CostEstimation-Substitution-Trodelvy-Intervention-Chemotherapy-Current-year-1
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Current
has intervention: Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
has number of patients: 222
has timepoint: 1
has total costs: 1426350

CostEstimation-Substitution-Trodelvy-Intervention-Chemotherapy-Current-year-2
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Current
has intervention: Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
has number of patients: 166
has timepoint: 2
has total costs: 1066550

CostEstimation-Substitution-Trodelvy-Intervention-Chemotherapy-Current-year-3
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Current
has intervention: Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
has number of patients: 138
has timepoint: 3
has total costs: 886650

CostEstimation-Substitution-Trodelvy-Intervention-Chemotherapy-Intervention-Trodelvy-Additional-year-1
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Additional
has intervention: Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
has intervention: Trodelvy
has number of patients: 55
has timepoint: 1
has total costs: 3425490

CostEstimation-Substitution-Trodelvy-Intervention-Chemotherapy-Intervention-Trodelvy-Additional-year-2
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Additional
has intervention: Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
has intervention: Trodelvy
has number of patients: 111
has timepoint: 2
has total costs: 6913262

CostEstimation-Substitution-Trodelvy-Intervention-Chemotherapy-Intervention-Trodelvy-Additional-year-3
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Additional
has intervention: Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
has intervention: Trodelvy
has number of patients: 139
has timepoint: 3
has total costs: 8657147

CostEstimation-Substitution-Trodelvy-Intervention-Chemotherapy-Intervention-Trodelvy-Total-year-1
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Total
has intervention: Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
has intervention: Trodelvy
has number of patients: 277
has timepoint: 1
has total costs: 1804222

CostEstimation-Substitution-Trodelvy-Intervention-Chemotherapy-Intervention-Trodelvy-Total-year-2
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Total
has intervention: Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
has intervention: Trodelvy
has number of patients: 277
has timepoint: 2
has total costs: 8693000

CostEstimation-Substitution-Trodelvy-Intervention-Chemotherapy-Intervention-Trodelvy-Total-year-3
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Total
has intervention: Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
has intervention: Trodelvy
has number of patients: 277
has timepoint: 3
has total costs: 10436889

CostEstimation-Substitution-Trodelvy-Intervention-Trodelvy-Substitution-year-1
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Substitution
has intervention: Trodelvy
has number of patients: 55
has timepoint: 1
has total costs: 377872

CostEstimation-Substitution-Trodelvy-Intervention-Trodelvy-Substitution-year-2
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Substitution
has intervention: Trodelvy
has number of patients: 111
has timepoint: 2
has total costs: 7626450

CostEstimation-Substitution-Trodelvy-Intervention-Trodelvy-Substitution-year-3
type: Observation
data set: Kostenraming voor substitutie met Trodelvy
has cost type: Substitution
has intervention: Trodelvy
has number of patients: 139
has timepoint: 3
has total costs: 9550239

Zorginstituut Nederland
type: FormalOrganization
has unit: Department Zorg I

Number of serious adverse events
type: Outcome
outcome classification: Adverse events
outcome measurement: Number of serious adverse events
is surrogate outcome: false

OutcomeMeasurement-Overall-Survival-MedianDifference-Trodelvy
type: STATO_0000617
IAO_0000039: UO_0000035
IAO_0000136: Cohort-ASCENT-Comparator
IAO_0000136: Cohort-ASCENT-Intervention
IAO_0000221: Overall Survival
STATO_0000129: 5.4

OutcomeMeasurement-ProgressionFree-Survival-MedianDifference-Trodelvy
type: STATO_0000617
IAO_0000039: UO_0000035
IAO_0000136: Cohort-ASCENT-Comparator
IAO_0000136: Cohort-ASCENT-Intervention
IAO_0000221: Progression-free Survival
STATO_0000129: 3.9

