Access to care: an old/new issue? Global and Eastern European issues

Alexandru ENIU, MD, PhD

Cancer Institute Ion Chiricuţă

Cluj-Napoca, Romania

Deputy Scientific Director, European School of Oncology

Coordinator, Eastern Europe and Balkan Region programme (EEBR)

Past Chair, ESMO Global Policy CommitteeESO-ESM

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For a medical oncologist, and the societyValue= Survival of (his) patients

De Angelis, et al: Cancer survival in Europe 1999–2007 by country and age: EUROCARE-5

Lancet Oncol, 2013

“reduction of deaths from cancer due to late diagnosis and/or inadequate treatment”

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Radiotherapy access in Europe

Rosenblatt E, et al. Lancet Oncol 2013;14:e79–86

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“only 5% of patients in

LIC and 20% in MICs

have access to safe,

affordable, and timely

cancer surgery”

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clinicaltrials.gov10 Feb 2019

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My take home messages from EEBR retreat

• Big educational need– Curriculum for training not followed ( only on paper..)

– Basic principles of oncology are not taught

– Lack of mentors/leadership/role models

– Need for fellowships in another center

– Access to journals and textbooks still a major issue

– ESO courses to be recognised at national level for credits

– Need for courses on specific topics for which local faculty does not have expertise

– Better advertising our eventsESO-ESM

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Resource-stratified guidelines: BHGIIncremental allocation & implementation

Eniu A et al, Cancer: 113 (8 suppl), 2008

*** If the costs associated with trastuzumab

were substantially lower, trastuzumab would be

used as a limited-level therapy.

➢ Basic level: Core resources or fundamental services necessary for any breast health care system to function.

➢ Limited level: Second-tier resources or services that produce major improvements in outcome such as survival.

➢ Enhanced level: Third-tier resources or services that are optional but important, because they increase the number and quality of therapeutic options and patient choice.

➢ Maximal level: Highest-level resources or services used in some high resource countries with lower priority on the basis of extreme cost

Anderson et al, The Breast J: 12 (1), 2006

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ESMO Anti-Neoplastic Medicines Surveys

Perception survey to map access to cancer medicines, including WHO Essential Medicines, reporting on:

◼ Approval status ( yes/no) across Europe and the world◼ Informative for new drugs

◼ Reimbursement ( yes/no)◼ Highlight differences in cancer policies

◼ Residual (out of pocket) cost to patients

◼ Delays in access due to special authorization

◼ Actual availability◼ Drug shortage for old drugs

◼ Unavailability in the pharmacy (parallel export) for expensive drugs

Cherny, Sullivan, Torode, Saar, Eniu Ann Oncol. 2017 Nov;28(11):2633–2647

Cherny, Sullivan, Torode, Saar, Eniu Ann Oncol. 2016 Aug;27(8):1423-43

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Adjuvant breast cancer: : formulary inclusion and availability : TAMOXIFEN

AvailabilityFormulary

and cost

to patients

Availability

◼ Drug shortages affect several essential, old and inexpensive drugs (tamoxifen, doxorubicin, cisplatin, 5-FU, bleomycin…)

◼ Not an issue of resources!Cherny, Sullivan, Torode, Saar, Eniu Ann Oncol. 2016 Aug;27(8):1423-43

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WHO ESSENTIAL MEDICINES LIST 2015Solid Tumors

Cytotoxics Cytotoxics Cytotoxics Hormones

bleomycin docetaxel irinotecan anastrozole

calcium folinate doxorubicin methotrexate bicalutamide

capecitabine etoposide oxaliplatin dexamethasone

carboplatin fluorouracil paclitaxel leuprorelin

cisplatin filgrastim rituximab tamoxifen

cyclophosphamide gemcitabine trastuzumab

dacarbazine Ifosfamide+mesna vinblastine

dactinomycin imatinib vincristine

vinorelbine

• UICC Task Force on EML: UICC, Dana Farber Cancer Institute, ESMO, ASCO, SIOP, US NCI, NCCN International & others• New drugs, tumor-specific indications

http://www.who.int/medicines/publications/essentialmedicines/EML2015_8-May-15.pdf

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Bleomycin Imatinib Irinotecan Methotr. Oxaliplatin Vinblastine

