Notice: Prescription Drug List (PDL): Multiple Additions
Date: July 23, 2021
Our file number: 21-113607-73
The purpose of this Notice of Amendment is to notify about the additions of the following medicinal ingredients on the Prescription Drug List (PDL) for human and veterinary use:
- Brexucabtagene autoleucel
- Idecabtagene vicleucel
- Trastuzumab deruxtecan
|Drugs containing any of the following||Including (but not limited to)||Qualifier|
|Pitolisant or its salts||-||-|
|Risdiplam or its salts or derivatives||-||-|
|Selpercatinib or its salts||-||-|
|Solriamfetol or its salts||-||-|
|Tepotinib or its salts||-||-|
These additions are effective at the time of posting.
A scientific review of these drugs against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that these drugs require prescription status.
Abecma (idecabtagene vicleucel) is a B-cell maturation antigen-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who are refractory to their last treatment.
Enhertu (trastuzumab deruxtecan) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received prior treatment with trastuzumab emtansine (T-DM1).
Evrysdi (risdiplam) is indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months and older.
Ilumya (tildrakizumab injection) is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Retevmo (selpercatinib) is indicated as monotherapy for the treatment of:
- metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in adult patients,
- RET-mutant medullary thyroid cancer in adult and pediatric patients 12 years of age and older with unresectable advanced or metastatic disease,
- RET fusion-positive differentiated thyroid carcinoma in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib and/or lenvatinib.
Sunosi (solriamfetol) is indicated for:
- the treatment of excessive daytime sleepiness in adult patients with narcolepsy
- the treatment of excessive daytime sleepiness in adult patients with obstructive sleep apnea.
Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
Tepmetko (tepotinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer harbouring mesenchymal-epithelial transition tyrosine kinase receptor exon 14 (METex14) skipping alterations.
Wakix (pitolisant hydrochloride tablets) is indicated for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy.
Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.
Should you have any questions on these amendments to the Prescription Drug List, please contact:
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
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