1. Herpes Zoster: Challenges of Surveillance, Challenges of Vaccination Rafael Harpaz, CDC National Immunization Conference Dallas, TX; April 1, 2009

2. 2 INTRODUCTORY REMARKS: The Challenges of HZ Surveillance & Vaccination

3. 3 Herpes Zoster (HZ) & Post-herpetic Neuralgia (PHN) HZ: pain syndrome (outcome we wish to prevent) About 1 million cases of HZ annually Key known risk factors: age, immunosuppression Lifetime risk: ~30%  We don’t really know what distinguishes the 30% that get HZ from the 70% that do not

4. 4 Herpes Zoster Vaccine (HZV) Vaccine efficacy: 51% vs. HZ, 67% vs. PHN  Vaccine efficacy declines from youngest to oldest vaccinees by 3- to 4-fold  Don’t know much about other risk factors for vaccine failure Single dose Requires freezer storage

5. 5 HZV target population: Adults ≥60 yrs: 55 million (17% of total population) and growing... Marked heterogeneity

6. 6 HZV target population: Marked Heterogeneity

7. 7 HZV Cost & Reimbursement Catalogue price: ~$150 (5-10 times PPV or TIV) Retail price: typically $200 to $300 Coverage and reimbursement:  Medicare Part D: 27 million adults ≥65 yr  Private insurance: 60-64 yr; also ~9 million ≥65yr working/retired w/ secondary private insurance  Other (Veterans Affairs, other Medicare, Merck Patient Assistance, HD’s) Pharmacies as vaccinators:  Authorized to do HZV vaccination in ~40 states

8. 8 HZV Cost & Reimbursement Medicare Part D reimbursement  Relationship of drug plans is with pharmacies  Therefore vaccination by doctors usually entails: –Filing claim (e.g. paying full price up front), or... –Referring to pharmacy for vaccination, or... –“Brown-bagging” (frozen vaccine!) or... –Deputizing as pharmacy/PD provider: eDispense™  Non-reimbursable costs: –Deductibles, co-pays, coverage gap/“donut hole” –Co-pays alone (basic benefit): $20 to $60 Commercial insurance  Deductibles and co-pays also apply

9. 9 Enabling Vaccination Challenges  HZV supply shortages (now largely resolved)  Provider barriers: awareness, up front cost, complexity of reimbursement, storage/handling  Patient barriers: awareness, financial, locating the vaccine  Health department barriers: not enough people, time, or money to make everything a priority  Shared barriers for all the above: our system doesn’t accommodate adult vaccines well

10. 10 Enabling Vaccination Potential roles for health departments/grantees (1) 1.Direct provision of HZV vaccination services  Opportunities to leverage resources –Become Medicare Part D providers (eDispense™) –Contract w/ Part D providers (pharmacies, public clinics, MDs, commercial vaccinators, retail outlets) –Inquire about Merck Patient Assistance Program  Bundle w/ adult vaccines & prevention services 2.Help coordinate HZV vaccination services  Engage Area Agencies on Aging: they know local resources & opportunities best  Refer to local HZ vaccinators (pharmacies, etc.)  Coordinate vaccine clinics  Include HZV in vaccine registries

11. 11 Enabling Vaccination Potential roles for health departments/grantees (2) 3.Public awareness, education, and promotion 4.Provider awareness and education  On ways to address financial barriers (eDispense, referral to pharmacies, etc.)  Regarding local resources and vaccinators 5.Partnerships are key for all the above, e.g.:  State APhA, pharm. chains, AAA/SUA, MD groups, commercial vaccinators, FQHC/Rural Clinics, VNAs, retail outlets, hospitals, tribes, local VA, employers

12. 12 Monitoring HZV Impact Challenges  Difficult to make HZ reportable, accordingly CSTE did not express interest in such measures  Difficult to monitor outcomes of greatest interest: severity & duration of pain

13. 13 To discuss approaches to HZV vaccination and surveillance: Email rharpaz@cdc.gov

14. 14 OUR PRESENTATIONS TODAY: 1.Christina Jackson: Descriptive Epidemiology of Adult Herpes Zoster and Post-Herpetic Neuralgia from An Active Surveillance Project, Antelope Valley, CA, 2006-2007 2.Laura Hurley: Herpes Zoster Vaccine, What Is Interfering with Uptake? 3.L.J. Tan: Herpes Zoster Vaccination: Key Challenges 4.All of you: Questions and Discussion

15. 15

16. 16 Monitoring HZV Impact Activities and Plans: CDC  Better define long-term HZ trends  Better define HZ risk factors  Validate methods to do HZ & PHN case finding using claims data  Establish prospective HZ & PHN surveillance

17. 17 Enabling Vaccination Activities and Plans: CDC Promotional & informational activities Provider training and education Provider survey on practices, barriers (today’s presentation) Planning patient survey to characterize barriers Develop national strategies to reduce barriers to vaccination

18. 18 Monitoring HZV Uptake Challenges  Given barriers to HZV vaccination, timely and thorough monitoring of uptake needed to see whether corrective measures are necessary  Given heterogeneity in target population, we need to know who is getting vaccinated to interpret performance  No routine state-level data available on HZV uptake (as exists for pediatric vaccines, i.e. NIS)

19. 19 Monitoring HZV Uptake Activities and Plans  Adult NIS (summer 2007; no repeat scheduled)  U of M Health & Retirement Study (biennial survey of 22,000 adults ≥50 yr on health, insurance, other): 2008 data on HZ rates/HZV uptake (results: July 2009)  NHIS (annual survey): 2008 data on HZV uptake from ~6,200 adults ≥60 yrs (results: July 2009)  BRFSS (annual survey): State-level data on HZV uptake (unknown if states will adopt module)  Biologic surveillance (semiannual): doses distributed  Medicare Part D claims data (data delayed)  State registries: only 1 state has HZV data

20. 20 Monitoring HZV Safety Challenges  1 st live (i.e. not inactive) vaccine targeted for seniors  Distinguishing cause and coincidence among the elderly who have high rates of medical events  Safety may vary by co-morbidities, medications, frailty in this heterogeneous population  Adult providers may be less experienced at reporting to VAERS Activities and Plans  VAERS surveillance (2 yr review in preparation)  Vaccine Safety Datalink protocol in development

21. 21 Assuring HZV Performance Challenges  No surrogates exist for vaccine protection  Greater understanding of baseline HZ trends, risk factors for HZ, characteristics of elderly who receive HZV is critical for designing studies to monitor HZV performance and duration of protection Activities and plans  Current & planned HZ studies should provide data needed to inform design of studies to measure HZV performance

22. 22 Monitoring HZV Impact Activities and Plans: CDC  Studies to better define long-term HZ trends (Olmsted county, Medstat, Medicare, Harvard)  Studies to better define HZ risk factors (Medstat, Marshfield, Medicare)  Developing & validating methods to conduct HZ & PHN case finding using claims data (Harvard)  Establishing prospective HZ & PHN surveillance (Medicare, Medstat, HRS, Varicella Active Surveillance Project)

23. 23