Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
Comparative Outcomes Group, Bristol, UK
ESO Task Force Advisory Board on
Access to Innovative Treatment in Europe
European School of Oncology
Dr Paul Cornes
Disclosures June 2019
▪ Honoraria received:
• Accord Healthcare
• Amgen
• Astro Pharma
• Biogen
• European Commission
• Generics& Biosimilar Medicines Association Australia
• Global Academy of Health Sciences
• Medicines for Europe/European Generics Association
• Merck Serono
• Mylan
• Napp
• Pfizer/Hospira
• Sandoz
• Teva
Why are we here?
The patterns of global disease are changing
Ref [1] https://upload.wikimedia.org/wikipedia/commons/thumb/c/c6/Noncommunicable_diseases_world_map-Deaths_per_million_persons-WHO2012.svg/2000px-
Noncommunicable_diseases_world_map-Deaths_per_million_persons-WHO2012.svg.png. Accessed Nov 3, 2016 [2] Non-communicable diseases. The Kings Fund.
https://www.kingsfund.org.uk/time-to-think-differently/trends/disease-and-disability/non-communicable-diseases. Accessed Nov 6, 2016
This is the map of Non-
Communicable Disease –
the darker the colour –
the higher the risk
Noncommunicable
diseases (NCDs),
including heart disease,
stroke, cancer, diabetes
and chronic lung
disease, are collectively
responsible for almost
70% of all deaths
worldwide.
We live in the era of Non-Communicable Disease –
with cancer the main threat
Ref [1] https://upload.wikimedia.org/wikipedia/commons/thumb/c/c6/Noncommunicable_diseases_world_map-Deaths_per_million_persons-WHO2012.svg/2000px-Noncommunicable_diseases_world_map-
Deaths_per_million_13 Octpersons-WHO2012.svg.png. Accessed Nov 3, 2016 [2] Non-communicable diseases. The Kings Fund. https://www.kingsfund.org.uk/time-to-think-differently/trends/disease-and-
disability/non-communicable-diseases. Accessed Nov 6, 2016.
This is the map of Non-
Communicable Disease –
the darker the colour –
the higher the risk
To manage this we need
INNOVATION –
in cancer prevention,
diagnosis and treatment
Good news for cancer medicine:
Lichtenberg Fr. The Expanding Pharmaceutical Arsenal in the War on Cancer. National Bureau of Economic research Working PaperNo. 10328. February 2004.
Estimated - new medicines
have accounted for 50-60
percent of the increase in
cancer survival rates since
1975.
Good news for cancer treatment:
Innovation in cancer medicines
<1960
5 cancer
drugs
1960s
+ 2
more
1970s
+ 18
more
1980s
+ 14
more
1990s
+ 24
more
2000s
+ 23
more
2010-18
+ 81 more
in only 8
years
At this rate our decade could add
more than 100 new cancer drugs
by 2020
Ref: [1] Cornes P. Pictogram created from data in - Savage P. Development and economic trends in cancer therapeutic drugs: Analysis of modern and historical treatment costs compared to the contemporary GDP per capita. J Clin Oncol 32, 2014 (suppl; abstr e17535) updated to 2014 with data from [2] 2014 New
Drug Approvals Hit 18-Year High. Forbes Jan 2, 2015. URL: http://www.forbes.com/sites/bernardmunos/2015/01/02/the-fda-approvals-of-2014/ . Accessed Sept 23, 2015, updated to 2015 with [3] Thomas D. 2015 FDA Approvals: Highest Levels in Over a Decade. Biotech-now.org. 01/08/2016. http://www.biotech-now.org/business-and-investments/2016/01/2015-fda-approvals-highest-levels-in-over-a-decade. Accessed Jan 27, 2016. [4] FDA Approved Drugs for Oncology. Centerwatch. https://www.centerwatch.com/drug-information/fda-approved-drugs/therapeutic-area/12/oncology. Accessed June 3, 2019
Future of ALL medicine budgets –
issues of affordability?
