Study design of a medical device pre-market assessment: a case study on electrochemotherapy

  • Eva Pirc Laboratory of Biocybernetics, Faculty of electrical engineering, university of Ljubljana, Ljubljana, Slovenia
  • Leandro Pecchia school of engineering, university of Warwick, Coventry, united Kingdom
  • Matej Reberšek Laboratory of Biocybernetics, Faculty of electrical engineering, university of Ljubljana, Ljubljana, slovenia
  • Gregor Serša institute of oncology Ljubljana, Ljubljana, slovenia
  • Marko Snoj Faculty of Medicine, university of Ljubljana, Ljubljana, slovenia
  • Aleš Grošelj department of otorhinolaryngology and Cervicofacial surgery, university Medical Centre Ljubljana, Ljubljana, slovenia
  • Damijan Miklvavčič Laboratory of Biocybernetics, Faculty of electrical engineering, university of Ljubljana, Ljubljana, slovenia
Keywords: health technology assessment (Hta), cost-e ectiveness analysis (Cea), Markov model, electroporation, electrochemotherapy (eCt)

Abstract

Final goal of the study is to estimate the cost-e ectiveness of electrochemotherapy for the tre- atment of basal-cell carcinoma and skin melanoma. Paper consists of two parts: the first part presents basic principles and concepts of health technology assessment and cost-e ectiveness analysis, and the second part reports an early cost-e ectiveness analysis of electrochemothe - rapy for the treatment of basal-cell carcinoma and skin melanoma that we are developing. Few cost-e ectiveness analyses of electrochemotherapy have already been done, but with a lack of information about intervention e ectiveness in terms of quality of life, which may result in inac- curate or even inadequate conclusions. In order to obtain the most realistic results, two general Markov models and their reduced versions for initial calculations are presented. The models were designed specifically to assess electrochemotherapy of basal-cell carcinoma and skin me- lanoma. Also, data required for successful calculations have been identified, some of which are missing and will be collected within di erent studies which are still under way, including rando- mized control trials. Additionally, recommendations for data collection process and follow-up reporting are made. With this paper we want to raise awareness about the importance of nume- ric quality of life reporting and usefulness/meaning of EQ-5D questionnaire that might not be self-evident at first sight, but are crucial for cost-e ectiveness analysis.

Downloads

Download data is not yet available.

References

Haberl S, Miklavcic D, Sersa G, Frey W, Rubinsky B. Cell membrane electroporation-Part 2: the applications. IEEE Electrical Insulation Magazine. 2013;29(1):29–37.

Kotnik T, Frey W, Sack M, Haberl Meglič S, Peterka M, Miklavčič D. Electroporation-based applications in biotechnology. Trends in Biotechnology. 2015;33(8):480–8.

Zorec B, Préat V, Miklavčič D, Pavšelj N. Active enhancement methods for intra- and transdermal drug delivery: a review. Zdrav Vestn. 2013;82(5):339–356.

Golberg A, Sack M, Teissie J, Pataro G, Pliquett U, Saulis G, et al. Energy-efficient biomass processing with pulsed electric fields for bioeconomy and sustainable development. Biotechnology for Biofuels. 2016;9(1).

Pirc E, Reberšek M, Miklavčič D. 12 Dosimetry in Electroporation-Based Technologies and Treatments. Dosimetry in Bioelectromagnetics: CRC Press; 2017. p. 233–68.

Stepišnik T, Jarm T, Grošelj A, Edhemović I, Djokić M, Ivanecz A, et al. Elektrokemoterapija – učinkovita metoda zdravljenja tumorjev s kombinacijo kemoterapevtika in električnega polja. Zdrav Vestn. 2016;85(1).

Mali B, Jarm T, Snoj M, Sersa G, Miklavcic D. Antitumor effectiveness of electrochemotherapy: A systematic review and meta-analysis. European Journal of Surgical Oncology (EJSO). 2013;39(1):4–16.

Narayanan DL, Saladi RN, Fox JL. Review: Ultraviolet radiation and skin cancer. International Journal of Dermatology. 2010;49(9):978–86.

Telfer NR, Colver GB, Morton CA. Guidelines for the management of basal cell carcinoma. British Journal of Dermatology. 2008;159(1):35–48.

Clover AJP, O’Mahony J, Soden D. Electrochemotherapy of Basal Cell Carcinoma. Handbook of Electroporation: Springer International Publishing; 2016. p. 1–12.

NICE. Electrochemotherapy for primary basal cell carcinoma and primary squamous cell carcinoma. [March 22, 2017] Available from: https://www.nice.org.uk/guidance/ipg478/resources/electrochemotherapy-for-primary-basal-cell-carcinoma-and-primary-squamous-cell-carcinoma-1899869938127557.

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA: a cancer journal for clinicians. 2016;66(1):7–30.

