Conference PaperPDF Available

Economic Evaluation of Ulipristal Acetate for the Treatment of Patients With Moderate and Severe Symptoms of Uterine Fibroids in Romania

Authors:
A510 VALUE IN HEALTH 17 (2014) A323–A686
ing an additional unintended pregnancy with ulipristal acetate as compared to
levonorgestrel is estimated to be 418 . Ulipristal acetate is most cost-effective in
the subgroup of intake within 24 hours, where it is more efficacious at a lower cost
compared to levonorgestrel. ConClusions: Ulipristal acetate is a cost-effective
alternative to levonorgestrel, given that the cost of avoiding an additional pregnancy
with ulipristal acetate is less than the average cost of said pregnancies. Therefore,
French minors should have free access to ulipristal acetate directly in a pharmacy.
Ulipristal acetate should be used rapidly after unprotected intercourse (within
24hours) to benefit from its cost-saving potential compared to levonorgestrel use.
PIH35
CervICal assessment WItH Progesterone In tHe PreventIon of
Preterm BIrtH: a strategy Based on Cost-effeCtIveness
Fonseca E.B.1, Nishikawa A.M.2, Paladini L.2, Clark O.A.C.2
1Universidade Federal da Paraíba, João Pessoa, Brazil, 2Evidencias, Campinas, Brazil
inTRoDuCTion: Preterm birth (PTB) complications are estimated to be the second
most common cause of death in under-five children and responsible for 3.1million
neonatal deaths. According to a worldwide analysis, Brazil is one of the top ten
countries with the highest number of PTB. Considering its long-term costs, strate-
gies that reduce incidence may be cost-effective. Treatment with progesterone is
one of the interventions recommended for PTB prevention due to the evidence
supporting its efficacy in women with short cervix and prior history of preterm
delivery. objeCTives: Determine whether treatment with progesterone for preg-
nant women with a short cervical length < 25mm identified in routine measurement
of second-trimester transvaginal cervical length by ultrasound in low-risk singleton
pregnancies is a cost-effective strategy under the Brazilian Healthcare System per-
spective. MeThoDs: A cohort model was developed according to the disease and
resources use. Epidemiology of pregnancies at risk of PTB eligible for progesterone
treatment were obtained from published data. To obtain national clinical data, births
were categorized by gestational week age at delivery specialist opinion. Progesterone
effectiveness data were obtained from systematic reviews, meta-analysis and spe-
cialist opinion. Costs included screening test, prenatal consultation, progesterone
and neonatal hospitalization. Exchange rate was 1USD= 2.30BRL. Results were pre-
sented in cost/PTB avoided. ResulTs: Considering 278.100 PTB, the inclusion of
screening test to identify pregnant women with short cervix and its prophylaxis
with progesterone shows significant economic savings of USD74 million. Although
the expenditure on drug, screening test and prenatal consultation increment the
total costs, the reduced number of PTB (263,052 vs 278.100) and neonatal UTI hos-
pitalization length (4,098,543 days vs 4,518,056 days) resulted in a total economic
saving. ConClusions: Prevention of PTB is dominant in women with short cervix
as compared to a no-prophylactic strategy scenario resulting in economic savings
to the Brazilian health care system.
PIH36
Cost-effeCtIveness of PalIvIzumaB use In HIgH rIsk CHIldren from
BrazIlIan HealtH system PersPeCtIve
Fernandes R.R.A.
UERJ - IMS, Rio de Janeiro, Brazil
objeCTives: This study aimed to investigate the cost-effectiveness of palivizumab
to different combinations of risk groups, such as premature children born with ges-
tational age (GA) 28 weeks, GA 32 weeks, children with congenital heart disease
and bronchopulmonary dysplasia. MeThoDs: Literature review was performed to
search effectiveness data. One Markov model (base case), and one decision tree
(alternative scenario) were built with a cohort simulation along a 18 years-time
horizon for the base case and a 1 year time horizon for the decision tree. Base case
consider sequelae after infection, and alternative scenario not. The Health System
perspective was used, with a discount rate of 5%. A probabilistic sensitivity analysis
(Monte Carlo simulation) with probability distributions fitted to the variables, was
performed under the different structural assumptions, as well as a deterministic
analysis, using Tornado diagram, to verify the variable modifications able to alter
the responses of the model. A threshold analysis was used to estimate the price
that palivizumab would fit under an acceptability threshold proposed for the health
system. ResulTs: The option of using the prophylaxis just in preterm children born
with GA 32 weeks dominated all others. The incremental effectiveness of base
case analysis compared with no prophylaxis (base line) was 0.19 QALY. However,
this strategy was not cost-effective, presenting an incremental cost-effectiveness
ratio (ICER) of R$ 81,627.31/QALY, value above of World Health Organization (WHO)
proposed threshold of three times GDP per capita (R$ 63,756.00/QALY). The ICER of
GA 32 weeks in alternative scenario was 2.023.045,72, showing the importance of
considering sequelae in analysis. Sensitivity analysis showed that some variables
when altered were able to change model final answers. ConClusions: Threshold
analyses demonstrated that palivizumab price must be reduced in at least 22% to
be incorporated to all populations use, based on WHO threshold.
