stoma appliance scheme - application and assessment guidelines · the components which support the...

Stoma Appliance Scheme

Application and Assessment Guidelines

January 2017

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Table of Contents

Table of Contents ABOUT THIS DOCUMENT ............................................................................................................................... 4

PART 1 – INTRODUCTION .................................................................................................................................... 4

PART 2 – APPLICATION GUIDELINES AND EVIDENCE REQUIREMENTS ................................................................ 4

PART 3 – ASSESSMENT GUIDELINES ................................................................................................................... 4

PART 4 - GLOSSARY ............................................................................................................................................ 4

PART 1 – INTRODUCTION .............................................................................................................................. 5 1.1. OVERVIEW OF THE STOMA APPLIANCE SCHEME .................................................................................. 5 1.2. SAS SCHEDULE .................................................................................................................................... 5

1.2.1. Groups and Subgroups ........................................................................................................................ 5

1.2.2. Benchmark products and prices .......................................................................................................... 8

1.2.3. Price premium products and prices in Groups 1 to 7 ......................................................................... 8

1.2.4. Maximum Quantities ........................................................................................................................... 8

1.3. THE STOMA PRODUCT ASSESSMENT PANEL ......................................................................................... 8 1.4. THE STOMA PRODUCT ASSESSMENT PANEL SECRETARIAT .................................................................. 9

PART 2 – APPLICATION GUIDELINES AND EVIDENCE REQUIREMENTS ..................................... 10 2.1. BEFORE COMMENCING THE APPLICATION PROCESS ............................................................................ 10

2.1.1. Who can apply ................................................................................................................................... 10

2.1.2. Products eligible to be listed on the Stoma Appliance Scheme ......................................................... 10 2.1.3. When to submit an application .......................................................................................................... 11

2.1.4. Product listings ................................................................................................................................. 11

2.1.5. Variations and Deletions ................................................................................................................... 11

2.2. APPLICATION TO LIST PRODUCTS ....................................................................................................... 12

2.2.1. Benchmark Listing and Price Premium Applications ....................................................................... 12

2.2.2. Section 1 – Applicant Details and Declaration ................................................................................. 12 2.2.3. Section 2 – Product Information ....................................................................................................... 13

2.2.4. Section 3 – Clinical Assessment Information .................................................................................... 14

2.2.5. Section 4 – Economic Assessment Information ................................................................................. 15

2.2.6. Section 5 – Financial Assessment Information ................................................................................. 15

2.2.7. Section 6 – Additional Information ................................................................................................... 16

2.3. APPLICATION TO AMEND A LISTING ................................................................................................... 16 2.3.1. Section 1 – Applicant Details and Declaration ................................................................................. 16

2.3.2. Section 2 – Application to Vary a Listing .......................................................................................... 16

2.3.3. Section 3 – Application to Delete a Listing ....................................................................................... 16

2.4. LODGING AN APPLICATION ................................................................................................................ 17

2.4.1. Applications to list new products ...................................................................................................... 17 2.4.2. Applications to amend product listings ............................................................................................. 17

2.4.3. Lodgement ......................................................................................................................................... 17

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PART 3 – ASSESSMENT GUIDELINES ........................................................................................................ 19 3.1. INTRODUCTION ................................................................................................................................... 19

3.2. SPAP SECRETARIAT ASSESSMENT ..................................................................................................... 19

3.3. ASSESSMENT BY SPAP ....................................................................................................................... 19 3.3.1 Assessing an application .................................................................................................................... 19

3.3.2 Assessment Questions ......................................................................................................................... 20

3.4. SPAP ASSESSMENT ............................................................................................................................ 29

3.4.1 Assessing evidence ............................................................................................................................. 30

3.5. SPAP RECOMMENDATIONS ................................................................................................................ 32

3.6. DECISION REVIEW .............................................................................................................................. 32

PART 4 - GLOSSARY OF TERMS ................................................................................................................. 33

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About this document As part of the 2009-10 review of the Stoma Appliance Scheme (SAS), the Australian Government agreed that a new pricing and listing framework would be introduced for the Scheme. This document comprises a Glossary and three separate parts which have been developed by the Department of Health (the Department), with input from the Stoma Product Assessment Panel (SPAP), the Department’s independent expert health technology assessment group, to explain the revised application and assessment processes for the Scheme.

Part 1 – Introduction The Introduction sets out the SAS operating framework. A brief overview of the Scheme and the components which support the revised application and assessment process for the Scheme is provided.

Part 2 – Application Guidelines and Evidence Requirements The purpose of the Application Guidelines is to provide a framework to help refine and clarify minimum requirements to apply to evidence that is used to support applications to list a stoma-related product on the SAS. This Part describes the stages that an application to list a product on the SAS will pass through, commencing with the preparation of the application through to the assessment processes undertaken following its lodgement with the Department. It provides guidance about the type of information in relation to safety, clinical efficacy and cost effectiveness that should be submitted as part of an application and provides details of where further assistance can be obtained. It also provides clarification of the evidence requirements for each application.

Part 3 – Assessment Guidelines The Assessment Guidelines provide detailed information about how an application will be assessed, including information about the assessment methods that will be employed, SPAP considerations and its recommendation process and the future incorporation of a decision review process if appropriate.

Part 4 - Glossary The Glossary specifies the definition of a number of terms which are used throughout the document

This document will continue to be revised when required to ensure that it remains contemporary and accurate and that it provides the information necessary to prepare high quality applications. The revision process will be managed by the Department and accepted changes will be communicated to all relevant stakeholders as well as published on the Department’s website.

Further feedback on this document is welcomed and should be forwarded to:

The Director Product Schemes Section Department of Health GPO Box 9848 CANBERRA ACT 2601 Email: [email protected]

mailto:[email protected]

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Part 1 – Introduction

1.1. Overview of the Stoma Appliance Scheme The Stoma Appliance Scheme (SAS) is an Australian Government programme that assists eligible people with stomas to better manage their condition by providing subsidised access to a range of different stoma-related products. The SAS commenced operation on 1 October 1975 and is legislated under Section 9A of the National Health Act (1953). Subsidised stoma-related products are distributed via regional stoma associations. A person with a stoma who wishes to access the SAS must firstly join one of these associations and pay an annual membership fee.

The Department of Health (the Department) and the Department of Human Services - Medicare (DHS-Medicare) administer the SAS on behalf of the Government. The Department has overall policy responsibility for the Scheme and manages the SAS Schedule and the product application and assessment process. It also provides secretariat support for the Stoma Product Assessment Panel (SPAP), the Department’s independent technical advice panel. DHS-Medicare administers the stoma association claiming and payment process and the registration of new participants in the Scheme.

Stoma-related products subsidised under the SAS currently include one-piece and two-piece pouching systems, irrigation devices, catheters, hernia support garments, creams and ointments, deodorants, protective films, skin cleansers, powders and pastes.

