Access to Diagnostics and Drugs for Lung Cancer in Central and Eastern Europe

Tanja Cufer, MD, PhD

University Clinic Golnik

Medical Faculty Ljubljana, Slovenia

ESO/ESMO Masterclass

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1.8 million

(1 in 5) estimated deaths worldwide

2.1 million

estimated new cases worldwide

Deaths from lung cancer =breast + colorectal + prostate

cancer

Lung Cancer: Leading Cause of Cancer Mortality Worldwide

Bray F, et al. GLOBOCAN 2018.

2093 2080

1850

1270

1760

620

880

350

0

500

1000

1500

2000

2500

Lung cancer Breast cancer Colorectal cancer Prostate cancer

Esti

mat

ed n

um

ber

s (t

ho

usa

nd

s)

GLOBOCAN 2018(Worldwide, both sexes)

Incidence Mortality

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Lung Cancer: Most Common Cancer in CEE Countries

Ferlay J, et al. GLOBOCAN 2012.

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Lung Cancer: Poorly Controlled Disease in CEE Countries

Bray F, et al. GLOBOCAN 2018.

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Novel Therapies Improve Survival of Lung Cancer Patients

Lung Cancer Mutation Consortium Kris MG, et al. JAMA 2014.

Survival of Advanced NSCLC Patients Treated or Not with Targeted Therapies

Survival of Advanced NSCLC Patients Treated or Not with Immunotherapy

Reck M, et al. J Clin Oncol 2019.

2-year OS: 51 %

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Access to Lung Cancer Targeted Agents: ESMO Survey, 2014

Cherny NI, et al. Ann Oncol 2016.

Western Europe

Eastern Europe

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Access to Molecular Diagnostics and Novel Drugs for NSCLC: CECOG Survey, 2017

▪ Survey on access to molecular diagnostic and novel drugs for NSCLC▪ Performed by CECOG Lung Cancer Expert Group, consisting of lung pathologists,

pulmonologists, clinical and medical oncologists, key opinion leaders from 10 CEE countries

▪ Represented countries: Austria, Bulgaria, Croatia, Czech Republic, Hungary,Poland, Romania, Serbia, Slovakia, Slovenia

CECOG Lung Experts Group Meeting6.12.2016, Vienna

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Access to Molecular Diagnostics and Novel Drugs for NSCLC: CECOG Survey, 2017

▪ Two step survey▪ Information about the molecular diagnosis procedures: testing process,

availability of diagnostic testing, and local reimbursement

▪ Evaluation the access and reimbursement of targeted therapies in NSCLC

▪ 31-item questionnaire on molecular testing distributed to 10 pathologists; data lock December 2017

▪ 4-key questions related to formulary and actual availability of novel drugs covered by ESMO guidelines valid at 2017, distributed to 10 clinicians; data lock March 2018

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Access to Molecular Diagnostics for NSCLC: CECOG Survey, 2017

Ryska A, et al. BMC 2018; Ryska A, et al. Oncologist 2018.

Country EGFR ALK ROS1 BRAF PD-L1 Turnaround time, days

Test Reimburs. Test Reimburs. Test Reimburs. Test Reimburs. Test Reimburs. IHC FISH DNA/ RNA

Austria ✓ Full, PHS ✓ Full, PHS ✓ Full, PHS ✓ Full, PHS ✓ Full, PHS 1-5 1-5 6-10

Bulgaria ✓ Pharma ✓ Pharma ✓ No, but available

No NA Ifrequested

Pharma >10 NA >10

Croatia ✓ Partly PHS/ Pharma

✓ Partly PHS/ Pharma

NST No, but available

Ifrequested

No ✓ Partly PHS/Pharma

1-5 NA 6-10

Czech Republic

✓ PHS (limited budget)

✓ PHS (limited budget)

✓ No, but available

No NA Ifrequested

No 1-5 1-5 6-10

Hungary ✓ PHS (limited budget)

✓ PHS (limited budget)

✓ PHS (limited budget)

✓ PHS(limited budget)

Ifrequested

PHS (limited budget)

1-5 6-10 6-10

Poland ✓ PHS (limited budget)

✓ PHS (limited budget)

✓ No, but available

✓ ✓ Ifrequested

Pharma 6-10 6-10 6-10

Romania ✓ Pharma ✓ Pharma ✓ No, but available

✓ ✓ Ifrequested

No 6-10 6-10 6-10

Serbia ✓ Pharma NST No NST No, but available

✓ ✓ Within CTs NA 1-5 NA 1-5

Slovakia ✓ PHS (limited budget)

