Coping with escalating - Oncology Leanring Network Lecture... · Bridging cancer prevention...

Josep Tabernero, MD PhD

Medical Oncology DepartmentVall d’Hebron University Hospital

Vall d’Hebron Insitute of Oncology (VHIO)Director R&D, Catalonian Cancers Centres Network

BarcelonaSpain

Coping with escalating healthcare costs in 2018

and beyond

DISCLOSURE SLIDE

Scientiic advisory role for Amgen, Bayer, Boehringer Ingelheim, Celgene, Chugai, Genentech, Inc., Lilly, MSD, Merck Serono, Novartis, Pizer, F. Hofmann-La Roche Ltd, Sanoi, Symphogen, Taiho and Takeda

The views expressed in this presentation are personal and do not have to coincide with the views of the European Society for Medical Oncology

ESMO 2020 VISIONSecuring the best possible outcomes for people with cancer

INTEGRATED CANCER CARE

1

SPECIALISEDEDUCATION

2

SUSTAINABLECANCER CARE

3

Bridging cancer prevention research, early-

diagnosis, and treatment to improve patient outcomes

Supporting oncologists in a fast-changing professional environment

Advocating for equal access to quality

treatment and for cancer prevention

SUSTAINABLE CANCER CARE

•Current cancer stats in 2015:

• Estimated 17.5 million

cancer cases globally, with

8.7 million deaths

• Cancer cases forecast to rise

by 75% over the next 20

years

• Skyrocketing costs of

oncotherapeutics and

supportive care drugs

The Economist

WHERE WE ARE TODAY


WHERE WE ARE TODAY

• Costs globally soared to $107

billion globally in 2015 – an

increase of 11.5% over 2014

• These costs are estimated to

reach $150 billion globally by

2020

• In the last 5 years:

• Costs of cancer medicines

increased by 72% over

2010 in the US

• By 50% in countries other

than the US

IMS Health, MIDAS, Dec 2015; Market Prognosis, Mar 2016;

IMS Institute for Healthcare Informatics, May 2016

Global Oncology Costs and Growth, 2010 – 2020


WHERE WE ARE TODAY

Data Courtesy of:Deined Health, Florham Park, NJ

Worldwide Sales by Therapeutic Area 2013-2020


WHERE WE ARE TODAY

Total spending on Cancer Therapeutics in 2016: 24bn €

Data Courtesy of:Murray Aitken, QuintilesIMS, MIDAS 2016,

QuintilesIMS Institute


WHERE WE ARE TODAY

Car-T Therapy Potentially curative

therapy Expected to be among

the most expensive of all time

Analysts estimation: $ 750,000 per patient

Financial Timeshttps://www.ft.com/content/7fce401e-8c47-11e7-a352-e46f43c5825d


WHERE WE ARE TODAY

Access to novel anti-cancer therapies:

• 49 new cancer medicines were launched between 2010 – 2014

• 17 of these are currently available in 10 or fewer countries

• Only 6 countries had access to at least half of the 49

• Lack of reimbursement under public insurance programs

• Of drugs approved 2014 – 2015 only US, Scotland and France have more than half on reimbursement lists (end 2015)

2015 Availability of Oncology Medicines Launched 2010-2014

Source IMS Health, MIDAS Q4 2015


WHERE WE ARE TODAY

Access to novel anti-cancer therapies:

• 49 new cancer medicines were launched between 2010 – 2014

• 17 of these are currently available in 10 or fewer countries

• Only 6 countries had access to at least half of the 49

• Lack of reimbursement under public insurance programs

• Of drugs approved 2014 – 2015 only US, Scotland and France have more than half on reimbursement lists (end 2015)

Reimbursement Status of Cancer Medicines Approved in 2014 and 2

Sources: National Institute for Health and Care Excellence (NICE) (England), Scottish Medicines Consortium (SMC)

(Scotland), The Dental and Pharmaceutical Benets Agency (TLV) (Sweden), Canadian Agency for Drugs and Technologies

in Health (Canada), Pharmaceutical Benets Scheme (PBS) (Australia), Federal Joint Committee (Germany), National

Comprehensive Cancer Network Guidelines (U.S.), IMS Institute for Healthcare Informatics, May 2016.

