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CMV (cytomegalovirus) Quantity Limit Program Summary

Policy Number: PH-1200

 

This prior authorization applies Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.  

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

10-01-2024            

07-01-2018

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

LIVTENCITY®

(maribavir)

Tablets

Treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet

2

LIVTENCITY®

(maribavir)

Tablets

Treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet

2

PREVYMIS®

(letermovir)

Tablets

Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant (HSCT) 

Prophylaxis of CMV disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])

1

PREVYMIS®

(letermovir)

Tablets

Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients (R+) of an allogeneic hematopoietic stem cell transplant (HSCT) 

Prophylaxis of CMV disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])

1

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

REFERENCES                                                                                                                                                                           

Number

Reference

1

PREVYMIS prescribing information. Merck Sharp & Dohme LLC. August 2023.

1

PREVYMIS prescribing information. Merck Sharp & Dohme LLC. August 2023.

2

LIVTENCITY prescribing information. Takeda Pharmaceuticals America, Inc. April 2023.

2

LIVTENCITY prescribing information. Takeda Pharmaceuticals America, Inc. April 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

Livtencity

Maribavir Tab

200 MG

120

Tablets

30

DAYS

Prevymis

letermovir tab

240 MG ; 480 MG

200

Tablets

365

DAYS

Quantity limit is cumulative across strengths

ADDITIONAL QUANTITY LIMIT INFORMATION

Wildcard

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Additional QL Information

Targeted NDCs When Exclusions Exist

Effective Date

Term Date

122000450003

Prevymis

letermovir tab

240 MG ; 480 MG

Quantity limit is cumulative across strengths

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Livtencity

Maribavir Tab

200 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Prevymis

letermovir tab

240 MG ; 480 MG

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 ONE of the following is met:

 

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does not have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
    3. BOTH of the following:
      1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication

 

Length of Approval: up to 12 months

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 _ CMV_QL _ProgSum_ 10-01-2024