Akılcı İlaç Kullanımı. Dr. Çetin Ordu

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1 Akılcı İlaç Kullanımı Dr. Çetin Ordu

2 Akılcı İlaç Kullanımı (AİK); hastaların ilaçları klinik ihtiyaçlarına uygun şekilde, kişisel gereksinimlerini karşılayacak dozlarda, yeterli zaman diliminde, kendilerine ve topluma en düşük maliyette almalarını gerektiren kurallar bütünüdür. Bu kurallara uyulmaması ise Akılcı Olmayan İlaç Kullanımı (AOİK) olarak anılmaktadır

3 Bu konuda yapılmış olan araştırmalarda tespit edilen temel problemler arasında gereğinden fazla ilaç yazdırılması (polifarmasi), ilaçların yanlış şekilde kullanılması, temel ilaç listelerine veya güncel kılavuzlara uygun olmayan ilaçların reçetelere yazılması, özel hasta gruplarına uygunsuz ilaç yazılması, gereksiz yere pahalı ilaçların kullanımı, gereksiz yere antibiyotik tüketimi gereksiz yere enjeksiyon önerilmesi vb. sayılabilir

4 AİK Doktorun hastayı değerlendirdikten sonra problemi belirlemesi Tedavideki amacın belirlenmesi Uygun ilaç tedavisinin seçilmesi Tedavinin ayrıntılarıyla uygulanması ve ilaç dışı tedavilerin tasarlanması Gerekli bilgi ve uyarıların verilmesi Tedavi sonuçlarının düzenli olarak takibi ve gerekirse ilaç tedavisinin kesilmesi

5 Dünya genelinde reçete edilen hazırlanan veya satılan ilaçların yarısından fazlasının uygun olmadığı tahmin edilmektedir. Hastaların yarısının kendisine reçete edilen ilaçları uygun kullanmadığı düşünülmektedir. ABD de ilaç yan etkilerine bağlı ölümler ilk 10 sıra içinde yeralmaktadır.

6 İlaçların bilimsel temelde doğru ve uygun kullanılması için öncelikli olarak hastalığın doğru teşhisi yapılmalıdır. Konulan teşhise bağlı olarak diğer tedavi seçeneklerinin değerlendirilmesi ve ilaç tedavisi uygun görülürse de mümkün olduğunca daha etkili, tedavi hedeflerine ulaşma hususunda daha çabuk sonuç veren, yan etkisi en az olan ve tedavi maliyeti daha ucuz olan ilacın tercihi AİK in genelprensipleri arasında sayılmaktadır

7 Kişilerin ilaçları; klinik gereksinimlerine uygun biçimde kişisel gereksinimi karşılayacak dozlarda yeterli zaman diliminde kendilerine/topluma en düşük maliyette kolayca almaları için uyulması gereken kurallar bütünü AKILCI İLAÇ KULLANIMI (WHO, 1985, Nairobi) Conference of Experts on the Rational Use of Drugs, World Health Organization, Nairobi, Kenya, WHO/CONRAD/WP/RI, ( ). 7

8 Ülkemizde - %18.1 ile antibiyotikler - %12.3 ile ağrı kesiciler - %11 ile antiromatizmal ilaçlar - %8.4 ile soğuk algınlığı ve öksürük ilaçları İşverenler Sendikası nın 2010 verilerine göre, Türkiye reçeteli ilaç pazarı tutar ölçeğinde %1.2 oranında daralarak 13.9 milyar TL ye (9.2 milyar USD), kutu ölçeğinde %2.8 oranında büyüyerek 1.45 milyar kutuya ulaşmıştır.

