Limited coverage drugs – teduglutide

Generic name

teduglutide

Strength & form

5 mg per vial powder for subcutaneous injection

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 pre-teduglutide volume

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