Pharmacy Prior Authorization Criteria

Crysvita (burosumab-twza)

Indications for Prior Authorization

Crysvita (burosumab-twza)

• For diagnosis of X-Linked Hypophosphatemia (XLH)
  Indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.

• For diagnosis of Tumor-Induced Osteomalacia
  Indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.

Criteria

Crysvita

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of X-Linked Hypophosphatemia

• Diagnosis of X-linked hypophosphatemia
AND
• Prescribed by or in consultation with one of the following:
• Endocrinologist
• Specialist experienced in the treatment of inborn errors of metabolism
AND
• One of the following:
• Patient is 6 months to 17 years of age
OR
• Both of the following:
• Patient is 18 years of age or older
AND
• Patient is a candidate for pharmacologic therapy by meeting one of the following: [2]
• Spontaneous insufficiency fractures
• Pending orthopedic procedures (e.g., joint replacement)
• Biochemical evidence of osteomalacia (i.e., elevated serum alkaline phosphatase)
• Disabling skeletal pain
AND
• Trial and failure, contraindication, or intolerance to conventional treatment with both of the following: [2, 3]
• Phosphate supplementation
• Vitamin D analog-based therapy (e.g, calcitriol, paricalcitol, doxercalciferol)

Crysvita

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of X-Linked Hypophosphatemia

• Patient demonstrates positive clinical response to therapy (e.g., improvement in rickets, improvement in serum phosphorus or Radiographic Global Impression of Change [RGI-C] scores)

Crysvita

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Tumor-Induced Osteomalacia

• Diagnosis of FGF23-related hypophosphatemia in Tumor-Induced Osteomalacia (TIO)
AND
• Tumor could not be curatively resected or localized
AND
• Patient is 2 years of age or older
AND
• Trial and failure, contraindication, or intolerance to conventional treatment with both of the following: [4, 5]
• Phosphate supplementation
• Vitamin D analog-based therapy (e.g., calcitriol, paricalcitol, doxercalciferol)
AND
• Prescribed by or in consultation with one of the following:
• Oncologist
• Endocrinologist

Crysvita

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Tumor-Induced Osteomalacia

• Patient demonstrates positive clinical response to therapy (e.g., increase in serum phosphorus level, improvement in osteoid thickness, osteoid surface, osteoid volume, mineralization lag time, or improvement as indicated by bone biopsy)

P & T Revisions

2024-07-16, 2023-09-13, 2023-08-02, 2022-08-03, 2021-08-02, 2020-07-27, 2020-02-25, 2019-12-05

References

1. Crysvita Prescribing Information. Ultragenyx Pharmaceutical Inc. Novato, CA. June 2020.
2. Carpenter TO, Imel EA, Holm IA, et al. A Clinician's guide to x-linked hypophosphatemia. J Bone Miner Res. 2011;26(7):1381-1388. doi:10.1002/jbmr.340.
3. Linglart A, Biosse-Duplan M, Briot K, et al. Therapeutic management of hypophosphatemic rickets from infancy to adulthood. Endocr Connect. 2014;3(1):R13-R30. doi:10.1530/EC-13-0103.
4. Chong W, Molinolo A, Chen C, Collins M. Tumor-induced osteomalacia. Endocr Relat Cancer. 2011;18(3):R53-R77.
5. Athonvarangkul D, Insogna K. New Therapies for Hypophosphatemia-Related to FGF23 Excess. Calcif Tissue Int. 2020.
6. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 Feb 29 – Identifier NCT02304367, Study of KRN23 in Adult Subjects With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS); December 1, 2014 [cited 2020 Jun 26]. Available from https://clinicaltrials.gov/ct2/show/NCT02304367.
7. Imanishi Y, Ito N, Rhee Y et al. Interim Analysis of a Phase 2 Open-Label Trial Assessing Burosumab Efficacy and Safety in Patients with Tumor-Induced Osteomalacia. J Bone Miner Res. 2020; 36(2):262-270.
8. Jan de Beur SM, Miller PD, Weber TJ, et al. Burosumab for the Treatment of Tumor-Induced Osteomalacia. J Bone Miner Res. 2021;36(4):627-635.

---

Revision History

• 2024-07-16: Annual Review - No criteria changes
• 2023-09-13: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-08-02: Annual Review - no criteria changes
• 2022-08-03: Annual Review - No clinical criteria changes
• 2021-08-02: 2021 UM Annual Review.
• 2020-07-27: Added criteria for new indication, tumor-induced osteomalacia.
• 2020-02-25: Updated indications section to reflect proper minimum age requirement.
• 2019-12-05: Updated criteria per expanded indication - SL - 10.31.19

---