Cost-Effectiveness and Net Monetary Benefit of olaparib Maintenance Therapy Versus No Maintenance Therapy After First-Line Platinum-Based Chemotherapy in Newly Diagnosed Advanced BRCA1/2-Mutated Ovarian Cancer in the Italian National Health Service

    • WHO International Agency for Research on Cancer

    Global cancer observatory (GCO).

    ()

  • GLOBOCAN 2018 Cancer Incidence And Mortality Worldwide: IARC Cancer Base. International Agency for Research on Cancer,
    2019
    • Doubeni C.A.
    • Doubeni A.R.B.
    • Myers A.E.

    Diagnosis and management of ovarian cancer.

    Am Fam Physician. 2016; 93: 937-944

    • Lisio M.A.
    • Fu L.
    • Goyeneche A.
    • Gao Z.H.
    • Telleria C.

    High-grade serous ovarian cancer: basic sciences, clinical and therapeutic standpoints.

    Int J Mol Sci. 2019; 20: 952

    • Jelovac D.
    • Armstrong D.K.

    Recent progress in the diagnosis and treatment of ovarian cancer.

    CA Canc J Clin. 2011; 61: 183-203

    • Bowtell D.D.
    • Bohm S.
    • Ahmed A.A.
    • et al.

    Rethinking ovarian cancer II: reducing mortality from high-grade serous ovarian cancer.

    Nat Rev Canc. 2015; 15: 668-679

  • Association of BRCA1/2 mutations with ovarian cancer prognosis: an updated meta-analysis.

    Medicine (Baltimore). 2018; 97: e9380

    • Neff R.T.
    • Senter L.
    • Salani R.

    BRCA mutation in ovarian cancer: testing, implications and treatment considerations.

    Ther Adv Med Oncol. 2017; 9: 519-531

    • Weiderpass E.
    • Tyczynski J.E.

    Epidemiology of patients with ovarian cancer with and without a BRCA1/2 mutation.

    Mol Diagn Ther. 2015; 19: 351-364

    • Colombo N.
    • Sessa C.
    • du Bois A.
    • et al.

    ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease dagger.

    Ann Oncol. 2019; 30: 672-705

    • Ledermann J.A.
    • Raja F.A.
    • Fotopoulou C.
    • Gonzalez-Martin A.
    • Colombo N.
    • Sessa C.

    Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.

    Ann Oncol. 2013; 24: vi24-vi32

    • Burger R.A.
    • Brady M.F.
    • Bookman M.A.
    • et al.

    Incorporation of bevacizumab in the primary treatment of ovarian cancer.

    N Engl J Med. 2011; 365: 2473-2483

    • Tewari K.S.
    • Burger R.A.
    • Enserro D.
    • et al.

    Final overall survival of a randomized trial of bevacizumab for primary treatment of ovarian cancer.

    J Clin Oncol. 2019; 37: 2317-2328

    • Coleman R.L.
    • Oza A.M.
    • Lorusso D.
    • et al.

    Rucaparib Maintenance Treatment for Recurrent Ovarian Carcinoma after Response to Platinum Therapy (ARIEL3): A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Trial.

    390. Lancet,
    London, England)2017: 1949-1961

    • Mirza M.R.
    • Monk B.J.
    • Herrstedt J.
    • et al.

    Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer.

    N Engl J Med. 2016; 375: 2154-2164

    • Pujade-Lauraine E.
    • Ledermann J.A.
    • Selle F.
    • et al.

    Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial.

    Lancet Oncol. 2017; 18: 1274-1284

  • ClinicalTrials.gov. Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy (SOLO-1) https://clinicaltrials.gov/ct2/show/NCT01844986. Last accessed: May 18, 2020.

    • Moore K.
    • Colombo N.
    • Scambia G.
    • et al.

    Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer.

    N Engl J Med. 2018; 379: 2495-2505

    • U.S. Food and Drug Administration (FDA)

    FDA Approved Olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the Maintenance Treatment of Adult Patients with Deleterious or Suspected Deleterious Germline or Somatic BRCA-Mutated (gBRCAm or sBRCAm) Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Are in Complete or Partial Response to First-Line Platinum-Based.

    ()19 December 2018

    • European Medicines Agency Committee for Medicinal Products for Human Use (EMA/CHMP)

    Summary of Opinion (Post Authorisation).

    ()28 February 2019

  • Front-line therapy of advanced ovarian cancer: new approaches.

    28. Ann Oncol,
    2017: viii46-viii50

    • Woods B.
    • Revill P.
    • Sculpher M.
    • Claxton C.

    Country-level Cost-Effectiveness Thresholds: Initial Estimates and the Need for Further Research.

    CHE Research Paper,
    2016: 109

  • TreeAge Pro 2019, R2.

    ()

    • Italian Association of Medical Oncology (AIOM)

    Linee Guida – Tumori Dell’ovaio.

    2018

    • Ledermann J.A.
    • Sessa C.
    • Colombo N.

    Ovarian cancer.

    Ann Oncol. 2016; 27 () (): v145

    • Aghajanian C.
    • Blank S.V.
    • Goff B.A.
    • et al.

    OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer.

    J Clin Oncol. 2012; 30: 2039-2045

    • National Institute for Health and Care Excellence (NICE)

    Olaparib for Maintenance Treatment of BRCA-Mutated Ovarian, Fallopian Tube and Peritoneal Cancer after Response to First-Line Platinum-Based Chemotherapy [ID1124].

    2019

    • Capri S.
    • Ceci A.
    • Terranova L.
    • Merlo F.
    • Mantovani L.

    Guidelines for economic evaluations in Italy: recommendations from the Italian group of pharmacoeconomic studies.

    Drug Info J. 2001; 35: 189-201

  • Plot Digitizer.