1.2. SAS Schedule All stoma-related products available under the Scheme are listed on the SAS Schedule.

The Schedule specifies the following information for each product:

• Group and Subgroup

• SAS code

• Company product code

• Product name

• Product description

• Pack size in units

• Allowable monthly/annual (if applicable) maximum quantity

• Price per pack

• Price Premium (if applicable)

1.2.1.Groups and Subgroups Stoma-related products which have comparable features or functions are placed together in a group. Products may be further classified on the basis of their distinct features and placed in subgroups. Groups are identified numerically, with alphabetical suffixes to indicate subgroups.

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The Schedule is currently divided into eleven groups and thirty eight subgroups:

Stoma Appliance Scheme Schedule Groups and Subgroups Table

Group Number

Main Group Sub Group

1 One-Piece Closed (a) Stoma Caps

(b) Flat Baseplate

(c) Convex Baseplate

2 One-Piece Drainable (a) Flat Baseplate

(b) Convex Baseplate

3 One-Piece Urostomy (a) Flat Baseplate

(b) Convex Baseplate

4 Two-Piece Baseplate (a) Mechanical Coupling – Flat

(b) Mechanical Coupling – Extended Wear

(c) Mechanical Coupling – Convex

(d) Adhesive Coupling – Flat

(e) Adhesive Coupling – Extended Wear

(f) Adhesive Coupling – Convex

5 Two-Piece Closed (a) Mechanical Coupling

(b) Adhesive Coupling

6 Two-Piece Drainable (a) Mechanical Coupling


7 Two-Piece Urostomy (a) Mechanical Coupling


8 Alternative Systems (a) Plug Systems

(b) Irrigation

(c) Catheters

(d) Rubber Appliances

9 Accessories (a) Adhesive Barrier

(b) Belts

(c) Clamps and Clips

(d) Cleansers and Solvents

(e) Convexity Inserts

(f) Creams and Ointments

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Group Number

Main Group Sub Group

(g) Deodorants

(h) Hernia Support Belts and Garments

(i) Night Drainage

(j) Powders and Pastes

(k) Protective Films

(l) Seals

(m) Miscellaneous

10 Paediatric (a) All

11 Fistulae (a) All

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1.2.2.Benchmark products and prices Product prices specified in the SAS Schedule are set by the Department following advice from SPAP and negotiation with suppliers.

The Department has defined a benchmark price for each subgroup in Groups 1 to 7 of the SAS Schedule. This allows new products which are to be listed on the SAS Schedule in these subgroups to be priced consistently and transparently in relation to other products already listed on the Scheme.

All new products seeking listing on the SAS Schedule must either be equivalent to or superior to a benchmark product of the relevant subgroup in terms of features and clinical effectiveness.

Note that products listed in Groups 8, 9, 10 and 11 will be reviewed by SPAP to determine the most appropriate benchmarking process for these products.

1.2.3.Price premium products and prices in Groups 1 to 7 Products listed in a subgroup, which has been assessed by SPAP as providing improved health outcomes in a cost effective manner over and above that provided by the benchmark product of that subgroup, may be eligible to be listed as price premium products and accordingly, listed at a price greater than the subgroup’s benchmark price.

The price premium is set by the Department following advice from SPAP. The price premium is determined by assessing the product against a benchmark product as to the improved quality of life and/or survival.

The premium column in the SAS Schedule specifies the actual premium applied to the pack price of listed premium products.

1.2.4.Maximum Quantities The SAS Schedule also specifies the maximum number of units of stoma-related products that are available to participants under the Scheme per month (or annually if relevant).

Monthly (or annual) maximum quantities for each subgroup are set by the Department after consultation with SPAP and are designed to reflect clinically appropriate monthly usage. The SAS also provides the facility for a participant to obtain additional supplies of stoma-related products, if required, where their condition cannot be managed utilising the specified maximum quantity.

The Department will request SPAP to review maximum quantities to ensure that supply of stoma-related products under the SAS is appropriate to meet participants’ clinical needs.

1.3. The Stoma Product Assessment Panel The Stoma Product Assessment Panel (SPAP) is an independent technical advice panel appointed by the Department to review applications from suppliers requesting inclusion of a stoma-related product on the SAS Schedule.

SPAP was established in 2002 by the Department in response to a recommendation from the 2001 review of the SAS. Following the 2009-2010 review of the Scheme, the Panel was restructured to enhance its independence and improve its ability to assess economic evidence.

SPAP currently comprises eight members including an independent chair; clinical and economic experts; a consumer representative; a non-voting representative from the Australian Council of Stoma Associations (ACSA); and an Industry representative.

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The primary role of individual voting Panel members is to apply their skills and experience to consider applications from suppliers for the listing of new products on the SAS and to make recommendations to the Department in regard to those applications.

All SPAP members will consider policy issues in relation to the SAS as requested by, and in consultation with, the Department and make recommendations as required.

The Terms of Reference for the Stoma Product Assessment Panel are:

1. Provide advice to the Department on definitions, criteria, and processes for the inclusion of products on the SAS;

2. Review and assess products considering effectiveness (in terms of health outcomes generated for participants), quality, ease of use, safety, cost and cost effectiveness and provide a recommendation to the Department for consideration;

3. Ensure that high quality stoma and stoma-related products are contained in the SAS, and periodically review products and associated pricing as required;

4. Where requested, provide advice to the Department on appropriate structuring of the SAS Schedule, and where appropriate recommend strategies or principles in relation to schedule management; and

5. Consider policy issues in relation to the SAS as directed by the Department.

1.4. The Stoma Product Assessment Panel Secretariat The SPAP Secretariat provides administrative support to SPAP. It is located within the Department’s Pharmaceutical Benefits Division in the Product Schemes Section.

The SPAP Secretariat’s functions include:

• Managing the receipt of applications to list stoma-related products on the SAS Schedule, including compliance with application administrative requirements;

• Maintaining the SAS Schedule and Schedule release arrangements;

• Managing the administrative aspects of SPAP meetings, including the collation of agenda papers and the preparation of Public Summary Documents; and

• Providing advice concerning SAS policy and administration of the Scheme.

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Part 2 – Application Guidelines and Evidence Requirements This part of the document is designed to provide guidance to suppliers who wish to submit an application to list a new stoma-related product on the SAS Schedule, vary a current product listing or delete a current product from the Schedule.

The evidence requirements to enable SPAP to assess the product with reference to participant health outcomes, safety, cost and cost effectiveness are described below.

Application forms can be found on the Department’s stoma webpage.

or can be obtained from the SPAP Secretariat:

Email: [email protected]

Phone: (02) 6289 2308

2.1. Before commencing the Application process There are a number of criteria which should be addressed before commencing the Application process.

