Nusinersen (Spinraza) (Medicaid Expansion)

Policy ID: ME-I-157-006-03

Section: Injections

Effective Date: January 01, 2022

Revised Date: May 09, 2024

Revision Effective Date: June 01, 2024

Last Reviewed: May 14, 2024

Applies To: Medicaid Expansion Only

Description

Nusinersen (Spinraza™) is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide given intrathecally, indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult individuals.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

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

The use of nusinersen (Spinraza) may be considered medically necessary when ALL of the following criteria are met:

The individual must have a diagnosis of spinal muscular atrophy (SMA) with each of the following:
- Bi-allelic deletions or mutations of SMN1 as confirmed by genetic testing, reported as ONE of the following:
  - Homozygous deletions of exon 7; or
  - Compound heterozygous mutations; and
- ONE of the following:
  - The individual has number of SMN2 gene copies greater than or equal to one (1) but less than or equal to four (4) as confirmed by genetic testing; or
  - The individual is symptomatic (e.g., loss of reflexes, motor delay, motor weakness, abnormal EMG/neuromuscular ultrasound); and
- Nusinersen (Spinraza) must be prescribed by or in consultation with a neuromuscular neurologist or neuromuscular physiatrist; and
- The individual must visit with a neuromuscular clinic (clinic name and contact information and date of last visit must be provided, and date of last visit must be within the last year); and
- The individual must not require continuous intubation greater than three (3) weeks; and
- The individual must not have received gene therapy (i.e., Zolgensma); and
- The individual's weight and prescribed dose must be provided and within dosing recommendations per the manufacturer label; and
The individual's baseline motor milestone score results must be provided from at least two (2) of the following assessments:
- Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorder (CHOP-INTEND)
- Hammersmith Infant Neurological Examination (HINE) Section 2 motor milestone score
- Hammersmith Functional Motor Scale Expanded (HFMSE)
- Motor Function Measure - 32 items (MFM-32)
- Revised Upper Limb Module (RULM)
- Six (6)-minute walk test (6MWT)
- Forced Vital Capacity (FVC) via Pulmonary Function Test; and
The individual must not have severe contractures or severe scoliosis.

Reauthorization Criteria

Continuation of therapy with nusinersen (Spinraza) may be considered medically necessary when ALL of the following are met:

The individual's weight and prescribed dose must be provided and within dosing recommendations per the manufacturer label; and
The individual must visit with a neuromuscular clinic (clinic name, contact information, and date of last visit must be provided, and date of last visit must be within the last year); and
The provider must submit documentation showing that the individual has experienced clinical benefit (defined as maintenance of baseline motor function or significant slowed rate of decline vs expected natural course of the disease) since starting treatment with nusinersen (Spinraza), as evidenced by documentation of one of the following:
- Current Forced Vital capacity (FVC and FEV1) via Pulmonary Function Test; or
- CHOP-INTEND, HINE, HFMSE, MFM-32, 6MWT, or RULM scores

The use of nusinersen (Spinraza) 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 Code

J2326

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. 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

G12.0

G12.1

G12.8

G12.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021- Effective January 1, 2022

Adopted Medicaid Expansion specific policy

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated diagnosis code list, and
Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 - Annual Review - no changes in criteria

Internal Medical Policy Committee 5-14-2024 Effective June 01, 2024

Updated criteria based on the DHHS PDL Version 2024.3

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: ME-I-157-006-02

Section: Injections

Effective Date: January 01, 2022

Revised Date: November 29, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 15, 2023

Archived Date: May 31, 2024

Applies To: Medicaid Expansion Only

Description

Criteria

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

The use of nusinersen (Spinraza) may be considered medically necessary when ALL of the following criteria are met:

The individual must have a diagnosis of spinal muscular atrophy (SMA) with each of the following (as evidenced with submitted documentation):
- Bi-allelic deletions or mutations of SMN1 as confirmed by genetic testing, reported as ONE of the following:
  - Homozygous deletions of exon 7; or
  - Compound heterozygous mutations; and
- ONE of the following:
  - The individual has number of SMN2 gene copies greater than or equal to one (1) but less than or equal to three (3) as confirmed by genetic testing; or
  - The individual is symptomatic (e.g., loss of reflexes, motor delay, motor weakness, abnormal EMG/neuromuscular ultrasound); and
- Nusinersen (Spinraza) must be prescribed by or in consultation with a neuromuscular neurologist or neuromuscular physiatrist; and
- The individual must visit with a neuromuscular clinic once per year and clinic name, contact information, and date of last visit must be provided; and
- The individual must not require continuous intubation greater than three (3) week; and
- The individual must not have received gene therapy (i.e., Zolgensma); and
- The individual’s weight and prescribed dose must be provided and within dosing recommendations per the manufacturer label; and
Documentation must be provided of the individual’s current motor function, as evidenced by scores from at least TWO (2) of the following assessments:
- Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorder (CHOP-INTEND)
- Hammersmith Infant Neurological Examination (HINE) Section 2 motor milestone score
- Hammersmith Functional Motor Scale Expanded (HFMSE)
- Motor Function Measure – 32 items (MFM-32)
- Revised Upper Limb Module (RULM)
- Six (6)-minute walk test (6MWT)
- Forced Vital Capacity (FVC) via Pulmonary Function Test; and
The individual must not have severe contractures or severe scoliosis.

Reauthorization Criteria

Continuation of therapy with nusinersen (Spinraza) may be considered medically necessary when ALL of the following are met:

The individual’s weight and prescribed dose must be provided and within dosing recommendations per the manufacturer label; and
The individual must visit with a neuromuscular clinic once per year and clinic name, contact information, and date of last visit must be provided; and
The provider must submit documentation showing that the individual has experienced clinical benefit (defined as maintenance of baseline motor function or significant slowed rate of decline vs expected natural course of the disease) since starting treatment with nusinersen (Spinraza), as evidenced by documentation of one of the following:
- Current Forced Vital capacity (FVC and FEV1) via Pulmonary Function Test; or
- CHOP-INTEND, HINE, HFMSE, MFM-32, 6MWT, or RULM scores

Procedure Codes

J2326

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

G12.0

G12.1

G12.8

G12.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021- Effective January 1, 2022

Adopted Medicaid Expansion specific policy

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated diagnosis code list, and
Updated initial criteria, and
Updated reauthorization criteria, and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 - Annual Review - no changes in criteria

Links

References (PDF)

Disclaimer

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Nusinersen (Spinraza) (Medicaid Expansion)

Description

Policy Application

Criteria

Procedure Code

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