CurrentAvMedPolicy N/A

Prior Authorization and Step-Edit Requirements for Multiple Sclerosis (MS) Drugs

Form and criteria governing prior authorization and step-edit requirements for specific disease-modifying therapies (DMTs) for multiple sclerosis for AvMed members; applies to prescribing providers and specialty pharmacy processing requests.

Policy Summary

PayerAvMed

PolicyPrior Authorization and Step-Edit Requirements for Multiple Sclerosis (MS) Drugs

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 30, 2025

Key ActionComplete and submit the AvMed PA form with prescriber signature and required clinical documentation, including prior DMT history and necessary labs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12listed MS drugs on form

2required prior treatment failures

1/dayMayzent limit

2 coursesMavenclad lifetime limit

>=800/µLMavenclad lymphocyte threshold

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.

Drug-specific Coverage Criteria

Extavia & Rebif: Prior therapy requirement

Criteria for Extavia and Rebif approval (interferon beta-1b and interferon beta-1a):

Extavia/Rebif approval

Required prior therapies: Select two tried/failed therapies from the enumerated list (Avonex, Betaseron, Plegridy)2
Check each therapy tried on the PA form

Bafiertam & Ponvory: Prior therapy requirement

Criteria for Bafiertam and Ponvory approval:

Bafiertam/Ponvory approval

Required prior therapies: Select two tried/failed therapies from the enumerated list (e.g., dimethyl fumarate, glatiramer acetate, fingolimod, teriflunomide, Vumerity, Zeposia, Kesimpta)2
Check each therapy tried on the PA form

Interferons and selected agents: Prior therapy requirement

Criteria for Avonex, Betaseron, Kesimpta, Plegridy, Vumerity, and Zeposia approval:

Interferons and selected agents approval

Required prior therapy: Select one tried/failed generic DMT from the list (e.g., dimethyl fumarate, glatiramer acetate, fingolimod, teriflunomide)1
Check each therapy tried on the PA form

Mayzent: Approval criteria

Mayzent-specific criteria:

Mayzent approval

Relapsing MS diagnosis: Member has ONE of: Relapsing‑remitting MS (RRMS), Active Secondary‑progressive MS (SPMS), or Clinically Isolated Syndrome (CIS)
Required prior therapies: Select two tried/failed therapies from the enumerated list (dimethyl fumarate, glatiramer acetate, fingolimod, teriflunomide, Vumerity, Zeposia, Kesimpta)2
Prescriber attestations: NO CYP2C9*3/*3 genotype; NO recent (6 months) myocardial infarction/unstable angina/stroke/TIA/decompensated heart failure/Class III/IV heart failure; NO Mobitz II or 3rd degree AV block or sick sinus syndrome unless pacemaker; NO concurrent use with other MS DMTs; NOT given concurrently with live vaccines

Cladribine (Mavenclad): Approval criteria and limits

Cladribine (Mavenclad) approval criteria and administration limits:

Mavenclad initial and lifetime use

Weight and labs: Prescriber must provide current weight and date; submit baseline LFTs and CBC with differential including lymphocyte count
Lymphocyte thresholds: Lymphocytes must be within normal limits before 1st treatment course and must be >= 800 cells per microliter before 2nd treatment course>= 800 cells per microliter
Lifetime and safety attestations: Attest member has not previously received 2 treatment courses; member does not have CIS; no current malignancy; negative pregnancy test if applicable; no active chronic infection; no concurrent DMTs; no live vaccines concurrent

The following member-level exclusions and clinical conditions must be confirmed on the PA form before cladribine (Mavenclad) will be approved. Prescriber must attest that the member has NOT previously received the FDA-recommended lifetime limit of 2 treatment courses (4 treatment cycles), that the member does NOT have clinically isolated syndrome (CIS), and that there is NO current diagnosis of malignancy. The prescriber must also attest to a negative pregnancy test for women of child-bearing potential, that the member does NOT have active chronic infection (e.g., hepatitis, tuberculosis, HIV), and that the member is not receiving concurrent MS disease-modifying therapies. Finally, the prescriber must confirm the medication will NOT be given concurrently with live vaccines.

Key Coding & Laboratory Thresholds

inv-07: Lymphocyte count before 2nd Mavenclad course

Required lymphocyte count before 2nd Mavenclad course>= 800 cells per microliter

Lymphocytes before 1st courseWithin normal limits (baseline CBC with differential required)

Documentation requiredSubmit lab documentation of lymphocyte count prior to 2nd treatment course

inv-08: Mayzent age

Minimum age for Mayzent use>= 18 years

Prescriber specialty requirementMedication prescribed by a neurologist

Confirmed diagnosis requirementMember must have a confirmed relapsing form of MS (RRMS, active SPMS, or CIS where specified)

Provider Responsibilities & Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed multiple sclerosis (MS) medications. Complete the AvMed PA/Step-Edit form fully, including prescriber signature (hand-signed; preprinted stamps not valid). Incomplete, incorrect, or illegible forms — or missing required administrative fields (member identifiers, prescriber contact, NPI) — may delay or result in denial.

Fax completed form to 1-305-671-0200
Prescriber signature and printed name required; date must be provided
Include Member AvMed #, member name, date of birth, prescriber name, office contact, phone and fax, and prescriber NPI

Step Therapy

Step-edit / Prior Therapy Requirements

Many MS agents on this form require prior therapy (step-edit) documentation. For approval, the prescriber must document trials and outcomes (failure, intolerance, or contraindication) of the specific DMTs listed for the requested drug.

