References
- Copenhagen Economics. Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe. [cited 2018 Sep 12]. Available from: https://www.copenhageneconomics.com/publications/publication/study-on-the-economic-impact-of-supplementary-protection-certificates-pharmaceutical-incentives-and-rewards-in-europe
- Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469–478.
- Leveque D. Subcutaneous administration of anticancer agents. Anticancer Res. 2014;34(4):1579–1586.
- Jackisch C, Müller V, Maintz C, et al. Subcutaneous administration of monoclonal antibodies in oncology. Geburtshilfe Frauenheilkd. 2014;74(4):343–349.
- Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013;109(6):1556–1561.
- Senkus ES, Kyriakides S, Ohno S, et al. Primary breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26:v8–v30.
- Coates AS, Winer EP, Goldhirsch A, et al. Tailoring therapies—improving the management of early breast cancer: St Gallen international expert consensus on the primary therapy of early breast cancer. Ann Oncol. 2015;26:1533–1546.
- Giordano SH, Temin S, Kirshner JJ, et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American society of clinical oncology clinical practice guideline. J Clin Oncol. 2014;32(19):2078–2099.
- European Medicines Agency. Herceptin. Summary of product characteristics. [cited 2018 Sep 12]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf
- Ismael G, Hegg R, Muehlbauer S, et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I-III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol. 2012;13:869–878.
- De Cock E, Pivot X, Hauser N, et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016;5(3):389–397.
- Tjalma W, Huizing M, Papadimitriou K. The smooth and bumpy road of trastuzumab administration: from intravenous (IV) in a hospital to subcutaneous (SC) at home. Facts Views Vis Obgyn. 2017;9(1):51–55.
- Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673–1684.
- Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659–1672.
- Moja L, Tagliabue L, Balduzzi S, et al. Trastuzumab containing regimens for early breast cancer. Cochrane Database Syst Rev. 2012;4:CD006243.
- Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783–792.
- Lammers P, Criscitiello C, Curigliano G, et al. Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets. Pharmaceuticals (Basel). 2014;7(9):943–953.
- Elek P, Takács E, Merész G, et al. Implication of external price referencing and parallel trade on pharmaceutical expenditure: indirect evidence from lower-income European countries. Health Policy Plan. 2017;32(3):349–358.
- Sowa PM, Butler JRG, Connelly LB. Unmet medical needs and health care accessibility in seven countries of Eastern Europe. MPRA Paper 75619. Germany: University Library of Munich; 2014. [cited 2018 Sep 12]. Available from: https://mpra.ub.uni-muenchen.de/75619/
- Kaló Z, Vokó Z, Östör A, et al. Patient access to reimbursed biological disease-modifying antirheumatic drugs in the European region. J Mark Access Health Policy. 2017;5(1):1345580.
- Rémuzat C, Kapuśniak A, Caban A, et al. Supply-side and demand-side policies for biosimilars: an overview in 10 European member states. J Mark Access Health Policy. 2017;5(1):1307315.
- Moorkens E, Jonker-Exler C, Huys I, et al. Overcoming barriers to the market access of biosimilars in the European Union: the case of biosimilar monoclonal antibodies. Front Pharmacol. 2016;7:193.
- Inotai A, Csanadi M, Petrova G, et al. Patient access, unmet medical need, expected benefits, and concerns related to the utilisation of biosimilars in Eastern European countries: a survey of experts. Biomed Res Int. 2018. 9597362. Available from: https://www.ncbi.nlm.nih.gov/pubmed/29546072
- Inotai A, Csanádi M, Vitezic D, et al. Policy practices to maximise social benefit from biosimilars. J Bioequivalence Bioavailability. 2017;9:467–472.
- Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1–e34.
- Jackisch C, Kim SB, Semiglazov V, et al. Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study. Ann Oncol. 2015;26(2):320–325.
- Gligorov J, Curigliano V, Muller V, et al. Switching between intravenous and subcutaneous trastuzumab: safety results from the PrefHer trial. Breast. 2017;34:89–95.
- Pivot X, Gligorov J, Müller V, et al. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013;14(10):962–970.
- Pivot X, Gligorov J, Müller V, et al. Patients’ preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol. 2014;25(10):1979–1987.
