7.4  Public Summary Documents

 

7.4   Public Summary Documents

Public Summary Documents (PSDs) inform the public of PBAC decisions and the basis for each PBAC outcome. This includes information on the clinical and cost effectiveness of medicines proposed for subsidy compared with alternative therapies (as required under the National Health Act 1953).

The following standardised approach to redaction processes supports the PBAC’s commitment for greater transparency and consistency of information published in the PSD.

More information about the PSD structure is available on the PBS website. PSDs conform to the Level AA accessibility requirement of the Web Content Accessibility Guidelines 2.0.

7.4.1   Steps to prepare and finalise PSDs

PSDs are based on the PBAC Minutes and applicants have a single opportunity to request redactions of information within the PSD prior to publication. See Section 7.4.3 for PSD publication timeframes.

The steps to prepare and finalise PSDs are as follows.

  1. Departmental officers:
    • Replace the following with a standard range as outlined in Section 7.4.5:
      • Incremental cost-effectiveness ratios (ICERs) or other measure of the estimated cost-effectiveness
      • Estimated numbers of patients and numbers of prescriptions dispensed
      • Estimated financial (budget) implications of supplying the medicine/vaccine through the PBS/NIP
    • Redact any related confidential financial and cost information within the PSD that is not clinical data, but is involved in generating any of these three types of estimates (including specific details of proposed risk sharing arrangements).
  2. The department provides the proposed PSD to the applicant’s designated contact or authorised representative by the end of week 27 following the PBAC meeting.
  3. Within five business days, the applicant reviews the proposed PSD and, in writing, either: confirms acceptance of the proposed PSD (and, for each instance where significant portions of data have been redacted by the department, the added descriptive paragraph to ensure the reader can understand the context of the redacted information) OR provides redaction and/or disclaimer and/or factual error requests to the department.
    • Refer to Section 7.4.4 for criteria for redactions of clinical data.
    • Redaction requests must include sufficient justification to support the request; further guidance on how to request redactions is at Appendix B – Supporting Guidance. Any request for a redaction that does not include a justification and meet the criteria will be rejected.
    • Where significant portions of data are requested for redaction, the applicant must also provide a descriptive paragraph in each case to ensure the reader can understand the context of the redacted information.
    • Refer to Section 7.4.6 for processes to request a disclaimer.
    • Refer to Section 7.4.7 for processes to address factual errors.
  4. The department reviews any redaction requests received and notifies the applicant of the outcome by the end of week 31. Where further redactions are made and/or disclaimers added, the revised version of the PSD is provided to the applicant. Where a request for redaction is not accepted, the rationale for this decision is also provided to the applicant.

This version of the PSD is considered final and is published in accordance with the publishing timelines outlined in Section 7.4.3.

The applicant is provided the final version of the PSD prior to publication. Where the standard process is followed, this is two weeks prior to publication. Where an internal review is requested (see Section 7.4.2), this could be three business days prior to publication.

7.4.2   Internal review

If an applicant does not agree with the final version of the PSD, the applicant is able to request an internal review of the decisions made regarding the redaction request (maximum of one review per published PSD). The request must be made in writing within three business days of receiving the final version of the PSD and must include the following:

  • Rationale for requesting the review, and
  • Any additional evidence to support that review’s delegate in making his/her final decision.

Where required, the review delegate (a senior officer to the officer who made the previous decision) may contact the applicant to discuss the review and redaction requests prior to making a decision.

The department provides the review decision and its rationale to the applicant prior to publishing the final PSD in accordance with the publishing timelines outlined in Section 7.4.3. Where the review results in changes to the PSD redactions, the department also provides an updated version to the applicant alongside this review decision.

7.4.3   Timeframe for Public Summary Document publication

The following table outlines the timeframes for preparing, finalising and publishing PSDs.

Week

Event                       

Responsible

17

PBAC Meeting (3 meeting cycles per year)

PBAC

20

PBAC Minutes to applicants with positive recommendations

Department

22

PBAC Minutes to applicants of all other submissions

Department

23

PBAC Outcomes published on PBS website

Department

27

Proposed PSDs provided to applicants with standardised redactions applied

Department

28

Applicants respond to proposed PSDs; provide any rationale and evidence to support any further redactions requested, and any descriptive paragraphs

Applicant

28-31

Any further redaction requests considered

Department

31

Finalised PSDs sent to applicants

Department

32

Applicants accept finalised PSDs or request an internal review

Applicant

32

Internal review undertaken (if required)

Department

33

For submissions recommended by PBAC for listing, and resubmissions to PBAC that were not recommended:

  • any applicants that requested an internal review advised of outcome and provided with final PSD
  • PSDs published on website

Department

35

For initial submissions not recommended for listing, and deferrals:

  • any applicants that requested an internal review advised of outcome and provided with final PSD
  • PSDs published on website

Department

For submissions made under the TGA–PBAC parallel process, PSDs are prepared following standard timelines but are not published until TGA registration has occurred.

7.4.4   Redaction criteria – clinical data

The PBAC’s preference is for all clinical data relevant to its decision-making to be published. This includes clinical data that are not already in the public domain from any type of clinical study, and from any type of analysis within or across or derived from these clinical studies, and any alternative estimates from sources other than clinical studies. The release of the information considered by the PBAC aims to increase the transparency of its decision-making process.

