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1.
Article in English | MEDLINE | ID: mdl-28675545

ABSTRACT

Although recent studies demonstrated that fulvestrant is superior to anastrozole as first-line treatment for hormone receptor (HR)-positive advanced breast cancer, the cost-effectiveness of fulvestrant versus anastrozole remained uncertain. Thus, the current study aimed to evaluate the cost-effectiveness of fulvestrant compared with anastrozole in the first-line setting. A Markov model consisting of three health states (stable, progressive and dead) was constructed to simulate a hypothetical cohort of patients with HR-positive advanced breast cancer. Costs were calculated from a Chinese societal perspective. Health outcomes were measured in quality-adjusted life-year (QALY). The incremental cost-effectiveness ratio (ICER) was expressed as incremental cost per QALY gained. Model results suggested that fulvestrant provides an additional effectiveness gain of 0.11 QALYs at an incremental cost of $32,654 compared with anastrozole, resulting in an ICER of $296,855/QALY exceeding the willingness-to-pay threshold of $23,700/QALY. Hence, fulvestrant is not a cost-effective strategy compared with anastrozole as first-line treatment for HR-positive advanced breast cancer.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/drug therapy , Estradiol/analogs & derivatives , Nitriles/therapeutic use , Triazoles/therapeutic use , Anastrozole , Antineoplastic Agents, Hormonal/economics , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , China , Cost-Benefit Analysis , Drug Costs , Estradiol/economics , Estradiol/therapeutic use , Female , Fulvestrant , Humans , Markov Chains , Nitriles/economics , Quality-Adjusted Life Years , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Triazoles/economics
2.
Ginecol Obstet Mex ; 84(9): 551-6, 2016 Sep.
Article in Spanish | MEDLINE | ID: mdl-29424969

ABSTRACT

Objetives: To identify the costs of family planning care in adolescents. Material and methods: Longitudinal study of the cost of care for family planning carried out in 2015 in a group of individuals with age limits of 10 and 19 years in a unit first level of health care in the state of Queretaro, Mexico. The profile of use of family planning (FP) was created for the teen was performed services through counseling, provision of contraception and review of intrauterine device (IUD) in a year; cost projections for the population of adolescents and different coverage scenarios between 5 and 100% were made. Results: The average annual cost was 228.84 Mexican pesos. Ideally the identified cost was 2,708.94 pesos. The projection with 20 % coverage was 207,251,330 pesos. The average annual family planning consultations was 0.9. The most commonly used method was with medroxyprogesterone-estradiol at doses of 25 and 5 mg. Conclusion: The cost of planning in adolescents is low, taking into account the costs that the care of high-risk pregnancies and associated comorbidities.


Subject(s)
Contraception/economics , Contraceptive Agents, Female/economics , Family Planning Services/economics , Intrauterine Devices/economics , Adolescent , Child , Contraception/methods , Contraceptive Agents, Female/administration & dosage , Drug Combinations , Estradiol/administration & dosage , Estradiol/economics , Female , Humans , Longitudinal Studies , Male , Medroxyprogesterone Acetate/administration & dosage , Medroxyprogesterone Acetate/economics , Mexico , Young Adult
3.
Eur J Obstet Gynecol Reprod Biol ; 184: 24-31, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25462215

ABSTRACT

OBJECTIVE: To compare the effectiveness and costs associated with first-line medical treatments for chronic heavy menstrual bleeding (HMB) in Spain. STUDY DESIGN: A cost-effectiveness analysis was conducted comparing the levonorgestrel-releasing intrauterine system (LNG-IUS) with the estradiol valerate/dienogest multiphase oral contraceptive (E2V/DNG), combined oral contraceptives (COC) and progestins (PROG). Study patients were fertile women diagnosed with HMB who initially wished to remain fertile. A Markov model based on reported clinical data and the opinion of a panel of experts was used. The time horizon of the analysis was 5 years. The analysis was conducted from the perspective of the Spanish National Health System (NHS), discounting both costs (€ 2013) and future effects at an annual rate of 3%. One-way sensitivity analyses and probabilistic sensitivity analysis were performed to test the robustness of the results. RESULTS: In the analysis at 5 years, the LNG-IUS was associated with a gain of 0.67, 2.22, and 3.53 symptoms free months (SFM) compared with E2V/DNG, COC and PROG, respectively. LNG-IUS contributed more quality-adjusted life months (QALM) than the other treatment alternatives (+1.74 vs. E2V/DNG, +3.33 vs. COC +3.53 vs. PROG). First-line LNG-IUS treatment resulted in savings of € 583, € 988, and € 1891 vs. E2V/DNG, COC and PROG, respectively. These cost benefits, coupled with the greater clinical benefits in terms of SFM and QALM, show that LNG-IUS is the dominant option (less costly and more effective). CONCLUSION: LNG-IUS is the medical treatment of choice and cost-saving option for the control of HMB in Spain.


