Cost-effectiveness analysis of oral nutritional supplements with nutritional counselling in head and neck cancer patients undergoing radiotherapy

Beatrice Martin, Emanuele Cereda, Riccardo Caccialanza, Paolo Pedrazzoli, Rosanna Tarricone, Oriana Ciani, Beatrice Martin, Emanuele Cereda, Riccardo Caccialanza, Paolo Pedrazzoli, Rosanna Tarricone, Oriana Ciani

Abstract

Objective: There is limited evidence regarding the economic effects of nutrition support in cancer patients. This study aims at investigating the cost-effectiveness profile of systematic oral nutritional supplementation (ONS) in head and neck cancer (HNC) patients undergoing radiotherapy (RT) and receiving nutritional counseling.

Methods: A cost-effectiveness analysis based on a RCT was performed to estimate direct medical costs, life years gained (LYG) and Quality-Adjusted Life Years (QALY) for nutritional counseling with or without ONS at 5-month and 6-year follow up time. Value of information analysis was performed to value the expected gain from reducing uncertainty through further data collection.

Results: ONS with nutritional counseling produced higher QALY than nutritional counseling alone (0.291 ± 0.087 vs 0.288 ± 0.087), however the difference was not significant (0.0027, P = 0.84). Mean costs were €987.60 vs €996.09, respectively in the treatment and control group (-€8.96, P = 0.98). The Incremental Cost Effectiveness Ratio (ICER) was -€3,277/QALY, with 55.4% probabilities of being cost-effective at a cost-effectiveness threshold of €30,000/QALY. The Expected Incremental Benefit was €95.16 and the Population Expected Value of Perfect Information was €8.6 million, implying that additional research is likely to be worthwhile. At a median 6-year follow up, the treatment group had a significantly better survival rate when adjusting for late effect (P = 0.039).

Conclusion: Our findings provide the first evidence to inform decisions about funding and reimbursement of ONS in combination with nutritional counseling in HNC patients undergoing RT. ONS may improve quality of cancer care at no additional costs, however further research on the cost-effectiveness of nutritional supplementation is recommended.

Trial registration: ClinicalTrials.gov: NCT02055833. Registered 5th February 2014 https://ichgcp.net/clinical-trials-registry/NCT02055833.

Conflict of interest statement

BM, OC, RT, PP declare no conflict of interest in relation to this study. RC and EC has served in advisory boards for Nestlè Health Science.

Figures

Fig. 1
Fig. 1
Utility profile of treatment (ONS + nutritional counseling) and control (nutritional counseling) group
Fig. 2
Fig. 2
Cost Effectiveness Plane (on the left) at a WTP = €30,000/QALY and Acceptability Curve (on the right)
Fig. 3
Fig. 3
Survival curves of treatment and control group

