CurrentMass General Brigham Health PlanPolicy N/A

Elaprase (idursulfase) — Prior authorization and coverage criteria

Prior authorization and coverage rules for Elaprase (idursulfase) under the pharmacy/specialty drug benefit for Mass General Brigham Health Plan (MassHealth UPPL plan reference). Affects providers requesting coverage or reauthorization for patients with MPS II.

Policy Summary

PayerMass General Brigham Health Plan

PolicyElaprase (idursulfase) — Prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeRevised

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis of MPS II (enzyme assay or genetic test) and documentation of current treatment for new-to-plan members within 90 days.

SourceLink

POLICY UPDATE CHANGES

Updated language for members who are new to the Plan regarding authorization when currently receiving treatment with the requested medication.

12 monthsApproval duration

90 daysNew-to-plan look-back

6-MWT / FVC / spleen-liverResponse measures

Coverage Criteria for Elaprase (idursulfase)

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Initial Therapy

Authorization may be granted when ALL of the following are met:

Initial Authorization for Elaprase: Member has a diagnosis of MPS II confirmed by enzyme assay demonstrating a deficiency of iduronate 2-sulfatase enzyme activity or by genetic testing.

Continuation of Therapy

Requests for reauthorization will be approved when the following criteria are met:

Continuation of Therapy: Member is responding to therapy (improvement, stabilization, or slowing of disease progression as measured by 6-minute walk test, %-predicted FVC, spleen volume, or liver volume).6-MWT, %-predicted FVC, spleen/liver volume

Approvals granted for 12 months.

For the purpose of determining whether a member who is new to the plan qualifies as "currently receiving treatment," products obtained only as samples or through a manufacturer's patient assistance program are excluded and will not satisfy that condition. Authorization for new-to-plan members (within 90 days) may be granted only when the member is actively receiving the requested medication by means other than samples or manufacturer assistance programs.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization requirements and duration

Reauthorization criteria: Member demonstrates clinical response to therapy (improvement, stabilization, or slowing of disease progression on clinical measures such as 6-minute walk test, %-predicted FVC, spleen volume, or liver volume).

Approvals and reauthorizations will be granted for 12 months.

Clinical Measures and Coding

Clinical response measures

6-minute walk test (6-MWT)Measure of functional exercise capacity used to assess clinical response to therapy.

Percent‑predicted forced vital capacity (%-predicted FVC)Pulmonary function measure used to track respiratory response or stabilization.

Spleen volumeImaging-based measure to evaluate change in organomegaly as a response indicator.

Liver volumeImaging-based measure to evaluate change in organomegaly as a response indicator.

Response definitionsImprovement, stabilization, or slowing of disease progression on the measures listed above.

Reauthorization durationApprovals for continuation of therapy are granted for 12 months when response criteria are met.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization required. May be granted for members new to the plan within the past 90 days who are currently receiving the medication (excludes products received only as samples or via manufacturer's patient assistance program).

Members new to plan within 90 days and currently receiving therapy may be eligible
Does not apply if medication only obtained as samples or through manufacturer's PAP

Documentation Required

Diagnostic Documentation Required

Authorization may be granted when diagnosis is confirmed and required documentation is provided. Documentation must show a diagnosis of MPS II confirmed by enzyme assay demonstrating deficient iduronate 2-sulfatase activity or by genetic testing.

Provide enzyme assay results showing iduronate 2-sulfatase deficiency or genetic testing report confirming pathogenic variant(s)

Documentation Required

Response and Continuation Documentation

For continuation/reauthorization, documentation must demonstrate clinical response. Requests will be approved when there is evidence of improvement, stabilization, or slowing of disease progression on objective measures such as 6-minute walk test (6‑MWT), percent predicted FVC, spleen volume, or liver volume over the prior authorization period (clinical notes, test results, and imaging reports recommended).

Documented response by 6‑MWT, %-predicted FVC, spleen or liver volume
Clinical progress notes and relevant test/imaging reports should accompany reauthorization requests
Reauthorization criteria apply to continuation of therapy

Step Therapy

Step Therapy Program Type

Step therapy program listed in policy. No specific step requirements for this product are detailed in the policy; verify plan-specific step-therapy rules where applicable.

Program Type: Step Therapy (verify any plan-specific steps)

Program	Specific step requirements for Elaprase
Step Therapy	No specific step requirements for Elaprase are detailed in this document.

Background

Elaprase (idursulfase) is an enzyme replacement therapy indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II), a lysosomal storage disorder caused by deficiency of iduronate 2-sulfatase that leads to accumulation of glycosaminoglycans. Prior authorization is required for coverage; members new to the plan may be eligible for authorization if they are currently receiving treatment (within 90 days of plan enrollment) provided the medication was not obtained solely as samples or via a manufacturer's patient assistance program.