CurrentCignaPolicy N/A

Bile Acid Sequestrants Step Therapy Policy

Defines step therapy requirements for bile acid sequestrant products for Cigna-administered health benefit plans; affects prescribers and pharmacists seeking coverage for listed agents.

Policy Summary

PayerCigna

PolicyBile Acid Sequestrants Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 18, 2025

Key ActionDocument that the patient has tried one Step 1 product to obtain authorization for a Step 2 product (approvals provided for 1 year).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2therapy steps (Step 1 and Step 2)

1 yearstandard approval duration

1prior Step 1 trial required

No criteria changesmost recent history note

Coverage Criteria

inv-01: Initial Step Therapy

Covered when ALL of the following are met

Step therapy requirement: Patient has tried one Step 1 product1 trial

If met, approve a Step 2 product for up to 1 year

Any use not meeting the Step Therapy criteria is considered not medically necessary. Coverage for bile acid sequestrant products is contingent on meeting the Step Therapy requirements described in this policy; if the Step Therapy rule is not met for a Step 2 product at the point of service, coverage will be determined by the Step Therapy criteria and any other exception is considered not medically necessary.

Exceptions that do not meet the specified Step Therapy criteria for Step 2 products are considered not medically necessary. The program requires trial of a Step 1 product before a Step 2 product will be covered; failure to document the required Step 1 trial means the request does not meet medical necessity under this policy.

Initial Therapy Criteria

Policy Summary

PayerCigna

PolicyBile Acid Sequestrants Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 18, 2025

Key ActionDocument that the patient has tried one Step 1 product to obtain authorization for a Step 2 product (approvals provided for 1 year).

SourceLink

On This Page

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Requirement	Details
Try one Step 1 product prior to Step 2
Step 1 products: cholestyramine oral suspension; colestipol oral suspension; colestipol micronized tablets; colesevelam tablets; colesevelam oral suspension; Prevalite oral suspension. If the patient has tried one Step 1 product, a Step 2 product may be approved for up to 1 year.

Coverage condition	Policy action
Step 2 products are available only after meeting the Step 1 trial
If the patient has tried one Step 1 product, approve a Step 2 product; all approvals are provided for 1 year. Any use not meeting the Step Therapy criteria is considered not medically necessary.

Provider Actions and Prior Authorization

Prior Authorization

Step Therapy Prior Authorization

Prior Authorization Required: Step therapy prior authorization is required for Step 2 products. Approvals are provided for 1 year.

Step 1 products must be tried before a Step 2 product will be approved.
If the patient has tried one Step 1 product, approve a Step 2 product.
Step 1 products: cholestyramine oral suspension; colestipol oral suspension; colestipol micronized tablets; colesevelam tablets; colesevelam for oral suspension; Prevalite oral suspension.
Step 2 products: Welchol tablets; Welchol for oral suspension; Questran oral suspension; Questran light oral suspension; Colestid oral suspension; Colestid micronized tablets.

Documentation Required

Documentation and Billing Requirements

Documentation & Billing: Providers must submit claims with appropriate procedure/diagnosis codes and supporting documentation demonstrating that step therapy criteria have been met.

Include documentation that the patient tried at least one Step 1 product (medication name, dates tried, and reason for discontinuation if applicable).
Use the most appropriate CPT/HCPCS/ICD-10/NDC codes as of the date of service.
Claims lacking covered codes or required documentation may be denied as not covered.

Denial Risk

Denial Risk for Unmet Step Therapy

Denial Risk if Step Criteria Unmet: If Step Therapy rule is not met at point of service for a Step 2 product, coverage will be determined by the Step Therapy criteria and may be denied if criteria are not satisfied.

Coverage determinations follow the Step Therapy criteria; exceptions not meeting criteria are considered not medically necessary.
All approvals are provided for one year in duration.

Definitions

Bile acid sequestrants — key definitions

DefinitionBile acid sequestrants: cholestyramine, colestipol, and colesevelam — agents that bind bile acids to reduce LDL-C.

Cholestyramine indicationAdjunctive therapy to diet for lowering serum cholesterol in primary hypercholesterolemia when diet or other measures alone are inadequate.

Colestipol indicationAdjunctive therapy to diet to reduce elevated total and LDL cholesterol in patients with primary hypercholesterolemia who do not respond adequately to diet.

Colesevelam adult indicationsAdjunct to diet and exercise to reduce elevated LDL-C in adults with primary hyperlipidemia (monotherapy or with a statin) and to improve glycemic control in adults with type 2 diabetes mellitus.

Colesevelam pediatric indicationApproved to reduce LDL-C in boys and postmenarchal girls aged 10–17 years with heterozygous familial hypercholesterolemia who cannot reach LDL-C targets despite diet and lifestyle modification (monotherapy or with a statin).

Background

Cholestyramine and colestipol are indicated as adjunctive therapies to diet for lowering elevated LDL-C in primary hypercholesterolemia when diet alone is inadequate; colesevelam is indicated as adjunct to diet and exercise for adults with primary hyperlipidemia and for glycemic control in type 2 diabetes, and is approved for certain pediatric patients with heterozygous familial hypercholesterolemia per product labeling. This Step Therapy policy has been developed to encourage use of a Step 1 product (for example, cholestyramine oral suspension, colestipol oral suspension, colestipol micronized tablets, colesevelam tablets, colesevelam oral suspension, Prevalite oral suspension) prior to a Step 2 product; all approvals are provided for 1 year.

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