University of Groningen. Health economics of targeted cancer therapies Mihajlovic, Jovan

Size: px

Start display at page:

Download "University of Groningen. Health economics of targeted cancer therapies Mihajlovic, Jovan"

Baldwin Dawson
5 years ago
Views:

1 University of Groningen Health economics of targeted therapies Mihajlovic, Jovan IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2016 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Mihajlovic, J. (2016). Health economics of targeted therapies: A comparative analysis for Serbia and the Netherlands. [Groningen]: Rijksuniversiteit Groningen. Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date:

2 APPENDIX to Chapter 3 - Overview of statuses and outcomes of CE evaluationes of all EMA approved TCTs in Seria, Scotland and the Netherlands DRUG AND INDICATION SERBIA (RFZO) SCOTLAND (SMC) THE NETHERLANDS (ZiNL) Drug generic name European Medicines Agency (EMA) approved Reimbursement status Pharmacoeconomic assessment Comment Reimbursement status Pharmacoeconomic assessment - ICER [ /] Comment Reimbursement status Pharmacoeconomic assessment - ICER [ /] or cost/unit of time Comment Afatinib patient access scheme (PAS) applied Cost minimisation analysis (CMA) - final outcome not available CMA compared afatinib and erlotinib; afatinib was cost saving when PAS was applied; Exempted from pharmacoeconomic (PE) assessment - If drug's budget impact (BI) crosses, PE assessment can be requested in Axitinib Renal cell carcinoma Cost utility analysis (CUA) - 33,837/ (for treatment after sunitinib); 56,343/ (after cytokine); Despite high ICER, (absence of an alternative and effect on survival) influenced positive decision assessment - Bevacizumab Colorectal R: potentially resectable liver metastases, with stage IVb/c; maximum use of 10 cycles; CUA - 24,000-60,000/ (when added to 5FU regimens); 78,000-93,000/ (when added to irinotecan regimens); Reasons for rejection: high ICER, uncertainties regarding utility estimates, resource use and choice of comparators; assessment - Bevacizumab for the assessment - Bevacizumab Renal cell carcinoma for the gavenegative assessment - Bevacizumab Ovarian for the CUA - 37,749/ high ICER; efficacy data were used from the study where bevacizumab was given in unlicensed dose; assessment - Bevacizumab Breast for the CUA - 77,318/ high ICER; uncertainty regarding extrapolation of overall survival; assessment - Costs analysis (CA), cost/month 4,828 Bortezomib Multiple myeloma prior to ahsct R: for the first line treatment of high risk patients under CUA - 23,077 / R: Use only as triple therapy in combination with dexamethasone and thalidomide, ICER 34,267/ 169

3 Bortezomib Progressive multiple myeloma Bosutinib Chronic myelogenous (CML) Not Brentuximab vedotin Hodgkin lymphoma Not Brentuximab vedotin Anaplastic large cell lymphoma Not Cabozantinib Medullary thyroid Not Carfilzomib Multiple myeloma Not Cetuximab Colorectal Cetuximab Squamous cell of the head and neck Crizotinib Dabrafenib Metastatic melanoma Not Dasatinib Chronic myelogenous Not R: for relapsing patients without polineuropathy R: in metastatic disease with KRAS wild type, after OX/IR regimen; R: (i) locally advanced, inoperable carcinoma; (ii) first line treatment of recurrent disease; for the Not / Not / under and when under Not / CUA - 24,492/ (with ) CUA - ICER varies from dominance to 376,475/ (depending on comparator and phase of disease) CUA - 22,802-26,763/ CUA - 6,870/ CUA - 36,691-42,295/ (without PAS) CUA - 44,456/ for accelarated and 63,727/ for blast phase of the disease PAS meant that manufacturer covers expenses for all patients without response to the treatment; lack of direct comparative efficacy data with any of the comparators; unscertainty on OS gain; high ICER; issued issued R: In metastatic chemotherapy naive patients, with potentially resectable liver metastases; R: Locally advanced disease; Patients not appropriate for chemoradiotherapy, without distant metastases; PAS makes a drug cost effective; ICER with PAS was not publically available; issued high ICER; NICE appraisal superseded earlier SMC decisions; /) /) assessment - assessment - assessment - assessment - assessment - assessment - CA, cost/patient 8,706-8,913 assessment - assessment - assessment - CA, cost/patient/year issued issued 170