PIH37
Cost-effeCtIveness analysIs of tHe neW BIomarkers for dIagnosIs of
aCute kIdney Injury In CHIldren after CardIaC surgery
Bogavac Stanojevic N.1, Petrovic S.1, Lakic D.2, Peco Antic A.3, Vulicevic I.4, Ivanisevic I.5,
Kotur Stevuljevic J.1, Jelic-Ivanovic Z.1
1University of Belgrade, Faculty of Pharmacy, Belgrade, Serbia and Montenegro, 2University of
Belgrade Faculty of Pharmacy, Belgrade, Serbia and Montenegro, 3School of Medicine, University
of Belgrade, Belgrade, Serbia, Belgrade, Serbia and Montenegro, 4University Children’s
Hospital, Belgrade, Serbia and Montenegro, 5University Children’s Hospital, Belgrade, Serbia and
Montenegro
objeCTives: Children undergoing cardiac surgery for congenital heart disease are
more likely to experience development of acute kidney injury (AKI) in the immedi-
ate postoperative period. In current clinical practice, AKI diagnosis is based on a
rise in serum creatinine (sCr) levels, which occurs 2-3 days after the initiating renal
insult. Many new biomarkers offer promise for earlier AKI diagnosis. The objective
for RT intervention and US$ 17.88/DALY for RPR intervention. Cost-effectiveness
ratios (CERs) were more sensitive to the prevalence rate, sensitivity of tests, and
DALY discount rate. ConClusions: Using the on-site antenatal rapid testing, same
day treatment for positive results, and confirmed by RPR testing approach is cost-
effective in Mongolia.
PIH32
Cost effeCtIveness of CalCIum suPPlement In reduCIng
PreeClamPsIa-related maternal mortalIty
Chicaiza-Becerra L.A.1, Garcia-Molina M.1, Oviedo S.1, Urrego J.2, Rincon C.J.3, Gomez P.I.1,
Rubio-Romero J.A.1
1Universidad Nacional de Colombia, Bogotá, Colombia, 2Facultad de Ciencias Económicas,
Universidad Nacional de Colombia, Bogotá, Colombia, 3Universidad Nacional de Colombia,
Bogota, Colombia
objeCTives: To estimate the cost-effectiveness of the supply of calcium of 1200mg
per day from the week 14 of pregnancy to all pregnant women compared to not
supplying it to reduce the incidence of preeclampsia. MeThoDs: A decision tree
was built in TreeAge® with outcome measured in life years gained (LYG) associated
to the reduction in maternal deaths. The costs were included from the perspective
of the Health System in Colombia. Pharmaceutical costs were obtained from 2008
SISMED (1) and the value of the procedures was calculated by adjusting the values
of Tariff Manual ISS 2001 + 30% (2), these values were compared with information
of costs supplied by three EPS. All costs are expressed in Colombian pesos of 2010.
The discount rate was 0%. It was performed sensitivity univariate and probabilistic
analyzes for costs and effectiveness. ResulTs: Compared to no intervention, calcium
supplement is a dominant alternative. If the incidence of preeclampsia is lower than
51.7 per 1000 pregnant women or the cost per tablet of calcium of 600 mg is greater
than $454, calcium supplement is no longer a cost-effective alternative in Colombia
for a threshold of 3 times the GDP per capita in Colombia of 2010 by LYG, equal to
$36,143,550. ConClusions: Supply of calcium to all pregnant women from week
14 of gestation is a dominant alternative compared to no intervention, which saves
200 LYG, while it decreases costs in the order of $5,304 million pesos per 100.000
pregnant women.
