PUBLIC SUMMARY DOCUMENT
Product: LoFric Intermittent Catheter
Applicant: Wellspect HealthCare
Date of SPAP Meeting: 8 November 2013
1. Proposed Listing on the Stoma Appliance Scheme
The applicant, Wellspect HealthCare, sought listing of the LoFric Intermittent Catheter in
Subgroup 8(c) of the Stoma Appliance Scheme (SAS) Schedule. The product, including 26
variants, was proposed for listing at a unit price of $1.75, with a maximum monthly quantity
of 120 units.
2. Comparator
The applicant nominated Unomedical products listed in Subgroup 8(c) of the SAS Schedule,
the Unomedical Nelaton Catheter (SAS code 3671F) and the Unomedical Tiemann Tip
Catheter (SAS code 9962H) as the comparators for the Nelaton and Tiemann variants of the
proposed product respectively. These products are listed at unit prices of $1.034 and $1.657
respectively, each with a maximum monthly quantity of 100 units.
The selection of the Unomedical Nelaton and Tiemann Catheters as the comparator products
was accepted by the Stoma Product Assessment Panel (SPAP).
3. Background
This was the SPAP’s first consideration of this product.
4. Clinical Place for the Product
The product is a hydrophilic intermittent urinary catheter with surface technology that
requires only clean water (as opposed to lubricant as in the case of uncoated catheters) to
activate.
5.
SPAP Comment
Clinical Analysis
The Panel noted that the applicant argued for the requested price on the basis of:
a) lower per-catheter cost than the comparator products; and
b) cost offsets related to the management of conditions including recurrent/resistant
urinary tract infection (UTI), multi-drug resistant bacteraemia, epididymitis,
prostatitis, stricture, haematuria and bladder stones.
The Panel noted that all data presented (including around UTI frequency) pertained to
intermittent urethral catheterisation, largely of male patients with spinal cord injury.
Furthermore, it was noted that the other conditions denoted above are risks associated with
urethral intubation and would not be observed in a patient with a urinary stoma (for example
an ileal conduit). The Panel therefore considered the relevance of the data presented to
urostomy patients to be highly uncertain. The Panel noted that there was no evidence of the
proposed product’s superiority in terms of ease of use, reduced trauma (through reduced
friction at intubation) and reduced infection in patients with urostomies.
Clinical advice to the Panel indicated that very few patients with urostomies would require
intermittent catheterisation, as intubation of a urinary stoma would only be indicated in the
very rare circumstance of recurrent UTI where it was necessary to obtain a sterile sample
from the ileal conduit. It was noted that small numbers of urostomy patients use catheters
for drainage at kidney level, but that this usually requires a balloon catheter. It was
AK#1
therefore the opinion of the Panel that the proposed product lacks clinical application in the
context of stoma care.
Economic Analysis
The SPAP raised several concerns in relation to the cost-effectiveness analysis presented by
the applicant, including that:
 information concerning literature search strategy and results – including inclusion
and exclusion criteria – was not provided. The Panel reiterated its position that the
selective use of data is unacceptable;
 neither full texts nor retrievable references for the various data inputs to the
economic model (frequencies, costs and utilities) were provided, meaning that the
model could not be evaluated;
 the input data concerned conditions that, for the reasons cited in Clinical Analysis
above, would not occur in patients accessing products under the Scheme (i.e. stoma
patients);
 treatment costs were derived from the United Kingdom and were not based on
Australian data; and
 an electronic copy of the spreadsheet was not provided, and as such the Panel was
unable to interrogate and verify the model.
Financial Analysis
Not undertaken.
6. SPAP Recommendation
The SPAP recommended that the application to list the LoFric Intermittent Catheter in
Subgroup 8(c) of the SAS Schedule be rejected – primarily as the clinical need for these
catheters on the Scheme has not been demonstrated, and secondarily due to significant
issues with the applicability of the data and verification of the economic model presented.
7. Context for Decision
The SPAP helps decide whether stoma products should be subsidised and, if so, the
conditions of their subsidisation in Australia. It considers submissions in this context. An
SPAP decision not to recommend listing or changes to a listing does not represent a final
SPAP view about the merits of a particular stoma product. A company can resubmit to the
SPAP following a decision not to recommend listing or changes to a listing. The SPAP is
an advisory committee and as such its recommendations are non-binding on Government.
All SPAP recommendations are subject to Cabinet/Ministerial approval.
8. Applicant’s Comment
Applicant’s response to statement: “Information concerning literature search strategy
and results – including inclusion and exclusion criteria – was not provided. The Panel
reiterated its position that the selective use of data is unacceptable; neither full texts nor
retrievable references for the various data inputs to the economic model (frequencies, costs
and utilities) were provided, meaning that the model could not be evaluated”
Wellspect Healthcare included references in support of its arguments at page 2 of the
submitted document. The available research relevant to the submission is limited.
Applicant’s response to statement: “The input data concerned conditions that, for the
reasons cited in Clinical Analysis above, would not occur in patients accessing products
under the Scheme (i.e. stoma patients)”
AK#1
The Stoma Appliance Scheme published statistics on the total volume of single use catheters
used under the Scheme. This includes the statement that 276,015 catheters under SAS code
3671F and 12,600 under SAS Code 9962H are purchased under the Scheme each year.
These two codes were accepted as comparators by the Stoma Product Assessment Panel. In
addition a significant number of other comparable single use catheters are listed as
purchased.
Source: SAS Products Utilisation and Expenditure (2012 - 13) (page 12)
Link https://www.health.gov.au/internet/main/publishing.nsf/Content/691B5C73BE70E880CA257C0E0012BD01/$File/sas-productsutilisation-and-expenditure-2012-13.pdf
Applicant’s response to statement: “treatment costs were derived from the United
Kingdom and were not based on Australian data”
Limited data was available to Wellspect HealthCare at the time of the submission.
Applicant’s response to statement: “an electronic copy of the spreadsheet was not
provided, and as such the Panel was unable to interrogate and verify the model.”
Wellspect HealthCare would welcome the opportunity to verbally discuss the spreadsheet
with the Panel or clinicians or to provide it in a more accessible way with future
submissions.
AK#1