CurrentCignaPolicy N/A

Betaine anhydrous (Cystadane) coverage

Defines Cigna's preferred specialty management and prior authorization requirements for betaine anhydrous powder (Cystadane and generic) for treatment of homocystinuria, including exception criteria for non-preferred products.

Policy Summary

PayerCigna

PolicyBetaine anhydrous (Cystadane) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization and documentation showing trial of the preferred generic betaine anhydrous powder and reasons a non-preferred product is required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration for non-preferred exception

Preferred/Non-Preferredproduct categories listed

Requireddocumentation

09/11/2024policy review

Coverage Criteria for Betaine Anhydrous (Cystadane)

Non-Preferred Product Exception Criteria (Cystadane)

Cystadane (non-preferred) is covered as medically necessary when ALL of the following are met:

Overall: Approve for 1 year if the patient meets BOTH of the following (A and B)

A: Patient meets the standard Metabolic Disorders - Betaine Anhydrous PA Policy criteria

See referenced PA policy

B: Patient meets BOTH of the following (i and ii)

i: Patient has tried generic betaine anhydrous powder

Policy Summary

PayerCigna

PolicyBetaine anhydrous (Cystadane) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization and documentation showing trial of the preferred generic betaine anhydrous powder and reasons a non-preferred product is required.

SourceLink

On This Page

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Documentation required

ii: Patient cannot continue to use the Preferred Product due to a formulation difference in the inactive ingredient(s) which, according to the prescriber, would result in a significant allergy or serious adverse reaction

Documentation required (e.g., differences in the stabilizing agent, buffering agent, and/or surfactant)

Any exception beyond the specified non-preferred product exception criteria is considered not medically necessary. This policy defines the only circumstances under which the non-preferred product (Cystadane) may be approved; requests that do not meet those criteria will be denied.

Requests for non-preferred betaine anhydrous products that do not meet the stated non-preferred product exception criteria are considered not medically necessary and will not be approved.

Provider Requirements and Authorization

Prior Authorization

Prior authorization required

All medications, including both Preferred and Non-Preferred betaine anhydrous products, require prior authorization under the standard Metabolic Disorders - Betaine Anhydrous prior authorization policy.

Prior Authorization

Cystadane prior authorization (exception)

Approvals for the non-preferred product Cystadane are granted for 1 year only when the patient meets the non-preferred product exception criteria (both A and B must be met).

A: Patient meets the standard Metabolic Disorders - Betaine Anhydrous PA Policy criteria.
B: Patient has tried generic betaine anhydrous powder and cannot continue the Preferred Product due to a formulation difference in inactive ingredients causing a significant allergy or serious adverse reaction (documentation required).

Step Therapy

Try preferred before non-preferred

The program requires the patient to try one Preferred Product (generic betaine anhydrous powder) before approval of a Non-Preferred Product; exception criteria apply if the preferred product cannot be used.

If the patient has not tried a Preferred Product, approval for a Preferred Product will be authorized.
Exception criteria permit non-preferred approval when preferred product trial is documented and a formulation difference prevents continued use.

Documentation Required

Required documentation

Documentation is required to support use of betaine anhydrous powder, including evidence the patient tried the preferred generic product and that a formulation difference would cause a significant allergy or serious adverse reaction.

Documentation examples: chart notes, prescription claims records, prescription receipts, and/or other information.
Documentation is required where noted in the criteria (e.g., trial of generic product and prescriber statement about formulation-related allergy/adverse reaction).

Denial Risk

Non-Preferred Product Denial Risk

Requests for the non-preferred product Cystadane that do not meet the stated non-preferred product exception criteria are considered not medically necessary and will be denied.

Background

Betaine anhydrous powder (Cystadane, generic) is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Use of Cystadane (a non-preferred product) is subject to the program’s non-preferred product exception criteria, which require meeting the standard Metabolic Disorders - Betaine Anhydrous prior authorization criteria and specific documented reasons why the preferred generic formulation cannot be used.

Definitions

Cystadane / betaine anhydrous powder — definition

Generic nameBetaine anhydrous powder

Brand nameCystadane

Drug class/mechanismMethylating agent

IndicationTreatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients

FormulationPowder