9 2010 yılında kişi başına düşen ilaç tüketimi Türkiye de 133 Dolar olarak bulunmuştur. ABD de kişi başı ilaç harcaması 956 Dolardır. Kişi başına ilaç tüketiminin gelişmiş ülkelerde daha fazla olduğunu görmekteyiz Onkoloji ilaçları ise 2003 te %3.8 iken 2010 da tüm ilaç harcamalarının %7.2 sini oluşturmaktadır

10 OECD ülkeleri başta olmak üzere gelişmiş ülkelerde ilaç harcamalarının toplam sağlık harcamaları içindeki payı %20 lere yaklaşırken, gelişmekte olan ülkelerde ilaç harcamalarının toplam sağlık harcamalarındaki payı %20-40 arasında değişmektedir. Avrupa ülkelerinde sağlık harcamalarının %10-15 i ilaç harcamalarına ayrılırken, ülkemizde bu oran % 40 ın üzerindedir Ülke ekonomisi zorlayacak kritik nokta %10

11 ÜLKE TÜKETİLEN İLAÇ TUTARI MİLLİ GELİR KİŞBAŞI MİLLİ GELİR ABD 198 MİLYAR$ 13.2 TRİLYON$ 44 BİN$ 661$ KİŞİBAŞI TÜKETİLEN İLAÇ TUTARI İNGİLTERE 15.7 MİLYAR$ 2.3 TRİLYON$ 39 BİN$ 260$ TÜRKİYE 7 MİLYAR$ 400 MİLYAR$ 5500$ 100$ 2006 yılında ilaç tüketiminin ulusal gelire oranı 1.75 ABD de bu oran 1.50

12 Ankara Ticaret Odası (ATO) tarafından hazırlanan İlaçta İsraf konulu rapora göre; ülkemizde eczanelerdeki ilaçların ortalama %7 si kullanım süresi dolduğu için çöpe atılmakta, evlerde ise ilaçların %60 ının kutusu dahi açılmadan tarihi sona ermektedir. Tüm bu çöpe giden ilacın maliyeti ise yaklaşık 500 milyon doları bulmaktadır

13 Ülkemizde Sosyal Güvenlik Kurumları nın ilaç harcamaları nominal olarak TL bazında 2010 da, 2005 yılına göre %76,7; reel olarak %15,4 oranında artmıştır.

14 2009 verilerine göre kanser tedavisinde 800 den fazla ilaç araştırma halinde, Bunların ancak %5-8 i kullanılabilir ilaç haline gelebilecek. FDA e yılları arasında yeni moleküler ajanlar için başvuru sayısında artış var.

15 Akılcı İlaç Kullanımında Dikkat Edilmesi Gereken Durumlar Hekim Hasta Eczacı İlaç Endüstrisi Sağlık Bakanlığı

16 AİK ilkeleri (WHO) İlaç politikalarını ve etkilerini takip edecek yapılar Kanıta dayalı tıp yada rehberlere uygun tedaviler düzenlenmesi Geri ödeme listesindeki ilaçları kullanmak Hastanelerde ilaç ve tedavi komiteleri kullanılması Üniversitelere farmokoterapiye yönelik eğitim programları kurmak Hizmet içi eğitim verilmesi

17 AİK ilkeleri (WHO)(devam) Denetim ve feedback mekanizmalarını geliştirmek İlaçlar ile ilgili bağımsız bilgilere ulaşılabilmesi İlaçlar ile ilgili halkın eğitilmesi AOİK ile ilgili yanlış ve özendirici reçetelemelerin önlenmesi WHO nun etik kriterlerine uygun ilaç promosyonlarının sağlanması Devletin güvenli ve kaliteli ilaç ve sağlık personelinin sağlanması için gerekli bütçe rezervlerinin sağlanması

18 Maliyet-etkinlik 139 onkolog %78 i hastalarını tedavi ederken maliyet etkinliği düşünmediğini ifade etmiş. Ortalama 2-4 aylık survival avantajının yıllık $ maliyeti makul bulmuşlar Önümüzdeki 5 yılda maliyet etkinlik hesaplarının önemli olacağını öngörmüşler Bevacizumabın yıllık maliyetinin gerçek maliyetinden daha yüksek olduğunu ve survival katkısının (metastatik kolorektal kanserde) daha düşük olduğunu tahmin etmişler. Nadler ve ark. Do Oncologists Believe New Cancer Drugs Offer Good Value? The Oncologist 2006;11:90 95

