Stoma Appliance Scheme
Application and Assessment Guidelines
January 2017
Table of Contents
Table of Contents
About this document
Part 1 – Introduction
Part 2 – Application Guidelines and Evidence Requirements
Part 3 – Assessment Guidelines
Part 4 - Glossary
Part 1 – Introduction
1.1.Overview of the Stoma Appliance Scheme
1.2.SAS Schedule
1.2.1. Groups and Subgroups
1.2.2. Benchmark products and prices
1.2.3. Price premium products and prices in Groups 1 to 7
1.2.4. Maximum Quantities
1.3.The Stoma Product Assessment Panel
1.4.The Stoma Product Assessment Panel Secretariat
Part 2 – Application Guidelines and Evidence Requirements
2.1.Before commencing the Application process
2.1.1. Who can apply
2.1.2. Products eligible to be listed on the Stoma Appliance Scheme
2.1.3. When to submit an application
2.1.4. Product listings
2.1.5. Variations and Deletions
2.2.Application to List Products
2.2.1. Benchmark Listing and Price Premium Applications
2.2.2. Section 1 – Applicant Details and Declaration
2.2.3. Section 2 – Product Information
2.2.4. Section 3 – Clinical Assessment Information
2.2.5. Section 4 – Economic Assessment Information
2.2.6. Section 5 – Financial Assessment Information
2.2.7. Section 6 – Additional Information
2.3.Application to Amend a Listing
2.3.1. Section 1 – Applicant Details and Declaration
2.3.2. Section 2 – Application to Vary a Listing
2.3.3. Section 3 – Application to Delete a Listing
2.4.Lodging an Application
2.4.1. Applications to list new products
2.4.2. Applications to amend product listings
2.4.3. Lodgement
Part 3 – Assessment Guidelines
3.1.Introduction
3.2.SPAP Secretariat Assessment
3.3.Assessment by SPAP
3.3.1 Assessing an application
3.3.2 Assessment Questions
3.4.SPAP Assessment
3.4.1 Assessing evidence
3.5.SPAP Recommendations
3.6.Decision Review
Part 4 - Glossary of Terms
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 processand 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:
1
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 1October1975and 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 includeone-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.
The Schedule is currently divided into elevengroups and thirtyeight subgroups:
Stoma Appliance Scheme Schedule Groups and Subgroups Table
Group Number / Main Group / Sub Group1 / 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
(b)Adhesive Coupling
7 / Two-Piece Urostomy / (a)Mechanical Coupling
(b)Adhesive 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
(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
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 transparentlyin 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, 10and 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 healthoutcomes 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 isset by the Departmentfollowing 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 SPAPand 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 maximumquantities 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 fromthe 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.
The primary role of individual votingPanel 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:
- Provide advice to the Department on definitions, criteria, and processes for the inclusion of products on the SAS;
- 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;
- Ensure that high quality stoma and stoma-related products are contained in the SAS, and periodically review products and associated pricing as required;
- 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
- 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.
- 1 -
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.
Theevidence requirements to enable SPAP to assess the product with reference to participanthealth outcomes,safety, cost and cost effectivenessare described below.
Application forms can be found on the Department’s stoma webpage.
or can be obtained from the SPAP Secretariat:
Email:
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.
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
Currentapplication 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 Departmentabout 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 producthas been given by SPAP, the Department will advise the Department of Finance and the Minister and seek approval toschedule 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.
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 SPAPSecretariat.
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 muchinformationas 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.