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.

TAMSULOSIN HYDROCHLORIDE, tablet (prolonged release), 400 microgram

Restriction: Unrestricted Benefit


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.