2.1.1.Who can apply A supplier of a stoma-related product may submit an application to list their stoma-related product on the SAS Schedule providing the following conditions are met:

• The supplier must have an Australian Business Number (ABN) which can be searched via ABN Lookup (at Australian Business Register) and an Australian business address.

• The supplier must be able to guarantee supply of the product which is the subject of the application to eligible stoma associations in Australia at the time of listing.

A participant in the SAS is not eligible to submit an application to list a product on the SAS Schedule unless he or she is also a supplier and meets the conditions listed above.

The Department is unable to list a product on the SAS Schedule unless its listing has been initiated by a supplier who meets the conditions listed above.

2.1.2.Products eligible to be listed on the Stoma Appliance Scheme Any product which is used in the management of a stoma may be considered for listing on the SAS Schedule providing it meets the following conditions:

2.1.2.1. Products at the Benchmark Price

• It has been registered on the Therapeutic Goods Administration (TGA)’s Australian Register of Therapeutic Goods (where relevant);

• The listing details from a valid ARTG certificate are specified in the application;

• There is a clinical need for the product;

• It will be able to be supplied from the date it is listed on the SAS Schedule;

• The product is no worse than its comparator in regard to safety and/or efficacy; and

• Its requested price does not exceed the benchmark price for the relevant subgroup.

http://www.heatlh.gov.au/stoma


http://www.abr.gov.au/

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2.1.2.2. Price Premium Products

• It has been registered on the Therapeutic Goods Administration (TGA)’s Australian Register of Therapeutic Goods (where relevant);

• The listing details from a valid ARTG certificate are specified in the application;

• There is a clinical need for the product;

• It will be able to be supplied from the date it is listed on the SAS Schedule;

• It has been compared to one or more comparators on the SAS Schedule and evidence satisfactory to the SPAP has been supplied that indicates:

- it is superior in efficacy and/or safety

- its incremental cost is relative to its incremental clinical effectiveness

or, where the product cannot be compared to a product currently listed on the SAS Schedule, evidence of its clinical and cost effectiveness is provided.

2.1.3.When to submit an application Applications can be submitted to the SPAP Secretariat at any time throughout the year. The Secretariat will process each application as soon as it is received and arrange for the application to be considered at the next SPAP meeting.

Applications are assessed by SPAP twice per financial year.

2.1.3.1. Application Timetable Current application timetable details can be found on the Department’s Stoma webpage.

SPAP will consider all applications to list products (benchmark and price premium) or amend products currently listed on the SAS Schedule.

When sending the application form and product samples to the SPAP Secretariat, it is recommended that a courier or trackable service, such as Australia Post Express Post or Platinum, be used.

2.1.4.Product listings Following consideration of the new products which have been the subject of applications to list on the SAS Schedule, SPAP provides recommendations to the Department about which products should be listed on the SAS Schedule.

The Department will consider SPAP recommendations.

Where a positive approval for the listing of a benchmark or price premium product has been given by SPAP, the Department will advise the Department of Finance and the Minister and seek approval to schedule a listing submission to be considered by Government.

If products are approved for listing by Government, the Department will facilitate publishing the SAS Schedule on the date determined by Government.

2.1.5.Variations and Deletions A supplier may apply to vary or delete a product which is currently listed on the SAS Schedule.

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It should be noted that under section 4 of the ‘Application to amend a listing on the SAS’, it is important to provide as much information about the variation or deletion, including the steps that will be taken to inform associations and participants in the SAS.

2.1.5.1. Variations Suppliers seeking to vary a product listing should use the Application to Amend a Listing form (refer to Part 2.3 – Application to Amend a Listing below). Variations are generally processed by the SPAP Secretariat. However, if a variation will affect a product’s classification, pricing, maximum quantity or composition (in certain circumstances), it will be necessary for the variation to be assessed by SPAP and the supplier seeking the variation should apply using the application to list new products.

Please note that SAS codes can only be varied by the SPAP Secretariat.

2.1.5.2. Deletions A supplier should apply to have a product deleted from the SAS Schedule if that product can no longer be distributed in Australia. Where possible, a period of notice of not less than six months should be given to allow users of the product to seek a suitable alternative and to enable stoma associations to manage their stock levels. The Department does not include suggested alternative products with its release of the SAS Schedule.

It is important to provide as much information as possible, including the steps that will be taken to inform associations and participants in the SAS about the deletion.

A product will automatically be deleted from the SAS Schedule if there has been no use of that product under the Scheme for a period of 24 months.

SPAP may recommend deleting a product from the SAS Schedule. If so, the supplier will be notified of the intended deletion and given six months’ notice of such intention.

2.2. Application to List Products

2.2.1.Benchmark Listing and Price Premium Applications The applicant should consider the type of application, i.e. if the application is for Benchmark Listing Groups 1-7 or Price Premium Groups 8-11 and other products, and use the relevant form when lodging an application.

The application form is divided into six sections. Information relating to the completion of each section is listed below. If a currently listed product is to be varied or deleted please refer to Part 2.3 – Application to Amend a Listing.

Note that products listed in Groups 8, 9, 10 and 11 will be reviewed by SPAP to determine the most appropriate benchmarking process for these products.

Applicants should complete all sections of the application form. Where information is not available, a statement to this effect should be included in the relevant section.

2.2.2.Section 1 – Applicant Details and Declaration The purpose of this section is to obtain contact information. The applicant must be the supplier of the stoma-related product in Australia. All contact information should be completed and it is important that the nominated contact officer is able to assist with any queries about the application at both the time of submission and when the application is

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considered by SPAP. The person who signs the application declaration must be able to legally bind the applicant.

2.2.2.1. Confidential Material The applicant should identify which parts of the information supplied as part of this application are considered to be confidential material and detail reasons why. Confidential material will not be included in any public documentation released by the Department, where there is sufficient justification for the information to be excluded. However, the applicant acknowledges that as part of the assessment process all information supplied in an application will be provided to SPAP for consideration.

The specification provided by the applicant under this section will be used by SPAP and the Department to determine the information which can be released as part of the publication of SPAP meeting summary outcomes and, if the product is approved for listing, the information that will be included to describe the product in the SAS Schedule.

2.2.3.Section 2 – Product Information The purpose of this section is to obtain information about the product which is the subject of the application. A sample of the product should accompany each copy of the application. In addition, an image of the product should be uploaded in the space provided in the application form.

An indication must be given as to which group and subgroup the product is to be listed in. If the product which is the subject of the application cannot be categorised in an existing group and subgroup, because the product is new technology or is satisfying a previously unmet clinical need or there is uncertainty, the applicant should complete the Price Premium Form. The features or technology which differentiates the product must be fully described.

The product name is the name under which the product which is the subject of the application is or will be supplied in Australia. This name should also appear on any product packaging. The quantity per pack should also be provided.

