State and School Employees' Health Insurance Plan - Oxlumo (lumasiran)

POLICY NUMBER

S.5.01.624

Oxlumo (lumasiran injection)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

DESCRIPTION

Primary hyperoxaluria (PH) is a rare, autosomal recessive disorder resulting in overproduction of oxalate, which is deposited as calcium oxalate in various organs. PH type 1 is the most common and severe form of the disease and is due to variants of the AGXT gene. Management aims to reduce calcium oxalate deposition and kidney impairment.

Oxlumo (lumasiran) is hydroxyacid oxidase 1 (HAO1)-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of PH Type 1 to lower urinary and plasma oxalate levels in pediatric and adult patients. Oxlumo (lumasiran) targets HAO1, which leads to a reduction of glycolate oxidase levels and results in decreased oxalate production.

POLICY

Oxlumo (lumasiran) is considered not medically necessary as there are other treatment options covered by the Plan for the treatment of primary hyperoxaluria type 1.

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Participant's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Participant's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Participant, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to the Participant. When applied to the care of an Inpatient, it further means that services for the Participant's medical symptoms or conditions require that the services cannot be safely provided to the Participant as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

09/15/2025: New policy added.

SOURCE(S)

1. Niaudet P. Primary hyperoxaluria.  In: UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed on September 3, 2025. Available at

   https://www.uptodate.com/contents/primary-hyperoxaluria

2. Oxlumo prescribing information. Alnylam Pharmaceuticals, Inc. April 2025. Last accessed September 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Not Medically Necessary Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.