Subject(s)
Contraceptives, Oral, Combined/economics , Cost-Benefit Analysis , Estradiol/analogs & derivatives , Intrauterine Devices, Medicated/economics , Levonorgestrel/economics , Menorrhagia/drug therapy , Nandrolone/analogs & derivatives , Contraceptives, Oral, Combined/therapeutic use , Drug Combinations , Estradiol/economics , Estradiol/therapeutic use , Female , Humans , Levonorgestrel/therapeutic use , Menorrhagia/economics , Models, Theoretical , Nandrolone/economics , Nandrolone/therapeutic use , Spain
4.
Clin Ther ; 35(3): 246-260.e5, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23453402

ABSTRACT

OBJECTIVE: The goal of this study was to examine the cost-effectiveness of fulvestrant 500 mg for the treatment of first progression or recurrence of advanced breast cancer in postmenopausal patients compared with generic nonsteroidal aromatase inhibitors (anastrozole and letrozole) in the United Kingdom. METHODS: A cost-utility model based on a time-in-state approach was used. Clinical effectiveness estimates used in the model were derived from a network meta-analysis for overall survival and serious adverse events. Overall survival was extrapolated by using a Weibull distribution, and progression-free survival (PFS) estimates were derived from a simultaneous network meta-analysis and extrapolation of PFS curves by using the log-normal distribution. Data on resource use, costs, and utilities were based on various sources, including expert opinion and published data. To explore uncertainty, 1-way and probability sensitivity analyses were conducted. The study was conducted from the perspective of the UK National Health Service, and costs are reported in 2010/2011 British pounds. RESULTS: The base case incremental cost-effectiveness ratio (ICER) for fulvestrant 500 mg versus letrozole was £34,528, with incremental costs of £14,383 and an incremental quality-adjusted life-year (QALY) of 0.417. Extended dominance occurred for anastrozole because the ICER for anastrozole versus letrozole was higher than the ICER for fulvestrant 500 mg versus anastrozole. Based on the probability sensitivity analyses, the probability that fulvestrant 500 mg was the most cost-effective treatment option was 3%, 20%, and 53% at a willingness-to-pay threshold of £20,000, £30,000, and £40,000 per QALY, respectively. According to the 1-way sensitivity analyses, the PFS estimates were the key drivers of the model results. CONCLUSIONS: Although fulvestrant 500 mg was found not to be a cost-effective option at a standard UK threshold of £20,000 to £30,000 per QALY, it may be relevant to apply a higher threshold due to the poor prognosis of patients with advanced breast cancer and the limited number of hormonal treatment options available for this stage of treatment. Certain subgroups may also benefit from fulvestrant as a treatment option; however, limited data are currently available to identify these subgroups.


Subject(s)
Antineoplastic Agents, Hormonal/economics , Aromatase Inhibitors/economics , Breast Neoplasms/drug therapy , Drug Costs , Estradiol/analogs & derivatives , Antineoplastic Agents, Hormonal/therapeutic use , Aromatase Inhibitors/therapeutic use , Estradiol/economics , Estradiol/therapeutic use , Fulvestrant , Humans , Survival Analysis , United Kingdom
5.
BMC Womens Health ; 12: 27, 2012 Sep 05.
Article in English | MEDLINE | ID: mdl-22950651

