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Coverage criteria policies

Nusinersen (Spinraza®) – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Nusinersen (Spinraza) requires prior authorization from HealthPartners Pharmacy Administration.

Coverage

  1. Initial authorization criteria:
    1. Be prescribed by a neurologist and prescriber’s specialty must be provided at time of request; and,
    2. At time of request, prescriber must confirm whether or not the patient is currently enrolled in clinical trials for Spinraza; and,
    3. Have a diagnosis of SMA and supporting documentation confirming:
      1. Homozygous SMN1 gene deletion or mutation; or,
      2. Compound heterozygous SMN1 mutation; and,
    4. Have sufficient number of copies of SMN2 gene defined as one of the following genetic tests demonstrating:
      1. If a pre-symptomatic infant, then ≤ 3 copies of SMN2 gene is required; or,
      2. If a symptomatic patient, then ≥ 2 copies of SMN2 gene is required; and,
      3. Documentation of age of onset of symptoms; and,
    5. Provide baseline assessment using at least one of the following:
      1. Hammersmith Functional Motor Scale Expanded (HFMSE)
      2. Hammersmith Infant Neurologic Exam (HINE)
      3. 6-minute walk test (6MWT)
      4. Upper limb module (ULM) score
      5. Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND)
    6. Provide baseline:
      1. Complete blood count; and,
      2. Quantitative spot urine protein testing; and,
      3. Coagulation status.
        Initial approvals will be limited to 6 months in duration.
        Initial approval max dose: five 5ml (12mg/5ml) vials for the first 6 months.
  2. Reauthorization criteria:
    1. Absence of toxicity from the drug including serious infections, glomerulonephritis, thrombocytopenia, etc. and
    2. Patient has demonstrated improvement or lack of progression from baseline in at least one of the following:
      1. Hammersmith Functional Motor Scale Expanded (HFMSE): at least 3 point increase from baseline
      2. Hammersmith Infant Neurologic Exam (HINE): at least 2 point (or maximal score) increase in ability to kick or at least 1 point increase in any other HINE milestone
      3. 6-minute walk test (6MWT): increase of 30 meters if ambulatory
      4. Upper limb module (ULM) score: at least 2 point increase from baseline
      5. Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND): at least 4 point increase from baseline
      6. Progression has been slower than otherwise would have been expected in this patient population
        Reauthorization max dose: three 5ml (12mg/5ml) vials for the subsequent 12 months.
  3. Denial criteria:
    1. Patient is currently enrolled in clinical trials for Spinraza
    2. SMA without chromosome 5q mutations or deletions 
    3. SMA pre-symptomatic patients with > 3 copies of SMN2 gene

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:

HCPCS Codes

    Codes

    Description

    J2326

    Injection, nusinersen, 0.1 mg

NDC Codes

    Codes

    Description

    64406005801

    Spinraza 12 MG/5ML SOLN

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

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/spinraza.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date

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