▪ Global spending on cancer medicines
Ref: [1]. Global Oncology Trends 2018. IQVIA Institute Report, May 24, 2018. IQVIA. https://www.iqvia.com/institute/reports/global-oncology-trends-2018. Accessed
March 7, 2019
$ 96
Billion
in 2013
$ 132
Billion
in 2017
Increasing at 12-14%
year-on-year
2x the
rate of
general
drug
spending
Global Health Challenge for today
Ref: [1] Melvin Sanicas . A Year of Successes in Global Health. www.project-syndicate.org, Jan 23, 2018. URL: https://www.project-syndicate.org/commentary/global-
health-18-success-stories-in-2017-by-melvin-sanicas-2018-01. Accessed Feb 20, 2018
Affordable Access to
healthcare
Our Greatest Challenge
for 2018 ?
Global Health Challenges – access to affordable care is not
just a problem for the poorer nations
▪ Thanks to coordinated global efforts, most people in Latin
America and the Caribbean are now immune to the Zika
mosquito-borne virus
▪ Polio eradication is near - Fewer than 20 new cases were
reported globally in 2017
▪ Globally, rates of premature death fell for non-
communicable diseases like cardiovascular disease, cancer,
diabetes, and chronic respiratory conditions.
Ref: [1] Gilbert Welch and Elliott Fisher. Health care costs are bankrupting us. CNN, Updated 1212 GMT (2012 HKT) May 11, 2017. https://edition.cnn.com/2017/05/11/opinions/health-care-costs-are-the-real-problem-opinion-welch-fisher/index.html. Accessed March 6, 2017. [2] Katherine Greifeld. A Third of Americans Are Still Struggling to
Find Affordable Healthcare. Bloomberg, 1 February 2017, 05:01 GM. https://www.bloomberg.com/news/articles/2017-02-01/health-care-costs-remain-high-despite-obamacare-coverage-gains. Accessed March 6, 2017. [3] Carmen Paun. Special report: EU health care. Politico 9/30/16, 11:53 AM CET, Updated 10/7/16, 4:21 PM CET.
https://www.politico.eu/article/europe-health-care-systems-on-life-support-special-report-drug-pricing-medicines-public-services/. Accessed March 18, 2018 [4] Anna Maresso et al. Economic crisis, health systems and health in Europe: countryA experience (2015). WHO Europe 2015, xxxi + 517 pages, ISBN 9789289050340.
http://www.euro.who.int/en/about-us/partners/observatory/publications/studies/economic-crisis,-health-systems-and-health-in-europe-country-experience-2015. Accessed March 18, 2018
Affordable Access to
healthcare
Our Greatest Challenge
for 2018 ?
Health Economics
▪ The only medicine that works
▪ Is one that we can afford to use
Ref: [1]. Medicine image. Pixabay - CC0 Creative Commons, Free for commercial use, No attribution required. https://pixabay.com/en/medications-cure-tablets-pharmacy-342462/. Accessed Aug 25,
2018
For example –
novel
checkpoint
inhibitors all
carry list prices
more than
$12,000 a month 4
median annual cost of a new
cancer drug launched in 2017
exceeded $150,000 2
Access to cancer biologics in Europe
Ref: [1] N. Cherny, R. Sullivan, J. Torode, M. Saar, A. Eniu; ESMO European Consortium Study on the availability, out-of-pocket costs and accessibility of
antineoplastic medicines in Europe, Annals of Oncology, Volume 27, Issue 8, 1 August 2016, Pages 1423–1443, https://doi.org/10.1093/annonc/mdw213
there are serious gaps in availability of
basic chemotherapeutic and biologic
medicines in many Central and Eastern
European countries.
Access to biologics in Europe: decided by wealth & not need
▪ Example - Access to biologic medicines for Inflammatory Bowel Disease patients1-2
60
40
20
0
10,000 20,000 30,000 40,000 50,000
SWE
FRA DEUESP
HUN
SVK
CZE
LVA
ROM
Gross domestic product per capita (Euro)
Pre
vale
nce
POL
Refs [1] Pentek M, et al. World J Gastroenterol 2017;23:6294–6305; [2] van der Valk ME, et al. Gut 2014;63:72–79.