“Health is a human right and as a society we should favour actions to facilitate equal access to optimal cancer care to all patients worldwide”Fortunato Ciardiello, MD, PhD, ESMO President.

“Medicine doesn´t work if it doesn’t get to the patient” Daniel Hayes, MD, FACP, FASCO, Past President of ASCO.


WHERE WE ARE TODAY

http://globocan.iarc.fr

Incidence (per 100.000)

Despite higher incidence rates in Western Europe,

the mortality rates are higher in Central Eastern Europe

Mortality (per 100.000)

Disparities in Cancer control in Europe


WHERE WE ARE TODAY

Inequalities in Access to Drugs: ESMO Anti-Neoplastic Medicines Survey 2014


WHERE WE ARE TODAY

Cherny N, et al. Ann Oncol 2016.

Western Europe

Eastern Europe

ESMO Survey 2014: NSCLC Targeted Agents


WHERE WE ARE TODAY

Costs of cancer care per person in EU countries

EU countries spend ≈ 10% of GDP on health; but, the money spend per capita ranges from 7.000$ to as low as 500$

Cancer care costs account for only 4 % of total EU health care expenditure.

Drug costs ≈ 27% (15% to 61%) of all

costs.

Luengo-Fernandez R, et al. Lancet Oncol 2013; Vogler S, et al. Lancet Oncol 2016.

Drug prices in 15 European countries, Australia and New Zealand, 2013

Diferences between countries varied from 28% to 388%.

Slide kindly provided by Tanja Cufer


DELIVERING ON ESMO´S MISSION OF FACILITATING EQUAL ACCESS TO OPTIMAL CANCER CARE TO ALL CANCER PATIENTS

ESMO in action:

• To tackle issues relating to equal access to both essential medicines and innovative cancer therapies ESMO´s Cancer Medicines Working Group (CMWG) launched in 2015



ESMO in action:

• To tackle issues relating to equal access to both essential medicines and innovative cancer therapies ESMO´s Cancer Medicines Working Group (CMWG) launched in 2015

Essential Inexpensive Cancer Medicines:

• Inexpensive, essential medicines: address the shortages, growing disparities of access within Europe and beyond, global depletion of stocks and lack of incentives to produce these medicines

• Progress to-date includes:• Partnered with The Economist´s Intelligence

Unit to develop report on Cancer Medicines Shortages in Europe: Policy recommendations to prevent and manage shortages

• High proile launch of report at the European Parliament outcomes: recommendations disseminated to policymakers at EU & national


ESMO in action:Expensive Innovative Cancer Medicines

• ESMO´s CMWG Task for Expensive, innovative medicines formally

addresses the issue of sustainability of healthcare systems

• The Task Force brings together experts from all over the world to

brainstorm and highlight challenges and work towards developing

solutions

• It aims to work on the potential development of an economic model

to tackle issues related to reimbursement of innovative, medicines

• Engaging and triggering the many must-have conversations among

stakeholders in oncology:

• WHO´s Fair Pricing Forum (May 2017)

• ASCO-ESMO Joint Symposium: Access to Cancer Medicines (June

2017)

• Biosimilars:

• ESMO Position Paper, published in ESMO Open (January

2017)



• Oncology drugs in clinical

development has expanded by

63% over the last decade

• In 2015: 586 molecules in late

phase oncology pipeline

• Novel and expensive

immunotherapies represent a

rapidly emerging area in oncology

R&D: set to expand the pipeline in

2020

• Our collective eforts MUST center

on proven eicacy, equitable

access, and adjusted pricing or

adequate value-based

reimbursement

The QALY is just a well researched number.

The value of a life is far more complex question

Many people are cheering a new potential solution: paying for drugs according to how well they actually

work.

