Oxlumo (lumasiran) for primary hyperoxaluria type 1 — Coverage Criteria
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Covers prior authorization, coverage criteria, and documentation requirements for Oxlumo (lumasiran) to treat primary hyperoxaluria type 1 (PH1) for BlueCross BlueShield of Tennessee members when approval criteria are met.
No material clinical or coverage changes in this revision.
Coverage Criteria for Oxlumo (lumasiran)
Initial Therapy
Covered when ALL of the following are met:
Authorization may be granted for 12 months if all conditions are met.
Continuation Therapy
Covered when ALL of the following are met:
Continuation authorized for 12 months when response documented; submit chart notes or medical records demonstrating response.
Not Medically Necessary / Experimental
Use of Oxlumo (lumasiran) for any indication other than the FDA‑approved indication for primary hyperoxaluria type 1 (PH1) is considered experimental/investigational and not medically necessary.
All indications beyond treatment of PH1 are considered experimental/investigational and not medically necessary and are not eligible for coverage under this policy.
Provider Requirements and Prior Authorization
Prior authorization required; 12‑month authorization when criteria met
Prior authorization is required. When all approval criteria are met (confirmed PH1 diagnosis, no prior liver transplant, elevated oxalate levels prior to therapy, and not co‑administered with Rivfloza), authorization may be granted for 12 months.
Combination therapy with Rivfloza (nedosiran) prohibited
Do not prescribe Oxlumo in combination with Rivfloza (nedosiran); the requested medication must not be used concurrently with Rivfloza.
- Coverage criteria explicitly state: "The requested medication will not be used in combination with Rivfloza (nedosiran)."
Required documentation for initial and continuation prior authorization
Submit required documentation with initial and continuation prior authorization requests: baseline oxalate testing and molecular/liver enzyme confirmation for initial requests; chart notes or medical records showing clinical response for continuation.
- Initial requests: baseline urinary oxalate, urinary oxalate:creatinine ratio, or plasma oxalate test results; molecular genetic test results demonstrating a pathogenic AGXT variant OR liver enzyme analysis showing absent/significantly reduced AGT activity.
- Continuation requests: chart notes or medical records demonstrating a positive response to therapy.
Indications outside PH1 are not medically necessary
Use of Oxlumo for any indication other than FDA‑approved primary hyperoxaluria type 1 (PH1) is considered experimental/investigational and not medically necessary and may be denied.
Definitions and Diagnostic Criteria
Background
Primary hyperoxaluria type 1 (PH1) is the FDA‑approved indication for Oxlumo (lumasiran). PH1 is a rare genetic disorder characterized by overproduction of oxalate that results in elevated urinary and plasma oxalate levels; treatment with Oxlumo is intended to lower these oxalate levels in pediatric and adult patients with PH1.
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