Faculty of Applied Mathematics and Control Processes, St. Petersburg State University 3

First Pavlov State Medical University of St. Petersburg1

Faculty of Medicine, St. Petersburg State University 2

THE COST-EFFECTIVENESS ANALYSIS FOR USE OF DYDROGESTERONE IN

PREMENSTRUAL SYNDROME

Kolbin A.1,2, Vilyum I.1, Kurylev A.1, Balykina Yu.3, Proskurin M.3

The  study  was  conducted  by  support  from  Abbo5  Laboratories.    

BACKGROUND

§ Premenstrual Syndrome (PMS) - a cyclical symptom that occurs during the premenstrual period and is characterized by somatic, neuropsychiatric, vegetative-vascular, metabolic and endocrine disorders.

§ Progesterone is a well-known drug for treatment of clinical symptoms of PMS.

§  In Russia the following drugs are used: micronized progesterone (Utrogestan®, oral and intravaginal administration); dydrogesterone (Duphaston®, oral); micronized progesterone (Krayon®, intravaginal).

§ These drugs are currently used for various gynecological indications, such as infertility, threatened miscarriage / habitual miscarriage, amenorrhea, dysfunctional uterine bleeding, dysmenorrhea, premenstrual syndrome, endometriosis and endometrial hyperplasia.

OBJECTIVES

The primary objective of the study is to analyze pharmaco-economic expediency of administration dydrogesterone (Duphaston®) for premenstrual syndrome (PMS) treatment in comparison with oral micronized progesterone (Utrogestan®).

For the calculation of the efficacy were used data of clinical trials (n = 3)

Author (year) Study (N of patients), age Wyatt K., et al.

(2001) Systematic review (n=909), 20-40

Dennerstein L., et al. (1985)

A double blind crossover trial (n=23), 18-45

Haspels A.A., et al (1981)

A double-blind, placebo-controlled, multi-center study

(n=130), 18 -40

MATERIALS

METHODS •  The  mathema9cal  modeling  with  dydrogesterone  or  oral  micronized  

progesterone  was  applied  in  the  study.  •  The  model  was  constructed  as  follows:  in  each  branch  of  the  decision  tree  cost  

and  efficacy  were  analyzed  for  a  group  of  100  pa9ents  (female  aged  18  -­‐  45  years)  and  per  pa9ent.  

•  Modeling  dura9on  was  3  months  (therapy  during  three  cycles).  •  The  incremental  cost-­‐effec9veness  ra9o  (ICER)  were  counted.  •  Results  were  evaluated  as  to  the  cost-­‐effec9veness  threshold.  •  Efficacy  was  es9mated  on  the  basis  of  clinical  trials.  •  Calcula9on  of  cost  included:  the  cost  of  treatment  course  with  selected  drugs;  

the  cost  of  gynecologist’s  consulta9ons  and  diagnosis;  the  cost  of  inefficient  therapy  –  costs  of  addi9onal  diagnos9c  examina9on.    

•  The  comprehensive  sensi9vity  analysis  was  performed.  

Female with premenstrual

syndrome

Administration of dydrogesterone (Duphaston®)

Administration of micronized progesteron

(Utrogestan®)

Effectiveness – symptoms were cured

Symptoms were not cured, further search for causes

of the disease

Symptoms were not cured, further search for causes

of the disease

DECISION TREE

Effectiveness – symptoms were cured

Results

•  The cost of the total course of therapy with dydrogesterone was more

expensive in comparison with micronized progesterone – 123.67$

against 121.47$.

•  Strategy of administration of dydrogesterone showed more efficacy

(73%) in comparison with oral micronized progesteron (65%) - 8%

increase of effectiveness.

•  CERs for dydrogesterone and micronized progesterone were 169.41

and 186.87 respectively.

•  The ICER for dydrogesterone amounts to 27.55$ per patient.

•  The sensitivity analysis confirmed conclusions of the main scenario.

123.67  

121.47  

Cost,  $  

Duphaston Utrogestan

Costs were calculated on the basis of Russian prices (grls.rosminzdrav.ru), 2013.

62.55  Co

sts  ,  $   48.44  

52.08  

40.17  

20.94   20.94  

Utrogestan Duphaston

Cost of treatment

course with selected

drugs

Costs of gynecologist’s

consultations and diagnosis

Cost of inefficient therapy – costs of

additional diagnostic examination

121

122

122

123

123

124

124

62,5% 65,0% 67,5% 70,0% 72,5% 75,0%

Cos

t, $

Efficacy, %

Дюфастон

Утрожестан

Duphaston

Utrogestan

Incremental Cost-Effectiveness Ratio

DRUGS Efficacy, Cost, $

CER Additional efficacy

Additional cost, $

ICER, $

Duphaston 0.73 123.67 169.41 0.08 2.2 27.55

Utrogestan 0.65 121.47 186.87

•  The ICER for dydrogesterone amounts to 27.55$ per patient

CONCLUSION

The administration of dydrogesterone in PMS is economically

expedient from the point of view of the cost-effectiveness ratio.

In addition, an increase in effectiveness was noted for the use of

dydrogesterone.

1.  Wyatt K. et al. Efficacy of progesterone and progestogens in management of premenstrual syndrome: systematic review. BMJ 2001;323:1–8

2.  Haspels AA. A double-blind, placebo-controlled, multi-center study of the efficacy of dydrogesterone (Duphaston). In: The premenstrual syndrome (Eds:Van Keep PA and Utian WH), Lancaster England:MTP Press Limited, 1981, 81-92.

3.  Martorano JT. Et al. Differentiating be-tween natural proges-terone and synthetic progestins: clinical implications for premenstrual syndrome and perimenopause management. ComprTher. 1998; 24(6&7):336–9.

4.  Dennerstein L. et al. Progesterone and the premenstrual syndrome: a double blind crossover trial. Br Med J (Clin Res Ed). 1985 Jun 1; 290(6482): 1617–21.

5.  O'Brien P.M. Helping women with premenstrual syndrome. BMJ. 1993 December 4; 307(6917): 1471–1475.

6.  Magill PJ. Investigation of the efficacy of progesterone pessaries in the relief of symptoms of premenstrual syndrome. British Journal of General Practice 1995;45(400):589–93.

7.  Vaneslow W, Dennerstein L, Greenwood KM, de Lignieres B. Effect of progesterone and its 5 alpha and 5 beta metabolites on symptoms of premenstrual syndrome according to route of administration. Journal of Psychosomatic Obstetrics and Gynaecology 1996;17(1):29–38.

List of References