Herbeoordeling farmacoeconomische analyse sacituzumab govitecan (Trodelvy®) bij de behandeling van inoperabele of gemetastaseerde triple-negatieve borstkanker
type: PackageStatement
contributor: Mr. Drs. K.G. Watson MD
issued: 2024-07-09
publisher: Team Pakket en Advies
has case number: 2024015841
has IIC assessment: IICAssessment-Trodelvy
has package type: Advice
has package type medication subtype: LockProcedureDrug
has serial number: 2024020563
has status: Definitive

TrendAssumption-Trodelvy-year-1
type: Observation
data set: Geschatte trend voor Trodelvy
has market penetration: 0.2
has number of patients: 277
has timepoint: 1

TrendAssumption-Trodelvy-year-2
type: Observation
data set: Geschatte trend voor Trodelvy
has market penetration: 0.4
has number of patients: 277
has timepoint: 2

TrendAssumption-Trodelvy-year-3
type: Observation
data set: Geschatte trend voor Trodelvy
has market penetration: 0.5
has number of patients: 277
has timepoint: 3

Budget Impact Analyse voor Trodelvy
type: BIA
has cost estimation: Kostenraming voor substitutie met Trodelvy
has trend assumption: Geschatte trend voor Trodelvy

Stand van de Wetenschap en Praktijk - Trodelvy
type: EMSMP
adheres to EMSMP: true
has PICO: PICO-Trodelvy
has relative effectiveness: Positive
has systematic literature review: Systematisch literatuuronderzoek voor Trodelvy

IICAssessment-Trodelvy
type: IICAssessment
has assessment type: Reassessment
has BIA: Budget Impact Analyse voor Trodelvy
has conclusion: Positive
has conclusion text: Onze conclusie is dat op basis van het huidige wetenschappelijk bewijs en aanvullende argumenten AFT na externe weefselexpansie een voldoende bewezen effectieve behandeling is voor deze groep vrouwen. Het Zorginstituut concludeert dan ook dat volledige borstreconstructie met AFT en een externe weefselexpander bij vrouwen na een totale borstverwijdering vanwege borstkanker of ter preventie hiervan voldoet aan de stand van de wetenschap en praktijk en daarmee kan worden toegelaten tot het basispakket.
has cost effectiveness: CostEffectiveness
  is cost effective: false
has EMSMP: Stand van de Wetenschap en Praktijk - Trodelvy
has indication: Volwassenen met lokaal gevorderde (inoperabele) triple-negatieve borstkanker
has intervention: Trodelvy
has managed entry agreement: ManagedEntryAgreement
  note: Het Zorginstituut acht een korting van tenminste 55% aangewezen.

Literatuur referentielijst voor Trodelvy SLR
type: SystematicLiteratureReview
had member: Trodelvy (sacituzumab govitecan) in metastatic triple-negative breast cancer: a review of the clinical evidence.
was generated by: Systematisch literatuuronderzoek voor Trodelvy
item list element: Trodelvy (sacituzumab govitecan) in metastatic triple-negative breast cancer: a review of the clinical evidence.
number of items: 1

Literatuur zoekopdracht voor klinische studies voor Trodelvy in Cochrane on 2022-04-28
type: LiteratureSearch
ended at time: 2022-04-28T00:00:00
name: Cochrane
query: (sacituzumab govitecan) AND (metastatic triple-negative breast cancer)
target: www.cochranelibrary.com
has evidence type: OBI_0003699

Literatuur zoekopdracht voor klinische studies voor Trodelvy in PubMed on 2022-04-28
type: LiteratureSearch
ended at time: 2022-04-28T00:00:00
name: PubMed
query: (sacituzumab govitecan) AND (metastatic triple-negative breast cancer)
target: pubmed.ncbi.nlm.nih.gov
has evidence type: OBI_0003699

Department Zorg I
type: OrganizationalUnit
has unit: Team Pakket en Advies

Dropout due to adverse events
type: Outcome
outcome classification: Dropout
outcome measurement: Dropout due to adverse events
is surrogate outcome: false

European Organization For Research And Treatment Of Cancer - Quality Of Life Questionnaire (EORTC QLQ-B23)
type: Outcome
outcome classification: Quality of Life
outcome measurement: European Organization For Research And Treatment Of Cancer - Quality Of Life Questionnaire (EORTC QLQ-B23)
is surrogate outcome: false

