Treatments of Advanced Non‑Small Cell Lung Cancer (NSCLC) in an Italian Center: Drug Utilization and the Treatment Costs of Innovative Drugs

Francovito Piantedosi, Raffaela Cerisoli, Ciro Battiloro, Francesca Andreozzi, Fabiana Vitiello, Marina Gilli, Valeria De Marino, Antonietta Letizia, Antonella Bianco, Ivana Caprice, Adele Savoia, Adriano Cristinziano, Giorgia Smeraglio, Danilo Rocco

DOI: https://doi.org/10.7175/fe.v20i1.1376

Abstract

AIM: To provide an updated picture of the therapies most commonly used in the advanced Non-Small Cell Lung Cancer (NSCLC) setting, together with the relevant costs.
METHODS: This study considered the clinical records of patients affected by stage IIIb and IV NSCLC treated in the AORN dei Colli - Plesso Monaldi in Naples during the period January 2016-July 2017 and diagnosed since 2014, as well as the pathology lab database. Multivariate analyses were performed in order to identify the main predictors of time to next treatment and the main cost drivers.
RESULTS: Data were collected on 575 patients, who were mainly affected by adenocarcinoma (62%) and squamous cell carcinoma (34%). 64% of patients were reported having been tested for molecular biomarkers (among the patients tested, 13% were EGFR+, 4% Alk t, and 1% ROS1 t). In accordance with the international guidelines, chemotherapy – as single agent or platinum-based doublets – was the prevalent first-line treatment, except among EGFR+ and ROS1 t patients, for whom the target therapy was authorized as first-line therapy. As second-line treatment, the target therapy and immune checkpoint inhibitors (nivolumab) were the most commonly used treatments. Drug expenditure per patient was remarkably higher in mutated patients (€ 29,053) versus wild-type patients, or patients with unknown mutational status (€ 11,854), who received just chemotherapy. The costs sustained in 2017 are proportionally higher than those sustained in 2016, mainly
due to the increasing eligibility to target therapy and immune checkpoint inhibitors and the wider biomarker analysis performed. From multivariate analyses, among the predictors of a longer time to next treatment (TTNT) were a better performance status and target therapy both in first and second line. The therapy for squamous cell carcinoma and other nonadeno histotypes turned out to be less expensive in patients treated just in the first line than that for adenocarcinoma and adenosquamous carcinoma. The use of immune checkpoint inhibitors in the second line results in increased costs compared to the use of chemotherapy. Also the target therapy in the first line results in an increase in the total costs with respect to chemotherapy in patients who received just a first-line therapy.
CONCLUSIONS: Generally, in this study population, the treatments administered are in accordance with the international guidelines. The costs borne by the Health Systems are higher for the target therapy and the immune checkpoint inhibitors.

