A cost-effectiveness analysis of the use of oral ibrexafungerp versus fluconazole for acute vulvovaginal candidiasis in the UK NHS primary care service.

BACKGROUND: Vulvovaginal Candidiasis (VVC) is a fungal infection causing inflammation of the vagina and/or the vulva. Symptoms include itching, irritation, and discharge. VVC presents commonly across primary care and, despite its mild symptoms, carries psychological burden and has a significant impact on women's quality of life. UK guidelines support treatment via oral or topical azole antifungal agents. Recent evidence attests to the superiority of novel non-azole antifungals. Thus, rigorous financial assessment of both antifungals is necessary for optimal VVC treatment allocation in UK primary care. AIM: To evaluate the cost-effectiveness of ibrexafungerp against the gold standard fluconazole as first-line treatment of VVC within the NHS. METHOD: A systematic review on the efficacy of ibrexafungerp and fluconazole in acute VVC was conducted. Cost-effectiveness analysis was initiated using health outcome data from the DOVE trial, a Phase 2 RCT. Costs in pound sterling were ascertained in monetary units, and effectiveness determined as reduced need for follow-up medication. RESULTS: An incremental cost-effectiveness ratio of £2185.74 was determined. This suggests oral ibrexafungerp being largely more costly yet slightly more effective than fluconazole, and thus has unfavourable net benefit. Two sensitivity analyses were conducted considering follow-up medication combination and market price, which provided confidence in the calculated cost-effectiveness ratio. CONCLUSION: This analysis highlights fluconazole's cost-effectiveness in current UK guidelines and favourability.

Global burden of recurrent vulvovaginal candidiasis: a systematic review.

Recurrent vulvovaginal candidiasis is a debilitating, long-term condition that can severely affect the quality of life of affected women. No estimates of the global prevalence or lifetime incidence of this disease have been reported. For this systematic review, we searched PubMed, Embase, and Web of Science databases for population-based studies published between 1985 and 2016 that reported on the prevalence of recurrent vulvovaginal candidiasis, defined as four or more episodes of the infection every year. We identified 489 unique articles, of which eight were included, consisting of 17 365 patients from 11 countries. We generated estimates of annual global prevalence, estimated lifetime incidence and economic loss due to recurrent vulvovaginal candidiasis, and predicted the number of women at risk to 2030. Worldwide, recurrent vulvovaginal candidiasis affects about 138 million women annually (range 103-172 million), with a global annual prevalence of 3871 per 100 000 women; 372 million women are affected by recurrent vulvovaginal candidiasis over their lifetime. The 25-34 year age group has the highest prevalence (9%). By 2030, the population of women with recurrent vulvovaginal candidiasis each year is estimated to increase to almost 158 million, resulting in 20 240 664 extra cases with current trends using base case estimates in parallel with an estimated growth in females from 3·34 billion to 4·181 billion. In high-income countries, the economic burden from lost productivity could be up to US$14·39 billion annually. The high prevalence, substantial morbidity, and economic losses of recurrent vulvovaginal candidiasis require better solutions and improved quality of care for affected women.

A cost-effectiveness analysis of rapid yeast detection kits.

OBJECTIVE: To determine the cost effectiveness of the utilization of over-the-counter yeast infection detection kits in the diagnosis of vaginal candidiasis. METHODS: A cost-benefit analysis based on a group of 70 adult women from a previous prospective study who presented with vaginitis symptoms. By constructing two decision trees, one in which the kits are an option to the women and one in which they are not, we predict the cost for diagnosing vaginal candidiasis in this group of women. RESULTS: For a group of 70 women presenting with vaginitis symptoms, the total cost of diagnosing their infections without the use of kits is predicted to be 7,051.10 dollars. For the same 70 women, the total of cost of diagnosing their infections with the use of kits is predicted to be 5,941.02 dollars. CONCLUSION: We conclude that the use of yeast infection detection kits could reduce the cost of diagnosis by 16%. The introduction of kits could save patients the time, money, and other resources involved in visiting a physician to confirm the diagnosis. Moreover, the sensitivity of yeast kits is superior to the traditional wet mount (77% vs. 52%), so there may be a role for the kits in the physician's office as well.

