Home > For Health Professionals > Health products and medicines > Health Technology Assessment Review

Health Technology Assessment Review

Discussion Paper 4 – Improved Administration of Commonwealth HTA Processes

This paper summarises stakeholder concerns about DoHA’s current approach to managing Commonwealth processes for market entry and reimbursement and presents a number of proposals to address these concerns.

Discussion Paper 4 – Improved Administration of Commonwealth HTA Processes (PDF 41 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 should 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

The Department of Health and Ageing (DoHA) has a legislative, policy and program framework to administer Commonwealth Health Technology Assessment (HTA) processes to inform:

• market entry regulation - to ensure that new therapeutic goods are safe, perform as intended and are produced using appropriate quality controls before granting marketing approval in Australia;
• reimbursement decisions – the assessment of comparative clinical and cost effectiveness of the use of health technologies, which informs decisions about:
  • public funding of medical services (with or without a device), pharmaceuticals and vaccines through the Medicare Benefits Schedule (MBS), the Pharmaceutical Benefits Scheme (PBS) and National Immunisation Program (NIP) respectively;
  • private health insurance reimbursement of prostheses through the Prostheses List (PL); and
• post market surveillance of marketed therapeutic goods and reimbursement of health technologies.

Top of Page
This paper summarises stakeholder concerns about DoHA’s current approach to managing Commonwealth processes for market entry and reimbursement and presents a number of proposals to address these concerns.

Concerns Raised in HTA Review Consultations

Concerns raised during the consultation process about DoHA’s administration of Commonwealth HTA processes included:

• public information about DoHA’s administration of the HTA processes to inform market regulation and reimbursement decision on websites and in program guidelines is not presented in a systematic manner nor on a central site. The Therapeutic Goods Administration (TGA) and each HTA advisory committee have a website and program guidelines that describe their individual role and function within the Commonwealth system but not how it interrelates with other HTA processes;
• reflecting this lack of information, stakeholders have difficulty understanding the different HTA processes performed by the various HTA advisory committees;
• Commonwealth HTA processes appear to be uncoordinated, with duplication and overlap between processes, especially in regard to safety assessment;
• the view that the Medical Services Advisory Committee (MSAC) and the Prostheses and Devices Committee (PDC) have unpredictable requirements and outcomes, lack transparency and procedural fairness and are inconsistent in decision-making, whereas the TGA and the Pharmaceutical Benefits Advisory Committee (PBAC) have predictable requirements and are viewed as transparent in their processes and decisions; and
• stakeholder desire for:
  • more extensive and clearer guidance on the HTA processes with greater consistency across all parts of the Commonwealth HTA system;
  • clearly defined roles and responsibilities for HTA advisory committees and evaluators;
  • process improvements that simplify and speed up the HTA assessment process;
  • more open, timely and mandated communication between the various HTA advisory committees;
  • an independent review mechanism for HTA advisory committee recommendations;
  • clearer explanation of the rationale(s) for HTA advisory committee recommendations and advice;
  • better handling of conflicts of interest especially in membership on HTA advisory committees and their supporting committees and panels;
  • better performance information, reporting and evaluation; and
  • standardised timelines for HTA processes and for each key step within each process.

Proposal 7 – Improved Public Information on HTA Processes

DoHA’s website could provide an overall view of the Commonwealth HTA system, including an explanation of each of the different HTA processes, a description of how these processes are implemented by each HTA advisory committee and regular updates on performance against agreed performance indicators.

Discussion
DoHA currently does not have an overall “HTA” website. Prime information sources for each of the HTA processes and advisory committees are contained on discrete sites on DoHA’s or TGA’s website. The format and content of each website is different and none provides a coherent link to the other sites. Only the TGA’s website includes a formal application tracking component which is updated in real time; only the TGA and PBS websites cater for different stakeholder groups.
Top of Page
A central website that provides a DoHA overview of HTA with links to the other HTA processes and advisory committee websites could improve the information publicly available to stakeholders, promote role clarity, transparency of processes and decrease stakeholder confusion about DoHA’s HTA processes.

Proposal 8 – Standard Approach to HTA Process Managemnent

DoHA could provide greater clarity about its current management framework for the Commonwealth HTA processes for market entry and reimbursement including:

• development of a guide to all Commonwealth HTA processes as a whole, as well as the purpose of each individual process and the interactions between the different DoHA and TGA HTA processes and advisory committees;
• development of a standard approach to structure and content (to the extent possible) for all HTA process guidelines, using consistent definitions and language and including descriptions of:
  • the appointment, roles and responsibilities of the HTA advisory committees
  • processes for handling conflict of interest;
  • decision making processes and criteria;
  • review mechanisms;
  • processes subsequent to HTA, but prior to a decision to provide reimbursement;
  • estimated timelines for HTA processes and decision making; and
  • the roles of particular stakeholders; and
• strengthened committee management by:
  • ensuring committee secretariats make better use of DoHA’s Committee Support Unit’s guidance (eg management of conflicts of interest);
  • more clearly articulating HTA advisry committee roles and responsibilities; and
  • enhancing expertise of DoHA staff to provide technical HTA support as well as secretariat support to the HTA advisory committees.

