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Pharmaceutical Benefits Scheme (PBS)

Activity Indicators for the Pharmaceutical Benefits Scheme 2004 to 2009

Third Report: 2004 to 2009

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Preamble

This report presents the third annual set of outcomes resulting from a collaborative project between Medicines Australia, the Department of Health and Ageing and the Pharmaceutical Benefits Advisory Committee (PBAC) to jointly develop indicators that can be used to monitor the listing processes as they apply to the Pharmaceutical Benefits Scheme (PBS) and National Immunisation Program (NIP). The primary purpose of these indicators is to facilitate the identification of trends in the process of adding items to the PBS/NIP that may provide the basis for further dialogue.

In developing the indicators, it was agreed that the data with which they are to be populated should, where possible, be publicly available and independently verifiable eg. in the form of the reporting of the PBAC agendas, PBAC outcomes and public summary documents (PSD, see web links below). This has necessitated a great deal of interaction and collaboration between all parties to ensure agreement on the definitions of the indicators and the data parameters utilised. Importantly, it is not possible to uphold the principle of independent verifiability with regard to outcomes based on the type of economic analysis reported in the submission for the period prior to the commencement of publication of PSDs (July 2005). Similarly, information regarding some non-sponsor-initiated matters and submissions relating to pricing matters is currently excluded from the publication of the PBAC agenda, outcomes and PSDs. Public release of information on some pricing matters is under discussion between the Department of Health and Ageing and Medicines Australia. In the meantime, submissions relating to pricing matters are included in the aggregate count for the first background and first core indicator graph but in none of the other indicators.

The intended perspective of these indicators is such that they reflect all published matters considered by the PBAC regardless of the source which initiated those considerations, or the subsequent PBAC recommendation. Accordingly, the indicators are presented in aggregate (without differentiation of the source of the underlying submission) and relate to the inputs to the PBS/NIP listing process (hence matters which are subsequently withdrawn are captured in these indicators).

This third report provides data on outcomes pertaining to PBAC deliberations of submissions, including the overall PBAC recommendation, and recommendations stratified by type of submission (major/minor), and by the economic basis of the submission and subsequent PBAC recommendation (cost-effectiveness where a price advantage is justified over the comparator therapy, cost-minimisation where a price advantage is not justified over the comparator therapy). The information it contains relates to considerations by the PBAC over the years 2004 to 2009 inclusive. Issues regarding the definition and data requirements for additional indicators such as those encompassing timelines within the listing process will continue to be explored throughout 2010, although outcomes for a transitional timelines indicator are included in this report.

Transnational timelines indicators

The transitional timelines indicator (cumulative PBAC recommendation percentage for initial major submissions by calendar year) was added to the second report of the Activity Indicators (released in 2009). The data in this indicator show all initial major submissions by the calendar year in which they were considered by the PBAC, and then reports the cumulative percentage with a positive recommendation for each subsequent calendar year. For example, the current table shows that by the third year after the year of initial consideration, between 84% and 92% of major submissions for a ‘drug-main indication’ pairing have received a positive PBAC recommendation. In contrast to most other Key Activity Indicators, which are based on submissions per PBAC meeting, the cumulative recommendation percentage over time follows submissions involving a ‘drug-main indication’ pairing forward as a cohort.

Explanatory notes: PBAC Outcomes

In viewing the report, it is important to recognise that most outcomes are presented on a per meeting basis. That is, the PBAC outcomes are reported as they pertained to each meeting with the submission date relating to the date of consideration not the date of lodgement. With the exception of the Transitional Timelines Indicator, the PBAC outcomes are not based on tracking serial submissions for related requests to the PBAC over time. Tracking across submissions requires pairing the particular drug involved with the main indication requested for its subsidised PBS use.

The terms “core” and “supportive” are used to classify the PBAC outcome indicators reported herein. There are four core and seven supportive indicators. Core indicators are those providing overarching information for the main elements of interest in the PBAC outcomes. The supportive indicators subsequently provide more detail regarding those core PBAC outcomes, and additional information not addressed by the core indicators. In addition to presenting information to populate the four core and seven supportive PBAC outcome indicators, an introductory background figure featuring the total number of PBAC submissions considered in each calendar year (classified as minor/major) and a transitional timelines indicator are presented.

