ModifiedCentenePolicy CP.PCH.41

Dimethyl Fumarate (Tecfidera), Diroximel Fumarate (Vumerity), Monomethyl Fumarate (Bafiertam)

Defines prior authorization and medical necessity criteria for Tecfidera, Vumerity, and Bafiertam for treatment of relapsing forms of multiple sclerosis in adults for Centene Commercial and HIM lines of business.

Policy Summary

PayerCentene

PolicyDimethyl Fumarate (Tecfidera), Diroximel Fumarate (Vumerity), Monomethyl Fumarate (Bafiertam)

Policy CodePolicy CP.PCH.41

Change TypeAdded productrevised redirection and justification language

Effective DateFeb 1, 2021

Next Review Date

Key ActionSubmit prior authorization with office notes, labs, baseline relapse count and EDSS; justify why generic dimethyl fumarate cannot be used for brand Tecfidera requests when applicable.

SourceLink

POLICY UPDATE CHANGES

Added Bafiertam to the policy and retired CP.PHAR.460.

Revised medical justification language to require use of the generic product.

Clarified requirement that medical justification for why generic dimethyl fumarate cannot be used applies only to brand Tecfidera requests.

Revised continued approval duration to reference the duration of total treatment received rather than number of re-authorizations to accommodate members continuing therapy from a different benefit.

3products listed

6 moinitial approval

12 mocontinued approval

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Coverage Criteria — Medical Necessity

Initial Therapy

Covered when ALL of the following are met:

Initial MS diagnosis: Member has a diagnosis of clinically isolated syndrome, relapsing‑remitting MS, or secondary progressive MS

Diagnosis must be one of a, b, or c in policy

CIS special requirement for Vumerity or Bafiertam: If request is for Vumerity or Bafiertam for clinically isolated syndrome, member is contraindicated to both, or has experienced clinically significant adverse effects to one, of the following at up to maximally indicated doses: an interferon‑beta agent (Avonex, Betaseron/Extavia, Rebif, or Plegridy) or glatiramer (Copaxone, Glatopa)

applies only to CIS requests for Vumerity/Bafiertam

RRMS requirement for Vumerity or Bafiertam: If request is for Vumerity or Bafiertam for relapsing‑remitting MS: failure of all of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: (1) dimethyl fumarate (generic Tecfidera); (2) Aubagio; (3) Gilenya; (4) an interferon‑beta agent (Avonex, Betaseron/Extavia, Rebif, or Plegridy) or glatiramer (Copaxone, Glatopa)

Prior authorization is required for all disease‑modifying therapies for MS

Prescriber and age: Prescribed by or in consultation with a neurologist; age ≥ 18 yearsage >= 18

Brand Tecfidera restriction: For brand Tecfidera requests, member must use generic dimethyl fumarate unless contraindicated or clinically significant adverse effects are experienced

No concurrent DMTs: Requested agent is not prescribed concurrently with other disease modifying therapies for MS

See Appendix D for list

Baseline documentation: Documentation of baseline number of relapses per year and expanded disability status scale (EDSS) score

Dose limits: Starting and maintenance dose limits must not be exceeded: Starting (first 7 days): Tecfidera 240 mg/day, Vumerity 462 mg/day, Bafiertam 190 mg/day; Maintenance: Tecfidera 480 mg/day, Vumerity 924 mg/day, Bafiertam 380 mg/daySee dosing thresholds

Starting: 7‑day titration; Maintenance limits specified

Continuation Therapy

Covered when ALL of the following are met:

Previous approval or continuity: Member is currently receiving medication via Centene benefit or previously met initial approval criteria, or is enrolled in a state/product with continuity of care regulations

Response criteria depending on duration: If member has received < 1 year of total treatment: member is responding positively to therapy; If member has received ≥ 1 year of total treatment: member meets one of the following: (i) no increase in number of relapses per year compared to baseline; (ii) has not had ≥ 2 new MRI‑detected lesions; (iii) has not had an increase in EDSS score from baseline; (iv) medical justification supports that member is responding positively to therapy