Listing details of a valid ARTG Certificate of Inclusion for the product must be supplied, where relevant. This includes the name of the sponsor/supplier, the ARTG ID number and a list of specific indications and/or conditions of inclusion of the product on the ARTG.

A product can still be assessed if it does not have an ARTG certificate, however it is not possible to list a product on the SAS Schedule until the listing details of the certificate are provided and verified by the SPAP Secretariat. Note that the name of the applicant should be the same as the supplier’s name that appears on the ARTG certificate.

It is important to include all the product’s features and relevant information. Do not include any promotional descriptions to describe the product’s features or technology.

If the application is for a product range, additional variants should be added using the “Add Variant” option. A comparator must be nominated from the SAS Schedule, including its group and subgroup.

The comparator will be the product most likely to experience a change in utilisation if the product which is the subject of the application is listed on the SAS Schedule. Other matters to consider include that:

• The comparator product is most likely to be the market leading product;

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• A comparator product and the product which is the subject of an application may be distributed by the same supplier.

2.2.4.Section 3 – Clinical Assessment Information The purpose of this section is to obtain all relevant clinical information about the product to enable the product to be fully assessed compared to its appropriate comparator. Information provided under this section will be used to assess the product’s clinical effectiveness and safety in relation to the condition it will manage or treat.

Information may include, but is not limited to, information concerning the clinical need for the product; evidence of the benefits of the product over the specified comparator or other relevant products; and clinical opinion concerning the product. If information on patient preferences is provided, it should be supported by objective data.

2.2.4.1. Clinical efficacy SPAP will consider the strength and quality of evidence and the relevance of the evidence to Australian practice and conditions when assessing an application.

It is important to consider the evidence provided in relation to the above, particularly with regard to leakage and skin condition where the product is expected to be in contact with the stoma or skin.

For applications requesting a price premium over the benchmark product, the SPAP will place the highest value on systematic reviews of high quality randomised trials (level 1). However, it should be noted that some randomised trials which are poorly organised may provide less information than a non-randomised trial. SPAP will, therefore, consider the strength and quality of evidence and the relevance of the evidence to Australian practice and conditions when assessing any application.

If a study is provided for a product that is not currently funded in Australia, it is important to consider whether the product is adequately described in the study and accompanying submission and can be compared to a product or products with similar features (for example, a benchmark product).

2.2.4.2. Safety If possible, a summary of the adverse events that are related to both the product for which listing is sought and if applicable, the comparator nominated in Section 2, should be provided.

Details of the events should be provided and include:

• The nature of the event;

• How often the event usually occurs (i.e. commonly, sometimes or rarely); and

• The outcome of the event (including whether it is insignificant, significant or severe).

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2.2.4.3. Literature Search A literature search should be conducted for Price Premium requests to identify evidence in support of the clinical nature, clinical effectiveness, safety and cost effectiveness of the product for which listing is being sought.

For other applications, a literature search should be considered. Results from literature searches of both published and unpublished (in house) databases should be provided in the application.

A description of the search strategy used to retrieve relevant studies of information, as well as the specific databases searched and dates of the searches should also be included.

Where a literature search has not provided any additional evidence, the applicant should indicate this via the relevant check box.

2.2.5.Section 4 – Economic Assessment Information The purpose of this section is to obtain relevant economic information, if available, about the product that will inform the cost and cost effectiveness of the product to be assessed in relation to the nominated comparator or other relevant products. This will enable SPAP to determine whether the product is likely to represent value in terms of expenditure on healthcare in Australia.

2.2.5.1. Benchmark Listing Applications for benchmark listing will be assessed on a cost minimisation basis.

2.2.5.2. Price Premium Applicants requesting a price premium should demonstrate to the satisfaction of SPAP, that the product for which listing is sought offers an improved health outcome over the appropriate benchmark comparator at a cost which can be justified for a new technology listing.

SPAP recognises that there are different best practice methods for assessing costs and outcomes in health economic analyses. The most widely used methods are cost effectiveness, cost utility and cost benefit analyses.

2.2.6.Section 5 – Financial Assessment Information This purpose of this section is to seek information about the proposed price, the proposed monthly (or annual) maximum quantity and potential utilisation of the product which is the subject of the application.

Information about the predicted change in utilisation of other products as a result of listing the new product and the corresponding cost offsets should also be submitted.

Predicted utilisation of the product under the SAS and corresponding costs for the first four full years should be specified. The inclusion of epidemiological data (which includes data about the incidence and prevalence of the condition for which the product will be used) should be included in this section. Data references for derived estimates are required.

All pricing information and cost calculations should be provided in Australian dollars.

Note: Where SPAP has rejected an application to list a price premium product on the basis of price, the Department may negotiate with the applicant to list the product in the relevant

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subgroup at the benchmark price provided it meets the requirements for a benchmark product listing.

2.2.7.Section 6 – Additional Information The purpose of this section is to allow any further information which has not been included in previous sections, which may be relevant to the assessment of the product for which listing is being sought, to be provided.

Additional information may include reports from international regulatory authorities and health technology assessment committees, unpublished studies and manufacturer studies. At the end of Section 6, the applicant should list the titles of all supporting documents that will be submitted with the application and the section of the application which they support.

Further information about how SPAP will assess applications can be found in Part 3 - Assessment Guidelines.

2.3. Application to Amend a Listing Suppliers wishing to vary or delete a currently listed product should complete an Application to Amend a Listing form. Note that only certain variations can be made using this form.

It is possible to apply to amend more than one product listing. Applicants should utilise the relevant option in the application form.

The Application to Amend a Listing form includes 3 Sections. Information relating to the completion of each section is listed below:

2.3.1.Section 1 – Applicant Details and Declaration The purpose of this section is to obtain contact information of the applicant. Please note that the Applicant must be the supplier of the stoma-related product in Australia. All contact information should be completed and it is important that the nominated contact officer is able to assist with any queries.

2.3.2.Section 2 – Application to Vary a Listing The purpose of this section is to establish the nature of the variation which is being sought. The product’s SAS code should be specified and the variation selected from the drop down menu.

It is important to provide as much information as possible, including the steps that will be taken to inform associations and participants in the SAS about the variation.

2.3.3.Section 3 – Application to Delete a Listing The purpose of this section is to establish which products an applicant wishes to delete from the SAS Schedule. The Department processes all applications to delete a SAS Schedule listing.

The SAS and company codes of all products which will be deleted should be specified.

A date of deletion should also be entered. This should be the date on which the product is to be removed from the Schedule. This date should be no less than six months from the date of application. The deletion will be actioned on the next SAS Schedule release date which occurs following the requested deletion date.

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If the product is to be deleted prior to the six month date, an explanation should be provided in the relevant area of the application form.

While a substitute product can be nominated it is not mandatory and the Department will not include this information with its release of the SAS Schedule. However, this information will be provided to SPAP at its next meeting. The applicant should also provide a reason for the deletion. This information will also be provided to SPAP.

