The National Immunisation Program in the modern era providing, nudging, and cajoling

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1 The National Immunisation Program in the modern era providing, nudging, and cajoling Professor Terry Nolan PHAA National Immunisation Conference 2016 Plenary One: Completing the Jigsaw Declarations Research contracts to MCRI from Novavax, Pfizer, GSK, SanofiPasteur and Novartis to conduct sponsored and investigator-led clinical vaccine studies. No personal remuneration or interest. Unpaid advice via Scientific Advisory Board on pertussis vaccine, GSK DSMB Chair, multi-centre RCT cervical cancer immunotherapy, sponsored by Zeria. World Health Organisation SAGE Immunisation Advisory Group (unpaid) Formerly Chair, ATAGI. 1

2 $ Millions '96-'97 '97-'98 '98-'99 '99-'00 '00-'01 '01-02 '02-'03 '03-'04 '04-'05 '05-'06 '06-'07 '07-'08 '08-'09 '09-'10 '10-11' '11-12' 12-13' 13-14' 14-15' 15-16' 5/07/2016 The Australian Immunisation System Comprehensive High quality regulatory, scientific, public funding mechanism, safety Underpinning data systems (ACIR) Coordinated national approach (mainly) High levels of public compliance and ownership But, we have several areas that we should address Australian Government Vaccine Expenditure Trend NIP Zoster? Point Plan Men C Pneumo HPV End HPV catch-up HepB & PCV end catch-up No Jab/Pay, 18m DTPa Financial Years is estimated expenditure Source: Australian Government 2

3 Target NIPS vaccination coverage Children 12 months Adolescents Vaccination coverage estimate All children 92% Aboriginal and Torres Strait Islander children 89% HPV girls 3 doses 77% HPV boys 3 doses 60% dtap? Varicella? Pregnant women Influenza ~70% DTPa (state-based funding only) ~70% Courtesy of Julie Leask, FluMum Investigators Objection and Refusal 3

4 Challenges Persist and Grow Schedule changes Changes in epidemiology including epidemics pertussis and 18m booster, ACWY instead of C for emerging W Simplifying or reducing licensure schedules Adolescent hep B, HPV 3-dose 2-dose Conjugate vaccines (PCV, MCC) New vaccines and yet to emerge data Men B Implementation hurdles of effective vaccines Childhood influenza vaccine Summary: problems with slow processes and delays in decision-making and then implementation Early Impact of LAIV in UK Children David Salisbury, ESPID 2016 Age GP ILI visits ED resp attend Hospital admit ICU admit 5 10y 94% 74% 93% 76% <5y 92% 65% 62% 61% >17y 59% 21% 34% 46% 16 children vaccinated will prevent 1 GP ILI consultation 117 children vaccinated will prevent 1 influenza hospitalisation 2205 children vaccinated will prevent 1 confirmed influenza ICU admission 4

5 UK Men B Comprehensive program implementation Modified schedule Paracetamol to deal with elevated temperature Data soon to be available Encouraging early signs of impact Possible men W cross-protection To be presented later in this conference Public Funding Issues PROVIDING 5

6 PBAC model It s a one-size fits all model, driven by sponsor commercial imperatives, albeit informed by ATAGI public health advice Based on new products for simple use, rather than complex scheduling for populations Schedule variation (time points and numbers of boosters) MMR second dose Pertussis 18m booster Also not adapted well for epidemic control versus ongoing NIP application Pregnancy pertussis NIP submissions who does it? Sponsor or Government or other Cannot be ATAGI Need capacity to get economic analysis done Several technical issues that have a major effect on PBAC judgments, including: societal (indirect) benefits herd immunity discount rate Dice is loaded against whole of population preventative interventions (such as vaccines) with substantial lifetime benefits beginning in early life 6

