Product Details

Tegsedi

Inotersen
284 mg/1.5 mL
Solution for Subcutaneous Injection
Single-Dose 1.5-mL Pre-Filled Syringe (Preservative-Free)

DIN/PIN/NPN

02481383

Manufacturer

Innomar Strategies, Inc.

Formulary Listing Date

2021-01-29  

Unit Price

8,043.4874

Amount MOH Pays

8,043.4874

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

N07XX15

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Metabolic/Genetic Modifiers

Inotersen

  • Brand(s): Tegsedi
  • Dosage Form/Strength: 284 mg/ 1.5 mL prefilled syringes

Initiation criteria:

For the treatment of polyneuropathy in patients with hereditary transthyretin-mediated amyloidosis (hATTR), meeting all the following criteria:

  1. Age 18 years of age or older; AND 

  1. Has a confirmed genetic diagnosis of hereditary transthyretin-mediated amyloidosis: AND 

  1. Symptomatic with Polyneuropathy disability stage I to ≤ IIIB or with Familial amyloidotic polyneuropathy stage I or II. 

  1. Under the care of a specialist with experience in the diagnosis and management of hATTR 

Exclusion Criteria: 

  • Pre-symptomatic patients 

  • Patients diagnosed with severe heart failure symptoms (defined as New York Heart Association class III or IV). 

  • Patients who are recipients of a liver transplant 

  • Patients with platelet count below 100 x 109/L before initiation of treatment 

  • Patients who will be using Inotersen in combination with other interfering ribonucleic acid drugs or transthyretin stabilizers used to treat hATTR.

Discontinuation criteria:

Treatment with inotersen will be discontinued for patients who are: 

  • Permanently bedridden and dependent on assistance for basic activities of daily living, or 

  • Receiving end-of-life/palliative care where survival of less than one year is expected.

Renewal Criteria:

Renewal of funding will be considered if patients do not meet the discontinuation criteria.

Dosage: 300 mg of inotersen sodium (284mg of inotersen) SC injection once a week.

Patients should be assessed after 9 months of treatment and then every six months thereafter.

Duration of Approval of initiation requests: 10 months

Duration of Approval of first renewal: 6 months 

Duration of Approval of 2nd and subsequent renewals: 1 year

Notes to Prescribers: 

  • Laboratory documentation for the genetic mutation for hATTR must be included with the application. 

  • Signs and symptoms of polyneuropathy should be listed. 

  • In your application, please list all drugs that the patient is using including whether he/she is using any of the following: Diflunisal, Patisiran, Tafamidis 

  • Confirmation that the patient does not meet each of the listed exclusions must be provided on the request. 

Definitions: 

Familial Amyloid Polyneuropathy (FAP) stage: Clinical staging system for the neuropathy symptoms of hATTR (formerly termed familial amyloid neuropathy). 

  • FAP Stage 1: Walking without assistance, mild neuropathy (sensory, autonomic, and motor) in lower limbs 

  • FAP Stage 2: Walking with assistance, moderate impairment in lower limbs, trunk, and upper limbs 

  • FAP Stage 3: wheelchair or bed-ridden, severe neuropathy

Polyneuropathy disability score (PND): A five-stage measure of neuropathy impairment ranging from 0 (no impairment) to 4 (confined to a wheelchair or bedridden). 

  • Stage 0: no impairment 

  • Stage I: sensory disturbances but preserved walking capability 

  • Stage II: impaired walking capability but ability to walk without a stick or crutches 

  • Stage IIIA: walking only with the help of one stick or crutch 

  • Stage IIIB: walking with the help of two sticks or crutches 

  • Stage IV: confined to a wheelchair or bedridden

EAP Drug Request Form:

Standard Form for EAP Drug Requests

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