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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

Prior authorization is required for Spinraza through HealthPartners pharmacy administration. Payment for Spinraza is restricted to Accredo Specialty Pharmacy.

Coverage

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

Initial approvals

  1. Diagnosis of SMA by neurologist or pediatric neuromuscular specialist and
  2. Documented genetic testing with documentation of deletion or mutation of survival motor neuron (SMN) 1 gene on chromosome 5q and
    1. No more than 2 copies of SMN2 gene or
    2. SMA-associated symptoms before 6 months of age and
  3. 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. The prescribed regimen is within the FDA-approved dosing regimen: 12mg intrathecal injection every 14 days for 3 doses, then 12mg intrathecal injection for 1 dose 30 days later, then 12mg intrathecal injection every 4 months thereafter

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 with 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

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

C9399

Unclassified drugs or biologicals (Hospital Outpatient use ONLY)

J3490

Unclassified drugs

NDC

Codes

Description

64406005801

Spinraza 2.4mg/1mL vial

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 2016
  2. FDA approves first drug for spinal muscular atrophy [Press release]. Updated December 23, 2016. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm534611.htm. Accessed December 30, 2016.
  3. U.S. FDA Approves Biogen’s SPINRAZA™ (nusinersen), The First Treatment for Spinal Muscular Atrophy [Press Release]. Updated December 23, 2016. Available at: http://media.biogen.com/press-release/neurodegenerative-diseases/us-fda-approves-biogens-spinraza-nusinersen-first-treatment. Accessed December 30, 2016.
  4. Biogen and Ionis Pharmaceuticals Announce SPINRAZA (nusinersen) Meets Primary Endpoint at Interim Analysis of Phase 3 CHERISH Study in Later-Onset Spinal Muscular Atrophy [Press Release]. Updated November 7, 2016. Available at: http://media.biogen.com/press-release/corporate/biogen-and-ionis-pharmaceuticals-announce-spinraza-nusinersen-meets-primary-. Accessed December 30, 2016.
  5. Prior TW, Russman BS. Spinal muscular atrophy. GeneReviews. Available at: www.ncbi.nlm.nih.gov/books/NBK1352/. Accessed December 28, 2016.
  6. UpToDate, Inc. Spinal muscular atrophy. UpToDate [database online]. Waltham, MA. Updated July 7, 2016. Available at: http://www.uptodate.com/home/index.html. Accessed December 30, 2016.
  7. Ionis Pharmaceuticals, Inc. An Open-Label Study (SHINE) for Patients With Spinal Muscular Atrophy (SMA) Who Participated in Studies With IONIS-SMNRx [online]. Available at: https://clinicaltrials.gov/ct2/show/NCT02594124. Accessed December 29, 2016.
  8. Lunn MR, Wang CH. Spinal muscular atrophy. Lancet. 2008; 371:2120-33.
  9. 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.
  10. FDA Center for Drug Evaluation and Research (CDER). Medical Review. NDA 209531; Spinraza (nusinersen). December 23, 2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209531Orig1s000TOC.cfm. Accessed February 23, 2017.
  11. Formulary Submission Dossier: SPINRAZA™ (Nusinersen) for Spinal Muscular Atrophy – December 30, 2016. Cambridge, MA: Biogen Inc.; Data reviewed February 2017.

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Policy activity

  • 03/13/2017 - Date of origin
  • 05/04/2017 - Effective date

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