Patient burden and healthcare resource utilization of regimens for ovarian stimulation.

RESEARCH QUESTION: Do women receiving corifollitropin alfa with a gonadotrophin-releasing hormone (GnRH) antagonist experience less emotional and/or physical exhaustion than women receiving standard of care gonadotrophin with daily administration of GnRH agonist or antagonist? DESIGN: The CoRifollitropin EvAluation in PracTicE (CREATE) study was a prospective observational study of fertility clinics in 17 countries in Europe and the Asia-Pacific region. Women undergoing IVF were categorized by treatment. Group A received single-dose corifollitropin alfa plus a GnRH antagonist; group B received usual care daily gonadotrophin regimens with a GnRH agonist or antagonist; and group B1i received daily GnRH agonist injections. For the primary analysis, two items from the Controlled Ovarian Stimulation Impact questionnaire were used to assess the level of emotional and physical exhaustion associated with ovarian stimulation. Secondary end-points included the impact of ovarian stimulation-related healthcare resource use. RESULTS: No statistical difference was found between the percentage of participants reporting emotional exhaustion in group A (11.6%) and B (13.1%) or the percentage reporting being 'often' or 'always' physically exhausted. More participants in group B1i (16.4%) reported being emotionally exhausted 'often' or 'always' during ovarian stimulation compared with group A (11.6%; P = 0.026). Patient questionnaire scores for psychological impact were higher in group A compared with group B, indicating less negative impact (72.7 versus 70.9; P = 0.004). Group A had fewer clinic visits, physician consultations, nurse contacts and transvaginal ultrasound scans (all P < 0.001) than group B1. CONCLUSIONS: Treatment with corifollitropin alfa resulted in similar or numerically small differences in psychological impact and lower clinic service use compared with daily gonadotrophin regimens.

Real-world cost-effectiveness of etonogestrel implants compared to long-term and short term reversible contraceptive methods in France.

BACKGROUND: To estimate the cost-effectiveness (CE) of etonogestrel implants compared to other long-term and short-term reversible contraceptive methods available in France. RESEARCH DESIGN AND METHODS: A 6-year Markov model compared effectiveness between the implant and six other contraceptive methods in sexually active, not-pregnancy-seeking French females of reproductive age. Contraception efficacy, switch rates and outcomes were based on French current medical practice. Incremental CE ratios (ICERs) were calculated as incremental cost per unintended pregnancy (UP) avoided. Efficiency frontier was plotted to identify cost-effective methods. Uncertainty was explored through sensitivity analyses. RESULTS: The implant was on the efficiency frontier along with combined oral contraceptive pill (COC) and copper IUD. Implant avoids between 0.75% and 3.53% additional UP per person-year compared to copper IUD and second generation COC, respectively, with an ICER of €2,221 per UP avoided compared to copper IUD. For the 240,000 French women currently using the implant, up to 8,475 UPs and up to 1,992 abortions may be prevented annually. CONCLUSION: With more unintended pregnancies avoided and comparable costs to copper IUD, the implant is a cost-effective option among long-term and short-term reversible contraceptive methods.

Preference for Contraceptive Implant Among Women 18-44 years old.

Introduction: This study aimed to understand women's preferences regarding the subdermal contraceptive implant and to assess the proportion of women who would be underserved (with increased unintended pregnancies as the consequence) by not providing implant access equal to that of uterine-based long-acting reversible contraceptive methods (LARCs). Methods: A total of 1,200 women aged 18-44 years old (mean: 30.42 ± 7.67 years) participated in a U.S. cross-sectional online survey. To qualify for the study, women had to be sexually active with a male and not pregnant or trying to get pregnant at the time of the study. Women who had undergone a hysterectomy, a bilateral salpingo-oophorectomy, or a tubal ligation, and women with general infertility or those with a vasectomized partner were excluded. Descriptive analyses were conducted and weighted estimates, projecting to the total U.S. population were also provided. Results: The majority of women (72.6%) reported that they would be willing to switch to a LARC, should it be readily available to them. Considering those women who already use an implant and those who would be willing to switch to it, 58% of women would be underserved by not being provided equal access to the subdermal implant. This reduced availability of this type of LARC may alone elevate the number of unintended pregnancies in the United States by ∼8% of all pregnancies per year. Conclusion: Thus, making all the available contraceptive methods and maintaining access to LARCs would help reduce unintended pregnancies and better serve women and their family planning needs.

Budget impact analysis of 8 hormonal contraceptive options.

