Draftblue cross blue shield - tennesseePolicy N/A

Aldurazyme (laronidase) for Mucopolysaccharidosis I

Covers prior authorization, clinical criteria, and continuation requirements for Aldurazyme (laronidase) for treatment of MPS I in BlueCross BlueShield of Tennessee members.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyAldurazyme (laronidase) for Mucopolysaccharidosis I

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateID_CHS_2026

Next Review DateN/A

Key ActionSubmit prior authorization with diagnostic confirmation and required documentation to request up to 12 months of coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

Hurler, Hurler‑Scheie, Scheieeligible phenotypes

clinical responsecontinuation requirement

enzyme/geneticdiagnostic confirmation

Coverage Criteria for Aldurazyme (laronidase)

Initial Therapy

Authorization of 12 months may be granted for treatment of MPS I when all both of the following criteria are met:

Initial authorization criteria: Member has a confirmed diagnosis of MPS I by enzyme assay demonstrating deficiency of alpha-L-iduronidase or by genetic testing AND member has one of the following phenotypes: Hurler (severe), Hurler‑Scheie (attenuated), or Scheie with moderate to severe symptoms (examples: normal intelligence with less progressive physical problems, corneal clouding, joint stiffness, valvular heart disease) AND member exhibits clinical signs and symptoms of disease at baseline (examples: coarse facial features, frequent upper respiratory infections, inguinal or umbilical hernia, hepatosplenomegaly, characteristic skeletal findings, noninflammatory arthropathy, corneal clouding, hydrocephalus, developmental delay).

Authorization period: 12 months

Continuation Therapy

Authorization of 12 months may be granted for continued treatment when the following are met:

Continuation authorization criteria: Member is receiving Aldurazyme for an indication listed in Coverage Criteria AND there is documentation of a clinically positive response to therapy defined as improvement, stabilization, or slowing of disease progression (examples include changes in forced vital capacity, 6‑minute walk test, apnea/hypopnea index (AHI), liver volume, active joint range of motion, or urinary glycosaminoglycan (GAG) levels).

Policy Summary

Payerblue cross blue shield - tennessee

PolicyAldurazyme (laronidase) for Mucopolysaccharidosis I

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateID_CHS_2026

Next Review DateN/A

Key ActionSubmit prior authorization with diagnostic confirmation and required documentation to request up to 12 months of coverage.

SourceLink

On This Page

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Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Authorization (prior authorization and reauthorization) — Prior authorization may be granted for up to 12 months when diagnostic confirmation and initial clinical criteria are met. Reauthorization may be granted for up to 12 months when continuation criteria demonstrating a clinically positive response are met.

Authorization period: up to 12 months for initial and reauthorization requests
Diagnostic confirmation required: enzyme assay demonstrating alpha-L-iduronidase deficiency or genetic testing
Clinical baseline signs/symptoms required for initial approval (see Documentation block)
Clinically positive response required for continuation (improvement, stabilization, or slowing of disease progression)

Documentation Required

Initial Request Documentation

Initial request documentation — Submit chart notes or medical records documenting baseline clinical signs and symptoms and diagnostic confirmation to initiate prior authorization review.

Chart notes/medical records documenting baseline clinical signs and symptoms (e.g., coarse facial features, frequent upper respiratory infections, inguinal/umbilical hernia, hepatosplenomegaly, characteristic skeletal findings, noninflammatory arthropathy, corneal clouding, hydrocephalus, developmental delay)
Alpha-L-iduronidase enzyme assay results or genetic testing supporting diagnosis

Documentation Required

Continuation Request Documentation

Continuation (reauthorization) request documentation — Provide chart notes or medical records demonstrating a clinically positive response to therapy.

Documentation of clinically positive response: improvement, stabilization, or slowing of disease progression
Examples of measures: forced vital capacity, 6-minute walk test, apnea/hypopnea index (AHI), liver volume, active joint range of motion, urinary glycosaminoglycan (GAG) levels

Note

Prescriber Specialty Requirement

Prescriber specialty — This medication must be prescribed by or in consultation with a physician who specializes in metabolic disease and/or lysosomal storage disorders.

Prescribing or consulting physician specialty: metabolic disease and/or lysosomal storage disorders

Denial Risk

Not Medically Necessary for Other Indications

Non‑FDA/unsupported indications — All other indications are considered experimental/investigational and not medically necessary.

Drug and Use Definitions

Aldurazyme (laronidase) — key details

ProductAldurazyme (laronidase), recombinant human alpha-L-iduronidase enzyme replacement therapy

FDA‑approved indicationsTreatment of adult and pediatric patients with Hurler and Hurler‑Scheie forms of Mucopolysaccharidosis I (MPS I)

Additional indicated populationPatients with the Scheie form who have moderate to severe symptoms

Typical authorization periodAuthorization may be granted for 12 months when criteria are met

Diagnostic confirmationDiagnosis established by enzyme assay demonstrating alpha-L-iduronidase deficiency or by genetic testing

Limitations of use

CNS effectThe effect of Aldurazyme on central nervous system manifestations has not been determined.

Mild Scheie patientsSafety and effectiveness in treating mildly affected Scheie patients have not been established.

Other indicationsUse for indications beyond those listed is considered experimental/investigational and not medically necessary.

OpenPayer

Aldurazyme (laronidase) for Mucopolysaccharidosis I

Coverage Criteria for Aldurazyme (laronidase)

Provider Actions, Prior Authorization, and Documentation Requirements

Drug and Use Definitions

Clinical Background