ABSTRACT

BACKGROUND: Frozen thawed embryo transfer (FET) is a cost-effective adjunct to IVF or IVF-ICSI treatment. In order to optimize treatment outcome, FET should be carried out during a period of optimal endometrial receptivity. To optimize implantation several methods for endometrium preparation have been proposed. In natural cycle FET (NC-FET), the endometrium develops under endogenous hormonal stimulation. The development of the dominant follicle and endometrium is monitored by ultrasound and FET is timed after triggering ovulation induction or determination of the spontaneous LH surge. In an artificial cycle FET (AC-FET) estrogens and progesterone are administered to prepare the endometrium for implantation. While the currently available data show no significant difference in pregnancy rates between these methods, well designed randomized controlled trials are lacking. Moreover there is little literature on difference in cancellation rates, cost-efficiency and adverse events. METHODS AND DESIGN: In this randomized, multi-centre, non-inferiority trial we aim to test the hypothesis that there is no significant difference in live birth rates between patients undergoing NC-FET versus AC-FET. The primary outcome will be live birth rate per embryo transfer procedure. Secondary outcomes will be ongoing and clinical pregnancy rate, cancellation rate, (serious) adverse events and cost-efficiency. Based on a live birth rate of 20% and a minimal clinical important difference of 7.5% (one-sided alpha 2.5%, beta 20%) a total of 1150 patients will be needed. Analyzes will be performed using both per protocol as well as intention to treat analyses. DISCUSSION: This prospective, randomized, non-inferiority trial aims to address the hypothesis that there is no significant difference in live birth rates between patients undergoing NC-FET versus patients undergoing AC-FET. Moreover it addresses cost-efficiency as well as the perceived burden of both treatments. TRIAL REGISTER: Netherlands trial register (NTR): 1586.


Subject(s)
Embryo Transfer/methods , Infertility, Female/therapy , Adolescent , Adult , Clinical Protocols , Cost-Benefit Analysis , Drug Administration Schedule , Embryo Transfer/adverse effects , Embryo Transfer/economics , Estradiol/administration & dosage , Estradiol/analogs & derivatives , Estradiol/economics , Estrogens/administration & dosage , Estrogens/economics , Female , Humans , Infertility, Female/economics , Intention to Treat Analysis , Live Birth , Menstrual Cycle , Netherlands , Patient Preference , Pregnancy , Pregnancy Rate , Progesterone/administration & dosage , Progesterone/economics , Progestins/administration & dosage , Progestins/economics , Single-Blind Method , Treatment Outcome , Young Adult
6.
J Oncol Pharm Pract ; 18(4): 394-401, 2012 Dec.
Article in English | MEDLINE | ID: mdl-22357638

ABSTRACT

PURPOSE: To determine the cost-effectiveness of fulvestrant 250 mg compared to 500 mg in postmenopausal women with estrogen receptor-positive metastatic breast cancer and disease progression after antiestrogen therapy. METHODS: A Markov model was constructed to find the incremental cost-effectiveness of fulvestrant 250 mg monthly when compared with the 500 mg monthly in patients with progression after antiestrogen therapy. The model duration was 24 months. Clinical efficacy data inputs were derived from a phase III clinical trial demonstrating a statistically significant increase in progression-free survival in patients receiving 500 mg versus 250 mg. Cost data utilized were all relevant Ambulatory Payment Classification payment rates from the 2011 Medicare Outpatient Prospective Payment System. A Monte Carlo simulation was performed to test the model at various willingness to pay thresholds. RESULTS: The incremental cost-effectiveness ratio as determined by the Markov model was US$10,972 per month of progression-free survival for the 500 mg dose compared with the 250 mg dose. Using a Monte Carlo simulation, it was found that 500 mg monthly was cost-effective at and above the willingness to pay threshold of US$15,000 per month. A series of one-way sensitivity analyses showed this result is robust to geographical practice variations in costs of drug administration and physician examination. CONCLUSION: From a third party payer perspective, the value of fulvestrant 500 mg monthly is dependent on the willingness to pay threshold. Despite a labeling change for fulvestrant in September 2010, fulvestrant 250 mg monthly appears to be a viable option in the target population.


Subject(s)
Breast Neoplasms/drug therapy , Breast Neoplasms/economics , Estradiol/analogs & derivatives , Estrogen Antagonists/administration & dosage , Estrogen Antagonists/economics , Breast Neoplasms/metabolism , Clinical Trials, Phase III as Topic/economics , Cost-Benefit Analysis , Disease Progression , Disease-Free Survival , Dose-Response Relationship, Drug , Drug Administration Schedule , Estradiol/administration & dosage , Estradiol/economics , Female , Fulvestrant , Humans , Markov Chains , Models, Economic , Monte Carlo Method , Postmenopause , Receptors, Estrogen/metabolism , United States
8.
Clin Ther ; 34(1): 37-55, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22169052