DrugEfectivenessStatistically signiicantClinically relevantCost-EfectiveValue ≠ CostQALYs

Value =

BeneitCost + Toxicity

RegimenCost of Nivolum

ab

Cost of Ipilimum

ab

Cost of Regime

n

Nivo+lpi for 11.5m

$144,408

$151,158

$295,566

Nivo for 6.9m $103,220 $0 $103,2

20

Ipilimumab for 2.9m $0 $158,25

2$158,2

52



ESMO in action:Expensive Innovative Cancer Medicines

Outline of the model: Reimbursement based on local-referenced value

Value of “X” drug(tumor type/setting)

HE parametersMCBSFrequency of the disease

Adapt to the country/region level

Country/Region parameters:GDP% of GDP in health expendituresFrequency of the disease (registries, extrapolation)

Planned Outcome:•Models and Tools (template) •No speciic discussions on speciic drugs/regions

Geographically-adapted value-based reimbursement



CHALLENGES & OPPORTUNITIES (I):MAJOR VALUE-BASED FRAMEWORKS - UPHOLDING PROVEN AS OPPOSED TO PROMISING

Major Value-Based Frameworks

• ESMO-Magnitude of Clinical Beneit Scale1-3

• ASCO Value Framework4

• Sloan Kettering Drug Abacus5

• NCCN Value Blocks6

1.- Cherny et al. Ann Oncol 2015; 2.- Tabernero J. Ann Oncol 2015; 3.- Cherny et al. Ann Oncol 2017, 4.- Schnipper et al. J Clin Oncol 2015; 5.- Bach P. http://www.drugabacus.org; 6.- http://www.nccn.org/about/news/newsinfo.aspx?NewsID=545

SUSTAINABLE CANCER CARESUSTAINABLE CANCER CARE

Major Value-Based Frameworks

• ESMO-Magnitude of Clinical Beneit Scale1-3

• ASCO Value Framework4

• Sloan Kettering Drug Abacus5

• NCCN Value Blocks6

1.- Cherny et al. Ann Oncol 2015; 2.- Tabernero J. Ann Oncol 2015; 3.- Cherny et al. Ann Oncol 2017, 4.- Schnipper et al. J Clin Oncol 2015; 5.- Bach P. http://www.drugabacus.org; 6.- http://www.nccn.org/about/news/newsinfo.aspx?NewsID=545


Magnitude of Clinically Beneit

Magnitude of Clinically Beneit

Overall survival,

Progression free

survival

Overall survival,

Progression free

survival

ToxicityToxicity

CostsCosts

Prognosis of the

condition

Prognosis of the

condition

Quality of Life

Quality of Life

HR, Long term survival,

RR

Not analyzed in view of signiicant “Heterogeneity”across Europe


ESMO – MCBS FACTORS TAKEN INTO ACCOUNT

Curative setting A & B or non-curative setting 5 & 4

Curative Non-curative

ESMO – MCBS SUBSTANTIAL IMPROVEMENTS

5

4

3

2

1

A

B

C


ESMO-MCBS – inclusion of scores in Guidelines

Metastatic NSCLC

aEMA approvals in 2016 to end August 2016. bESMO-MCBS version 1.0 [181], cEMA approval, October 2015

dCo-primary end points (overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50% of tumour cells)

Therapy Disease setting

Trial Control Absolute survival gain

HR(95% CI)

QoL/toxicity

MCBS scoreb

Nivolumab Advanced Nivolumab versus docetaxel in advanced squamous-cell NSCLC [98] Phase III NCT01642004

Docetaxel in patients with advanced SCC who have disease progression during or after 1st-line chemotherapy. Control OS 6 months

OS gain: 3.2 months. 2-year survival gain 15%

OS: HR for death 0.59 (0.44-0.79)

Improved toxicity proile

5(Form 2a)c

Nivolumab Advanced Nivolumab versus docetaxel in advanced non-squamous NSCLC [104] Phase III NCT01673867

