CurrentHawaii Medical Service Association (HMSA)Policy N/A

Vimizim (elosulfase alfa) Coverage Criteria

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This policy governs HMSA Medicare Advantage coverage and precertification for Vimizim (elosulfase alfa) used to treat Mucopolysaccharidosis type IVA (MPS IVA, Morquio A syndrome), including initial authorization and reauthorization.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyVimizim (elosulfase alfa) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateJune 26, 2026

Last ReviewApr 1, 2026

Next Review DateN/A

Key ActionSubmit precertification through the HMSA medical specialty drug policy website before requesting Vimizim coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial and reauthorization approval period

1FDA-approved covered indication

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CurrentHawaii Medical Service Association (HMSA)Policy N/A

Vimizim (elosulfase alfa) Coverage Criteria

Customize your policy alerts

Sign up for all Hawaii Medical Service Association (HMSA) policy alerts

Know when Hawaii Medical Service Association (HMSA) releases new policies or updates existing guidance.

Monitor payer policy activity

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

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyVimizim (elosulfase alfa) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateJune 26, 2026

Last ReviewApr 1, 2026

Next Review DateN/A

Key ActionSubmit precertification through the HMSA medical specialty drug policy website before requesting Vimizim coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial and reauthorization approval period

1FDA-approved covered indication

RequiredPrecertification

Enzyme assay or genetic testingDiagnostic confirmation required for initial approval

Coverage Criteria

Initial Authorization

Authorization of 12 months may be granted when the diagnosis of MPS IVA (Morquio A syndrome) is confirmed by enzyme assay or genetic testing.

ALL of the following

The member has a diagnosis of MPS IVA (Morquio A syndrome).
The diagnosis is confirmed by enzyme assay demonstrating a deficiency of N-acetylgalactosamine 6-sulfatase enzyme activity or by genetic testing.

Continuation Without Previous Authorization

All members, including new members and members currently receiving treatment without prior authorization, must meet the initial approval criteria.

ALL of the following

The member has no previous authorization or precertification for the requested medication through HMSA.
The member meets all initial approval criteria, including confirmation of MPS IVA (Morquio A syndrome) by enzyme assay demonstrating a deficiency of N-acetylgalactosamine 6-sulfatase enzyme activity or by genetic testing.

Reauthorization

Authorization of 12 months may be granted to members previously authorized by HMSA/CVS when all of the following criteria are met.

ALL of the following

The member is currently receiving therapy with the requested medication.
The requested medication is being used to treat an indication enumerated in the coverage criteria section.
The member is receiving benefit from therapy. Benefit is defined as a clinically positive response to therapy, including improvement, stabilization, or slowing of disease progression.

The indications below, including FDA-approved indications and compendial uses, are considered a covered benefit provided that all approval criteria are met and the member has no exclusions to the prescribed therapy.

Vimizim (elosulfase alfa) is covered for treatment of MPS IVA (Morquio A syndrome) when the applicable authorization criteria are met and no member or therapy exclusions apply.

Initial Therapy Criteria

Initial Authorization

Authorization of 12 months may be granted for treatment of MPS IVA when the diagnosis is confirmed by enzyme assay or genetic testing.

Initial Vimizim therapy

The requested treatment is for MPS IVA (Morquio A syndrome).
ONE of the following confirmation methods
- An enzyme assay demonstrates a deficiency of N-acetylgalactosamine 6-sulfatase enzyme activity.
- Genetic testing confirms the diagnosis of MPS IVA.

Continuation and Reauthorization Criteria

No Previous Authorization or Precertification

When there is no previous authorization or precertification, all members must meet the initial approval criteria.

No previous authorization or precertification

All members, including new members and members currently receiving treatment without prior authorization, must meet the criteria for initial approval.
Apply the initial authorization criteria, including confirmation of MPS IVA by enzyme assay or genetic testing.

Reauthorization — Continued Vimizim Coverage

For reauthorization, all of the following must be met:

Reauthorization

The member was previously authorized by HMSA/CVS.

Provider Actions and Documentation

Prior Authorization

Precertification Required

Precertification is required. Refer to the HMSA medical specialty drug policy website for the applicable fax form.

Documentation Required

Initial Diagnostic Documentation

For an initial request, make documentation available upon request showing the diagnosis is supported by an N-acetylgalactosamine 6-sulfatase enzyme assay or genetic testing results.

Include enzyme assay results demonstrating deficient N-acetylgalactosamine 6-sulfatase enzyme activity or genetic testing results supporting the diagnosis.

Documentation Required

Policy Background

Vimizim (elosulfase alfa) is an enzyme replacement therapy covered under this policy for patients with Mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. Before initial treatment, the diagnosis must be confirmed by deficient or reduced N-acetylgalactosamine 6-sulfatase enzyme activity or by genetic testing.

Key Definitions

MPS IVA (Morquio A syndrome)

Covered indicationMucopolysaccharidosis type IVA (MPS IVA), also called Morquio A syndrome, is the covered disease indication for Vimizim.

MedicationVimizim (elosulfase alfa).

Diagnostic confirmation

Enzyme assayDiagnosis is confirmed by an enzyme assay demonstrating deficient or reduced N-acetylgalactosamine 6-sulfatase enzyme activity.

Genetic testingGenetic or molecular testing may be used to confirm the diagnosis.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyVimizim (elosulfase alfa) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateJune 26, 2026

Last ReviewApr 1, 2026

Next Review DateN/A

Key ActionSubmit precertification through the HMSA medical specialty drug policy website before requesting Vimizim coverage.

SourceLink

On This Page

The member is currently receiving therapy with Vimizim.

Vimizim is being used to treat an indication listed in the coverage criteria.MPS IVA (Morquio A syndrome)

The member is receiving a clinically positive response to therapy.Improvement, stabilization, or slowing of disease progression

Continuation Response Documentation

For a continuation request, submit chart notes documenting a clinically positive response to therapy, including improvement, stabilization, or slowing of disease progression.

Document the member’s clinical benefit from therapy, including improvement, stabilization, or slowing of disease progression.

Denial Risk

Unconfirmed Diagnosis or Noncovered Indication

Requests may be denied when the diagnosis is not confirmed or when Vimizim is requested for an indication that is not enumerated in the coverage criteria.

For MPS IVA (Morquio A syndrome), confirm the diagnosis by enzyme assay demonstrating deficient N-acetylgalactosamine 6-sulfatase enzyme activity or by genetic testing.
Authorization is available only for covered indications when all approval criteria are met.

Denial Risk

Exclusions or Unmet Approval Criteria

Coverage is contingent on meeting all applicable approval criteria and having no exclusions to the prescribed therapy. Requests may be denied when an exclusion applies or required criteria are not met.

Verify that no exclusion applies to the prescribed therapy.
Confirm that all applicable approval criteria are satisfied.

Denial Risk

Reauthorization Criteria Not Met

Reauthorization may be denied if the member is not currently receiving Vimizim, the medication is not being used for a covered indication, or the member is not receiving clinical benefit from therapy.

The member must have been previously authorized by HMSA/CVS and be currently receiving the requested medication.
The medication must be used to treat an indication listed in the coverage criteria.
Document benefit as improvement, stabilization, or slowing of disease progression.