ABSTRACT

BACKGROUND: Estradiol valerate/dienogest (E2V/DNG) is a combined oral contraceptive (COC) with 2 new hormonal entities and a unique 4-phasic dosing regimen indicated for women to prevent pregnancy. OBJECTIVE: The purpose of this article is to review the pharmacology, pharmacokinetics, clinical efficacy, tolerability, and cost of E2V/DNG. METHODS: MEDLINE (1966-June 2011) and EMBASE (1966-June 2011) were searched for original research and review articles published in the English language using the terms Natazia or Qlaira or estradiol valerate and dienogest. The reference lists of identified articles were reviewed for additional pertinent publications. Abstracts from the 2005 to 2011 American Society of Reproductive Medicine and American College of Obstetricians and Gynecologists meetings were searched using the same terms. RESULTS: The search provided 56 articles that addressed the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, and tolerability of E2V/DNG in women of reproductive age. Articles reporting efficacy or tolerability in the setting of menopause were excluded. The initial efficacy of E2V/DNG on ovulation inhibition was investigated in 2 prospective, randomized, open-label, Phase II dose-finding studies. The dose that was approved by the Food and Drug Administration resulted in 3.13% of women ovulating in the second cycle of treatment (90% CI, 0.2%-6.05%). Rate of pregnancy prevention with this agent was reported with a Pearl Index ranging from 0.73 to 1.27 (unadjusted) to 0.34 to 0.72 (adjusted for method failure only). The mean duration of withdrawal bleeding was 4.3 days (range, 4.0-4.6 days) among 2266 women receiving 13 treatment cycles. Adverse events reported in >1% of patients included abdominal pain, acne, breast pain, dysmenorrhea, emotional lability, headache, nausea, and weight increase. CONCLUSIONS: Estradiol valerate/dienogest is a new contraceptive formulation. It offers efficacy, tolerability, and an acceptable safety profile with a potentially better bleeding pattern than levonorgestrel-containing COCs. This COC may be especially useful for older women of reproductive age who are adherent to therapy and looking for shorter and/or lighter menstrual cycles. Studies will need to be performed to determine whether clinically significant differences in outcomes exist among E2V/DNG and other available COCs.


Subject(s)
Contraceptives, Oral, Combined/therapeutic use , Contraceptives, Oral, Hormonal/therapeutic use , Estradiol/analogs & derivatives , Nandrolone/analogs & derivatives , Administration, Oral , Animals , Contraceptives, Oral, Combined/administration & dosage , Contraceptives, Oral, Combined/adverse effects , Contraceptives, Oral, Combined/economics , Contraceptives, Oral, Combined/pharmacokinetics , Contraceptives, Oral, Hormonal/administration & dosage , Contraceptives, Oral, Hormonal/adverse effects , Contraceptives, Oral, Hormonal/economics , Contraceptives, Oral, Hormonal/pharmacokinetics , Drug Administration Schedule , Drug Combinations , Drug Costs , Estradiol/administration & dosage , Estradiol/adverse effects , Estradiol/economics , Estradiol/pharmacokinetics , Estradiol/therapeutic use , Female , Humans , Nandrolone/administration & dosage , Nandrolone/adverse effects , Nandrolone/economics , Nandrolone/pharmacokinetics , Nandrolone/therapeutic use , Pregnancy , Treatment Outcome
9.
Ann Pharmacother ; 45(10): 1256-61, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21917554

ABSTRACT

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of the new oral contraceptive estradiol valerate/dienogest. DATA SOURCES: Searches of PubMed (1966-July 2011) and International Pharmaceutical Abstracts (1970-July 2011) were conducted using the key words estradiol valerate, dienogest, Natazia, and Qlaira. Bibliographies of retrieved articles were reviewed to identify additional references. STUDY SELECTION AND DATA EXTRACTION: All identified studies published in English and involving efficacy and safety of estradiol valerate/dienogest as an oral contraceptive were reviewed. DATA SYNTHESIS: Estradiol valerate/dienogest is a 4-phasic oral contraceptive approved for the prevention of pregnancy. The 4-phasic design allows for acceptable cycle control with this hormonal combination. In efficacy trials of estradiol valerate/dienogest in women aged 18-35 years, the Pearl Index ranged from 0.40 to 1.64, a range comparable to that of other combination oral contraceptives. The safety profile was also similar to that of other oral contraceptives, with headache, metrorrhagia, breast tenderness, nausea or vomiting, acne, and weight gain reported as the most common adverse effects. Menstrual bleeding patterns and cycle control with estradiol valerate/dienogest were comparable to those of a monophasic oral contraceptive containing ethinyl estradiol/levonorgestrel. Estradiol valerate/dienogest differs from other oral contraceptives in that it necessitates more stringent dosing guidelines for maximum contraceptive efficacy. New starts should be on the first day of menses only, and a back-up method of contraception is required for the first 9 days, as compared to 7 days with other oral contraceptives. Back-up contraception is usually required for any pill taken more than 12 hours later than scheduled. CONCLUSIONS: Estradiol valerate/dienogest is an effective oral contraceptive. Because it has more stringent start times and requires a longer duration of backup contraception and stricter adherence, estradiol valerate/dienogest should be reserved for patients who are intolerant of other combination oral contraceptives.


