Australian Technical Advisory Group on Immunisation Then and Now. Professor Terry Nolan AO

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1 Australian Technical Advisory Group on Immunisation Then and Now Professor Terry Nolan AO

2 Declarations See World Health Organisation SAGE website GE_DOI_public_statement_October_2017.pdf?ua=1 Member , NHMRC National Immunisation Strategy Committee Chair , NHMRC Committee on Immunisation Procedures and National Immunisation Schedule Member ATAGI , Chair

3 Pre-ATAGI (NHMRC) In the 1990s, recommendations for public funding of vaccines for the Australian mass immunisation schedule came from an expert subcommittee within the National Health and Medical Research Council s (NHMRC) advisory committee structure. Also responsible for the National Immunisation Handbook the national clinical guidelines aimed at all health professionals. This expert advisory committee and its clinical guidelines were not directly connected to Government vaccine purchasing decisions for vaccines free for national use.

4 ATAGI, phase 1 ( ) In 1997, the Government decided to bring this advisory function inside the Department of Health and Ageing (DoHA) and remove it from under NHMRC governance. However, a link to NHMRC was maintained to endorse the National Immunisation Handbook.

5 ATAGI, Phase 2 (2005 ) Government introduced legislation to bring vaccine funding applications into the same transparent and predictable mechanism that had been used successfully for drugs. The Australian Pharmaceutical Benefits Scheme (PBS) had a long history of acceptability to Government and to industry, with an effective methodology to minimise price and to standardise a decision framework using cost-effectiveness evaluation based on a price per disability- or quality-adjusted life year saved. High quality policy framework that has supported the introduction and public funding of many new vaccines.

6 ATAGI Terms of Reference 1. provide technical advice to the Minister for Health on the medical administration of vaccines available in Australia, including those on the National Immunisation Program 2. advise the Pharmaceutical Benefits Advisory Committee on matters relating to the ongoing strength of evidence pertaining to existing, new and emerging vaccines in relation to their effectiveness and use in Australian populations 3. produce the Australian Immunisation Handbook for the approval of the National Health and Medical Research Council 4. consult with the National Immunisation Committee (NIC) on the content and format of the Australian Immunisation Handbook and associated implementation strategies 5. consult with the Communicable Diseases Network Australia (CDNA) and the Advisory Committee on Vaccines (ACV) on matters relating to the implementation of immunisation policies, procedures and vaccine safety 6. through the department, provide advice to research funding bodies regarding the status of current immunisation research and areas where additional research is required

7 One year ago, we asked... Will it work? First real tests now passed Rotavirus vaccines HPV vaccines Demonstrated flexibility and taxpayer benefit in PBAC assessment process around vaccine price negotiation and its impact on PBAC advice process and Government decision thresholds? Are working through policy changes and cost consequences of immunisation, but are outside PBS. cervical cancer screening changes to commencement age, screening interval, etc. Time pressures on interaction between ATAGI, PBAC and industry have been handled... only possible through resources to NCIRS and exceptional ATAGI member and NCIRS staff contributions

8 ATAGI Scoping Phase ATAGI-PBAC Process Horizon scanning Interaction with companies Interaction with PBAC Pre-PBAC Submission Advice (ATAGI Working Party prepares draft for ATAGI approval, then sent to both PBAC and Company) Vaccine clinical development TGA PBAC Phase Economic Sub-committee (ESC) Further specific advice from ATAGI as Post-submission Advice (to both PBAC and Company) PBAC recommendation to Minister Company initiates submission to PBAC Application for licensure Licence recommendation Post-Submission Phase PBPA evaluation Funding determination Vaccine supply Cabinet decision on funding (formerly Minister if <$10m) New Vaccine Funded NIP or PBS

9 Elements for Good Policy

10 So we can feel pretty proud of a strong and integrated system that is performing optimally for the public good given the tools we have or can we?

11 Then there was this

12 Something is rotten in the State of Denmark! Shakespeare, in Hamlet (1.4), Marcellus to Horatio

13 Uncontrolled Pertussis in Australia Slide courtesy of Dr Helen Quinn, and colleagues at the National Centre for Immunisation Research and Surveillance, including Prof Peter McIntyre, Dr Melina Georgousakis, Dr Nick Wood, Dr Sophie Hale, and Dr Brynley Hull

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15 Uncontrolled Influenza in Australia Influenza 2017

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17 Uncontrolled Meningococcal disease in Australia Emergence of W and Y serogroup disease Continued disease from serogroup B 2016 IMD national rates in infants are around 10 per 100,000 but 60+ for ATSI infants! UK experience has shown 4v Men B vaccine is highly effective and safe 2-dose VE 83% against all Men B, and estimated 94% against covered strains (Parikh, Lancet 2016) emerging evidence of high levels of cross-protection against Men W with Men B vaccine (Campbell, EID 2017).

18 But, let s stand back and think about this What do all of these have in common? We have effective, safe and affordable vaccines now that could save lives, prevent lifelong disability and serious acute illness. High level of public concern and awareness State Governments are increasingly funding vaccines dtap in pregnancy Men ACWY in adolescence Influenza vaccine in children (WA, QLD, possibly Victoria) Maybe this is telling us something about the national system

19 The public funding model Here are some of the problems: 1. Who makes the submission to PBAC? Industry is the usual sponsor; ATAGI cannot sponsor; Government can but this has been difficult Maybe we need a more active route that is driven by the public health interest, not just as a response to a crisis, but more proactively when there is no industry protagonist 2. The sponsor is responsible for CEA, though ESC and the PBAC thoroughly evaluate it. This is not the case in other jurisdictions (e.g. NICE in the UK) 3. Uncertainty for a new vaccine, population data on outcomes and herd immunity, in particular, impairs its chances of being funded 4. For VPDs of variable incidence (influenza, pertussis, mening), this may mean that vaccine will not be publically funded until significant (preventable) mortality/morbidity appears 5. We do have to consider the ethics of not using an existing safe and effective vaccine 6. The community has a view about its willingness to pay, expressed currently through State Government ad hoc funding decisions. We have no formal mechanism to survey the community itself, though all the companies do it in deciding how to price their vaccines for the private market.

20 Licensure and marketed availability Better vaccines not yet available in Australia Adjuvanted influenza vaccine (MF59) children Live attenuated Influenza vaccine (LAIV, nasal spray) High dose influenza vaccines This is complex and is sometimes due to the manufacturer not willing to submit for licensure. Sometimes, there are issues with delay in TGA approvals, or rejection.

21 Managed Entry Scheme via PBAC Restricted to submissions where the PBAC agrees that there is a clinical need for the intervention, and when: the PBAC would not otherwise recommend the listing of the drug at the proposed price because the extent or value of the clinical effect is uncertain; and there is a randomised clinical trial (or comparable fit-for-purpose evidence), due to report within a reasonable timeframe, which the PBAC is satisfied will resolve the identified area of uncertainty. The parties note that this does not preclude use of other tools for managing uncertainty (e.g. risksharing agreements) where appropriate Opportunity for 4v Men B vaccine Regarded as too risky by State and Commonwealth Government authorities This was a lost opportunity.

22 Number of cases Complacency costs MeNZB vaccine in New Zealand Start of immunisation programme July Pre-epidemic level Year

23 Can we afford to think: It will be all right! Horatio replies "Heaven will direct it" (91), meaning heaven will guide the state of Denmark to health and stability. Source: The Old Globe, Hamlet season, September 2017

24 I don t think so It s time to have a critical and independent look at refining the PBAC mechanism for vaccines.