Tamsulosin hydrochloride, tablet (prolonged release), 400 microgram, Flomaxtra®
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Product: Tamsulosin hydrochloride, tablet
(prolonged release), 400 microgram, Flomaxtra®
Sponsor: CSL Biotherapies Limited
Date of PBAC Consideration: November 2010
1. Purpose of Application
The re-submission sought a restricted benefit listing for the
treatment of lower urinary tract symptoms (LUTS) due to benign
prostatic hyperplasia (BPH).
2. Background
The PBAC had considered tamsulosin for PBS listing on two previous
occasions.
At its March 2008 meeting, the PBAC rejected a submission seeking
an unrestricted benefit listing on the basis of high and uncertain
cost-effectiveness. At its November 2008 meeting, the PBAC rejected
a submission seeking a restricted benefit listing for LUTS
associated with BPH, again on the basis of high and uncertain
cost-effectiveness ratios. (See Public Summary Documents of
March 2008 and November 2008).
3. Registration Status
This formulation of tamsulosin was TGA registered on 18 January
2006, for the relief of LUTS associated with BPH.
4. Requested Listing and PBAC’s View
Restricted Benefit
Lower urinary tract symptoms due to benign prostatic
hyperplasia
See Recommendation and Reasons for PBAC’s
view.
5. Clinical place for the proposed therapy
Tamsulosin is used to relieve LUTS associated with BPH.
6. Comparator
The re-submission nominated prazosin and placebo as the main
comparators. The PBAC considered these were the appropriate
comparators.
7. Clinical Trials
No changes had been made to the trial data presented in the
previous submission. (See list of published trials in Public
Summary Document of March 2008).
8. Results of Trials
No new efficacy and toxicity data were presented in the
re-submission. (See results of trials in Public Summary
Documents of March 2008 and November 2008).
The re-submission reviewed the clinical management algorithm for
LUTS associated with BPH based on the recently released 2010
European Association of Urology (EAU) Guidelines on Conservative
Treatment of non-neurogenic Male LUTS. (See http://www.uroweb.org).
9. Clinical Claim
The re-submission claimed tamsulosin is superior in terms of
comparative effectiveness and inferior in terms of comparative
safety over placebo, and that tamsulosin is non-inferior compared
with prazosin, for the treatment of LUTS due to BPH.
For PBAC’s view, see Recommendation and Reasons.
10. Economic Analysis
The submission presented an updated economic evaluation, to which a
proposed price reduction for tamsulosin was applied.
The dispensed price for maximum quantity (DPMQ) proposed in the
re-submission was based on the assumed relative proportionate use
of prazosin (10%) and placebo (90%).
The incremental cost per Quality Adjusted Life Year (QALY) gained
was between $15,000 - $45,000, based on the trial duration of
12-weeks. From the results of the updated modelled economic
evaluation, the incremental cost per QALY gained over 12 months
(assuming the utility differences at 12 weeks are maintained at 52
weeks) was also between $15,000 - $45,000.
11. Estimated PBS Usage and Financial Implications
The likely number of patients per year was previously estimated to
be in the range of 100,000–200,000. The likely financial cost
per year to the PBS was estimated in the re-submission to be up to
$10-30 million in Year 5.
The financial estimates were considered uncertain given the use of
dutasteride had not been considered, and the use of prazosin for
patients with LUTS/BPH had been significantly underestimated in the
re-submission.
12. Recommendation and Reasons:
The PBAC recommended the listing of tamsulosin on the PBS as an
unrestricted benefit on a cost-minimisation basis compared with
prazosin. The equi-effective doses are tamsulosin 400 micrograms
once daily and prazosin 2 mg twice daily.
The PBAC considered that tamsulosin was non-inferior to prazosin
but more effective than placebo and therefore listing on a
cost-minimisation basis compared with prazosin was more
appropriate, based on evidence previously presented to the
PBAC.
The PBAC noted the consumer comments received for this item.
Recommendation
TAMSULOSIN HYDROCHLORIDE, tablet (prolonged release), 400
microgram
Restriction: Unrestricted Benefit
NOTE:
Shared Care Model: For prescribing by nurse practitioners where care of a patient is shared between a nurse practitioner and medical practitioner in a formalised arrangement with an agreed management plan. Further information can be found in the Explanatory Notes for Nurse Practitioners.
Maximum quantity: 30
Repeats: 5
13. Context for Decision
The PBAC helps decide whether and, if so, how medicines should be
subsidised in Australia. It considers submissions in this context.
A PBAC decision not to recommend listing or not to recommend
changing a listing does not represent a final PBAC view about the
merits of the medicine. A company can resubmit to the PBAC or seek
independent review of the PBAC decision.
14. Sponsor’s Comment
CSL Biotherapies is disappointed with the PBAC decision to only
recommend tamsulosin at the same treatment cost as prazosin rather
that at the requested price based on cost-effectiveness in
untreated patients. Tamsulosin will remain available through a
private prescription.
