Notice: Prescription Drug List (PDL): Multiple Additions
Date: May 27, 2021
Our file number: 21-110028-562
The purpose of this Notice of Amendment is to notify about the additions of:
- Strain Russian BCG-I to the "including (but not limited to)" column of the |Bacillus Calmette-Guérin (BCG)" entry on the Prescription Drug List (PDL) for human and veterinary use,
- Bedinvetmab to the PDL for veterinary use, and
- Binimetinib, Brillant Blue G, encorafenib, eptinezumab, mecasermin, onasemnogene abeparvovec, ponesimod, ranolazine, triheptanoin and zanubrutinib to the PDL for human and veterinary use.
The new drugs will be added to the PDL as the following:
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Bacillus Calmette-Guérin (BCG) | Strain Russian BCG-I | when sold or recommended as an antineoplastic agent |
| Bedinvetmab | - | - |
| Binimetinib or its salts | - | - |
| Brillant Blue G or its derivatives | - | - |
| Encorafenib or its salts | - | - |
| Eptinezumab | - | - |
| Mecasermin | - | - |
| Onasemnogene abeparvovec | - | - |
| Ponesimod | - | - |
| Ranolazine or its salts | - | - |
| Triheptanoin | - | except in preparations for topical use |
| Zanubrutinib or its salts | - | - |
These additions are effective at the time of posting.
Rationale:
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.
Braftovi (encorafenib) is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.
Brukinsa (zanubrutinib) is indicated for the treatment of adult patients with Waldenström's macroglobulinemia (WM).
Corzyna (ranolazine extended-release tablets) is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies, including beta-blockers and calcium channel blockers.
Dojolvi (triheptanoin) is indicated for the treatment of adult and pediatric patients with long chain fatty acid oxidation disorders (LC-FAOD).
Increlex (mecasermin) is indicated for the treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (SPIGFD). SPIGFD is defined by:
- height standard deviation score ≤ -3.0 and;
- basal IGF-1 levels below the 2.5th percentile for age and gender and;
- GH sufficiency.
- Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.
Librela (bedinvetmab injection) is indicated for the alleviation of pain associated with osteoarthritis in dogs.
Mektovi (binimetinib) is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.
Ponvory (ponesimod) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).
Tissueblue (Brilliant Blue G Injection) is indicated for use as an aid in ophthalmic surgery by selectively staining the internal limiting membrane (ILM)
Verity-BCG (Bacillus Calmette-Guérin [BCG]: Strain Russian BCG-I) is indicated for adjuvant therapy after transurethral resection (TUR) of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage Ta (grade 2 or 3) or T1 (grade 1, 2, or 3), without concomitant carcinoma in situ. It is only recommended for stage Ta grade 1 papillary tumors, when there is judged to be a high risk (>50%) of tumor recurrence.
Vyepti (eptinezumab for injection) is indicated for the prevention of migraine in adults who have at least 4 migraine days per month.
Zolgensma (onasemnogene abeparvovec) is indicated for the treatment of pediatric patients with 5q spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and:
- 3 or fewer copies of SMN2 gene; or
- infantile-onset SMA.
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:
Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Email: hc.drug.prescription.status-statut.dordonnance.des.drogues.sc@canada.ca
Telephone: 343-998-9304
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