Keywords

Carcinoma; Non-Small Cell Lung Cancer; Economics; Mutation

Full Text

HTML PDF

References

  • AIOM, CCM, AIRTUM. I numeri del cancro in Italia 2016. Roma: Il Pensiero Scientifico Editore, 2016
  • Savic Prince S, Bubendorf L. Predictive potential and need for standardization of PD-L1 immunohistochemistry. Virchows Arch 2018 Sep 1 [Epub ahead of print]; https://doi.org/10.1007/s00428-018-2445-7
  • Hanna N, Johnson D, Temin S, et al. Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update Summary. J Oncol Pract 2017; 13: 832-7; https://doi.org/10.1200/JOP.2017.026716; https://doi.org/10.1200/JCO.2017.74.6065
  • Novello S, Barlesi F, Califano R, et al; ESMO Guidelines Committee. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2016; 27(suppl 5): v1-v27; https://doi.org/10.1093/annonc/mdw326
  • ESMO Guidelines Committee. eUpdate 28 June 2017: Treatment Recommendations and Revised ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) Grading for Metastatic Non-small-cell Lung Cancer. Available at http://www.esmo.org/Guidelines/Lung-and-Chest-Tumours/Metastatic-Non-Small-Cell-Lung-Cancer/eUpdate-Treatment-Recommendation (last accessed November 2018)
  • ESMO Guidelines Committee. eUpdate 28 June 2017: New eUpdate featuring Updated Treatment Algorithms for Metastatic Non-small-cell Lung Cancer. Available at http://www.esmo.org/Guidelines/Lung-and-Chest-Tumours/Metastatic-Non-Small-Cell-Lung-Cancer/eUpdate-Treatment-Algorithms (last accessed November 2018)
  • National Comprehensive Cancer Reports®. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Version 1.2018. Non-Small Cell Lung Cancer. Available at https://www.nccn.org/professionals/physician_gls/recently_updated.aspx (last accessed November 2018)
  • Crinò L, Metro G, Baldini E, et al. AIOM. Linee guida neoplasia del polmone. Edizione 2016. Available at http://www.aiom.it/C_Common/Download.asp?file=/$Site$/files/doc/LG/2016_LG_AIOM_Polmone.pdf (last accessed November 2018)
  • Ascierto PA, Cartenì G, Gridelli C, et al. What have we learned from immunotherapy? Report from the 3rd and 4th meetings of the Campania Society of Oncology Immunotherapy (SCITO). J Immunother Cancer 2016; 4: 41; https://doi.org/10.1186/s40425-016-0144-y
  • Keytruda. Riassunto delle caratteristiche del prodotto
  • de Marinis F, Ardizzoni A, Fontanini G, et al; LIFE Study Team. Management of Italian patients with advanced non-small-cell lung cancer after second-line treatment: results of the longitudinal phase of the LIFE observational study. Clin Lung Cancer 2014; 15: 338-45.e1; https://doi.org/10.1016/j.cllc.2014.04.004
  • Agenzia Italiana del Farmaco. Determina 16 febbraio 2017. Regime di rimborsabilità e prezzo a seguito di nuove indicazioni terapeutiche del medicinale per uso umano «Opdivo». (Determina n. 252/2017). (17A01392) (GU Serie Generale n.43 del 21-02-2017). http://www.gazzettaufficiale.it/eli/id/2017/02/21/17A01392/sg;jsessionid=SQ5FyToybg0qsmQstokMJA__.ntc-as5-guri2a
  • Edge SB, Byrd DR, Compton CC, et al. (editors). AJCC cancer staging manual (7th ed). New York, NY: Springer; 2010
  • Agenzia Italiana del Farmaco. Determinazione 20 marzo 2008. Gazzetta Ufficiale della Repubblica Italiana – Serie Generale n. 76, 31-3-2008
  • Friedman J, Hastie T, Tibshirani R. Regularization Paths for Generalized Linear Models via Coordinate Descent. Journal of Statistical Software 2010; 33: 1-22; https://doi.org/10.18637/jss.v033.i01
  • R Core Team (2013) R: A language and environment for statistical computing R Foundation for Statistical Computing, Vienna, Austria URL http://www.r-project.org/
  • de Castro J, Tagliaferri P, de Lima VCC, et al. Systemic therapy treatment patterns in patients with advanced non-small cell lung cancer (NSCLC): PIvOTAL study. Eur J Cancer Care (Engl) 2017; 26; 1-15; https://doi.org/10.1111/ecc.12734
  • Masters GA, Temin S, Azzoli CG, et al. Systemic therapy for stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol 2015; 33: 3488-515; https://doi.org/10.1200/JCO.2015.62.1342
  • Narod A. Guideline on Stage IV Non-Small-Cell Lung Cancer Therapy Updated. August 14, 2017