Docetaxel in patients with NSCC who progressed during or after platinum-based doublet chemotherapy. Control OS 9.4 months

OS gain: 2.8 months. 2-year survival gain 16%

OS: HR for death 0.73 (0.59-0.89)


5 (Form 2a)

Ramucirumab

Advanced Ramucirumab plus docetaxel vs placebo + docetaxel for 2nd-line treatment of stage IV NSCLC after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial [94] Phase III NCT01168973

Placebo + docetaxel in patients with SCC or NSCC who progressed during or after a 1st-line platinum-based chemotherapy regimen. Control OS 9.1 months

OS gain: 1.4 months OS: HR for death 0.86 (0.75-0.98)

Deteriorated toxicity proile

1 (Form 2a)

Pembrolizumab

Advanced Pembrolizumab vs docetaxel for previously treated, PD-L1-positive, advanced NSCLC (KEYNOTE-010): a randomised controlled trial [96] Phase III NCT01905657

Docetaxel in patients with previously treated,PD-L1-positive, advanced NSCLC. Control OS 8.5 months

In PD-L1 >1%:d OS gain: 1.9 months In PD- L1 >50%:d OS gain: 6.7 months

In PD-L1 >1%:d OS: HR for death 0.71 (0.58–0.88) In PD-L1 >50%:d OS: HR for death 0.54 (0.38–0.77)


In PD-L1 >1%: 3(Form 2a) In PD-L1 >50%: 5(Form 2a)




Distribution ESMO-MCBS grades EMA approved solid tumor drugs since 2016



Vivot et al, Ann Oncol 2017

No relation between price and clinical beneit of 38 FDA approved anticancer drugs 2000-2015



CHALLENGES & OPPORTUNITIES (II): SAFEGUARDING ACADEMIC CLINICAL CANCER RESEARCH OF EXCELLENCE

• Academia-based researchers have driven many therapeutic breakthroughs and standards of treatments by validating complex therapeutic strategies

• 65% of all clinical trials, globally, are supported by health systems, government funds, universities and other research organisations1

• Countless patients across the globe have beneited from practice-changing discoveries made by basic and clinical cancer researchers over decades

• In the era of precision medicine academic research is crucial to prioritizing treatments independently, based on sound evidence

*Workman P et al. Cell. 2017 Feb 9;168(4):579-581. https://clinicaltrials.gov/ Last accessed 28 April 2016

* Figure: The Academic Drug Discovery and Development Continuum and Its Relationships with Stakeholders

SUSTAINABLE CANCER CARESUSTAINABLE CANCER CARE

What is non-commercial or academic clinical research in the EU?

WHOThe party responsible for carrying out an independent, non-commercial clinical trial in the EU, i.e., the trial sponsor, can be a university or hospital or any other non-proit organisation or researcher recognised as a non-commercial sponsor.

WHATThe trial sponsor is responsible for the design, conduct, access to data and biological material, recording and reporting of the clinical trial and owns all data and indings resulting from the trial.

WITH WHOMProvided these principal conditions for independence are met, the sponsor can also enter into agreements with third parties, including commercial partners, to secure trial funding or delegate some responsibilities, such as drug manufacturing, supply or monitoring.

PRNewsfoto/ESMO

• ESMO-EORTC-EACR decided to address this crucial topic through the Clinical Academic Cancer Research Forum (CAREFOR) that was created in 2014

• CAREFOR intends to:1. Raise awareness about the importance of non-

commercially sponsored clinical trials2. Provide a space for key actors in this area to discuss

advances and solve challenges3. Engage with the EU institutions to come up with

ways to safeguard & foster independent academic trials

4. Ensure appropriate implementation of the EU Clinical Trials & Data Protection Regulations

• CAREFOR’s paper, Safeguarding the future of independent, academic clinical cancer research in Europe for the beneit of patients, published in ESMO Open (2017)

Integrating Science into Oncology for a Better Patient Outcome can and will only happen when all partners, all stakeholders in oncology, better understand and embrace the importance of economic returns in improved health outcomes and major impact on public health driven by academic research

CHALLENGES & OPPORTUNITIES (II): SAFEGUARDING ACADEMIC CLINICAL CANCER RESEARCH OF EXCELLENCE


• A study* showed that out of 124 oncology agents in the pipelines of the 9 companies examined, 74% had an overlapping mechanism of action

• There are too many ´me too´ drugs – contributing to the current health budget burden

• The ´me too´ approach to drug development hampers other areas of essential research

We must be collectively better organized to avoid costly duplication which is no longer sustainable.

