INEQUALITIES IN ACCESS TO TREATMENT. Tanja Čufer, MD, PhD Professor of Oncology Medical Faculty, University of Ljubljana Slovenia

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1 INEQUALITIES IN ACCESS TO TREATMENT Tanja Čufer, MD, PhD Professor of Oncology Medical Faculty, University of Ljubljana Slovenia Brussels, November 2015

2 Global Lung Cancer Incidence

3 Global Lung Cancer Incidence Lung cancer: Major health issue Control cornerstones Prevention Early detection Treatment Rehabilitation Lung cancer treatment: Surgery Radiotherapy Systemic therapy

4 Access to drugs Average time delay between marketing authorization and drugs uptake: all products, authorization Ann Oncol 2007, Suppl 3 Country No. of molecules Average ( min-max) days Belgium ( ) Czech Republic ( ) Finland (0 1310) France ( ) Germany 74 0 (0 0) Hungary (79 791) Ireland (0 552) Italy (28 920) Netherlands (0 711) Norway (0 426) Portugal (0 1071) Slovakia ( ) Slovenia (0 1383) Spain (0 662) Sweden (0 805) UK 76 0 (0 0)

5 Access to Targeted Cancer Drugs in Slovenia and Selected EU Countries Država Alemtuzumab Bevacizumab (MabCampath (Avastin ) ) Bortezomib (Velcade ) Cetuksimab (Erbitux ) Erlotinib (Tarceva ) Ibritumomab (Zevalin ) Imatinib (Glivec ) Rituksimab (MabThera ) Trastuzumab (Herceptin ) Avstrija 4K K K K K K K K K 2000 Francija 1K K K K K 2005 bv 3K K K 1999 Italija 2K K K K 2005 bv 3K K K K 2001 Nemčija 3K K K K K K K K K 2000 Slovenija 1K K K K K 2005 bv 3K K K 2001 Švedska 4K K K K K K K K K 2000 Švica 2K K K K K 2005 bv 3K K K 1999 Združeno kraljestvo 3K K K K K 2005 bv 4K K K K: prvi kvartal, 2K: drugi kvartal, 3K: tretji kvartal, 4K: četrti kvartal prvi vstopi first so označeni entry z zeleno bv: brez vstopa do konca leta 2005 For some drugs, such as rituximab, it was a substantial delay in drug uptake in Slovenia, of approx. 2 years. In addition, the utilization of targeted drugs in Slovenia was in most cases lower than in comparison countries! Kos et al, E J Cancer, 2008

6 ESMO Anti-Neoplastic Medicines Availability Survey: Lung Cancer Anti EGFR Afatinib Anti ALK Crizotinib

7 Lung Cancer: Chemotherapy Availability in Western Europe Always Usually Half thetime Occasionally Never Not available

8 Lung Cancer: Chemotherapy Availability in Eastern Europe Always Usually Half thetime Occasionally Never Not available

9 Lung Cancer: Targeted Therapy Availability Always Usually Half thetime Occasionally Never Not available

10 Why?

11 Hurdles and Barriers in Access to Anticancer Drugs in EU Drug approval process by EMA (Efficacy & Safety) Centralized procedure since 1995, indicative time 210 days : 20 anti-cancer drugs approved (63% approval rate, actual time 418 days). Pricing and reimbursement policy ED 89/105/EEC52: 120 days. In reality huge deviations: from immediate access (Germany, UK) to various lag times (France, Belgium, Nordic countries, etc.), lack of data for EE countries. Main reason: Low level of controlled, standardized processes despite 2004 EUnetHTAnetwork (63 partners from 23 countries). Assessment tailored per country and not on a EU level. Utilization of drugs Lack of centralized procedures/guidelines on clinical importance. Ades F et al, ecancer 2014

12 Extremely high price tags Regimen Drug cost per month of therapy in Slovenia (Euro) Old chemotherapy regimens, 1990 Cisplatin/etoposide 158 Cisplatin/gemcitabine 290 New chemotherapy regimens, 2000 Carboplatin/paclitaxel 1088 Cisplatin/pemetrexed 3823 Targeted agents, Gefitinib/Erlotinib/Afatinib 1959 Crizotinib 4618 Immunotherapy, 2015 Nivolumab The near doubling of median survival has been accompanied by a 20- fold increase in drug costs! The costs of immunotherapy might reach 100 times the costs of chemotehrapy!

13 What can we do together?

14 Advocating for more Budget On average only 10% of health spending is allocated to cancer care, yet it is the worlds biggest killer! 5% 10% 95% 90% Cancer drugs Total drug costs Cancer drugs Cancer care costs

15 Optimal use of resources Relationship between survival for colorectal cancer and total health expenditure. Data from OECD Cure rates can almost double for similar annual percapita expenditure on health OECD Health Policy Studies 2013: OECD Publishing. Hofmarcher, T et al, Access to high-quality oncology care accross the Europe, IHE Report 2014

16 Common approach to prioritization Ø The ESMO-MBCS (Magnitude of Clinical Benefit Scale), established in 2015, is a standardized, semi-quantitative tool for grading clinical benefit and prioritizing therapies which should be rapidly accessible to all EU citizens! When a new anticancer drug is EMA approved, its benefit will be «scaled» by a dedicated ESMO committee, the drugs with the highest scores should represent the priority! Curative A B C Non-curative Cherny, N et al, Ann Oncol epub, 30 May 2015

17 Clinical Research: A way to Improve Access to Novel Therapies International participation in Phase 3 Industry-Driven Clinical Trials Spending on cancer research Per capita in : ECRM Forum 2005 Glickman SW et al, NEJM, 2009

18 Access to Novel Therapies: Key Points Common EU pricing policy. Grading of clinical benefit for each anti-cancer drug and its indication. Reimbursement policies following the level of clinical benefit, resource-stratified reimbursement policy. Effective organization of cancer care (human resources, equipment). Cross-board access to clinical trials! Ø Joined EU level action of patients advocacy groups, scientists and EU bodies in order to improve access to novel therapies and to minimize inequalities in EU is the only way forward!