19 Subcategory: Cost Category: Health Services Research Meeting: 2014 ASCO Annual Meeting Session Type and Session Title: Oral Abstract Session, Health Services Research Abstract Number: 6502 Citation: J Clin Oncol 32:5s, 2014 (suppl; abstr 6502) Author(s): Daniel A. Goldstein, Qiushi Chen, David H. Howard, Joseph Lipscomb, Turgay Ayer, Bassel F. El-Rayes, Christopher Flowers; Winship Cancer Institute of Emory University, Atlanta, GA; H. Milton Stewart School of Industrial & Systems Engineering, Georgia Institute of Technology, Atlanta, GA; Emory University Department of Health Policy and Management, Atlanta, GA; Rollins School of Public Health; Winship Cancer Institute, Atlanta, GA; H. Milton Stewart School of Industrial and Systems Engineering, Georgia Institute of Technology, Atlanta, GA; The Winship Cancer Institute of Emory University, Atlanta, GA; Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^). Abstract Disclosures Abstract: Background: The addition of Bev to 5-Fluorouracil (5-FU)-based chemotherapy is the standard of care for previously untreated mcrc. A recent randomized trial demonstrated a 1.4 month increase in median overall survival (OS) when Bev is continued beyond the first progression, thus making it standard practice to use Bev with 5-FU based chemotherapy in both first- and second-line. International CEAs have evaluated Bev in the 1st-line setting. The objective of this study is to determine the cost effectiveness of Bev in the 1st line setting and when continued beyond progression from the US-payer perspective. Methods: We developed two Markov models to compare the cost and effectiveness of 5-FU, leucovorin and oxaliplatin (FOLFOX) with or without Bev in the first-line treatment, and subsequent chemotherapy with or without Bev in the second-line treatment of mcrc. Weibull models were fitted to the published survival curves, and were used to extrapolate the cause-specific mortality and progression risks. Costs for administration and management of adverse events were based on Medicare reimbursement rates for hospital and physician services, and drug costs based on the Medicare average sale prices (all in 2013 US $). Health outcomes were measured in life years (LY) and quality-adjusted life years (QALYS). The simulated OS and progression free survival (PFS) were validated by the fitted survival models. Model robustness was addressed by univariate and probabilistic sensitivity analyses (PSA).Results: Using Bev in first-line therapy provided an additional QALYs (0.412 LYs) at a cost of $69,381. The incremental cost-effectiveness ratio (ICER) was $240,195/QALY. Continuing Bev beyond progression provided an additional QALYs (0.167 LYs) at a cost of $23,788. The ICER was $219,742/QALY. In all one way sensitivity analyses, the ICER of Bev was > $100,000/QALY. The ICER of Bev was greater than $100,000/QALY in > 99.9% of PSAs. Conclusions: This is the first US based CEA of Bev in mcrc. Bev provides minimal incremental benefit at high incremental cost per QALY in both the first and second-line setting. The ICER of Bev could be improved by use of an effective biomarker to select patients most likely to benefit.