  • Carrato A, Vergnenègre A, Thomas M, et al. Clinical management patterns and treatment outcomes in patients with non-small cell lung cancer (NSCLC) across Europe: EPICLIN-Lung study. Curr Med Res Opin 2014; 30: 447-61; https://doi.org/10.1185/03007995.2013.860372
  • Jeremić B, Miličić B, Milisavljevic S. Clinical prognostic factors in patients with locally advanced (stage III) nonsmall cell lung cancer treated with hyperfractionated radiation therapy with and without concurrent chemotherapy: single-Institution Experience in 600 Patients. Cancer 2011; 117: 2995-3003; https://doi.org/10.1002/cncr.25910
  • Schild SE, Tan AD, Wampfler JA, et al. A new scoring system for predicting survival in patients with non-small cell lung cancer. Cancer Med 2015; 4: 1334-43; https://doi.org/10.1002/cam4.479
  • Osservatorio Nazionale sull’impiego dei Medicinali. L’uso dei farmaci in Italia. Rapporto Nazionale 2017. Roma: Agenzia Italiana del Farmaco, 2018. Available at http://www.aifa.gov.it/content/luso-dei-farmaci-italia-rapporto-osmed-2017 (last accessed July 2018)
  • Collicelli C, Maietta F, Castro C, et al. L’impatto dei farmaci innovativi sulla sanità italiana. 8° Rapporto sulla condizione assistenziale dei malati oncologici. Roma 12-15 maggio 2016. XI Giornata nazionale del malato oncologico. Available at https://www.favo.it/ottavo-rapporto.html (last accessed November 2018)
  • Melazzini M. Recepire l’innovazione e garantire sostenibilità al sistema il contributo dell’AIFA. Italian Health Policy Brief 2017; 7: 1-3
  • Agenzia Italiana del Farmaco. Criteri per la classificazione dei farmaci innovativi e dei farmaci oncologici innovativi (05/04/2017). Comunicazione AIFA. Available at http://www.agenziafarmaco.gov.it/content/criteri-la-classificazione-dei-farmaci-innovativi-e-dei-farmaci-oncologici-innovativi-050420 (last accessed November 2018)
  • Curto A, Scroccaro G. Il ruolo delle regioni. Quaderni della SIF 2017; 13: 18-20
  • AIFA, 2017c. ALLEGATO 2 Fondo farmaci oncologici innovative. Available at http://www.aifa.gov.it/sites/default/files/ALLEGATO-2_Fondo_farmaci_oncologici_innovativi_26.06.2017.pdf (last accessed December 2018)
  • Matter-Walstra K, Schwenkglenks M, Aebi S, et al.; Swiss Group for Clinical Cancer Research. A Cost-Effectiveness Analysis of Nivolumab versus Docetaxel for Advanced Nonsquamous NSCLC Including PD-L1 Testing. J Thorac Oncol 2016; 11: 1846-55; https://doi.org/10.1016/j.jtho.2016.05.032
  • NICE appraisal, Nivolumab for previously treated locally advanced or metastatic non-squamous non-small-cell lung cancer [ID900] https://www.nice.org.uk/guidance/indevelopment/gid-tag524/documents 1 November, 2017
  • Restelli U, Artale S, Pacelli V, et al. Budget impact analysis of a patients’ selection strategy based on the expression of Programmed-Death Ligand 1 for the administration of immuno-oncologic treatments to patients affected with Non-Small Cell Lung Cancer in Italy. Clinicoeconomics Italian articles on outcomes research 2017; 12: 155-64
  • NICE 2017b. Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer. 28 June 2017. Available at https://www.nice.org.uk/guidance/indevelopment/gid-ta10092/documents (last accessed December 2018)
  • NICE 2017c. Pembrolizumab for treating PDL1-positive non-small-cell lung cancer after chemotherapy. Technology appraisal guidance. Published: 11 January 2017. Available at https://www.nice.org.uk/guidance/ta428/resources/pembrolizumab-for-treating-pdl1positive-nonsmallcell-lung-cancer-after-chemotherapy-pdf-82604670410437 (last accessed December 2018)
  • Scottish Medicines Consortium. pembrolizumab 50mg powder for concentrate for solution for infusion (Keytruda® ) SMC No. (1204/17). 16 January 2017. Available at https://www.scottishmedicines.org.uk/files/advice/pembrolizumab_Keytruda_FINAL_Dec_2016_amended_020117_for_website.pdf (last accessed December 2018)
  • Haute Autorité de Santé (HAS). Commission De La Transparence Avis 3 mai 2017. Available at https://www.has-sante.fr/portail/upload/docs/evamed/CT-15634_KEYTRUDA_PIC_EI_poumon_Avis3_modifiele03052017_CT15634.pdf (last accessed December 2018)

Statistics

Abstract: 292 views
HTML: 98 views
PDF: 104 views

Refbacks

  • There are currently no refbacks.




© SEEd srl