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Presentation: Transparency initiatives and the TGA

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

18 August 2016

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Presentation

  • Presented by: Dr Peter Papathanasiou
  • Presented at: ARCS Scientific Congress Canberra
  • Presentation date: 10-11 August 2016
  • Presentation summary: This presentation provides an overview of the web publication of Australian Public Assessment Reports (AusPARs), including findings of the recent survey.

Transcript

Prescription medicine registration process performance

The milestone-based process 2010 - 2016

Dr Peter Papathanasiou
Transparency & Advisory Management Section
Prescription Medicines Authorisation Branch
Market Authorisation Division, TGA

ARCS Scientific Congress Canberra 2016, 10 - 11 August 2016

Slide 1 - Two transparency initiatives

  1. Web publication of Australian Public Assessment Reports (AusPARs):
    1. Peer-reviewed review article in Drug Discovery Today co-authored with the European Medicines Agency (EMA): published 29 June 2016
    2. Survey findings on Australian public assessment reports (AusPARs): closed 31 July 2016
  2. Web publication of recently registered:
    1. new chemical entities
    2. new or extended uses, or new combinations, of already registered medicines before AusPAR is prepared.

Slide 2 - 1. Web publication of AusPARs

  1. Peer-reviewed review article in Drug Discovery Today: published 29 June 2016
  2. Survey findings: closed 31 July 2016

Slide 3

Australian Public Assessment Reports for prescription medicines (AusPARs)
  • First AusPAR published Nov 2009 as part of increased transparency strategy under the Business Process Reforms for prescription medicines
  • Generally, AusPARs are prepared for applications considered for entry, or variation of entry, into the Australian Register of Therapeutic Goods (ARTG) where TGA has sought advice from its Advisory Committee on Prescription Medicines (ACPM)

Slide 4 - AusPAR content

  • Each AusPAR page contains three documents:
    1. AusPAR itself, which includes summaries of TGA evaluation reports:
      • Quality
      • Nonclinical
      • Clinical
      • Risk Management Plan
      • Delegate’s considerations (benefit-risk balance)
        • Sponsor’s response to Delegate's consideration
      • ACPM’s considerations
      • Outcome
    2. Extract from Clinical Evaluation Report (CER)
      • CER redacted of commercially confidential information
    3. Product Information (PI)
      • Approved applications only

Slide 5

Australian Public Assessment Report (AusPAR) guidance document

“This document provides information about the structure, and processes for the compilation, review and publishing of an AusPAR, including guidance on the principles for determining what information is commercially confidential.

Slide 6

Slide 7

Slide 8 - AusPAR content

  • AusPAR structure was modelled on that of EPARs, with some differences:
    • EPARs are published according to each medicine: initial EPAR published, then updates added
      • AusPARs are published as separate reports according to each evaluation
    • EPARs publish public-friendly Q+A document ("EPAR summary") translated into 25 EU languages
      • AusPARs: do not publish summary
    • EPARs publish all clinical information within document
      • AusPARs: publish all clinical information in separate document (since July 2013)

Slide 9

Transparency in drug regulation: public assessment reports in Europe and Australia. Peter Papathanasiou, Laurent Brassart, Paul Blake, Anna Hart, Lel Whitbread, Richard Pembrey and Jill Kieffer.

Slide 10

  • To the end of 2015, TGA had published 445 AusPARs for 378 individual prescription medicines

Graph displaying the number of AusPARs published each year from 2009 to 2015

Slide 11

  • To the end of 2015, EMA had published 1179 initial human EPARs, along with 565 EPAR updates (extensions of indications)

Graph displaying the number of EPARs (initial & updates) published each year from 1995 to 2015

Slide 12

  • Majority of published AusPARs were for new drug entities (chemical or biological) (35.4%) and extensions of indications (34.7%)

Pie chart displaying the percentage of total AusPARs published from 2009 to 2015 according to submission type

Slide 13

  • According to decision outcome:
    • approved: n = 407
    • withdrawn: n = 22
    • rejected: n = 16
  • TGA has published all types of decisions from inception; EMA only began publishing withdrawals & rejections from 1999

Pie graph displaying the percentage of total AusPARs published from 2009 to 2015 according to decision outcome

Slide 14 - Audiences for AusPARs

  • Pharmaceutical industry
    • Approx. 65% readers
  • Other health authorities
  • Other national medicines regulators
  • Healthcare professionals & patients

Slide 15

  • TGA web trends indicate a steady annual rise in visits to AusPAR pages: from 0.74% in 2010 to 11.47% in 2014, a 15-fold increase in 5 years
  • EMA web trends shows that EPAR pages are the most viewed pages on the EMA website:
    • Nov 2014: 8.90%
    • Sep 2015: 10.36%

Graph displaying the Number of online visits to AusPAR webpages, visits to the TGA website and % of visits to AusPAR pages

Slide 16

AusPAR remains the most viewed document online, outperforming Extract CER and PI documents overall

Graph displaying the number of Visits to individual document types on AusPAR web pages per quarter (July 2013 to December 2014)

Slide 17

Although most AusPAR online users are from Australia, there is also substantial international interest, particularly from the US & China

Graph displaying the number of online visits to Auspar pages from 2010 to 2014 for Australia, United States, China, India and United Kingdom

Slide 18

  • Top five most viewed AusPAR documents online during 2010-2014:
Rank Indication ATC code # views
1 insomnia N 28,730
2 premature ejaculation G 26,251
3 benign prostatic hyperplasia G 22,775
4 reducation of blood loss during surgery B 21,254
5 pain management N 19,663

World Health Organisation ATC codes:

  • N = Nervous system
  • G = Genito-urinary system and sex hormones
  • B = Blood and blood forming organs

