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

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

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

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)

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

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

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

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

Survey Administration Survey administered over an 8-week period by internet or mail based on preference Internet protocol: Web-based survey company Emails sent with links to internet survey Up to 9 e-mail 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

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 email * Minor difference but did not reach significant difference

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%

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

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%

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%

The Burden Of HZ And Its Complications Warrants Vaccine GIM (n=270) No difference between age groups 60-79 and >80 = NS p=<.0001 Ref NS

The Burden Of HZ And Its Complications Warrants Vaccine FM (n=325) No Difference between age groups 60-79 and > 80 = NS p=<.0001 Ref NS

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

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

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

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

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%

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%

“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

“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

Perceptions Associated With Reporting Being Very Likely To Recommend Herpes Zoster Vaccine To Adults 60-79 (FM/GIM Combined; N=572) Physician perceptions Multivariate OR** (95% CI) Specialty FM vs GIM 1.23 (0.84-1.81) HZ and PHN disease cause high burden in older patients 2.75 (1.85-4.09) Insufficient information about duration of protection afforded by vaccine 0.40 (0.24-0.67) Need to store herpes zoster vaccine in a freezer 0.31 (0.13-0.75) Not thinking patients need the vaccine 0.32 (0.16-0.63) Concern that If herpes zoster is not covered by insurance, patients will be unwilling to pay out of pocket 0.57 (0.38-0.86)

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

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 60-79 compared with patients 50-59 years of age FM 29% vs 17% GIM 40% vs 15%

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 50-59 years FM 78% vs 60% GIM 79% vs 57%

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

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

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

(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)

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

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