| Atomoxetine Hydrochloride capsules, 10 mg, 18 mg, 25 mg, 40 mg and 60 mg, Strattera®
Eli Lilly Australia Pty Ltd
|
Treatment for attention deficit hyperactivity disorder |
Authority required listing |
The PBAC rejected the application mainly because of uncertain cost-effectiveness,
but also because of issues about the applicability of the randomised trials to the
proposed population and the impractical restriction proposed.
|
| Sponsor's comments: |
The sponsor disagrees with the decision but needs to clarify the decision with the
PBAC.
|
| Etoricoxib tablets 60 mg and 90 mg, Arcoxia®
Merck Sharp & Dohme (Australia) Pty Limited
|
Treatment for osteoarthritis and rheumatoid arthritis |
Restricted benefit listing for symptomatic treatment of osteoarthritis and rheumatoid
arthritis
|
The claim of superiority over traditional NSAIDs in terms of reducing perforations,
ulcers and bleeds (PUBs) was accepted.
However, the PBAC rejected the submission because of uncertainty over some aspects
of the comparative safety claim.
|
| Sponsor's comments: |
The sponsor needs to clarify the
decision with the PBAC.
|
| Thalidomide capsule 50 mg Thalidomide Pharmion®
Pharmion Pty Ltd
|
Treatment for multiple myeloma and erythema nodosum leprosum |
Section 100 (Private Hospital Authority Required) listing for the end-stage treatment
of multiple myeloma after failure of standard therapies for relapsed or refractory
disease, where standard therapies are defined as:
- Melphalan and prednisolone for older patients (over 70 years)
- In younger patients (< 70 years), 1-2 chemotherapy regimens (including VAD) and /or
high dose melphalan conditioning and autologous stem cell transplantation.
|
- The PBAC rejected the application because of uncertainty about the comparative extent
of clinical benefit in the population in which it is used and the resulting uncertain
cost-effectiveness.
|
| Sponsor's comments: |
The sponsor will be considering its position regarding any future course of action. |
| Milk Protein and Fat Formula with Vitamins and Minerals and low in Carbohydrate, powder
300 g,
Scientific Hospital Supplies
|
A food for inborn errors of metabolism |
Restricted benefit listing |
The PBAC rejected the application because of uncertain cost-effectiveness. |
| Sponsor's comments: |
The sponsor has no comment |