It is important to provide as much information as possible, including the steps that will be taken to inform associations and participants in the SAS about the deletion.

2.4. Lodging an Application The SPAP Secretariat manages application lodgements. Applications should be completed using the electronic forms located at: Stoma Appliance Scheme Schedule webpage

A checklist is provided at the end of each Application Form to prompt applicants to check that they have included all relevant and requested information.

2.4.1.Applications to list new products Applicants should complete all sections of the relevant application form. Incomplete applications will be returned to the applicant. Once completed, the application form can be printed, signed and attached to the front of all supporting information.

Applicants should provide two hard copies of the completed application and four product samples. Applicants must also provide an electronic version, USB’s or CD’s will not be accepted, of the application and all supporting information. An image of the product which is the subject of the application should also be included as part of the electronic version of the application. A scanned copy of the supporting information is permissible. This version should be compatible with Microsoft Word® 2010 and Microsoft Excel® 2010. Please ensure that your electronic version includes a scanned version of the signature of the applicant.

2.4.2.Applications to amend product listings Applicants should complete all sections of the relevant application form. Incomplete applications will be returned to the applicant. Once completed, the application form can be printed and included with a copy of all supporting information.

Applicants should provide two hard copies of the completed documentation and an electronic version of the documentation. Applicants must also provide an electronic version, USB’s or CD’s will not be accepted, of the application and all supporting information. This version should be compatible with Microsoft Word® 2010 and Microsoft Excel® 2010. Please ensure that your electronic version includes a scanned version of the signature of the applicant.

2.4.3.Lodgement When the application has been completed and all relevant information and samples attached, it should be sent to the SPAP Secretariat:

Stoma Product Assessment Panel (SPAP) Secretariat

PO Box 9848 Department of Health CANBERRA ACT 2601

http://www.health.gov.au/stoma

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If more than one application is being submitted, please ensure that all documents for each application are bundled together and separated from the documents related to other applications. A cover sheet which lists all the applications which have been submitted should be provided for multiple applications.

Any questions about the lodgement process should be directed to the SPAP Secretariat via the address listed above or via email: [email protected] or Phone: (02) 6289 2308.


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Part 3 – Assessment Guidelines

3.1. Introduction This part of the Guidelines is intended to provide information to applicants concerning the process which will be used to assess applications to list new stoma-related products on the SAS Schedule. It provides direction in relation to the way clinical and economic evidence will be assessed by SPAP and the process that occurs following a SPAP recommendation.

An application is firstly examined by the SPAP Secretariat to ensure that it complies with administrative requirements. Once the Secretariat has determined its positive compliance, the application is then considered by the SPAP at their next scheduled meeting, which will make a recommendation as to whether the product should be considered for listing on the SAS Schedule.

Following the conclusion of the meeting, the Chair of SPAP will communicate the Panel’s recommendations to the Department.

Note that the ASCA nominee is a non-voting member of the committee. However, they may be called upon to provide information which may be used in relation to an assessment.

3.2. SPAP Secretariat Assessment Upon receipt of an application to list a stoma-related product on the SAS Schedule, the SPAP Secretariat within the Department will conduct a preliminary examination of the application to ensure that it complies with the application process.

When an application is received by the Department, it is logged by SPAP Secretariat staff and an email confirmation is sent to the applicant within 48 hours. The Secretariat is responsible for confirming that the application contains all information which will be required to support an application to list a new product at a benchmark price or a new product at a price premium is included and will contact the applicant to clarify information if required.

When the Secretariat receives applications that are incomplete, they will contact the applicant to ask for the additional information. If that additional information is not received by the formal application closing date, the application will be scheduled for the following meeting.

3.3. Assessment by SPAP If an SPAP member identifies a conflict of interest which prevents examination of an application, he or she will advise the Secretariat within three working days and return all application material to the Secretariat.

This method of assessment is consistent with the principles of other Health Technology Assessment (HTA) assessment processes.

3.3.1 Assessing an application

3.3.1.1 To list a price premium product In order for a product to be granted a price premium over a currently listed comparator product, evidence requirements that are satisfactory to SPAP must be provided that demonstrates:

• an incremental clinical benefit is provided to patients; and

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• the incremental costs are justified by demonstrating that the product is of acceptable cost-effectiveness at the price requested.

3.3.1.2 To list a new product at the benchmark price For applications requesting consideration of an application for a product at the benchmark price for a given Group/Sub-Group, evidence must be presented that the product is “no worse than” its comparator in regard to both safety and efficacy.

The following questions/discussion points will be addressed by the SPAP.

3.3.2 Assessment Questions The following assessment questions will be asked to obtain a clear understanding of the intention of the application.

A clear understanding of the intention of the application

Aims Relevant questions/discussion points

Proposed listing on the SAS

1. What are the relevant features of the product being proposed for inclusion on the SAS? For a Price Premium, what advantages are claimed for the product over its comparator?

2. What are the circumstances of use proposed for the product? Specifically,

• Are any specific initiation criteria required to be satisfied in order for a participant to be able to have access to the product on the SAS? Is there any targeting of participants with specific characteristics? For example, is listing only requested for participants with a specific medical condition (e.g. participants with continuing excoriation of peristomal skin despite use of a product with the following features)?

• Are there any proposed restrictions to circumstances of use? e.g. second-line treatment after failure to achieve benefit from another product or length of treatment restrictions because of adverse events etc?

• How often that the participant needs to replace the product?

• What is the monthly (or annual) maximum quantity suggested for the product? Is this consistent with how often the participant needs to replace the product?

• Do any other products need to be used in conjunction with the product? (e.g., if the product necessitates cleaning of the skin with a particular product). How does this compare with other

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products already listed on the SAS that are comparable to the product under consideration?

• Are there any contraindications to use of the product?

• What products are likely to be replaced if the product under consideration is listed on the SAS? What are the features of the replaced product – with specific consideration to the monthly (or annual) maximum issue, concomitant product use etc.

The context in which the application is considered


Background 3. Is there any background information that is relevant to the current application? For example,

• if an application has previously been received for this product and it was rejected, what were the reasons for that rejection? Has the current application addressed the issues leading to the prior rejection?

• If an application for an equivalent product has previously been considered by SPAP, and a public summary document is available, what were the findings of SPAP, the recommendation and the reasons given for that recommendation? Do the same issues apply to the current application and are those issues adequately addressed?

The findings


SPAP’s view on the proposed listing

4. Is the requested listing appropriate?

• Are the circumstances of use proposed for the product appropriate given the available evidence? For example, is listing requested for all participants where it may be more appropriate, either on clinical or cost-effectiveness grounds, to limit use to a more targeted population (e.g. evidence may only be available for a specific subset of the population)?

