REMOVABLE DINOPROSTONE VAGINAL DELIVERY SYSTEM:...
Transcript of REMOVABLE DINOPROSTONE VAGINAL DELIVERY SYSTEM:...
Pacocha K1, Pieniążek I1, Stelmachowski J1, Walczak J1, Bierut A2, Sajdak S3, Wilczak M4, Jaworowski A5, Rokita W6, Młodawski J6, Baev OR7, Bila J8, Pitko V9, Zhemela O10, Chorna O11, Lohinova O12
1Arcana Institute, a Certara Company, Cracow, Poland, 2Ferring Pharmaceuticals Poland Sp. z o. o., Warsaw, Poland, 3Clinic of Surgical Gynaecology, University of Medical Sciences, Poznań, Poland, 4Department of Maternal and Paediatric Health, Gynaecology and
Obstetrics Hospital of the Medical University in Poznań, Poland, 5Clinical Department of Obstetrics and PerinatologyThe University Hospital in Cracow, Poland, 6Clinic of Gynaecology and Obstetrics, Provincial Integrated Hospital in Kielce, Poland, 7National
Medical Research centre for obstetrics, gynaecology and perinatology named after AcademicianV.I. Kulakov, MOSCOW, Russian Federation, 8Clinic of Obstetrics and Gynaecology, Clinical Centre of Serbia, Belgrade, Serbia, 9The Government hospital Obstetrics,
Gynaecology and Reproductology Kcharkiv, Kcharkiv, Ukraine, 10Lviv нац. Мед университет, Lviv, Ukraine, 11The Obstetrics and Gynaecology Department #2 KNMU, Kiev, Ukraine, 12Medical Academy Kcharkiv, Kcharkiv, Ukraine
REMOVABLE DINOPROSTONE VAGINAL DELIVERY SYSTEM:
COST-CONSEQUENCES MODEL
FOR CENTRAL AND EASTERN EUROPEAN COUNTRIES
To compare costs and clinical effectiveness of DVDS with local standard of care regarding IOL To demonstrate the safety profile of DVDS versus its alternatives To reveal changes in consumption of the hospital staff’s time due to DVDS administration To indicate savings connected with the use of DVDS instead of other local alternatives from the hospital’s
perspective
OBJECTIVES
The aim of the project was to develop a user-friendly decision model to assess the savings and health benefits ofinduction of labour (IOL) when Dinoprostone Vaginal Delivery System (DVDS) is used instead of alternativetechnologies in local European practice. The model allowed to reveal changes in time consumed by hospital staffdue to DVDS administration, demonstrate the safety profile of DVDS versus its alternatives and calculate thetotal cost of IOL for local settings.
BACKGROUND
METHODS
The model was adapted to conditions of 11 countries:
• Croatia
• Czech Republic
• Estonia
• Hungary
• Poland
• Romania
• Russia
• Serbia
• Slovakia
• Slovenia
• Ukraine
Calculations were performed from the hospital’s perspective.
Results were presented in the form of a comparison between DVDS and current practice.
In the model, cost and resource use inputs acquired from local clinical practices were combined with data on clinicalevents retrieved from randomised controlled trials (or meta-analyses of these trials, if required).
current practice = set of interventions used in IOL in the particular country (or medical centre), i.e. weighted comparator (alternative technology) for DVDS
INTERVENTION USED IN
LABOUR INDUCTION
COUNTRY
CROATIA CZECH REP. ESTONIA HUNGARY POLAND ROMANIA RUSSIA SERBIA SLOVAKIA SLOVENIA UKRAINE
Oxytocin + + + + + + + + +
Balloon catheter + + + + + + + + +
DCG + + + + + + + +
DVG + + + +
DVT + + + + +
MVT +
MVI + + +
Mifepristone +
Amniotomy + +
HCD (Dilapan) +
List of interventions used in the current practice in CEE countries
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ISPOR 21th Annual European Congress
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Abbreviations used: DVDS = dinoprostone vaginal delivery system; DCG = dinoprostone cervical gel; DVG = dinoprostone vaginal gel; DVT = dinoprostone vaginal tablets; MVT = misoprostol vaginal tablets; MVI = misoprostol vaginal insert; HCG = hygroscopic cervical dilators
Cost and resource use data came from local clinical practices, as local data sources consisted of hospitals and medical
centers. Data were collected from the hospital’s perspective via a dedicated questionnaire.