Even though the most published AusPARs have been for cancer drugs (23%), the most viewed AusPARs are for nervous system drugs (28%)

Slide 19

Web traffic of individual documents over time showed that audience interest was cyclical for certain AusPARs, e.g. spikes for influenza vaccines during the influenza season

AusPAR web traffic of download numbers versus time: examples of two new influenza vaccines (top panel, 2012-2014; bottom panel, 2011-2013)

Slide 20

  • AusPAR publication requires resources but facilitates answering requests for information or access to documents.
  • Today, about 1/3 requests for information to TGA from healthcare professionals and patients resulted in reference to AusPARs, while about 1/4 requests to EMA were directed to EPARs.
  • Publication has also served as an ‘internal audit’, raising the bar for readability of assessment reports.
  • Graph displaying the number of requests for information made to TGA during 2010-2015

    Slide 21

    “The full impact and readership of EPARs and AusPARs by target audiences is not currently known...”

    Screenshot of AusPARs user web survey run from 1 May to 31 July 2016

    Slide 22

    (Q) Which group best describes you?

    Graph displaying answers to the question 'which group best describes you?' Academic: 3.8%, Consumer/Patient: 2.9%, Government: 10.5%, Health Care Professional: 14.3%, Medicines Regulator: 3.8%, Media: 0%, Pharmaceutical Industry: 67.6%

    Slide 23

    Graph displaying answers to the question 'Which documents do you mostly access?' AusPAR: 83.8%, Extract from the Clinical Evaluation Report: 56.2%, Product Information: 64.8%.

    (Q) How often do you access AusPAR pages?

    Graph displaying answers to the question 'How often do you access AusPAR pages?' Every time a new AusPAR is published: 191.%, Only when AusPARs on drugs from certain classes are published (e.g. cardiovascular): 54.3%, Rarely: 26.7%.

    Slide 24

    (Q) For which purpose do you use AusPAR information?

    Graph displaying answers to the question 'For which purpose do you use AusPAR information?' Academic research: 2.9%, Government related: 11.4%, Market research: 20.0%, Medical prescriber interest: 4.8%, Personal interest: 10.5%, Other - please specify: 50.5%

    Slide 25

    (Q) How well do AusPAR documents serve their purpose of providing transparency of the TGA’s decision process of prescription medicines?

    Graph displaying answers to the question 'How well do AusPAR documents serve their purpose of providing transparency of the TGA’s decision process of prescription medicines?' Very well: 38.1%, Well: 39.1%, Somewhat: 20.0%, Not at all: 2.9%

    Slide 26

    (Q) How useful are AusPAR documents for your needs?

    Graph displaying answers to the question 'How useful are AusPAR documents for your needs?' Very useful: 36.2%, Useful: 46.7%, Somewhat useful: 15.2%, Not at all useful: 1.9%

    Slide 27

    (Q) How likely are you to access AusPARs in the future?

    Graph displaying answers to the question 'How likely are you to access AusPARs in the future?' Very likely: 68.6%, Likely: 17.1%, Somewhat likely 11.4%, Unlikely: 2.9%

    Slide 28

    (Q) Do you have any further comments about AusPAR documents?

    “I find AusPARs are an extremely valuable tool for ensuring transparency of TGA assessments.”
    “Overall, documents are great. A similar document should be released for medical devices.”
    “Definitely keep AusPARs. TGA needs to ensure greater transparency in its decision-making, not less.”
    “Too much information is given in AusPARs. I prefer AusPARs were not published at all.”

    Slide 29

    (Q) Do you have any further comments about AusPAR documents?

    “The targeted time period for publishing is not routinely met. Timing can range from 2 to 12 months. It would be great to see an improvement.”
    “Publishing timeframes are sometimes too slow for the purpose of advanced consideration of practice implications with new medications.”
    “I would much prefer to see AusPARs in EPAR format: a true executive summary, rather than cut and paste from evaluation reports.”
    “A short, plain English summary aimed at a non-technical audience would be extremely useful.”

    Slide 29

    (Q) Do you have any further comments about AusPAR documents?

    “I think AusPARs are great. They are clearly a well thought-out, well structured document. They are a substantive and meaningful improvement in making medicines regulations more transparent. That said, I work as a medical division employee in a pharmaceutical organisation. If I was a consumer, I think I would have difficulty in understanding AusPARs. They are not written in ‘simple’ English and often include highly technical medical information. If TGA’s objective is to publish documents for the general public, then the current process could be improved to increase public understanding and awareness. I genuinely believe we (all stakeholders) need to do more about making the regulatory process more accessible to patients and the general public. This would certainly raise awareness of the critical role TGA plays in safeguarding the Australian community.”

    Slide 30 - 2. Web publication of recently registered:

  1. new chemical entities
  2. new or extended uses, or new combinations, of already registered medicines

before AusPAR is prepared.

Slide 31

Subscribe to updates

The TGA has a number of email lists to which you can subscribe to receive updates by email.

  • TGA AusPAR email list
    An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application. This email alert service advises subscribers whennew AusPARs are published on the TGA Internet site.
Email list established: 20 May 2011
# subscribers: 4 Sep 2014 502
28 Apr 2016 585
26 Jul 2016 623

Slide 33

Prescription medicines: registration of new chemical entities in Australia

Screenshot of part of a page from the TGA website: 'Prescription medicines: registration of new chemical entities in Australia'. An arrow points to the words 'Throughout the year'

Slide 34

Prescription medicines: new or extended uses, or new combinations of registered medicines

Screenshot of part of a page from the TGA website: 'Prescription medicines: new or extended uses, or new combinations of registered medicines'. An arrow points to the words 'Throughout the year'

Slide 35

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