Treatment costs of bladder pain syndrome/interstitial cystitis in Austria: a pharmacoeconomic approach following current guidelines.

BACKGROUND: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a chronic disease with a significant impact on quality of life. A broad range of therapies are used to treat this condition, and patients are often excluded from receiving more expensive and more effective therapies because of cost issues. OBJECTIVE: The objective of this study was to assess the mid- and long-term costs (over 1, 5 and 10 years) of various therapies for BPS/IC. METHODS: Costs in an open-access health system (Austria) for three BPS/IC-specific therapies (intravesical hyaluronan, pentosanpolysulfate and amitriptyline), taken from the American Urological Association guidelines, were evaluated and compared with those of non-specific symptomatic therapies. Response rates for the different therapies were taken from peer-reviewed publications and used to define the need for therapy maintenance with regard to symptom improvement. RESULTS: Despite the highest initial costs, the reduced need for further therapy in patients with long-term symptom remission after hyaluronan therapy resulted in the lowest total treatment costs at all three timepoints. Hyaluronan was cost saving against all alternatives in standard assumptions and in all sensitivity analyses. As a limitation, treatment costs in this study are specific for Austria. However, the template used for calculation of treatment costs can be transferred to all countries by inserting local prices. CONCLUSION: Disease-specific therapies with high remission rates result in significantly lower long-term costs in BPS/IC. Non-specific symptomatic therapies are most expensive. Long-term cost effectiveness is crucial in the treatment of chronic diseases to limit expenses in individual healthcare systems.

A potent oral P-selectin blocking agent improves microcirculatory blood flow and a marker of endothelial cell injury in patients with sickle cell disease.

Abnormal blood flow accounts for most of the clinical morbidity of sickle cell disease (SCD) [1,2]. Most notably, occlusion of flow in the microvasculature causes the acute pain crises [3] that are the commonest cause for patients with SCD to seek medical attention [4] and major determinants of their quality of life [5]. Based on evidence that endothelial P-selectin is central to the abnormal blood flow in SCD we provide results from four of our studies that are germane to microvascular blood flow in SCD. A proof-of-principle study established that doses of heparin lower than what are used for anticoagulation but sufficient to block P-selectin improved microvascular blood flow inpatients with SCD. An in vitro study showed that Pentosan Polysulfate Sodium (PPS) had greater P-selectin blocking activity than heparin. A Phase I clinical study demonstrated that a single oral dose of PPS increased microvascular blood flow in patients with SCD. A Phase II clinical study that was not completed documented that daily oral doses of PPS administered for 8 weeks lowered plasma levels of sVCAM-1 and tended to improve microvascular blood flow in patients with SCD. These data support the concept that P-selectin on the microvascular endothelium is critical to both acute vascular occlusion and chronically impaired microvascular blood flow in SCD. They also demonstrate that oral PPS is beneficial to microvascular sickle cell blood flow and has potential as an efficacious agent for long-term prophylactic therapy of SCD.

Assessment of prospective preventive therapies for chronic wasting disease in mule deer.

We compared prion infection rates among mule deer (Odocoileus hemionus) receiving pentosan polysulfate, tannic acid, tetracycline HCl, or no treatment 14 days before to 14 days after (dpi) oral inoculation with tonsil tissue homogenate. All deer were infected, but the rapid disease course (230-603 dpi) suggested our challenge was overwhelming.

Treatment choice, duration, and cost in patients with interstitial cystitis and painful bladder syndrome.

INTRODUCTION AND HYPOTHESIS: In order to better understand provider treatment patterns for interstitial cystitis (IC)/painful bladder syndrome, we sought to document the therapies utilized and their associated expenditures using a national dataset. METHODS: A cohort was created by applying the ICD-9 diagnosis of IC (595.1) to INGENIX claims for the year 1999. Subjects were followed for 5 years, and patterns of care and related expenditures were evaluated. RESULTS: Of 553,910 adults insured in 1999, 89 subjects had a diagnosis of IC with 5-year follow-up data. All subjects were treated with oral medication(s), 26% received intravesical treatments, and 22% underwent hydrodistension. Total expenditures per subject were $2,808. CONCLUSIONS: The majority of IC expenditures were attributable to oral medical therapy. Hydrodistension and intravesical instillations were utilized in less than 25% of patients. Hydrodistension was used more frequently among subjects with a new diagnosis; this may reflect its utilization as part of a diagnostic algorithm.

Treatment modalities, health care resource utilization, and costs in patients diagnosed with interstitial cystitis.

