Approval of proposal relating to various Pfizer products: voriconazole, azithromycin, minoxidil, midazolam, sunitinib and dalteparin

Special Authority for Subsidy

Initial application (invasive fungal infection) only from a haematologist, infectious disease specialist or clinical microbiologist. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

1. Patient is immunocompromised; and
2. Applicant is part of a multidisciplinary team including an infectious disease specialist; and
3. Any of the following:
   1. Patient has proven or probable invasive aspergillus infection; or
   2. Patient has possible invasive aspergillus infection; or
   3. Patient has fluconazole resistant candidiasis; or
   4. Patient has mould strain such as Fusarium spp. and Scedosporium spp.

Renewal (invasive fungal infection) only from a haematologist, infectious disease specialist or clinical microbiologist. Approvals valid for 3 months for applications meeting the following criteria:

All of the following:

1. Patient is immunocompromised; and
2. Applicant is part of a multidisciplinary team including an infectious disease specialist; and
3. Any of the following:
   1. Patient continues to require treatment for proven or probable invasive aspergillus infection; or
   2. Patient continues to require treatment for possible invasive aspergillus infection; or
   3. Patient has fluconazole resistant candidiasis; or
   4. Patient has mould strain such as Fusarium spp. and Scedosporium spp.

Sunitinib - Retail Pharmacy –Special Authority for Subsidy

Initial application - (RCC) - only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 3 months, for applications meeting the following criteria:

All of the following:

1. The patient has metastatic renal cell carcinoma; and
2. Any of the following:
   1. The patient is treatment naive; or
   2. The patient has only received prior cytokine treatment; or
   3. The patient has only received prior treatment with an investigational agent within the confines of a bona fide clinical trial which has Ethics Committee approval; or
   4. Both:
      1. The patient has discontinued pazopanib within 3 months of starting treatment due to intolerance; and
      2. The cancer did not progress whilst on pazopanib; and
3. The patient has good performance status (WHO/ECOG grade 0-2); and
4. The disease is of predominant clear cell histology; and
   The patient has intermediate or poor prognosis defined as:
5. Any of the following:
   1. Lactate dehydrogenase level > 1.5 times upper limit of normal; or
   2. Haemoglobin level < lower limit of normal; or
   3. Corrected serum calcium level > 10 mg/dL (2.5 mmol/L) ; or
   4. Interval of < 1 year from original diagnosis to the start of systemic therapy; or
   5. Karnofsky performance score of ≤ 70; or
   6. ≥ 2 sites of organ metastasis; and
6. Sunitinib to be used for a maximum of 2 cycles.

Initial application - (GIST) - only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

1. The patient has unresectable or metastatic malignant gastrointestinal stromal tumour (GIST); and
2. Either:
   1. The patient’s disease has progressed following treatment with imatinib; or
   2. The patient has documented treatment-limiting intolerance, or toxicity to, imatinib

Renewal - (RCC) - only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 3 months for applications meeting the following criteria:

Both:

1. No evidence of disease progression; and
2. The treatment remains appropriate and the patient is benefiting from treatment.

Renewal – (GIST) - only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 6 months for applications meeting the following criteria:

The patient has responded to treatment or has stable disease as determined by Choi's modified CT response evaluation criteria as follows:

1. Any of the following:
   1. The patient has had a complete response (disappearance of all lesions and no new lesions), or
   2. The patient has had a partial response (a decrease in size of >/= 10% or decrease in tumour density in Hounsfield Units (HU) of >/= 15% on CT and no new lesions and no obvious progression of non measurable disease), or
   3. The patient has stable disease (does not meet criteria the two above) and does not have progressive disease and no symptomatic deterioration attributed to tumour progression; and
2. The treatment remains appropriate and the patient is benefiting from treatment.

Notes: RCC - Sunitinib treatment should be stopped if disease progresses.