powerpoint presentation · spain 400 belgium 350 poland 1000 belarus 250 russian federation 4000...
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Overall survival: 1st line therapy
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2-year OS phase III studies mM
Bloomberg Business weekly 26 Feb 2015
Prices per month of oncology medicines
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Presented By Veena Shankaran at 2016 ASCO Annual Meeting
Presented By Veena Shankaran at 2016 ASCO Annual Meeting
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–
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30 countries filled the survey35 oncology center included
Spain400
Belgium350
Poland1000
Belarus250
Russian Federation4000
Sweden500
Albania30
Slovenia150
30 countries, leading national melanoma centers
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Switzerland: T-Vec registration and reimbursement
VEMURAFENIB DABRAFENIB VEMURAFENIB COBIMETINIB
DABRAFENIB TRAMETINIB
IPILIMUMAB PEMBROLIZUMAB NIVOLUMAB
Western Europe
Austria
Belgium ** **
Denmark
France
Germany
Greece ** **
Italy
Netherlands
Portugal ** ** ** ** ** ** **
Spain *** ***
Sweden
Switzerland **
UK
Eastern Europe
and South
Eastern Europe
Albania
Belarus
Bosnia and Herzegovina
Bulgaria
Croatia
Czech republic * * ** **
Estonia
Hungary ** ** ** ** **
Lithuania
Macedonia
Montenegro **
Poland * * ** **
Romania
Russia *** **** **** **
Serbia
Slovenia
Ukraine
Registered
Reimbursed
Not registered
Not reimbursed
*Reimbursed, but only for first-line treatment
**Reimbursed, but with large and time-consuming administrative work needed to obtain the medicine for the patient
***Reimbursed, but not fully available due to the hospital-restricted budget
****Reimbursed, but not available due to the drug shortage
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Country Estimatedtotalnumber
ofmetastatic
melanomapatients
Estimated%ofpatients
treatedwithinnovative
medicines
Estimated%ofpatients
withoutaccessto
innovativemedicines
Estimatednumberof
patientswithoutaccess
toinnovativemedicines
WesternEurope
Austria 200 >90% 10%* /
Belgium 350 70-90% 10%* /
Denmark 350 >90% 10%* /
France 2000 >90% 10%* /
Germany 3000 >90% 10%* /
Greece NA 70-90% 10%* /
Italy 2000 70-90% 10%* /
Netherlands 800 70-90% 10%* /
Portugal 200 30-50% 50% 100
Spain 400 70-90% 10%* /
Sweden 100 50-70% 30%* /
Switzerland 350 70-90% 10%* /
UK 2000 10-30% 10%* /
TotalWE 11750 100
EasternandSouth-EasternEurope
Albania 30 10-30% 70% 21
Belarus 250 <10% 90% 225
BosniaandHerzegovina
60 <10% 90% 54
Bulgaria 150 30-50% 50% 75
Croatia 100 10-30% 70% 70
Czechrepublic 400 30-50% 50% 200
Estonia 50 50-70% 30% 15
Hungary 400 50-70% 30% 120
Lithuania 50 30-50% 50% 25
Macedonia 80 <10% 90% 72
Montenegro 30 10-30% 70% 21
Poland 1000 70-90% 10%* /
Romania NA 10-30% 70% NA
Russia 4000 <10% 90% 3600
Serbia 200 <10% 90% 180
Slovenia 150 >90% 10%* /
Ukraine 500 <10% 90% 450
TotalSEE 7450 5128
TotalWE+EE+SEE 19250 5228
• 19250 patients with metastatic melanoma in Europe• 7450 (39.7%) treated in Eastern and South-Eastern
Europe• 5128/7450 (69%) do not have the access to first-line
therapy recommended by the European guidelines(ESMO, EDF/EORTC/EADO).
• 5228/19250 (27%), i.e. almost third of all metastaticmelanoma patients do not have access to innovativemedicines.
*never in the first-line treatment
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Serbia: vemurafenib reimbursed (without MEK inhibitor)pembrolizumab reimbursed for BRAF negative patients
Croatia: dabrafenib trametinib reimbursed pembrolizumab reimbursed
Romania: vemurafenib, dabrafenib trametinibnivolumab reimbursed
Estonia: nivolumab, pembrolizumab reimbursed BRAF+MEK inhibitor reimbursed
DELAY IN ACCESS THROUGH REIMBURSEMENT: 4-5 YEARS
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Country nivo+ipi
Austria X
Belgium X
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark X
Estonia
Finland X
France X
Germany X
Greece XHungary
Iceland
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands X
Norway
Poland
Portugal
Romania
Slovakia
SloveniaSpain X
Sweden X
Switzerland X
United Kingdom X
EMA registration: May 2016
Reimbursed in 32.4% countries
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• Difficulties in implementing CU and EAP programmes:
– unharmonised legislative in some countries
– programmes are active only until the EMA registration, while reimbursementis in significant delay
• Insufficient number of clinical studies
– At least one clinical study for stage IV melanoma was available in 12/13 (92%) Western centers, and 6/17 (35%) from Eastern Europe centers in the surveyperiod.
