Verslag Adviescommissie Pakket (ACP) 24 maart 2017

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Pagina 17 van 20 Zorginstituut Nederland Pakket Datum 27 maart 2017 Onze referentie ACP 67-2 Bijlage 3 bij verslag openbare vergadering ACP d.d. 24 maart 2017:

i

nspreektekst

Pau

l

ine

Evers

(

namens de patiëntenverenigingen NFK/BVN)

b

i

j

a

gendapunt 4: pakketbeoordeling palbociclib bij borstkanker 400

Inspraak

adv

iescomm

iss

ie

pakket

24

maart

2017

Pa

lboc

ic

l

ib

Pau

l

ine

Evers

Neder

landse

Federat

ie

van

Kankerpat

iëntenorgan

isat

ies

405

Harte

l

i

jke

dank

dat

de

Borstkankerveren

ig

ing

Neder

land en

de

Neder

landse

Federat

ie

Kankerpat

iëntenorgan

isat

ies

hun

men

ing

mogen

geven

over

het

m

idde

l

Ibrance

o

f

Pa

lboc

ic

l

ib

b

i

j

gevorderde

o

f

gemetastaseerde

hormoon

pos

it

ieve

,

her2

negat

ieve

borstkanker

in

comb

inat

ie

met



aromatase

remmers

in

de

eerste

l

i

jn

o

f

410



fu

lvestrant

in

de

teede

l

i

jn

Therapeutische meerwaarde

Anderhalf jaar geleden stonden wij hier ook, ook voor borstkanker, maar precies voor de andere helft van onze achterban, namelijk niet

415

hormoongevoelig en wel her2 positief. Het middel dat vandaag voorligt is weliswaar ‘alweer een borstkanker middel’ maar dus voor een andere doelgroep.

De therapeutische meerwaarde van palbociclib is aangetoond zowel voor de eerste als voor de tweede lijn:

420

 in de eerste lijn neemt de progressievrije overleving toe met 11,2

maanden van 19,3 naar 30,5 maanden. Over de toename in overleving

valt niets te zeggen omdat de tijd daar nog niet rijp voor is. Bovendien zullen patiënten bij wie de tumor terugkeert met andere middelen behandeld worden waardoor niet meer duidelijk is waar een

425

overlevingswinst aan toegeschreven kan worden.

 In de tweede lijn neemt de progressievrije overleving toe met 6,6

maanden van 4.6 naar 11.2. Ook hier zijn (nog) geen gegevens over OS.

In deze studie werd ook QOL geëvalueerd en dat liet geen verschil zien

430

tussen beide armen.

De ACP vraagt naar het aantonen van winst in OS. Dit is een vraag die keer op keer terugkomt als hier oncologische producten besproken worden. Ik wil hier graag benadrukken dat de eis van het aantonen van OS winst in veel gevallen geen haalbare kaart is. De controle arm bij

435

palbociclib laat een gemiddelde overleving zien van 4-5 jaar. Om een relevant verschil aan te tonen is een studie nodig die al snel 7-8 jaar in beslag neemt. Een onmogelijke eis dus. Zeker patiënten die in de eerste lijn palbociclib krijgen, maar ook na een tweedelijns behandeling, krijgen patiënten vaak nog andere therapie. Voeg daarbij dat patiënten die

440

progressie vertoonden op de controle arm alsnog met palbociclib behandeld werden en het is ook duidelijk dat een eventuele

overlevingswinst niet meer direct en eenduidig aan palbociclib te linken valt. Dat is de realiteit in de oncologie waarmee we te maken hebben en waar de ACP dus mee moet werken.

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Pagina 19 van 20 Zorginstituut Nederland Pakket Datum 27 maart 2017 Onze referentie ACP 67-2 Bijlage 4 bij verslag openbare vergadering ACP d.d. 24 maart 2017:

i

nspreektekst

Marga

Schr

ieks

(

namens de patiëntenverenigingen

NFK/BVN)

b

i

j

a

gendapunt 6: scoping mammaprint 500

I

nspraak

mammapr

int

ACP

24

maart

2017

door

Marga

Schr

ieks

,

Borstkanker

veren

ing

ing

Neder

land

505

Graag

maak

ik

van

de

ge

legenhe

id

gebru

ik

om

namens

BVN

en

NFK

onze

v

is

ie

te

geven

op

de

voorste

l

len

voor

eva

luat

ie

voor

pakket

opname

van

de

mammapr

int

.

In

2010

is

deze

in

Neder

land

ont

ikke

lde

test

geëva

lueerd

door

CVZ

.

Op

dat

moment

erd

,

gebaseerd

op

een

retrospect

ieve

stud

ie

,

geconc

ludeerd

dat

deze

test

n

iet

vo

ldeed

aan

de

stand

van

etenschap

en

prakt

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vraag

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f

de

voorgeste

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ju

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ia

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i

jn

aarop

deze

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