Cost and utility in immunocompromised subjects who developed herpes zoster during the randomized V212 inactivated varicella-zoster vaccine (ZV_IN) trial

ABSTRACT

Objectives: Immunocompromised subjects are at increased risk for herpes zoster (HZ) and HZ-related complications, such as post-herpetic neuralgia (PHN). We describe health utilities, health care resource utilization (HCRU), productivity loss and health care costs in recipients of autologous hematopoietic stem-cell transplantation (Auto-HSCT) who developed confirmed HZ in the phase 3 clinical trial.

Methods: HCRU, costs, and EQ-5D-3L utility were assessed for 155 confirmed HZ cases observed after receiving inactivated varicella-zoster virus (VZV) vaccine (ZV_IN) or placebo. In a prospective, longitudinal 6-month follow up, costs and utilities were analyzed for two health states, HZ without PHN and HZ with PHN.

Results: There was a clinically relevant difference in utility between HZ without PHN (mean 0.814) and HZ with PHN (0.729). The disutility for HZ without PHN was estimated to −0.117 and to −0.186 for HZ with PHN. Direct costs (2017 USD) associated with a HZ without PHN episode and HZ with PHN episode was estimated at $3,412 and $3,711, respectively, of which hospitalizations accounted for 90% of the costs.

Expert opinion: Both HZ and PHN are associated with considerable disutility in recipients of Auto-HSCT. Costs were comparable to published estimates in other immunocompromised subjects.

The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT01229267).

KEYWORDS:

• Herpes zoster
• vaccine
• costs
• EQ-5D
• immunocompromised patients

Article highlights

• Herpes zoster (HZ) presents with painful, blistering rash and may result in postherpetic neuralgia (PHN) which is defined as persisting pain lasting for longer than 90 days.

• Immunocompromised subjects are at increased risk for HZ and PHN.

• In this study, health care resource use, costs, and utility in subjects who underwent autologous hematopoietic stem-cell transplantation (Auto-HSCT) and developed confirmed HZ in the phase 3 clinical trial was assessed.

• The disutility for HZ without PHN was estimated to −0.117 and to −0.186 for HZ with PHN.

• Direct costs (2017 USD) associated with a HZ without PHN episode and HZ with PHN episode was estimated at $3,412 and $3,711, respectively.

• This analysis in immunocompromised subjects who developed HZ after undergoing Auto-HSCT addresses a gap in the current literature and shows a considerable disutility associated with HZ and HZ with PHN while costs were similar to other studies in this area.

Acknowledgments

We thank the patients who participated in the V212 trial.

Author contributions

JE, MH were involved in the concept, design, analysis, and interpretation of the data. FB, RT were involved in the analysis and interpretation of the data. LF, YJ, and ZP were involved in the concept, design and interpretation of the data. JE and RT drafted and revised the manuscript. All authors were involved in reviewing the manuscript critically for intellectual content, reviewed and approved the final version to be published. All authors are accountable for all aspects of the work.

Availability of data and material

The datasets generated and/or analyzed during the current study are not publicly available to protect the privacy of the individuals.

Declaration of interest

J Eriksson, M Hunger, F Bourhis and R Thorén are employed by ICON plc, a contract research organization conducting research on behalf of pharmaceutical companies. L Finelli, Z Popmihajlov and Y Jiang are employees of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, and may own stock and/or stock options in the company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

A reviewer on this manuscript has disclosed that they received grants and non-financial support from producers of HZ vaccines (GSK, MSD).

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

The study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.