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The process for assessing Proposals for Changes to Product and Services Funded Under the National Blood Supply Arrangements is being reviewed.
The following processes will however remain in place until further notice.
The Multi-Criteria Analysis (MCA) Framework (see Attachment A) has been agreed by governments as the primary tool to assess applications for:
An assessment under the MCA framework can involve one or two cycles, depending on the complexity of the evaluation and information supplied.
The Framework has been designed to ensure that assessment of new products or services addresses the primary and secondary policy objectives of the National Blood Agreement (see Attachment B), as well as broader government policy objectives.
New products cannot be submitted for listing on the National Product and Services List unless they are registered with the Therapeutic Goods Administration (TGA) for supply in Australia.
New products may also be subject to a detailed cost effectiveness analysis which will be undertaken by the Department of Health and Ageing Health Technology Assessment process. More details on this process are available from www.health.gov.au.
The National Product and Services List does not list specific products but rather a generic description of a product category (see Attachment C). Attachment C contains a list of all categories of product that have been approved previously by government and are therefore on the National Product and Services List (NPSL). It is important to note that just because a product is on the list, does not mean that government is committed to buy any particular quantity of the product at any particular time, nor are governments committed to any particular brand of a product. A decision to purchase a product is always subject to additional processes after completion of the MCA assessment.
The MCA framework will apply to the following change proposals.
Within category proposals
Within category proposals are defined as changes to products already approved by Health Ministers and which are already listed on the NPSL.
A within category change will be assessed by the NBA against the MCA Framework. A decision on whether to approve or not approve the change would usually be made by either the NBA or the Jurisdictional Blood Committee (JBC). In general, the NBA is able to approve the change if the MCA assessment shows that the change is either positive or neutral against all criteria. If the change is not neutral or positive against all of the MCA criteria, the proposal must be forwarded to the JBC for consideration. The JBC will assess the application and either approve/reject the proposal or require further analysis of the proposal via Cycle 2.
OR
Outside category proposals
An Outside Category proposal is a proposal for:
Examples may include:
All Outside Category proposals are considered as Schedule 4 applications and must be considered by the JBC (see Figure 1). JBC has three options for the decisions;
Figure 1
*Subject to any relevant procurement/contract provisions
All proposals to change products currently supplied under the National Blood Arrangements or proposed additions to the National Product and Services List (NPSL) of new blood products or services, must be assessed against MCA framework. Multi-criteria Analysis can consist of one or two cycles, depending on the complexity of the evaluation needed.
Cycle 1
The objective of the first cycle is to identify whether there is sufficient evidence to support a change to blood products or services funded under the National Blood Arrangements.
All proposals must be developed and submitted against ALL of the following MCA criteria:
Cycle 2
Following Cycle 1, if the JBC considers that further analysis or information is needed, this will be undertaken in Cycle 2.
The JBC will provide guidance on the scope and nature of the criterion/criteria requiring additional work and the advisor/entity best suited to provide it.
The JBC will then consider the additional information.
Applicants will have to provide comprehensive information against each of the criteria. Guidance will be provided on the type and nature of information required.
The NBA is happy to offer a pre-submission interview to manufacturers/suppliers to discuss their proposed application.
You may be asked to provide further information during the process.
There is no definitive time frame guaranteed for the processing of any application.
Outside category applications which are material, will need to be considered by Ministers and any decision may be also subject to government budget processes. This could take in excess of two years.
National Blood Authority
January 2012
Attachments
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This page last modified on January 12, 2012
