CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy and prior authorization for Vumerity (diroximel fumarate)

Defines step therapy requirements and authorization criteria for coverage of Vumerity for treatment of relapsing forms of multiple sclerosis for members under UnitedHealthcare Pharmacy clinical programs; affects prescribers and pharmacy benefit adjudication.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy and prior authorization for Vumerity (diroximel fumarate)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionPrior authorization is required and will be issued for 12 months when the step therapy criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

1 + 2step therapy

8/1/25effective

majority excludedcoverage exclusion

Coverage Determinations for Vumerity (diroximel fumarate)

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Initial Therapy — Vumerity will be approved based on both of the following:

Vumerity will be approved based on both of the following:

Overall requirement: Approval requires both Node A and Node B

Node A: Trial and failure (after trial of at least 4 weeks), contraindication, or intolerance to both Bafiertam (monomethyl fumarate) AND dimethyl fumarate (generic Tecfidera) with trial date that started August 20, 2020 or later; document drug, date, and duration of trial.>=4 weeks or documented contraindication/intolerance

dimethyl fumarate trial date requirement: started August 20, 2020 or later

Node B: Trial and failure (after trial of at least 4 weeks), contraindication, or intolerance to at least two of the following agents: glatiramer acetate, interferon β-1a, interferon β-1b, peginterferon β-1a, teriflunomide, siponimod, fingolimod, ozanimod, ofatumumab; document drug, date, and duration of trial.>=4 weeks or documented contraindication/intolerance

At least two agents from the enumerated list are required.

Step	Requirement
1
Member must trial Bafiertam (monomethyl fumarate) or dimethyl fumarate AND at least two additional preferred multiple sclerosis therapies (choose at least two from: glatiramer acetate; interferon β-1a [Avonex]; interferon β-1b [Betaseron]; peginterferon β-1a [Plegridy]; teriflunomide [Aubagio]; siponimod [Mayzent]; fingolimod [Gilenya]; ozanimod [Zeposia]; ofatumumab [Kesimpta]). Trials must be for at least 4 weeks unless a documented contraindication or intolerance is present; provider must document drug name, start date, and duration of each trial.

Provider Responsibilities and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be issued for 12 months when the step therapy criteria are met. State mandates, federal regulatory requirements, and the member's benefit plan may affect coverage. Authorization may be based on previous claims/medication history, diagnosis codes, and/or claim logic where applicable.

Authorization duration: 12 months
State/federal/member benefit plan may alter coverage

Step Therapy

Step Therapy Program

Member must trial and fail (after at least a 4-week trial), have a documented contraindication, or demonstrate intolerance to Bafiertam (monomethyl fumarate) and dimethyl fumarate before Vumerity will be approved. In addition, the member must trial and fail (after at least a 4-week trial), have a documented contraindication, or demonstrate intolerance to at least two other preferred MS medications from the list below.

Required initial trials: Bafiertam (monomethyl fumarate) and dimethyl fumarate (generic Tecfidera) — dimethyl fumarate trial date must have started August 20, 2020 or later
Plus trial of ≥2 of: glatiramer acetate; interferon β-1a (Avonex, Rebif); interferon β-1b (Betaseron); peginterferon β-1a (Plegridy); teriflunomide (Aubagio); Mayzent (siponimod); fingolimod (Gilenya); Zeposia (ozanimod); Kesimpta (ofatumumab)

Documentation Required

Required Documentation

Provider must document the drug name, start date, and duration of trial for Bafiertam and dimethyl fumarate, and for each of at least two of the listed alternative MS therapies. Documentation must also support reasons for discontinuation (failure), contraindication, or intolerance where applicable.

Document: drug name, trial start date, and duration for Bafiertam and dimethyl fumarate
Document: drug name, trial start date, and duration for at least two alternate agents from the required list
If claiming contraindication/intolerance, provide clinical rationale and supporting documentation

Denial Risk

Denial Triggers

Requests may be denied if the member has not trialed and failed (after at least 4 weeks) the required agents or if contraindications/intolerances are not adequately documented. Note that Vumerity may be excluded from coverage under some benefit plans; verify member-specific benefits and any applicable exclusions or supply limits.

Denial triggers: missing/insufficient trials of Bafiertam and dimethyl fumarate or fewer than two alternate agents
Denial triggers: lack of documented contraindication or intolerance when claimed
Verify member benefit exclusions — Vumerity may be excluded under many benefits

Initial Authorization Criteria

Initial Therapy — Initial authorization conditions

Initial authorization conditions

Initial authorization: Provider must document drug name, date, and duration of each trial. Trials should be at least 4 weeks unless a contraindication or intolerance is documented. UnitedHealthcare may consider previous claim/medication history, diagnosis codes, and/or claim logic in lieu of documented trials.>=4 weeks or documented contraindication/intolerance

Document trials for Bafiertam and dimethyl fumarate (dimethyl fumarate trial must have started August 20, 2020 or later) and for at least two additional agents from the list.

Step therapy requirement: Member must have trialed and had failure of, or have a contraindication or intolerance to, both Bafiertam (monomethyl fumarate) and dimethyl fumarate (generic Tecfidera) AND at least two of the listed alternative disease‑modifying therapies prior to approval.

See enumerated agent list in the Initial Therapy criteria; document dates and durations of trials.

Reauthorization / Continuation Criteria

Reauthorization — Reauthorization rules and required follow-up for continued coverage

Reauthorization rules

Reauthorization: Authorization will be issued for 12 months. UnitedHealthcare may approve initial and reauthorization based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic. State mandates and the member's benefit plan may impact coverage.12 months

Other policies, utilization management programs, medical necessity, supply limits, and notification requirements may apply.

Key Definitions

Relapsing forms of MS — definition

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

Typical indicationsDisease‑modifying therapies such as Vumerity (diroximel fumarate), dimethyl fumarate, Bafiertam (monomethyl fumarate), and listed alternatives are indicated for these relapsing forms of MS.

PopulationAdults with clinically isolated syndrome, relapsing‑remitting MS, or active secondary progressive MS.

Relevance to policyPolicy step therapy and prior authorization criteria apply when Vumerity is prescribed for relapsing forms of MS.

Examples of alternative therapiesGlatiramer acetate; interferon β‑1a (Avonex); interferon β‑1b (Betaseron); peginterferon β‑1a (Plegridy); teriflunomide (Aubagio); siponimod (Mayzent); fingolimod (Gilenya); ozanimod (Zeposia); ofatumumab (Kesimpta).

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