June 2003 PBAC Outcomes - Deferrals

Deferrals made by the Pharmaceutical Benefits Advisory Committee (PBAC) in June 2003

table showing June 2003 PBAC Outcomes - Deferrals
Drug and Form Drug Use / Type Listing requested by Sponsor PBAC Recommendation
Imatinib Mesylate capsule 100 mg, Glivec®

Novartis Pharmaceuticals Australia Pty Ltd

 Treatment for chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours Section 100 special authority listing for:
Initial treatment with imatinib mesylate (up to six months) of adult patients with an histologically-confirmed malignant gastrointestinal stromal tumour which is:
  1. Metastatic or unresectable; and
  2. Confirmed by the detection of CD117 on immunohistochemical staining.

Patients being treated with imatinib mesylate for a gastrointestinal stromal tumour (as defined above) for less than six months up to the date at which this listing took effect will be eligible for consideration for initial treatment with imatinib mesylate as a pharmaceutical benefit. Patients who have been treated with imatinib mesylate for a gastrointestinal stromal tumour for more than six months up to the date at which this listing took effect are not eligible for initial treatment but may be considered eligible for continuing treatment on the PBS as per the criteria defined below.

Continuing treatment of adult patients with a gastrointestinal stromal tumour (as defined above) who remain free of disease progression and have:

  1. received initial treatment with imatinib mesylate as a pharmaceutical benefit; or
  2. received treatment with imatinib mesylate for a period of six months or more up to the date at which this listing took effect.
    Disease progression is defined as:
  3. 25% increase in the sum of the products of the perpendicular diameters of all measurable lesions(see Note); or
  4. unequivocal progression of a non-index lesion that could be radiologically evaluated (but was not measurable); or
  5. reappearance of any gastrointestinal stromal tumour lesion or the presence of a new gastrointestinal stromal tumour lesion.
The PBAC deferred the re-submission and suggested that the sponsor provide a new major submission to investigate the cost-effectiveness of imatinib in patients who achieve partial response, addressing the uncertainties raised by the PBAC.

Sponsor's comments:
The sponsor intends to lodge a re-submission.

Insulin Glargine, injection, 100 units per mL, 3 mL, Lantus®

Aventis Pharma Pty Ltd

 Treatment for diabetes Authority required listing for:
For the treatment of type 1 insulin-requiring diabetic patients with an HbA1c of > 8%; and
For the treatment of type 2 insulin-requiring diabetic patients with an HbA1c of > 8% to be used in combination with oral anti-diabetic agents or short-acting insulin.

The sponsor also proposed a continuation rule, if deemed necessary by the PBAC, which would limit continued PBS-subsidised access only to patients who demonstrate improved glycaemic control.

The PBAC deferred the re-submission to allow the sponsor to respond to new information.

Sponsor's comments:
The sponsor is considering its position regarding any future course of action.

Sirolimus, tablet 1 mg and oral solution 1 mg per mL,
Rapamune®

Wyeth Australia Pty Limited

 Treatment for management of rejection in kidney transplant Section 100 listing. The PBAC deferred the re-submission and suggested that the sponsor provide a new major submission to address the clinical place and cost-effectiveness of sirolimus.