State and School Employees' Health Insurance Plan - Radicava (edaravone)

POLICY NUMBER

S.5.01.514

Radicava (edaravone)

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

DESCRIPTION

Amyotrophic lateral sclerosis (ALS), often called Lou Gehrig disease, is a rare, progressive, neurodegenerative disease that destroys motor neurons. As nerve cells can no longer stimulate muscles, individuals with ALS gradually lose their ability to control voluntary muscles involved in breathing, chewing, talking, and walking. The majority of individuals with ALS die within 3 to 5 years of developing symptoms. Currently, there is no cure for ALS, and treatment is limited to symptom control and supportive therapies.

On May 5, 2017, the Food and Drug Administration (FDA) approved Radicava (edaravone) for the treatment of individuals with ALS. The mechanism by which Radicava exerts its therapeutic effect in individuals is unknown. It has been characterized as a free radical scavenger, which is thought to block radicals that mediate both neuronal and vascular damage.

POLICY

The use of samples by an individual will not be considered current or stable therapy for purposes of Medical Policy review. 

Initial Criteria

Radicava (edaravone) may be considered medically necessary when ALL of the following criteria are met:

1. The individual is 18 years of age or older;

2. The individual has documented diagnosis of amyotrophic lateral sclerosis (ALS), diagnosed within the previous 24 months, defined as ONE of the following:

   1. Clinically definite ALS defined by ONE of the following:

      1. Presence of upper motor neuron (UMN) and lower motor neuron (LMN) signs in the bulbar region and at least two spinal regions; OR

      2. Presence of UMN and LMN signs in three spinal regions; OR

   2. Clinically probable ALS defined as the presence of UMN and LMN signs in at least 2 regions with some UMN signs necessarily rostral to (above) the LMN signs;

3. The individual's baseline (within 60 days of initiation of edaravone) ALS Functioning Rating Scale; Revised (ALSFRS-R) score is 2 points or higher on ALL ALSFRS-R criteria [see Policy Guidelines section];

4. The individual has normal respiratory function (i.e., FVC ≥80% predicted);

5. The prescriber is a specialist (i.e., neurologist) or has consulted with a specialist in an area of the individual's diagnosis;

6. The requested quantity (dose) is within FDA labeled dosing for the requested indication; AND

7. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent.

Length of Approval: 6 months

Renewal Criteria

Radicava (edaravone) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for therapy with the requested agent through the BCBSMS PA process;

2. The individual has had clinical benefit with the requested agent (i.e., maintenance of baseline ALSFRS-R score, slowing of disease progression, etc.);

3. The individual is NOT dependent on invasive ventilation or tracheostomy;

4. The prescriber is a specialist (i.e., neurologist) or has consulted with a specialist in an area of the individual's diagnosis;

5. The requested quantity (dose) is within FDA labeled dosing for the requested indication; AND

6. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent. 

Length of Approval: 6 months

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

State Health Plan (State and School Employees): Self-administered drugs may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a self-administered drug are not covered under the medical benefit.

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.

ALS Functioning Rating Scale-Revised (ALSFRS-R)

The ALSFRS-R scale consists of 12 questions that evaluate the fine motor, gross motor, bulbar, and respiratory function of individuals with ALS (speech, salivation, swallowing, handwriting, cutting food, dressing/hygiene, turning in bed, walking, climbing stairs, orthopnea, and respiratory insufficiency). Each item is scored from 0 to 4, with higher scores representing greater functional ability.

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.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

POLICY HISTORY

07/01/2023: New policy added.

10/01/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Renewal criteria revised to remove the following statement: The individual has been adherent to medication. Sources updated.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description and policy section revised with minor changes for clarity purposes; coverage criteria unchanged. Sources updated.

SOURCE(S)

1. ALS Association. Who gets ALS? May 2019. Available at

   http://www.alsa.org/about-als/what-is-als.html

   . Accessed May 2020.

2. Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000;1(5):293?299.

3. Radicava prescribing information. Mitsubishi Tanabe Pharma America, Inc. December 2023. Last accessed August 2024.

CODE REFERENCE

This is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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