New Brunswick provides coverage for SMA treatments through Special Authorization. Please see below for coverage details of each of the available SMA treatments. Please discuss your eligibility with your health-care provider.

SMA Treatments:

 Evrysdi (generic name: risdiplam)

• Coverage criteria can be found here by downloading the PDF and searching for ‘Evrysdi’ in the document. For convenience, full coverage criteria is posted below.

 

Full coverage criteria

 

For the treatment of 5q spinal muscular atrophy (SMA), if the following criteria are met:

• Genetic documentation of 5q SMA homozygous gene deletion, or compound heterozygous mutation; and
• Patient is not requiring permanent invasive ventilation; and
• Patient who is symptomatic with two or three copies of the SMN2 gene and is:

– 2 months to 7 months of age, or

– 8 months to 25 years of age and non-ambulatory.

 

Discontinuation Criteria:

• There is failure to demonstrate maintenance in motor milestone function as assessed using age-appropriate scales since treatment initiation; or
• permanent invasive ventilation is required.

 

Clinical Notes:

1. An age-appropriate scale is defined as the Hammersmith Infant Neurological Examination (HINE) Section 2, Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND), or Hammersmith Functional Motor Scale-Expanded (HFMSE).
2. A baseline assessment using an age-appropriate scale must be completed prior to initiation of treatment.
3. Yearly assessments must be completed using an age-appropriate scale no more than 12 weeks prior to the renewal date.
4. Permanent invasive ventilation is defined as the use of tracheostomy and a ventilator due to progression of SMA that is not due to an identifiable and reversible cause.

 

Claim Notes:

• The patient must be under the care of a specialist experienced in the treatment of SMA.
• Combination therapy with nusinersen will not be reimbursed.
• Requests for risdiplam will not be considered for patients who have received adeno-associated virus (AAV) vector-based gene therapy.
• Patients currently receiving SMA drug therapy may be eligible to switch to an alternate SMA drug therapy; however, patients will not be permitted to switch back to a previously trialed SMA drug.
• Approvals will be for a maximum of 0.2 mg/kg/day for patients 2 months to less than 2 years of age, 0.25mg/kg/day for patients greater than or equal to 2 years of age weighing less than 20 kg, or 5 mg/day for patients greater than or equal to 2 years of age and weighing greater than or equal to 20 kg.
• Approval period: 1 year.
• Claims that exceed the maximum claim amount of $9,999.99 must be divided and submitted as separate transactions as outlined here.

Spinraza (generic name: nusinersen)

• Coverage criteria can be found here by downloading the PDF and searching for ‘Spinraza’ in the document. For convenience, full coverage criteria is posted below.

 

Full coverage criteria

 

For the treatment of 5q spinal muscular atrophy (SMA), if the following criteria are met:

• Genetic documentation of 5q SMA homozygous gene deletion, homozygous mutation, or compound heterozygous mutation; and
• Patient is not requiring permanent invasive ventilation; and
• Patient who:

− is pre-symptomatic with genetic documentation of two or three copies of the survival motor neuron 2 (SMN2) gene, or

− has had disease duration less than 6 months, two copies of the SMN2 gene, and symptom onset after the first week of birth and on or before 7 months of age, or

− is under the age of 18 with symptom onset after 6 months of age.

 

Discontinuation Criteria:

Prior to the fifth dose or every subsequent dose:

• There is failure to demonstrate achievement or maintenance of motor milestone function as assessed using ageappropriate scales since treatment initiation in patients who were pre-symptomatic at the time of treatment initiation; or
• There is failure to demonstrate maintenance in motor milestone function as assessed using age-appropriate scales since treatment initiation in patients who were symptomatic at the time of treatment initiation; or
• Permanent invasive ventilation is required.

 

Clinical Notes:

1. An age-appropriate scale is defined as the Hammersmith Infant Neurological Examination (HINE) Section 2, Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND), or Hammersmith Functional Motor Scale-Expanded (HFMSE).
2. A baseline assessment using an age-appropriate scale must be completed prior to initiation of nusinersen treatment.
3. Permanent invasive ventilation is defined as the use of tracheostomy and a ventilator due to progression of SMA that is not due to an identifiable and reversible cause.

 

Claim Notes:

• The patient must be under the care of a specialist experienced in the treatment of SMA.
• Combination therapy with risdeplam will not be reimbursed.
• Requests for nusinersin will not be considered for patients who have received adeno-associated virus (AAV) vector-based gene therapy
• Patients currently receiving SMA drug therapy may be eligible to switch to an alternate SMA drug therapy; however, patients will not be permitted to switch back to a previously trialed SMA drug.
• Approval period: 1 year.
• Claims that exceed the maximum claim amount of $9,999.99 must be divided and submitted as separate transactions as outlined here.

.

Zolgensma (generic name: onasemnogene abeparvovec)

 

• Coverage criteria can be found here by downloading the PDF and searching for ‘Zolgensma’ in the document. For convenience, full coverage criteria is posted below.

 

Full coverage criteria

 

For the treatment of spinal muscular atrophy (SMA) in individuals who meet all of the following criteria:

• Genetic documentation of 5q SMA with biallelic mutations in the survival motor neuron 1 (SMN1) gene; and
• Patient is 180 days of age or younger at the time onasemnogene abeparvovec is administered; and
• Patient is pre-symptomatic or symptomatic with one to three copies of the survival motor neuron 2 (SMN2) gene;

and

• Patient does not require permanent ventilatory support (invasive or non-invasive) or a permanent feeding tube.

 

Clinical Note:

• Permanent ventilatory support is defined as the need for a tracheostomy or requirement of 16 hours or more of respiratory assistance per day (via non-invasive ventilatory support) for 14 or more consecutive days in the absence of an acute reversible illness excluding perioperative ventilation.

 

Claim Notes:

• The patient must be under the care of a specialist experienced in the diagnosis and treatment of SMA.
• No treatment with nusinersen, risdiplam or other medications indicated for the treatment of SMA will be considered after the patient has received a dose of onasemnogene abeparvovec.
• Approvals will be limited to one lifetime administraton of 1.1 x 1014 vector genomes/kg.
• Patients who have received a prior dose of onasemnogene abeparvovec accessed by any mechanism (e.g. private insurance plan, clinical trial, compassionate access) will not be funded.
• Patients with 4 or more copies of the SMN2 gene will not be funded.

The information on this page was last updated in May 2024