OXLUMO (lumasiran)

OXLUMO (lumasiran) 

OFFICE ADMINISTRATION - SUBCUTANEOUS

Indications for Prior Authorization:

• Oxlummo is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

Patients must meet the following criteria:

Primary hyperoxaluria type 1 (PH1):

• Submission of medical records (e.g., chart notes, laboratory values) documenting a diagnosis of primary hyperoxaluria type 1 (PH1); AND
• Diagnosis is confirmed by both of the following:
  • Elevated urinary oxalate excretion, AND
  • Elevated plasma oxalate concentration; AND
• Genetic testing demonstrating a mutation in the alanine:glyoxylate aminotransferase (AGXT) gene; AND
• Prescribed by or in consultation with one of the following: nephrologist, urologist, geneticist, or specialist with expertise in the treatment of PH1; AND
• Patient has not received a liver transplant.

Reauthorization:

• Documentation of positive clinical response to therapy (e.g., decreased urinary oxalate excretion, decreased plasma oxalate concentration); AND
• Prescribed by or in consultation with one of the following: nephrologist, urologist, geneticist, or specialist with expertise in the treatment of PH1; AND
• Patient has not received a liver transplant.

This Medication Is Not Approvable for the Following Condition(s):

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.

Dosing:

• 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: 3 mg/kg once monthly.
  • 10kg to less than 20 kg:
    • Loading Dose: 6 mg/kg once monthly for 3 doses.
    • Maintenance Dose: 6 mg/kg once every 3 months.
  • 20 kg and above:
    • Loading Dose: 3 mg/kg once monthly for 3 doses.
    • Maintenance Dose: 3 mg/kg once every 3 months.

Approval:

• Up to 12 months.

Additional Information:

• Oxlumo is intended for subcutaneous use and should be administered by a healthcare professional (HCPCS Code: J1427; Injection, viltolarsen, 10 mg).

Review History:

• 04/20/2021- New policy.

References:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Hoppe B, Beck BB, Milliner DS. The primary hyperoxalurias. Kidney Int. 2009 Jun;75(12):1264-1271. doi: 10.1038/ki.2009.32.
• 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.
• 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.
• Oxlumo [formulary dossier], Cambridge, MA: Alnylam Pharmaceuticals, Inc.; 2020.
• Oxlumo [package insert], Cambridge, MA: Alnylam Pharmaceuticals, Inc.; November 2020.