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Health Technology Assessment Review

Discussion Paper 2 – Streamlining Application Processes

Discussion Paper 2 – Streamlining Application Processes (PDF 131 KB) If you have any difficulty accessing the PDF, please contact mbd.web@health.gov.au

Disclaimer

The proposals for reform to Commonwealth Health Technology Assessment (HTA) processes as outlined in this Discussion Paper represent a range of responses to the issues raised in submissions to the HTA Review and during stakeholder consultation. The Discussion Papers are intended to stimulate discussion at the forthcoming consultations and any proposal presented or omitted could not be taken to represent the policy position of the Government. The HTA Review is required to put forward proposals that can be sustained within existing funding levels and that are consistent with Government policy objectives.

Introduction

A range of policy, program and legislative arrangements underpin the multiple advisory committees and associated administrative processes which make up Commonwealth Health Technology Assessment (HTA) processes. These HTA processes inform decisions about market regulation and listing of medical services, pharmaceuticals, vaccines and devices on the Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Schedule (PBS), National Immunisation Program (NIP) and the Prostheses List (PL) respectively.

Currently, applicants are required to traverse four different public interfaces within the Department of Health and Ageing (DoHA) to make applications for the Australian Register of Therapeutic Goods (ARTG), MBS, PBS/NIP and PL. These four interfaces have different processes and approaches to the management of applications.This paper presents a number of proposals to facilitate streamlined, efficient and timely application processes – including how applications are managed through the different assessment processes and the factors taken into consideration in determining the assessment pathway.

Concerns Raised in HTA Review Consultations

Concerns raised by stakeholders during public consultations included:

• DoHA manages the HTA advisory committees (Medical Services Advisory Committee (MSAC), Pharmaceutical Benefits Advisory Committee (PBAC) and Prostheses and Devices Committee (PDC)) differently. As a consequence, DoHA’s approach has been criticised as being siloed, overlapping, duplicated and lacking in coordination;
• there is limited formal and routine interaction between the different areas of DoHA about their functions despite the fact that HTA eligibility criteria includes successful completion of a previous step (e.g. ARTG listing and MBS Item);
• the sequential (rather than concurrent) nature of lodging applications for HTA for market entry and reimbursement causes delays and that processes should take place concurrently;
• there is perceived duplication of HTA assessment activities between the market entry and the reimbursement processes. This delays use of the technology and limits the already short life-cycle of health technologies;
• there was general criticism of the HTA processes undertaken by MSAC and the PDC, in particular their perceived inconsistent application requirements and assessment outcomes, the lack of transparency of processes, timelines and decisions, the lack of procedural fairness (including application costs) and the availability in the public hospital system of products which are not available on the MBS or the PL – creating perceived equity of access issues;
• however, stakeholders also expressed support for:
  • the HTA processes undertaken by the TGA and PBAC (which can be attributed to factors such as key processes being prescribed in legislation and depth of departmental experience in their execution resulting in greater transparency, predictability of requirements, and specified timeframes and outcomes);
  • a single entry point or “umbrella” function for Commonwealth HTA processes; and
  • the establishment of an “independent” HTA agency.

Proposal 2 Single Entry Point

Establishment of a single entry point within the health agency portfolio to manage applications for the Commonwealth HTA processes for market entry and reimbursement which could include the following features:

1. a public interface with stakeholders (through a website and guidance documents);
2. capacity to monitor the progress of applications;
3. single liaison point for applicants and the HTA processes;
4. responsibility for organising broad based pre-lodgement meetings – which could provide a “whole-of-HTA system” view to aid an applicant’s understanding of how its application could progress through the various Commonwealth HTA processes and advisory committees, and the likely evidence requirements;
5. a coordination function for those applications which would need to be assessed by multiple HTA processes and advisory committees such as hybrid ¹ or co-dependent ² technologies;
6. management of information requests between the HTA processes and advisory committees and the applicants; and
7. responsibility for coordination of evidence requirements and assessment processes to promote greater consistency across the HTA processes and advisory committees.

Discussion

A single entry point could improve role clarity and provide better co-ordination of Commonwealth HTA processes by facilitating concurrent or integrated processes where assessments are built on those completed by other HTA processes (including international) rather than undertaken sequentially and from the ground up.

It could ensure that appropriate communication and collaboration takes place among the TGA and HTA advisory committees (MSAC, PBAC and PDC), as well as public and private payers and State and Territory Governments.It could provide an opportunity to standardise application requirements (including guidance), where appropriate, to be consistent with the flexibility of the parallel proposal to introduce a risk-based assessment process. Discussion Paper 3 – Proposal 5 “Implementation of a risk-based approach to evidence requirements and methodologies” explores options for triaging of HTA levels of assessment.