Created from reference 1
CZE: Czech Republic; DEU: Germany; ESP: Spain; FRA: France; HUN: Hungary;
LVA: Latvia; POL: Poland; ROM: Romania; SWE: Sweden; SVK: Slovakia
There is a strong correlation between the wealth of a country and the number of patients
on biologics1
The reality of cancer care now
▪ “We must confront a stark
reality: cancer care is not
affordable for most
patients, many payers,
and nearly all
governments. This is a
real and immediate issue
across the world” 1
Ref: [1] Thomas R et al. Delivering affordable cancer care a value challenge to health systems. Report of the WISH Delivering Affordable Cancer Care Forum 2015. URL: www.wish.org.qa.
Accessed Oct 17, 2016 [2] Image – CCO License - https://upload.wikimedia.org/wikipedia/commons/c/cc/Science_and_Mechanics_Nov_1931_cover.jpg. Accessed Nov 2, 2016
We Have a Problem …
Ref: [1] Steven Brill. Bitter Pill: Why Medical Bills Are Killing Us. Time April 4, 2013 [2] Silverman E. Biotechnol Healthc. 2012;9(4):13-16.
The reality of cancer care now
Ref: [1]. Stott K. Pharma’s broken business model: An industry on the brink of terminal decline. Endpoints news, November 28, 2017. https://endpts.com/pharmas-
broken-business-model-an-industry-on-the-brink-of-terminal-decline/. Accessed March 7, 2019
Only patients in the United States, Germany and United Kingdom have access to more than 40 of the 55 oncology medicines initially
launched between 2012 and 2016, due to manufacturers not filing for regulatory approval, delays or denials of approval, or
manufacturers awaiting the results of reimbursement negotiations prior to launching the drug in the country.
2 years from launch only 3 nations had 70% or more of
innovative cancer medicines available (2017) 1
& 6 nations more than half
The Payers’ perspective:
Medical strategies and metrics will have to change
▪ Pre-EBM - Evidence Based Medicine
• Focus on a novel mechanism of action?
• Response = CR, PR, SD, PD
▪ EBM - Evidence Based Medicine
• Focus on efficacy OS, QoL
▪ VBM - Value Based Medicine
• Focus on effectiveness and “value” to
stakeholders Cost/QALY
Huber B et al. Oncology Drug Development and Value-based Medicine. http://www.quintiles.com/library/white-papers/oncology-drug-development-and-value-based-
medicine.pdf. Accessed June 27, 2014
VBM
“Is this worth doing
compared with other
things we could do with
the same resource?”
EBM
“Does this intervention
make you live
significantly longer or
live better?”
The Evolution of Medical Decision Making:
Huber B et al. Oncology Drug Development and Value-based Medicine. http://www.quintiles.com/library/white-papers/oncology-drug-development-and-value-based-
medicine.pdf. Accessed June 27, 2014
VBM
“Is this worth doing
compared with other
things we could do with
the same resource?”
▪ We have to lean to provide
▪ The most effective treatments
▪ In the most cost effective way
Important Similarities Between
Physicians and Economists
1. Realistic approach to life’s
problems
2. Reliance on quantitative
information
3. Often must make difficult
choices in the face of
uncertainty
4. Good decisions require
comparing benefits and
risks (costs)
Ref: [1] Image - office work, CCO license, Pixabay. https://pixabay.com/vectors/office-business-work-meeting-3493282/. Accessed July 3, 2019
Important Similarities & Differences Between
Physicians and Economists
1. Realistic approach to life’s
problems
2. Reliance on quantitative
information
3. Often must make difficult
choices in the face of
uncertainty
4. Good decisions require
comparing benefits and
risks (costs)
Physicians are usually concerned
with an individual patient or small
numbers of patients
Economists are usually concerned
with large aggregations:
• organisations, industries,
governments,
• society as a whole
Ref: [1] Image - office work, CCO license, Pixabay. https://pixabay.com/vectors/office-business-work-meeting-3493282/. Accessed July 3, 2019
So – why the Economic Focus on GI cancers?
Ref [1] Nils Wilking, Gilberto Lopes, Klaus Meier, Steven Simoens, Wim van Harten5, and Arnold Vulto. Can we Continue to Afford Access to Cancer Treatment? Touch Oncology, 2017; DOI:
https://doi.org/10.17925/EOH.2017.13.02.114
What’s the cost of GI cancer in Europe?
