Notice: Prescription Drug List (PDL): Multiple additions

Date: July 15, 2020
Our file number: 20-109282-899

The purpose of this Notice of Amendment is to notify about the additions of Alpelisib, Baloxavir marboxil, Betula verrucosa (white birch), Brolucizumab, Cabotegravir, Caplacizumab, Ciclesonide, Darolutamide, Entrectinib, Fremanezumab, Glasdegib, Isatuximab, Siponimod, Tenapanor, Tetracosactide and Tucatinib to the Prescription Drug List (PDL) for human and/or 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
Alpelisib or its salts - -
Baloxavir marboxil - -
Brolucizumab - -
Cabotegravir or its salts - -
Caplacizumab - -
Ciclesonide - -
Darolutamide - -
Entrectinib or its salts - -
Fremanezumab - -
Glasdegib or its salts - -
Currently: Immunogenic substances Currently: Dactylis glomerata L.(cocksfoot), anthoxanthium odoratum L. (sweet vernal grass), lolium perenne L. (rye grass), poa pratense L. (meadow grass), phleum pratense L. (timothy grass)


New addition: Betula verrucosa (white birch)
Currently: when recommended for sublingual use
Isatuximab - -
Siponimod or its salts - -
Tenapanor or its salts - -
Tetracosactide or its salts - -
Tucatinib or its salts or derivatives - -

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.

AJOVY (fremanezumab) is indicated for the prevention of migraine in adults who have at least 4 migraine days per month.

ASERVO EQUIHALER (ciclesonide) is indicated for the treatment of horses with moderate to severe clinical signs of equine asthma.

BEOVU (brolucizumab) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).

CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is indicated:

CABLIVI (caplacizumab) is indicated for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PE) and immunosuppressive therapy.

COSACTHEN (tetracosactide) is indicated for the evaluation of adrenal function as part of the diagnosis of adrenocortical insufficiency (Addison's) or hyperadrenocorticism (Cushing's) in dogs.

DAURISMO (glasdegib) is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients who are age ≥75 years or who are not eligible to receive intensive induction chemotherapy.

IBSRELA (tenapanor) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

ITULATEK (Standardized Allergen Extract, White Birch [Betula Verrucosa] Sublingual Tablet) is indicated as an allergy immunotherapy for the treatment of moderate to severe seasonal allergic rhinitis, with or without conjunctivitis, induced by pollen from birch, alder and/or hazel, in adults 18 to 65 years of age who have a clinical history of symptoms of allergic rhinitis, despite use of symptom-relieving medication, and a positive test of sensitization to one or more of the pollen of birch, alder or hazel (skin prick test and/or specific IgE).

MAYZENT (siponimod) is indicated for the treatment of patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, to delay the progression of physical disability.

NUBEQA (darolutamide) is indicated for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC).

PIQRAY (alpelisib), in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor-positive, HER2-negative, PIK3CA- mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.

ROZLYTREK (entrectinib) is indicated for the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options.

SARCLISA (isatuximab for injection) is indicated in combination with pomalidomide and dexamethasone, for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

TUKYSA (tucatinib) is indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least 3 prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant, or metastatic setting.

VOCABRIA (cabotegravir tablets) is indicated, in combination with EDURANT (rilpivirine tablets), as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL) as:

XOFLUZA (baloxavir marboxil tablets) is indicated for the treatment of uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza complications.

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
Facsimile: 613-941-1812

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