Savoia P, Fava P, Nardò T, Osella-Abate S, Quaglino P, Bernengo MG. Skin metastases of malignant melanoma: a clinical and prognostic survey. Melanoma Research. 2009;19(5):321–6.

(14) Campana LG, Sepulcri M, Valpione S, Corti L, Rossi CR. Electrochemotherapy for Superficially Metastatic Melanoma. Handbook of Electroporation: Springer International Publishing; 2017. p. 2095–112.

Quaglino P, Mortera C, Osella-Abate S, Barberis M, Illengo M, Rissone M, et al. Electrochemotherapy with Intravenous Bleomycin in the Local Treatment of Skin Melanoma Metastases. Annals of Surgical Oncology. 2008;15(8):2215–22.

Campana LG, Mocellin S, Basso M, Puccetti O, De Salvo GL, Chiarion-Sileni V, et al. Bleomycin-Based Electrochemotherapy: Clinical Outcome from a Single Institution’s Experience with 52 Patients. Annals of Surgical Oncology. 2009;16(1):191–9.

Campana LG, Valpione S, Mocellin S, Sundararajan R, Granziera E, Sartore L, et al. Electrochemotherapy for disseminated superficial metastases from malignant melanoma. British Journal of Surgery. 2012;99(6):821–30.

van Tulder M. Health technology assessment (HTA) increasingly important in spine research. European Spine Journal. 2011;20(7):999–1000

The Organisation for Economic Co-operation and Development (OECD)“Health Resources - Health Spending - OECD Data.” theOECD. [March 22, 2017] Available from: http://data.oecd.org/healthres/health-spending.htm.

Pallikarakis N, Moore R. Health Technology in Europe - Regulatory Framework and Industry Perspectives of the »New Approach«. IEEE Engineering in Medicine and Biology Magazine. 2007;26(3):14–7.

Analiza zdravstavenega Sistema v Sloveniji; Pregled izdatkov v zdravstvu; Končno poročilo, oktober 2015. [ June 30, 2016] Available from: http://www.mz.gov.si/fileadmin/mz.gov.si/pageuploads/Analiza/04022016porocila SL/Report Expenditure review Slovenia FINAL FORMATTED SI 4.pdf.

Statistični urad republike slovenije- Starejše prebivalstvo. [March 22, 2017] Available from: http://www.stat.si/doc/StarejsePrebivalstvo.pdf.

Analiza zdravstvenega sistema v Sloveniji Povzetek in ključne ugotovitve. [March 22,2017] Available from: http://www.mz.gov.si/fileadmin/mz.gov.si/pageuploads/Analiza/analiza_ZS_povzetek_in_kljucne_ugotovitve_lektorirana_verzija.pdf.

Ministrstvo za zdravje RS. Postopek obravnave vlog za nove zdravstvene programme 2015. Available from: http://www.mz.gov.si/si/o_ministrstvu/zdravstveni_svet_in_ostala_posvetovalna_telesa/zdravstveni_svet/postopek_za_vloge/.

Turchetti G, Spadoni E, Geisler E. Health Technology Assessment. IEEE Engineering in Medicine and Biology Magazine. 2010;29(3):70–6.

World Health Organization [June 30, 2016]. Available from: http://www.who. int/medical devices/assessment/en/.

Pecchia L, Craven MP. Early stage Health Technology Assessment (HTA) of biomedical devices. The MATCH experience. IFMBE Proceedings: Springer Berlin Heidelberg; 2013. p. 1525–8.

Thokala P, Duenas A. Multiple Criteria Decision Analysis for Health Technology Assessment. Value in Health. 2012;15(8):1172–81.

Clifford S, Goodman. HTA 101 Introduction to Health Technology Assessment. Bethesda,MD: National Library of Medicine (US); 2014. [July 4, 2016] Available from: https://www.nlm.nih.gov/nichsr/ hta101/HTA 101 FINAL 7–23–14.pdf.

Weinstein MC, Torrance G, McGuire A. QALYs: The Basics. Value in Health: The Journal of the International Society for Pharmacoeconomics and Outcomes Research 12 Suppl 1:S5–9.

Patrick DL, Starks HE, Cain KC, Uhlmann RF, Pearlman RA. Measuring Preferences for Health States Worse than Death. Medical Decision Making. 1994;14(1):9–18.

EuroQol official pag. [July 4, 2016] Available from: http://www.euroqol.org/.

Rabin R, Charro Fd. EQ-SD: a measure of health status from the EuroQol Group. Annals of Medicine. 2001;33(5):337–43.

Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB. Recommendations of the Panel on Cost-effectiveness in Health and Medicine. Jama. 1996;276(15):1253–8.

Guide to the methods of technology appraisal 2013. [April 4, 2013] Available from: https://www.nice.org.uk/process/pmg9.

