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SMABcare study: subcutaneous monoclonal antibody in cancer care: cost-consequence analysis of subcutaneous rituximab in patients with follicular lymphoma

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Abstract

Rituximab is used as a standard of care for follicular lymphoma and is usually administered intravenously. A novel subcutaneous formulation recently showed non-inferior efficacy with similar pharmacokinetic and safety profiles compared to intravenous rituximab in patients with follicular lymphoma. This new approach is promising in terms of comfort for patients and time-saving for hospital staff. To evaluate the real-life economic impact of subcutaneous rituximab as maintenance therapy in patients with follicular lymphoma in real life, we conducted a cost-consequence analysis from the hospital’s point of view in three French teaching hospitals. Health-related quality of life (EQ-5D-3L) was investigated as well as patients’ and nurses’ perception. Compared to intravenous rituximab, subcutaneous administration showed an estimated cost-saving of €109.20 per patient per cycle (p < 0.001), 78.6% of which could be attributed to the rituximab cost. Health-related quality of life showed no significant difference between the two groups despite tendencies for greater pain in the subcutaneous group and greater anxiety in the intravenous group. Thus, subcutaneous rituximab had a favorable pharmacoeconomic profile, with clinical efficacy similar to that of intravenous rituximab. The subcutaneous form was preferred by almost all patients, but further consideration should be given to improve the patients’ experience: a dedicated day unit with trained medical, nursing, and pharmaceutical staff could be helpful.

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References

  1. Monnereau A, Remontet L, Maynadié M, et al (2013) Lymphome folliculaire. In: Estim. Natl. L’incidence Cancers En Fr. Entre 1980 2012 Partie 2—Hémopathies Malignes. Institut de Veille Sanitaire, Saint Maurice (Fra), p 24–27

  2. Sant M, Allemani C, Tereanu C et al (2010) Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project. Blood 116:3724–3734

    Article  CAS  PubMed  Google Scholar 

  3. Tan D, Horning SJ, Hoppe RT et al (2013) Improvements in observed and relative survival in follicular grade 1-2 lymphoma during 4 decades: the Stanford University experience. Blood 122:981–987

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Zinzani PL, Marchetti M, Billio A et al (2013) SIE, SIES, GITMO revised guidelines for the management of follicular lymphoma. Am J Hematol 88:185–192

    Article  CAS  PubMed  Google Scholar 

  5. Dreyling M, Ghielmini M, Rule S et al (2016) Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 27:v83–v90

    Article  CAS  PubMed  Google Scholar 

  6. Salles G, Seymour JF, Offner F et al (2011) Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet Lond Engl 377:42–51

    Article  CAS  Google Scholar 

  7. Vidal L, Gafter-Gvili A, Salles G et al (2011) Rituximab maintenance for the treatment of patients with follicular lymphoma: an updated systematic review and meta-analysis of randomized trials. J Natl Cancer Inst 103:1799–1806

    Article  CAS  PubMed  Google Scholar 

  8. Salles GA, Seymour JF, Feugier P, et al (2013) Updated 6 year follow-up of the PRIMA study confirms the benefit of 2-year rituximab maintenance in follicular lymphoma patients responding to frontline immunochemotherapy. In: Blood. New Orleans, p 21

  9. Shpilberg O, Jackisch C (2013) Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer 109:1556–1561

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. F. Hoffmann-La Roche RCP MabThera SC. https://www.roche.fr/content/dam/roche_france/fr_FR/doc/Produits/Mabthera/MABTH1400IN_160526rcp.pdf. Accessed 11 Aug 2016

  11. Davies A, Mihaljevi B, Marcadal S, et al (2015) Comparison of subcutaneous and intravenous rituximab in the maintenance setting: updated safety results of the phase III SABRINA study in patients with follicular lymphoma. EHA Learning Center. https://learningcenter.ehaweb.org/eha/2015/20th/100828. Accessed 4 Jan 2016

  12. Davies A, Merli F, Mihaljevic B et al (2014) Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol 15:343–352

    Article  CAS  PubMed  Google Scholar 

  13. Rule S, Collins GP, Samanta K (2014) Subcutaneous vs intravenous rituximab in patients with non-Hodgkin lymphoma: a time and motion study in the United Kingdom. J Med Econ 17:459–468

