Protecting against vaccinepreventable. this together

Transcription

1 Protecting against vaccinepreventable diseases We are in this together Canadian Immunization Conference December 4, 2014 Litjen (L.J) Tan, MS, PhD Chief Strategy Officer, Immunization Action Coalition Co-Chair, United States Adult and Influenza Immunization Summit

2 Disclosures In the past year, I have received honoraria from Pfizer, Merck, Novartis, Temptime Corp., and TruMedSystems for service as a scientific consultant. My honoraria is donated to the IAC I do NOT intend to discuss an unapproved or investigative use of a commercial product/device in my presentation.

3 Disclaimer The opinions expressed in this presentation are solely those of the presenter and do not necessarily represent the official positions of the Immunization Action Coalition, or the National Adult and Influenza Immunization Summit

4 Outline: We are in this together Immunization successes are generally associated with strong private/public collaboration we are in it together. Adult Immunization are we in it together? Maintaining the future of immunization challenges that keep us apart and how do we get together?

5 Why do we vaccinate? Vaccination is a critical tool for maintaining the public s health A well-vaccinated population will be more resilient to potential public health emergencies (natural disasters resulting in displaced populations, disease outbreaks, etc). Any health infrastructure that is developed and sustained to deliver vaccinations to every child, adolescent, and adult can be leveraged to deliver care, vaccines and medications in times of crisis.

6 Why do we vaccinate? Vaccine, Good! Disease, Bad! Diseases eliminated from the US: Disease Smallpox 1949 Polio 1979 Measles 1993 Rubella 2004 Last Case* *Indigenous case. Importations may occur except for smallpox, which was eradicated from the planet in 1977.

7 Benefits of Immunization are Clear Arguably one of the top public health interventions of all time Tremendous reduction in mortality and morbidity attributed to immunization Vaccine-preventable disease rates in children in the US have been dramatically reduced; some are close to eradication Vaccines save money as well as lives Increasing interest in disease prevention in US Immunizations are an important preventive service

8 Our Success! Historical Comparison of Morbidity and Mortality for VPDs Roush, S. W. et al. JAMA 2007;298:

9 Global pediatric efforts are yielding strong successes! Vaccine-preventable diseases responsible for nearly 20% of the 8.8 million deaths/year among children <5 years In 1974, <5% of children were immunized in their first year against 6 targeted diseases WHO launched the Expanded Programme on Immunization (EPI) in 1974 to develop and expand immunization programs around the world By 2005, 80% of children immunized in their first year against 6 targeted diseases EPI efforts prevent an estimated 3 million deaths/year

10 Common denominators we are in this together, at least for children Our current success in immunizing our children is predicated on successful collaborative immunization programs to develop, deliver, administer, and evaluate the vaccines. Vaccines do not give themselves Medical necessity drives vaccine development Public health and clinical recommendations emphasize importance of protection against disease Private/public commitment ensures vaccines are delivered to providers Providers are committed to protecting their pediatric patients Public and private sector payment systems pay adequately for provision of vaccines.

11 Vaccination Programs Are Not Static Collaboration dictates our continued success Disease agents evolve, epidemiology changes Immunization programs must also evolve to keep pace Boosters; new vaccines; new delivery systems New effectiveness and safety data New payment models Infrastructure remains precarious due to erosion of resources for federal, state, and local public health Reactive as opposed to proactive Shift resources as necessary to manage situation

12 But What about Adults? Adult coverage rates are poor No significant infrastructure in place and lack of programmatic support Significant mortality and morbidity 50,000 adults die annually from pneumococcal disease, influenza, hepatitis B in the US. Hundreds of thousands more are hospitalized. Significant cost to the healthcare system ~$15 billion annually in the US based on zoster, pneumococcal disease, influenza, and pertussis

13 Vaccination Coverage for Target Groups by Vaccine, Age, and High-risk Status* Percentage (%) Influenza, HPV in women, Age-based 2012 High Risk 2012 Age-based and older Tdap, Hepatitis B, 19-59, diabetes Pneumococcal (ppv23 or PCV13) *Data source: 2012 National Health Interview Survey. CDC. Adult Vaccination Coverage United States, MMWR 2014; 63(05);