Country: GCT CRC MBC Adj BC Ovarian Lung Lung Sarcoma Ovarian GCT Adj BC MBC Adj BC MBC Adj. BC MBC Sarcoma GCT Lung Adj. BC MBC CRC Ovarian Lung GCT Sarcoma GIST CRC Adj BC CRC Ovarian Adj BC MBC Lung prostate Adj.BC MBC GCT Lung MBC

Austria

Belgium

Cyprus

Denmark

Finland

France

Germany

Greece

Holland

Ireland

Israel

Italy

Luxembourg

Norway

Portugal

Spain

Sweden

Switzerland

Turkey

United Kingdom

Albania

Bosnia and Herzegovina

Bulgaria

Croatia

Czech Republic

Estonia

Hungary

Kosovo, Republic of

Latvia

Lithuania

Macedonia

Malta

Montenegro

Poland

Romania

Serbia

Slovenia

Slovakia

Bleomycin Imatinib Irinotecan Methotr. Oxaliplatin Vinblastine

Country: GCT CRC MBC Adj BC Ovarian Lung Lung Sarcoma Ovarian GCT Adj BC MBC Adj BC MBC Adj. BC MBC Sarcoma GCT Lung Adj. BC MBC CRC Ovarian Lung GCT Sarcoma GIST CRC Adj BC CRC Ovarian Adj BC MBC Lung Prostate Adj.BC MBC GCT Lung MBC

Austria

Belgium

Cyprus

Denmark

Finland

France

Germany

Greece

Holland

Ireland

Israel

Italy

Luxembourg

Norway

Portugal

Spain

Sweden

Switzerland

Turkey

United Kingdom

Albania

Bosnia and Herzegovina

Bulgaria

Croatia

Czech Republic

Estonia

Hungary

Kosovo, Republic of

Latvia

Lithuania

Macedonia

Malta

Montenegro

Poland

Romania

Serbia

Slovenia

Slovakia

Trastuz. VinorelbineDoxo. Etoposide 5-FU Gemcit. Ifos. Paclitaxel

Ifos. Paclitaxel Trastuz. Vinorelbine

ESSENTIAL MEDICINES LIST: Actual Availability

Capecitabine CarboP. CisP Cyclophos. (IV) Docetax.

ESSENTIAL MEDICINES LIST: Formulary and cost

Capecitabine CarboP. CisP Cyclophos. (IV) Docetax. Doxo. Etoposide 5-FU Gemcit.

Always

Usually

Half the time

Occasionally

Never

Not available

Missing data

WHO ESSENTIAL CANCER MEDICINES IN EUROPE

Formulary and Cost

Actual Availability

Cherny, Sullivan, Torode, Saar, Eniu. Ann Oncol. 2016 Aug;27(8):1423-43

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IMPACT OF ONCOLOGY DRUG SHORTAGES ON PATIENT THERAPY

DIRECT CONSEQUENCE: SUBOPTIMAL

THERAPY

• Delay of therapy

• Lack of therapy

• Less effective drug combinations

• Dosage compromises

• Non-therapeutic switches

• Medication errors / confusion

• Decreased therapy-compliance

• Increased use of resources

• Upfront payment / self payment

• Adverse patient outcomes

Oncology medicine

shortages affects

many patients and

increased at an

alarming rate. Drug

shortages have

substantial economic

costs and mandate

treatment changes

that may affect

efficacy and toxicity.

Virtually all cancer patients need some of these agents!

These medicines are not profitable, therefore companies stop producing them!

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Global Oncology Costs and Growth

• Costs globally soared to $107 billion globally in 2015 – an

increase of 11.5% over 2014 ($150 billion 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

This pressure directly affects (also) cheap medicines!ESO-E

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Luengo-Fernandez R. Economic burden of cancer across the European Union: a population-based cost analysis. TheLancet Oncology: 2013 Nov;14(12):1165–74.Jönsson B. The cost and burden of cancer in the European Union 1995-2014. Eur J Cancer. 2016 Oct;66:162–70.

Cost of Cancer Care in Europe

Total direct healthcare cost of cancer care• €51 billion in Europe in 2009 (Luengo et al, 2013)

– €83 billion in Europe in 2014 (Jönsson et al, 2016)

• €75 billion due productivity loss and informal care

Cancer care: around 4-6 % of health expenditure• Four cancers take about 44 % of cancer budget

• Variation between EU countries (16 – 184 €/capita)

Medicines account for 27% of cancer care• Which equals ≈1% of total healthcare budget

• Grown from 12% (2005) to 23% (2014) (Jönsson, 2016)

• Spending seems to be balanced by reductions on inpatient hospital care

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Metastatic breast cancer (formulary inclusion and cost to patients): Anti-Her2 therapy

Trastuzumab

Trastuzumab TDM-1

TDM-1

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5 yrs 10 yrs2 yrs

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How will the ESMO-MCBS be used?

