Abstract

Background Herpes zoster (HZ), or shingles, is a painful rash caused by reactivation of latent varicella zoster virus infection. To better inform health economic evaluation of interventions against HZ, we synthesised evidence from studies measuring the health-related quality of life (HRQoL) of patients with HZ using the EuroQol EQ-5D instrument.

Methods We systematically reviewed the scientific literature up to 31st October 2024 to identify all studies of HRQoL with HZ from PubMed and Web of Science. We obtained individual-level data from cohorts measuring HRQoL using the EQ-5D. We fit a survival model to the duration of the disutility period, and a mixture distribution to capture changes in HRQoL during the disutility period, to estimate the quality-adjusted life years (QALY) lost due to HZ by age.

Results We identified 22 studies reporting a measure of HRQoL with HZ. Of these, 13 studies, covering 16 patient cohorts, measured HRQoL using the EQ-5D tool. We included individual patient data from 9 of these 16 cohorts (1,345 patients) in our quantitative synthesis. We estimated the disutility period for HZ to range between 121 (95% credible interval [CrI]: 112-134) days for 50-year-olds to 193 (163-226) days for 90-year-olds. We estimated the QALY loss due to an HZ episode to range from 0.095 (0.086 – 0.104) at 50 years to 0.146 (0.124 – 0.172) at 90 years of age.

Conclusions This study is the first to derive a QALY loss estimate for HZ through a systematic review of the literature and analysis of individual patient data. Longer follow-up studies for HZ patients will be important in the future to robustly capture the effect of long-term sequelae and may potentially lead to a higher estimated QALY loss.

Competing Interest Statement

AR, KBP, AvW, PH, JB, MBr, MBa, NA, AJvH and MJ have no conflicts of interest to declare. AG is an employee of Adelphi Values, a health outcomes agency commissioned by Sanofi Pasteur MSD, to conduct, analyse and communicate findings from the ZQOL study on their behalf. AG has no further competing interests to declare. KJ is an employee and shareholder of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. SC is an employee of Sanofi Pasteur. Sanofi Pasteur does not have any shingles vaccines currently licenced nor in the pipeline. SC is also an elected local councillor and Lead Member for Adult Social Care and Public Health in the Royal Borough of Windsor and Maidenhead. MD had consulted for GSK for the HZ vaccine more than 3 years ago.

Funding Statement

AR, JB, MBa, KBP, NA, AJvH and PH had no sources of additional funding to carry out this work. CK, MJ, and ND were supported by the National Institute for Health and Care Research Health Protection Research Unit (NIHR HPRU) in Immunisation at the London School of Hygiene & Tropical Medicine in partnership with the UK Health Security Agency (UKHSA) [grant number NIHR200929]. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health and Social Care or UKHSA. The following funders are relevant to the data included in the meta-analysis presented in this manuscript: KJ: The MASTER study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Merck & Co., Inc. did not provide any additional funding for the meta-analysis or drafting of this manuscript. AvW: The Van Wijck et al.44 study was supported by an unrestricted grant from Sanofi Pasteur MSD. The funding source had no role in the study design; data collection, analysis or interpretation of the data. Sanofi Pasteur MSD did not provide any additional funding for the meta-analysis or drafting of this manuscript. AG and SC: The ZQOL study was funded by Sanofi Pasteur MSD. Sanofi Pasteur MSD did not provide any additional funding for the meta-analysis or drafting of this manuscript.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

All patients provided informed consent prior to their inclusion in each of the MASTER studies (including additional data provided in Drolet et al.7), the Scott et al.43, the Van Wijck et al.44, and the Gater et al.45. All studies were conducted as per Good Clinical Practices and the tenets of the Declaration of Helsinki. All data were collected in an anonymous fashion and as per local data protection laws, and all studies were approved by local and central Ethics Boards, as required, for each participating site. This post-hoc analysis of available data was covered in the original ethics submission.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Footnotes

↵^ Joint first authorship

↵† Joint last authorship

Data Availability

The datasets generated and/or analysed during the current study are not publicly available due to limitations provided by the funders of the original studies (Sanofi Pasteur MSD, MSD) but are available from the corresponding author on reasonable request.

List of abbreviationsCrIcredible intervalHRQoLhealth-related quality of lifeHTAhealth technology assessmentHZherpes zosterPHNpost-herpetic neuralgiaQALYquality-adjusted life years