Oral versus intra-vaginal imidazole and triazole anti-fungal agents for the treatment of uncomplicated vulvovaginal candidiasis (thrush): a systematic review.

OBJECTIVES: To compare the relative effectiveness, cost effectiveness and safety of oral versus intra-vaginal anti-fungal treatments for uncomplicated vulvovaginal candidiasis (thrush) and establish patient preference for the route of anti-fungal administration. DESIGN: A systematic review of studies comparing oral and intra-vaginal anti-fungal treatments for uncomplicated vulvovaginal candidiasis. Standard Cochrane Collaboration methods were used. DATA SOURCES: The following sources were searched: the Cochrane Controlled Trials Register; the Cochrane Sexually Transmitted Disease review group Specialised Register of Controlled Trials; EMBASE (January 1980 to January 2000); and MEDLINE (January 1985 to May 2000). The reference list of each trial was checked for additional references. The manufacturers of anti-fungal treatments in the UK were asked for information on trials fulfilling the inclusion criteria. METHODS: There was duplicate, independent examination and selection of the electronic search results followed by duplicate data abstraction. Disagreements regarding inclusion status and data abstraction were resolved by discussion between reviewers and the editor of the Cochrane Sexually Transmitted Disease group. Randomised controlled trials conducted worldwide and published in any language were included. The primary outcome measure was clinical cure. Mycological cure, patient preference and safety were secondary outcome measures. RESULTS: Seventeen trials were included in the review, reporting 19 oral versus intra-vaginal anti-fungal treatment comparisons. No statistically significant differences were shown between oral and intra-vaginal anti-fungal treatment for clinical or mycological cure. All 10 trials that reported a preference favoured oral treatment (compared with intra-vaginal or no preference). No trials presented cost data. CONCLUSIONS: There is no difference between the relativeeffectiveness of oral and intra-vaginal anti-fungal treatment for thrush.

Impact of vaginal antifungal products on utilization of health care services: evidence from physician visits.

BACKGROUND: Recently many medications formerly available only by prescription have been approved for over-the-counter (OTC) status. In 1990, clotrimazole became the first available OTC drug to treat candidal vaginitis. Subsequently several other prescription antifungal medications have also been available in OTC products. One proposed benefit of these switches from prescription to OTC status is a reduction in the utilization of health care services. METHODS: Using National Ambulatory Medical Care Survey data, the average numbers of annual visits for vaginal complaints were estimated for 1985, 1990, and 1994. These years were chosen because they represented periods before, close to, and after the approval of the OTC antifungal preparations. The estimated visits for each year were compared using a chi-square analysis with a sample weight correction. RESULTS: There was a 15% decline in the number of vaginitis visits from 1990 to 1994 that potentially could be attributed to the availability of the OTC antifungal preparations. The decrease in physician visits results in approximately $45 million in direct cost savings and another $18.75 million in indirect savings by reducing time lost from work. CONCLUSIONS: It appears that the availability of OTC anticandidal fungal preparations reduces the number of physician visits for vaginitis, resulting in cost savings.

Candida vaginitis: self-reported incidence and associated costs.

BACKGROUND AND OBJECTIVES: Incidence of Candida vaginitis by age and racial or ethnic group is poorly described. GOAL: Estimate incidence, cumulative probability of presumed C vaginitis by age, racial or ethnic group, and associated costs. STUDY DESIGN: Random digit-dialing survey of 2000 US women. RESULTS: A total of 6.5 percent (95% CI, 5.4-7.5%) of women older than 18 years reported a least one episode of presumed C vaginitis during the previous 2 months. Women reporting a 1-year period with four or more episodes comprised 8.0% of the sample but accounted for 37.2% of women reporting episodes. Black women reported approximately three times more yeast infections in the previous 2 months (17.4%; 95% CI, 11.2-23.5%) than white women (5.8%; 95% CI, 4.7-6.9%). CONCLUSION: The high incidence and the propensity for recurrence underscore the need for a better understanding of the epidemiology and pathogenesis, and stress the need for the development of more accurate, rapid diagnostics and effective treatments.