The majority of the terms appearing within this report are self-explanatory or are defined within the Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (Version 4.3, December 2008).
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Type of submission – Major/Minor

Submissions to list a new drug on the Schedule of Pharmaceutical Benefits or to make substantial changes to current listings are classified as major submissions. Major submissions require presentation of an economic analysis. They are evaluated by the Pharmaceutical Evaluation Section, the Economics Sub-Committee, the Drug Utilisation Sub-Committee and the Australian Technical Advisory Group on Immunisation before consideration by the PBAC. Submissions that relate to new forms of previously listed products or changes to the conditions of use e.g. change in maximum quantity/repeats or clarifying the wording of a restriction (while not altering the intended use) are considered to be minor submissions. These do not usually require the presentation of an economic analysis. Typically, they are not evaluated by the Pharmaceutical Evaluation Section or relevant sub-committees prior to consideration by the PBAC.

Status of submission – Initial/Resubmission/Other

Major or minor submissions are classed as “initial” if it is their first presentation to the PBAC to add a new listing or to request a change to an existing listing. “Resubmissions” result in a re-consideration by the PBAC for a ‘drug-main indication’ pairing that has failed to be recommended on a previous occasion or has not proceeded to listing if it has been recommended. “Ever major” resubmissions result in a PBAC re-consideration of a ‘drug-main indication pairing’ which at some time was considered by the PBAC as a major submission. In such cases the initial presentation to the PBAC and/or the submission resulting in the PBAC outcome itself may have involved a minor submission. All submissions outside of these categories, for example deferrals or pricing matters, are classed as “other”.

Basis of economic analysis

The economic basis of the submission may be identified using section 9 (Clinical Claim) and/or section 10 (Economic Analysis) of the relevant PSD, while the economic basis of the recommendation is available from the PBAC outcomes posting on the Department of Health and Ageing web-site, and section 12 (Recommendation and Reasons) of the PSD. Since PSDs are only available from July 2005, supportive indicators 1, 2, 5 and 6 begin from this time instead of the 2004 calendar year seen with the other indicators.The economic basis of the submission is that of the submission which generated the relevant PBAC outcome rather the economic basis of the submission when it was first lodged. The two broad types of economic analysis presented in these indicators are cost-effectiveness and cost-minimisation. Submissions using a cost-utility analysis, cost-benefit analysis or a partial economic analysis (such as cost-analysis) have been included with those submissions having cost-effectiveness as the economic basis of submission. Submissions which do not contain an economic analysis are included in the total count of PBAC submissions (background graph), core indicators 1 and 2 and the transitional timelines indicator but are excluded from the supportive indicators 1, 2, 5 and 6 which relate to the basis of economic analysis.
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Changes to PBS listing

The indicator presenting the number of PBAC recommendations to either tighten or broaden an existing restriction is sourced from the PBAC Short Minutes ‘Changes to present (or recommended) PBS availability’. It reviews whether the change to listing was less restrictive (resulting in an increase in the eligible patient population), more restrictive (resulting in a reduction in the eligible patient population) or no change (where no change to the eligible patient population was anticipated). Block additions to this section, such as Palliative Care items or access by new prescriber groups, are excluded.

Special explanatory notes for 2009 figues

A footnote has been added to the 2009 data in Supportive indicator 2 ‘Initial major cost-minimisation submissions by outcome’. It indicates that the 2009 total of these submissions recommended on a cost-minimisation basis includes a submission (olanzapine pamoate monohydrate to the July 2009 PBAC meeting) that was granted a cost-effectiveness recommendation based upon a precedent in relation to different formulations of the same drug.