14 Vaccines recommended for older adults Vaccine Coverage % Influenza (65+) ( )** 66.2% (CI ) Pneumococcal (ppv23) (65+)* 59.9% (CI ( ) Zoster (60+)* 20.1% (CI ) *Data source: 2012 National Health Interview Survey ** CDC. FluVaxView. Available at:

15 Burden of Adult Vaccine-preventable Disease Among U.S. Adults Invasive pneumococcal disease (IPD) 1 39,750 total cases and 4,000 total deaths in % of IPD and nearly all IPD deaths among adults Influenza 2 3,000 to 49,000 total related deaths per year ~90% among adults 65 years and older Pertussis 3 ~24,231 total reported cases 2013 ~5,000 among adults Hepatitis B 4 2,890 acute cases reported ,800 estimated Zoster 5 about 1 million cases of zoster annually U.S. 1. CDC. Active Bacterial Core Surveillance. findin gs/survreports/spneu10.pdf. 2. CDC. Estimates of deaths associated with seasonal influenza United States, MMWR. 2010;59(33): CDC. Provisional 2013 Reports of Notifiable Diseases. Available at: mwrhtml/mm6252md.htm?s_cid=mm62 52md_w. 4. CDC. Viral Hepatitis Surveillance United States, National Center for HIV/AIDS, Viral Hepatitis, STD& TB Prevention/Division of Viral Hepatitis. 5. CDC. Prevention of Herpes Zoster. MMWR (RR 5): 1 30.

16 2010 US Census Cost Burden of 4 Adult Vaccine Preventable Diseases to the U.S. Disease Age Group Est. Cases Est. Direct Cost Est. Indirect Cost Est. Total Cost Est. Total Cost (per case) (per case) (per case) (all cases) Influenza 18 14,800,993 a 140 b 377 b 517 $7,652,113,319 S. Pneumoniae ,207 c $4,563,871,132 Bacteremia 50 29,628 c 23,568 d 1,297 d 24,865 $736,696,394 Meningitis 50 1,883 c 29,995 d 1,390 d 31,385 $59,095,033 NPP (inpatient) ,314 c 15,569 d 1,014 d 16,584 $3,438,040,889 NPP (outpatient) ,382 c 549 d 481 d 1,030 $330,038,816 Herpes Zoster ,019 e 1,034 f 2,636 f 3,670 $2,477,318,929 Pertussis ,833 g 395 h 542 h 937 $386,824,301 Total 17,007,258 $15,080,127,681 NPP is non-bacteremic pneumococcal pneumonia caused by S. pneumoniae. 'NPP inpatient' refers to cases of NPP that require hospitalization where as 'NPP outpatient' refers to cases of NPP that do not require hospitalization. All costs were adjusted to 2010 U.S. dollars. McLaughlin, JM., Tan, L., et al JOPP. Manuscript submitted.

17 And adult vaccination commitment and policies vary tremendously across countries* Varying policies recommending: vaccination for adults funding mechanisms for adult vaccine administration, and routine adult vaccination coverage assessment Many countries with advanced economies lack any form of adult immunization policies Newer vaccines are less likely than older ones to be recommended for adults Stable funding, standard recommendations, and routine vaccine coverage assessment are essential components for an adult immunization strategy *Wu, L. et al Available at:

18 Ramifications exist when we fail to vaccinate adults Beyond the impact to the health of the public, our ineffectiveness in immunizing adults: Creates disincentive for manufacturers to enter the market Leaves chronically ill vulnerable Failure to include immunizations as part of adult preventive care for those chronically ill Creates disparities in access to care Absence of commitment exacerbates existing barriers to immunization for those in the lower socioeconomic strata and for the racial and ethnic minorities

19 Disparities are widespread Vaccination Group % Vaccinated Whites Disparity, Blacks Disparity, Hispanics Disparity, Asians Pneumo., HR yrs Pneumo., 65 yrs Tetanus, yrs Tetanus, yrs Tetanus, 65 yrs Tdap, 19 yrs Tdap, yrs Tdap, 65 yrs HepA, yrs HepB, yrs Herpes Zoster, 60 yrs HPV, Females yrs Tdap, HCP 19 yrs HepB, HCP 19 yrs

