Currentmoda_health_plan_incPolicy M-0848

Avlayah (tividenofusp alfa-eknm) coverage for Hunter syndrome (MPS II)

Customize your policy alerts

Sign up for moda_health_plan_inc Policy M-0848 alerts

Get alerted when Policy M-0848 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Defines prior authorization, dosing, coverage criteria, and billing/coding for Avlayah (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) for eligible members.

Policy Summary

Payermoda_health_plan_inc

PolicyAvlayah (tividenofusp alfa-eknm) coverage for Hunter syndrome (MPS II)

Policy CodePolicy M-0848

Change TypeNo material change

Effective DateMay 5, 2026

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization; initial approval is valid for 12 months and may be renewed every 12 months thereafter.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial prior authorization length

1,800 mgmaximum units (per 7 days)

3→7.5→15 mg/kgdose escalation (weekly)

J3590HCPCS billing code

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

Currentmoda_health_plan_incPolicy M-0848

Avlayah (tividenofusp alfa-eknm) coverage for Hunter syndrome (MPS II)

Customize your policy alerts

Sign up for moda_health_plan_inc Policy M-0848 alerts

Get alerted when Policy M-0848 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Defines prior authorization, dosing, coverage criteria, and billing/coding for Avlayah (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) for eligible members.

Policy Summary

Payermoda_health_plan_inc

PolicyAvlayah (tividenofusp alfa-eknm) coverage for Hunter syndrome (MPS II)

Policy CodePolicy M-0848

Change TypeNo material change

Effective DateMay 5, 2026

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization; initial approval is valid for 12 months and may be renewed every 12 months thereafter.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial prior authorization length

1,800 mgmaximum units (per 7 days)

3→7.5→15 mg/kgdose escalation (weekly)

J3590HCPCS billing code

Coverage Criteria for Avlayah (tividenofusp alfa-eknm)

Initial Therapy

Covered when ALL of the following are met:

Eligibility and baseline: Member weighs at least 5 kg; documented baseline age-appropriate values obtained (for >=5 years: 6-minute walk test (6MWT), percent predicted forced vital capacity (FVC), joint range of motion, left ventricular hypertrophy, growth, quality of life measure (CHAQ/HAQ/MPS HAQ), and/or urinary glycosaminoglycan (uGAG)/urinary heparan sulfate (uHS); for <5 years: spleen volume, liver volume, FVC, 6-MWT, and/or uGAG/uHS).weight >= 5 kg

For very young members in which FVC or 6-MWT are not suitable for measuring, requests will be reviewed on a case-by-case basis

Diagnosis: Definitive diagnosis of MPS II confirmed by either deficient/absent iduronate 2-sulfatase (I2S) enzyme activity in cells/plasma with normal activity of at least one other sulfatase OR detection of pathogenic/likely pathogenic IDS gene variant; AND clinical documentation of neurologic manifestations OR provider attestation that the member is presymptomatic and at high risk for neuronopathic disease; AND provider attestation that the member does not have advanced neurological impairment.diagnostic confirmation required

Combination therapy exclusion: Will not be used in combination with other enzyme replacement therapies indicated for treatment of Hunter Syndrome (e.g., idursulfase).no concurrent Hunter ERT

Renewal (Continuation) Therapy

Prior authorization may be renewed when ALL of the following are met:

Ongoing criteria: Member continues to meet the universal and indication-specific criteria identified for initiation; absence of unacceptable toxicity (examples include severe hypersensitivity/anaphylaxis, severe infusion-associated reactions, severe anemia, membranous nephropathy); AND member has demonstrated beneficial response compared to pretreatment age-appropriate baseline in one or more measures (>=5 years: stabilization or improvement in percent predicted FVC and/or 6-MWT, increased joint range of motion, decreased left ventricular hypertrophy, improved growth, improved quality of life (clinically meaningful change in CHAQ/HAQ/MPS HAQ), and/or reduction in uGAG/uHS; <5 years: reductions in spleen and/or liver volume, stabilization/improvement in FVC and/or 6-MWT, and/or reduction in uGAG/uHS).demonstrated benefit vs baseline

Examples of unacceptable toxicity provided

The policy explicitly excludes concurrent use of Avlayah with other enzyme replacement therapies (ERTs) indicated for Hunter syndrome. Examples include idursulfase. Requests for coverage involving combination therapy with another Hunter ERT will not meet the coverage criteria and may be denied.

Medicare rules may supersede the policy for Part B outpatient drugs. Where applicable, providers must follow relevant National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs)

Initial authorization criteria require that the member weighs at least 5 kg. Requests for members weighing less than 5 kg are not supported by the initial approval criteria and therefore do not meet the policy's eligibility requirements.

Initial Dosing and Eligibility

Initial dosing

Initial dosing and escalation for pediatric members weighing at least 5 kg.

Starting dose: 3 mg/kg administered once weekly via intravenous infusion for pediatric members weighing at least 5 kg (weeks 1–4).