4 Dasatinib Acute lymphoblastic (ALL) Denosumab Giant cell tumor of the bone Denosumab Bone metastasis from solid tumors Erlotinib Erlotinib Pancreatic Everolimus Pancreatic neuroendocrine Everolimus Renal cell carcinoma Everolimus Breast Gefitinib Ibritumomab tiuxetan Non-Hodgkin's lymphoma (NHL) Not Not Not for the R: Adenocarcinoma stages IIIb/IV; second line treatment; for the for the for the for the R: NSCLC stage IIIb/ IV, first line treatment for EGFR-TK positive patients; CUA not provided (manufacturer assumed same ICER as for CML ) CUA - with 21,491/ (when ) CUA - 14,562/ (vs. sunitinib); 24,998/ (vs. BSC); CUA - 61,330/; CUA - 28,912/ CUA - 73,827/ (when compared with gemcitabine/carboplatin) CUA - 22,445/ not sufficient economic evidence high ICER; survival gain depends on method used for cross over - high uncertainty; unsecure gain in survival derived from wrong extrapolation; overestimated utility values; high ICER; uncertainty with hazard ratio applied for overall survival; unclear model used in CUA; insufficiently robust ICER; /) assessment - CA, cost/patient/year assessment - CUA available - ICER 37,059/ - 45,791/ (vs. BSC18); cost saving (vs. docetaxel) assessment - assessment - assessment - CA, cost/patient 13,354 assessment - assessment - CA, cost/3 months 6,552 assessment - CA, cost/patient 12,845 issued

5 Ibrutinib Mantle-cell lymphoma Not Ibrutinib Chronic lymphocytic leukaemia (CLL) Not Imatinib GastrointestinaI stromal tumor Imatinib Dermatofibrosarcoma protuberans Not Imatinib Multiple hematologic malignancies (ALL and CML) Ipilimumab Metastatic or unresectable melanoma Not Lapatinib Metastatic breast Nilotinib Chronic myelogenous Obinutuzumab Chronic lymphocytic Not Ofatumumab Chronic lymphocytic Not Panitumumab Colorectal R: Locally advanced inoperable or metastatic disease R: First line treatment in new CML patients, with chronic disease, Philadelphia+ R: Second line metastatic HER2 positive disease, in patients pretreated with antracyclines and/or taxanes and trastuzumab; R: Second line for patients with CML, resistant or intolerant to any previous treatment, including imatinib for the Not / Not / under under Not / CUA - 21,745/ CUA - 20,665/ CUA - 36,118/ (when ) CUA - 24,227/ (vs. trastuzumab), 78,503/ (vs. vinorelbine) and 93,825/ (vs. capecitabine); CUA - 11,000/ (when nilotinib is given in first and imatinib in second line) CUA - 108,815/ issued issued R: patients at high risk of recurrence following complete resection R: in patients at high risk of recurrence following complete resection Despite high ICER, (absence of an alternative and effect on survival) influenced positive decision use of trastuzumab after progression has not been assessed by SMC (inappropriate comparison); other comparisons resulted in unacceptably high ICER; Choice of drugs' (nilotinib, imatinib, dasatinib) sequence largely influences ICER; SMC accepted sequences that would start either with imatinib or with nilotinib; issued Reasons for rejection: high ICER; underestimate of BSC arm survival; /) /) /) assessment - assessment - assessment - assessment - CA, cost/patient/year 84,000 PE concluded that the drug (when prescribed with aromatase inhibitors) has same therapeutic value and less cost compared to trastuzumab assessment - CA, cost/month 4,178 assessment - CA, cost/patient 515, ,000, ICER 45,729/ issued issued R: only HER2 positive patients, given together with aromatase inhibitors; the future; issued 172

6 Pazopanib Renal cell carcinoma Pazopanib Soft tissue sarcoma Pertuzumab Metastatic breast Ponatinib Chronic myelogenous Not Ponatinib Acute lymphoblastic Not Regorafenib Colorectal Not NHL - folicular lymphoma, relapsed/ refractory NHL - folicular lymphoma, previously untreated NHL - folicular lymphoma, stabile disease; induction and maintenance therapy; Reimbursed NHL - diffuse B-cell; in untreated patients; with CHOP regimen; for the for the for the R: restriction actually corresponds with the defined R: restriction actually corresponds with the defined Not mentioned as such, encompassed within two previous s R: Newly diagnosed diffuse B cell lymp. patients (diagnosed as C , C.83.6., C83.9); under and when Not / Not / Not / under under under under CUA - 1,790 (vs sunitinib); 32,988 (vs. BSC) 38,925/ (vs. interferon alfa); CUA - dominates (vs. ifosfamid); 62,856/ (vs. BSC) CUA - 122, ,815/ (depending on compar); CUA - 7,721/ CUA - 7,417-10,472/ CUA - 15,978/ (maintenance phase); Not available (induction phase); CUA - R: only in the first-line treatment of advanced unjustified comarator and uncertainties regarding indirect comparison performed (vs. ifosfamid); high ICER (vs. BSC) High ICER; uncertainty regarding extrapolation of overall survival; although some could apply (survival gain); issued issued issued ; assessment - assessment - assessment - assessment - assessment - assessment -, ICER 27,094/ assessment -, ICER 6,412/ assessment - 173