▪ Main cancer
diagnoses
among men
and women in
EU countries,
2018
Ref: [1] OECD/EU (2018), Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. https://doi.org/10.1787/health_glance_eur-2018-en
More diagnoses than
Breast Cancer
Respiratory
Cancers
Haematological
Malignancies
Reproductive
Organ Cancers
Urological
Cancers
Gastrointestinal
Malignancies
651,102
Europeans
diagnosed in 2018
What’s the cost of GI cancer in Europe?
▪ European cancer mortality, 2015
Ref: [1] OECD/EU (2018), Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. https://doi.org/10.1787/health_glance_eur-2018-en
More deaths than
Breast Cancer
More deaths than
Lung Cancer
Gastrointestinal
Malignancies
349,508
Europeans died
in 2015
What’s the cost of GI cancer in Europe?
Ref: [1] OECD/EU (2018), Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. https://doi.org/10.1787/health_glance_eur-2018-en
Gastrointestinal
Malignancies
651,102
Europeans
diagnosed in
2018
349,508
Europeans died
in 2015
Morbidity Mortality
What’s the cost of GI cancer in Europe?
▪ The Economic perspective
Ref: [1] OECD/EU (2018), Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. https://doi.org/10.1787/health_glance_eur-2018-en
Gastrointestinal
Malignancies
651,102
Europeans
diagnosed in
2018
349,508
Europeans died
in 2015
MorbidityMedical Care
“Direct Costs”
Mortality
Including Patient
Co-PaymentsThis affects families as well as patients
“Indirect Costs”
What’s the Direct Cost of GI cancer in Europe?
▪ The Economic perspective – NHS England Data 2
Ref: [1] OECD/EU (2018), Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. https://doi.org/10.1787/health_glance_eur-2018-en. [2] Mauro Laudicella,
Brendan Walsh, Elaine Burns & Peter C Smith. Cost of care for cancer patients in England: evidence from population-based patient-level data. Br J Ca, 2016;114:1286–1292 (24 May 2016)
Gastrointestinal
Malignancies
651,102
Europeans
diagnosed in
2018
349,508
Europeans died
in 2015
Colorectal Cancer
costs more over a
decade than
Breast, Prostate
or Lung Cancer
Direct Costs
What’s the Direct Cost of GI cancer in the USA?
▪ The Economic perspective – USA Data 2
Ref: [1] eborah R. Kaye et al. Costs of Cancer Care Across the Disease Continuum. The Oncologist July 2018 vol. 23 no. 7 798-805 [2] Gastrointestinal Cancers: An Urgent Need. GI Cancer
Alliance. https://www.gicancersalliance.org/resources/gastrointestinal-cancers-an-urgent-need/. Accessed July 3, 2019
Gastrointestinal
Malignancies
286,480
Americans
diagnosed in
2018
147.090
Americans died
in 2015
3 of the top 5 US
cancers by
annual direct
costs are
Gastrointestinal 1
European Data shows very different performance
between Health Systems
▪ Colorectal cancer (CRC) mortality rates vs spend in 7 European
countries 1
Ref: [1] Kanavos P, Schurer W. The dynamics of colorectal cancer management in 17 countries. Eur J Health Econ. 2010;10 (Suppl 1):S115-S129.
Spending per case on CRC – in € 1000’s
5y O
S
Spend in
EUROPE
varies 20 fold
without clear
evidence of
benefit
European Data shows very different performance
between Health Systems
▪ Colorectal cancer (CRC) mortality rates vs spend in 7 European
countries 1
Ref: [1] Kanavos P, Schurer W. The dynamics of colorectal cancer management in 17 countries. Eur J Health Econ. 2010;10 (Suppl 1):S115-S129.