• When a new anticancer drug is EMA approved, its benefit will be «scaled» by a dedicated ESMO committee

• Drugs which obtain the highest scores (A&B or 5&4):

1. will be highlighted in the ESMO guidelines2. represent the highest priority for rapid

endorsement by national bodies across Europe

54321

A

B

C

Curative Non-curative

Cherny, N et al, Ann Oncol epub 30 May 2015

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Example of using MCBS data: Breast cancer, Romania

Medication SettingPrimary

outcome

ESMO-

MCBS

Availability and

cost

2015

Availability

and cost

2019Chemotherapy +/-

trastuzumab

(Neo)adjuvant HER-2

positive tumoursDFS A Yes Yes

T-DM1 vs lapatinib +

capecitabine

2nd line metastatic after

trastuzumab failurePFS and OS 5 No Yes

Trastuzumab +

chemotherapy +/-

pertuzumab

1st line metastatic PFS 4 No Yes

Lapatinib +/-

trastuzumab3rd line metastatic PFS 4 No No

Capecitabine +/-

lapatinib

2nd line metastatic after

trastuzumab failurePFS 3 No Yes

Eribulin vs other

chemotherapy

3rd line metastatic after

anthracycline and taxaneOS 2 No No

Paclitaxel +/-

bevacizumab1st line metastatic PFS 2 Yes Yes

Exemestane +/-

everolimus

Metastatic after failure

of aromatase inhibitor

(with PFS > 6 mth)

PFS 2 No NoESO-E

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Value based payment

• Countries seeking to provide (universal) access to health care for all citizens have finite resources at their disposal (“there will NOT be more money for health!”)

• Payment for cancer medicines is a budget decision for the health care system

• Decisions must be made on objective and verifiable criteria where expenditures are compared to relevant alternative uses within and outside cancer care

• Value based payment requires development of sophisticated systems where payment is based on outcome in clinical practiceESO-E

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APHINITY: Intent-to-Treat Primary

Endpoint Analysis Invasive

Disease-free Survival

4yr iDFS absolute benefit = 1.7%

Number needed to treat: 112

Presented by Gunter von Minckwitz at 2017 ASCO Annual Meeting

112 * 48182=5.396.384 EURO!!

EMA approval ( N+) 56 * 48182=2.731.792 EURO!!ESO-E

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Clinical Benefit, Price and Approval Characteristics of FDA-approved New Drugs for Treating Advanced Solid Cancer, 2000-2015 A. Vivot, Ann OncolDOI:https://doi.org/10.1093/annonc/mdx053Published: 08 February 2017

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How Innovation in Clinical Care Increase Costs

◼ Treating conditions that were untreatable

◼ Treating people who previously were untreated

◼ Increasing safety of interventions

◼ More acceptable, less invasive interventions

◼ Changing attitudes towards age limits

◼ Changing expectations about health and disease

◼ Providing more expensive types of treatment

◼ More expensive medicines, surgery, radiotherapy

◼ More expensive tests, staff, more frequent

◼ Longer duration of treatment

◼ More tests, more professional interventions, more treatments per partient

Muir Gray & David Kerr( eds.), How to get better Value Cancer Care, Oxford Press, 2013

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ELIMINATE WASTE

◼ Over diagnosis

◼ Overtreatment

◼ Lack of MTD coordination

◼ Failures of various processes…

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Conclusions

◼ Important disparities exist across Europe in cancer outcomes

◼ Eastern Europe/ Balkan region has many unmet needs in providing interventions for cancer patients

◼ Radiotherapy, cancer medicines, screening, research, palliation…

◼ Education- role for ESO

◼ Drug shortages affect several “essential”, old and inexpensive drugs

◼ THIS SHOULD BE UNACCEPTABLE !

◼ The current situation, where new therapies providing marginal benefit in highly selected patients are approved at high price, is neither desirable nor sustainable

◼ WE, as oncologists, should stop saying it is not our problem, and ACT to implement change in all areasESO-E

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