References

    1. Elia M, Normand C, Norman K, Laviano A. A systematic review of the cost and cost effectiveness of using standard oral nutritional supplements in the hospital setting. Clin Nutr. 2016;35(2):370–380. doi: 10.1016/j.clnu.2015.05.010.
    1. Elia M, Normand C, Laviano A, Norman K. A systematic review of the cost and cost effectiveness of using standard oral nutritional supplements in community and care home settings. Clin Nutr. 2016;35(1):125–137. doi: 10.1016/j.clnu.2015.07.012.
    1. Elia M, Russell C. Combating malnutrition: recommendations for action. A report from the advisory group of malnutrition, led by BAPEN. Report No.: 978 1 899467 36 5, London; 2009.
    1. Citak E, Tulek Z, Uzel O. Nutritional status in head and neck cancer patients. Rev Med Pharmacol Sci. 2007;1993:239–243.
    1. Hébuterne X, Lemarié E, Michallet M, et al. Prevalence of malnutrition and current use of nutrition support in patients with cancer. JPEN. 2014;38:196–204. doi: 10.1177/0148607113502674.
    1. Dechaphunkul T, Martin L, Alberda C, Olson K, Baracos V, Gramlich L. Malnutrition assessment in patients with cancers of the head and neck A call to action and consensus. Crit Rev Oncol Hematol. 2013;88:459–476. doi: 10.1016/j.critrevonc.2013.06.003.
    1. Gorenc M, Kozjek N, Strojan P. Malnutrition and cachexia in patients with head and neck cancer treated with (chemo)radiotherapy. Rep Pract Oncol Radiother. 2015;20(4):249–258. doi: 10.1016/j.rpor.2015.03.001.
    1. Ravasco P. Nutritional support in head and neck cancer how and why. Anti- Cancer Drugs. 2011;22:639–646. doi: 10.1097/CAD.0b013e328345b4c5.
    1. Colasanto JM, Prasad P, Decker RH, Wilson LD. Nutritional support of patients undergoing radiation therapy for head and neck cancer. Oncology. 2005;19:371–379.
    1. Ng K, Leung SF, Johnson PJ, Woo J. Nutritional consequences of radiotherapy in nasopharynx cancer patients. Nutr Cancer. 2004;49:156–161. doi: 10.1207/s15327914nc4902_6.
    1. Bossola M. Nutritional interventions in head and neck cancer patients undergoing chemoradiotherapy a narrative review. Nutrients. 2015;7:265–276. doi: 10.3390/nu7010265.
    1. Rosenthal D. Consequences of mucositis-induced treatment breaks and dose reductions on head and neck cancer treatment outcomes. J Support Oncol. 2007;9(suppl 4):23–31.
    1. Lin A, Jabbari S, Worden FP, Bradford CR, Chepeha DB, Teknos TN, Liao JJ, Nyquist GG, Tsien C, Schipper MJ, Urba S, Wolf GT, Eisbruch A. Metabolic abnormalities associated with weight loss during chemoirradiation of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2005;63:1413–1418. doi: 10.1016/j.ijrobp.2005.05.012.
    1. Langius JAE, Zandbergen MC, Eerenstein SEJ, van Tulder MW, Leemans CR, Kramer MHH, Weijs PJ. Effect of nutritional interventions on nutritional status, quality of life and mortality in patients with head and neck cancer receiving (chemo)radiotherapy a systematic review. Clin Nutr. 2013;32:671–678. doi: 10.1016/j.clnu.2013.06.012.
    1. Paccagnella A, Morello M, Mosto MCD, Baruffi C, Marcon ML, Gava A, Baggio V, Lamon S, Babare R, Rosti G, Giometto M, Boscolo-Rizzo P, Kiwanuka E, Tessarin M, Caregaro L, Marchiori C. Early nutritional intervention improves treatment tolerance and outcomes in head and neck cancer patients undergoing concurrent chemoradiotherapy. Support Care Cancer. 2010;18:837–845. doi: 10.1007/s00520-009-0717-0.
    1. Cawood AL, Elia M, Stratton RJ. Systematic review and meta-analysis of the effects of high protein oral nutritional supplements. Ageing Res. 2012;11:278–296. doi: 10.1016/j.arr.2011.12.008.
    1. Stratton RJ, H’ebuterne X, Elia M. A systematic reviewand meta-analysis of the impact of oral nutritional supplements on hospital readmissions. Ageing Res. 2013;12:884–897. doi: 10.1016/j.arr.2013.07.002.
    1. Cereda E, Cappello S, Colombo S, Klersy C, Imarisio I, Turri A, Caraccia M, Borioli V, Monaco V, Benazzo M, Pedrazzoli P, Corbella F, Caccialanza R. Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy. Radiother Oncol. 2018;126:81–88. doi: 10.1016/j.radonc.2017.10.015.
    1. Hofmarcher T, Lindgren P, Wilking N, Jönsson B. The cost of cancer in Europe 2018. Eur J Cancer. 2020;129:41–49. doi: 10.1016/j.ejca.2020.01.011.
    1. Bray F, Sankila R, Ferlay J, Parkin D. Estimates of cancer incidence and mortality in Europe in 1995. Eur J Canc. 2002;38(1):99–166. doi: 10.1016/S0959-8049(01)00350-1.
    1. Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol. 2007;18(3):581–592. doi: 10.1093/annonc/mdl498.
    1. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs A, Mauskopf J, Loder E, Force CT. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Value Health. 2013;16(2):231–250. doi: 10.1016/j.jval.2013.02.002.
    1. Beck ACC, Kieffer JM, Retèl VP, van Overveld LFJ, Takes RP, van den Brekel MWM, van Harten WH, Stuiver MM. Mapping the EORTC QLQ-C30 and QLQ-H&N35 to the EQ-5D for head and neck cancer: can disease-specific utilities be obtained? PLoS One. 2019;14(12):e0226077. doi: 10.1371/journal.pone.0226077.
    1. Rubin DB. Multiple imputation for nonresponse in surveys. Wiley; 1987.
    1. Sanitaria AIE. Proposta di linee guida per la valutazione economica degli interventi sanitari. Poilitiche Sanitarie. 2009;10:91–99.
    1. AIRTUM. I numeri del cancro in Italia. 2019. .