Escalation: Escalate to 7.5 mg/kg once weekly for weeks 5–8, then 15 mg/kg once weekly for week 9 and beyond; administer each dosage level for at least 4 weeks before escalating; do not escalate if the current dosage level is not tolerated.

Maximum units: Maximum 1,800 mg every 7 days (HCPCS unit limit).

Renewal (Continuation) Criteria

Renewal criteria

Renewal criteria require ongoing benefit and absence of unacceptable toxicity.

Renewal nodes: Member continues to meet universal and indication-specific criteria; absence of unacceptable toxicity; demonstrated clinical or biochemical benefit compared to pretreatment baseline as specified per age group.

Provider Actions, Documentation & Authorization

Prior Authorization
Prior authorization validity
Prior authorization is required. Initial authorization will be provided for 12 months (365 days) and may be renewed every 12 months (365 days) thereafter.

Prior Authorization
PA considered per NQTL Factor Checklist
Prior authorization was considered for Avlayah based on the NQTL Factor Checklist, which identified indication and safety/efficacy as reasons to consider PA for this drug.

Step Therapy
No prerequisite ERT; combination disallowed
No prerequisite trial of other enzyme replacement therapies is required; the policy explicitly states Avlayah will not be used in combination with other ERTs indicated for Hunter syndrome.

Billing, Codes & Authorization Length

HCPCS CodesHCPCS

J3590

Unclassified biologics

NDCNDC

84976-0001-xx

Avlayah 150 mg lyophilized powder for injection in a single-dose vial

Covered Diagnosis CodesICD-10Covered

E76.1

Mucopolysaccharidosis, type II

Covered ICD-10 CodesICD-10Covered

E76.1

Mucopolysaccharidosis, type II

Medicare Part B MAC Jurisdictionsmixed

Jurisdiction E (1)	CA, HI, NV, AS, GU, CNMI — Noridian Healthcare Solutions, LLC
Jurisdiction F (2 & 3)	AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ — Noridian Healthcare Solutions, LLC
Jurisdiction 5	KS, NE, IA, MO — Wisconsin Physicians Service Insurance Corp (WPS) National Government Services, Inc. (NGS)
Jurisdiction 6	MN, WI, IL — (contractor not specified)
Jurisdiction 8	MI, IN — Novitas Solutions, Inc.
Jurisdiction N (9)	MI, IN FL, PR, VI — First Coast Service Options, Inc.
Jurisdiction J (10)	TN, GA, AL — Palmetto GBA
Jurisdiction M (11)	(states not listed) — Palmetto GBA
Jurisdiction L (12)	NC, SC, WV, VA (excluding below) DE, MD, PA, NJ, DC — Novitas Solutions, Inc.
Jurisdiction K (13 & 14)	NY, CT, MA, RI, VT, ME, NH — National Government Services, Inc. (NGS)

1–10 of 11
1/2

Initial authorization length

Initial authorization lengthPrior authorization provided initially for 12 months (365 days).

Renewal frequencyPrior authorization may be renewed every 12 months (365 days).

Policy referenceSee 'I. Length of Authorization' for full details and renewal conditions.

Maximum dosing frequency/units

Maximum dosing frequency/unitsMaximum 1,800 mg every 7 days (HCPCS unit limit).

Measurement period

Step Therapy / Prior Treatments

Step	Requirement
1	No prerequisite enzyme replacement therapy required; prior trial of another Hunter syndrome ERT (e.g., idursulfase) is not required.
Concurrent use	Will not be used in combination with other enzyme replacement therapies indicated for the treatment of Hunter Syndrome (e.g., idursulfase); concurrent use is prohibited and may result in denial.

Definitions and Non-Quantitative Treatment Limitations

Definitive diagnosis of MPS II

Definitive diagnostic criteriaDeficient or absent iduronate 2-sulfatase (I2S) enzyme activity in white cells, fibroblasts, or plasma with normal activity of at least one other sulfatase.

Genetic confirmationDetection of pathogenic or likely pathogenic variants in the IDS gene by molecular genetic testing.

Additional requirementPlus documentation of neurologic manifestations OR provider attestation of presymptomatic high risk for neuronopathic disease, and provider attestation that the member does not have advanced neurological impairment.

Non-Quantitative Treatment Limitations (NQTL)

NQTL definitionNon-quantitative treatment limitations (NQTLs) are methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan.

Background: Hunter Syndrome (MPS II)

Hunter syndrome (Mucopolysaccharidosis type II; MPS II) is a rare lysosomal storage disorder caused by deficient iduronate 2‑sulfatase (I2S) activity or pathogenic variants in the IDS gene. Clinical manifestations can include somatic and neurologic involvement; treatment with enzyme replacement aims to stabilize or improve pulmonary function, mobility, organomegaly, growth, and biochemical markers such as urinary glycosaminoglycans. Baseline, age‑appropriate assessments (for example, 6‑minute walk test, percent predicted FVC, joint range of motion, organ volume measurements, growth, and uGAG/uHS) are required to document pretreatment status and monitor response to therapy.