Product Details

Rosiglitazone

Rosiglitazone
8 mg
Tablet


DIN/PIN/NPN

02403382

Manufacturer

A A Pharma Inc.

Formulary Listing Date

2017-02-28  

Unit Price

2.7452

Amount MOH Pays

2.7452

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

A10BG02

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02403382 Rosiglitazone 2.7452 2.7452
02241114 Avandia NA NA
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Antidiabetic Agents

Rosiglitazone

  • Brand(s): Avandia
  • Dosage Form/Strength: 2 mg, 4 mg, 8 mg tablet

For the treatment of type 2 diabetes mellitus in patients with:

  1. Inadequate glycemic control (HbA1c >7%) from ALL other oral antidiabetic agents* funded through one of the Ontario Drug Benefit Programs, in monotherapy or in combination OR

  2. Where ALL other oral antidiabetic agents are inappropriate due to contraindications or intolerance AND

  3. The patient has refused or is not able to take insulin AND

  4. There is no known contraindication to rosiglitazone

*Oral antidiabetics include the following agents:

  • glyburide

  • metformin

  • gliclazide (Diamicron, Diamicron MR)

  • sitagliptin (Januvia)

  • saxagliptin (Onglyza)

  • repaglinide (GlucoNorm)

  • pioglitazone (Actos)

Note: A trial with acarbose is not a mandatory requirement.

Note: It is not necessary for patients to have tried the following oral antidiabetic agents that are currently not funded by the OPDP for the purposes of obtaining rosiglitazone:

  • glimepiride (Amaryl)

  • nateglinide (Starlix)

Duration of Approval: 5 years

Renewals will be considered where patients have benefited and continue to benefit from rosiglitazone treatment as demonstrated by recent HbA1c levels ≤7% while on treatment with rosiglitazone AND in those who continue to have no known contraindication(s) to rosiglitazone.

Duration of Approval: 5 years

EAP Drug Request Form:

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

Rosiglitazone

  • Brand(s): Avandia
  • Dosage Form/Strength: 2 mg, 4 mg, 8 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 the treatment of type 2 diabetes mellitus in patients with: 

  1. Inadequate glycemic control (HbA1c >7%) from ALL other oral antidiabetic agents* funded through one of the Ontario Drug Benefit (ODB) Programs, in monotherapy or in combination OR 

  2. Where ALL other oral antidiabetic agents are inappropriate due to contraindications or intolerance AND 

  3. The patient has refused or is not able to take insulin AND 

  4. There is no known contraindication to rosiglitazone. 

*Oral antidiabetics that need to be tried prior to consideration of rosiglitazone include the following agents currently reimbursed through the Ontario Public Drug Programs:

  • glyburide 

  • metformin 

  • gliclazide (Diamicron, Diamicron MR) 

  • sitagliptin (Januvia) 

  • repaglinide (GlucoNorm) 

  • pioglitazone (Actos) 

  • saxagliptin (Onglyza) 

Note: A trial with acarbose is not a mandatory requirement. 

Note: It is not necessary for patients to have tried the following oral antidiabetic agents that are currently not funded by the Ontario Public Drug Programs for the purposes of obtaining rosiglitazone:

  • glimepiride (Amaryl)

  • nateglinide (Starlix)

Standard Approval Duration: 5 years

Renewals will be considered where patients have benefited and continue to benefit from rosiglitazone treatment as demonstrated by achieving adequate glycemic control. This is shown by a recent HbA1c levels ≤7% while on treatment with rosiglitazone AND in who continue to have no known contraindication(s) to rosiglitazone. 

Standard Approval Duration: 5 years

Product Monograph

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