Subject(s)
Contraceptives, Oral/pharmacology , Estradiol/analogs & derivatives , Nandrolone/analogs & derivatives , Clinical Trials as Topic , Contraceptives, Oral/adverse effects , Contraceptives, Oral/economics , Drug Combinations , Drug Costs , Estradiol/adverse effects , Estradiol/economics , Estradiol/pharmacology , Female , Humans , Nandrolone/adverse effects , Nandrolone/economics , Nandrolone/pharmacology
11.
Bioprocess Biosyst Eng ; 34(2): 189-95, 2011 Feb.
Article in English | MEDLINE | ID: mdl-20734205

ABSTRACT

The estrogenic compound 17ß-estradiol (E2) is widely studied for its potential endocrine disruption effects. Due to the low level of E2 present in the environment, it is highly desirable to develop a sensitive and efficient separation and enrichment method for E2 analysis. In this paper, we proposed a novel E2 preconcentration method using anti-E2 aptamer-anchored isothiocyanate-modified beads (NCS beads). The glass beads are chemically modified with primary amino group, and then treated with phenylene diisothiocyanate (PDITC) to generate an isothiocyanate group, which is reactive towards the amine group. The amino-modified anti-E2 aptamer can be easily covalently immobilized onto the as-prepared NCS beads. The experimental results demonstrated that the aptamer affinity microbeads could selectively retain and separate E2 compound. The effects of the operation parameters on retention of E2, including washing condition, eluting condition, the number of beads, and the incubation time were investigated. Moreover, high-performance liquid chromatography with preconcentration of E2 on the aptamer affinity microbeads was applied to detect the E2 in the spiked water samples and obtained a good recovery.


Subject(s)
Aptamers, Nucleotide/chemistry , Chromatography, Affinity/methods , Estradiol/economics , Microspheres , Estradiol/chemistry
12.
J Anim Sci ; 88(11): 3759-66, 2010 Nov.
Article in English | MEDLINE | ID: mdl-20656966

ABSTRACT

Crossbred steers were grazed in the spring and early summer on endophyte-infected (Neotyphodium coenophialum), Kentucky-31 tall fescue (Lolium arundinaceum) pastures to evaluate effects and interactions of feeding pelleted soybean hulls (PSBH) and steroid hormone implants (SHI) on steer performance, serum prolactin, and hair coat ratings (HCR). Steers were stratified by BW for assignment to six 3.0-ha toxic tall fescue pastures. With or without daily PSBH feeding, treatments were assigned randomly to pastures as the main plot treatment in a split-plot design. Pelleted soybean hulls were group-fed to provide 2.3 kg(steer·d(-1)) (as fed). With or without SHI (200 mg of progesterone and 20 mg of estradiol) treatments were randomly assigned as the subplot treatment to 2 steer subgroups within each pasture. Sixty-four steers were grazed for 77 d in 2007, and 60 steers were grazed for 86 d in 2008. Pasture forage mass declined linearly over time, but the rate of decline was greater (P = 0.001) in 2007 than in 2008. Pasture forage mass was never below 2,300 kg of DM/ha in either year. Average daily gain for steers on the combined PSBH and SHI treatments was greater (P < 0.01) than for those on the PSBH-only, SHI-only, and control (no SHI, no PSBH) treatments. Average daily gain for the PSBH-only steers was greater (P < 0.01) than for SHI-only and control steers and tended (P = 0.063) to be greater for SHI-only than for control steers. Steroid implants did not affect (P = 0.826) serum prolactin concentrations; however, prolactin concentrations in PSBH steers, with or without SHI, were increased (P = 0.01) 2-fold over SHI-only and control steers. Feeding PSBH and SHI treatments both reduced (P < 0.05) the percentage of steers with rough HCR, and a greater percentage of steers fed PSBH tended (P < 0.076) to have sleek hair coats. An economic analysis was conducted, which determined that costs of additional ADG with PSBH feeding were below breakeven costs over a wide range of PSBH costs and cattle prices. Breakeven costs for PSBH-only treatment for a range of cattle prices of $1.80 to $2.40/kg of BW were less than $120/t, whereas with PSBH feeding combined with SHI the breakeven cost was less than $240/t. Results indicate that steers grazing endophyte-infected tall fescue can be fed PSBH and implanted with steroid hormones to cost effectively increase ADG and that feeding PSBH can increase serum prolactin concentrations and induce some shedding of rough hair coats.


