1. Primary Care Physician Attitudes Regarding Herpes Zoster Vaccine: A National Survey
Allison Kempe, MD, MPH

2. Vaccine Policy Collaborative Initiative
Matthew F. Daley, MD
Lori A. Crane, PhD, MPH
Brenda L. Beaty, MSPH
Miriam Dickinson, PhD
Jennifer Barrow, MSPH
Christine Babbel, MSPH
John Steiner, MD, MPH
Arthur Davidson, MD, MSPH
Stephen Berman, MD
CDC Collaborators
Shannon Stokley, MSPH
Rafael Harpaz, MD, MPH
Mona Marin, MD

3. Herpes Zoster Morbidity
Herpes zoster (HZ) results from the reactivation of the varicella zoster virus
Incidence of HZ increases with age—10 per 1,000 persons > 75 years old
> 1 million people each year in U.S. affected
Postherpetic neuralgia (PHN):
Pain lasting > 3 months after crusting of HZ rash
Can be difficult to treat
May result in multiple office visits, subspecialty care and medications

4. Herpes Zoster Vaccination
Clinical trial of a vaccine against HZ reported in the Shingles Prevention Study in 2005:
Participants ≥60 years, Hx varicella or lived in U.S. for ≥30 years, not immunocompromised
↓ of 61% in HZ burden score; ↓ of 51% in incidence
↓ of 67% in incidence of PHN
Vaccine was licensed in 5/2006
Provisional ACIP recommendations 10/2006 :
A single dose for adults > 60 years of age
Persons with chronic medical conditions may be vaccinated, unless contraindication or precaution
*(Oxman et al., NEJM 2005)

5. Study Objectives
To determine in a nationally representative sample of general internists and family medicine physicians:
Perceived burden of Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN) in primary care practice
Intentions for recommending a new HZ vaccine
Perceived barriers to HZ vaccination

6. Study Populations
Survey conducted in two Sentinel Provider Networks (GIM and FM)
Providers recruited from random samples of ACP and AAFP to participate in 2-4 short surveys per year
Initial respondents post-stratified to be representative of ACP and AAFP with respect to:
Region of country (NE, S, MW, W)
Location (urban, suburban, rural)
Setting (private, managed care, community/hospital-based)
Respondents practicing <50% primary care excluded
Address the AMA

7. Final GIM and FM Sentinel Provider Networks
438 GIM physicians eligible and selected
433 FM physicians eligible and selected
In prior studies involving these two networks, attitudes of sentinel physicians found to be comparable to attitudes of physicians randomly sampled from the AMA

8. Survey Design Survey conducted from November - December 2005
Contained informational paragraph about the clinical trial regarding the new herpes zoster vaccine—providers asked to respond based on this information
Pilot-tested in community advisory panel composed of internists and family medicine physicians from across country

9. Survey Administration
Survey administered over an 8-week period by internet or mail based on preference
Internet protocol:
Web-based survey company
s sent with links to internet survey
Up to 9 reminders
Mail protocol: (Dillman protocol)
A pre-letter, 3 days later an initial cover letter and survey sent
5 days later a reminder postcard and up to 2 additional follow-up surveys

10. Results: Response Rates
GIM response rate - 62% (N=272)
FM response rate - 76% (N=328)
Respondent and non-respondents did not differ significantly in either group by:
Age or gender of physician
Practice type, practice location or region of the country
*2\3 surveyed by
* Minor difference but did not reach significant difference

11. Characteristics of Respondents
GIM (n=270)
FM (n=325)
Gender (male)
65%
61%
Practice Setting
Private
Hospital or clinic
HMO/other
79%
17% 4%
19% 3%
Region
West
South
Northeast
Midwest
24%
27%
22%
25%
31%
15%
29%
Location of practice
Urban, inner-city
Suburban / Urban, non-inner city
Rural
12%
73% 5%
60%
35%

12. Perception Of Burden Of Disease Caused By HZ And PHN
Median # per year
FM/GIM Combined
(n=595)
HZ cases in immunocompetent ≥ 50 y.o.
3 - 4
PHN cases in immunocompetent ≥ 50 y.o.
1 - 2
Median # visits to treat HZ 2
Median # visits to treat PHN 4

13. Perception Of Burden Of Disease Caused By HZ And PHN
Combined FM / GIM
(n=595)
Refer to subspecialist for HZ
26%
Refer to subspecialist for PHN
64%
Most commonly refer HZ patients to. .
Ophthalmologist
24%
Dermatologist 6%
Most commonly refer PHN patients to. .
Pain Specialist
40%
Neurologist
32%

14. Perceived Burden of HZ and PHN
Combined FM / GIM
(n=595)
HZ and PHN cause significant burden of disease in my older patients
Strongly agree
Somewhat agree
Somewhat or strongly disagree
35%
46%
19%

15. The Burden Of HZ And Its Complications Warrants Vaccine
GIM (n=270)
No difference between age groups and >80 = NS
p=<.0001
Ref NS

16. The Burden Of HZ And Its Complications Warrants Vaccine
FM (n=325)
No Difference between age groups and > 80 = NS
p=<.0001
Ref NS