• If there is a proposed restriction, in terms of

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restricting use based on participant characteristics: - Is each criterion of any restriction adequately

defined? - Are there any other criteria that should be

included based on the characteristics of participant in the evidence provided?

- Is there any ambiguity in the interpretation of the criteria?

- Are the criteria objective and verifiable/auditable?

• Another example may be limiting use to second-line treatment after failure to achieve benefit from another product or length of treatment restrictions because of adverse events etc: - How are these defined and are they

reasonable based on the available evidence? - Are they objective and verifiable/auditable?

• Is the monthly (or annual) maximum quantity proposed appropriate given the evidence in relation to how frequently a product needs to be changed?

SPAP’s view on the clinical place for the product

5. Is there a clinical need for the product? Does the product satisfy an unmet clinical need in participants with specific characteristics or is this likely to be an alternative product substituting for other currently available products?

6. What does the application suggest is the positioning of the product in the clinical pathway, relative to other products currently available? For example, the application may claim that the product will substitute for combined use of a convex skin barrier and a seal. What is the basis of the nomination of the positioning of the product in the clinical pathway? Is that evidence appropriate and/or robust? In the case of a product requesting listing at the benchmark price, it is likely that the application will claim that the product is a direct substitute for the products listed at the benchmark price.

7. Is the application’s suggested positioning of the product in the clinical pathway adequately supported? For example, is the application’s claim that the product will be used as a substitute for another product supported by the evidence presented? Is there evidence to suggest that the positioning may be different (e.g. altogether different to that suggested by the application or may be appropriate in a number of positions, where only one is considered by the application)?

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• Does the evidence provided support the idea that the single product will in fact substitute for a combination of products? Is there additional evidence (from other sources) that this may be different to that suggested in the application? Is the nominated substitution likely to represent what will occur in practice (e.g. are participants likely to continue using products even though they may not need to)?

SPAP’s view on the appropriate comparator

8. What comparator is nominated by the application?

9. Is the comparator selected appropriate?

10. What are the attributes of the product and how do they compare with the comparator?

11. What product is used in the absence of availability of the proposed product? For example,

• Is the nominated comparator the appropriate comparator? Is the rationale for the nomination of the comparator sound? What evidence is provided to support the nomination of the comparator (e.g. treatment guidelines, relative usage of products already listed in the SAS, etc)?

• Will the comparator be the product most likely to be replaced by the proposed product? If the product under consideration is an alternative product for which numerous variations within a group exist, the comparator is likely to be the product with the greatest market share. The comparator can include “no product” where the proposed product is satisfying some previously unmet need and can also include a basket of products (e.g. where the proposed product may replace one product in one participant group but another product in another participant group). Where a basket of products is nominated as the appropriate comparator, the extent of substitution for each product should be specified (e.g. x% of use of the new product will be as a result of substitution for Product A, y% of use of the new product will be as a result of substitution for Product B, etc.)

SPAP’s view on the clinical 12. What approach was used to locate evidence for

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evidence presentation in the application? Is the approach taken likely to have identified all of the relevant evidence (e.g. a thorough search of the published literature and any company databases with search strategies used provided in the application to be able to verify if all relevant search terms have been included)? Has an independent search located any potentially relevant evidence not included in the application? If the application is requesting listing in a sub-population, is there any evidence available of the use of the product in different populations (may suggest use outside of that restriction)?

13. What evidence is provided in terms of:

• characteristics of the studies, (consideration of the level of evidence, any potential bias in the results given the conduct of the study (e.g. unblinded), randomisation methods in randomised controlled trials (RCTs), methods of analysis (e.g. on the basis of intention-to-treat (ITT));

• measures used to minimise bias in the studies;

• characteristics of the participants recruited to the studies;

• interventions examined by the studies (is the product under consideration and its nominated comparator being used as is requested and listed, respectively?);

• outcomes assessed by the studies (are these participant relevant);

• methods used to analyse outcomes (e.g. ITT preferable in an RCT); and

• the results of those studies is provided with the application comparing the proposed product with the appropriate comparator?

• If the study is on a product that is not funded in Australia, is the product adequately described in terms of features to compare the product with a funded product?

14. Was an appropriate, systematic approach used to select the evidence presented in the application?

• Have the inclusion/exclusion criteria been determined a priori (based on theoretical deduction rather than empirical observation)?

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• Are the inclusion/exclusion criteria appropriate? Have the nominated criteria been applied consistently in selecting studies for inclusion in the application?

• Does the evidence presented adequately support the application’s claim in relation to the comparative safety and effectiveness of the product versus the comparator? Is the data presented applicable? (i.e. are the populations in the studies consistent with those for whom listing is sought)?

- Are the characteristics of the populations in the studies representative of those of the likely participants in Australia?

- If the request for listing is narrower than the study population: has sub-group analysis been conducted? Was that sub-group analysis determined a priori? Is there a clinical rationale for limiting use to this group, if not, is there potential for leakage?

- If the request for listing is broader than the study population: is the evidence to suggest/reasonable to assume that safety/effectiveness in population presented in the evidence would be applicable to a wider population (e.g. all participants)?

• Does the evidence demonstrate a statistically significant difference between products, and is that difference likely to be clinically significant?

• Any statistical analysis of the results needs to be considered in conjunction with any potential biases that exist in the evidence presented (i.e. unblinded study design etc.)

15. Have trade-offs between competing attributes been adequately considered (e.g. a product that is associated with improved adhesion may be associated with an increased risk of skin irritation)? Have they been considered reasonably (e.g. do the benefits outweigh the harms or vice versa)?

16. Are there any key uncertainties that remain to be addressed in order for the application’s claim to be considered adequately supported? Would these uncertainties be easily addressed (i.e. during phone conversation whilst SPAP is sitting) or does this require a substantial amount of investigation?

SPAP’S view on the 13. What type of economic analysis (e.g. cost-

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economic analysis effectiveness, cost-utility) is presented with the application?

17. Has a cost-minimisation economic analysis been used as requested? (A cost minimisation analysis is the appropriate economic analysis to be presented in applications requesting listing of a product at the benchmark price. A cost-minimisation analysis is an analysis that identifies the least costly product or that there is no difference in cost, once the proposed product has been accepted to be no worse than its main comparator in terms of outcomes).

18. What data sources were used to construct the economic analysis presented in the application? Is the evidence used in the economic analysis derived from the evidence presented to establish the safety and effectiveness of the product provided in the application? Have additional sources of information been included for the purposes of the economic analysis? Have these additional sources of information been located and included in a systematic fashion or is there potential for bias in the inclusion of some data rather than others?

19. What are the results of the economic analysis (including results of sensitivity analysis) presented in the application? How are the results presented (e.g. in terms of a cost per particular outcome or as a cost per quality adjusted life year (QALY)?