The department considers redaction requests to clinical data under the following circumstances, where the data:

  1. is from a clinical study for which no results at all would have entered the public domain at the time of publishing the PSD, and the applicant is able to demonstrate both that the publication of the information in the PSD would prevent the publication of any results from this study elsewhere, and also that there is a documented requirement external to the applicant that these results (with or without other results) of the clinical study are to be published once they have been more completely generated.
    • This is to protect the ability for any results of this study to be published in a widely accessible publication.

This criterion does not apply in the more common circumstance of where some/any results of a clinical study have already entered the public domain (for which, see the next criterion).

  1. is included in a draft manuscript that has been submitted for publication in an identified journal and the applicant is able to demonstrate the publication of the information in the PSD would prevent publication in that journal.
    • This is to protect the ability for these specific results to be published in a widely accessible publication.

This criterion only applies where the applicant has already submitted for journal publication (e.g. evidence of receipt of the submitted article by that journal). It does not apply where an applicant indicates that it intends to submit for journal publication at some stage in the future. The applicant also needs to provide evidence that the publication of data in the PSD would prevent publication in that particular journal. Such evidence may include providing the prospective journal’s specific rules concerning pre-publication of data.

  1. can be shown to potentially breach study participant confidentiality.
    • This is to protect the privacy of individuals within clinical studies.

Any disclosure of confidential pricing information is avoided by including ranges in place of estimates in a published PSD (the types of estimates affected are specified in Section 7.4.5), therefore the department will not agree to a request for redaction of clinical data on the basis of seeking to avoid disclosing confidential pricing information.

Where a redaction is requested (refer to the Supporting Guidance document at Appendix B for further information), the applicant is required to provide a suitable description to replace the redacted information. The department finalises the description in the final version of the PSD. Where clinical data is redacted to allow its publication in a journal, the PSD identifies, at the place that the redaction occurs, the name of any identified journal to which the data has been submitted (criteria 1 or 2) or is proposed to be submitted (criterion 1).

7.4.5   Standard ranges for presenting economic and financial information in PSDs

Departmental officers replace relevant economic and financial information with the following standard ranges.

  1. ICER/QALY:
    • Dominant (i.e. cost saving and health improving),
    • $0 to < $5,000, then
    • $10,000 increments to $55,000, i.e. $5,000 to < $15,000, $15,000 to < $25,000, etc., then
    • $20,000 increments to $155,000, i.e. $55,000 to < $75,000, $75,000 to < $95,000, etc., then
    • $100,000 increments to $1,055,000, i.e. $155,000 to < $255,000, $255,000 to < $355,000 etc., then
    • > $1,055,000.
  2. Estimated numbers of patients (adding “per year” if estimating annual incidence rather than prevalence) or prescriptions dispensed in the utilisation information:
    • < 500 (reflecting the Life Saving Drugs Program’s current definition of rare disease being a prevalence of 1 in 50,000 and an Australian population of 25 million),
    • 500 to < 5,000, then
    • 5,000 to < 10,000, then
    • 10,000 increments to 100,000, i.e. 20,000 to < 30,000, 30,000 to < 40,000, etc., then
    • 100,000 increments to 1,000,000, i.e. 100,000 to < 200,000, 200,000 to < 300,000, etc., then
    • 1,000,000 increments to 10,000,000, i.e. 1,000,000 to < 2,000,000, 2,000,000 to < 3,000,000, etc., then
    • > 10,000,000.
  3. Estimated financial implications (adding ‘per year’ if estimating annual implications rather than a combined estimate):
    • net cost saving,
    • $0 to < $10 million, then
    • $10 million increments to $100 million, i.e. $10 million to < $20 million, $20 million to < $30 million, etc., then
    • $100 million increments to $1,000 million ($1 billion), i.e. $100 million to < $200 million, $200 million to < $300 million, etc., then
    • > $1 billion.

7.4.6   Disclaimers

Where specific clinical data has been provided specifically for the purposes of PBAC consideration, but it does not meet the criteria for a redaction request, the applicant may instead request that a disclaimer be included as a footnote to that specific data in the PSD to further inform the reader.

  • This is to enable the publication of this information, whilst ensuring that the applicant’s concerns of potential misinterpretation are suitably addressed.
  • In these circumstances, the information will not be redacted; instead the following footnote will be applied to the paragraph, table or figure in which the clinical data is published in the PSD:

* Note that the results presented in Paragraph X/ Figure X/ Table X are derived from ad-hoc/ post-hoc analyses conducted by the applicant/ during the evaluation/ by the ESC/ PBAC specifically for the purposes of informing the PBAC consideration. These analyses were not part of the pre-specified statistical plan for Study nnn-999.  Interpretation of the results and their application should therefore be limited to seeking to understand the basis for the PBAC outcome and should not be used for any other purpose.

The applicant is responsible for completing the details in each requested disclaimer and for submitting with (or without) any redaction requests.

7.4.7   Factual errors

If an applicant notices a factual error in the PSD, a request for correction should be sent to the department.

The applicant should request any correction within the five business days allocated for review of the proposed PSD after week 27 (along with any redaction and/or disclaimer requests if applicable).

Correction of any residual factual errors noticed in the final version of the PSD sent after week 31 must also be notified within three business days of receipt, however these usually should not require an internal review process for correction.

 

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