7 Present Value ($) 5/07/2016 Example: Discounting We tend to place a greater value on things if we can have them now rather than in the future Similarly costs seem less of a constraint if we have to pay for them in the future Economists deal with positive time preference through discounting. Nothing to do with inflation Higher discount rates mean a lower present value of future costs and benefits The same discount rate is applied to both costs and outcomes on the premise that they face the same rate of time preference. However, there are compelling arguments for discounting health benefits at a lower rate than costs. Source: Philip Clarke, Health Economics Unit, Centre for Health Policy, Melbourne School of Population and Global Health; Parkinson and De Abreu Lourenço, CHERE, UTS Sydney, CREST Fact Sheet, 2005 Discount rates have large effects over time Difference between 5% (AUS) and 3.5% (UK) discount rates for $100 of future cost savings Year when the $100 is incurred 3.50% 5% Source: Dr Natalie Carvalho, Health Economics Unit, Centre for Health Policy, Melbourne School of Population and Global Health 7

8 Discount Rates Source: Parkinson and De Abreu Lourenço, CREST Fact Sheet, 2005 PBAC Managed Access Scheme What happens when there is residual uncertainty about critical determinants of cost-effectiveness, e.g. vaccine effectiveness (and coverage), duration of vaccine protection, herd immunity cocoon and meningococcus B? PBAC s Managed Access Scheme enables PBS/NIP listing, under special circumstances of high unmet clinical need, on terms that allow for the resolution of otherwise unacceptable clinical or economic uncertainty for the PBAC. Where there are not sufficient high quality data to clarify the efficacy and safety of a drug (vaccine). Studies are not subsidised via the PBS. This scheme is complementary to risk sharing agreements (RSAs) which address financial or budgetary uncertainty. In fact, this was discussed with both pertussis vaccine (cocoon) and men B vaccine sponsors, but unable to progress due to either manufacturer or Commonwealth/States unwilling to proceed Difficulties in getting the required research done Unwillingness to pull a vaccine off the NIP if the research showed the subsequent value not there, fearing a loss of public confidence 8

9 States going it alone What happens when the PBAC bar is too high, or if there is no PBAC submission? Willingness to pay override by the States Examples, cocoon and then maternal pertussis vaccination, influenza vaccine, acellular pertussis, conjugate pneumococcal vaccine, rotavirus vaccine, hepatitis A vaccine in FNQ Is this a bad thing? Remember the days before the 1993 National Immunisation strategy Research Investment Medical Research Future Fund focus is on innovation and benefit to Australia Data Whole of Life Register (aim is Q implementation) Prime Minister and Cabinet initiative Productivity Commission review 9

10 PUBLIC SECTOR DATA MANAGEMENT July 2015 Publishing data will enable innovation outside the APS Publish the right public sector data The Commonwealth s role in fostering innovation includes: publishing the right data responding to requests for datasets from the private sector; publishing it in the right way use international standards to determine formats and licensing; enabling trusted accessibility support appropriate ways to interface with data across the spectrum from personal to open data; and providing channels for feedback actively engage with external stakeholders through boards and dialogue. Commonwealth In the emerging digital economy, public sector data is a new commodity. While estimated benefits of this data vary, all studies agree there is significant economic value from opening access to public sector data and improving data analytics. Create markets for new or better products/services Grow the economy with new data interfaces, products and applications Enable benchmarking and innovation Increase productivity by benchmarking performance across economy Identify customer and citizen segments Enable more effective segmentation and market analysis Improve/automate decision-making Use algorithms and data to make better, faster decisions Provide transparency and accountability Use transparency to encourage new efficiencies Other Sectors E.g. National Map (NICTA) new, open software combined with geospatial data, creating subsequent applications and new business entities E.g. NYC power benchmarks (US) open data on power usage used by building owners to benchmark and reduce energy spend E.g. Starbucks growth strategy (US) used demographic data to inform new store locations E.g. Patient Admissions Prediction tool (Aus) uses data to predict patient admissions, used to inform staffing / resource decisions E.g. Sydney Local Health (Aus) hospitals share data to provide transparency on performance 11 Sources: McKinsey, Open Data Unlocking performance through liquid information, October 2013 and PricewaterhouseCoopers, Deciding with Data: How data-driven innovation is fueling Australia s economic growth, September

