CurrentAetnaPolicy N/A

Aldurazyme (laronidase) Medication Precertification Request Form — Coverage Criteria

Aetna's medication precertification request form for Aldurazyme (laronidase) to request initiation or continuation of infusion therapy for suspected or confirmed MPS I; applies to providers seeking prior authorization and specifies required diagnostic confirmation, phenotype, infusion setting, and documentation of benefit for continuation.

Policy Summary

PayerAetna

PolicyAldurazyme (laronidase) Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit precertification using the form with diagnostic confirmation (enzyme assay or genetic testing), phenotype, infusion setting, full clinical documentation, and dates to request initiation or continuation of Aldurazyme.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Pages

1-866-752-7021Precert Phone

1-888-267-3277Alt Phone

All requiredClinical fields

Coverage Criteria for Aldurazyme (laronidase)

Policy Summary

PayerAetna

PolicyAldurazyme (laronidase) Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

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Coverage criteria for Aldurazyme precertification

Covered when ALL of the following are met

Diagnostic confirmation: Diagnosis confirmed by enzyme assay demonstrating deficiency of alpha-L-iduronidase activity and/or by genetic testing

Form requests indication of confirmation

Diagnosis of MPS I: Patient has a diagnosis of mucopolysaccharidosis I (MPS I) with phenotype specified (Hurler, Hurler-Scheie, Scheie)

Form asks provider to indicate phenotype

Infusion safety and setting: Provider documents infusion setting and whether patient has severe adverse events, IgE antibodies, severe venous access issues, significant behavioral or cognitive impairment without caregiver, or medical instability necessitating outpatient hospital setting

These items determine suitability of setting and need for hospital outpatient infusion

For continuation: Documentation of clinically positive response to therapy (improvement, stabilization, or slowing of disease progression)

Required for continuation requests

Initial Therapy Requirements

Initial therapy requirements

Initiation requests require diagnostic confirmation and phenotype.

Diagnostic confirmation: Was the diagnosis confirmed by enzyme assay demonstrating a deficiency of alpha-L-iduronidase enzyme activity and/or by genetic testing?

Yes/No checkbox on form

Phenotype specification: Provider to indicate which MPS I form the patient has (Hurler, Hurler-Scheie, Scheie)

Checkboxes on form

Precertification and Documentation Requirements

Prior Authorization

Prior Authorization Required

Precertification is required for Aldurazyme (laronidase) for both initiation and continuation of therapy. Use the Aetna Aldurazyme Medication Precertification Request form and indicate whether this is a start of treatment (include start date) or a continuation of therapy (include date of last treatment).

Contact phone: 1-866-752-7021 (TTY: 711); Alternate: 1-888-267-3277
Fax contact available on the precertification form
Use the Medicare Request Form for Medicare Advantage Part B members

Step Therapy

No Step Therapy Specified

No explicit step therapy sequence is specified on the Aldurazyme precertification form. There are no required prior trials of other drugs listed on the form as a condition for approval.

Documentation Required

Required Clinical Documentation

Providers must complete all required clinical information on the precertification form for ALL requests. For all requests, indicate infusion setting, history of adverse events and whether adverse events were refractory to conventional interventions, laronidase IgE antibody status, venous access issues, behavioral/physical/cognitive issues and caregiver availability, and medical stability (respiratory, cardiovascular, renal). For initiation requests, provide confirmation of diagnosis by enzyme assay and/or genetic testing and indicate the MPS I phenotype. For continuation requests, document clinically positive response to therapy (improvement, stabilization, or slowing of disease progression). Include patient identifiers and dates where requested.

Infusion setting: outpatient hospital?
Adverse event history: type, severity, response to interventions
Laronidase IgE antibody status (yes/no)
Venous access issues and any special interventions required
Behavioral or cognitive impairments affecting infusion safety and caregiver status; description if applicable
Medical instability details (cardiopulmonary, respiratory, renal, other) and descriptions
For initiation: enzyme assay and/or genetic testing confirmation; specify MPS I form (Hurler, Hurler-Scheie, Scheie) and symptom severity
For continuation: documentation of clinically positive response (improvement, stabilization, or slowed progression)

Denial Risk

Incomplete or Fraudulent Requests

Incomplete, illegible, or materially false information may lead to denial of the precertification request and could prompt a fraud investigation. The plan may request additional information or clarification as needed to evaluate requests. The form requires a signature and date for the person completing the request.

Signature and date required on the request
Failure to provide complete and legible information may result in denial or request for more information
Providing materially false information may constitute fraudulent insurance act subject to criminal and civil penalties

Place of Administration

Note

Specify and justify site of care

Indicate the place of administration on the form (self-administered, physician's office, outpatient infusion center, home infusion center, etc.) and justify the need for outpatient hospital infusion if the patient has severe adverse events, positive IgE, severe venous access issues, significant behavioral/medical instability, or requires special interventions.

Select the appropriate site: Self-administered, Physician's Office, Outpatient Infusion Center, Home Infusion Center
If outpatient hospital setting is selected or required, provide clinical justification (e.g., severe reaction history, IgE positivity, venous access issues, medical instability)

Key Definitions and Diagnostic Criteria

MPS I phenotype

MPS I phenotypes listed on the formHurler; Hurler-Scheie; Scheie

Hurler form descriptionSevere MPS I

Hurler-Scheie form descriptionAttenuated MPS I

Scheie form descriptionScheie syndrome (attenuated MPS I)

Diagnostic confirmation

Diagnostic confirmation methodEnzyme assay demonstrating deficiency of alpha-L-iduronidase activity and/or genetic testing

Initiation requests requirementYes/No checkbox on form to indicate confirmation

Clinical documentation noteRequired clinical information must be completed in its entirety for all precertification requests

Background

Background: Aldurazyme (laronidase) is an enzyme replacement therapy indicated for patients with mucopolysaccharidosis I (MPS I). The precertification form requires documentation that the patient has a diagnosis of MPS I and asks the provider to indicate diagnostic confirmation (by enzyme assay or genetic testing) and to specify the MPS I phenotype. The form also collects detailed information about infusion safety and setting, including whether the infusion will occur in an outpatient hospital setting, history of severe or unresponsive adverse events, presence of laronidase IgE antibodies, severe venous access issues, significant behavioral or cognitive impairment without a caregiver, and medical instability that would necessitate hospital outpatient infusion.

Primary ICD Code	primary diagnosis code field
Other ICD Code	additional diagnosis code field

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