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• Clinically meaningful benefit of the treatment
• Acceptable toxicity profile
• Improvement of quality of life
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MCBS v1.1
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• Grading derived from the ESMO-MCBS provides a backbone for value evaluations for cancer medicines.
• ESMO-MCBS A+B for curative therapies and 4+5 for non-curative therapies should be highlighted for accelerated assessment of value and cost-effectiveness.
• While a high ESMO-MCBS score does not automatically imply high value (that depends on the price), the scale can be used to frame such considerations and can help public policymakers advance ‘ accountability for reasonableness’ in resource allocation deliberations
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Presented By Elisabeth De Vries at 2017 ASCO Annual Meeting
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1. ESMO in current and future guidelines
2. Doctors in everyday practice (patient care and teaching)
3. Academic groups
4. Industry
5. Organisations and countries using the scale as policy tool
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Presented By Elisabeth De Vries at 2017 ASCO Annual Meeting
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1. ESMO in current and future guidelines
2. Doctors in everyday practice (patient care and teaching)
3. Academic groups
4. Industry
5. Organisations and countries using the scale as policy tool
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Presented By Elisabeth De Vries at 2017 ASCO Annual Meeting
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VEMURAFENIB DABRAFENIB VEMURAFENIB COBIMETINIB
DABRAFENIB TRAMETINIB
IPILIMUMAB PEMBROLIZUMAB NIVOLUMAB
Western Europe
Austria
Belgium ** **
Denmark
France
Germany
Greece ** **
Italy
Netherlands
Portugal ** ** ** ** ** ** **
Spain *** ***
Sweden
Switzerland **
UK
Eastern Europe
and South
Eastern Europe
Albania
Belarus
Bosnia and Herzegovina
Bulgaria
Croatia
Czech republic * * ** **
Estonia
Hungary ** ** ** ** **
Lithuania
Macedonia
Montenegro **
Poland * * ** **
Romania
Russia *** **** **** **
Serbia
Slovenia
Ukraine
Registered
Reimbursed
Not registered
Not reimbursed
Switzerland: T-Vec registration and reimbursement
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ESMO-MCBS could be used as a policy tool in HTA and reimbursement decisions at the national level?
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Presented By Elisabeth De Vries at 2017 ASCO Annual Meeting
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WHO Essential anti-
neoplastic medicines 2015
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• Added: nilotinib and dasatinib for imatinib resistant CML
• Establishment of EML cancer medicines working group to coordinate comprehensive evaluation of cancer medicines for the EML
• Cooperation between ESMO and WHO: possible implementation of ESMO-MCBS in evaluation of medicines for the WHO essential list?
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Non-curative setting: 1st line
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Medication Trial nameFirst author
Early crossover
Primary outcome
PFScontrol(months)
PFS gain (months)
PFS HROS control(months)
OS gain(months)
OS HR
Increase in 2-year OS ≥10%
QoL ToxicityESMO MCBS v1.1 non-curative
DABRAFENIB TRAMETINIB COMBI-D
Long G 2015, 2017 no PFS 8.8 2.2 0.67 18.7 6.4 0.63 YES + 4
VEMURAFENIB COBIMETINIB
COBRIM Ascierto P 2016 no PFS 7.2 1 0.58 17.4 4.9 0.65 YES + 4
IPILIMUMAB Maio 2015 Maio 2015 yes OS 2.6 0.2 0.76 6.4 2.1 0.72 YES 4
NIVOLUMABCHECKMATE 066
Robert 2015 Atkinson SMR 2015 no OS 2.2 2.9 0.43 11.2 NR 0.43 YES + 4
PEMBROLIZUMABKEYNOTE-006
Robert 2015 Schachter ASCO 2016 yes OS 3.3 5 0.58 15.9 16.4 0.7 YES 4
NIVOLUMAB + IPILIMUMAB
CHECKMATE 067
Larkin 2015 Larkin AACR 2017 Scadendorf2017 no OS 4 4.6 0.42 NR NR ND ND same + 3
NIVOLUMAB + IPILIMUMAB PDL1
CHECKMATE 067Larkin 2015 Larkin AACR 2017
no OS 3.9 6.2 0.57 NR NR ND ND 4
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Curative setting
