access to antineoplastic drugs in latam & esmo- mcbs a ... · access to antineoplastic drugs in...
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Access to antineoplastic drugs in LATAM & ESMO-MCBS
-A tool to separate chaff from the wheat in the era
of high cost drugs?
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Felipe RoitbergMedical Oncologist – Thoracic and Head & Neck Cancer Division- University of São Paulo (ICESP)- Hospital Sírio Libanês
Disclosure / Possible Conflicts of Interest
- Clinical Trials: Boehringer Ingelheim, Bristol Meyers Squibb, AstraZeneca, Roche
‒ Speaker/Lectures: Boehringer-Ingelheim, AstraZeneca, Bayer, Bristol MeyersSquibb, Merck Sharp Dohme
‒ Advisory Board: Boehringer Ingelhein
‒ No stocks from pharmaceutical companies
‒ ESMO, IALSC, SBOC member, State of São Paulo HTA affiliated, JGO reviewer
Cancer Drugs Costs
Source: Quinteles IMS and Reuters
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Perspectives
Survival Gain/CureQuality of Life/Toxicity
Survival Gain/CureQuality of Life
Hazard Ratio, RR, PFSStatistically significant
Cost-Effectiveness (QALY, DALY, ICER)Budget Impact
“Statistically Significant Benefit”
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OS Gain: 6,24m x 5,91 10 days
IC 95% HR 0,82 (0,69-0,99)
7J Clin Oncol 2015; 33:1191-1196
OS Benefit in 5years: 18,2 x 8,8%
Cytotoxics Miscellaneous Hormones
Bleomycin Doxorubicin Oxaliplatin Calcium folinate Anastrozole
Capecitabine Etoposide Paclitaxel Filgrastim Bicalutamide
Carboplatin Fluorouracil Procarbazine Imatinib Dexamethasone
Cisplatin Gemcitabine Vinblastine Trastuzumab Leuprorelin
Cyclophosphamide Ifosfamide + mesna Vincristine Zoledronic acid Tamoxifen
Dactinomycin Irinotecan Vinorelbine
Docetaxel Methotrexate
WHO Model List of Essential Medicines 20th List (March 2017) (Amended August 2017)
AA
EML Essential Medicines List– WHO (2015)
ESMO-MCBS
Quality of Life
Magnitude of Clinically
Benefit
Overall survival,
Progression free
survivaL
ToxicityPrognosis
of the condition
HR,Long term survival,
RR
Cherny et al, Ann Oncol 2015 & 2017
Factors taken into account for ESMO-MCBS Substantial improvements:A & B in curative and 5 & 4 in non curativesetting
Available at: https://www.esmo.org
Courtesy: Prof E. de Vries
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Evaluation form 1: for new approaches to adjuvant therapy or new potentially curative
therapiesGrade A
Mark with X if relevant
>5% improvement of survival at ≥3 years follow-upImprovements in DFS alone (primary endpoint) (HR <0.65) in studies without mature survival data
≥ 3% but ≤ 5% improvement at ≥3 years follow-upImprovement in DFS alone (primary endpoint) (HR 0.65 - 0.8) without mature survival dataNon-inferior OS or DFS with reduced treatment toxicity or improved Quality of Life (with validated scales)Non-inferior OS or DFS with reduced treatment cost as reported study outcome (with equivalent outcomes and risks)
<3% improvement of survival at ≥ 3 years follow-upImprovement in DFS alone (primary endpoint) (HR >0.8) in studies without mature survival dataImprovements in pCR alone (primary endpoint) by >30% relative AND >15% absolute gain in studies without mature survival data
Grade B
Grade C
Courtesy: Prof E. de Vries
Non Curative Therapies: more variables to address
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Overall Survival
(Absolute Gain & HR)
Progression Free Survival
Others than OS & PFS
Quality Outcomes:• Toxicity• QOL
Single Arms Studies (Rare Diseases & Unmet Medical Needs)
“Every System is perfectly Designed to get the results it gets”
What Is Value in Health Care? Michael E. PorterN Eng J Med 363;26