OBJECTIVE: The aim of this study was to examine treatment modalities, health care resource utilization, and costs in patients diagnosed with interstitial cystitis (IC). STUDY DESIGN: Patients with a diagnosis of IC were identified from a national managed care administration claims database and classified into treatment cohorts. All-cause health care resource utilization and costs were calculated by treatment cohort. RESULTS: Patients treated with narcotics plus nonnarcotic analgesics were associated with higher mean health care costs. Patient cohorts treated with some of the more common oral therapies for interstitial cystitis, including pentosan polysulfate sodium, amitriptyline, and hydroxyzine, were associated with lower costs. Physician visits were fewest among patients treated with pentosan polysulfate sodium plus amitriptyline and hydroxyzine. Physician visits were higher for cohorts that included dimethyl sulfoxide plus cystoscopy or bladder irrigation, or narcotics plus nonnarcotic analgesics. CONCLUSION: Interstitial cystitis is associated with substantial costs and health care resource utilization.

Interstitial Cystitis: Cost, treatment and co-morbidities in an employed population.

INTRODUCTION: Recent literature indicates that interstitial cystitis (IC) may affect 20% of women and a smaller proportion of men, although many individuals with IC may be misdiagnosed or remain undiagnosed. Factors that can contribute to the cost of IC include medical and drug utilisation related to treatment and diagnosis of IC and associated conditions (e.g. depression), as well as employee work loss. This study assesses the direct medical cost and indirect cost of work loss for IC patients in the first year after diagnosis, and evaluates IC treatment patterns and prevalence of co-morbidities. METHODS: Data for patients under the age of 65 years with at least one diagnosis of IC (n = 749) were drawn from a de-identified, administrative database of approximately 2 million beneficiaries that included medical, drug and disability claims for 1999-2002. A 2 : 1 matched control sample of patients without an IC diagnosis (non-IC sample) was randomly selected based on patient characteristics. Indirect costs were calculated from a subgroup of 152 IC patients (plus their matched controls) who had disability information available. Costs incurred in the first year after IC diagnosis and co-morbidities were compared between IC patients and the non-IC sample, with the difference in costs defined as 'excess costs' of IC patients. Treatment patterns were profiled in the 2 months following initial diagnosis of IC. Descriptive statistics are presented. A multivariate two-part model was applied to estimate the IC direct medical cost, indirect cost and total cost to adjust for observed patient demographics and co-morbidities. Statistical significance was evaluated by the bootstrap method. RESULTS: The average IC patient had 130% higher direct costs (p < 0.05) and the average IC employee patient had 84% higher indirect costs than the average non-IC control individual. IC patients also had a higher diagnostic prevalence of prostatitis (relative risk [RR] = 40.0), endometriosis (RR = 7.4), vulvodynia (RR = 6.9), chronic pelvic pain (RR = 5.8) and urinary tract infections (RR = 5.1) [all p < 0.05]. IC patients were also more likely to report depression (RR = 2.8) and anxiety (RR = 4.5 ) than non-IC controls (all p < 0.05). Seventeen percent of IC patients received pentosan polysulfate therapy, the only US FDA-approved oral drug therapy indicated for treating IC, within the first 2 months after diagnosis. Of these patients, 69% received at least one 'other' drug from the non-approved oral medications studied. Approximately one-third of IC patients received only 'other' drug therapies, and almost half of IC patients received no drug treatment within the first 2 months after the initial diagnosis. CONCLUSIONS: IC is a costly disease associated with co-morbidities. Following diagnosis, patients with IC are commonly untreated or treated with non-approved drug therapies. It is possible that more accurate diagnosis and earlier and more appropriate treatment of IC would lead to better management (or even prevention) of co-morbidities and reduce healthcare costs, and this should be investigated in future studies.

Can histological assessment predict the outcome in interstitial cystitis?

In a retrospective study we compared the outcome of 39 patients with interstitial cystitis to the histological findings at initial diagnostic bladder biopsy. The degree of inflammation and fibrosis and the mast cell counts were assessed on each biopsy. The prognostic relevance of the clinical features of age, duration of symptoms, frequency, nocturia, pain and bladder capacity was assessed. The study showed no statistical correlation between the severity of histological findings at diagnosis and the eventual outcome of the disease. Over 50% of patients with severe histological abnormalities responded to conservative treatment. Although the majority of patients with mild pathological changes responded to conservative treatment, some did require surgical intervention. The clinical features of pain, nocturia and bladder capacity showed significant differences between the 2 patient groups. However, the former 2 features are subject to many variables and the latter probably has too wide a range to be useful as a prognostic indicator. Only the response of patients to conservative treatment will indicate those who are not being helped and who may eventually require surgical treatment.