J0224 — Injection, lumasiran, 0.5 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Diagnosis of PH1 by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the diagnosis of PH1.
- Confirmation of the PH1 diagnosis based on metabolic testing demonstrating one of the following: increased urinary oxalate excretion [e.g., greater than 1 mmol / 1.73 m2 per day (90 mg / 1.73 m2 per day), increased urinary oxalate: creatinine ratio relative to normative values for age]; or increased plasma oxalate and glyoxylate concentrations.
- Genetic testing confirming a mutation in the alanine: glyoxylate aminotransferase (AGT or AGXT) gene.
- Documentation that the patient has not received a liver transplant.
Key Coverage Criteria
- Oxlumo is proven for the treatment of primary hyperoxaluria type 1 (PH1) in patients who meet all of the following criteria: For initial therapy, all of the following: Diagnosis of PH1; and Patient is not receiving Oxlumo in combination with Rivfloza (nedosiran); and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Initial authorization will be for no more than 12 months.
- Oxlumo is proven for the treatment of primary hyperoxaluria type 1 (PH1) in patients who meet all of the following criteria: For continuation of therapy, all of the following: Documentation of positive clinical response to Oxlumo; and Patient is not receiving Oxlumo in combination with Rivfloza (nedosiran); and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Reauthorization will be for no more than 12 months.
- Oxlumo is medically necessary for the treatment of PH1 in patients who meet all of the following criteria: For initial therapy, all of the following: Diagnosis of PH1 by, or in consultation with, a specialist (e.g., geneticist, nephrologist, urologist) with expertise in the diagnosis of PH1; and Confirmation of the PH1 diagnosis based on both of the following: Metabolic testing demonstrating one of the following: Increased urinary oxalate excretion [e.g., greater than 1 mmol / 1.73 m2 per day (9 [...]
- Oxlumo is medically necessary for the treatment of PH1 in patients who meet all of the following criteria: For continuation of therapy, all of the following: Submission of medical records (e.g., chart notes, laboratory values) documenting a positive clinical response to therapy from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate: creatinine ratio, decreased plasma oxalate concentrations); and Patient has not received a liver transplant; and Pati [...]
- Rivfloza for provider administration is proven for the treatment of primary hyperoxaluria type 1 (PH1) in patients who meet all of the following criteria: For initial therapy, all of the following: Diagnosis of PH1; and Patient is at least 2 years of age and older; and Patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL / min / 1.73 m2); and Patient is not receiving Rivfloza in combination with Oxlumo; and Dosing is in accordance with the United States Food and Drug Administrati [...]
- Rivfloza for provider administration is proven for the treatment of primary hyperoxaluria type 1 (PH1) in patients who meet all of the following criteria: For continuation of therapy, all of the following: Documentation of positive clinical response to Rivfloza; and Patient has relatively preserved kidney function (e.g., eGFR ≥ 30 mL / min / 1.73 m2); and Patient is not receiving Rivfloza in combination with Oxlumo (lumasiran); and Dosing is in accordance with the United States Food and Drug Adm [...]
9 Active Policies
UHC-POL-oxlumo — Oxlumo (Lumasiran) and Rivfloza (Nedosiran)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-oxlumo — Oxlumo (Lumasiran) and Rivfloza (Nedosiran)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-oxlumo — Oxlumo (Lumasiran) and Rivfloza (Nedosiran)
Related Codes
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