Product Details

Jamp Pomalidomide

Pomalidomide
2 mg
Capsule


DIN/PIN/NPN

02538075

Manufacturer

Jamp Pharma Corporation

Formulary Listing Date

2023-08-31  

Unit Price

425.0000

Amount MOH Pays

425.0000

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AX06

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02520435 Apo-Pomalidomide 425.0000 425.0000
02506408 Nat-Pomalidomide 425.0000 425.0000
02419599 Pomalyst 500.0000 425.0000
02504081 Reddy-Pomalidomide 425.0000 425.0000
02523981 Sandoz Pomalidomide 425.0000 425.0000
02538075 Jamp Pomalidomide 425.0000 425.0000
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Pomalidomide

  • Brand(s): Pomalyst and generics
  • Dosage Form/Strength: 1 mg, 2 mg, 3 mg, 4 mg capsules
  • Effective date: February 6, 2015
  • Updated: May 31, 2023

Initial criteria:

For the treatment of patients with relapsed and/or refractory multiple myeloma who meet ALL of the following criteria: 

  1. Patient has failed treatment on a lenalidomide-based regimen administered either alone or in combination in any prior line of treatment (Note 1); AND 

  1. Patient has failed treatment on a proteasome inhibitor-based regimen (e.g., bortezomib, carfilzomib) administered either alone or in combination in any prior line of treatment (Note 1); AND 

  1. Patient is deemed to be pomalidomide sensitive, defined as having disease that has not been refractory to a pomalidomide-based regimen, and/or has not experienced progression while on a pomalidomide-based regimen (Note 2); AND

  2. Patient is using pomalidomide in one of the following circumstances;
    a)
    As dual therapy in combination with dexamethasone;
    OR

    b) As a triple therapy regimen in combination with isatuximab and dexamethasone after two prior lines of therapy in a patient who has not been refractory to an anti-CD38 monoclonal antibody (e.g. daratumumab, isatuximab) used in another prior line of treatment (Note 3).

    AND 

  1. Patients must have been refractory to the last line of therapy; AND 

  1. Patient has good performance. 

Notes: 

  1. Patient must be lenalidomide resistant AND bortezomib resistant or if they are not bortezomib resistant, they must have experienced disease progression on another proteasome inhibitor (PI)-based treatment regimen. If a patient is contraindicated or has unacceptable toxicities to lenalidomide and/or bortezomib, please include details in your request application for case-by-case consideration. 

  1. Refractory disease is defined as:
    a) Disease progression within 60 days after stopping treatment OR
    b) Progression on any dose of lenalidomide or bortezomib/PI therapy including while on maintenance therapy OR
    c) Non-responsive disease during therapy (either failure to achieve minimal response or disease progression).

    Relapsed / Progressive disease is defined as having one or more of the following:
    a)
    An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200 mg/24 hours).
    b)
    An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels).
    c)
    Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
    d)
    Development of hypercalcemia (corrected serum calcium greater than 11.5 mg/dL or 2.5 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

  1. Although pomalidomide with isatuximab and dexamethasone is funded after progression on two prior lines of therapy, if a patient is resistant or refractory to first line lenalidomide and bortezomib as part of an earlier lenalidomide- bortezomib-dexamethasone regimen (RVD), the patient would be eligible for funding of second line isatuximab as part of IsaPd upon meeting other initial criteria.

  1. Patients must meet the eligibility requirements for isatuximab through the New Drug Funding Program (NDFP).

  1. Isatuximab can be added to pomalidomide and dexamethasone provided the patient met the eligibility criteria for isatuximab (See note 4) and has not progressed.

Exclusions:

  1. Patients with primary amyloidosis

Renewal criteria:
Pomalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the pomalidomide-based regimen. 

Dosing regimen:

Pomalidomide 4 mg on days 1–21 of each 28-day cycle

If pomalidomide is given in combination with isatuximab and dexamethasone:

Dexamethasone 40 mg oral or IV weekly (20 mg if aged ≥75 years) on days 1, 8, 15, and 22 of each cycle.

Isatuximab Dosing:
Cycle 1: Isatuximab 10 mg/kg intravenously (IV) on days 1, 8, 15, and 22
Cycle 2 and onwards: Isatuximab 10 mg/kg IV on days 1 and 15

[1 cycle = 28 days]

Approval duration of initials and renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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