Subject(s)
Cattle/growth & development , Estradiol/pharmacology , Glycine max , Poaceae/microbiology , Progesterone/pharmacology , Animal Feed/analysis , Animal Feed/microbiology , Animal Nutritional Physiological Phenomena , Animals , Body Composition , Diet/veterinary , Drug Implants/economics , Estradiol/administration & dosage , Estradiol/economics , Male , Mycoses , Neotyphodium , Poaceae/growth & development , Progesterone/administration & dosage , Progesterone/economics , Prolactin/blood , Time Factors , Weight Gain/drug effects
13.
Breast Cancer Res Treat ; 117(2): 305-17, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19130218

ABSTRACT

Therapy decisions in advanced breast cancer (ABC) increasingly require assessment not only of treatment efficacy but also of cost-effectiveness. To this end, we performed a cost-utility analysis by comparing treatment sequences including/omitting fulvestrant in a hypothetical population of hormone receptor-positive (HR+) postmenopausal women with ABC. The analysis was performed from the German health care perspective. Using a first-order sequential Markov model, expected costs and utilities were calculated over a time horizon of 10 years for cohorts of patients with HR+ ABC, previously treated for at least 5 years using adjuvant endocrine therapies. Utilities were primarily quantified in terms of quality adjusted life years (QALY). "Base-case" estimates of state transition rates, resource utilization, and other model parameters were derived from published evidence and expert assessment. The impacts of uncertainties in all key model parameters were evaluated by sensitivity analysis. Costs and benefits were discounted at 3% annually. Including second-line fulvestrant in the treatment sequence led to greater estimated health gains (0.021 QALY) and cost savings of 564 euros ($745, 380 pounds) per patient, i.e. the fulvestrant-containing sequence was "dominant". The prediction of a cost savings was robust with respect to variations in all key parameters. The probability of acceptable cost-effectiveness for the fulvestrant sequence was 72% at a willingness to pay (WTP) of 30,000 euros/QALY ($39,621/QALY, 20,198 pounds/QALY); the probability was even higher at lower WTP and substantially exceeded 50% for any realistic WTP. In a representative population of women with HR+ advanced breast cancer, inclusion of fulvestrant in the treatment sequence provides a cost-effective alternative from the German health care perspective. A high probability of cost-effectiveness is maintained under variations in all key parameters. The results reflect a tendency for patients receiving fulvestrant at an early stage to maintain high quality of life for a longer interval.


Subject(s)
Antineoplastic Agents, Hormonal/economics , Breast Neoplasms/economics , Estradiol/analogs & derivatives , Quality-Adjusted Life Years , Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/drug therapy , Cost-Benefit Analysis , Estradiol/economics , Estradiol/therapeutic use , Female , Fulvestrant , Germany , Humans , Markov Chains , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism
14.
Br J Cancer ; 99(12): 1984-90, 2008 Dec 16.
Article in English | MEDLINE | ID: mdl-19018261