20 Other Ramifications Exist By failing to prepare, we are preparing to fail - Benjamin Franklin Leaves us vulnerable during times of crisis when the ability to reach 250 million adults with vaccines/medications is crucial Pandemic influenza Our failure to successfully immunize adults in healthy times predicts our failure to immunize them in times of crisis

21 Why is it so hard to vaccinate adults?

22 Barriers to Adult Immunization Competing social and economic demands among adults Competing demands for providers time and vaccines often not integrated into adult medical care practice Adult vaccine schedule is complex Especially for certain occupational and medical target groups Fewer public health resources for adult immunization Pediatric purchases on federal contracts in Dec 2010-Dec 2011: $3,535 billion Adult vaccine purchases: $44 million Limited patient awareness and demand for adult vaccinations except perhaps for influenza vaccine

23 Are any of the following vaccines recommended for you as an adult? Yes (%) No (%) Don t Know (%) Influenza Hepatitis A Hepatitis B Pneumococcal Tdap FallStyles (September-October, 2012). Sheedy.pdf

24 Factors Associated with Low Vaccination Among Adults Patient factors May not have regular health care provider or only see specialists Inconvenient access, competing social and economic demands Many underinsured adults years of age Provider factors Many other health issues compete with preventive services Lack of provider recommendation Lack of effective reminders to offer vaccinations Concern over adequate payment System factors Fewer requirements for vaccination (e.g. by employers) State regulations differ on who can vaccinate and types of vaccine allowed (e.g. pharmacists, visiting nurse associations) Complex adult vaccine schedule

25 Adults - we all can be in it together! 1. Drive demand by improving valuation in both patients and providers! (eg, via education and outreach) 2. Improve access to all adult vaccines by: a) Ensuring supply and delivery by improving infrastructure; b) Initiating/improving surveillance for adult vaccine preventable diseases and vaccine coverage; c) Creating collaborative provider relationships and public-private partnerships to facilitate/promote adult immunization i. Quality Measurement d) Ensuring vaccinations are documented 3. Ensure adequate payment a) Adult immunization should not be a money-losing proposition for providers b) Patients should not have to shoulder large costs to get vaccinated

26 Adults - we all can be in it together! All three steps must be advanced simultaneously. Progress in all areas necessary for success. Leadership (national, provincial, & providerled ) to solicit, initiate, and coordinate solutions Work in each problem area should be coordinated with all other stakeholders in adult immunization and they must be given an opportunity to contribute.

27 Unifying the message bringing us together Leadership to solicit, initiate, and coordinate solutions In the US: National Vaccine Advisory Committee (NVAC) Adult Immunization White Paper June 2011 NEW Adult IZ Practice Standards September 2013 National Adult and Influenza Immunization Summit is an CDC/IAC/NVPO co-sponsored partnership Five WGs established Annual event but year-round engagement Modeled after success of the National Influenza Vaccine Summit

28 Unifying the message bringing us together Leadership to solicit, initiate, and coordinate solutions

29 NEW Adult Immunization Practice Standards Fundamental Paradigm Shift in Adult IZ Adult immunization standards should be applied to all providers of care to adults, those who do and do not vaccinate New standards recognize the importance of the healthcare provider recommendation for patients to receive needed vaccines Highlights the current low vaccination rates among U.S. adults Reflects the changed environment within which adult vaccines are now given

30 Fundamental Paradigm Shift in Adult IZ ALL providers of health care to adults are to: 1. Routinely assess patient s status for all recommended vaccines; 2. Educate and counsel the patient on the recommended vaccines 3. Strongly recommend needed vaccines; ideally, provide the recommended vaccines at the same visit. Providers who do not stock the recommended vaccine are to refer the patient to a vaccinating provider. Follow up! 4. Document the receipt of the recommended vaccine