Discussion
This proposal could assist in:

• enhancing applicant understanding of requirements prior to making an application as well as improving understanding of how the various functions and processes fit into the overall Commonwealth HTA process;
• enhancing transparency of the Commonwealth HTA processes, through clear articulation of the HTA processes for market entry and reimbursement and increasing public confidence in DoHA’s HTA processes;
• improving internal process consistency and minimising any duplication and burden on applicants; and
• providing a smoother transition towards the better alignment of HTA advisory committees (whether in parallel or in series for co-dependent or hybrid technologies) to reduce timeframes, and minimise any real or perceived duplication in HTA processes.

Proposal 9 - Specified Communication Points

External communication

Proposals 7 and 8 would assist with improving external communication. However, key communication points could be introduced across the HTA processes so that applicants could more easily monitor progress of their application through the Commonwealth HTA processes. The communication points could align with key decision points in the HTA processes and could be monitored internally and externally.

Key communication points could be at the time of:

• pre-lodgement meetings;
• application receipt;
• application acceptance, eligibility and triaging;
• stages within the assessment phase (eg to enable questions about the application, procedural fairness to the applicant with opportunities to review and comment on finalised documents prepared in response to its application, and input from stakeholders other than the applicant);
• finalisation of the HTA assessment documents prior to their consideration by the HTA advisory committees;
• meetings of HTA advisory committees at which they decide what recommendations and advice to provide, together with a rationale for each decision (whether the recommendation is positive or negative);
• subsequent reimbursement decision; and
• implementation of final listing.

Top of Page

DoHA (internal) communication

In the short-term, communication between all HTA functions and processes across DoHA could be more formalised. This could involve regular meetings of the chairs of HTA advisory committees and/or secretariats across the HTA processes.

Discussion
Key communication points would need to be agreed with stakeholders as increased points of communication will impact timeliness.
The proposal for internal communication through regular meetings of the HTA advisory committees secretariats could assist in addressing concerns about insufficient coordination.
In the long-term, the single entry point proposal in Discussion Paper 2 may also assist in addressing concerns raised about communication.

Proposal 10 – Establish Review Mechanisms for HTA Processes and Decisions

The two key HTA advisory committees within the scope of the HTA Review (MSAC and PDC) are non-statutory committees. By contrast, PBAC and its functions are determined by legislation. These facts influence the possible proposals that might be contemplated for reviews of recommendations and advice made by these HTA advisory committees to the Minister for Health and Ageing about public funding decisions.

There are a number of issues to be considered in developing any new review mechanisms, including the type of review, who conducts the review, and the particular matters to be reviewed.

Types of review

Merits review is the process by which a person or body other than the primary decision-maker reconsiders the facts, law and policy aspects of the original decision and determines the correct and preferable decision. The result of a merits review is the affirmation or variation of the original decision.

A process review considers whether the process was administered appropriately. The result of a process review does not necessarily change the original decision. If errors of process are found, then it would be recommended that the correct processes be instituted before the original decision is re-considered by the primary decision maker. In other words, a review of process might not necessarily alter the nature of the recommendation or advice of the HTA advisory committee.Top of Page

Issues to be reviewed

Reviews could address the recommendation by a decision-maker.

Conduct of the review

A review could be conducted either by the original agency/decision-maker, or by an independent body.

Taking the current independent review mechanism arrangements related to PBAC decisions not to recommend PBS listing as an example, a review could be triggered by an applicant indicating its dispute with specific technical matters relied upon by the HTA advisory committee. An independent convenor could appoint a reviewer from a panel of identified experts. The appointed reviewer could then have access to all the information placed before the HTA advisory committee and might seek clarification from the applicant, the HTA advisory committee, DoHA or other relevant experts as needed. However, no new information would be provided to the reviewer. The reviewer would finally submit a report to the HTA advisory committee to reconsider the original application in light of the review findings.

DoHA could also implement a consistent internal review of process across the Commonwealth HTA processes (being more efficient than a system of process reviews of individual HTA advisory committee recommendations). This could be initiated by the relevant secretariats and considered by an appropriately qualified DoHA officer independent of these processes. Alternatively, an external complaints commissioner or probity adviser could be appointed in conjunction with the HTA advisory committees and DoHA to review these processes for a set period of time.

Discussion
The majority of stakeholders supported independent review of decisions by HTA advisory committees where the committee recommended that a health technology not be supported (noting that payers were not as supportive as applicants).
A review mechanism independent of the HTA advisory committee and DoHA should provide for greater accountability.

Proposal 11 – Better Information on Performance of the HTA System

Good performance information would help demonstrate the extent to which the Commonwealth HTA processes are effective and efficient.

The development of a set of Key Performance Indicators (KPIs) for Commonwealth HTA processes is proposed where DoHA and/or the relevant HTA advisory committee has control over the outcomes and the KPIs can be measured and reported against. If this proposal were accepted, the KPIs could be made publicly available (in the guidance documentation), with a view to aligning these KPIs across the HTA processes over time. Information reporting the results against these KPIs would also be made publicly available in performance reports and on HTA websites, to enable comparisons of these results over time and across HTA processes.

The KPIs could include:

• timeliness of assessment;
• HTA outcomes: supported, rejected, conditionally supported;
• other HTA advisory committee activity;
• alignment of HTA outcome with reimbursement decision; and
• improvements in health outcomes achieved (currently difficult to measure).

Discussion
The inclusion of KPIs would provide for greater accountability and while it would be desirable to align KPIs, the KPIs should also be fit for the purpose for each Commonwealth HTA process. The HTA processes would endeavour to reach defined levels of performance where appropriate, for example where it is clear that the KPI measures an outcome over which the HTA process has sole control.
Top of Page