Elaprase (idursulfase)
Indications for Prior Authorization
Elaprase (idursulfase) [1]
-
For diagnosis of Hunter Syndrome
Is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). Elaprase has been shown to improve walking capacity in patients 5 years and older.In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with Elaprase has reduced spleen volume similarly to that of adults and children 5 years of age and older.
The safety and efficacy of Elaprase have not been established in pediatric patients less than 16 months of age.
Criteria
Elaprase (idursulfase)
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- Diagnosis of Hunter syndrome (Mucopolysaccharidosis II, MPS II)
Elaprase (idursulfase)
Prior Authorization (Reauthorization)
Length of Approval: 24 Month(s)
- Patient demonstrates positive clinical response to therapy
P & T Revisions
2024-07-31, 2023-12-20, 2023-09-13, 2023-07-05, 2022-07-06, 2021-07-07, 2021-05-19, 2020-06-16
References
- Elaprase Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA. October 2021.
Revision History
- 2024-07-31: 2024 Annual Review. No criteria changes.
- 2023-12-20: Program update to standard reauthorization language. No changes to clinical intent.
- 2023-09-13: Program update to standard reauthorization language. No changes to clinical intent.
- 2023-07-05: Annual review, changed initial auth to 12 months, added 24 month reauth.
- 2022-07-06: Annual Review, no criteria changes.
- 2021-07-07: Annual Review
- 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
- 2020-06-16: Annual Review - No Changes
HEALTHY LIVING