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Medication Trial name First authorEarly crossover
Primary outcome
PFScontrol(months)
PFS gain (months)
PFS HROS control(months)
OS gain(months)
OS HR
Increase in 2-year OS ≥10%
>5% imp. of survival at ≥3 year FU
QoL Toxicity
ESMO MCBS v1.1 curative
ESMO MCBS v1.1 non-curative
DABRAFENIB TRAMETINIB COMBI-D Long G 2015, 2017 no PFS 8.8 2.2 0.67 18.7 6.4 0.63 YES YES + A 4
VEMURAFENIB COBIMETINIB
COBRIM Ascierto P 2016
no PFS 7.2 1 0.58 17.4 4.9 0.65 YES NA + ND 4
IPILIMUMAB Maio 2015 Maio 2015yes OS 2.6 0.2 0.76 6.4 2.1 0.72 YES YES A 4
NIVOLUMAB CHECKMATE 066Robert 2015 Atkinson SMR 2015 no OS 2.2 2.9 0.43 11.2 NR 0.43 YES YES + A 4
PEMBROLIZUMABKEYNOTE-006
Robert 2015 Schachter ASCO 2016
yes OS 3.3 5 0.58 15.9 16.4 0.7 YES YES A 4
NIVOLUMAB + IPILIMUMAB
CHECKMATE 067Larkin 2015 Larkin AACR 2017
no OS 4 4.6 0.42 NR NR ND ND NA same + ND 3
NIVOLUMAB + IPILIMUMAB PDL1+
CHECKMATE 067Larkin 2015 Larkin AACR 2017
no OS 3.9 6.2 0.57 NR NR ND ND NA ND 4
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Adjuvant interferon-alpha meta analysis Ives NJ et al. Eur J Cancer 2017; 82: 171-83.OS improvement 3% at 5 years (HR 0.9, CI 0.85-0.97), grade BSubgroup analysis: Ulcerated tumors OS improvement 10.5% at 10 years (HR 0.77, CI 0.64-0.92), grade A
Adjuvant ipilimumab, EORTC 18081OS improvement 11% at 5 years (HR 0.72), grade ASubstantial toxicity, QoL not deteriorated, downgrade to B?
ESMO 2017: Dabrafenib+trametinib ?Vemurafenib ?Pembrolizumab ? 35
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0
10
20
30
40
50
60
70
80
90
100
Vemurafenib Dabrafenib Vemurafenibcobimetinib
Dabrafenibtrametinib
Ipilimumab Pembrolizumab Nivolumab Nivolumabipilimumab
(%)
registration reimbursement
ESMO MCBS 4 4 4 (5) 4 (5) 4 4 (5) 4 (5) 3 (4)
Perc
enta
ge o
f co
un
trie
s
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o EU Directive – recommendation that registered medicine should be available on the market in 120 days, but delays are common
o EU Network for Health Technology Assessment: o Harmonization of cost-effectiveness analysis until 2020o Parallel submissions to EMA and EU HTA proposedo Common EU price?o ESMO-MCBS as a tool for centralized prioritization?
o Harmonization of reimbursement process?o Added value reimbursement prioritization based on the central
assessment of added value for each medicine OR assessment of added value at the national level
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Pricing?
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National reimbursement listing determinants of new cancer drugs: a retrospective analysis of 58 cancer treatment appraisals in 2007–2016 in South Korea. Kim ES, et al. Expert Rev Pharmacoecon Outcomes Res. 2017 Jan 3:1-9.
• Three variables increased the likelihood of reimbursement listing:• clinical improvement, • below alternative’s price, • risk-sharing arrangement.
• Cancer drug’s listing increased from 17% to 47% after risk-sharing agreement implementation.
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• Take an active role through involvement in professional oncological organizations to start and maintain a dialogue with:
– European and national policy makers
– Patients’ organizations
– Pharmaceutical industry
• to improve the access to innovative medicines for their patients.
• Education of practicing oncologists is necessary to ensure basic understanding of the process of drug approval and reimbursement in order to be able to actively participate in the process.
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• A dynamic tool with planned revisions and updates based on careful and transparent revision process
• Commitment to “accountability for reasonableness”
• Could serve as useful tool for establishing a fair process for priority setting in public policy
• Further adjustments: patient reported outcomes
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Thank you for your attention!
EU Policy Committee, Global Policy Committee
Working Group for the access to medicines
Task Force for innovation in skin cancer care