Multiple Sclerosis — Disease‑Modifying Therapies
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Defines prior authorization, preferred‑drug sequencing, and medical necessity criteria for disease‑modifying therapies for relapsing and other forms of multiple sclerosis for Blue Cross Blue Shield - Iowa members.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Initial Approval — listed DMTs
Agents may be considered medically necessary for members diagnosed with a relapsing form of multiple sclerosis (including relapsing‑remitting and secondary progressive disease with ongoing relapses).
Approval durations specified per agent elsewhere in policy
Mavenclad (cladribine) Initial Approval
Mavenclad (cladribine) may be considered medically necessary when ALL of the following are met:
Approval will be for 90 days
Ocrevus / Ocrevus Zunovo initial/indication-specific criteria
Ocrevus (ocrelizumab) and Ocrevus Zunovo may be considered medically necessary for the following diagnoses:
Approval durations: see policy (90 days for some indications; 12 months for others)
Lemtrada (alemtuzumab) Initial and Subsequent Courses
Alemtuzumab (Lemtrada) courses:
Approval for first course: 30 days (5 doses)
Approval for subsequent course: 30 days (3 doses)
Continuation Therapy — general
Continuation of therapy:
Approval will generally be for 12 months
Mavenclad Continuation
Mavenclad continuation-specific criteria (must meet ALL):
Approval will be for 90 days
Non‑Formulary Exception / Coverage Conditions
Non‑Formulary Exception Criteria and general coverage conditions when requesting non‑formulary MS medications
Diagnostic testing/lab results and supporting documentation required when applicable
Quantity limits and dosing
Quantity limits and dosing frameworks applied to specific products
Approvals may be subject to dosing limits in accordance with FDA labeling and accepted compendia
Members must not use the requested medication concomitantly with other disease‑modifying multiple sclerosis agents. Requests that propose concurrent use with another DMT are subject to denial. (Note: Ampyra and Nuedexta are not disease‑modifying agents and are exempted from this prohibition.)
This policy may not apply to members covered under the Federal Employee Program (FEP). Benefit determinations for FEP members are governed by the Federal Employee Program and not by this policy.
Non‑formulary medications will only be considered for coverage when the request meets the standard Criteria for Approval and the Non‑Formulary Exception Criteria. The non‑formulary exception requires that the requested drug be used for an FDA‑approved indication or an indication supported in accepted compendia, that the prescribed dose/quantity fall within FDA labeling or compendia dosing guidance, and that all covered formulary alternatives have been shown to be ineffective, not as effective, caused adverse effects, or are contraindicated — with supporting documentation of prior treatment failure, dosage/duration, or severity of adverse events.
Drugs included in this policy are considered not medically necessary for members who do not meet the specific initial or continuation criteria described in the policy. Failure to satisfy the applicable criteria for the requested agent will result in a determination of not medically necessary.
Requests that lack required documentation to support prior formulary alternative failure, intolerance, contraindication, or appropriate indication/dosing may be considered not medically necessary. For non‑formulary exception requests, documentation must include chart notes or other records showing prior treatment failure (including dosage and duration), the severity of any adverse events, or documentation of contraindication to formulary alternatives; diagnostic testing or laboratory results should be provided when applicable.
Procedures and Billing Codes
| J0202 | Injection, alemtuzumab, 1 mg |
| J2323 | Injection, natalizumab, 1 mg |
| J2350 | Injection, ocrelizumab, 1mg |
| J2351 | Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq (effective 4/1/2025) |
| J2329 | Injection, ublituximab-xiiy, 1 mg |
| Q5134 | Inj, tyruko, 1 mg |
| J3590 | Unclassified biologicals |
| C9399 | Unclassified drugs or biologicals |
Prior Authorization, Documentation, and Step Therapy
Obtain prior authorization from plan
Prior authorization is required. The medication must be prescribed by or in consultation with a neurologist or other prescriber specializing in the treatment of multiple sclerosis, and the initial submission must include required documentation of prior therapies and responses.
- Prescriber specialty: neurologist or MS specialist or consultative documentation
- Include prior therapy history and responses with the initial request
Submit prior authorization plus non‑formulary exception when applicable
For non‑formulary medications, submit a prior authorization request that meets the policy Criteria for Approval and the Non‑Formulary Exception Criteria; approvals may be subject to dosing/quantity limits consistent with FDA labeling and accepted compendia.
