Benefit Setting Arrangements
PurposeThe purpose of this Bulletin is to update stakeholders in relation to the development of benefit setting arrangements for new products to be listed on the Prostheses List which do not fit into existing groups.
BackgroundThe department is developing benefit setting arrangement for the Prostheses List that is appropriate, robust, equitable and sustainable. This development is in two stages. Under the first stage an Interim Benefit Setting Arrangement is being used while the long term solution is finalised.
The Review of Health Technology Assessment (HTA) in Australia (2009) made a number of recommendations regarding the development of a single benefit for products included in groups and the abolition of negotiation for individual benefits. These recommendations have been finalised with the cessation of the Negotiating Oversight Committee (NOC) in 2012 and the almost completed group benefit review. Implementation of these recommendations has identified that an interim benefit setting arrangement is needed while the long term benefit setting arrangements are finalised.
Interim benefit setting arrangementsAs part of the interim arrangements, benefits are being proposed by an expert group which includes the health economists who are members of PLAC, a departmental advisor and where necessary clinical and/or industry representatives. In order to establish fair and equitable benefits the expert group may request additional information from sponsors to support the determination of an appropriate benefit. This information will then be provided to PLAC for consideration in the context of the application for listing and making a recommendation to the Minister for Health.
The interim benefit setting arrangements will be used for new products recommended to list on the Prostheses List that:
- Do not have a comparator on the Prostheses List;
- Are new/novel products;
- Do not have a current group, sub-group and/or suffix; and/or
- The sponsor has established clear superiority of their product compared to those in an existing group.
What would help your application?In support of your application, the PLAC expert group may seek additional information from the sponsor to assist in establishing an appropriate benefit. This information may include:
- Availability of the product;
- Utilisation data (current and projected utilisation where available);
- The price in the public hospital sector; and
- Other information which the sponsor sees as relevant and useful.
In the futureAs identified above, the PLAC has convened an expert group to assist with determining appropriate benefits. As well as supporting the interim benefit setting arrangements, this expert group will review all pricing options to develop a benefit setting arrangement which can be consistently applied across all groups, is fair, equitable and sustainable into the future.
It is expected that the expert group may consider a range of factors when determining a benefit to be applied to products without a comparator on the Prostheses List, new or novel products, products requiring a new group, sub-group and/or suffix or where a clear case of product superiority has been established. These factors may include but are not limited to the following:
- Clinical advice on the comparative clinical effectiveness of the product when compared with other listed products;
- The benefits of comparators suggested and agreed by clinicians, or nominated by clinicians;
- Relativities to other groups (the proportion of additional benefit payable in respect of a suffix for products in other groups within the assessment body or category);
- Benefits proposed by the sponsor;
- Benefits for alternative products;
- utilisation data if and where appropriate (current and projected utilisation may also be used if available).