Phillips C, Thompson G. What is a QALY Health economics 2nd ed. Newmarket: Hayward Medical Communications; 2009.

Burckhardt CS, Anderson KL. Health and Quality of Life Outcomes. 2003;1(1):60.

Hunt SM, McKenna SP, McEwen J, Williams J, Papp E. The Nottingham health profile: Subjective health status and medical consultations. Social Science & Medicine Part A: Medical Psychology & Medical Sociology. 1981;15(3):221–9.

Stavrianou K, Pallikarakis N. Quality of life of end-stage renal disease patients and study on the implementation of nocturnal home hemodialysis in Greece. Hemodialysis International. 2007;11(2):204–9.

Longworth L, Rowen D. Mapping to Obtain EQ-5D Utility Values for Use in NICE Health Technology Assessments. Value in Health. 2013;16(1):202–10.

Torrance GW, Feeny D. Utilities and Quality-Adjusted Life Years. International Journal of Technology Assessment in Health Care. 1989;5(04):559–75.

Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: A non-parametric approach to confidence interval estimation. Health Economics. 1997;6(4):327–40.

Hill SR. Cost-effectiveness analysis for clinicians. BMC Medicine. 2012;10(1).

Fenwick E, Marshall DA, Levy AR, Nichol G. Using and interpreting cost-effectiveness acceptability curves: an example using data from a trial of management strategies for atrial fibrillation. BMC Health Services Research. 2006;6(1).

O’Mahony JF, Paulden M. NICE’s Selective Application of Differential Discounting: Ambiguous, Inconsistent, and Unjustified. Value in Health. 2014;17(5):493–6.

Claxton K, Paulden M, Gravelle H, Brouwer W, Culyer AJ. Discounting and decision making in the economic evaluation of health-care technologies. Health Economics. 2010;20(1):2–15.

Weinstein MC, O'Brien B, Hornberger J, Jackson J, Johannesson M, McCabe C, et al. Principles of Good Practice for Decision Analytic Modeling in Health-Care Evaluation: Report of the ISPOR Task Force on Good Research Practices—Modeling Studies. Value in Health. 2003;6(1):9–17.

Andronis L, Barton P, Bryan S. Sensitivity analysis in economic evaluation: an audit of NICE current practice and a review of its use and value in decision-making. Health Technology Assessment. 2009;13(29).

Rodina-Theocharaki A, Bliznakova K, Pallikarakis N. Markov Chain Monte Carlo simulation for projection of end stage renal disease patients in Greece. Computer Methods and Programs in Biomedicine. 2012;107(1):90–6.

Craven MP, Morgan SP. Early Stage Economic Evaluation with a Small Medical Device Start-Up Company Using a Markov Model. Journal of Medical Devices. 2011;5(2):027516.

Foster KR, Koprowski R, Skufca JD. Machine learning, medical diagnosis, and biomedical engineering research - commentary. BioMedical Engineering OnLine. 2014;13(1):94.

Colombo G. Cost-effectiveness analysis of electrochemotherapy with the Cliniporator™ vs other methods for the control and treatment of cutaneous and subcutaneous tumors. Therapeutics and Clinical Risk Management. 2008;4:541–8.

CADTH Rapid Response Reports. Irreversible Electroporation for Tumors of the Pancreas or Liver: A Review of Clinical and Cost-Effectiveness. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016.

Pecchia L, Craven MP. Early stage Health Technology Assessment (HTA) of biomedical devices. The MATCH experience. IFMBE Proceedings: Springer Berlin Heidelberg; 2013. p. 1525–8.

Spratt DE, Gordon Spratt EA, Wu S, DeRosa A, Lee NY, Lacouture ME, et al. Efficacy of Skin-Directed Therapy for Cutaneous Metastases From Advanced Cancer: A Meta-Analysis. Journal of Clinical Oncology. 2014;32(28):3144–55.

Briggs AH. Handling Uncertainty in Cost-Effectiveness Models. PharmacoEconomics. 2000;17(5):479–500.

Komorowski M, Raffa J. Markov Models and Cost Effectiveness Analysis: Applications in Medical Research. Secondary Analysis of Electronic Health Records: Springer International Publishing; 2016. p. 351–67.

O’Mahony JF, Newall AT, van Rosmalen J. Dealing with Time in Health Economic Evaluation: Methodological Issues and Recommendations for Practice. PharmacoEconomics. 2015;33(12):1255–68.

Bianchi G, Campanacci L, Ronchetti M, Donati D. Electrochemotherapy in the Treatment of Bone Metastases: A Phase II Trial. World Journal of Surgery. 2016;40(12):3088–94.

Brizio M, Ribero S, Campana LG, Clover AJP, Gehl J, Kunte C, et al. International Network for Sharing Practices on Electrochemotherapy (InspECT): An Integrative Patients Treatment Consortium. Handbook of Electroporation: Springer International Publishing; 2016. p. 1–18.