    ()

  • Reconstructing time-to-event data from published Kaplan-Meier curves.

    Stata J. 2017; 17: 786-802

    • Guyot P.
    • Ades A.E.
    • Ouwens M.J.
    • Welton N.J.

    Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves.

    BMC Med Res Methodol. 2012; 12: 9

    • Diaby V.
    • Adunlin G.
    • Montero A.J.

    Survival modeling for the estimation of transition probabilities in model-based economic evaluations in the absence of individual patient data: a tutorial.

    Pharmacoeconomics. 2014; 32: 101-108

  • NICE DSU technical support document 14: survival analysis for economic evaluations alongside clinical trials—extrapolation with patient-level data.

    ()

    • Cress R.D.
    • Chen Y.S.
    • Morris C.R.
    • Petersen M.
    • Leiserowitz G.S.

    Characteristics of long-term survivors of epithelial ovarian cancer.

    Obstet Gynecol. 2015; 126: 491-497

    • Javellana M.
    • Hoppenot C.
    • Lengyel E.

    The road to long-term survival: surgical approach and longitudinal treatments of long-term survivors of advanced-stage serous ovarian cancer.

    Gynecol Oncol. 2019; 152: 228-234

    • Italian National Institute of Statistics (ISTAT)

    Tavole di mortalità della popolazione residente.

    ()2019

    • Colombo N.
    • Kutarska E.
    • Dimopoulos M.
    • et al.

    Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer.

    J Clin Oncol. 2012; 30: 3841-3847

    • Ferrandina G.
    • Ludovisi M.
    • Lorusso D.
    • et al.

    Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer.

    J Clin Oncol. 2008; 26: 890-896

    • Monk B.J.
    • Herzog T.J.
    • Kaye S.B.
    • et al.

    Trabectedin plus pegylated liposomal Doxorubicin in recurrent ovarian cancer.

    J Clin Oncol. 2010; 28: 3107-3114

    • Bartoletti M.
    • Pelizzari G.
    • Gerratana L.
    • et al.

    Bevacizumab or PARP-inhibitors maintenance therapy for platinum-sensitive (PS) recurrent ovarian cancer (rOC)? A network meta-analysis (NMA).

    J Clin Oncol. 2019; 37: 5564

    • National Institute for Health and Care Excellence (NICE)

    Bevacizumab in Combination with Gemcitabine and Carboplatin for Treating the First Recurrence of Platinum-Sensitive Advanced Ovarian Cancer.

    2013

    • National Institute for Health and Care Excellence (NICE)

    Rucaparib for Maintenance Treatment of Relapsed Platinum-Sensitive Ovarian, Fallopian Tube or Peritoneal Cancer [ID1485].

    2019

    • Italian Medicines Agency (AIFA)

    Riclassificazione del medicinale per uso umano «Lynparza» ai sensi dell’articolo 8, comma 10, della legge 24 dicembre 1993.

    ()n. 537. 2019

    • Italian Medicines Agency (AIFA)

    Regime di rimborsabilita’ e prezzo di vendita del medicinale «Yondelis (trabectedina)» – autorizzata con procedura centralizzata europea dalla Commissione europea.

    2009 ()

    • Italian Medicines Agency (AIFA)

    Regime di rimborsabilita’ e prezzo a seguito di nuove indicazioni terapeutiche del medicinale «Caelyx» (doxorubicina cloridrato liposomiale pegilata).

    2009 ()

    • Italian Medicines Agency (AIFA)

    Regime di rimborsabilita’ e prezzo a seguito di nuove indicazioni terapeutiche del medicinale per uso umano «Avastin».

    2016 ()

    • Italian Medicines Agency (AIFA)

    Regime di rimborsabilita’ e prezzo del medicinale per uso umano «Zejula».

    2018 ()

    • Italian Medicines Agency (AIFA)

    Riclassificazione del medicinale per uso umano «Rubraca» ai sensi dell’art. 8, comma 10, della legge 24 dicembre 1993.

    n. 537. 2019 ()

  • Italian Medicines Agency (AIFA), Elenchi farmaci di classe A e H.

    • Guy H.
    • Walder L.
    • Fisher M.

    Cost-effectiveness of niraparib versus routine surveillance, olaparib and rucaparib for the maintenance treatment of patients with ovarian cancer in the United States.

    Pharmacoeconomics. 2019; 37: 391-405

    • Italian Ministry of Health

    Decreto del Ministero della salute 18 ottobre 2012, allegato 1, “Tariffe delle prestazioni di assistenza ospedaliera per acuti, per tipo di ricovero.

    ()

    • Guest J.F.
    • Ruiz F.J.
    • Greener M.J.
    • Trotman I.F.

    Palliative care treatment patterns and associated costs of healthcare resource use for specific advanced cancer patients in the UK.

    Eur J Canc Care (Engl). 2006; 15: 65-73

    • Migliorino M.R.
    • Santo A.
    • Romano G.
    • et al.

    Economic burden of patients affected by non-small cell lung cancer (NSCLC): the LIFE study.

    J Canc Res Clin Oncol. 2017; 143: 783-791

    • National Institute for Health and Care Excellence (NICE)

    Niraparib for Maintenance Treatment of Relapsed, Platinum-Sensitive Ovarian, Fallopian Tube and Peritoneal Cancer [ID1041].

    2018

    • National Institute for Health and Care Excellence (NICE)

    Olaparib for Maintenance Treatment of Relapsed, Platinum-Sensitive, BRCA Mutation-Positive Ovarian, Fallopian Tube and Peritoneal Cancer after Response to Second-Line or Subsequent Platinum-Based Chemotherapy [ID735].

    2016

    • Italian Ministry of Health

    Nomenclatore dell’assistenza specialistica ambulatoriale.

    ()

  • Comments are closed.