Prince Edward Island (PEI) provides coverage for SMA treatments through their Pharmacare. 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 ‘Risdiplam’ in the document. For convenience, full coverage criteria is posted below.

 

Full coverage criteria

 

For patients diagnosed with 5q Spinal Muscular Atrophy (SMA) under the care of a

specialist with experience in the diagnosis and management of SMA, if the following

clinical criteria are met:

• Genetic documentation of 5q SMA homozygous gene deletion or compound

heterozygote, AND

• Patients who:

o are symptomatic and have genetic documentation of two or three copies of the SMN2 gene, AND

o aged between 2 months and 7 months (inclusive), OR

o aged 8 months up to 25 years and are non-ambulatory

• Patient is not currently requiring permanent invasive ventilation*, AND
• A baseline assessment using an age-appropriate scale (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]) must be completed prior to initiation of risdiplam treatment.

 

• For continued coverage, the patient must meet the following criteria:

There is demonstrated achievement or maintenance of motor milestone function (as assessed using age-appropriate scales: the [HINE] Section 2, CHOP INTEND, or HFMSE) after treatment initiation in patients aged between 2 months and 2 years at the time of treatment initiation; OR

o There is demonstrated maintenance of motor milestone function (as assessed using age-appropriate scales: the HINE Section 2, CHOP INTEND, or HFMSE) after treatment initiation in patients aged between 2 years and 25 years at the time of treatment initiation; AND

o Patient does not require permanent invasive ventilation*.

The decision to discontinue reimbursement should be based on 2 assessments

separated by no longer than a 12-week interval.

 

Claim Notes:

• Approval: 12 months

* 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.

 

Patients requesting coverage through the High Cost Drug Program must submit a

patient application, available from the Drug Programs Office or online at

http://healthpei.ca/pharmacareforms.

 

Spinraza (generic name: nusinersen)

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

 

Full coverage criteria

 

For patients diagnosed with 5q Spinal Muscular Atrophy (SMA) if the following clinical

criteria are met:

1) Genetic documentation of 5q SMA homozygous gene deletion, homozygous

mutation, or compound heterozygote, AND

2) Patients who:

• are pre-symptomatic with two or three copies of SMN2, OR
• have had disease duration of less than six months, two copies of SMN2, and symptom onset after the first week after birth and on or before seven months of

age, OR

• are under the age of 18 with symptom onset after six months of age,

AND

3) Patient is not currently requiring permanent invasive ventilation*, AND

4) A baseline assessment using an age-appropriate scale (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] must be completed prior to initiation of nusinersen treatment.

 

Other patients with SMA type 2 or 3 who are over the age of 18 may be considered

on a case by case basis.

 

For continued coverage, the patient must meet the following criteria:

1) There is demonstrated achievement or maintenance of motor milestone function (as assessed using age-appropriate scales: the [HINE] Section 2), CHOP INTEND, or HFMSE since treatment initiation in patients who were pre- symptomatic at the time of

treatment initiation; OR

There is demonstrated maintenance of motor milestone function (as assessed using age-appropriate scales: the HINE Section 2, CHOP INTEND, or HFMSE since treatment initiation in patients who were symptomatic at the time of treatment initiation;

AND

2) Patient does not require permanent invasive ventilation*.

Treatment should be discontinued if, prior to the fifth dose or every subsequent dose of

nusinersen, the above renewal criteria are not met.

* 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.

• Approval Period: 1 year.
• Claims that exceed the maximum claim amount of $9,999.99 must be divided and

submitted as separate transactions using the DIN first, and then PDINs.

Patients requesting coverage through the High Cost Drug Program must submit a

patient application, available from the Drug Programs Office or online at

www.healthpei.ca/pharmacareforms.

Zolgensma (generic name: onasemnogene abeparvovec)

• No information available at this time. Please discuss eligibility with your healthcare provider.

The information on this page was last updated in May 2024