*Fojo T et al. JAMA Otolaryngol Head Neck Surg. 2014 Dec;140(12):1225-36.

Comparison of Cancer Therapies in the Pipelines of PharmaceCompanies According to Their Putative Mechanisms of Action

CHALLENGES & OPPORTUNITIES (III): ‘ME TOO’ – TOO MANY


CHALLENGES & OPPORTUNITIES (IV):THE ADVENT OF BIOSIMILARS

A recent ESMO position paper* reported on the potential promise of biosimilar medicinal products in obtaining sustainability:

• Positively impact on the purse strings of national healthcare budgets

• Spur competition and lead to reduced prices of respective reference products

• Represent a timely and necessary opportunity for physicians and patients

• The EU has pioneered the approval of 23 biosimilars up to 2016

• With several monoclonal antibodies coming of patent by 2020 there will be many more biosimilars that will also impact on current innovative treatment strategies

• Biosimilars are here to stay and represent essential, more accessible anti-cancer weaponry - now and in the future*Tabernero J et al. ESMO Open. Jan 2017, 1 (6) e000142


A recent ESMO position paper* reported on the potential promise of biosimilar medicinal products in obtaining sustainability:

• Positively impact on the purse strings of national healthcare budgets

• Spur competition and lead to reduced prices of respective reference products

• Represent a timely and necessary opportunity for physicians and patients

• The EU has pioneered the approval of 23 biosimilars up to 2016

• With several monoclonal antibodies coming of patent by 2020 there will be many more biosimilars that will also impact on current innovative treatment strategies

• Biosimilars are here to stay and represent essential, more accessible anti-cancer weaponry - now and in the future*Tabernero J et al. ESMO Open. Jan 2017, 1 (6) e000142



The physician and patient´s joint and fully

informed decision to switch requires:

• Knowledge when a product is being switched

• Deep understanding of the product

• Factual information to fully brief the patient

• Close and multidisciplinary monitoring of the patient

to track adverse events

• Automatic switching is not an option



• European Commission Stakeholder Event on Biosimilar Medicinal Products, Josep Tabernero, ESMO President-elect, chaired a session “Collaborative Approach in the Use of Biosimilar Medicines” in May 2017.

• 15th Biosimilar Medicines Conference organised by Medicines for Europe in March 2017: ESMO was represented by Rosa Giuliani, ESMO PPSC member, who participated in a panel discussion.

• ESMO special session during ESMO 2017 in Madrid: “The incoming wave of biosimilars in oncology”.

• ESMO survey on awareness of biosimilars launched during ESMO 2017 in Madrid. Results to be presented in ESMO Asia 2017.

• ESMO meeting with the Biosimilar Medicinal Products Working Party (BMWP) – EMA in London, 21st September

• ESMO Colloquium on biosimilars during

ESMO special session during ESMO 2017 in Madrid: “The incoming wave of biosimilars in oncology700 participants



CHALLENGES & OPPORTUNITIES (V):POLICY POINTS

• Major societies including ESMO share the will and the

responsibility to lead public policy debate on

equitable access and afordable pricing and value-

based reimbursement of anti-cancer therapies across

borders

• Reliable value frameworks including ESMO-MCBS

provide policymakers with expanded data on eicacy

and value of oncology treatments

• We must collectively engage and consider the views

of all stakeholders towards regional-based priority

setting factoring in ´local´ socioeconomics and

reimbursement models


Framing of oncopolicy must embrace all assessment methodologies and include other specialists from in and out of oncology to also successfully tackle the pricing/reimbursement and performance of cancer medicines, the current state of research, drug development and treasury.

