Product Details

Auro-Pioglitazone

Pioglitazone HCl
45 mg
Tablet


DIN/PIN/NPN

02384922

Manufacturer

Auro Pharma Inc.

Formulary Listing Date

2012-09-28  

Unit Price

3.3105

Amount MOH Pays

3.3105

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

A10BG03

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02274930 Teva-Pioglitazone 3.3105 3.3105
02297922 Sandoz Pioglitazone 3.3105 3.3105
02303140 PMS-Pioglitazone 3.3105 3.3105
02339595 Pioglitazone Hydrochloride Tablets 3.3105 3.3105
02326493 Mint-Pioglitazone 3.3105 3.3105
02365537 Jamp-Pioglitazone 3.3105 3.3105
02302896 Act Pioglitazone 3.3105 3.3105
02384922 Auro-Pioglitazone 3.3105 3.3105
02302977 Apo-Pioglitazone 3.3105 3.3105
02242574 Actos 5.2710 5.2710
02303469 Accel Pioglitazone 2.9500 2.9500
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Antidiabetic Agents

Pioglitazone

  • Brand(s): Actos, Generics
  • Dosage Form/Strength: 15 mg, 30 mg, 45 mg tablet

For the treatment of type 2 diabetes in patients who require:

  1. Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR

  2. Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR

  3. Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin.
    Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy.

***Those with one or more of the following contraindications/precautions to therapy with pioglitazone/rosiglitazone will not be considered:

  • Patients with type 1 diabetes

  • Patients who will be using this as monotherapy

  • Combination use with a nitrates

  • Combination use with insulin

  • Patients with any stage of heart failure (i.e., NYHA Class I, II, III, IV)

  • Patients at high risk for bone fracture (i.e., post-menopausal women with previously confirmed osteoporosis or osteopenia)

  • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina)

*Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl) 4 mg/day.

**Note: For the purpose of the EAP submission, maximal dose of metformin is considered to be 2000 mg/day.

Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment.

Duration of Approval: 5 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Oral Hypoglycemic Agents – Telephone Request Service (TRS) Drugs

Pioglitazone

  • Brand(s): Generics
  • Dosage Form/Strength: 15 mg, 30 mg, 45 mg tablet

Note: Prescribers do not need to make an EAP request for patients currently receiving pioglitazone or rosiglitazone through ODB. Physicians will be required to make an application for coverage for any patient new to ODB that is being started on either of these drugs or any ODB recipient who is new to using these drugs. 

Requests for ongoing treatment with pioglitazone or rosiglitazone for patients who were previously covered by other means may be considered according to renewal criteria. 

Funding under the EAP for pioglitazone or rosiglitazone will not be provided in the following clinical settings: 

  • Patients with type 1 diabetes 

  • Monotherapy, even if patient is intolerant or has contraindications to both metformin and sulfonlyureas 

  • Combination use with either nitrates or insulin 

  • Patients with any stage of heart failure (NYHA Class I, II, III, IV) 

  • Patients at high risk for bone fracture (post-menopausal women with previously confirmed osteoporosis or osteopenia) 

  • Patients with recent history (in the past 3 months) of ischemic cardiovascular event (myocardial infarction, unstable angina) 

  • Patients with active bladder cancer, a history of bladder cancer or uninvestigated macroscopic haematuria

For dual combination therapy of type 2 diabetes, in patients with: 

  1. Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR

  2. Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin

For triple combination therapy of type 2 diabetes, in patients with: 

  1. Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if:
    •     physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin,
    AND
    • both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy.     

Standard Approval Duration: 5 years

Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. 

Standard Approval Duration: 5 years

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