20. What are the key assumptions driving the results of the economic analysis presented in the application? (e.g what links are assumed between surrogate and final outcomes in economic analysis)? Has the application provided evidence to establish any links between the surrogate and final outcomes? Is that evidence appropriate and/or robust? NB - A surrogate outcome is a substitute outcome that predicts final participant-related outcomes. This type of outcome is often used when observation of clinical outcomes requires long follow-up.

21. Is the approach to economic analysis adopted in the application appropriate? For example:

• Is the type of analysis presented in the application appropriate given the clinical conclusion?

• Is the time horizon over which the analysis presented in the application is conducted appropriate? (e.g. for products that are assumed to be used for chronic states, a life-time horizon may

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be warranted to capture all relevant costs and consequences, whereas for products required for acute relief of symptoms a shorter time horizon may be deemed appropriate).

• Is the structure of the analysis presented in the application appropriate (e.g. the relationship assumed between surrogate and final outcomes)? Have all of the relevant health states been considered? Does the movement of users through the health states match with the clinical progression likely to be seen in users? Is there an established relationship between the surrogate and final outcomes? If not, does the application provide any evidence to establish such a link? What is the quality of that evidence?

• For an application requesting listing of the new product at the benchmark price, where the proposed product substitutes for the comparator on a one-for-one basis, the products can be compared at the unit level. Where there is some discrepancy in the proposed substitution, e.g. if it is proposed that one unit of the proposed product will replace two units of the comparator, then the prices of the products should be compared on this basis (provided the evidence supports the claim for the proposed substitution rate).

22. Are all the relevant costs and consequences for the proposed product and appropriate comparator included in the economic analysis presented in the application? Have costs associated with concomitant therapies, treatment of adverse events etc, if relevant, been separately specified?

23. Is the extent of use of resources valued appropriately in the economic analysis presented in the application? Is the assumed quantity of product use consistent with the proposed use (as specified in Question 2 above)? Are appropriate unit costs applied to resources? How have the unit costs been derived and can they be verified?

24. Are assumptions in the structure of the economic analysis presented in the application, (e.g. those linking surrogate and final outcomes, adequately supported by the available evidence)? Are outcomes valued appropriately given the available evidence?

25. Is uncertainty around the values attributed to variables in the economic evaluation adequately explored?

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Sensitivity analysis should explore the impact of assuming different incremental rates of effectiveness/safety (generally use point estimate in base case and upper and lower confidence intervals in sensitivity analyses), different costs (for products/procedures where a range of costs have been reported), analysis of the use of different utility weights in cost-utility analyses (where different values have been reported).

26. Given all of the above considerations, are the results of the economic analysis credible and accurate? Has the applicant specifically used costs, utilities, and other assumptions that are likely to favour their product, or have they used the most reasonable values reported?

27. Are the conclusions drawn in the application in relation to the cost-effectiveness of the proposed product relative to the comparator adequately supported by the economic analysis?

28. Is any claim for a price premium in the application adequately supported by the clinical evidence and the economic analysis? Has a real clinical benefit been demonstrated by the evidence and is this reasonably estimated by the economic analysis? E.g. if the product claims fewer skin irritations, (which would be of clinical benefit, but would not result in, for example, increased survival of users), and the economic analysis estimates increased survival of users where this decrease in skin irritations is being valued, it is unlikely that the observed clinical benefit is being correctly valued.

SPAP’s views on financial analysis

29. What is the likely extent of use of the product according to the application? How many SAS participants will use the product? How many products would be required based on the number of participants?

30. What change is likely in the extent of use of the comparator according to the application? Would there be complete substitution of one product to another? Is it possible that participants may use a combination of the products? Where concomitant products are required would there be complete substitution (i.e. from two products to a single one) or are participants likely to continue using products even though they may not need to (see Question 7)?

31. What are the financial implications associated with inclusion of the product on the SAS according to the

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application? These should be calculated as the extent of use multiplied by the unit cost of the product plus any costs associated with other items that are required to be used in conjunction with the product.

32. What are the offsets to these financial implications according to the application? These can be calculated as the reduction in use of the comparator product multiplied by the unit cost.

33. Are the estimates of extent of use and financial implications presented in the application adequately justified and correctly calculated? • Are the application’s assumptions regarding the

likely substitution reasonable? • Have all substitutions been considered? Are they

appropriate?

• Are the assumed substitutions adequately supported? What is the likely impact on the financial estimates if these are included or excluded?

Recommendations of SPAP


SPAP’s recommendations and reasoning

34. Should the proposed product be considered for inclusion on the SAS at the benchmark price?

35. Should the proposed product be considered for inclusion on the SAS at a premium price to its benchmark comparator?

36. Reasons should be based on the findings based on the available evidence, economic and financial analyses.

3.4. SPAP Assessment SPAP provides advice to the Department concerning which stoma-related products are suitable for listing on the SAS Schedule. SPAP must have regard to comparative clinical function and effectiveness, comparative cost effectiveness and comparative safety.

While not directly part of the Australian Government’s HTA system, SPAP endeavours to ensure that it undertakes the SAS’s application assessment process in a way that is:

• sustainable;

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• transparent, accountable and independent;

• consultative and reflective of Australian community values;

• administratively efficient;

• flexible and fit for purpose; and

• informed by robust and relevant evidence. The SPAP assessment process has been restructured to conform as closely as practical to the Australian Government HTA system.

3.4.1 Assessing evidence As noted in Part 2.2 – Application to List products, there is a minimum level of evidence required, and it is acknowledged that the level of evidence available may vary among applications however, SPAP will consider the relevance and propriety of the evidence submitted including:

• Has an appropriate approach been used to select studies for presentation in the application (i.e. is there any risk that there is selection bias in the presentation of studies)?

• What is the quality of the studies (i.e. what is the likelihood that the results of the studies have been affected by bias during their conduct)?

• Are the results of the studies presented consistent and are they consistent with the results of studies that may have been excluded from presentation in the application?

• Is there any reason why results of the studies may not be generalised to the Australian setting?

• Does the trial design minimise bias, e.g. carry-over effects? For studies involving the measure of skin integrity, the minimum duration should be no less than 4 weeks for each phase of the study;

• Are the end-points measured relevant to patients e.g. leakage, skin integrity, ballooning?

• Are the endpoints surrogate outcomes, and if so, have they been validated? E.g. air flow rates through filters on ostomy bags should be correlated with the incidence of ballooning and/or odour;

• If standardised measures are used e.g. for skin integrity, what is the inter (the degree of agreement among raters) and intra-rater variability (the degree of agreement among repeated administrations of a diagnostic test performed by a single rater)? How was this tested and how may this influence the results of the studies?

• Are patient-preference studies included in the application? How were these studies conducted to minimise the confounding of the results? Is there a correlation between differences in patient relevant outcomes and expressed patient preferences? If not, why not?

