WHA

OXLUMO (lumasiran) 

OFFICE ADMINISTRATION - SUBCUTANEOUS

Diagnosis considered for coverage:
  • Primary Hyperoxaluria Type 1 (PH1): Indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.
Coverage Criteria:

For diagnosis of PH1:

  • Diagnosis of primary hyperoxaluria type 1 (PH1), AND
  • Patient has not received a liver transplant, AND
  • Prescribed by or in consultation with one of the following: 
    • Hepatologist
    • Nephrologist
    • Urologist
    • Geneticist
    • Specialist with expertise in treatment of PH1, AND
  • Diagnosis has been confirmed by BOTH of the following: 
    • One of the following: 
      • Elevated urinary oxalate excretion
      • Elevate plasma oxalate concentration
      • Sport urinary Oxalate to creatinine molar ratio greater than normal for age
        AND
    • One of the following: 
      • Genetic testing demonstrating a mutation in the alanine: glyoxylate aminotransferase (AGXT) gene 
      • Liver biopsy demonstrating absence or reduced alanine: glyoxylate aminotransferase (AGT) activity 
Reauthorization:
  • Documentation of positive clinical response to therapy (e.g., decreased urinary oxalate excretion, decreased plasma oxalate concentration), AND
  • Patient has not received a liver transplant, AND
  • Prescribed by or in consultation with one of the following: 
    • Hepatologist
    • Nephrologist
    • Urologist
    • Geneticist
    • Specialist with expertise in treatment of PH1
Coverage Duration: 
  • Initial: 12 months
  • Reauthorization: 12 months
Dosing:

For diagnosis of PH1:

  • If a dose is delayed or missed, administer OXLUMO as soon as possible. Resume prescribed monthly or quarterly dosing, from the most recently administered dose. 
  • The recommended dose of Oxlumo by subcutaneous injection is based on body weight:
    • Less than 10 kg:
      • Loading Dose: 6 mg/kg once monthly for 3 doses.
      • Maintenance Dose (begin 1 month after the last loading dose): 3 mg/kg once monthly.
    • 10 kg to less than 20 kg:
      • Loading Dose: 6 mg/kg once monthly for 3 doses.
      • Maintenance Dose (begin 1 month after the last loading dose): 6 mg/kg once every 3 months.
    • 20 kg and above:
      • Loading Dose: 3 mg/kg once monthly for 3 doses.
      • Maintenance Dose (begin 1 month after the last loading dose): 3 mg/kg once every 3 months.
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:
  • Oxlumo is intended for subcutaneous use and should be administered by a healthcare professional (HCPCS Code: J1427; Injection, viltolarsen, 10 mg).
Policy Updates:
  • 4/20/2021- New policy.
  • 9/1/2024 (policy effective date)- New policy approved by WHA P&T Committee. (P&T 8/20/2024) (P&T Meeting August)
References:
  1. ClinicalTrials.gov. A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1 (ILLUMINATE-B). https://clinicaltrials.gov/ct2/show/NCT03905694. Updated January 14, 2021[b]. Accessed January 21, 2021.
  2. ClinicalTrials.gov. A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1 (ILLUMINATE-A). https://clinicaltrials.gov/ct2/show/results/NCT03681184. Updated January 19, 2021[a]. Accessed January 21, 2021.
  3. ClinicalTrials.gov. A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 (ILLUMINATE-C). https://clinicaltrials.gov/ct2/show/NCT04152200. Updated January 13, 2021[c]. Accessed January 21, 2021.
  4. Cochat P, Hulton SA, Acquaviva C, et al. Primary hyperoxaluria type 1: Indications for screening and guidance for diagnosis and treatment. Nephrol Dial Transplant. 2012 May;27(5):1729-36. doi: 10.1093/ndt/gfs078.
  5. Food and Drug Administration. FDA Approves First Drug to Treat Rare Metabolic Disorder [news release]. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-rare-metabolic-disorder. November 23, 2020. Accessed January 21, 2021.
  6. Food and Drug Administration. Oxlumo integrated review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214103Orig1s000IntegratedR.pdf. December 21, 2020. Accessed January 21, 2021.
  7. Hoppe B, Beck BB, Milliner DS. The primary hyperoxalurias. Kidney Int. 2009 Jun;75(12):1264-1271. doi: 10.1038/ki.2009.32.
  8. Hulton SA. The primary hyperoxalurias: A practical approach to diagnosis and treatment. Int J Surg. 2016 Dec;36(Pt D):649-654. doi: 10.1016/j.ijsu.2016.10.039.
  9. Milliner DS, Harris PC, Cogal AG, Lieske JC. Primary Hyperoxaluria Type 1. In: Adam MP, Ardinger HH, Pagon RA, et al, eds. GeneReviews. Seattle, WA: University of Washington, Seattle. https://www.ncbi.nlm.nih.gov/books/NBK1283/. Updated November 30, 2017. Accessed January 21, 2021.
  10. Oxlumo [package insert], Cambridge, MA: Alnylam Pharmaceuticals, Inc.; November 2020.
  11. Oxlumo. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed June 3, 2024. http://www.micromedexsolutions.com.
  12. Oxlumo prescribing information. Alnylam Pharmaceuticals, Inc. Cambridge, MA. September 2023. 
  13. UptoDate: Primary hyperoxaluria. Available at https://www.uptodate.com/contents/primary-hyperoxaluria?search=primary%20hyperoxaluria%20type%201&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H2667808272. Accessed January 3, 2024. 

 

 

Last review date: September 1, 2024