ModifiedCignaPolicy N/A

Multiple Sclerosis Preferred Specialty Management Policy

Defines preferred and non-preferred specialty multiple sclerosis medications, prior authorization expectations, and exception criteria for Cigna-administered health benefit plans; affects providers requesting coverage for MS disease-modifying therapies.

Policy Summary

PayerCigna

PolicyMultiple Sclerosis Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeMaterial revisionsMavenclad program added

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of trial of generic cladribine and formulation-difference evidence when requesting brand Mavenclad.

SourceLink

POLICY UPDATE CHANGES

A new Mavenclad (Brand) Preferred Specialty Management Program was added which directs requests for brand Mavenclad to generic cladribine tablets.

Brand Mavenclad exception requires trial of generic cladribine and documentation that the patient cannot continue generic due to formulation difference in inactive ingredients causing significant allergy or serious adverse reaction.

Preferred Products and required trials for multiple sclerosis agents were revised (e.g., removal of some agents as Non-Preferred and requirement to try both generic glatiramer injection AND generic dimethyl fumarate delayed-release capsules).

Tecfidera (Brand) Preferred Specialty Management: generic dimethyl fumarate capsules will be auto-approved if patient met standard prior authorization criteria but has not tried the generic.

1 yearapproval duration for all approvals

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria and Exception Pathways

Mavenclad (Brand) Exception Criteria

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

Overall approval conditions: A) Patient meets the standard Multiple Sclerosis (Oral - Other) - Cladribine Prior Authorization Policy criteria; AND B) Patient meets BOTH of the following (i and ii):

B - brand-specific conditions: i. Patient has tried generic cladribine tablets [documentation required]; AND ii. Patient cannot continue to use generic cladribine tablets due to a formulation difference in the inactive ingredient(s) (e.g., differences in dyes, fillers, preservatives) between the Brand and the bioequivalent generic which, per the prescriber, would result in a significant allergy or serious adverse reaction [documentation required].

Any request for a non-preferred multiple sclerosis product that does not meet the specific non-preferred product exception criteria listed in this policy is considered not medically necessary.

If the patient meets the standard Multiple Sclerosis (Oral - Other) - Cladribine Prior Authorization Policy criteria but does not meet the brand-specific exception requirements for Mavenclad (i.e., the patient has not met both trial of generic cladribine tablets and documentation that the patient cannot continue the generic because of a formulation-difference-related significant allergy or serious adverse reaction), the policy directs approval of generic cladribine tablets rather than approval of the brand.

Any exception request that is not one of the explicitly listed non-preferred product exception criteria in this policy is considered not medically necessary.

Preferred Products and Coding Examples

Multiple Sclerosis Preferred Products (examples listed)mixed

No codes listed

Tecfidera (Brand) Preferred Program - Preferred Productmixed

No codes listed

S1P Preferred Program - Preferred Products (examples listed)mixed

No codes listed

Aubagio Preferred Program - Preferred Products (examples listed)mixed

No codes listed

Mavenclad Preferred Program - Preferred Product (generic cladribine)mixed

No codes listed

Provider Requirements, Step Therapy, and Documentation

Documentation Required

Documentation requirements

For all medications (Preferred and Non-Preferred), the patient is required to meet the respective standard Prior Authorization Policy criteria. Documentation may include, but is not limited to, chart notes, prescription claims records, prescription receipts, magnetic resonance imaging (MRI) reports, and/or other information. All documentation must include patient-specific identifying information.

Documentation must support trials of Preferred Products and reasons for discontinuation or inability to use Preferred Products.
Acceptable documentation examples: chart notes; prescription claims/receipts; MRI reports; other patient-specific clinical records.

Documentation Required

Mavenclad (Brand) prior authorization and required documentation for brand exception

Brand Mavenclad requests require prior authorization and will be approved for 1 year only if the patient meets the standard Multiple Sclerosis (Oral - Other) - Cladribine Prior Authorization criteria and provides documentation that the patient has: (1) tried generic cladribine tablets and (2) cannot continue to use the generic due to a formulation difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives) that, per the prescriber, would result in a significant allergy or serious adverse reaction.

Preferred Product Definitions

Preferred Products

DefinitionProducts favored by each program intended to be tried before Non-Preferred branded products (examples include generic glatiramer injection, generic dimethyl fumarate delayed‑release capsules, generic fingolimod, generic teriflunomide, generic cladribine).

PurposeEncourage use of clinically appropriate generic (Preferred) products prior to approval of Non‑Preferred branded therapies to manage cost and utilization.

Examples (preferred)Generic glatiramer injection; generic dimethyl fumarate delayed‑release capsules; generic fingolimod capsules; generic teriflunomide tablets; generic cladribine tablets.

Exception pathway impactBrand products may be approved only if specific exception criteria are met (e.g., trial of Preferred product and documented inability to continue due to formulation‑difference‑related allergy or serious adverse reaction).

Related requirementFor all medications (Preferred and Non‑Preferred), patients must meet the respective standard Prior Authorization Policy criteria; approvals are generally for 1 year.

Policy Background and Scope

This policy applies to selected self‑administered injectable and oral disease‑modifying therapies (DMTs) for multiple sclerosis in adults. It establishes preferred versus non‑preferred products and exception pathways that require prior authorization and, when applicable, documentation of trials, intolerance, or formulation‑difference‑related allergic reactions.

Policy Summary

PayerCigna

PolicyMultiple Sclerosis Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeMaterial revisionsMavenclad program added

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of trial of generic cladribine and formulation-difference evidence when requesting brand Mavenclad.

SourceLink

On This Page

Step Therapy

Step therapy requirement — Mavenclad directed to generic cladribine

Step therapy: Requests for brand Mavenclad will be directed to the Preferred Product (generic cladribine tablets). Brand Mavenclad will only be approved if the patient has tried the generic cladribine tablets and meets the exception documentation described above; otherwise, approve the generic cladribine tablets when standard prior authorization criteria are met.

If patient meets standard Cladribine PA criteria but has not tried the generic, approval will be for the generic cladribine tablets.
All approvals are provided for 1 year.
Offers to review for Preferred Products will be made when a patient requesting a Non-Preferred Product has not tried the Preferred Product(s).