Interactive Drug Benefit List
DIN/NPN/PIN 02465663 SPINRAZA 2.4 MG / ML INJECTION NUSINERSEN SODIUM
920000 MISCELLANEOUS THERAPEUTIC AGENTS
929200 OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Date Listed/Coverage Update: 01-Dec-2018
Unit Price: 23,600.0000
LCA Price: N/A
MAC Price:

N/A

Unit of Issue: Millilitre
Manufacturer: BIOGEN IDEC CANADA INC (BIO)
ATC: N07
1
Interchangeable Products: No

Coverage Status: SPECIAL AUTHORIZATION
Applies to Clients of: Non-Group Coverage (Group 1)
Coverage for Seniors (Group 66)
Palliative Coverage (Group 20514, Please note your client may have Group 1 or Group 66 coverage)
Child and Family Services (Group 20403)
Alberta Child Health Benefit (Group 20400)
Children and Youth Services (Group 19824)
Income Support (Group 19823)
Alberta Human Services (AISH) (Group 19823)
Alberta Adult Health Benefit (AAHB) (Group 23609)

Special Authorization Request Form:

Nusinersen/Risdiplam Special Authorization Request Form (ABC 60064)

SPECIAL AUTHORIZATION

"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:

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, regardless of the ability to walk independently.
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 who do not meet the expanded funding criteria may be considered in exceptional cases.

Initial coverage may be approved for three 12 mg doses at Day 0, Day 14 and Day 28, followed by one 12 mg dose at Day 63.

Patients will be limited to receiving one dose of nusinersen per prescription at their pharmacy.

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*.

Continued coverage may be considered for one 12 mg maintenance dose at a time, to be administered at 4-month intervals.
Each maintenance dose cannot be considered prior to 4 months elapsing from the date of the previous dose.
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.

SMA drug therapy and adeno-associated virus (AAV) vector-based gene therapy may not be used concomitantly. Additionally, use of a SMA drug therapy after administration of an AAV vector-based gene therapy will not be permitted, and coverage will not be approved when any SMA drug therapies are to be used in combination.

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."

All requests (including renewal requests) for nusinersen must be completed using the Nusinersen/Risdiplam Special Authorization Request Form (ABC 60064).

Review Status / Past Decisions

Indication Reviewing
Body
Submission
Completion
Date
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
Review
Status
SPINAL MUSCULAR ATROPHY Common Drug Review 2021/12/16 2022/08/11 View CDR - Do not list
SPINAL MUSCULAR ATROPHY Common Drug Review 2018/08/08 2019/06/17 Special Authorization Criteria Change
SPINAL MUSCULAR ATROPHY Common Drug Review 2018/08/08 2022/03/01 Special Authorization Criteria Change
SPINAL MUSCULAR ATROPHY Common Drug Review 2018/08/08 2019/02/27 View CDR - List with clinical criteria and/or conditions
SPINAL MUSCULAR ATROPHY Common Drug Review 2017/07/13 2018/12/01 Special Authorization
SPINAL MUSCULAR ATROPHY Common Drug Review 2017/07/13 2017/12/20 View CDR - List with clinical criteria and/or conditions
Indication SPINAL MUSCULAR ATROPHY
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2021/12/16
CDR
Recommendation
Date
2022/08/11
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - Do not list
Indication SPINAL MUSCULAR ATROPHY
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2018/08/08
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2019/06/17
CDR
Recommendation
Review
Status
Special Authorization Criteria Change
Indication SPINAL MUSCULAR ATROPHY
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2018/08/08
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2022/03/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change
Indication SPINAL MUSCULAR ATROPHY
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2018/08/08
CDR
Recommendation
Date
2019/02/27
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
Indication SPINAL MUSCULAR ATROPHY
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2017/07/13
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2018/12/01
CDR
Recommendation
Review
Status
Special Authorization
Indication SPINAL MUSCULAR ATROPHY
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2017/07/13
CDR
Recommendation
Date
2017/12/20
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
To return to the printable Drug Benefit List and related publications, click here
Last Updated:
NOTICE:
The DBL, DBS and related publications require knowledgeable interpretation and are intended primarily for professional health care practitioners, pharmacies, hospitals and organizations associated with the manufacture, distribution and use of pharmaceutical preparations.
Electronic versions of all DBL and DBS related publications are unofficial versions and are provided for convenience and private use only. Official paper versions can be obtained from Alberta Blue Cross who publishes them on behalf of Alberta Health and Alberta Human Services.
Alberta Health reserves the right to make changes, without notice, to the List through the Interactive DBL(iDBL), and any such changes to the Interactive DBL(iDBL) are effective the date of the change (unless otherwise stated) and regardless of the date of publication in the paper version or updates.