bristol, uk

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


▪ European cancer mortality, 2015


More deaths than

Breast Cancer

More deaths than

Lung Cancer

Gastrointestinal

Malignancies

349,508

Europeans died

in 2015



Gastrointestinal

Malignancies

651,102

Europeans

diagnosed in

2018

349,508

Europeans died

in 2015

Morbidity Mortality


▪ The Economic perspective


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



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



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



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


▪ 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



▪ 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



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





▪ 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




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



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



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.



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

bristol, uk

Documents