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Original research
Use of the Aptima mRNA high-risk human papillomavirus (HR-HPV) assay compared to a DNA HR-HPV assay in the English cervical screening programme: a decision tree model based economic evaluation
  1. Georgie Weston1,
  2. Caroline Dombrowski1,
  3. Michael J Harvey1,
  4. Thomas Iftner2,
  5. Maria Kyrgiou3,4,
  6. Christina Founta5,
  7. Elisabeth J Adams1
  1. 1Aquarius Population Health, London, UK
  2. 2Department of Medical Virology, University Hospital Tübingen, Tübingen, Germany
  3. 3Institute of Reproductive and Developmental Biology, Department of Surgery & Cancer, Imperial College London, London, UK
  4. 4Queen Charlotte’s and Chelsea, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK
  5. 5Department of Gynaecological Oncology, Musgrove Park Hospital, Taunton & Somerset NHS Foundation Trust, Taunton, Somerset, UK
  1. Correspondence to Dr Elisabeth J Adams; elisabeth.adams{at}aquariusph.com

Abstract

Objective To estimate the impact of using the Aptima messenger RNA (mRNA) high-risk human papilloma virus (HR-HPV) assay versus a DNA HR-HPV assay in a primary HPV cervical screening programme.

Design One hypothetical cohort followed for 3 years through HPV primary cervical screening.

Setting England.

Participants A hypothetical cohort of women aged 25–65 years tested in the National Health Service (NHS) Cervical Screening Programme (CSP) for first call or routine recall testing.

Methods A decision tree parameterised with data from the CSP (2017/18) and the HORIZON study. Uncertainty analyses were conducted using data from the FOCAL and GAST studies, other DNA HPV tests in addition to one-way and probabilistic sensitivity and scenarios analyses, to test the robustness of results.

Interventions Aptima mRNA HR-HPV assay and a DNA HR-HPV assay (cobas 4800 HPV assay).

Main outcome measures Primary: total colposcopies and total costs for the cohort. Secondary: total HPV and cytology tests, number lost to follow-up.

Results At baseline for a population of 2.25 million women, an estimated £15.4 million (95% credibility intervals (CI) £6.5 to 24.1 million) could be saved and 28 009 (95% CI 27 499 to 28 527) unnecessary colposcopies averted if Aptima mRNA assays are used instead of a DNA assay, with 90 605 fewer unnecessary HR-HPV and 253 477 cytology tests performed. These savings are due to a lower number of HPV positive samples in the mRNA arm. When data from other primary HPV screening trials were compared, results indicated that using the Aptima mRNA assay generated cost savings and reduced testing in every scenario.

Conclusion Using the Aptima mRNA assay versus a DNA assay would almost certainly yield cost savings and reduce unnecessary testing and procedures, benefiting the NHS and women in the CSP.

  • colposcopy
  • health economics
  • gynaecological oncology
  • microbiology
  • public health
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

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  • Contributors EJA designed the study and oversaw the project, MJH and GW constructed the model, GW ran the analyses and drafted the paper, CD identified data for the model and helped draft the paper, CF, MK and TI provided input on the analysis, helped interpret results and reviewed the article. TI also provided the raw data from the GAST study.

  • Funding Aquarius Population Health received funding from Hologic for this study; the design, results and interpretation of the study are independent and the authors’ own.

  • Competing interests EJA, GW, MJH and CD report grants from Hologic to their Employer (Aquarius Population Health) during the conduct of the study, and grants on diagnostics from Cepheid, Enigma Diagnostics, Jupiter Diagnostics, Binx, Momentum Bioscience, St Georges University of London, BIVDA and Roche Diagnostics, outside the submitted work. TI reports grants from Hologic and from Becton Dickinson, outside the submitted work to his institution (University Hospital Tuebingen) and personal speaker honoraria from Hologic Inc during the conduct of the study. MK received grants from Welcome Trust, NIHR, Genesis Trust, Imperial BRC, Imperial Charity outside the submitted work.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. All data used in this study is already in the public domain.