Product Details

Mylan-Tadalafil

Tadalafil
2.5 mg
Tablet


DIN/PIN/NPN

02410621

Manufacturer

Mylan Pharmaceuticals ULC

Formulary Listing Date

2016-09-29  

Unit Price

3.6471

Amount MOH Pays

3.6471

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

G04BE08

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02440148 Teva-Tadalafil 3.8616 3.8616
02452081 Ran-Tadalafil 3.6471 3.6471
02409410 PMS-Tadalafil 3.6471 3.6471
02410621 Mylan-Tadalafil 3.6471 3.6471
02452286 Mar-Tadalafil 3.6471 3.6471
02451824 Jamp-Tadalafil 3.6471 3.6471
02296888 Cialis NA NA
02435896 Auro-Tadalafil 3.6470 3.6470
02422085 Apo-Tadalafil 3.6470 3.6470
02428628 Act Tadalafil 3.6471 3.6471
02512262 PRZ-Tadalafil 3.6470 3.6470
02536676 Tadalafil 3.8616 3.8616
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Cardiology Drugs

Tadalafil

  • Brand(s): Adcirca and generics, Cialis and generics
  • Dosage Form/Strength: 20 mg (Adcirca versions); 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis versions)
  • Effective date: September 9, 2022

For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary to scleroderma (systemic sclerosis) or scleroderma-like disease: 

  • After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB in a patient who has experienced an emergency situation such as threatened ischemic digit(s) requiring hospitalization 

  • Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular surgeon) 

Duration of initial approval: 6 months 

Renewals will be considered on a case-by-case basis for patients who demonstrate benefit from treatment (e.g., positive response in the duration, frequency and or severity of RP and/or improvement in the size or number of digital ulcers.) 

Duration of renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Pulmonary Arterial Hypertension

Sildenafil

  • Brand(s): Revatio
  • Dosage Form/Strength: 20 mg tablet

Tadalafil

  • Brand(s): Adcirca
  • Dosage Form/Strength: 20 mg tablet

Drugs for Pulmonary Arterial Hypertension (PAH) under EAP 

  1. Phosphodiesterase (PDE)-5 inhibitor: sildenafil (Revatio), tadalafil (Adcirca) 

  1. Endothelin receptor antagonists (ERAs): ambrisentan (Volibris), bosentan (Tracleer), macitentan (Opsumit) 

  1. Prostanoids: epoprostenol (Flolan, Caripul), treprostinil (Remodulin), selexipag (Uptravi) 

All requests (initial, renewal, monotherapy, combination therapy) for a PAH drug must come from one of the following recognized PAH referral centres:

  • Pulmonary Hypertension Centre
    Hamilton Health Sciences – General Hospital 

  • The Firestone Institute Pulmonary Hypertension Program
    St. Joseph's Healthcare Hamilton and McMaster University 

  • Pulmonary Hypertension Clinic
    Hotel Dieu Hospital/Kingston General Hospital 

  • Pulmonary Hypertension Program
    London Health Science Centre – Victoria Hospital 

  • Ottawa Pulmonary Hypertension Clinic
    University of Ottawa Heart Institute and the Ottawa Hospital 

  • University Health Network Pulmonary Hypertension Program
    Toronto General Hospital

Requests from other physicians/centres must include a recent (less than or equal to 3 months old) consult note/recommendation from a recognized PAH referral centre that supports the request; 

Out-of-province referral centre consults (e.g., from Winnipeg for patients in Northern Ontario) will also be considered on a case-by-case basis

Initial Criteria:

For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1 Pulmonary hypertension] who meet all the following criteria:

  1. PAH defined as a resting mean pulmonary artery pressure (mPAP) of ≥ 25 mmHg at rest AND normal pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg on right heart catheterization1; AND 

  2. The drug request meets one of the following circumstances of use:
    a) Drug is being used as monotherapy in a patient with WHO-functional class II (Note that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II (unless contraindicated or demonstrated intolerance), III, or IV;
    OR
    b) Drug is being used as sequential dual therapy in combination with a funded ERA (i.e., ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e., epoprostenol, treprostinil) in a patient who has had an inadequate response with monotherapy (i.e., failure to achieve WHO-FC I or II; or 6MWD >440 metres; or no/mild RV failure);
    OR
    c)     Drug is being used as up-front dual therapy in combination with a funded ERA (i.e., ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol, treprostinil) in a patient with advanced disease (i.e., WHO- functional class III or IV, 6MWD less than 380 metres; OR evidence of RV failure.)

1Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.

For all funded PAH Drugs, case-by-case consideration may be provided for the following:

  • Requests for triple therapy (Including patients awaiting lung transplant.) 

  • Patients who may have mixed co-morbidities that include ILD, COPD or LV failure (i.e., patients with mixed WHO Group 1 and Group 3 pulmonary hypertension OR mixed WHO Group 1 and Group 2 pulmonary hypertension) 

Exclusion Criteria: 

Combinations of drugs targeting similar pathways will not be funded (i.e., combination regimen may only include one agent from each drug class -- phosphodiesterase type 5 [PDE-5] inhibitors, endothelin receptor antagonists (ERA), and/or prostanoids) 

Renewal criteria for funded PAH Drugs:

Renewals will be provided for patients who remain under the care of a physician from a recognized PAH Centre (see list above) and who continue to benefit from therapy. 

Approval Durations:
- Duration of Approval for Initial Requests: 1 year
- Duration on triple therapy regimens awaiting lung transplantation: 1 year
- Duration of first renewal: 1 Year
- Duration of subsequent renewals: 5 Years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph