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1

Marc Van de Casteele, internist PhD

coördinator expertise farmaca

Contracten Farmaca

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2

RIZIV-INAMI

Montgomery Sq. Brussel

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3

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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4

Contract (ex-art 81)

tussen

farmaceutisch bedrijf

en

RIZIV - INAMI

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5

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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6

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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7

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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8

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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9

Managed Entry Agreements (KCE)

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10

KCE 2017

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11

KCE 2017

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12

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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13

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

13

End of contract: TO BE SOLVED CANNOT BE SOLVED

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14

Intermutualistisch Agentschap

Standard operating procedures

Data collectie

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15

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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21

Pharma future

EvaluatePharma

2017

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22

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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24

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