31 The New Adult IZ Standards of Practice

32 The New Adult IZ Standards of Practice

33 Advocacy Matters!

34 We are in it together a unified message supporting adult IZ To other providers, of the importance of adult immunization Specialists, in particular, see the most vulnerable patients The new paradigm for adult immunization standards in the U.S. is relevant globally To decision makers, of the importance of providing resources to support adult vaccination To the public on the importance of adult vaccines Providers are the most important influencer of vaccine acceptance by patients

35 Maintaining the Future of Immunizations

36 A perspective on the evolution of the vaccine environment Pre-1980s, the public health years 1980s to 2010, the ROI years 2010 to the near future? A rocky path ahead The challenge to evolve and recognize again, that we are all in this together

37 Evolution of vaccine R & D environment over the years pre-1980, the public health years Vaccines seen as a public health good Vaccine prices were low No significant return on investment to vaccine manufacturers No strong leadership to recommend use of vaccines No commitment to invest in vaccines and vaccination programs to improve prevention Liability to manufacturers real and costly, leading to crisis in the early 1980s Manufacturers beginning to leave vaccine R & D

38 Evolution of vaccine R & D environment over the years 1980s to 2010, the ROI years Vaccines seen as good public health value AND good commercial investments Vaccination programs developed to support use of vaccines Leadership commitment to address unmet medical need by preventing disease via immunization Liability to manufacturers ameliorated with the Vaccine Injury Compensation Program New vaccines introduced into programs were paid at prices that were comparable to therapeutic interventions That allowed Returns on Investment (ROI)

39 Evolution of vaccine R & D environment over the years 1980s to 2010, the ROI years These Changes Helped Stimulate New Manufacturers to enter a Growing Market Over the last 2 decades, more than a dozen new vaccines have been introduced and the number of companies developing products has increased. There was re-investment of profits from new vaccines into improving current vaccines and developing new ones as there was now comparable ROI relative to new biologicals and pharmaceuticals. Large and small companies, as well as investors, are continually assessing these ROI s and making decisions on resource allocation priorities. Graphic courtesy of Biotechnology Industry Organization

40 Evolution of vaccine R & D environment over the years 1980s to 2010, the ROI years A positive ROI assessment leads to a win-win situation We have seen drops in infectious diseases as a result of new vaccines, such as pneumococcal conjugate vaccine, rotavirus vaccine, varicella vaccine, and HPV vaccine, when we can get high coverage And we see new vaccines in the pipeline, and new delivery technologies, when the ROI assessment shows promise

41 Evolution of vaccine R & D environment over the years 1980s to 2010, the ROI years Targets for vaccine development include traditional viruses and bacteria, and also noncommunicable diseases. Vaccines may become a key part of anti-microbial stewardship programs. Over the next decade, we may see: New Vaccines for Global Health Malaria Dengue Ebola Tuberculosis Chikungunya New Adult or Pediatric Vaccines Universal influenza Meningococcal A,C, Y, W-135 Meningococcal B CMV RSV Streptococcus vaccines New Healthcare-acquired Infection Vaccines Clostridium difficile Staphylococcus aureus Tuberculosis Pseudomonas aeruginosa Candida BUT Norovirus New combinations of existing pediatric vaccines Graphic courtesy of Biotechnology Industry Organization

42 Evolution of vaccination paradigms over the years Now and Beyond Challenges to the ROI years are showing up New vaccine targets are more difficult the easy ones are all done Clinical trials are more complicated now It is not always possible to do an efficacy trial It s very difficult to detect rare events

43 Evolution of vaccination paradigms over the years Now and Beyond Challenges to the ROI years are showing up Renewed focus on the price of vaccines, as opposed to the value but costs HAVE to go up, and hence prices Constant quality control and FDA-required upgrades of facilities Constant requirement to assess and improve current vaccines New clinical development programs Large clinical trial sizes Post-marketing requirements for safety

44 Vaccines Present a Unique Need for Continuous Investment Increasing Costs R&D Introduction Facility Maintenance New Indications Technology Developments New Vaccine R&D Product Timeline Graphic courtesy of Biotechnology Industry Organization

