Lumasiran (Oxlumo)

Policy ID: I-233-006

Section: Injections

Effective Date: January 15, 2021

Revised Date: November 14, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 15, 2023

Applies To: Commercial Only

Description

Lumasiran (Oxlumo^TM) is a HAO1-directed double-stranded small interfering ribonucleic acid (siRNA), covalently linked to a ligand containing N-acetylgalactosamine (GalNAc). Lumasiran (Oxlumo) reduces levels of glycolate oxidase (GO) enzyme by targeting the hydroxyacid oxidase 1 (HAO1) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Lumasiran (Oxlumo) is considered medically necessary for the treatment of primary hyperoxaluria type 1 (PH1) when the following criteria are met:

Individual meets at least ONE of the following:
- Individual has signs and symptoms of PH1 (e.g., recurrent kidney stones, urolithiasis, infantile oxalosis, failure to thrive and renal failure, nephrocalcinosis associated with decreased GFR, oxalate crystals in any biological fluid or tissue, increased serum creatinine with calcium oxylate (CaOx) stones, CaOx tissue deposits, renal failure of unknown causes, etc.); or
- Individual does not have signs or symptoms but does have a family history of genetically confirmed PH1; and
Individual has genetic testing indicating homozygosity or compound heterozygosity for known mutations of AGXT; and
Individual has ONE of the following:
- Plasma oxalate (POx) greater than the upper limit of normal; or
- Urine oxalate (UOx) greater than the upper limit of normal; or
- UOx/creatinine (Cr) greater than the normal for age; and
Individual does not have secondary causes of hyperoxaluria (e.g., diet with excessive intake of oxalate, gastric bypass surgery, IBD, other intestinal disorders, etc.); and
Individual has not had or is not scheduled for a liver and/or kidney transplant; and
Lumasiran (Oxlumo) is prescribed by or in consultation with a nephrologist or other healthcare provider experience in treating PH1.

Reauthorization of lumasiran (Oxlumo) is considered medically necessary when the following criteria are met:

Individual diagnosed with PH1; and
Individual has reduced signs and symptoms of PH1 with lumasiran (Oxlumo) treatment; and
Individual's laboratory values have improved or normalized; and
Lumasiran (Oxlumo) is prescribed by or in consultation with a nephrologist or other healthcare provider experience in treating PH1.

The use of lumasiran (Oxlumo) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J0224

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

E72.53

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-19-2021 Adopted new pre-certification policy - Effective January 15, 2021

Internal Medical Policy Committee 3-17-2021 - Effective April 1, 2021

Added new code C9074 to policy

Internal Medical Policy Committee 7-22-2021 - Effective July 1, 2021

Removed code C9074 from policy; and
Added new code J0224

Internal Medical Policy Committee 7-21-2022 Annual review, no clinical content change

Internal Medical Policy Committee 11-29-2022

Added criteria "Plasma oxalate (POx) greater than the upper limit of normal"; and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-233-003

Section: Injections

Effective Date: January 15, 2021

Revised Date: May 27, 2021

Revision Effective Date: July 01, 2021

Last Reviewed: July 21, 2022

Archived Date: December 31, 2022

Applies To: Commercial Only

Description

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Lumasiran (Oxlumo) is considered medically necessary for the treatment of primary hyperoxaluria type 1 (PH1) when the following criteria are met:

Individual meets at least ONE of the following:
- Individual has signs and symptoms of PH1 (e.g., recurrent kidney stones, urolithiasis, infantile oxalosis, failure to thrive and renal failure, nephrocalcinosis associated with decreased GFR, oxalate crystals in any biological fluid or tissue, increased serum creatinine with calcium oxylate (CaOx) stones, CaOx tissue deposits, renal failure of unknown causes, etc.); or
- Individual does not have signs or symptoms but does have a family history of genetically confirmed PH1; and
Individual has genetic testing indicating homozygosity or compound heterozygosity for known mutations of AGXT; and
Individual has ONE of the following:
- Urine oxylate (UOx) greater than the upper limit of normal; or
- UOx/creatinine (Cr) greater than the normal for age; and
Individual does not have secondary causes of hyperoxaluria (e.g., diet with excessive intake of oxylate, gastric bypass surgery, IBD, other intestinal disorders, etc.); and
Individual has not had or is not scheduled for a liver and/or kidney transplant; and
Lumasiran (Oxlumo) is prescribed by or in consultation with a nephrologist or other healthcare provider experience in treating PH1; and
Initial authorization will be for 6 months.

Reauthorization of lumasiran (Oxlumo) is considered medically necessary when the following criteria are met:

Individual diagnosed with PH1; and
Individual has reduced signs and symptoms of PH1 with lumasiran (Oxlumo) treatment; and
Individual's laboratory values have improved or normalized; and
Lumasiran (Oxlumo) is prescribed by or in consultation with a nephrologist or other healthcare provider experience in treating PH1; and
Reauthorization will be for 12 months.

Lumasiran (Oxlumo) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence does not support its use for any other indication.

Procedure Codes

J0224

Diagnosis Codes

E72.53

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-19-2021 Adopted new pre-certification policy effective 1-15-2021

Internal Medical Policy Committee 3-17-2021 Added new code C9074 to policy effective 4-1-2021

Internal Medical Policy Committee 7-22-2021 Added new code J0224 and removed code C9074 from policy effective 7-1-2021

Internal Medical Policy Committee 7-21-2022 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

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Medical Policies Quick Search

Lumasiran (Oxlumo)

Description

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer