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Limited coverage drugs – teduglutide

Last updated on September 3, 2026

 

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Generic name

teduglutide

Strength & form

5 mg per vial powder for subcutaneous injection

Special Authority criteria

Approval period

Initial

Pediatrics:

For the treatment of short bowel syndrome (SBS) in pediatric patients (aged 1 to under 18 years) who are dependent on parenteral support (PS)1, and meet ALL of the following criteria:

  • PS requirements are stable, or there has been no improvement in enteral feeding over the preceding three months

AND

  • PS provides more than 30% of caloric and/or fluid/electrolyte needs

AND

  • The cumulative lifetime duration of PS is at least 12 months

AND

  • Special Authority request is submitted by a gastroenterologist currently working within a specialized multi-disciplinary intestinal rehabilitation program

Adults:

For the treatment of short bowel syndrome (SBS) in adult patients (≥ 18 years of age) who are dependent on parenteral support (PS), and meet ALL of the following criteria:

  • SBS is a result of major intestinal resection (e.g., due to injury, volvulus, vascular disease, cancer, Crohn's disease, etc.)

AND

  • Resection has resulted in dependency on PS over the entire 12-month period immediately preceding this request

AND

  • PS is required at least three times weekly to meet caloric, fluid or electrolyte needs due to ongoing malabsorption

AND

  • PS frequency and volume have been stable over the preceding month

AND

  • Special Authority request is submitted by a gastroenterologist with expertise in treating SBS

6 months

Renewal

Pediatrics and adults:

  • The patient has attained and maintained a minimum reduction of at least 20% in PS volume compared to baseline volume2 (i.e., the 4-week period immediately preceding teduglutide initiation)

AND

  • Special Authority request is submitted by a gastroenterologist currently working within a specialized multi-disciplinary intestinal rehabilitation program for pediatric patients, or by a gastroenterologist with expertise in treating SBS in adult patients
 12 months

Practitioner exemptions

  • None

Special notes

  • 1PS is defined as parenteral nutrition (intravenous feeding of protein, carbohydrate, fat, vitamins, minerals, and other nutrients needed to meet nutrition needs) and/or intravenous hydration
  • 2The determination of reduction in PS volume compared to pre-teduglutide baseline will be made as follows: 

Pediatric patients (aged 1 to under 18 years): treatment response will be assessed using the weight-normalized reduction in PS volume, calculated as

Weight-normalized PS volume (average daily value):

Average Daily PS Volume/kg = (Prescribed weekly PS volume / 7) / Weight (kg) 

Percent reduction from baseline:

% Reduction = ((Baseline average daily PS volume/kg - Current average daily PS volume/kg) / Baseline average daily PS volume/kg) x 100

Adult patients (aged 18 years and older) who initiated teduglutide before age 18 and have remained on continuous therapy: treatment response will be assessed by comparing the patient's current PS volume with an adjusted initial PS volume. The adjusted initial PS volume will be calculated using the patient's last available pediatric (under 18 years) weight, as follows:

Adjusted initial PS volume: 

Adjusted Initial PS Volume = (Last available pediatric weight (kg) x Baseline PS volume) / Pre-treatment baseline weight (kg) 

Percent reduction from adjusted initial PS volume:

% Reduction = ((Adjusted initial PS volume - Current PS volume) / Adjusted initial PS volume) x 100  

Adult patients (aged 18 years and older) who initiated teduglutide at age 18 years or older: treatment response will be assessed using the absolute reduction in PS volume from pre-treatment baseline, calculated as:

Percent reduction from baseline:

% Reduction = ((Baseline PS volume - Current PS volume) / Baseline PS volume) x 100 

  • PharmaCare covers a maximum 28-day supply of teduglutide per fill
  • Continuation of teduglutide in patients who have achieved PS autonomy should be made based on a benefit-risk consideration

Special Authority requests