Nodes for ≥1 year contain multiple options

Brand Tecfidera restriction for continuation: For brand Tecfidera requests, member must use generic dimethyl fumarate unless contraindicated or clinically significant adverse effects are experienced

Not Medically Necessary / Not Authorized

Not authorized indications:

Excluded indications: Primary progressive MS and non‑FDA approved indications not addressed in this policy (unless sufficient off‑label documentation per CP.CPA.09 or HIM.PA.154 or evidence of coverage documents are provided) are not authorized

See CP.CPA.09 or HIM.PA.154 for off‑label documentation pathways

Requests for therapy with dimethyl fumarate, diroximel fumarate, or monomethyl fumarate for primary progressive multiple sclerosis (PPMS) are not authorized. This exclusion is explicit in the policy and applies regardless of prior treatment history or documentation submitted for other forms of MS.

Per the policy modification notes (2Q 2021 and related amendments), the prior redirection to Mayzent (siponimod) was removed. The policy now specifies alternative redirection and step therapy requirements for relapsing‑remitting MS that do not include Mayzent as a required substitute.

Use of these agents for non‑FDA approved indications that are not addressed in this policy is not authorized unless the request is supported by sufficient off‑label documentation following the referenced off‑label use policies (CP.CPA.09 for Commercial or HIM.PA.154 for HIM). Absent that documentation, requests for unapproved indications may be denied.

Product Coding, Strengths, and Dosing

NDC (not listed)NDC

Not listed

NDC not listed in source

Product strengthsmixed

Tecfidera	120 mg, 240 mg delayed-release capsules
Vumerity	231 mg delayed-release capsule
Bafiertam	95 mg delayed-release capsule

Maximum daily maintenance doses

Dimethyl fumarate (Tecfidera)Maximum maintenance dose: 480 mg/day (240 mg PO BID); 2 capsules per day

Diroximel fumarate (Vumerity)Maximum maintenance dose: 924 mg/day (462 mg PO BID); 4 capsules per day

Monomethyl fumarate (Bafiertam)Maximum maintenance dose: 380 mg/day (190 mg PO BID); 4 capsules per day

Starting dose (first 7 days)

Dimethyl fumarate (Tecfidera)Starting dose (first 7 days): 120 mg PO BID (240 mg/day); 2 capsules per day

Diroximel fumarate (Vumerity)Starting dose (first 7 days): 231 mg PO BID (462 mg/day); 2 capsules per day

Provider Actions, Prior Authorization and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for dimethyl fumarate (Tecfidera®), diroximel fumarate (Vumerity®), and monomethyl fumarate (Bafiertam™). Providers must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria before therapy is authorized.

Affected products: Tecfidera, Vumerity, Bafiertam
Approval requires documentation of baseline relapses per year and EDSS score
Requests for brand Tecfidera require trial of generic dimethyl fumarate unless contraindicated or clinically significant adverse effects documented

Step Therapy

Prior Authorization and Redirection Requirements

Requests may be redirected to generic dimethyl fumarate or denied if step-therapy/redirection requirements are not met. For relapsing‑remitting MS, Vumerity (and other brand agents when specified) requires documented failure of or contraindication to listed alternatives at maximally indicated doses prior to approval.

Background

Tecfidera (dimethyl fumarate), Vumerity (diroximel fumarate), and Bafiertam (monomethyl fumarate) are members of the class of Nrf2 activators indicated for treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS. Tecfidera and Vumerity are prodrugs of Bafiertam and each product has specific prescribing information referenced in the policy.

Definitions

inv-20: Expanded Disability Status Scale (EDSS)

DefinitionExpanded Disability Status Scale (EDSS).

PurposeStandardized scale to quantify disability in multiple sclerosis across neurologic functional systems.

Use in policyBaseline EDSS score is required documentation to support initial and continuation coverage determinations.

inv-21: Disease-modifying therapies (DMTs)

DefinitionDisease-modifying therapies (DMTs): therapies intended to modify the course of multiple sclerosis.

Examples referencedIncludes interferons, glatiramer, fingolimod, teriflunomide, dimethyl/diroximel/monomethyl fumarates and others as listed in Appendix B or prescribing information.