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Nasal Antiepileptics Quantity Limit Program Summary

Policy Number: PH-1189

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 

04-01-2024            

FDA APPROVED INDICATIONS AND DOSAGE

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

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

Nayzilam

midazolam nasal spray soln

5 MG/0.1ML

10

Sprays

30

DAYS

Nayzilam

Midazolam Nasal Spray Soln 5 MG/0.1 ML

5 MG/0.1ML

10

Bottles

30

DAYS

Valtoco 10 mg dose

Diazepam Nasal Spray 10 MG/0.1 ML

10 MG/0.1ML

10

Packs

30

DAYS

Valtoco 15 mg dose

Diazepam Nasal Spray Ther Pack 2 x 7.5 MG/0.1ML (15 MG Dose)

7.5 MG/0.1ML

10

Packs

30

DAYS

Valtoco 20 mg dose

Diazepam Nasal Spray Ther Pack 2 x 10 MG/0.1ML (20 MG Dose)

10 MG/0.1ML

10

Packs

30

DAYS

Valtoco 5 mg dose

Diazepam Nasal Spray 5 MG/0.1 ML

5 MG/0.1ML

10

Packs

30

DAYS

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Nayzilam

midazolam nasal spray soln

5 MG/0.1ML

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

Nayzilam

Midazolam Nasal Spray Soln 5 MG/0.1 ML

5 MG/0.1ML

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

Valtoco 10 mg dose

Diazepam Nasal Spray 10 MG/0.1 ML

10 MG/0.1ML

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

Valtoco 15 mg dose

Diazepam Nasal Spray Ther Pack 2 x 7.5 MG/0.1ML (15 MG Dose)

7.5 MG/0.1ML

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

Valtoco 20 mg dose

Diazepam Nasal Spray Ther Pack 2 x 10 MG/0.1ML (20 MG Dose)

10 MG/0.1ML

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

Valtoco 5 mg dose

Diazepam Nasal Spray 5 MG/0.1 ML

5 MG/0.1ML

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. Information has been provided to support 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. Information has been provided to support 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. Information has been provided to support 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 _ Nasal_Antiepileptics_QL _ProgSum_ 04-01-2024