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

10-14 November 2018

Barcelona, Spain

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