Transparency initiatives and the TGA Dr Peter Papathanasiou Transparency & Advisory Management Section Prescription Medicines Authorisation Branch Market Authorisation Division, TGA ARCS Scientific Congress Canberra 2016
Two transparency initiatives 1. Web publication of Australian Public Assessment Reports (AusPARs): a) Peer-reviewed review article in Drug Discovery Today co-authored with the European Medicines Agency (EMA): published 29 June 2016 b) Survey findings on Australian public assessment reports (AusPARs): closed 31 July 2016 2. Web publication of recently registered: a) new chemical entities b) new or extended uses, or new combinations, of already registered medicines before AusPAR is prepared. Transparency initiatives and the TGA 1
1. Web publication of AusPARs a) Peer-reviewed review article in Drug Discovery Today : published 29 June 2016 b) Survey findings: closed 31 July 2016 Transparency initiatives and the TGA 2
https://www.tga.gov.au/australian- public-assessment-reports- 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) 3
AusPAR conten t • Each AusPAR page contains three documents: 1) AusPAR itself, which includes summaries of TGA evaluation reports: • Quality • Nonclinical • Clinical • Risk Management Plan Sponsor’s response • Delegate’s considerations (benefit-risk balance) to Delegate’s • ACPM’s considerations considerations • Outcome 2) Extract from Clinical Evaluation Report (CER) • CER redacted of commercially confidential information 3) Product Information (PI) Approved applications only Transparency initiatives and the TGA 4
https://www.tga.gov.au/publication/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 .” Transparency initiatives and the TGA 5
Differences between EPARs & AusPARs: The view from EMA... Transparency initiatives and the TGA 6
The view from TGA... Transparency initiatives and the TGA 7
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) Transparency initiatives and the TGA 8
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• To the end of 2015, TGA had published 445 AusPARs for 378 individual prescription medicines Average / year = 73 Transparency initiatives and the TGA 10
• To the end of 2015, EMA had published 1179 initial human EPARs, along with 565 EPAR updates (extensions of indications) Average / year = 83 Transparency initiatives and the TGA 11
• Majority of published AusPARs were for new drug entities (chemical or biological) (35.4%) and extensions of indications (34.7%) Transparency initiatives and the TGA 12
• 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 Transparency initiatives and the TGA 13
Audiences for AusPARs • Pharmaceutical industry – Approx. 65% readers • Other health authorities • Other national medicines regulators • Healthcare professionals & patients Transparency initiatives and the TGA 14
• 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% Transparency initiatives and the TGA 15
AusPAR remains the most viewed document online, outperforming Extract CER and PI documents overall Transparency initiatives and the TGA 16
Although most AusPAR online users are from Australia, there is also substantial international interest, particularly from the US & China Transparency initiatives and the TGA 17
• Top five most viewed AusPAR documents online during 2010-2014: World Health Organisation ATC codes: Even though the most published N = Nervous system AusPARs have been for cancer drugs G = Genito-urinary system and sex hormones (23%), the most viewed AusPARs are B = Blood and blood forming organs for nervous system drugs (28%) Transparency initiatives and the TGA 18
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 Transparency initiatives and the TGA 19
Requests for information made to TGA during 2010-2015: • 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. Transparency initiatives and the TGA 20
“The full impact and readership of EPARs and AusPARs by target audiences is not currently known...” n = 105 Transparency initiatives and the TGA 21
(Q) Which group best describes you? 3.8% 2.9% 10.5% 14.3% 3.8% 0% 67.6% Transparency initiatives and the TGA 22
(Q) Which documents do you mostly access? 83.8% 56.2% 64.8% (Q) How often do you access AusPAR pages? 19.1% 54.3% 26.7% Transparency initiatives and the TGA 23
(Q) For which purpose do you use AusPAR information? 2.9% 11.4% 20.0% 4.8% 10.5% 50.5% Transparency initiatives and the TGA 24
(Q) How well do AusPAR documents serve their purpose of providing transparency of the TGA’s decision process of prescription medicines? 38.1% 39.1% 20.0% 2.9% Transparency initiatives and the TGA 25
(Q) How useful are AusPAR documents for your needs? 36.2% 46.7% 15.2% 1.9% Transparency initiatives and the TGA 26
(Q) How likely are you to access AusPARs in the future ? 68.6% 17.1% 11.4% 2.9% Transparency initiatives and the TGA 27
(Q) Do you have any further comments about AusPAR documents? “I find AusPARs are an extremely “Definitely keep AusPARs. TGA needs valuable tool for ensuring to ensure greater transparency in its transparency of TGA assessments.” decision-making, not less.” “Overall, documents are great. “Too much information is given in A similar document should be AusPARs. I prefer AusPARs were not published at all.” released for medical devices.” Transparency initiatives and the TGA 28
(Q) Do you have any further comments about AusPAR documents? “The targeted time period for “I would much prefer to see publishing is not routinely met. AusPARs in EPAR format: a true Timing can range from 2 to 12 executive summary, rather than cut months. It would be great to see an and paste from evaluation reports.” improvement.” “Publishing timeframes are “A short, plain English summary sometimes too slow for the purpose of aimed at a non-technical audience advanced consideration of practice would be extremely useful.” implications with new medications.” Transparency initiatives and the TGA 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.” Transparency initiatives and the TGA 30
2. Web publication of recently registered: a) new chemical entities b) new or extended uses, or new combinations, of already registered medicines before AusPAR is prepared. Transparency initiatives and the TGA 31
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