PIH33
eConomIC evaluatIon of ulIPrIstal aCetate for tHe treatment of
PatIents WItH moderate and severe symPtoms of uterIne fIBroIds
In romanIa
Lorenzovici L.1, Székely A.1, Ágh T.2, Vámossy I.3, Kelemen L.J.4, Finta H.5, Kaló Z.6
1Syreon Research Romania Ltd, Tirgu Mures, Romania, 2Syreon Research Institute, Budapest,
Hungary, 3Gedeon Richter Plc, Budapest, Hungary, 4Gedeon Richter Romania SA, Corunca,
Romania, 5University of Medicine and Pharmacy of Tirgu Mures, Tirgu Mures, Romania, 6Eötvös
Loránd University, Budapest, Hungary
objeCTives: Ulipristal acetate is a selective progesterone receptor modulator
that has been demonstrated to be an effective 3-month pre-operative treatment
for moderate to severe symptoms of uterine fibroids in adult women of repro-
ductive age. The aim of this analysis was to assess the cost-effectiveness of 5 mg
ulipristal acetate as an add-on therapy to standard pre-surgical observation and
treatment or immediate hysterectomy in Romania. MeThoDs: A Markov model
was developed using a 10-year time horizon. Ulipristal acetate was compared with
pre-surgical observation and immediate hysterectomy. The model comprised the
following mutually exclusive health states: mild, moderate, severe, or persistent
severe excessive bleeding disorder; myomectomy; post-myomectomy with mildly to
moderately excessive bleeding disorder; post-myomectomy with severely excessive
bleeding disorder; hysterectomy; post-hysterectomy; post-menopause; and death.
Transition probabilities and utility values were obtained from clinical trials and the
scientific literature. Resource utilisation and unit costs were derived from the con-
sensus panel of clinical experts and the Romanian National Insurance House tariffs.
Cost vectors in RON were converted to EUR by using 2013 Romanian National Bank
average exchange rate (1 EUR = 4.419 RON). ResulTs: Adding a 3-month course of
ulipristal acetate to pre-operative observation was predicted to achieve an addi-
tional 0.021 quality-adjusted life years (QALYs) at an estimated incremental cost of
367 , which would result in an incremental cost of 17,749 /QALY. When 3 months
of ulipristal acetate therapy was compared with immediate hysterectomy, the incre-
mental cost-effectiveness ratio was reduced to 2,300 /QALY. The results were most
sensitive to the utility value of the post-hysterectomy health state but responsive
to changes in other model parameters. ConClusions: The results of this analysis
suggest that adding ulipristal acetate treatment to standard pre-surgical therapy
represents a good value for money in Romania. The inclusion of societal benefits
may considerably reduce the cost-effectiveness ratio.
PIH34
tHe Cost-effeCtIveness of emergenCy Hormonal ContraCePtIon
WItH ulIPrIstal aCetate versus levonorgestrel for mInors In
franCe
Schmid R.
HRA Pharma, Paris, France
objeCTives: To compare the cost and effectiveness of two emergency contracep-
tive methods in minors in France and to support the payer’s analysis if it is worth
to deliver ulipristal acetate for free to minors. MeThoDs: Based on a decision-
analytical model, the cost-effectiveness of two emergency contraceptive meth-
ods is compared. Pregnancy rates, outcome of unintended pregnancy in minors
and resource utilization are derived from literature. Resources and their costs are
considered until termination or a few days after delivery. Costs are taken from a col-
lective perspective. Sensitivity analyses are performed on the most sensitive input
parameters. ResulTs: Using emergency contraception is superior to no method.
The cost of an unintended pregnancy in a French minor is estimated to be 1630
(1330 - 1803 ). Almost 4 million (3.1-13.7million ) could have been saved by using
ulipristal acetate instead of levonorgestrel in 2010. The incremental cost of avoid-
Article
Background: Leiomyomas (fibroids), the most common benign solid tumours in females, originate from the myometrium and are associated with poor quality of life for patients. The current management of uterine leiomyomas mainly includes surgical interventions such as hysterectomy and myomectomy, either by laparoscopy or laparotomy, which have several complications and are not ideal for preserving fertility. Therefore, there is a need to develop or repurpose medical treatments that do not require surgical intervention. Objective: Many drugs are used to treat the symptoms associated with uterine fibroids. The main objective of this systematic review is to give an up-to-date account of potential pharmacological agents (non-surgical methods) for the management of uterine leiomyomas. Search strategy: PubMed was searched for scientific and clinical literature using the keyword 'uterine fibroids' along with the drug names described in each section. For example, 'uterine fibroids' and 'ulipristal acetate' were the keywords used to search for literature on ulipristal acetate (UPA). Results: Various preclinical and clinical studies have shown that some drugs and herbal formulations exhibit activity in the management of uterine leiomyomas. Recent studies found that drugs such as UPA, elagolix, EC313, asoprisnol, nutritional supplements and herbal preparations were helpful in treating the symptoms associated with uterine leiomyomas. Conclusion: Many drugs show efficacy in patients with symptomatic uterine fibroids. UPA is one of the most studied and prescribed medicines for uterine fibroids; however, its usage has been restricted due to a few recent incidences of hepatic toxicity. Herbal drugs and natural supplements have also shown promising effects on uterine fibroids. The synergistic effects of nutritional and herbal supplements have been reported in certain cases, and should be studied in detail. Further research is warranted to identify the mode of action of the drugs, and to determine the precise conditions that would explain the causes of toxicity in some patients.
ResearchGate has not been able to resolve any references for this publication.