Spending per case on CRC – in € 1000’s
5y O
S
Outcomes in
EUROPE can
vary 9%
Absolute
absolute for
same costs
North America Data shows very different
performance between Health Systems
▪ First Line Metastatic Colorectal cancer (CRC) treatment costs compared 2
Ref: [1] Image - Map North America, CCO License, Wikipaedia. https://en.wikipedia.org/wiki/North_America. Accessed July 2, 2019. [2] Todd Yezefski et al. Comparison of chemotherapy use, cost, and survival in patients with
metastatic colorectal cancer in Western Washington and British Columbia. Journal of Clinical Oncology 2018 36:18_suppl, LBA3579-LBA3579
Spend in North
America varies
2 - fold without
clear evidence
of benefit
British Columbia:
-
Monthly Cost $6,195 USD
Western Washington State:
-
Monthly Cost $12,345; P < .01
“Variation” is a trigger word for Health Economists
Ref: [1]. OECD/EU (2018), Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. https://doi.org/10.1787/health_glance_eur-2018-en
Variation suggests 3 lines of
investigation
Looking at patient pathways – NHS England
Ref: [1]. Cost-effective commissioning of colorectal cancer care - An assessment of the cost-effectiveness of improving early diagnosis. Public Health England.
Version 1.0/ October 2016. https://assets.publishing.service.gov.uk/.../cost-effectiveness-early-diagnosis-colorectal...Accessed July 2, 2019
Health systems typically look at Direct
Costs of care as a ”Patient Pathway”
Example – Colorectal Cancer CRC
Step 1: Prevention and Early Diagnosis
Ref: [1]. Cost-effective commissioning of colorectal cancer care - An assessment of the cost-effectiveness of improving early diagnosis. Public Health England. Version 1.0/ October 2016.
https://assets.publishing.service.gov.uk/.../cost-effectiveness-early-diagnosis-colorectal...Accessed July 2, 2019 [2] Mauro Laudicella, Brendan Walsh, Elaine Burns & Peter C Smith. Cost of care for cancer patients in England:
evidence from population-based patient-level data. Br J Ca, 2016;114:1286–1292 (24 May 2016)
Stage I
93.2% 5 year OS
Stage IV
8.8% 5 year OS
Treatment Cost =
£3559 / €396910 Year Pathway Cost, all Colorectal Cancer = £38,098 / €42,473
VALUE OF EARLY DIAGNOSIS:
1/10th the cost to diagnose and
treat as stage I
Step 3: Primary Treatment
Ref: [1]. Cost-effective commissioning of colorectal cancer care - An assessment of the cost-effectiveness of improving early diagnosis. Public Health England.
Version 1.0/ October 2016. https://assets.publishing.service.gov.uk/.../cost-effectiveness-early-diagnosis-colorectal...Accessed July 2, 2019
Primary
Treatment
IDEA-Study: SHORTER NON-INFERIOR
3y DFS rate NSD for CAPOX regimens:
5,071 patients randomised
95% CI: 0.85–1.06
CAPOX Available as an all-generic regimen
since 2013
Using CAPOX saves $4080 USD / €3590 over
FOLFOX 3,4
Patients prefer oral Capecitabine over IV
regimens 5
VALUE OF PRIMARY TREATMENT:
Less Hospital Resource / Less cost /
Patient Preferred
Step 3B: Post Primary Treatment
Ref: [1]. Cost-effective commissioning of colorectal cancer care - An assessment of the cost-effectiveness of improving early diagnosis. Public Health England.
Version 1.0/ October 2016. https://assets.publishing.service.gov.uk/.../cost-effectiveness-early-diagnosis-colorectal...Accessed July 2, 2019
Primary
Treatment
Further lines
of treatment?
Further lines
of treatment?
Further lines
of treatment?
Step 3B: Post Primary Treatment –
2017 Guideline Options Include...
Ref: [1]. Cost-effective commissioning of colorectal cancer care - An assessment of the cost-effectiveness of improving early diagnosis. Public Health England. Version 1.0/ October 2016. https://assets.publishing.service.gov.uk/.../cost-effectiveness-early-diagnosis-colorectal...Accessed July 2, 2019 [2]. David Bai, and Michael R.
Page. Guidelines Consider Use of Targeted Therapies in Colorectal Cancer. Targeted Oncology, Published Online: Nov 30,2017. https://www.targetedonc.com/publications/targeted-therapy-news/2017/november-2017/guidelines-consider-use-of-targeted-therapies-in-colorectal-cancer. Accessed July 2, 2019. [3] Colon Cancer - NCCN.
https://www.nccn.org/patients/guidelines/colon/files/assets/common/.../colon.pdf. Accessed July 2, 2019
▪ Targeted Therapies
▪ Bevacizumab
▪ Ramucirumab
▪ Ziv-aflibercept
▪ Cetuximab
▪ Panitumumab
▪ Regorafenib
▪ Vemurafenib
▪ Immunotherapies
▪ Ipilimumab
▪ Nivolumab
▪ Pembrolizumab
Step 3B: Post Primary Treatment
Ref: [1]. Cost-effective commissioning of colorectal cancer care - An assessment of the cost-effectiveness of improving early diagnosis. Public Health England. Version 1.0/ October 2016. https://assets.publishing.service.gov.uk/.../cost-effectiveness-early-diagnosis-colorectal...Accessed July 2, 2019 [2]. David Bai, and Michael R.