ABSTRACT

Drug therapies for advanced breast cancer in hormone-receptor-positive disease include both hormonal and chemotherapies. Current UK practice is to minimise toxicity by using sequential hormonal agents for as long as clinically appropriate. A Markov model was developed to investigate the cost effectiveness of different sequences of therapies, particularly exploring the effects of adding an additional hormonal agent, fulvestrant, to the treatment pathway. A systematic review was undertaken and a panel of seven UK oncologists validated assumptions used for treatment efficacy, treatment pathways and resources used. Fulvestrant was found to be a cost-effective treatment option when added to the treatment sequence as a second- or third-line hormonal therapy for advanced disease. For a cohort of 1000 patients, fulvestrant as a second-line hormone therapy provided an additional 47 life years and 41 quality-adjusted life years (QALYs), at an additional cost of pound 301 359. This equated to pound 6500 per life years gained and pound 7500 per QALY. When used as a third-line option, the fulvestrant arm was dominant providing an increase in health benefit of 27 QALYs for the whole cohort, at a mean overall cost reduction of pound 430 per patient. Sensitivity analyses showed these results to be robust, demonstrating that fulvestrant is an economically viable additional endocrine option in the United Kingdom for the treatment of hormone responsive advanced breast cancer.


Subject(s)
Antineoplastic Agents/economics , Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/metabolism , Estradiol/analogs & derivatives , Receptors, Estrogen/metabolism , Antineoplastic Agents/adverse effects , Breast Neoplasms/economics , Breast Neoplasms/pathology , Estradiol/adverse effects , Estradiol/economics , Estradiol/therapeutic use , Fulvestrant , Hormone Replacement Therapy , Humans , Neoplasm Staging , Substrate Specificity
15.
Klin Med (Mosk) ; 81(10): 19-24, 2003.
Article in Russian | MEDLINE | ID: mdl-14664167

ABSTRACT

The study was undertaken to define the specific features of daily variations of blood pressure (BP) and autonomic cardiac regulation (ACR), as well as the functional status of the myocardium and vascular endothelium in females with menopausal arterial hypertension (MPAH) and to assess the pharmacotherapeutic and economical aspects of the combined use of arifon retard and clinonorm. The study enrolled 30 reproductive females with mild and moderate arterial hypertension (AH) and 65 females with MPAH who were randomly divided into 2 groups according to the therapeutic model. MPAH was characterized by more unfavorable hemodynamic changes that AH in the presence of preserved fertile function: greater load on target organs, elevated BP, its inadequate nocturnal lowering, greater BP variations, the magnitude and rate of its morning elevation. In AH, the vasomotor function of the endothelium varies with the clinical form of the disease and with the functional status of the female reproductive system. By and large, in the group of patients with MPAH, the latter was characterized by a more significant decrease in endothelium-dependent vasodilation (EDVD). Arifon retard monotherapy has an adequate antihypertensive effect in female patients with MPAH, by ensuring 24-hour control of BP and affecting its chronostructure. A combination of arifon retard and climonorm has no cumulative effect on the level of BP and on the parameters of pressure-induced load; however, this is a pathogenetically grounded combination that potentiates the positive effects of a diuretic in significantly improving EDVD and ACR. The use of arifon retard in combination with climonorm in MPAH is the most cost-effective for public health care facilities and effective for patients. The course of MPAH is of certain peculiarity, which should be taken into account in choosing a therapeutic model for this category of patients.


Subject(s)
Diuretics/therapeutic use , Estradiol/analogs & derivatives , Estradiol/therapeutic use , Hypertension/drug therapy , Hypertension/physiopathology , Indapamide/therapeutic use , Levonorgestrel/therapeutic use , Menopause , Circadian Rhythm , Diuretics/economics , Drug Combinations , Drug Therapy, Combination , Estradiol/economics , Female , Heart/physiopathology , Humans , Hypertension/economics , Indapamide/economics , Levonorgestrel/economics , Treatment Outcome
16.
Pharmacoeconomics ; 18(5): 477-86, 2000 Nov.
Article in English | MEDLINE | ID: mdl-11151401