    1. Schmidt H. Chronic disease prevention and health promotion. Springer; 2016.
    1. Freidlin B, Korn EL. Methods for accommodating nonproportional hazards in clinical trials ready for the primary analysis. J Clin Oncol. 2019;10:35.
    1. Baio G, Berardi A, Heath A. Bayesian cost-effectiveness analysis with the R package BCEA. International Springer; 2017.
    1. Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic evaluations in clinical trials. 2. Oxford University Press; 2015.
    1. Thorn J, Coast J, Andronis L. Interpretation of the expected value of perfect information and research recommendations: a systematic review and empirical investigation. Med Decis Making. 2016;36(3):285–295. doi: 10.1177/0272989X15586552.
    1. Fleming TR, Harrington DP. Counting processes and survival analysis. New York: Wiley; 1981.
    1. Tyler R, Barrocas A, Guenter P, Araujo T, Bechtold M, Chan L, Collier B, Collins N, Evans D, Godamunne K, Hamilton C, Hernandez B, Mirtallo J, Nadeau W, Partridge J, Perugini M, Valladares A. ASPEN value project scientific advisory council. value of nutrition support therapy: impact on clinical and economic outcomes in the United States. JPEN J Parenter Enteral Nutr. 2020;44(3):395–406. doi: 10.1002/jpen.1768.
    1. Elia M, Stratton R, Russell C, Green C, Pang F. The cost of disease-related malnutrition in the UK and economic considerations for the use of oral nutritional supplements (ONS) in adults. A report by the Health Economic Group of The British Association for Parenteral and Enteral Nutrition (BAPEN). BAPEN; Report No. 2005. vol. 1, p. 89946
    1. Zhong Y, Cohen J, Goates S, Luo M, Nelson J, Neumann P. The cost-effectiveness of oral nutrition. Appl Health Econ Health Policy. 2017;15:75–83. doi: 10.1007/s40258-016-0269-7.
    1. Neelemaat F, Bosmans JE, Thijs A, Seidell JC, van Bokhorst-de van der Schueren MA. Oral nutritional support in malnourished elderly decreases functional limitations with no extra costs. Clin Nutr 2012; 31: 183-190
    1. Ballesteros-Pomar MD, Llińas DM, Goates S, Barriuso RS, Sanz-Paris A. Cost-effectiveness of a specialized oral nutritional supplementation for older adult patients in Spain. Nutrients. 2018;10:246. doi: 10.3390/nu10020246.
    1. Norman K, Pirlich M, Smoliner C, Kilbert A, Schulzke JD, Ockenga J, Lochs H, Reinhold T. Cost-effectiveness of a 3-month intervention with oral nutritional supplements in disease-related malnutrition a randomised controlled pilot study. Eur J Clin Nutr. 2011;65:735–742. doi: 10.1038/ejcn.2011.31.
    1. Wyers CE, Reijven PL, Evers SM, et al. Cost-effectiveness of nutritional intervention in elderly subjects after hip fracture. A randomized controlled trial. Osteoporos Int. 2013;24:151–162. doi: 10.1007/s00198-012-2009-7.
    1. Smedley F, Bowling T, James M, Stokes E, Goodger C, O’Connor O, et al. Randomized clinical trial of the effects of preoperative and postoperative oral nutritional supplements on clinical course and cost of care. Br J Surg. 2004;91:983–990. doi: 10.1002/bjs.4578.
    1. Seguy D, Hubert H, Robert J, Meunier JP, Guerin O, Raynaud-Simon A. Compliance to oral nutritional supplementation decreases the risk of hospitalisation in malnourished older adults without extra health care cost: Prospective observational cohort study. Clin Nutr. 2019;39(6):1900–19007. doi: 10.1016/j.clnu.2019.08.005.
    1. Byford S, Raftery J. Perspectives in economic evaluation. Br Med J. 1998;316(7143):1529–1530. doi: 10.1136/bmj.316.7143.1529.
    1. Jonsson B. Ten arguments for a societal perspective in the economic evaluation of medical innovations. Eur J Health Econ. 2009;10(4):357–359. doi: 10.1007/s10198-009-0173-2.
    1. Neumann P, Sanders G, Russell L, Siegel J, Ganiats T. Cost effectiveness in health and medicine. Oxford University Press; 2016.
    1. Walker S, Griffin S, Asaria M, et al. Striving for a societal perspective: a framework for economic evaluations when costs and effects fall on multiple sectors and decision makers. Appl Health Econ Health Policy. 2019;17(5):577–590. doi: 10.1007/s40258-019-00481-8.
    1. Lee JW. Some versatile tests based on the simultaneous use of weighted log-rank statistics. Biometrics. 1996;52:721–725. doi: 10.2307/2532911.
    1. Lin CY, Kosorok MR. The versatility of function-indexed weighted log-rank statistics. J Am Stat Assoc. 1999;94:320–332. doi: 10.1080/01621459.1999.10474145.
    1. Yang S, Prentice R. Improved log rank-type tests for survival data using adaptive weights. Biometrics. 2010;66:30–38. doi: 10.1111/j.1541-0420.2009.01243.x.
    1. Karrison T. Versatile tests for comparing survival curves based on weighted logrank statistics. Stand Genomic Sci. 2016;16:678–690.
    1. Kim H, Vargo JA, Beriwal S, et al. Cost-effectiveness analysis of salvage therapies in locoregional previously irradiated head and neck cancer. Head Neck. 2018;40:1743–1751. doi: 10.1002/hed.25037.
    1. Banz K, Bischoff H, Brunnera M, Chouaidc C, De Castro Carpe˜no J, de Marinise F, Grossif F, Vergnengreg A, Walzer S. Comparison of treatment costs of grade 34 adverse events associated with erlotinib or pemetrexed maintenance therapy for patients with advanced non-small-cell lung cancer (NSCLC) in Germany, France, Italy, and Spain. Lung Cancer. 2011;74:529–534. doi: 10.1016/j.lungcan.2011.04.010.

Source: PubMed

3
Subscribe