Page. Guidelines Consider Use of Targeted Therapies in Colorectal Cancer. Targeted Oncology, Published Online: Nov 30,2017. https://www.targetedonc.com/publications/targeted-therapy-news/2017/november-2017/guidelines-consider-use-of-targeted-therapies-in-colorectal-cancer. Accessed July 2, 2019. [3] Colon Cancer - NCCN.
https://www.nccn.org/patients/guidelines/colon/files/assets/common/.../colon.pdf. Accessed July 2, 2019 [4]. Daniel A. Goldstein et al. Bevacizumab (bev) for metastatic colorectal cancer (mCRC): A global cost-effectiveness analysis. ASCO 2016; Abstract 6518. https://ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.6518.
Accessed July 2, 2019 [5] Robert A. Nagourney. The Cost of Care for Stage 4 Colon Cancer: How Much is Too Much? July 6, 2017, MD Accessed July 2, 2019. https://www.nagourneycancerinstitute.com/blog/cost-of-care-stage4-colon-cancer-how-much-too-much. Accessed July 2, 2019
▪ Targeted Therapies
▪ Bevacizumab
▪ Ramucirumab
▪ Ziv-aflibercept
▪ Cetuximab
▪ Panitumumab
▪ Regorafenib
▪ Vemurafenib
▪ Immunotherapies
▪ Ipilimumab
▪ Nivolumab
▪ Pembrolizumab
Step 3C-5: Post Post Primary Treatment
Ref: [1]. Cost-effective commissioning of colorectal cancer care - An assessment of the cost-effectiveness of improving early diagnosis. Public Health England. Version 1.0/ October 2016. https://assets.publishing.service.gov.uk/.../cost-effectiveness-early-diagnosis-colorectal...Accessed July 2, 2019 [2] Vogel, A. et al. Treatment
decisions in metastatic colorectal cancer – Beyond first and second line combination therapies. Cancer Treatment Reviews, Volume 59, 54 - 60, 2017
2017 Vogel identified at least 5 treatment options
beyond 2nd line with evidence for effect
Further lines
of treatment?
Further lines
of treatment?
Likely to be in further lines of
treatment that most cost-
variation occurs
Further lines
of treatment?
Many more therapies had ACTIVITY with PFS or
DFS gains – but how useful are SURROGATE
OUTCOMES to predict CLINICAL BENEFIT
Form many potential lines of therapy –
Can we select effective treatments ?
▪ Does the ESMO Magnitude of Benefit Scale direct our choices to cost-
effective care?
Ref: [1] ESMO Press Release: ESMO Announces a Scale to Stratify the Magnitude of Clinical Benefit of Anti-Cancer Medicines. ESMO 30 May 2015.
http://www.esmo.org/Press-Office/Press-Releases/ESMO-Announces-a-Scale-to-Stratify-the-Magnitude-of-Clinical-Benefit-of-Anti-Cancer-Medicines. Accessed July
1, 2016
Form many potential lines of therapy –
Can we select effective treatments ?
▪ Does the ESMO Magnitude of Benefit Scale direct decisions to cost-
effective care?
Principles - ESMO Scale for Assessing Value of Cancer Drugs
1. Cure takes precedence over deferral of death.
2. Direct endpoints, such as overall survival and quality of life, take precedence
over surrogates such as progression-free survival (PFS) and response rate (RR).
3. Disease-free survival in curative disease is a more valid surrogate than PFS and
RR in noncurative disease.
