Last Review Date: 10/24/2022

Date of Origin: 01/05/2021

Dates Reviewed: 01/2021, 04/2021, 07/2021, 01/2022, 11/2022

1. Length of Authorization

Coverage will be provided for 6 months initially and may be renewed annually thereafter.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Oxlumo 94.5 mg/0.5 mL in a single-dose vial for injection: 4 vials every month for 3 doses then every 3 months thereafter

B. Max Units (per dose and over time) [HCPS Unit]:

• 756 billable units every month for 3 doses then every 3 months thereafter

3. Initial Approval Criteria

Coverage is provided in the following conditions:

Universal Criteria ^1-5

• Patient has not had a liver transplant; AND
• Must be prescribed by, or in consultation with, a specialist in genetics, nephrology or urology; AND

Primary Hyperoxaluria type 1 (PH1) † Ф ^1-5

• Patient has a definitive diagnosis of primary hyperoxaluria type 1 as evidenced by one of the following:
  • Patient has a biallelic pathogenic mutation in the alanine: glyoxylate aminotransferase (AGXT) gene as identified on molecular genetic testing; OR
  • Identification of alanine: glyoxylate aminotransferase (AGT) enzyme deficiency on liver biopsy; AND
• Patient has a baseline for one or more of the following:
  • Urinary oxalate excretion level (corrected for BSA)
  • Spot urinary oxalate: creatinine ratio
  • Estimated glomerular filtration rate (eGFR)
  • Plasma oxalate level

† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include severe injection site reactions, etc.; AND
• Disease response as evidenced by a decrease in urinary oxalate excretion from baseline, a reduction in spot urinary oxalate: creatinine ratio from baseline, stabilization of glomerular filtration rate and/or a decrease in plasma oxalate level from baseline

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS:

• J0224 – Injection, lumasiran, 0.5 mg; 1 billable unit = 0.5 mg

NDC:

• Oxlumo 94.5 mg/0.5 mL in a single-dose vial solution for injection: 71336-1002-xx

7. References

1. Oxlumo [package insert]. Cambridge, MA; Alnylam Pharm., Inc., October 2022. Accessed October 2022.
2. Milliner DS, Harris PC, Cogal AG, et al. Primary Hyperoxaluria Type 1. https://www.ncbi.nlm.nih.gov/books/NBK1283/ .(Accessed on November 25, 2020).
3. Garrelfs SF, Frishberg Y, Hulton SA, et al; ILLUMINATE-A Collaborators. Lumasiran, an RNAi Therapeutic for Primary Hyperoxaluria Type 1. N Engl J Med. 2021 Apr 1;384(13):1216-1226. doi: 10.1056/NEJMoa2021712.
4. Hayes W, Sas DJ, Magen D, et al. Efficacy and safety of lumasiran for infants and young children with primary hyperoxaluria type 1: 12-month analysis of the phase 3 ILLUMINATE-B trial. Pediatr Nephrol. 2022 Aug 1. doi: 10.1007/s00467-022-05684-1.
5. Michael M, Groothoff JW, Shasha-Lavsky H, et al. Lumasiran for Advanced Primary Hyperoxaluria Type 1: Phase 3 ILLUMINATE-C Trial. Am J Kidney Dis. 2022 Jul 14:S0272-6386(22)00771-5. doi: 10.1053/j.ajkd.2022.05.012.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Articles (LCAs) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A