| Fludarabine Phosphate tablet 10 mg, Fludara®
Schering Pty Limited
|
For use as second-line therapy in patients with chronic lymphocytic leukemia (CLL) |
Not PBS listed |
|
PBAC rejected the application because of uncertainty in the nature and extent of clinical
benefit in the proposed population and the resulting uncertain cost-effectiveness.
|
| Authority required listing for second-line treatment of chronic lymphocytic leukaemia
in patients where first-line treatment with an alkylating agent has failed to achieve
at least a partial remission, or where the disease has relapsed after initially responding
to first-line treatment with an alkylating agent.
|
PBAC was concerned about the appropriateness of the criteria based on partial and
complete response, given that the validity of these surrogate outcomes to determine
overall survival was not shown in the key trial.
|
Comparator:
CAP (cyclophosphamide, doxorubicin [Adriamycin], prednisone)
|
Accepted |
Clinical claim:
Fludara is significantly more effective than CAP and has less toxicity.
|
Rejected. Although (IV) fludarabine is shown to be more effective than CAP, in terms
of complete+partial remissions, there is no difference in median survival and no statistically
significant difference in progression-free survival.
|
Economic claim:
A cost-effectiveness analysis was presented.
|
Rejected. In addition to the clinical uncertainties leading to economic uncertainty,
there were a number of problems with the economic model.
|
| Sponsor's comments: |
The sponsor has no comment. |
| Ramipril capsule 10 mg, Tritace®
Aventis Pharma Pty Ltd
|
|
Unrestricted listing |
The addition of a Note at the beginning of ACE inhibitor section of the Schedule of
Pharmaceutical Benefits, as follows:
Proposal #1
The base priced drugs and the various strengths of the base priced drugs listed above
may not have either clinical evidence or TGA approval for equivalent uses - please
refer to the Prescribing Information.
Proposal #2
The level of evidence supporting the use (sic) this class of drugs in different indications
may differ between individual drugs and between individual strengths of drugs - please
refer to the Prescribing Information.
|
The PBAC noted that the sponsor indicated that it would have no objection to the PBAC
secretariat proposal of the wording "By writing a PBS prescription, the prescriber
is certifying use is in accordance with the registered indications which differ between
agents in this class". However, the PBAC remained concerned about the precedent set
by allowing any such wording to apply, even as a note, to a drug or group of drugs
that are listed as unrestricted benefits. It therefore decided to reject the application
and to request that the Department be asked to produce a discussion document for consideration
at the July 2004 meeting.
|
| Sponsor's comments: |
None |
|
|
| Teriparatide injection 250 micrograms per mL, 3 mL, Forteo®
Eli Lilly Australia Pty Limited
|
Treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis
in men when other agents are considered unsuitable and when there is a high risk of
fractures.
|
Not PBS listed |
|
PBAC rejected the submission because of doubts about the claims of superior effectiveness
over alendronate and the resulting uncertain cost-effectiveness.
|
Authority required listing for established osteoporosis in postmenopausal women and
primary osteoporosis in men. The patient must have evidence of:
The patient must have two or more fragility fractures demonstrated radiologically
by plain x-ray, CT-scan, MRI, or morphometry by DXA. The date of the radiographic
test must be included in the authority application; and
At least one fracture must have occurred while on antiresorptive therapy of proven
efficacy and safety; and
The patient must have received at least 6 months continuous antiresorptive of proven
efficacy and safety (see Notes for antiresorptive therapies of proven efficacy and
safety).
Teriparatide is available with a lifetime maximum of 18 months teriparatide therapy
(19 pens), a maximum of 19 pens will be reimbursed through the PBS. Teriparatide must
be initiated only by a specialist/consulting physician treating osteoporosis.
|
|
Comparator:
Alendronate
|
Accepted |
Clinical claim:
Teriparatide is significantly more effective than alendronate, but has more toxicity.
|
Rejected. The indirect comparison across the large randomised trials did not support
a claim of superiority. The randomised head-to-head trial shows a statistically significant
reduction in new non-vertebral fractures, but this used double the recommended dose
of teriparatide.
|
Economic claim:
A cost utility analysis was presented.
|
Rejected. In addition to the clinical uncertainties leading to economic uncertainty,
there were a number of problems with the economic model.
|
| Sponsor's comments: |
The sponsor disagrees with the decision but needs to clarify the decision with the
PBAC.
|