CHALLENGES & OPPORTUNITIES (V):POLICY POINTS

ENSURING SUSTAINABLE CANCER CARE

Looking to the future for issues afecting all Oncology Professionals

Cancer Medicines CommitteeExpensive, innovative

cancer medicines

It aims to develop an economic

model to tackle issues related to

reimbursement of innovative medicines

Cancer Medicines CommitteeExpensive, innovative

cancer medicines

It aims to develop an economic

model to tackle issues related to

reimbursement of innovative medicines

Cancer Medicines

Committee Inexpensive,

essential cancer medicines

Report on Cancer Medicines

Shortages in Europe developed

with The Economist

Intelligence Unit.

Recommendations made to policy

makers on how to prevent and

manage shortages

Cancer Medicines

Committee Inexpensive,

essential cancer medicines

Report on Cancer Medicines

Shortages in Europe developed

with The Economist

Intelligence Unit.

Recommendations made to policy

makers on how to prevent and

manage shortages

ESMO MCBS

Designed to assess the therapeutic

beneit of drugs registered for the

treatment of cancer

ESMO MCBS

Designed to assess the therapeutic

beneit of drugs registered for the

treatment of cancer

Biosimilars

Tailored educational material for

oncologists & patients

ESMO Colloquia on biosimilars during

ESMO 2018 & ESMO Asia 2018

European Commission 2018 Stakeholder Event

on Biosimilar Medicinal Products

Biosimilars

Tailored educational material for

oncologists & patients

ESMO Colloquia on biosimilars during

ESMO 2018 & ESMO Asia 2018

European Commission 2018 Stakeholder Event

on Biosimilar Medicinal Products



COPING WITH ESCALATING HEALTHCARE COSTS IN 2017 AND BEYOND:THE ´WHERE TO´ NEXT

“I don´t think limits” - Usain Bolt,

retired Jamaican Sprinter

Neither should we.


Members of Public Policy

Steering Committee

Members of Magnitude of

Clinical Beneit Committee

Invitees to Cancer Medicines Committee

TF on Expensive Medicines

TF on Inexpensive Medicines

Name Name Name Name

Paolo CasaliElisabeth G. E. de Vries

Elisabeth G. E. de Vries

Elisabeth G. E. de Vries

Alexandru Eniu Jan Bogaerts Fatima Cardoso Paolo CasaliJosep Tabernero Nathan I. Cherny Paolo Casali Alex Eniu

Rosa Giuliani Urania DafniFortunato Ciardiello Fatima Cardoso

Fatima CardosoGeorge Pentheroudakis Alexandru Eniu

Jean-Yves Douillard

Martine J. Piccart Rosa GiulianiFortunato Ciardiello

Josep Tabernero Elisabeth de Vries Elisabeth de Vries

Christoph ZielinskiJean-Yves Douillard Rosa Giuliani

Ana Clopes Vlad Voiculescu Bill Evans Klaus Meier Maarten IJzerman Annete Freidank

Gilberto LopesBernhard Wörmann

Bengt Jonsson Franco Cavalli Francesco PerronePetar Stefanovski Jose Maria Borras Timur Ceric Rosanna TarriconeSmruti Koppikar

Leadership: Fortunato Ciardiello, Solange Peters, Jean-Yves Douillard, Keith McGregor, Rolf StahelESMO Staf: Malvika Vyas, Gracemarie Bricali, Nicola Latino, Monica Gheorghe

ACKNOWLEDGEMENTS

Other Stakeholders: WHO, EMA, EU, EORTC, ASCO, EUnetHTA, …VHIO: Amanda Wren

BE PART OF THE ESMO COMMUNITY! JOIN ESMO TODAY

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Coping with escalating - Oncology Leanring Network Lecture... · Bridging cancer prevention...

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