20 Pharmacoeconomics Dec 1;30(12): doi: / Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal. Whyte S 1, Pandor A, Stevenson M. Author information Abstract The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of bevacizumab (Roche Products) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of patients with metastatic colorectal cancer (mcrc), as part of the Institute's Single Technology Appraisal (STA) process. The School of Health and Related Research (ScHARR) at the University of Sheffield was commissioned to act as the Evidence Review Group (ERG). This paper provides a description of the company submission, the ERG review and NICE's subsequent decisions. The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology provided within the manufacturer's submission to NICE. The ERG also independently searched for relevant evidence and modified the manufacturer's decision analytic model to examine the impact of altering some of the key assumptions. The main clinical effectiveness data were derived from a phase III, multicentre, multinational, two-arm, randomized, open-label study with the primary objective of confirming the non-inferiority of oxaliplatin plus capecitabine (XELOX) compared with oxaliplatin plus 5-fluorouracil and folinic acid (FOLFOX-4) in adult patients with histologically confirmed mcrc who had not previously been treated. The ERG considered that the NO16966 trial was of reasonable methodological quality and demonstrated a significant improvement in both progression-free and overall survival when bevacizumab is added to either XELOX or FOLFOX-4. The ERG considered that the size of the actual treatment effect of bevacizumab was uncertain due to trial design limitations, imbalance of a known prognostic factor, relatively short treatment duration compared with that allowed within the trial protocol, and interpretation of the statistical analyses. The manufacturer's submission included a de novo economic evaluation using a cost-effectiveness model built in Microsoft Excel. The ERG believed that the modelling structure employed was appropriate but highlighted several areas of uncertainty that had the potential to have a significant impact on the resulting incremental cost-effectiveness ratios (ICERs). The areas of uncertainty identified by the ERG included whether chemotherapy would be administered continuously or intermittently, patient access scheme (PAS) costs and uptake, survival that was dependent on the statistical analyses used, and the likely duration of continued treatment with bevacizumab after cessation of oxaliplatin and the efficacy associated with continuation. The STA described here highlighted the challenges in appraising interventions with a complex PAS. Based on the analyses that include a discount to the list price of oxaliplatin, the ERG concluded that the ICERs for the addition of bevacizumab to XELOX or FOLFOX were both over The NICE Appraisal Committee concluded that bevacizumab in combination with oxaliplatin and either 5-fluorouracil plus folinic acid or capecitabine (i.e. FOLFOX or XELOX) was not recommended for the treatment of mcrc.

21 Clin Ther Oct;29(10): Cost-effectiveness analysis of bevacizumab combined with chemotherapy for the treatment of metastatic colorectal cancer in Japan. Shiroiwa T 1, Fukuda T, Tsutani K. Author information Abstract BACKGROUND: Rapid progress has been made in the treatment of metastatic colorectal cancer (mcrc). New treatment regimens for mcrc include not only cytotoxic chemotherapy but also targeted monoclonal antibodies, including bevacizumab. However, bevacizumab is an expensive medication, which costs from 300,000 yen to 400,000 yen (US $2500-$3300) per month. OBJECTIVE: The purpose of this cost-effectiveness analysis was to examine the economic efficiency of treating mcrc with bevacizumab plus chemotherapy versus chemotherapy alone in Japan. METHODS: We searched an electronic database (MEDLINE, UpToDate, and American Society of Clinical Oncology [ASCO] Virtual Meeting; key terms: bevacizumab limited to randomized controlled trial; years: 2000 to present [June 29, 2007]) to detect randomized controlled trials (RCTs) that compared chemotherapy alone with chemotherapy plus bevacizumab. To analyze the cost-effectiveness of bevacizumab, we used the Weibull regression model and determined an expected treatment duration at each state using reported survival curves of RCTs. We included only the direct medical costs (2006) of these medications to estimate the expected values of incremental costs; thus, the analysis was conducted from the perspective of the health care payer. The incremental cost-effectiveness ratios (ICERs) were calculated from these expected values of incremental life-years and incremental costs. RESULTS: We identified 5 articles using MEDLINE and 1 trial found on UpToDate and ASCO Virtual Meeting; these data composed the final analysis group. First-line chemotherapy regimens included in this analysis were bevacizumab + 5-fluorouracil/leucovorin (FU/LV), irinotecan/fu/lv (IFL), infusional FU/LV/ oxaliplatin (FOLFOX6), bolus FU/LV/oxaliplatin (bfol), and capecitabine/oxaliplatin (CAPOX). The only second-line chemotherapy regimen included was FOLFOX4. The ICERs of additional bevacizumab when combined with FU/LV,IFL,FOLFOX6, bfol, and CAPOX were 17.4 million yen (US $145,000), 11.9 million yen ($99,000), 13.5 million yen ($113,000), 16.9 million yen ($141,000), and 8.5 million yen ($71,000), respectively, per life-year gained; the ICER was 14.1 million yen ($118,000) with second-line FOLFOX4. CONCLUSIONS: In this cost-effectiveness analysis in Japan, the ICERs of bevacizumab + FU/LV combination treatment, IFL, and second-line FOLFOX4 were high compared with other chemotherapies for mcrc. It remains difficult to assess first-line therapies comprising bevacizumab with oxaliplatin-based regimens, especially CAPOX. Further information is needed to assess costeffectiveness.