For Extavia® and Rebif®: documented failure/contraindication/intolerance to TWO specified DMTs (e.g., Avonex®, Betaseron®, Plegridy®)
For Bafiertam™ and Ponvory™: documented failure/contraindication/intolerance to at least TWO specified DMTs (e.g., Tecfidera®, Glatopa®/Copaxone®, Gilenya®, Aubagio®, Vumerity®, Zeposia®, Kesimpta®)
For Avonex®, Betaseron®, Kesimpta®, Plegridy®, Vumerity®, Zeposia®: documented failure/contraindication/intolerance to at least ONE generic DMT (e.g., Tecfidera®, Glatopa®/Copaxone®, Gilenya®, Aubagio®)
For Mayzent® and other agents: follow drug-specific step-therapy checks listed on the form

Documentation Required

Required Clinical Documentation

Submit supporting clinical documentation with the PA form. Chart notes and required labs must be provided to demonstrate criteria are met; lack of these documents may result in denial.

Chart notes supporting diagnosis and prior therapy trials must be attached
For cladribine (Mavenclad®): submit baseline LFTs and CBC with differential including lymphocyte count; lymphocytes must be within normal limits before first course and ≥800 cells/µL before second course
Provide date and value for member weight when required by the specific drug criteria

Note

Administrative Data Required

Administrative fields on the form must be complete and legible to avoid processing delays.

Include member identifiers (AvMed #, DOB, name) and ICD code/diagnosis where applicable
Provide prescriber contact information, office contact, phone/fax, and NPI
Ensure form is legible and all required checkboxes and dates are completed

Denial Risk

Form Completeness & Denial Risk

Missing or incomplete information will delay or may cause denial of the request. Verify the PA form and all supporting documentation are accurate and present before submission.

Incomplete/incorrect/illegible PA forms can delay or cause denial
Missing chart notes, labs, or diagnostics may result in denial
Prescriber attestations required for certain agents (e.g., Mayzent®, cladribine) must be completed

Policy Background

This prior authorization form and the accompanying criteria apply to disease-modifying therapies for multiple sclerosis and must be completed for agents requiring PA, including cladribine and other DMTs listed on the form. For certain drugs (for example, Mavenclad and Mayzent) the form requires prescriber attestation of specialty (neurologist), member age, prior DMT trials, and safety-related items (e.g., negative pregnancy test, baseline labs, genotype and cardiac/vaccine exclusions) as specified on the checklist. Completion of the AvMed PA form with prescriber signature and the required clinical documentation is required to determine coverage under these criteria.

Key Definitions

inv-16: Confirmed relapsing forms of MS

Relapsing-remitting MS (RRMS)Included as a confirmed relapsing form of MS

Active secondary‑progressive MS (active SPMS)Included as a confirmed relapsing form of MS

Clinically isolated syndrome (CIS)Included where specified for certain agents (e.g., Mayzent); treat as a confirmed relapsing form when listed

Initial Authorization Requirements

Step Therapy Checklist

Prior therapy (checked on PA form)	Verification method / notes
Avonex (interferon beta-1a)	Checked on PA form for Extavia/Rebif and other interferon-related approvals; prior therapy will be verified via pharmacy paid claims or submitted chart notes per step-therapy requirement
Betaseron (interferon beta-1b / Extavia listed separately)	Checked on PA form for Extavia/Rebif; documented failure, contraindication, or intolerance required; verification via claims or chart documentation
Plegridy (peginterferon beta-1a)	Listed on PA form as a prior therapy option for interferon approvals; verification through paid pharmacy claims or submitted documentation
Dimethyl fumarate (Tecfidera)	Checked on PA form for multiple agents (e.g., Bafiertam, Ponvory, Avonex group); prior trial required (one or two depending on agent); verified by claims or chart notes
Glatopa or glatiramer acetate (Copaxone)	Included on PA form across agents as an enumerated prior therapy; verification via pharmacy claims or submitted chart notes
Fingolimod (Gilenya)	Listed on PA form as a prior DMT option; required prior failure/contraindication/intolerance per agent-specific rules; verified by claims or documentation
Teriflunomide (Aubagio)	Checked on PA form where applicable; prior trial documented on form and confirmed via claims or chart notes
Vumerity (diroximel fumarate)	Appears on PA form (requires PA for some agents); prior therapy trial to be checked on form and verified through claims or submitted documentation
Zeposia (ozanimod)	Listed on PA form (requires PA for some agents); documented prior therapy status on form will be verified by pharmacy claims or chart documentation
Kesimpta (ofatumumab)	Included on PA form for agents requiring two prior DMTs (e.g., Bafiertam/Ponvory); prior use to be checked on form and verified by claims or chart notes
Other checked therapies per form (as applicable)	Provider must check each therapy tried on the PA form; previous therapies will be verified through pharmacy paid claims or submitted chart notes per step-therapy requirement

Quantity Limits and Dispensing Rules

inv-19: Mayzent (siponimod)

Mayzent quantity limit1 tablet per day

Maximum per prescription periodRefer to plan-specific dispensing limits; quantity limit set at 1 tablet/day

Prescribing notesMedication must be prescribed by a neurologist and member >=18 years

inv-20: Mavenclad (cladribine)

Annual tablet limit20 tablets per year (40 tablets total over 2 years)

Per‑day maximumNot more than 2 tablets (20 mg) per day

Dose schedule guidanceTotal cumulative 3.5 mg/kg over 2 years divided as 1.75 mg/kg each year, with each year's dose divided into two cycles; do not administer more than 2 tablets/day

Weight‑based tablet countsDose per cycle and number of 10 mg tablets determined by patient weight (see dosing table)

Dispensing Site & Specialty Pharmacy