• Is the data on comparative safety and effectiveness the result of head-to-head trials with the comparator or via indirect analyses?

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3.4.1.1 National Health and Medical Research Council SPAP will refer to the National Health and Medical Research Council (NHMRC)’s Hierarchy of Evidence when assessing the quality of evidence presented in applications.

NHMRC Evidence Hierarchy table

Level Intervention

I (highest)

A systematic review of level II studies

II A randomised controlled trial

III-1 A pseudo randomised controlled trial (i.e. alternate allocation or some other method)

III-2 A comparative study with concurrent controls:

• Non-randomised experimental trial

• Cohort study

• Case-control study

• Interrupted time series with control group

III-3 A comparative study without concurrent controls:

• Historical control study

• Two or more single arm studies

• Interrupted time series without a parallel control group

IV (lowest)

Case series with either post-test or pre-test/outcomes

Product information or statements and testimonials from suppliers or clinicians will not be sufficient to demonstrate clinical effectiveness or superiority.

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3.5. SPAP Recommendations Following full consideration of an application to list a new product on the SAS Schedule, SPAP will decide whether to recommend the product for listing. At the conclusion of each SPAP meeting, the Chair will write to the appropriate Departmental delegate about the outcomes of the meeting.

A recommendation will include:

• whether the product which is the subject of the application should be listed on the SAS Schedule; and

• an explanation of SPAP recommendations. If SPAP recommends that the product should be considered for listing on the SAS Schedule, it will also provide the following information:

• Monthly (or annual) maximum quantity for the product;

• The price at which the product should be listed; and

• Any usage restrictions, if relevant. All suppliers will be given the opportunity to meet with the Chair of SPAP to discuss the outcomes of the SPAP meeting.

Where SPAP has rejected an application to list a price premium product on the basis of price, the Department may negotiate with the applicant to list the product in the relevant subgroup at the benchmark price provided that:

• SPAP has confirmed that the product is no worse than its comparator in regard to safety and efficacy; and

• SPAP has confirmed that it does not intend to expand the subgroup’s benchmark product definition.

3.6. Decision Review As noted above, SPAP provides reasons for all its recommendations in relation to applications to list a new product or vary the listing of a product currently listed on the SAS Schedule.

All unsuccessful applications can be resubmitted to SPAP for consideration at a subsequent SPAP meeting providing they include additional information which addresses SPAP concerns outlined in its initial advice.

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Part 4 - Glossary of Terms The following terms and abbreviations have the meanings indicated:

Term Definition

“ACSA” the Australian Council of Stoma Associations

“Adverse Event” any unfavourable or unintended change in health or side effect that occurs while a participant is receiving treatment for a condition or using a specific stoma-related product for that condition

“ARTG” the Australian Register of Therapeutic Goods as established under the Therapeutic Goods Act 1989

“ARTG Certificate of Inclusion” the certificate which can be printed from the TGA eBS system following a product’s successful inclusion on the ARTG

“Benchmark Product” the notional stoma-related product within each subgroup that comprises a specified set of features, as updated from time to time, which represents the minimum standard product which would be used by a participant in the SAS who has a need for a product in the subgroup

“Benchmark Product Price” referred to as the Benchmark Price. The price of the benchmark product in a subgroup. Derived by calculating the sum of the base product price plus the specified cost of each key feature of the benchmark product additional to the base product’s set of key features. For a product to receive the benchmark price that applies for a subgroup, the product must include all the specified key features

“Clinical Effectiveness” the measurement of the improvement of health outcomes attributable to a stoma-related product

“Comparative Effectiveness” the measurement of the clinical and economic benefits of a stoma-related product compared to an alternative product

“Comparator” a stoma-related product nominated by an applicant as the product most likely to be replaced, or experience a decrease in utilisation, if the applicant’s product is listed

“Confidential material” information which may be withheld from the public or unauthorised persons because disclosure would cause a foreseeable harm to the organisation which supplied the information

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Term Definition

“Cost Effectiveness” the measurement of the incremental cost relative to the incremental health outcomes achieved by a stoma-related product compared to the alternative product that is most likely to be replaced

“Cost Minimisation Analysis” Analysis which considers whether the proposed intervention is demonstrated to provide a health outcome which is at least no worse than another intervention at the same or a lower price

“The Department” the Department of Health

“Departmental Delegate” the relevant Departmental Officer holding delegation to make formal decisions in relation to the SAS

DHS – Medicare Department of Human Services - Medicare

“Feature” a specified component of a stoma-related product

“Finance” the Department of Finance

“Group” a collection of stoma-related products which comprise similar features listed together within the SAS Schedule

“Health Outcome” a change (or lack of change) in a person’s health status as a result of utilisation of the stoma-related product of interest compared to health status when using the comparator. Health status may be assessed when using disease-specific measures, health-related quality of life measures; measurement of survival; or a combination of these measures

“Manufacturer Code” the code assigned to distinguish a supplier by the Department, as specified in the SAS Schedule

“Maximum Quantity” the number of units of a product which can be provided to a participant in the SAS per month (or annually where relevant)

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Term Definition

“Participant” a current member of a stoma association who has successfully applied to receive stoma-related products through the SAS

“Price Difference” the difference in the price paid between the price of the benchmark product and the premium price product in each subgroup

“Price Premium” the incremental price that has been justified for a key feature that provides improved health outcomes, additional to those provided by the benchmark product

Term Definition

“Price Premium Product” a stoma-related product within a subgroup, which has one or more key features for which a price premium has been approved

“Product” a stoma-related product used in the management of a stoma and/or fistula

“Related Feature” a feature, as determined by SPAP, which must be part of a benchmark product

“SAS” the Stoma Appliance Scheme

“SAS Code” the five or six digit alphanumerical code given to stoma-related product when listed on the SAS Schedule which is used to identify the product for Department of Human Services - Medicare claiming purposes. The SAS Code is also referred to as the PBS item code.

“SAS Schedule” the list of stoma-related products which can be accessed under the SAS and their associated SAS codes, supplier codes, product descriptions, prices and maximum quantities. The SAS Schedule also specifies whether a stoma-related product is a benchmark product or a price premium product

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Term Definition

“SPAP” the Stoma Product Assessment Panel

“SPAP Secretariat” the Secretariat located within the Department which provides support to SPAP

“Stoma” for the purposes of the SAS, a stoma is an opening, either natural or surgically created, which facilitates the removal of urine and/or products of the gastrointestinal tract.

“Stoma-Related Product” a therapeutic device, appliance, aid or product which is used in the management of a stoma or fistula.

“Subgroup” a collection of stoma-related products with similar key features which form part of a group in the SAS Schedule

“Supplier” the manufacturer or distributor of stoma-related products in Australia which are listed or may be listed on the SAS Schedule

“TGA” the Therapeutic Goods Administration

“Variant” a form of a related feature