45 Evolution of vaccination paradigms over the years Now and Beyond Challenges to the ROI years are showing up Under-developed vaccination programs, eg adults! Remember that ROI is dependent on market size Example: relative success of influenza and Tdap vaccination during pregnancy has stimulated development of new vaccines targeted at maternal immunization, such as GBS and RSV Increased concerns over safety Increased risk management/risk communications issue for providers and patients What s the impact on vaccine acceptance? And hence ROI? Spillover into regulatory? How will new vaccine technology be approved? Detection of rare event difficult

46 Evolution of vaccination paradigms over the years Now and Beyond And will a vaccine get a recommendation?! It is now difficult to predict whether a new vaccine will achieve a use recommendation Focus on medical necessity in past years is now replaced with a focus on cost effectiveness (ACIP has much power in the US due to ACA) Vaccines that clearly qualify for a routine recommendation are mostly done; new vaccines now prevent diseases with low incidence, eg meningococcal disease Cost of R & D is now very high Phase III trials are large and complicated Manufacturing facility needs to be built prior to the recommendation

47 Number of subjects enrolled in pivotal vaccine efficacy clinical trials Trial Number subjects enrolled PCV7 ~38, HPV4 ~18, HPV4 ~19, Rotavirus (pentavalent) ~70, Influenza high dose ~32, PCV13 (CAPiTA) ~85, Dengue ~40, Year trial completed

48 Evolution of vaccination paradigms over the years Now and Beyond Uncertainty over a vaccine use recommendation combined with increasing resource intensity (fiscal and otherwise) of development, has increased the risk associated with vaccine R & D

49 So where does that leave us? Aren t we in this together? Academic institutions may start basic research into new vaccines but partnership with a large manufacturer is needed to scale up production There is a high barrier to entry for new manufacturers They will need partners with competency Joint ventures/partnerships are increasingly important in investment decisions Or their project may be sold to a large multinational, who has to satisfy its investors And there is internal competition for dollars

50 So where does that leave us? Aren t we in this together? Most vaccine companies are publicly traded and ROI is a major driver for strategic investment A medical need is no longer enough to drive investment, there has to be an expected ROI The availability and size of the market for the vaccine, if it is licensed, will determine ROI Decisions to develop a new vaccine are no longer based on just medical and public health need Will national governments recommend the vaccine? Will there be public funding for the vaccine? Is the price controlled? What else is already in the market? Relying on the private market for revenue is insufficient for investment purposes

51 So where does that leave us? And the investment decision WILL compete for resources with other potentially more profitable products, eg. drugs, which may have bigger revenues Ultimately, investment in development in new vaccines and technology will occur where there is a commercial reason to do so.

52 How can we all get together to keep preventing diseases through vaccination? Strengthen regulatory science to allow for innovative clinical trial designs that shorten development timelines and reduce costs without impacting safety and efficacy Proactive engagement on new vaccine technology Need balance on safety and efficacy end points Establish clear transparent recommendation processes and regular dialogue between stakeholders and manufacturers during all phases of development Need dialogue on which vaccines are considered to address unmet medical/public health need How will cost effectiveness come into play?

53 How can we all get together to keep preventing diseases through vaccination? Return on investment needs to be comparable to other therapeutic areas to encourage continued participation in vaccine science, and R & D Improve coverage rates in the adult and pregnancy platforms to drive a market Communicate on the known benefits of vaccination for adults and pregnant women Improve access to vaccines for all All providers must give strong recommendations to all patients

54 We ARE all in this together. For the future to remain positive, there must be increased cooperation and communication between the public and private sector Working together, all stakeholders can succeed In order to work together, the value, and the needs, of all partners have to be understood, recognized, and integrated.

55 Visit IAC/Summit Resources! 25% of our website users are outside North America! Use our publications! Visit our websites! Stay ahead of the game! Subscribe to our updates!

56 Amanda, died at age 4½ yrs from influenza Why do we immunize against influenza? Breanne, died at age 15 mos from influenza complications Lucio, died at age 8 yrs from influenza complications 56 Alana, died at age 5½ yrs from influenza Slide Courtesy of Families Fighting Flu Barry, a veteran fire-fighter, died at age 44 yrs from influenza

57 Thank You!