- Document that the requested drug is for an FDA‑approved indication or supported compendia indication
- Prescribed dose/quantity must fall within FDA labeling or compendia dosing guidelines
- Provide required prior therapy documentation (see non‑formulary exception details)
Meet preferred‑product step therapy before targeted agents
Use of the plan's preferred multiple sclerosis products is required before requesting nonpreferred/targeted products unless documented clinical circumstances justify bypass (e.g., inadequate response, intolerable adverse effects, or current positive response on the nonpreferred agent).
- Preferred products list includes Avonex, Betaseron, Kesimpta, Mayzent, Plegridy, Ponvory, Rebif, Vumerity, Zeposia, etc.
- Provide documentation of inadequate response or intolerable adverse effect to preferred products to bypass step therapy
Document failure/intolerance of formulary alternatives for non‑formulary coverage
To obtain coverage of a non‑formulary drug, document that all covered formulary alternatives were ineffective, less effective, caused adverse effects, or are contraindicated; include dosage and duration of prior treatments.
- Chart notes or other documentation showing prior treatment failure with dosage and duration
- Documentation of severity of adverse events if adverse effects prompted switch or discontinuation
- If contraindicated, provide supporting clinical rationale
Include complete clinical documentation with initial requests
For initial prior authorization requests submit chart notes, medical records, or claims history showing prior medications tried (if applicable) and response to therapy; if therapy is inadvisable, provide clinical reason to avoid the therapy.
- Include prior medication history and clinical response
- If requesting to avoid a therapy, include documented clinical reason
Provide documentation of clinical benefit for continuation
For continuation requests submit chart notes or medical record documentation supporting positive clinical response or remission while on the requested medication.
- Evidence of disease stability or improvement
- For agents with specified continuation rules (e.g., Mavenclad, Lemtrada), ensure continuation-specific criteria are documented
Submit supporting records for non‑formulary exception requests
For non‑formulary exception requests include documentation that formulary alternatives were ineffective, not tolerated, or contraindicated, and provide dosage and duration of prior treatments and severity of adverse events when applicable.
- Chart notes or other records indicating prior treatment failure with dosage and duration
- Severity and nature of adverse events if intolerance is claimed
- Diagnostic testing/lab results when relevant
Required evidence for non‑formulary exception decisions
Documentation supporting a non‑formulary exception must include chart notes or other records showing prior treatment failure, severity of adverse events, dosage and duration of prior treatment, or contraindication to formulary alternatives; include diagnostic testing/lab results when applicable.
- Specific prior treatment dates, doses, and duration
- Clinical notes describing ineffectiveness or adverse events
- Relevant lab or diagnostic test results if required by indication
Do not prescribe concomitant DMTs
Members must not use the requested medication concomitantly with other disease‑modifying multiple sclerosis agents; prior authorization requests proposing concomitant DMT use may be denied.
- Ampyra and Nuedexta are not disease‑modifying and are exceptions to this prohibition
- Ensure chart notes and medication lists reflect no concurrent DMTs
Risk of denial if criteria are not met
Drugs will be considered not medically necessary and may be denied if the member does not meet the specific initial or continuation criteria outlined in the policy.
- Verify diagnosis (relapsing form of MS) and all agent‑specific criteria before submission
- Failure to meet agent‑specific thresholds (e.g., prior courses, lab values, timing) risks denial
Non‑formulary denial triggers
Non‑formulary requests may be denied if the drug is not for an FDA‑approved indication or an indication supported in accepted compendia, if dosing exceeds FDA/compendia guidance, or if documentation does not show formulary alternatives were ineffective, contraindicated, or caused adverse effects.
- Confirm indication is FDA‑approved or supported by accepted compendia (AHFS, Micromedex, guidelines)
- Ensure prescribed dosing/quantity aligns with FDA labeling or compendia
- Provide clear documentation of prior formulary alternative failure or contraindication
Background and Scope
This policy governs prior authorization, preferred‑drug sequencing, and medical necessity criteria for disease‑modifying therapies (DMTs) used to treat relapsing forms of multiple sclerosis, including relapsing‑remitting and secondary progressive disease in patients who continue to experience relapses, as well as related indications referenced in the policy. It groups FDA‑approved and generic DMTs into preferred and nonpreferred lists, defines documentation and prior authorization requirements, and specifies product‑specific limits and approval durations.
Key Definitions
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