European Organization For Research And Treatment Of Cancer - Quality Of Life Questionnaire (EORTC QLQ-C30)
type: Outcome
outcome classification: Quality of Life
outcome measurement: European Organization For Research And Treatment Of Cancer - Quality Of Life Questionnaire (EORTC QLQ-C30)
is surrogate outcome: false

EQ-5D-5L - Quality of Life
type: Outcome
outcome classification: Quality of Life
outcome measurement: EQ-5D-5L
is surrogate outcome: false

Overall Survival
type: Outcome
outcome classification: Survival
outcome measurement: Overall Survival
is surrogate outcome: false

Progression-free Survival
type: Outcome
outcome classification: Survival
outcome measurement: Progression-free Survival
is surrogate outcome: true

…
type: OutcomeGroup
endpoint: Between 12 and 15 months
outcome: Dropout due to adverse events
outcome: European Organization For Research And Treatment Of Cancer - Quality Of Life Questionnaire (EORTC QLQ-B23)
outcome: European Organization For Research And Treatment Of Cancer - Quality Of Life Questionnaire (EORTC QLQ-C30)
outcome: EQ-5D-5L - Quality of Life
outcome: Overall Survival
outcome: Progression-free Survival

OutcomeMeasurement-DropoutDueToAdverseEvents-AbsoluteDifference-Trodelvy
type: STATO_0000614
IAO_0000039: UO_0000187
IAO_0000136: Cohort-ASCENT-Comparator
IAO_0000136: Cohort-ASCENT-Intervention
IAO_0000221: Dropout due to adverse events
STATO_0000129: -0.1

OutcomeMeasurement-DropoutDueToAdverseEvents-RiskRatio-Trodelvy
type: STATO_0000245
IAO_0000136: Cohort-ASCENT-Comparator
IAO_0000136: Cohort-ASCENT-Intervention
IAO_0000221: Dropout due to adverse events
STATO_0000129: 0.99

OutcomeMeasurement-EORTC-QLQ-C30-MeanDifference-Trodelvy
type: STATO_0000457
IAO_0000136: Cohort-ASCENT-Comparator
IAO_0000136: Cohort-ASCENT-Intervention
IAO_0000221: European Organization For Research And Treatment Of Cancer - Quality Of Life Questionnaire (EORTC QLQ-C30)
STATO_0000129: 4.08

OutcomeMeasurement-Overall-Survival-HazardRatio-Trodelvy
type: STATO_0000677
IAO_0000136: Cohort-ASCENT-Comparator
IAO_0000136: Cohort-ASCENT-Intervention
IAO_0000221: Overall Survival
STATO_0000129: 0.48

OutcomeMeasurement-ProgressionFree-Survival-HazardRatio-Trodelvy
type: STATO_0000677
IAO_0000136: Cohort-ASCENT-Comparator
IAO_0000136: Cohort-ASCENT-Intervention
IAO_0000221: Progression-free Survival
STATO_0000129: 0.41

OutcomeMeasurement-SeriousAdverseEvents-AbsoluteDifference-Trodelvy
type: STATO_0000614
IAO_0000039: UO_0000187
IAO_0000136: Cohort-ASCENT-Comparator
IAO_0000136: Cohort-ASCENT-Intervention
IAO_0000221: Number of serious adverse events
STATO_0000129: 17.6

OutcomeMeasurement-SeriousAdverseEvents-RiskRatio-Trodelvy
type: STATO_0000245
IAO_0000136: Cohort-ASCENT-Comparator
IAO_0000136: Cohort-ASCENT-Intervention
IAO_0000221: Number of serious adverse events
STATO_0000129: 1.38

Trodelvy (sacituzumab govitecan) in metastatic triple-negative breast cancer: a review of the clinical evidence.
type: JournalArticle

Team Pakket en Advies
type: OrganizationalUnit

Volwassenen met lokaal gevorderde (inoperabele) triple-negatieve borstkanker
type: Population
age: Adult
condition: T3 Category
condition: Triple-negative breast cancer
treatment: Chemotherapy