11 The legislative environment needs to support the use of data Recommendation 14 Create a legislative environment that supports the use of data while maintaining privacy. In the short-term: staff should be trained on how to interpret privacy and secrecy laws. Guidelines should be published to support this, including guidelines from the ABS given its experience with deidentification protocols. In the medium-term: legislation should be reviewed to identify whether privacy and secrecy laws can be streamlined and modernised to enable data to be better used for policy and research, building on a possible Productivity Commission inquiry. Think differently about legislation Significant gains can be made in the short-term by educating staff on how to interpret legislation to share and make better use of data. This requires a change in mindset for staff to look for ways to make data available within the law. Health is seeking to link extracts of PBS and Medicare Benefits Schedule (MBS) data, to be shared with the States. Publishing guidelines can also reduce risk aversion. It provides support for staff to take a pragmatic interpretation of the law. For example, the Privacy Guidelines published by the Information Commissioner have enabled staff to release data where it was previously not released due to uncertainty. The guidelines could indicate that the term reasonably identifiable should take into account: who will have access to information; what information they have; and the likelihood of being able to re-identify information. 7. Bill English, Deputy Prime Minister of New Zealand, June Legal Counsel, Global Regulatory Affairs, June Aligning objectives of legislation with the data agenda In the medium-term, legislation should be reviewed to identify whether privacy and secrecy laws can be streamlined and modernised through an overriding principlebased law to enable data to be better used for policy and research. If the Commonwealth progresses a Productivity Commission inquiry into data, as recommended by the Financial Systems Inquiry, the terms of reference could focus on the review of legislation. NZ Revisiting legislation As part of their data agenda, in 2012 New Zealand amended its Statistics Act to facilitate access to individuallevel data for non-government researchers. The Hon. Bill English, Deputy Prime Minister said a rewrite of privacy laws had removed barriers to "common sense" solutions. 7 Changes to the Act included guidance and clarity on its interpretation. 8 Statistics New Zealand is currently refreshing their legislation with a view to modernisation and better sharing of data. 36 CAJOLING OR CAJOLING 11

12 No Jab, No pay and No Play No Pay: Child Care Benefit (CCB) and Child Care Rebate (CCR) and Family Tax Benefit (FTB) Part A supplement No Play: State Government access to child care Government-led rather than expert-advised policy transitions Benefits and Risks Benefits Marginal improvement in population disease outcomes Minimal effects on herd immunity Risks Fuel anti-vaccination lobby No fault compensation for vaccine injury Exclusion from kindergarten or school by parents to avoid penalties, and further marginalisation 12

13 Conclusions 1. Need a better-developed PBAC alternate funding pathway for NIP that is less sponsor-dependent 2. Timelines between vaccine availability and public health roll-out need to be considerably shortened. 3. Discount rate issue needs serious study in the broader context of the PBS and NIP for preventative interventions, especially vaccines (but also NCDs) 4. PBAC Managed Access scheme needs re-thinking. Commonwealth and States must find a more flexible way to manage risk when the evidence base is incomplete for definitive decisions, and when that evidence gap can only be filled with research on population-level immunisation programs 5. Need a mechanism to conduct timely policy-relevant research (MRFF is an opportunity) 6. Data access and linkage and for immunisation-related research needs whole of Government approach to unlock this public good resource, and to take full advantage of the new Australian Immunisation Register 7. If we do not keep up the innovation drive, Australia risks losing its leadership status globally, which has real and material consequences (access to goods, security of supply) Julie Leask Natalie Carvalho Philip Clarke Darius Everett Peter McIntyre Acknowledgements 13

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