Web-links

General PBS information: www.pbs.gov.au

PBAC agenda: www.health.gov.au/internet/main/publishing.nsf/Content/PBAC-Meeting-Agenda-and-Consumer-Comments-lp

PBAC outcomes: www.health.gov.au/internet/main/publishing.nsf/Content/pbac-outcomes-info

Public summary documents: www.health.gov.au/internet/main/publishing.nsf/Content/public-summary-documents

Guidelines for preparing submissions to the PBAC: www.health.gov.au/internet/main/publishing.nsf/Content/pbacguidelines-index

Errata

An error in recording some aspects of a drug-main indication submission within the 2008 data in the second report has been corrected for this edition. Adjustment for the error has impacted on the data previously reported for Core Indicator 4, Supportive Indicator 5 and the Transitional Timelines Indicator in the following manner:

1. Core indicator 4 'Resubmissions of ever majors by outcome': the number of recommendations for the calendar year 2008 has increased from 22 to 23.
2. Supportive indicator 5 'Ever major cost effectiveness resubmissions by outcome': the number of recommendations on a CEA basis has increased from 11 to 12.
3. Transitional Timelines Indicator: the number of initial major submissions in tables 1 and 2 increases from 27 to 28 for the cumulative number recommended in the index year of 2008.

PBAC Outcome activity indicators

Background figure: PBAC submissions

Core indicator 1: PBAC submissions by outcome

Core indicator 2: Initial major submissions by outcome

Core indicator 3: Initial minor submissions by outcome

Supportive indicator 1: Initial major cost-effectiveness submissions by outcome

Supportive indicator 2: Initial major cost-minimisation submissions by outcome

Supportive indicator 3: Number of submissions referred for independent review over past 12 months

Supportive indicator 4: Percentage of submissions referred for independent review over past 12 months for which the PBAC reverses its decision.

Core indicator 4: Resubmissions of ever majors by outcome

Supportive indicator 5: Ever major cost-effectiveness resubmissions by outcome

Supportive indicator 6: Ever major cost minimisation resubmissions by outcome

Supportive indicator 7: Changes to PBS listing
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Timelines activity indicator

Transitional timelines indicator: Cumulative PBAC recommendation percentage for initial major submissions by calendar year, 2004-2009.

Table 1: This table links information in table 2 below with that in KAI core indicator 2.

		2004	2005	2006	2007	2008	2009
From Key Activity Indicator	recommended	23	31	26	29	24	29
% initial major submissions recommended (Core Indicator 2)	%	64%	63%	53%	55%	49%	64%
From Cumulative recommendation % in table 2 below	recommended	24	31	31	33	28	34
Year of initial submission only	%	67%	63%	63%	62%	57%	76%

Table 1 presents a comparison of the KAI data with the closest corresponding detail of the data in Table 2, specifically the numbers in italics compare Core Indicator 2, which is the recommendation percentage at first consideration, with the recommendation percentage from the cumulative model in Table 2. The number of recommendations in most cases is slightly higher in the cumulative model because an initial major, not recommended in March, may be recommended in November on resubmission within the same calendar year. N.B. For initial major submissions not recommended at initial consideration in Table 2, subsequent submissions (major and minor) involving the drug-main indication were examined to identify a recommendation occurring in that or a later calendar year.

Table 2: Cumulative PBAC recommendation percentage for initial major submissions by calendar year, 2004-2009 (see also Figure 1).

			2004	2005	2006	2007	2008	2009
	2004	submissions recommended	24	29	32	33	33	33
Total initial majors	36	% rec	67%	81%	89%	92%	92%	92%
	2005	submissions recommended		31	39	44	44	44
Total initial majors	49	% rec		63%	80%	90%	90%	90%
	2006	submissions recommended			31	39	41	41
Total initial majors	49	% rec			63%	80%	84%	84%
	2007	submissions recommended				33	41	43
Total initial majors	53	% rec				62%	77%	81%
	2008	submissions recommended					28	35
Total initial majors	49	% rec					57%	71%
	2009	submissions recommended						34
Total initial majors	45	% rec						76%

Table 2 covers all initial major submissions by the calendar year in which they were first considered by PBAC and then follows the cumulative recommendation percentage forward by calendar year. In contrast to most other KAIs, which are analysed on a per meeting basis, the cumulative recommendations over time follows submissions for a drug-main indication forward as a cohort. The count is based only on that of the initial major submission.
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Figure 1: Cumulative PBAC recommendation percentage for Initial Major submissions by calendar year, 2004-2009

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