✓ PHS (limited budget)

✓ PHS (limited budget)

No NA Ifrequested

PHS (limited budget)

1-5 6-10 NA

Slovenia ✓ Full, PHS ✓ Full, PHS ✓ No, but available

✓ No ✓ Pharma 1-5 6-10 1-5

PHS-Public Health System; Pharma-Pharmaceutical Companies; NST-No Systemic Testing; NA- not applicable; CTs-clinical trials.Recommended time: Up to 10 working days

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Access to Molecular Diagnostics: CECOG Survey, 2017

▪ In comparison to similar study by Ryska et al. performed in 2013 (EGFR and ALK only) improvement in molecular testing is obvious.

▪ However, in majority of CEE countries:▪ Testing is still not performed on reflex basis ▪ Health insurance systems do not cover the costs of testing

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Access to Novel Drugs for NSCLC: CECOG Survey, 2018

Brcic L, et al. WCLC 2018, Abstract P2.15-03.

Novel anti-cancer drugs per indication of use in NSCLC included in the survey

* - in combination with chemotherapy, MA – marketing approval

Active substance Indication

Afatinib EGFR+ NSCLC first-lineAfatinib SCC second-lineErlotinib EGFR+ NSCLC first-lineErlotinib EGFR unknown NSCLC second-lineGefitinib EGFR+ NSCLC first-lineOsimeritinib T790 + NSCLC first-lineCrizotinib ALK+ NSCLCCeritinib ALK+ NSCLC second-lineAlectinib ALK+ NSCLC second-lineCrizotinib ROS1 + NSCLC first-line or second-line

Necitumumab* SCC first-lineRamucirumab* NSCLC second-lineBevacizumab* NSCLC first-lineNintedanib* NSCLC adenocarcinoma second-lineNivolumab NSCLC second-linePembrolizumab NSCLC, PD-L1 ≥ 50% first-linePembrolizumab NSCLC, PD-L1 ≥ 1% second-line

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Access to Novel Drugs for NSCLC: CECOG Survey, 2018

Availability in first-line

Availability in second-line

a refers to use of crizotinib in ALK+; b refers to crizotinib in ROS1+ in first- or second-line.

Brcic L, et al. WCLC 2018, Abstract P2.15-03.

Country AUT BLG CRO CZR HUN POL ROM SRB SLK SLO

Drug

Afatinib

Erlotinib

Gefitinib

Crizotinib a

Crizotinib b

Bevacizumab

Necitumumab

Pembrolizumab

Afatinib

Erlotinib

Osimeritinib

Ceritinib

Alectinib

Ramucirumab

Nintedanib

Nivolumab

Pembrolizumab

Registered and available for majority of patients through governmental/private insuranceRegistered and available for a minority of patients with special insurance/other

Registered but not available/reimbursed

Not yet registered

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Brcic L, et al. WCLC 2018, Abstract P2.15-03.

Time from registration to reimbursement of novel medicines.

Data are expressed as % of products/time interval/country.

Access to Novel Drugs for NSCLC: CECOG Survey, 2018

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Time to Access to Novel Drugs in Slovenia

Therapies WITHOUT SUBSTANTIAL BENEFIT per ESMO-MCBS (1-3, C) Therapies WITH SUBSTANTIAL BENEFIT per ESMO-MCBS (4-5, A-B)

Median times: 398 & 416 D

Median times: 377 & 451 D

Janzic U, et al. ESMO 2018, Ann Oncol 2018, Abstract 1565.

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Time to Access to Novel Drugs in Slovenia

Time to EMA MA (marketing authorization), national RA (reimbursement approval) and overall time to access per ESMO MCBS

Janzic U, et al. ESMO 2018, Ann Oncol 2018, Abstract 1565.

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▪ Novel drugs, especially for first-line therapy are sooner or later available in majority of CEE countries, however lag time between marketing approval and reimbursement is far too long for lung cancer patients in great majority of countries.

• There is no improvement in access to novel drugs, when compared to ESMO 2014 survey.

• With numerous novel targeted drugs and IOs entering the market the proportion of unavailable drugs is increasing.

➢ To ensure adequate NSCLC control in CEE, faster uptake of novel drugs is urgently needed.

➢ To ensure sustainability of social heath care system more than ever thoughtful clinical value-oriented uptake of novel drugs is needed in CEE!

Access to Novel Drugs for NSCLC:CECOG Survey Conclusions

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