Cigna Drug Coverage Policy for Famotidine: Uses, Criteria, and Background, Study Guides, Projects, Research of Business

Cigna's drug coverage policy for famotidine, including its approved indications, off-label uses, and coverage criteria. The background section provides information on famotidine's uses in treating gerd, esophagitis, and ulcers, as well as relevant guidelines from acg, aga, and naspghan.

Typology: Study Guides, Projects, Research

2021/2022

Uploaded on 09/27/2022

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EFFECTIVE DATE: 1/1/2021
Page 1 of 4
Coverage Policy Number: IP0010
Drug and Biologic Coverage Policy
Effective Date ............................................ 1/1/2021
Next Review Date..................................... 1/1/2022
Coverage Policy Number ............................... IP0010
Famotidine
Table of Contents
Overview .............................................................. 1
Coverage Policy Statement ................................. 1
FDA Indication Criteria ......................................... 2
Other Uses with Supportive Evidence Criteria .... 2
Specific Additional Criteria ................................... 2
Preferred Product Requirement Criteria .............. 2
Conditions Not Covered....................................... 2
Background .......................................................... 3
References .......................................................... 3
Related Coverage Resources
INSTRUCTIONS FOR USE
The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of
business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan
language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting
certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document
[Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may
differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan
document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit
plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage
mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific
instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable
laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular
situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for
treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support
medical necessity and other coverage determinations.
Overview
This policy supports medical necessity review for famotidine (Pepcid).
Coverage Policy Statement
Famotidine (Pepcid) is medically necessary when the following are met:
1. Criteria associated with FDA Indications
2. Criteria associated with Other Uses with Supportive Evidence
3. Specific Additional Criteria [when part of Cigna managed drug list or plan requirements]
4. Preferred Product Requirement Criteria [when part of Cigna managed drug list or plan requirements]
When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of
care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted
based upon severity, alternative available treatments, and previous response to therapy.
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Page 1 of 4

Drug and Biologic Coverage Policy

Effective Date ............................................ 1/1/ Next Review Date… ..................................... 1/1/ Coverage Policy Number ............................... IP

Famotidine

Table of Contents

Overview .............................................................. 1 Coverage Policy Statement ................................. FDA Indication Criteria......................................... Other Uses with Supportive Evidence Criteria .... Specific Additional Criteria ................................... Preferred Product Requirement Criteria .............. Conditions Not Covered....................................... Background .......................................................... References .......................................................... 3

Related Coverage Resources

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

Overview

This policy supports medical necessity review for famotidine (Pepcid).

Coverage Policy Statement

Famotidine (Pepcid) is medically necessary when the following are met:

  1. Criteria associated with FDA Indications
  2. Criteria associated with Other Uses with Supportive Evidence
  3. Specific Additional Criteria [ when part of Cigna managed drug list or plan requirements ]
  4. Preferred Product Requirement Criteria [ when part of Cigna managed drug list or plan requirements ]

When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy.

Page 2 of 4

Approval duration is 12 months unless otherwise stated.

Note: Receipt of sample product does not satisfy any criteria requirements for coverage.

Documentation: When documentation is required, the prescriber must provide written documentation supporting the trials of these other agents. Documentation may include, but is not limited to, chart notes, prescription claims records, and/or prescription receipts

Refer to each criteria section below.

FDA Indication Criteria

NONE

Other Uses with Supportive Evidence Criteria

NONE

Specific Additional Criteria

NONE

Preferred Product Requirement Criteria Coverage varies across plans. Refer to the customer’s benefit plan document for coverage details. Where coverage requires the use of preferred products, the following criteria apply:

Approve for an individual when there is documentation of ONE of the following:

  • The individual has had inadequate efficacy OR contraindication according to FDA label OR significant intolerance to ALL of covered alternatives according to the table below OR
  • The individual is not a candidate for ALL covered alternatives according to the table below due to being subject to a warning per the prescribing information (labeling), having a disease characteristic, individual clinical factor[s], or other attributes/conditions or is unable to administer and requires this dosage formulation

Employer Group Non-Covered Products and Preferred Covered Alternatives by Drug List: Non-Covered Product

Standard / Performance

Value / Advantage

Cigna Total Savings

Legacy

Pepcid (famotidine)

Meets Multi-Source Brand Name Drugs Policy criteria* AND ONE of the following: cimetidine (tablet or solution), nizatidine (capsule or solution), or ranitidine (tablet, capsule, or syrup) *Documentation that individual has tried the bioequivalent generic product AND cannot take due to a formulation difference in the inactive ingredient(s) [for example, difference in dyes, fillers, preservatives] between the brand and the bioequivalent generic product which, per the prescribing physician, would result in a significant allergy or serious adverse reaction

Conditions Not Covered

Any other exception is considered not medically necessary

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  1. Ramakrishnan A, Katz PO. Pharmacologic management of gastroesophageal reflux disease. Curr Gastroenterol Rep. 2002;4(3):218-224.
  2. AGA Institute. American Gastroenterological Association medical position statement on the management of gastroesophageal reflux disease. Gastroenterol. 2008;135:1383-1391.
  3. Rosen R, Vandenplas Y, Singendonk M, et al. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2018;66(3):516-554.
  4. Lightdale JR, Gremse DE, and section on gastroenterology, hepatology, and nutrition. Gastroesophageal reflux disease: management guidance for the pediatrician. Pediatrics. 2013;131(5):e1684-1695.

“Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2021 Cigna.