Product Details

Sandoz Posaconazole

Posaconazole
100 mg
DR Tablet


DIN/PIN/NPN

02496259

Manufacturer

Sandoz Canada Inc.

Formulary Listing Date

2021-01-29  

Unit Price

42.6030

Amount MOH Pays

42.6030

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

J02AC04

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02496259 Sandoz Posaconazole 42.6030 42.6030
02424622 Posanol 53.7642 42.6030
02542021 GLN-Posaconazole 42.6030 42.6030
02543311 Taro-Posaconazole 42.6030 42.6030
02544644 Mint-Posaconazole 42.6030 42.6030
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anti-Infectives

Posaconazole

  • Brand(s): Posanol
  • Dosage Form/Strength: 100 mg tablet, 40 mg/mL Suspension

For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant.

Duration of Approval: Limited to 4 months

For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case-by-case basis.

Note: Please provide details of the patient’s clinical condition including all medications used to treat the condition with your request application.

Duration of Approval: Up to 4 months

Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD.

Duration of Approval: Case-by-case

For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole.

*Invasive aspergillosis should be confirmed by fungal culture.

Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis.

Duration of Approval: 3 months

Renewals will be considered on a case-by-case basis.

For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR

Duration of Approval: 3 months

For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent.

**Mucormycosis infection must be confirmed by fungal culture.

Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis.

Duration of Approval: 3 months

Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information (Infectious disease consultation/radiology report)

Duration of Approval: 3 months 

Duration of Approval of subsequent renewal: Case-by-case

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Anti-Infectives – Telephone Request Service (TRS) Drugs

Posaconazole

  • Brand(s): Posanol
  • Dosage Form/Strength: 40 mg/mL Suspension, 100 mg tablets

  1. For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. 

  1. For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case- by-case basis.

    Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. 

  1. For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole.

    *Invasive aspergillosis should be confirmed by fungal culture.

    Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis.

    Renewals will be considered on a case-by-case basis.

  1. For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B;
    OR
    For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent.

    **Mucormycosis infection must be confirmed by fungal culture.

    Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g., radiology reports, histopathology, etc.) will be considered on a case-by-case basis.

    Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information (Infectious disease consultation/radiology report).

Product Monograph

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