- Pivot X, Verma S, Fallowfield L, et al. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017;86:82–90.
- Jackisch C, Hegg R, Stroyakovskiy D, et al. HannaH phase III randomised study: association of total pathological complete response with event-free survival in HER2-positive early breast cancer treated with neoadjuvant-adjuvant trastuzumab after 2 years of treatment-free follow-up. Eur J Cancer. 2016;62:62–75.
- Quartino AL, Hillenbach C, Li J, et al. Population pharmacokinetic and exposure-response analysis for trastuzumab administered using a subcutaneous manual syringe injection or intravenously in women with HER2-positive early breast cancer. Cancer Chemother Pharmacol. 2016;77(1):77–88.
- Pivot X, Spano JP, Espie M, et al. Patients’ preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: results of the randomised MetaspHer study. Eur J Cancer. 2017;82:230–236.
- Cebas AL, Cascajares SC, Bravo SP, et al. Subcutaneous versus intravenous administration of trastuzumab: preference of HER2+breast cancer patients and financial impact of its use. J Buon. 2017;22(2):334–339.
- Lopez-Vivanco G, Salvador J, Diez R, et al. Cost minimization analysis of treatment with intravenous or subcutaneous trastuzumab in patients with HER2-positive breast cancer in Spain. Clin Transl Oncol. 2017;19(12):1454–1461.
- North RT, Harvey VJ, Cox LC, et al. Medical resource utilization for administration of trastuzumab in a New Zealand oncology outpatient setting: a time and motion study. Clinicoecon Outcomes Res. 2015;7:423–430.
- Olofsson S, Norrlid H, Karlsson E, et al. 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. 2016;29:140–146.
- Olsen J, Jensen KF, Olesen DS, et al. Costs of subcutaneous and intravenous administration of trastuzumab for patients with HER2-positive breast cancer. J Comp Eff Res. 2018;7(5):411–419.
- Ponzetti C, Canciani M, Farina M, et al. Potential resource and cost saving analysis of subcutaneous versus intravenous administration for rituximab in non-Hodgkin’s lymphoma and for trastuzumab in breast cancer in 17 Italian hospitals based on a systematic survey. Clinicoecon Outcomes Res. 2016;8:227–233.
- Tjalma WAA, Van den Mooter T, Mertens T, et al. Subcutaneous trastuzumab (Herceptin) versus intravenous trastuzumab for the treatment of patients with HER2-positive breast cancer: A time, motion and cost assessment study in a lean operating day care oncology unit. Eur J Obstet Gynecol Reprod Biol. 2018;221:46–51.
- Farolfi A, Silimbani P, Gallegati D, et al. Resource utilization and cost saving analysis of subcutaneous versus intravenous trastuzumab in early breast cancer patients. Oncotarget. 2017;8(46):81343–81349.
- Papadmitriou K, Trinh XB, Altintas S, et al. The socio-economical impact of intravenous (IV) versus subcutaneous (SC) administration of trastuzumab: future prospectives. Facts Views Vis Obgyn. 2015;7(3):176–180.
- Stoner KL, Harder H, Fallowfield LJ, et al. Intravenous versus subcutaneous drug administration. Which do patients prefer? A systematic review. Patient. 2015;8:145–153.
- Harbo T, Andersen H, Hess A, et al. Subcutaneous versus intravenous immunoglobulin in multifocal motor neuropathy: a randomized, single-blinded cross-over trial. Eur J Neurol. 2009;16:631–638.
- Inotai A, Csanadi M, Harsanyi M, et al. Drug policy in Central Eastern Europe – Hungary. Value Health Reg Issues. 2017;13:16–22.
- World Health Organisation. Data and statistics. Shortage of nurses and midwives. [cited 2018 Sep 12]. Available from: http://www.euro.who.int/en/health-topics/Health-systems/nursing-and-midwifery/data-and-statistics
- Renwick MJ, Smolina K, Gladstone EJ, et al. Postmarket policy considerations for biosimilar oncology drugs. Lancet Oncol. 2016;17(1):e31–e38.
- Khor S, Beca J, Krahn M, et al. Real world costs and cost-effectiveness of Rituximab for diffuse large B-cell lymphoma patients: a population-based analysis. BMC Cancer. 2014;14:586.