17. Comparison Of GIM And FM: Strongly Agree That Burden Of HZ And Its Complications Warrants Vaccine
p=NS
p=.007
p=.02

18. Likelihood Of Recommending HZ Vaccination (FM/GIM Combined; n=595)

19. Comparison Of GIM And FM: Very Likely To Recommend HZ Vaccination
p=NS
p=NS
p=NS

20. Barriers to Vaccination – Ranked Highest to Lowest
Combined GIM / FM
(n=595)
Lack of adequate reimbursement*
Definitely a barrier
38% (GIM 31%, FM 44%)
Somewhat a barrier
38%
Not a barrier / minor barrier
24%
Patients unwilling to pay if not covered by insurance
37%
43%
19%
“Up-front” costs to purchase vaccine
30%
35%
*p-value = .002

21. Barriers to Vaccination – Ranked Highest to Lowest
Combined GIM / FM
(n=595)
Patients will not think they need this vaccine
Definitely a barrier
Somewhat a barrier
Not a barrier / minor barrier
22%
45%
33%
Insufficient information about duration of protection
40%
38%
Insufficient information about safety
17%
35%
48%
Physician doesn’t think patients need vaccine
14%
20%
65%

22. Barriers to Vaccination – Ranked Highest to Lowest
Combined GIM / FM
(n=595)
Patients will be concerned about the safety of administering a live attenuated vaccine to patients w/ chronic medical conditions
Definitely a barrier
Somewhat a barrier
Not a barrier / minor barrier
12%
37%
50%
Degree of effectiveness of the vaccine is insufficient to warrant its use
11%
33%
56%
Physician concerns about immunosupressed household members of the patient potentially being exposed to vaccine virus
10%
52%

23. “Definitely A Barrier” For Less Than 10% Of Providers
Need to store HZ vaccine in a freezer rather than a refrigerator
Physician concerns about safely administering a live attenuated virus to patients with chronic medical conditions
Concern that many patients will not be eligible if the FDA does not approve the vaccine for persons excluded from the study
Fact that vaccine will not be licensed for immunosupressed patients

24. “Definitely A Barrier” For Less Than 10% Of Providers
Concern that many patients will be unsure of whether they have had varicella in the past
Concern that many older patients are foreign-born, have been in the U.S. less than 30 years and therefore will not be eligible to receive this vaccine
Concern that the vaccine could be mistakenly given to a child

25. Perceptions Associated With Reporting Being Very Likely To Recommend Herpes Zoster Vaccine To Adults (FM/GIM Combined; N=572)
Physician perceptions
Multivariate OR**
(95% CI)
Specialty FM vs GIM
1.23 ( )
HZ and PHN disease cause high burden in older patients
2.75 ( )
Insufficient information about duration of protection afforded by vaccine
0.40 ( )
Need to store herpes zoster vaccine in a freezer
0.31 ( )
Not thinking patients need the vaccine
0.32 ( )
Concern that If herpes zoster is not covered by insurance, patients will be unwilling to pay out of pocket
0.57 ( )

26. Study Limitations Potential for bias in those who respond to surveys
Measuring intention to vaccinate rather than action taken

27. Summary of Findings
Approximately 80% of FM and GIM providers strongly/somewhat agreed that HZ and PHN cause significant burden of disease in their older patients
The percentage of physicians strongly agreeing that burden was sufficient to warrant a vaccine was significantly higher for patients compared with patients years of age
FM 29% vs 17%
GIM 40% vs 15%

28. Summary of Findings
Overall, both FM and GIM providers reported being very/somewhat likely to recommend HZ vaccination for all age groups, but were significantly more likely to recommend in patients ≥60 than those years
FM 78% vs 60%
GIM 79% vs 57%

29. Summary of Findings
Major perceived barriers to vaccine included:
Financial - top 3 (inadequate reimbursement, up-front costs, patient unwillingness to pay)
Patients not perceiving the need
Insufficient info about duration of protection/safety

30. Summary of Findings
Physician characteristics and perceptions associated with being very likely to recommend included:
(+) Perceiving high burden of HZ disease
(-) Perceiving insufficient info about duration of protection, need to store in a freezer, and concerns about insurance coverage of vaccine

31. Acknowledgments
This investigation was funded by the Centers for Disease Control and Prevention, through the Rocky Mountain Prevention Research Center, Denver, CO

32. (15% of pooled respondents)
Open-ended responses re: groups that physicians would consider for off-label use
(15% of pooled respondents)
Overtly immunocompromised patients
Functionally immunocompromised patients and those with various chronic diseases
Persons with less ability to tolerate shingles
Persons with varicella during infancy
Persons with prior history of shingles, especially if severe
Immigrants
Persons that could pose risk of infection to others
Healthy persons < 50 with history of varicella
Healthy children and adults susceptible to varicella
-Overtly immunocompromised patients including HIV w/ high CD4, on steroids, cancer prior to chemo
-Functionally immunocompromised patients and those with various chronic diseases such as diabetes, multiple sclerosis, MS, asthma, alcoholics
-Persons with less ability to tolerate shingles including those with functional/chronic pain syndromes, mentally retarded, nursing home residents, athletes
-Persons with varicella during infancy
-Persons with prior history of shingles, especially if severe
-Immigrants
-Persons that could pose risk of infection to others such as health care workers
-Healthy persons < 50 with history of varicella (all or various age subgroups)
-Healthy children and adults susceptible to varicella (in lieu of varicella vaccine)

33. Comparison of GIM and FM: Strongly/Somewhat Agree that burden of HZ and its complications in patients warrant vaccine use
p=NS
p=.01
p=.01

34. Comparison of GIM and FM: Very/Somewhat Likely to recommend HZ vaccination
p=NS
p=NS
p=NS
p=NS