Clinical and cost considerations in the pharmacotherapy of vulvovaginal candidiasis.

Vulvovaginal candidiasis (VVC) is a frequent cause of morbidity in women of reproductive age. Most women will experience 1 or 2 episodes in their lifetime, but a smaller population develop chronic recurrent disease. There are few data on cost or pharmacoeconomic considerations in the management of this condition. The disease does not usually result in long term disability, loss of employment or death, but could affect a woman's work performance through irritability, frustration and unhappiness. This review attempts to estimate the least costly programme or regimen (as the efficacy of different regimens is similar) that would be applicable to patients, third-party payers and society. Nonprescription or over-the-counter (OTC) antifungal preparations could have an impact on overall cost in the management of VVC. In the management of infrequent acute VVC, an OTC preparation would be least costly to the healthcare system (provided that the diagnosis was correct). The strategies used to control symptoms in patients with chronic recurrent VVC should be based on the frequency of recurrent episodes. For patients with less than 12 episodes a year, empirical self-treatment at the onset of symptoms with an OTC agent (e.g. intravaginal clotrimazole 500mg) is less costly and preferable to patients than monthly prophylaxis. Patients with a greater frequency of recurrences may benefit from monthly, daily or twice weekly prophylaxis. At present, for very frequent recurrences, intravaginal clotrimazole 200mg twice weekly appears to be as effective as daily oral ketoconazole, and may be safer and less costly. However, because of the lack of prospective controlled studies, most of these recommendations are based on hypothetical reasonings. Furthermore, the disadvantages of OTC antifungals include the potential for overuse and inappropriate use, possibly resulting in the delayed diagnosis and treatment of other conditions. On balance, OTC preparations may provide patients with faster and more economical care, and improve healthcare delivery.

The value of prophylactic (monthly) clotrimazole versus empiric self-treatment in recurrent vaginal candidiasis.

OBJECTIVE: To determine the comparative efficacy and cost benefit of prophylactic monthly (perimenstrual) clotrimazole, versus empiric self-treatment with the same agent at the onset of symptoms in recurrent vulvovaginal candidiasis. DESIGN: Prospective, randomised, open cross-over study of women with proven recurrent vulvovaginal candidiasis. Clinical and microbiological assessments were done every two months for 12 months. SETTING: Women's Clinic of a University Teaching Hospital. SUBJECTS: Twenty-three otherwise healthy, non-pregnant women with greater than four proven episodes of candida vaginitis in the last year were enrolled into the study. INTERVENTION: Patients were randomised to receive: (1) a single dose of prophylactic clotrimazole 500 mg ovule just before or on the last day of the menses each month for 6 months; (2) or a single dose of clotrimazole 500 mg ovule empirically at the onset of symptoms for 6 months. After the first 6 months patients were crossed-over to the opposite regimen. MAIN OUTCOME MEASURES: Symptoms of recurrent vulvovaginitis during each period, and number of clotrimazole ovules used for each 6 month period. The personal preference of the patients for the two different regimens were assessed at the end of study. RESULTS: During the prophylactic 6 months period of the study, 23 patients had 50 episodes of symptomatic vaginitis (mean 2.2 episodes per patient), versus 86 episodes (mean 3.7 episodes/patient) during the empiric self-treatment 6 months period (P = 0.05). However, during the prophylactic period a total of 168 clotrimazole ovules were used (mean 7.3 per patient), versus 84 ovules (mean 3.6 per patient) during the empiric self-treatment period, p < 0.001. The personal preference of the patients for the type of regimen employed were 17 (73.9%) in favour of the empirical treatment, versus 4 (17.4%) in favour of the prophylactic treatment and 2 (8.7%) no personal preference, p < 0.01. CONCLUSION: Empiric self-treatment is more cost-effective and preferable to patients than cyclical monthly prophylactic use of 500 mg clotrimazole vaginal ovules.