4. Cost is not taken into account
Ref: [1] ESMO Press Release: ESMO Announces a Scale to Stratify the Magnitude of Clinical Benefit of Anti-Cancer Medicines. ESMO 30 May 2015.
http://www.esmo.org/Press-Office/Press-Releases/ESMO-Announces-a-Scale-to-Stratify-the-Magnitude-of-Clinical-Benefit-of-Anti-Cancer-Medicines. Accessed July
1, 2016
Form many potential lines of therapy –
Can we select effective treatments ?
Ref: [1] Multiple Myeloma. Version 2.2016. NCCN.org. http://www.nccn.org/professionals/physician_gls/pdf/myeloma_blocks.pdf. Accessed Nov 25, 2015
[2] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with NCCN Evidence Blocks™. NCCN.org.
http://www.nccn.org/evidenceblocks/.Accessed Nov 25, 2015
Cost-effectiveness is not
shown
NCCN Panel members score
each measure using a
standardized scale from “1”
to “5” with “1” being the least
and “5” the most favorable.
ECONOMISTS
Never Say
“Cheap” or
“Expensive”
Treatments are
either COST-
EFFECTIVE or NOT
COST-EFFECTIVE
a high cost regimen may
be highly effective – and
so good value
The EU reports on strategies for sustainable care
▪ Key recommendations include
Ref: [1] Joint Report on Health Care and Long-Term Care Systems and Fiscal Sustainability, Volume 1, October 2016. EU.
http://ec.europa.eu/economy_finance/publications/eeip/pdf/ip037_vol1_en.pdf. Accessed Nov 17, 2016
Brand Competition for treatment options in
the 2017 Guidelines
Ref: [1]. Cost-effective commissioning of colorectal cancer care - An assessment of the cost-effectiveness of improving early diagnosis. Public Health England. Version 1.0/ October 2016. https://assets.publishing.service.gov.uk/.../cost-effectiveness-early-diagnosis-colorectal...Accessed July 2, 2019 [2]. David Bai, and Michael R.
Page. Guidelines Consider Use of Targeted Therapies in Colorectal Cancer. Targeted Oncology, Published Online: Nov 30,2017. https://www.targetedonc.com/publications/targeted-therapy-news/2017/november-2017/guidelines-consider-use-of-targeted-therapies-in-colorectal-cancer. Accessed July 2, 2019. [3] Colon Cancer - NCCN.
https://www.nccn.org/patients/guidelines/colon/files/assets/common/.../colon.pdf. Accessed July 2, 2019
▪ Targeted Therapies
▪ Bevacizumab patent expires 2010
▪ Ramucirumab
▪ Ziv-aflibercept
▪ Cetuximab patent expired 2016
▪ Panitumumab
▪ Regorafenib
▪ Vemurafenib
▪ Immunotherapies
▪ Ipilimumab
▪ Nivolumab
▪ Pembrolizumab
Bevacizumab Biosimilars
Approved – for potential
launch 2020
Cetuximab No Biosimilars
Approved – despite expired
patent
1 Option to save coming soon
Brand Competition for treatment options in
the 2017 Guidelines
Ref: [1]. Cost-effective commissioning of colorectal cancer care - An assessment of the cost-effectiveness of improving early diagnosis. Public Health England. Version 1.0/ October 2016. https://assets.publishing.service.gov.uk/.../cost-effectiveness-early-diagnosis-colorectal...Accessed July 2, 2019 [2]. David Bai, and Michael R.
Page. Guidelines Consider Use of Targeted Therapies in Colorectal Cancer. Targeted Oncology, Published Online: Nov 30,2017. https://www.targetedonc.com/publications/targeted-therapy-news/2017/november-2017/guidelines-consider-use-of-targeted-therapies-in-colorectal-cancer. Accessed July 2, 2019. [3] Colon Cancer - NCCN.
https://www.nccn.org/patients/guidelines/colon/files/assets/common/.../colon.pdf. Accessed July 2, 2019
Bevacizumab Biosimilars
Approved – for potential
launch 2020
Cetuximab No Biosimilars
Approved – despite expired
patent
1 Option to save coming soon
“Variation” is a trigger word for Health Economists –
With 2 clear areas for future work in colorectal cancer
Ref: [1]. OECD/EU (2018), Health at a Glance: Europe 2018: State of Health in the EU Cycle, OECD Publishing, Paris. https://doi.org/10.1787/health_glance_eur-2018-en
Example: Colorectal Cancer
2 years from launch only 3 nations had 70% or more of
innovative cancer medicines available (2017) 1
Deciding the Value of Innovation?
