers: Emergency Use Authorization for Paxlovid. Pfizer Labs. November 2023. 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. Lancet. 2021;397(10280):1204. Epub 2021 Mar 17.
5	Leidi A, Koegler F, Dumont R, et al. SEROCoV-POP study group, Risk of Reinfection After Seroconversion to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): A Population-based Propensity-score Matched Cohort Study. Clinical Infectious Diseases, February 2022, Pages 622-629, https://doi.org/10.1093/cid/ciab495
6	Paxlovid prescribing information. Pfizer Laboratories Division of Pfizer Inc. May 2023.

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	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
Paxlovid	Nirmatrelvir Tab	20 x 150 MG & 10 x 100MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Paxlovid	Nirmatrelvir Tab	10 x 150 MG & 10 x 100MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

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.

Commercial _ PS _ Anti-COVID19__QL _ProgSum_ 10-01-2024