22 The clinical effectiveness and costeffectiveness of cetuximab (mono- or combination chemotherapy), bevacizumab (combination with non-oxaliplatin chemotherapy) and panitumumab (monotherapy) for the treatment of metastatic colorectal cancer after first-line chemotherapy (review of technology appraisal No. 150 and part review of technology appraisal No. 118): a systematic review and economic model M Hoyle,1 * L Crathorne,1 J Peters,1 T Jones-Hughes,1 C Cooper,1 M Napier,2 P Tappenden3 and C Hyde1 1 Peninsula Technology Assessment Group (PenTAG), University of Exeter, Exeter, UK 2 Royal Devon & Exeter Foundation Trust Hospital, Exeter, UK 3 School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK

23 Printer-friendly version Cost-effectiveness analysis of cetuximab and panitumumab as first-line metastatic colorectal cancer therapies in Spain. Subcategory: Colorectal Cancer Category: Gastrointestinal (Colorectal) Cancer Meeting: 2012 ASCO Annual Meeting Session Type and Session Title: This abstract will not be presented at the 2012 ASCO Annual Meeting but has been published in conjunction with the meeting. Abstract Number: e14093 Citation: J Clin Oncol 30, 2012 (suppl; abstr e14093) Author(s): Victor Moreno, Brezo Martinez-Amores, Jorge Barriuso, Laura Mezquita, Inmaculada Ibañez de Cáceres, Angel Ayuso Sacido, Jose Maria Peña, Rosario Perona, Cristobal Belda-Iniesta; Medical Oncology Division, University Hospital La Paz, Madrid, Spain; Hospital Príncipe de Asturias, Madrid, Spain; Medical Oncology Division, University Hospital La Paz, Madrid, Spain; Centro Integral Oncologico Clara Campal (CIOCC), Madrid, Spain; Biomarkers and Experimental Therapeutics of Cancer, IdiPAZ, Madrid, Spain; School of Informatics, UPM, Madrid, Spain; Centro Integral Oncológico Clara Campal (CIOCC), Madrid, Spain Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^). Abstract Disclosures Abstract: Background: Current practice of clinical oncology is a challenge where increased efficacy of new-targeted therapies is counteracted by increasing costs. International financial crisis forces national health systems to optimize all therapeutic strategies maintaining clinical outcomes. Personalized medicine tries to select specific subpopulation of patients by biomarkers to refine therapeutic algorithms. We have performed a cost-effectiveness analysis to assess incremental cost-effectiveness ratio (ICER) per radiological response (RR) for cetuximab or panitumumab based scheduled as 1st line therapies for mcrc patients in Spain. Methods: Efficacy data were computed from all randomized trials (RT) that guided on-label uses of bevacizumab (K-Ras mut), panitumumab and cetuximab. Non- significant outcomes and toxicity as predictor of efficacy were excluded. Prices for drugs in Spain were assumed to represent the best-value for each drug including all possibilities to reduce pharmacy costs. For 1st line, median duration of therapy reported by RT was used to calculate the final budget. 70kg and 1.7 m were used as reference for patient dose calculations. Results: We simulated 3 main scenarios based on the possibilities of therapy for K-Ras wt patients assuming that all patients harboring a K-Ras mut. tumor received bevacizumab based chemotherapy. So, in scenario A K-Ras wt patients received weekly cetuximab combined with FOLFOX, ORR reaches 54% and global cost per RR sums 36,964. Scenario B: administering panitumumab-folfox yields 51% ORR and 38,880 per RR. Scenario C: cetuximab biweekly combined with FOLFOX yields 54% and 36,474. ICER for scenario A vs B is estimated at 4,394 per additional response. ICER for scenario C vs B yields a negative value of 4,432 per additional response. Conclusions: 1st line oxalipatin combinations of biweekly cetuximab for wt and bevacizumab for mutated patients optimize cost per additional response rate rather than panitumumab based schedules. Marginal cost differences between cetuximab and panitumumab therapies are exceeded by efficacy gap as measured by response rates in RT