In the basic (simple) version of the model, the user can define market shares, cost of interventions used in the
induction of labour, cost of inpatient stay, wages of medical staff involved in labour induction, while in the advanced
version of the model – all costs and resource use data inputs.
Whenever possible, incidence of included clinical events for local comparators were taken from real-world data (i.e.
obtained from questionnaires sent to countries participating in the project). In case no data from questionnaires are
available, inputs from other countries or from randomised controlled trials may be used.
Costs and resource use inputs
Market shares
Cost of interventions used in labour induction
Cost of inpatient stay
Wages of medical staff involved in labour induction
Cost of treating adverse events
Frequency of instrumental vaginal deliveries
Frequency of Cesarean sections
Average time spent by the patient in wards
Average nurse per patient time
Average midwife per patient time
Average anaesthesiologist per patient time
Average obstetrician-gynaecologist per patient time
Average neonatologist per patient time
Clinical events inputs
Time from induction to delivery
Time from induction to active labour
Incidence of Cesarean delivery
Incidence of instrumental delivery (or operative vaginal delivery)
Incidence of oxytocin administration
Incidence of adverse events
Simultaneously, data on relative efficacy and safety (DVDS vs technologies used in the current practice) were retrieved from RCTs/meta-analyses based on a previously performed systematic literature review conducted in the main medical databases.
Comparisons and number of RCTs included in the systematic review
Current practice (comparator): base-case scenario
RESULTS
Foley’s catheter; 88%
oxytocin; 10%
amniotomy; 1%
DCG; 1% MVI; 0%
POLAND
Mifepristone; 50%
DCG; 20%
Foley’s catheter; 10%
oxytocin ; 10%
HCD; 10%
RUSSIA
DCG; 50%
Foley’s catheter; 20%
DVT; 20%
oxytocin; 10%
SERBIA
From the hospital's perspective, the use of DVDS in comparison with the current clinical practice results insavings related to lower costs of patient hospitalisation and salaries of medical staff (less time-consumed forDVDS patients)
The use of DVDS reduces time to delivery, which results in a decrease in the time of inpatient stay and in thetime spent by medical staff per patient
Decrease of the percentage of patients with instrumental vaginal delivery and Cesarean delivery is alsoreported (in 2 out of 3 countries)
CONCLUSION
The cost-consequences model developed for profitability of DVDS assessment combines real life data fromlocal practices with experimental data retrieved from RCTs. The model is a transparent tool which providesinformation on treatment standards and costs of IOL in CEE countries.
Results of the model indicate that DVDS is an effective therapeutic option which involves benefits for both thepatient and the hospital.
Difference between DVDS and current practice
OUTCOME POLAND RUSSIA SERBIA
Decrease / increase in
percentages of patients
with mode of delivery
instrumental vaginal
deliveryreduction reduction reduction
Cesarean delivery growth reduction reduction
Decrease / increase
in the time of:
inpatient stay reduction reduction reduction
medical Staff’s working
time on patientreduction reduction reduction
Costs difference
(hospital’s perspective)
interventions in IoL growth growth growth
length of inpatient stay reduction reduction reduction
medical staff salaries reduction reduction reduction
adverse events growth growth No data
additional oxytocin use reduction reduction No data
total cost difference per
100 patients(-) EUR 613 (-) EUR 3,328 (-) EUR 2,407
INARA CERTARA COMPANY
As an example of the model results outcomes for 3 out of 11 countries are presented.
• Pubmed – 626 abstracts found, 100 abstracts selected, 64 full texts selected
• Cochrane – 1198 abstracts found, 200 abstracts selected, 63 full texts selected
Databases
• 38 RCTs included
• placebo – 3, Foley’s catheter – 3, Cook’scatheter – 4, oxytocin – 4, DCG – 12, DVG– 3, DVT – 1, MVI – 1, MVT - 7
Directcomparison
(head to head)
• 12 RCTs included
• HCD– 2, amniotomy – 3, mifepristone -7Indirect
comparison
DVDS
placebo
oxytocin
DCG
DVT
MVTMVI
Cook's catether
DVG
Foley's catheter
HCD
amniotomy mifepristone
THE PROJECT WAS SPONSORED BY FERRING PHARMACEUTICALS