Ref: [1]. Stott K. Pharma’s broken business model: An industry on the brink of terminal decline. Endpoints news, November 28 , 2017. https://endpts.com/pharmas-broken-business-model-an-industry-on-the-brink-of-terminal-decline/. Accessed March 7, 2019 [2] ICER. ICER Value Assessment Framework.
https://icer-review.org/methodology/icers-methods/icer-value-assessment-framework/. Accessed July 1, 2019 [3] NICE. The guidelines manual - Process and methods [PMG6] Published date: November 2012. https://www.nice.org.uk/process/pmg6/chapter/assessing-cost-effectiveness. Accessed July 1, 2019 [4] IQWiG presents a method for evaluating the relation between cost and benefit. 2009-10-19. https://www.iqwig.de/en/press/press-releases/iqwig-presents-a-method-for-evaluating-the-relation-between-cost-and-benefit.2402.html. Accessed July 1, 2019
2 years from launch only 3 nations had 70% or more of
innovative cancer medicines available (2017) 1
Health Systems are adopting
“Value Based Medicine”
Ref: [1]. Stott K. Pharma’s broken business model: An industry on the brink of terminal decline. Endpoints news, November 28 , 2017. https://endpts.com/pharmas-broken-business-model-an-industry-on-the-brink-of-terminal-decline/. Accessed March 7, 2019 [2] ICER. ICER Value Assessment Framework.
https://icer-review.org/methodology/icers-methods/icer-value-assessment-framework/. Accessed July 1, 2019 [3] NICE. The guidelines manual - Process and methods [PMG6] Published date: November 2012. https://www.nice.org.uk/process/pmg6/chapter/assessing-cost-effectiveness. Accessed July 1, 2019 [4] IQWiG presents a method for evaluating the relation between cost and benefit. 2009-10-19. https://www.iqwig.de/en/press/press-releases/iqwig-presents-a-method-for-evaluating-the-relation-between-cost-and-benefit.2402.html. Accessed July 1, 2019
All 3 use the same metric: The cost to gain
one extra year of good quality life.
2 years from launch only 3 nations had 70% or more of
innovative cancer medicines available (2017) 1
Health Systems are adopting
“Value Based Medicine”
Ref: [1]. Stott K. Pharma’s broken business model: An industry on the brink of terminal decline. Endpoints news, November 28 , 2017. https://endpts.com/pharmas-broken-business-model-an-industry-on-the-brink-of-terminal-decline/. Accessed March 7, 2019 [2] ICER. ICER
Value Assessment Framework. https://icer-review.org/methodology/icers-methods/icer-value-assessment-framework/. Accessed July 1, 2019 [3] NICE. The guidelines manual - Process and methods [PMG6] Published date: November 2012.
https://www.nice.org.uk/process/pmg6/chapter/assessing-cost-effectiveness. Accessed July 1, 2019 [4] IQWiG presents a method for evaluating the relation between cost and benefit. 2009-10-19. https://www.iqwig.de/en/press/press-releases/iqwig-presents-a-method-for-
evaluating-the-relation-between-cost-and-benefit.2402.html. Accessed July 1, 2019 [4] C2H Japan. https://c2h.niph.go.jp/en/info/news/index.html. Accessed July 3, 2019
All 3 use the same metric: The cost to gain
one extra year of good quality life.
C2H Japan
1st Assessments June 11, 2019
Ritsumeikan University
Comparative Outcomes Group, Bristol, UK
ESO Task Force Advisory Board on
Access to Innovative Treatment in Europe
European School of Oncology
Cancer Care is
becoming
UNAFFORDABLE
– the treatment
advances we hear
of at ESMO may
be implemented in
just a few wealthy
nations
GI Cancers Matter
–
the Human Cost
and Financial
Cost is significant
--
Europe shows 20x
variation in costs
for no benefit &
9% OS difference
without cost
PATHWAY
ANALYSIS
shows that we
have had
successes – as
well as failures
GUIDELINE
TOOLS
from ESMO and
NCCN are helpful
– but are not yet
VALUE-BASED