¹Where the characteristics of different health technologies (eg a medicine or a medical device or a biologic) are combined in one intervention (eg laser activated medicines such as photodynamic therapy, or drug eluting stents)
² Where therapy involving the use of one health technology to directly improve health (eg a medicine or a medical device or a procedure) is improved by the use of another health technology which might more accurately identify patient subsets most likely to gain from the therapy or monitors therapy response.

It might also lead to efficiency gains through the processing of applications in a consistent manner, and improved communication with applicants. Management of pre-requisites (ARTG number, MBS item) could be simplified, and the flow of applications across more than one HTA process could be better controlled.

Set out below are a number of ways a singe entry point might be implemented.

Option 2A – A new single entry point to process and manage all applications

A new single entry point could be established to process and manage all applications for HTA for market entry and reimbursement.

Discussion

This would provide an opportunity for consistent processes and guidelines to be developed. In addition, potential applicants would only be required to interact with one Commonwealth process to seek information about and apply for HTA for both market regulation and reimbursement.


Diagram 1 – Option 2A

Option 2B – A single entry point manages applications for HTA for market regulation and a single entry point manages applications for HTA for reimbursement

The TGA maintains its role as the market entry regulator and another area within the Health portfolio assumes responsibility for coordinating all applications for Commonwealth HTA processes for reimbursement.

Discussion

This option could maintain the current separation of HTA for market regulation and HTA for reimbursement activities which may reduce role confusion. However, it might also continue the perception that there is fragmentation between HTA for market entry and HTA for reimbursement, particularly whenever market authorisation is part of the eligibility criteria for HTA for reimbursement, noting that stakeholders have been critical of the coordination of timing of granting market authorisation and the commencement of HTA for reimbursement.

The DoHA area taking responsibility for overall coordination of the current HTA processes and advisory committees (MSAC/PDC/PBAC) would have an opportunity to develop more consistent processes and/or manage the different application requirements.



Diagram 2 – Option 2B

Proposal 3 Triaging of HTA Applications

The overall triaging process could determine:

• the most appropriate HTA process(es) and HTA advisory committee(s) to undertake assessment of the product or service (including any combination of these); and
• the most appropriate assessment level for different types of applications within each HTA process (such as new products, “me-too” products, variations to existing products and co-dependent and hybrid products), the likely evidence and time implications.

This proposal seeks to implement a more consistent approach to triaging applications across DoHA, while allowing for the individual requirements of the different HTA processes.

Note: The proposal for triaging is not dependent on the proposal for a single entry point.

Discussion

Both the TGA and PBAC processes incorporate triage systems to inform the assessment pathway and assessment levels for applications using a risk based approach. The PDC process has an informal triaging process for its applications. Applications to MSAC are currently accepted without triaging.

The triage within an assessment process could determine whether the application requires a full HTA, targeted HTA, listing advice on the basis of the triage report or is unsuitable for further assessment (or listing) on the basis of the triage report.

Implementing an overall triaging process could aid applicant understanding of the HTA processes and create resource efficiencies by enabling planning for upcoming HTA assessments (including assignment of resources [HTA assessors and funding]).

Proposal 4 Allowing Submission Based Assessment Based Assessment for Potential New Medicare Benefit Items

MSAC applicants could be expected to gather all necessary evidence to support their application, rather than the evidence being generated during the assessment process. Applications would be made to the MSAC Secretariat and be independently evaluated (using appropriate expertise). The evaluation report would be provided to MSAC alongside the application which would determine whether to recommend the proposed health technology for listing on the MBS. If the application provided an insufficient basis to recommend MBS listing, the MSAC reasons would identify the deficiencies in the application.

Discussion

This proposal could be assisted through improvements to application forms, clearer eligibility criteria and evidence requirements and improved pre-lodgement consultation mechanisms. It could represent a shift from the current practice of MSAC commissioning a full HTA by external evaluators and might assist DoHA with triaging applications (refer to Proposal 2 above).

This proposal could reduce assessment timelines, enhance procedural fairness, build capability in Australia (including increased skills in conducting trials, health economic [cost effectiveness] analyses), increase the evidence base for potential new Medicare Benefit items and increase clinical trial capacity in Australia in relation to medical devices and medical procedures.

Should an applicant provide insufficient information to support an application, it could be directed (prior to reapplying to MSAC) to either:

• undertake its own research to generate the necessary evidence; or
• seek the assistance of a coordinating research body to apply for a funded trial of its procedure/device which could contribute to the evidence base.