Volwassenen met lokaal gevorderde (inoperabele) triple-negatieve borstkanker
type: Population
age: Adult
condition: T4 Category
condition: Triple-negative breast cancer
treatment: Chemotherapy

Systematisch literatuuronderzoek voor Trodelvy
type: SystematicLiteratureReview
has part: Literatuur zoekopdracht voor klinische studies voor Trodelvy in Cochrane on 2022-04-28
has part: Literatuur zoekopdracht voor klinische studies voor Trodelvy in PubMed on 2022-04-28
result: Literatuur referentielijst voor Trodelvy SLR

Substitutie met Trodelvy
type: Scenario
description: Substitutie van chemotherapie door Trodelvy bij patiënten met inoperabele of gemetastaseerde triple-negatieve borstkanker die ten minste twee eerdere systemische therapieën hebben ondergaan, waaronder een taxaan-bevattende therapie en ten minste één therapie voor gevorderde ziekte.

Trial of Sacituzumab Govitecan in Participants With Refractory/​Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) (ASCENT)
type: OBI_0003699
source: Clinicaltrials.gov

Geschatte trend voor Trodelvy
type: DataSet
has scenario: Substitutie met Trodelvy

Chemotherapy (eribuline, capecitabine, vinorelbine of gemcitabine)
type: Intervention
applied intervention: Chemotherapy
intervention classification: Pharmacological Interventions
intervention rationale: Systemische behandelen van TNBC

Trodelvy
type: Intervention
applied intervention: Trodelvy
intervention classification: Pharmacological Interventions
intervention rationale: Systemische behandelen van TNBC
has ATC code: L01FX17
has EMA ref: EMEA/H/C/005182/0000
has INN: Sacituzumab govitecan
has marketing authorization holder: Gilead Sciences Netherlands B.V.

Kostenraming voor substitutie met Trodelvy
type: DataSet
has scenario: Substitutie met Trodelvy

STATO_0000196
BFO_0000051: STATO_0000314
  STATO_0000129: 29.3
BFO_0000051: STATO_0000315
  STATO_0000129: 7.4
IAO_0000136: OutcomeMeasurement-SeriousAdverseEvents-AbsoluteDifference-Trodelvy

STATO_0000196
BFO_0000051: STATO_0000314
  STATO_0000129: 6.0
BFO_0000051: STATO_0000315
  STATO_0000129: -2.8
IAO_0000136: OutcomeMeasurement-DropoutDueToAdverseEvents-AbsoluteDifference-Trodelvy

STATO_0000196
BFO_0000051: STATO_0000315
  STATO_0000129: 0.82
BFO_0000051: STATO_0000314
  STATO_0000129: 7.35
IAO_0000136: OutcomeMeasurement-EORTC-QLQ-C30-MeanDifference-Trodelvy

STATO_0000196
BFO_0000051: STATO_0000314
  STATO_0000129: 1.63
BFO_0000051: STATO_0000315
  STATO_0000129: 1.16
IAO_0000136: OutcomeMeasurement-SeriousAdverseEvents-RiskRatio-Trodelvy

STATO_0000196
BFO_0000051: STATO_0000314
  STATO_0000129: 0.52
BFO_0000051: STATO_0000315
  STATO_0000129: 0.32
IAO_0000136: OutcomeMeasurement-ProgressionFree-Survival-HazardRatio-Trodelvy

STATO_0000196
BFO_0000051: STATO_0000315
  STATO_0000129: 0.45
BFO_0000051: STATO_0000314
  STATO_0000129: 2.16
IAO_0000136: OutcomeMeasurement-DropoutDueToAdverseEvents-RiskRatio-Trodelvy

STATO_0000196
BFO_0000051: STATO_0000315
  STATO_0000129: 0.38
BFO_0000051: STATO_0000314
  STATO_0000129: 0.59
IAO_0000136: OutcomeMeasurement-Overall-Survival-HazardRatio-Trodelvy