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Sucralfate Suspension Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1099

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

 

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

10/1/2022              

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Carafate®

(sucralfate)

Oral suspension

Tablet

Oral suspension:

  • Short-term (up to 8 weeks) treatment of active duodenal ulcer

 

Tablet:

  • Short-term treatment (up to 8 weeks) of active duodenal ulcer
  • Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers

ª- Generic equivalent available

1 ; 2

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

CLINICAL RATIONALE

Safety

Carafate is contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.(1,2)

REFERENCES                                                                                                                                                                           

Number

Reference

1

Carafate suspension prescribing information. Allergan USA, Inc. August 2017.

2

Carafate tablet prescribing information. Allergan USA, Inc. April 2013.

 

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Agent Names

Strength

Targeted MSC

Available MSC

Effective Date

CARAFATE*sucralfate susp  ; SUCRALFATE*sucralfate susp

1 GM/10ML

M ; N ; O ; Y

N ; O ; Y

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Agent GPI

Agent Names

Strength

QL Amount

Dose Form

Days Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Effective Date

49300010001820

SUCRALFATE*Sucralfate Susp 1 GM/10ML

1 GM/10ML

1200.0

MLS

30

Days

CLIENT SUMMARY – PRIOR AUTHORIZATION

Agent Names

Strength

Client Formulary

CARAFATE*sucralfate susp  ; SUCRALFATE*sucralfate susp

1 GM/10ML

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

CLIENT SUMMARY – QUANTITY LIMITS

Agent Names

Strength

Client Formulary

SUCRALFATE*Sucralfate Susp 1 GM/10ML

1 GM/10ML

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

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Target Agent(s) will be approved when BOTH of the following are met:

  1. The prescriber has provided information that the use of the tablet formulation is not clinically appropriate for the patient AND
  2. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval: 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

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. ALL of the following:
    1. The requested quantity (dose) is greater than the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. 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. ALL of the following:
    1. The requested quantity (dose) is greater than the program quantity limit AND
    2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
    3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

 

 

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

 

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.

 

 

BCBSAL _  PS _ Sucralfate Suspension Prior Authorization with Quantity Limit _ProgSum_ 10/1/2022  _