7 CLL in previously untreated patients; with FC regimen; CLL in previously treated patients; with FC regimen; Sipuleucel-T Prostate Not Sorafenib Hepatocellular carcinoma Sorafenib Renal cell carcinoma Sorafenib Thyroid carcinoma Sunitinib Renal cell carcinoma Sunitinib Gastrointestinal stromal tumour Sunitinib Pancreatic neuroendocrine tumours Temsirolimus Renal cell carcinoma R: restriction actually corresponds with the defined R: if drug (Rx) was not used in the first line, or, if used, patient relapsed >24 months after Rx use; for the for the for the R: First line treatment of locally advanced and/or metastatic disease for the for the for the under under Not / Not / under and when when Not / CUA - 15,593/ CUA - 6,279/ CUA - 67,012/ CUA - 35,523/ CUA - 33,371/ CUA - 27,485/ (when ) CUA- 22,660/ (when ) issued Reasons for rejection: high ICER; insufficiently robust ICER; wrong extrapolation of overall survival; high ICER; issued uncertainty on overall survival gain; high ICER; R: by a physician experienced in the treatment of GIST; could be applied (absence of an alternative and effect on survival); "Decision modifiers" also apply (absence of an alternative and effect on survival); issued to UFAP, under, ICER 15,847-22,191/; to UFAP, under, ICER 15,847-22,191/; Not reimbursed; Rejected by ZiNL assessment - assessment - CA, cost/patient/year assessment - assessment - CA, cost/patient/year 42,105 assessment - CA, cost-saving in comparison to imatinib assessment - CA, cost/patient 27,435 available with US data, ICER $170, ,701/ R: with FCR regimen; Drug should be reassessed 4 years after initial approval; currently under R: with FCR regimen; Drug should be reassessed 4 years after initial approval; currently under Rejected due to lack of clinical evidence 174

8 Temsirolimus Mantle cell lymphoma Trametinib Metastatic melanoma Not Trastuzumab Metastatic breast Reimburssed with restriction Trastuzumab Early breast Reimburssed with restriction Trastuzumab Gastric Trastuzumab emtansine Breast Not Vandetanib Medullary thyroid Not Vemurafenib Metastatic melanoma Vismodegib Basal cell carcinoma Not Ziv-aflibercept Metastatic colorectal Not for the R: first line treatment, in combination with taxanes, 6-8 cycles; monotherapy of trastuzumab therafter until progression; R: (a) as continuation of adjuvant antracyclines based chemotherapy, monoth/w taxanes; (b) locally advanced disease, w taxanes; for the for the Not / under under Not / under and when CMA (s.c. vs. i.v. trasutuzumab) proves s.c. trastuzumab cost saving (no information on i.v. vs. standard therapy) CUA (i.v. trastuzumab vs standard th) - < 3,000/ CUA - 39,644 (vs. 5FU); 41,464/ (vs. capecitabine) CUA - 39,617/ (when ) CUA - 34,623/ ( 27,424/ for subgroup with liver metastases) issued R: (in mbc) excludes its use in combination with an aromatase inhibitor; R: use by breast specialists; Reasons for rejection: high ICER; insufficiently robust ICER; issued "Decision modifiers" applied (absence of an alternative, gain in survival and quality of life); R: for use in the first-line treatment of BRAF metastatic melanoma. Despite high ICER, (gain in survival and defined subgroup that benefits more from the treatment) influenced positive decision /) /) to UFAP, under, under /) assessment - CA cost/patient 36,400-36,800 assessment - CA cost/patient 43,600-44,100;, ICER 86, ,262/ assessment - assessment -, ICER 104,430/ assessment - issued issued R: HER2 positive, metastatic, with FC regimen; Drug should be reassessed 4 years after initial approval; currently under R: only for symtomatic and agressive disease; drug's budget impact already over issued 175

National Cancer Drugs Fund List - Approved

National Cancer Drugs Fund List - Approved DRUG Abiraterone Aflibercet Albumin Bound Paclitaxel Axitinib CDF INDICATION (EXCLUDING APPROVED CRITERIA ) Metastatic Prostate Cancer Metastatic Colorectal Cancer