Transparency initiatives and the TGA Dr Peter Papathanasiou - - PowerPoint PPT Presentation

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.

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• 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

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https://www.tga.gov.au/australian- public-assessment-reports- prescription-medicines-auspars

• First AusPAR published Nov 2009 as part
• f 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
• Delegate’s considerations (benefit-risk balance)

Sponsor’s response to Delegate’s considerations

• ACPM’s considerations
• Outcome

2) Extract from Clinical Evaluation Report (CER)

• CER redacted of commercially confidential information

3) Product Information (PI)

• Approved applications only

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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.”

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Differences between EPARs & AusPARs: The view from EMA...

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The view from TGA...

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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)

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• To the end of 2015,

TGA had published 445 AusPARs for 378 individual prescription medicines

Average / year = 73

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• To the end of 2015,

EMA had published 1179 initial human EPARs, along with 565 EPAR updates (extensions of indications) Average / year = 83

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• Majority of published

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

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• 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

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Audiences for AusPARs

• Pharmaceutical industry

– Approx. 65% readers

• Other health authorities
• Other national medicines regulators
• Healthcare professionals & patients

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• 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

• n the EMA website:

‒ Nov 2014: 8.90% ‒ Sep 2015: 10.36%

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AusPAR remains the most viewed document

• nline, outperforming

Extract CER and PI documents overall

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

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• Top five most viewed AusPAR documents online during 2010-2014:

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%)

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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

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• 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.

Requests for information made to TGA during 2010-2015:

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

n = 105

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(Q) Which group best describes you? 3.8% 2.9% 10.5% 14.3% 3.8% 0% 67.6%

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(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%

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(Q) For which purpose do you use AusPAR information? 2.9% 11.4% 20.0% 4.8% 10.5% 50.5%

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(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%

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(Q) How useful are AusPAR documents for your needs? 36.2% 46.7% 15.2% 1.9%

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(Q) How likely are you to access AusPARs in the future? 68.6% 17.1% 11.4% 2.9%

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(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.”

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(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.”

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(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.”

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• 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.

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https://www.tga.gov.au/subscribe-updates

26 Jul 2016 # subscribers: 246

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https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia

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https://www.tga.gov.au/prescription-medicines-new-or-extended-uses-registered-medicines

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auspars@tga.gov.au