HIGHMARK COMMERCIAL MEDICAL POLICY - DELAWARE

 
 
Medical Policy:
I-157-004
Topic:
Nusinersen (Spinraza)
Section:
Injections
Effective Date:
October 29, 2018
Issued Date:
October 29, 2018
Last Revision Date:
June 2018
Annual Review:
June 2018
 
 

 

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 patients.

 

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

Nusinersen (Spinraza) may be considered medically necessary for individuals with symptomatic SMA type I, II, or III caused by mutations in chromosome 5q when the following criteria are met:

·         Individual has had SMA diagnostic test results confirming 0 copies of SMN1; or

·         Molecular genetic testing of 5q SMA for any of the following:

o    homozygous gene deletion; or

o    homozygous conversion mutation; or

o    compound heterozygote; and

·         Patient has at least 2 copies of SMN2

·         Nusinersen (Spinraza) is prescribed by or in consultation with a neuromuscular specialist or neurologist with experience and expertise in the treatment and ongoing management individuals with SMA; and

·         The individual is 15 years of age or younger at initiation of treatment; and

·         For individuals 2-24 months old: baseline documentation of the Hammersmith Infant Neurologic Exam (HINE); and

·         Baseline documentation of the CHOP-Intend (typically assessed 1 month to 4 years of age)

·         For SMA type II (onset 6 months through 18 months) nusinersen (Spinraza) may be authorized if the member meets the above criteria.

 

Continuation of treatment with nusinersen (Spinraza) beyond 6 months after initiation of therapy, and every 6 months thereafter, may be considered medically necessary for the treatment of spinal muscular atrophy when individuals meet BOTH of the following:

·         When initial therapy was determined to meet the above criteria; and

·         When there is documentation demonstrating individual is stable or shows clinically significant improvement in SMA-associated symptoms, for example: progression, stabilization or decreased decline in motor function compared to the predicted natural history trajectory of disease, or

·         As demonstrated by stable or improved motor function test results compared to baseline (HINE, ULM, CHOP, etc.)

The use of nusinersen (Spinraza) for any other indication other than spinal muscular atrophy caused by mutations in chromosome 5q is considered experimental/investigational and therefore non-covered due to the lack of scientific evidence to support efficacy and safety.

 

J2326

 

 

 

 

 

 


Dosage recommendations per the FDA label.

Related Policies

Refer to medical policy L-166 Spinal Muscular Atrophy Testing for additional information.

 


Covered Diagnosis Codes for J2326

G12.0

G12.1

G12.8

G12.9

G12.25

 

 


Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of nusinersen (Spinraza) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business



Links





This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.




    Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

    Discrimination is Against the Law
    The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.