    Article  PubMed  Google Scholar 

  14. Brédart A, Dolbeault S (2005) Évaluation de la qualité de vie en oncologie: I—Définitions et objectifs. Rev Francoph Psycho-Oncol 4:7–12

    Article  Google Scholar 

  15. Department of Economics and Public Health Assessment (2012) Choices in methods for economic evaluation. https://www.has-sante.fr. Accessed 25 Sept 2015

  16. Collège des économistes de la santé (CES) (2004) French guidelines for the economic evaluation of healthcare technologies: methodological recommendations 1–90

  17. Chevalier J, de Pouvourville G (2013) Valuing EQ-5D using time trade-off in France. Eur J Health Econ HEPAC Health Econ Prev Care 14:57–66

    Article  Google Scholar 

  18. Rovira J, Espín J, García L, Olry de Labry A (2011) The impact of biosimilars’ entry in the EU market. Andal Sch Pub Health 30:1–83

    Google Scholar 

  19. Lieutenant V, Toulza É, Pommier M, Lortal-Canguilhem B (2015) Herceptin® (trastuzumab) par voie sous-cutanée : une mini révolution ? Étude pharmaco-économique. Bull Cancer (Paris) 102:270–276

    Article  Google Scholar 

  20. Cesarec A, Likić R (2017) Budget Impact Analysis of Biosimilar Trastuzumab for the Treatment of Breast Cancer in Croatia. Appl Health Econ Health Policy 15:277-286. https://doi.org/10.1007/s40258-016-0285-7

  21. Rummel M, Kim TM, Aversa F et al (2017) Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol 28:836–842

    CAS  PubMed  Google Scholar 

  22. Deconinck E, Miadi-Fargier H, Pen CL, Brice P (2010) Cost effectiveness of rituximab maintenance therapy in follicular lymphoma: long-term economic evaluation. PharmacoEconomics 28:35–46

    Article  PubMed  Google Scholar 

  23. Witzens-Harig M, Reiz M, Heiss C et al (2009) Quality of life during maintenance therapy with the anti-CD20 antibody rituximab in patients with B cell non-Hodgkin’s lymphoma: results of a prospective randomized controlled trial. Ann Hematol 88:51–57

    Article  PubMed  Google Scholar 

  24. Cock ED, Kritikou P, Tao S et al (2013) Time savings with rituximab subcutaneous (SC) injection vs rituximab intravenous (IV) infusion: final analysis from a time-and-motion study in 8 countries. Blood 122:1724–1724

    Article  Google Scholar 

  25. Mihajlović J, Bax P, van Breugel E et al (2017) Microcosting study of rituximab subcutaneous injection versus intravenous infusion. Clin Ther 39:1221–1232.e4. https://doi.org/10.1016/j.clinthera.2017.05.342

    Article  PubMed  Google Scholar 

  26. Olofsson S, Norrlid H, Karlsson E et al (2016) Societal cost of subcutaneous and intravenous trastuzumab for HER2-positive breast cancer—an observational study prospectively recording resource utilization in a Swedish healthcare setting. Breast Edinb Scotl 29:140–146

    Article  Google Scholar 

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Acknowledgements

We would like to acknowledge the medical, pharmaceutical, and nursing teams of the three centers.

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Correspondence to Catherine Rioufol.

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The authors declare that they have no conflict of interest.

Research involving human participants and/or animals

This study was carried out in line with the Declaration of Helsinki, French regulations, and institutional guidelines; given the nature of this research, no ethics committee approval was needed.

Informed consent

For this type of study, formal consent is not required. An information note, in which the whole project was explained, was given and explained to patients before interview.

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Fargier, E., Ranchon, F., Huot, L. et al. SMABcare study: subcutaneous monoclonal antibody in cancer care: cost-consequence analysis of subcutaneous rituximab in patients with follicular lymphoma. Ann Hematol 97, 123–131 (2018). https://doi.org/10.1007/s00277-017-3147-y

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  • DOI: https://doi.org/10.1007/s00277-017-3147-y

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