1. Next Generation Reimbursement: regulation in times of fast evolution
Anouk Waeytens
RIZIV - INAMI
OLV Waregem – lezing WKBWV June 20, 2017

2. impact of personalised medicine on the Belgian health care system
Cover Time Magazine, 28 may 2001
OLV Waregem – lezing WKBWV June 20, 2017

3. impact of personalised medicine on the Belgian health care system
OLV Waregem – lezing WKBWV June 20, 2017

4. impact of personalised medicine on the Belgian health care system
Challenges
Report of the Belgian EU Presidency, endorsed by the EU Council of Ministers of Health in Dec 2010
OLV Waregem – lezing WKBWV June 20, 2017

5. impact of personalised medicine on the Belgian health care system
innovation challenge
rapid evolution: complexity increases
simple tests…….multimarker tests…….full genome/exome
new technologies
integration challenge
different expertise
good clinical practice
infrastructure challenge
link patient data from different areas/ fields of specialisation
real-world data
(number of relevant mutations, combination of mutations, relationship with possible targets, combination of medicines for treating to targets)
(oncology, clinical biology, anatomopathology, clinical pharmacy, datamanager, genetician, GP
OLV Waregem – lezing WKBWV June 20, 2017

6. impact of personalised medicine on the Belgian health care system
financial challenge
Projection of the budget impact of the Dx from 2008 to 2020
Vlerick HMC report
oncology horizon scanning based on NIHDI data
MORSE report 2015
OLV Waregem – lezing WKBWV June 20, 2017

7. impact of personalised medicine on the Belgian health care system
financial challenge
Projection of the budget impact before savings of reimbursed PMx in Belgium from 2005 to 2020
Vlerick HMC report
oncology horizon scanning based on NIHDI data
OLV Waregem – lezing WKBWV June 20, 2017

8. impact of personalised medicine on the Belgian health care system
quality impact: influence of different parameters on cost effectiveness (trastuzumab/HER2 example)
KCE report 240 (Van de Bulcke et al 2015)
OLV Waregem – lezing WKBWV June 20, 2017

9. impact of personalised medicine on the Belgian health care system
regulatory challenge
different commission
different timelines
different budget
within NIHDI: different departments
reimbursement of medicines (CRM)
versus
reimbursements of acts/diagnostic tests (TMC)
OLV Waregem – lezing WKBWV June 20, 2017

10. impact of personalised medicine on the Belgian health care system
Medicines:
6 months + suspensions
Tests:
first: WG Clinical Biology, then:
minimum 18 months
CRM
Minister MD
TMC
Medico-mut
CBC
Ins Com
Minister RD
OLV Waregem – lezing WKBWV June 20, 2017

11. NIHDI point of view: reimbursement of personalised medicine
access to personalized medicine
 health care reimbursement procedures should be adapted to achieve a simultaneous reimbursement start for treatment and test
 Challenge:
2 different technologies/processes/expertise
flexible
transparant
timely
OLV Waregem – lezing WKBWV June 20, 2017

12. reimbursement of personalised medicine: actions
current projects for new nomenclature (art33bis)
Novel markers/validated technologies, e.g. PCR:
linked reimbursement procedure
simultaneous reimbursement drug-test
Novel testing technologies, e.g. NGS:
convention
OLV Waregem – lezing WKBWV June 20, 2017

13. Personalised medicine: linked reimbursement procedure
package drug – test: single short HTA
Proposal: the Commission for Reimbursement of Medicines (CRM) advises the Minister on the reimbursement of the drug and the “companion” tests
advise: platform CDx
single Ministerial Decree
Nomenclature for tests:
stays competence of TMC
OLV Waregem – lezing WKBWV June 20, 2017

14. Personalised medicine: linked reimbursement procedure
Concept:
article 33ter:
new “generic” nomenclature codes for tests linked to a drug (diagnostic/prognostic: article 33bis)
defined by TMC
published by royal decree
chapter “VIII”:
“personalised” drugs
+ list with “companion” tests
if the Minister decides to reimburse the drug, the marker will be added to the list by the same Ministerial Decree
OLV Waregem – lezing WKBWV June 20, 2017

15. Personalised medicine: linked reimbursement procedure
nomenclature (TMC):
art. 33ter
platform CDx
drugs (CRM):
chapter VIII
reimbursement possible after testing for an associated predictive marker
Code “A” (B-1800)
marker-indication combo in the list of chapter “VIII”
(level 1)
§ 123
Reimbursement of specialty drug Herceptin in metastatic breast cancer if amplification of the gene HER2 with a test performed as per article 33ter of the nomenclature + other criteria
registration of result obligatory
Code “B” (B-3000)
marker-indication combo in the list of chapter “VIII”
(level 2)
list with marker-indication combo:
Pseudocode abc
amplification HER2 in breast cancer, code C
Code “C” (B-4000)
marker-indication combo in the list of chapter “VIII”
(level 3)
OLV Waregem – lezing WKBWV June 20, 2017

16. Personalised medicine: linked reimbursement procedure
reimbursement procedure chapter VIII:
submission CRM
the CRM evaluates the package drug-marker
the CRM is advised by clinical + technical experts
the CRM formulates, timely, a proposal to the Minister who decides wether or not to reimburse of the drug and to add the marker on the list
the list specifies a pseudocode for every combination of marker and indication (transparent) and the generic code
the decision of the Minister on new reimbursements, or on modifications, is published every month (flexible)
every addition of a new marker to the list and every change of the list is discussed in the platform CDx and subsequently validated by the TMC
OLV Waregem – lezing WKBWV June 20, 2017

17. Personalised medicine: linked reimbursement procedure
tarification procedure for tests through art 33ter:
every test can be charged, whatever the result
the lab that received the test request
registers the test + result in the HealthData registry
automatically receives a registration code
the lab submits the invoice of the test together with:
the registration code
the pseudonomenclature code (specific biomarker + indication)
the generic nomenclature code (2x3 codes: level 1, level 2, level 3)
only once
OLV Waregem – lezing WKBWV June 20, 2017

18. reimbursement of personalised medicine: actions
Feasibility study: ‘NGS –Targeted therapy’
OLV Waregem – lezing WKBWV June 20, 2017

19. NGS convention
Roadmap for ‘NGS in routine analysis in oncology and haemato-oncology’
ComPerMed: Scientific board expert WG
NGS guidelines and checklist; NGS gene panel
Pilot study /19
Benchmarking test (2016)
Real-life pilot study ( )
Data management (actionable mutations, reimbursement, registry)
Informed Consent
Education and training
OLV Waregem – lezing WKBWV June 20, 2017

20. reimbursement of personalised medicine: actions
Commission Personalized Medicine (ComPerMed)
launched December 2015
General aim:
Advisory board on clinical utility of ‘omics’ in (haemato-)oncology
Principle tasks:
Develop a methodology to assess the clinical utility of novel somatic mutations
Assess novel somatic mutations to be retained in reimbursed NGS gene panels, including registration
Assess novel ‘omics‘ technology for application in (haemato-) oncology
Present evidence-based advise to officials
OLV Waregem – lezing WKBWV June 20, 2017

22. Personalised medicine: linked reimbursement procedure
OLV Waregem – lezing WKBWV June 20, 2017

23. Personalised medicine: linked reimbursement procedure
OLV Waregem – lezing WKBWV June 20, 2017