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Marc Van de Casteele, internist PhD
coördinator expertise farmaca
Contracten Farmaca
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RIZIV-INAMI
Montgomery Sq. Brussel
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Directoraat
Farmaceutisch Beleid
Ap. Arickx
Expertise
Farmaca
(HTA)
Procedures
Terugbetaling
Contracten
Databanken
E-Government
Frontdesk
Yoeriska Antonissen
en collega’sVinciane Knappenberg
en collega’s
Marc Van de Casteele
& collega’s
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Contract (ex-art 81)
tussen
farmaceutisch bedrijf
en
RIZIV - INAMI
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Managed Entry Agreements
● Scientific uncertainties and/or disproportionately high price
● Real cost of the drug should ≤ list price
● Confidential according to Belgian Law
● Which pharmaceuticals ?- class 1 claim by the applicant- orphan drugs- new indication for which a therapeutic or social need exists- children when adult indication is under contract- comparator under contract (several possibilities)
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RIZ
IV -
INA
MI
MIN
ISTE
R
EC.A
FFA
IRS
Evaluation
Dra
ft r
epo
rt
Max. price
Dra
ft p
rop
osa
l
60 18015080 90
Reimbursement procedureR
eact
ion
s
Fin
al r
epo
rt
120
Rea
ctio
ns
Fin
al p
rop
oso
l
,,,0
Op
tio
nal
Co
ntr
act
Proposal
MIN
ISTE
R
BU
DG
ET
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Managed Entry Agreements (legal)
Royal Decree Febr. 1st 2018
- art. 111: no proposal of the commission
- art. 112: commission proposes
- art. 113: commission proposes negatively
but Minister wants negociations (new)
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Managed Entry Agreements: who ?
Beslissende rol:
- Fabrikant nieuw: met meegebrachte expert
- Minister van Sociale Zaken
- Minister van Begroting
Adviserende rol:
- V.I. aangeduid door het Verzekeringscomité
- (Vice-) voorzitter van de CTG; academische leden
van de CTG (gelimiteerd)
- Pharma.be
- Minister van Economische Zaken
Ondersteunende rol
- RIZIV :
Cel Contracten.
Interne deskundigen
Dossierbeheerders
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Managed Entry Agreements (KCE)
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KCE 2017
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KCE 2017
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Pay for Performance
- Macro-economic approach→ based on existing RCT or large (foreign) registers
- Individual patient approach→ more cumbersome as you need reliable follow-up data
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Problems vs uncertaintiesExemples
Criteria Uncertainties Problems
Clinical evidence Efficacy, safety
long term data
target population
No added therapeutic
value, comparator under
convention
Budget impact volume High budget impact,
packaging
Cost-effectiveness « value for money » is
unclear
High ICER
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End of contract: TO BE SOLVED CANNOT BE SOLVED
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Intermutualistisch Agentschap
Standard operating procedures
Data collectie
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Managed Entry Agreements:
Belgian experience
● Since 2010: 200 requests55% still valid ; letter “T”; > 80 active compounds17% stopped20% refused4% never started4% now in discussion
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Type of uncertainty
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Managed Entry Agreements will be more used
→ Uncertainties reduce the cost.
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Pharma future
EvaluatePharma
2017
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BeNeLuxApilots on joint HTA and negotiations
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Eligibility for a joint procedure• Selection of pilots case-by-case. Not all applications can be accepted.
• Reimbursement applications for a pilot candidate have not been submittedyet in any of the participating countries. A candidate is preferably selectedat least three months before a CHMP opinion is published.
• A candidate for a pilot must comply with national legislations, for example:• in the Netherlands only hospital pharmaceuticals that enter the “lock procedure”• in Belgium only pharmaceuticals submitted as Class 1 or orphan application• in Austria only pharmaceuticals that are outpatient products in Austria
• A product is not eligible if the manufacturer is not willing to commercializethe pharmaceutical in a BeNeLuxA country after a pilot with a positivedecision on reimbursement.
23BeNeLuxA guidance joint assessment & joint negotiations
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Met dank aan
- Francis ARICKX- Vinciane KNAPPENBERG- Marie-Laurence LAMBERT- Annemie QUANTEN- Katrien VAN DER VEKEN- Inneke VAN DE VIJVER
Dank u voor uw aandacht