ABSTRACT

OBJECTIVE: To estimate the economic impact of using tibolone 2.5 mg compared with 17 beta-estradiol 2 mg/norethisterone acetate 1 mg (E2/NETA) in postmenopausal women with climacteric symptoms. DESIGN AND SETTING: This was a modelling study performed from the perspective of the UK's National Health Service (NHS). METHODS: The clinical outcomes from a previously reported trial were used as the clinical basis for the analysis, which showed that 48 weeks' treatment with tibolone and E2/NETA significantly alleviated the climacteric symptoms experienced by postmenopausal women. These data were combined with resource utilisation estimates derived from a panel of 10 GPs and 3 gynaecologists, enabling us to construct a Markov model depicting changes in the health status of postmenopausal women. The model was used to estimate the expected NHS costs and consequences after 48 weeks' treatment with tibolone and E2/NETA. MAIN OUTCOME MEASURES AND RESULTS: The mean expected direct healthcare cost of using tibolone and E2/NETA to manage postmenopausal women for 48 weeks was estimated to be 260 Pounds and 239 Pounds (1997/1998 prices) per patient, respectively. Starting hormone replacement therapy (HRT) with tibolone instead of E2/NETA was equally effective in alleviating climacteric symptoms (65.9 and 62.2%, respectively; p = 0.516) over 48 weeks and significantly reduced the incidence of vaginal bleeding by 36% (p < 0.0001) and breast tenderness by 57% (p < 0.0001) for a mean additional cost of 21 Pounds (ranging between -3 Pounds and 42 Pounds) per patient. The acquisition cost of HRT was the primary cost driver for tibolone-treated patients, whereas the cost of managing adverse events was the primary cost driver for E2/NETA-treated patients. CONCLUSIONS: The true cost of prescribing tibolone and E2/NETA is impacted on by a broad range of resources, not only drug acquisition costs. Although the acquisition cost of tibolone is higher than that of E2/NETA, the difference in the expected NHS cost of the first year of treatment between the 2 HRTs is negligible. This is because of the higher incidence of adverse events among E2/NETA-treated patients, which also results in a higher continuation rate among tibolone-treated patients. Factors such as patient preferences should also be taken into consideration so that treatment choices are not decided solely on the basis of acquisition costs.


Subject(s)
Anabolic Agents/economics , Hormone Replacement Therapy/economics , Norpregnenes/economics , Postmenopause , Anabolic Agents/adverse effects , Anabolic Agents/therapeutic use , Drug Costs , Estradiol/adverse effects , Estradiol/economics , Estradiol/therapeutic use , Female , Hormone Replacement Therapy/adverse effects , Hormone Replacement Therapy/methods , Humans , Markov Chains , Models, Economic , Norethindrone/adverse effects , Norethindrone/analogs & derivatives , Norethindrone/economics , Norethindrone/therapeutic use , Norethindrone Acetate , Norpregnenes/adverse effects , Norpregnenes/therapeutic use , United Kingdom
17.
Pharmacoeconomics ; 14(5): 559-73, 1998 Nov.
Article in English | MEDLINE | ID: mdl-10344918

ABSTRACT

OBJECTIVE: The aim of this study was to evaluate the cost effectiveness of multi-therapy treatment strategies in the prevention of vertebral fractures in postmenopausal women with osteoporosis. DESIGN: A retrospective, incremental cost-effectiveness analysis was conducted from a societal perspective. It compared 9 treatment strategies over 3 years and incorporated the willingness of patients to initiate and continue each therapy. MAIN OUTCOME MEASURES AND RESULTS: Four nondominated strategies formed the efficient frontier in the following order: (i) calcium-->no therapy; (ii) ovarian hormone therapy (OHT)-->calcium-->no therapy [166 Canadian dollars ($Can)]; (iii) OHT-->etidronate-->calcium-->no therapy ($Can2331); and (iv) OHT-->alendronate-->calcium-->no therapy ($Can40,965). The figures in parentheses are the incremental costs per vertebral fracture averted to move to that strategy from the previous strategy for patients who had undergone a hysterectomy. CONCLUSIONS: We identified 4 efficient multi-therapy strategies for the treatment of vertebral osteoporosis in postmenopausal women, 2 of which were consistent with the practice guidelines of the Osteoporosis Society of Canada. Decision-makers may select from among these efficient strategies on the basis of incremental cost effectiveness.


Subject(s)
Alendronate/economics , Calcium/economics , Estrogen Replacement Therapy/economics , Etidronic Acid/economics , Osteoporosis, Postmenopausal/economics , Spinal Fractures/economics , Aged , Alendronate/therapeutic use , Calcium/therapeutic use , Cost-Benefit Analysis , Drug Therapy, Combination , Estradiol/economics , Estradiol/therapeutic use , Estrogens/economics , Estrogens/therapeutic use , Etidronic Acid/therapeutic use , Female , Humans , Middle Aged , Osteoporosis, Postmenopausal/complications , Quality-Adjusted Life Years , Retrospective Studies , Sensitivity and Specificity , Spinal Fractures/etiology , Spinal Fractures/prevention & control
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