The Cancer Registry of Republic of Slovenia. Available from: http://www.onko-i.si/rrs/.

Trakatelli M, Morton C, Nagore E, Ulrich C, Del Marmol V, Peris K. Update of the European guidelines for basal cell carcinoma management. European Journal of Dermatology 2014;24(3):312–29.

Marty M, Sersa G, Garbay JR, Gehl J, Collins CG, Snoj M, et al. Electrochemotherapy – An easy, highly effective and safe treatment of cutaneous and subcutaneous metastases: Results of ESOPE (European Standard Operating Procedures of Electrochemotherapy) study. European Journal of Cancer Supplements. 2006;4(11):3–13.

Campana LG, Clover AJ, Valpione S, Quaglino P, Gehl J, Kunte C, et al. Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review. Radiology and oncology. 2016;50(1):1–13.

Larkin JO, Collins CG, Aarons S, Tangney M, Whelan M, O??Reily S, et al. Electrochemotherapy. Annals of Surgery. 2007;245(3):469–79.

Sersa G, Cufer T, Paulin SM, Cemazar M, Snoj M. Electrochemotherapy of chest wall breast cancer recurrence. Cancer Treatment Reviews. 2012;38(5):379–86.

Mariotto AB, Robin Yabroff K, Shao Y, Feuer EJ, Brown ML. Projections of the Cost of Cancer Care in the United States: 2010–2020. JNCI Journal of the National Cancer Institute. 2011;103(2):117–28.

National Cancer Institute, Cancer Prevalence and Cost of Care Projec- tions. Available from: https://costprojections.cancer.gov/.

David Parkin. Techniques of Economic Appraisal (Including Cost- Effectiveness Analysis and Modelling, Cost-Utility Analysis, Option Ap- praisal and Cost-Benefit Analysis, the Measurement of Health Benefits in Terms of QALYs and Related Measures E.g. DALYs). Health Economics 4d. Available from: https://www.healthknowledge.org.uk/public-health-textbook/medical-sociology-policy-economics/4d-health-economics/economic-appraisal.

Black WC. The CE Plane. Medical Decision Making. 1990;10(3):212–4.

Lido P, Paolino G, Feliziani A, Santurro L, Montuori M, Sanctis Fd, et al. Cutaneous metastasis of unknown primary presenting as massive and invasive abdominal lesion: an elective approach. Anais Brasileiros de Dermatologia. 2015;90(6):879–82.

Ribero S, Balagna E, Sportoletti Baduel E, Picciotto F, Sanlorenzo M, Fierro MT, et al. Efficacy of electrochemotherapy for eruptive legs keratoacanthomas. Dermatologic Therapy. 2016;29(5):345–8.

Refaat T, Choi M, Gaber G, Kiel K, Mehta M, Gradishar W, et al. Markov Model and Cost-Effectiveness Analysis of Bevacizumab in HER2-Negative Metastatic Breast Cancer. American Journal of Clinical Oncology. 2014;37(5):480–5.

Cost of living index. [July 4, 2016] Available from: https://www.expatistan.com/cost-of-living/index/europe.

Bertino G, Sersa G, De Terlizzi F, Occhini A, Plaschke CC, Groselj A, et al. European Research on Electrochemotherapy in Head and Neck Cancer (EURECA) project: Results of the treatment of skin cancer. European Journal of Cancer. 2016;63:41–52.

Amin MB, Edge SB, Greene FL, Byrd DR, Brookland RK, Washington MK, et al. Organization of the AJCC Cancer Staging Manual. AJCC Cancer Staging Manual: Springer International Publishing; 2016. p. 31–7.

Pecchia L, Bracale U, Bracale M. Health Technology Assessment of Home Monitoring for the Continuity of Care of patient suffering from congestive heart failure. IFMBE Proceedings: Springer Berlin Heidelberg; 2009. p. 184–7.

Ijzerman MJ, Koffijberg H, Fenwick E, Krahn M. Emerging Use of Early Health Technology Assessment in Medical Product Development: A Scoping Review of the Literature. PharmacoEconomics. 2017;35(7):727–40.

Fasterholdt I, Krahn M, Kidholm K, Yderstræde KB, Pedersen KM. Review of early assessment models of innovative medical technologies. Health Policy. 2017;121(8):870–9.

Published
2018-03-02
How to Cite
1.
Pirc E, Pecchia L, Reberšek M, Serša G, Snoj M, Grošelj A, Miklvavčič D. Study design of a medical device pre-market assessment: a case study on electrochemotherapy. SlovMedJour [Internet]. 2Mar.2018 [cited 19Dec.2018];87(1-2). Available from: https://vestnik.szd.si/index.php/ZdravVest/article/view/2482