Skip to main content
HealthPartners

Coverage criteria policies

Nusinersen (Spinraza)

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

Spinraza requires prior authorization from HealthPartners Pharmacy Administration. Payment for Spinraza is restricted to Accredo Specialty Pharmacy. Accredo can be reached by phone at 855-778-1510 option 3, and by fax at 866-579-4655.

Coverage

Spinraza is generally covered for spinal muscular atrophy (SMA) when all of the following criteria are met:

Initial approvals

  1. Diagnosis of 5q SMA by neurologist or pediatric neuromuscular specialist and, confirmed by genetic testing with documentation of deletion or mutation of survival motor neuron (SMN) 1 gene on chromosome 5q, and
  2. Type 1, Type 2 with symptomatic disease, or Type 3 with symptomatic disease, and
    1. Patients must be 12 years of age or younger at initiation of treatment, and
    2. Symptomatic patients must be able to sit independently, and
    3. Patients must not be dependent on either of the following:
      1. Invasive ventilation or tracheostomy, or
      2. Use of non-invasive ventilation beyond use for naps and nighttime sleep

and

  1. Documentation of baseline motor function by one of the following exams:
    1. Hammersmith Infant Neurologic Exam [HINE] (infant to early childhood)
    2. Hammersmith Functional Motor Scale Expanded [HFMSE]
    3. Upper Limb Module [ULM] test (non-ambulatory)
    4. Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders [CHOP-INTEND]

and

  1. Prescribed by a neurologist or pediatric neuromuscular, and
  2. The prescribed regimen is within the FDA-approved dosing regimen

Authorizations will be provided for 6 months with a limitation of a maximum of 6 doses during the first year and 3 doses annually thereafter.

Reauthorizations

Renewals will be provided every 6 months when all of the following criteria are met:

  1. Documentation of clinically significant improvement of motor function as demonstrated in one of the following exams:
    1. HINE:
      1. One of the following:
        1. Improvement or maintenance of previous improvement of at least 2 point (or maximal score) increase in ability to kick or
        2. Improvement or maintenance of previous improvement of at least 1 point increase in any other HINE milestone (e.g. head control, rolling, sitting, crawling, etc) excluding voluntary grasp

and

      1. One of the following:
        1. Demonstrated improvement in more categories than worsening (excluding voluntary grasp) from pretreatment baseline or
        2. Achievement or maintenance of any new motor milestones when they would otherwise be unexpected to do so
    1. HFMSE: One of the following:
      1. Improvement or maintenance of previous improvement of at least 3 point increase in score from pretreatment baseline score or
      2. Achievement or maintenance of any new motor milestones when they would otherwise be unexpected to do so
    2. ULM: One of the following:
      1. Improvement or maintenance of previous improvement of at least 2 point increase in score from pretreatment baseline score or
      2. Achievement or maintenance of any new motor milestones when they would otherwise be unexpected to do so
    3. CHOP-INTEND: One of the following:
      1. Improvement or maintenance of previous improvement of at least 4 point increase in score from pretreatment baseline score or
      2. Achievement or maintenance of any new motor milestones when they would otherwise be unexpected to do so

and

  1. Patients must not be dependent on either of the following:
    1. Invasive ventilation or tracheostomy, or
    2. Use of non-invasive ventilation beyond use for naps and nighttime sleep

Indications that are not covered

Spinraza is considered investigational/experimental when used for all other conditions, including but not limited to non-5q SMA or any other types of SMA not specified above. There is not sufficient reliable evidence in the form of high quality peer-reviewed medical literature to establish the safety and efficacy of this treatment or its effect on health care outcomes in these conditions.

Definitions

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

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:
HCPC

    Codes

    Description

    J2326

    Injection, nusinersen, 0.1 mg (Spinraza)

NDC

    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. Spinraza Prescribing Information, Biogen Inc. Cambridge, MA 02142, December 2017
  2. Prior TW, Russman BS. Spinal muscular atrophy. GeneReviews. Available at: www.ncbi.nlm.nih.gov/books/NBK1352/. Accessed December 28, 2016.
  3. Lunn MR, Wang CH. Spinal muscular atrophy. Lancet. 2008; 371:2120-33.
  4. Sugarman EA, Nagan N, Zhu H, et al. Pan-ethnic carrier screening and prenatal diagnosis for spinal muscular atrophy: clinical laboratory analysis of >72,400 specimens. Eur J Hum Genet. 2012;20:27–32.
  5. Formulary Submission Dossier: SPINRAZA™ (Nusinersen) for Spinal Muscular Atrophy – December 30, 2016. Cambridge, MA: Biogen Inc
  6. Mercuri E, Darras BT, Chiriboga CA, et al. Nusinersen versus Sham Control in Later-Onset Spinal Muscular Atrophy. N Engl J Med. 2018;378:625-635.
  7. Finkel RS, Mercuri E, Darras BT, et al. Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy. N Engl J Med. 2017;377:1723-1732.

Go to

Policy activity

  • 03/13/2017 - Date of origin
  • 05/07/2018 - Effective date
Review date
  • 02/2018
Revision date
  • 05/07/2018

Related content