CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Mavenclad (cladribine) — Coverage Criteria for Relapsing Multiple Sclerosis

Covers medical necessity and authorization criteria for Mavenclad (cladribine) for treatment of relapsing forms of multiple sclerosis for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMavenclad (cladribine) — Coverage Criteria for Relapsing Multiple Sclerosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date12/2019

Next Review DateN/A

Key ActionObtain prior authorization with documentation of neurologist involvement and prior inadequate response or intolerance to two MS disease-modifying therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

45 daysauthorization length

2max courses

43 weeksmin interval

20/270dquantity limit

Coverage Criteria for Mavenclad (cladribine)

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Initial Authorization Criteria: 1. Medication prescribed by or in consultation with a neurologist; 2. Inadequate response to, or unable to tolerate, two disease-modifying drugs indicated for the treatment of multiple sclerosis; 3. Member does not have clinically isolated syndrome (CIS); 4. Member has not received 2 courses (i.e., 4 cycles) of Mavenclad; 5. Member will not use Mavenclad concomitantly with other medications used for the treatment of multiple sclerosis (excluding Ampyra).45-day authorization

Initial authorization duration specified as 45 days

inv-02: Subsequent requests

Covered when ALL of the following are met:

Subsequent Authorization Criteria: 1. Medication prescribed by or in consultation with a neurologist; 2. Member has not received 2 courses (i.e., 4 cycles) of Mavenclad; 3. Member will not use Mavenclad concomitantly with other medications used for the treatment of multiple sclerosis (excluding Ampyra); 4. The member has not received Mavenclad in the last 43 weeks.45-day authorization

Subsequent authorization duration specified as 45 days

This policy applies to use of Mavenclad (cladribine) for treatment of relapsing forms of multiple sclerosis in Neighborhood Health Plan of Rhode Island members. Mavenclad is not recommended for clinically isolated syndrome (CIS) due to its safety profile, and uses outside FDA‑approved or compendial indications are considered experimental/investigational and are not covered.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial authorizations may be granted for up to 45 days when criteria are met.

Authorization applies to Mavenclad (cladribine) for relapsing forms of multiple sclerosis including relapsing‑remitting and active secondary progressive disease.

Prior Authorization

Subsequent Prior Authorization

Subsequent authorizations may be granted for up to 45 days when criteria are met. Requests must meet the documented clinical and timing requirements for continuation therapy.

Subsequent requests require neurologist involvement and review of prior treatment courses.
Member must not have received Mavenclad within the last 43 weeks.
Member must not have already received 2 courses (4 cycles) of Mavenclad.

Step Therapy

Step Therapy Preference

Step therapy expectation: try and fail appropriate alternatives prior to Mavenclad.

Because of Mavenclad's safety profile, it is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative FDA‑approved disease‑modifying therapies for MS.

Documentation Required

Required Documentation for Initial Requests

Initial prior authorization requests must document the neurologist involvement, prior therapies tried, and relevant clinical details to support medical necessity.

Prescribed by or in consultation with a neurologist.
Documentation of inadequate response to, or intolerance of, two disease‑modifying drugs indicated for treatment of multiple sclerosis.
Confirmation that the member does not have clinically isolated syndrome (CIS).
Statement that the member has not previously received 2 courses (4 cycles) of Mavenclad.
Plan showing Mavenclad will not be used concomitantly with other MS treatments (Ampyra excepted).

Documentation Required

Required Documentation for Subsequent Requests

For subsequent/renewal requests include documentation of prior course(s) and treatment response, clinician oversight, and timing since last dose.

Prescribed by or in consultation with a neurologist.
Documentation that the member has not received 2 courses (4 cycles) of Mavenclad.
Confirmation that Mavenclad will not be used concomitantly with other MS medications (Ampyra excepted).
Documentation showing the member has not received Mavenclad within the last 43 weeks.
Clinical notes describing response to prior Mavenclad course(s) and justification for additional treatment.

Denial Risk

Non‑Covered Indications

Non‑covered indications and investigational use are not eligible for authorization.

Mavenclad is not recommended for clinically isolated syndrome (CIS) and CIS is a non‑covered indication.
All other uses not FDA‑approved or supported by compendia are considered experimental/investigational and are not covered.

Background

Background: Mavenclad (cladribine) is an oral disease‑modifying therapy used in adults for relapsing forms of multiple sclerosis. Because of its safety profile, the drug is reserved for appropriate candidates and is not recommended for clinically isolated syndrome (CIS); other non‑approved indications are treated as experimental/investigational and not covered.

Definitions

Relapsing forms of MS — definition

Included disease typesRelapsing-remitting MS and active secondary progressive MS

Exclusion — CISClinically isolated syndrome (CIS) is not recommended for Mavenclad use

Scope of FDA indicationMavenclad indicated for relapsing forms of MS in adults

Non-covered usesAll other indications beyond relapsing forms of MS are considered experimental/investigational and not covered