OBJECTIVES: To develop a model comparing costs of 8 hormonal contraceptives and determine whether acquisition costs for implants and intrauterine devices (IUDs) were offset by decreased pregnancy-related costs over a 3-year time horizon from a managed care perspective. STUDY DESIGN: A model was developed to assess the budget impact of branded or generic oral contraceptives (OCs), quarterly intramuscular depot medroxyprogesterone, etonogestrel/ethinyl estradiol vaginal ring, etonogestrel implant, levonorgestrel IUD, norelgestromin/ethinyl estradiol transdermal contraceptive, and ethinyl estradiol/levonorgestrel extended-cycle OC. METHODS: Major variables included drug costs, typical use failure rates, discontinuation rates, and pregnancy costs. The base case assessed costs for 1000 women initiating each of the hormonal contraceptives. RESULTS: The etonogestrel implant and levonorgestrel IUD resulted in the fewest pregnancies, 63 and 85, respectively, and the least cost, $1.75 million and $2.0 million, respectively. In comparison, generic OC users accounted for a total of 243 pregnancies and $3.4 million in costs. At the end of year 1, costs for the etonogestrel implant ($800,471) and levonorgestrel IUD ($949,721) were already lower than those for generic OCs ($1,146,890). Sensitivity analysis showed that the cost of pregnancies, not product acquisition cost, was the primary cost driver. CONCLUSIONS: Higher initial acquisition costs for the etonogestrel implant and levonorgestrel IUD were offset within 1 year by lower contraceptive failure rates and consequent pregnancy costs. Thus, after accounting for typical use failure rates of contraceptive products, the etonogestrel implant and levonorgestrel IUD emerged as the least expensive hormonal contraceptives.

The long-term fiscal impact of funding cuts to Danish public fertility clinics.

This study evaluated the fiscal impact attributed to recent policy changes that limited funding to public fertility clinics in Denmark. Taking into consideration that introducing patient co-payments will influence the numbers of couples treated, the number of children born every year from assisted reproductive technology will be affected. To reflect the government perspective, the model assessed the average life course of a cohort of assisted-conception singletons taking into consideration age-specific, per-capita government transfers (e.g. education, health care, family allowances, education, pensions) and lifetime gross tax contributions to derive the discounted net tax contribution from assisted-conception singletons. An investment of €11,078 in a mother aged <40 to achieve an assisted-conception singleton was valued at €154,100 in cumulative discounted net tax revenue when the child reaches age 50. A reduction in the number of live births generated additional savings of €67-112 million due to reduced government transfers by age 25. However, by age 50, because of fewer children born and consequently fewer tax payers, a €74-123 million loss to government was estimated. The projected discounted net tax revenue attributed to assisted-conception children suggests that publicly funded treatment provides economic benefits to government over the lifetime of the conceived children. In January 2011, the Danish Parliament introduced a law that limited reimbursement to publicly funded fertility clinics in Denmark. Because reimbursement for fertility services can influence couples' ability to receive treatment, this will consequently result in fewer children being born each year. To inform the policy decision, this study assessed the fiscal consequences of the policy change on the government over many generations. The analytical framework discussed here estimates the net tax revenue of a cohort of assisted-conception children and the discounted net tax revenue that these children pay to the Danish government over their lifetime. The analysis illustrates that the government will save more costs than those directly related to public fertility services because fewer children are likely to be born and consequently to require government services (e.g. education, health care, family allowances). However, over time as the assisted-conception cohort matures and enters the work force. the reduced number of assisted-conception children, attributed to the funding cuts, will negatively impact government accounts due to lost tax revenue. The policy analysis described here suggests that the economic impact of the fertility policy change is dependent on the time frame over which the analysis is considered. In the short term, it is possible to save on assisted reproduction treatment costs; however, taking into consideration the life course of the diminished size of the assisted-conception cohort, this will negatively influence government accounts in the future.

Comparative analysis of length of stay, total costs, and treatment success between intravenous moxifloxacin 400 mg and levofloxacin 750 mg among hospitalized patients with community-acquired pneumonia.

OBJECTIVE: This study aimed to evaluate the length of stay (LOS), costs, and treatment consistency among patients hospitalized with community-acquired pneumonia (CAP) initially treated with intravenous (IV) moxifloxacin 400 mg or IV levofloxacin 750 mg. METHODS: Adults with CAP receiving IV moxifloxacin or IV levofloxacin for > or =3 days were identified in the Premier Perspective comparative database. Primary outcomes were LOS and costs. Secondary outcomes included treatment consistency, which was defined as 1) no additional IV moxifloxacin or levofloxacin after > or =1 day off study drug; 2) no switch to another IV antibiotic; and 3) no addition of another IV antibiotic. RESULTS: A total of 7720 patients met inclusion criteria (6040 receiving moxifloxacin; 1680 receiving levofloxacin). Propensity matching created two cohorts (1300 patients each) well matched for demographic, clinical, hospital, and payor characteristics. Before the patients were matched, mean LOS (5.87 vs. 5.46 days; P = 0.0004) and total costs per patient ($7302 vs. $6362; P < 0.0001) were significantly greater with moxifloxacin. After the patients were matched, mean LOS (5.63 vs. 5.51 days; P = 0.462) and total costs ($6624 vs. $6473; P = 0.476) were comparable in both cohorts. Treatment consistency was higher for moxifloxacin before (81.0% vs. 78.9%; P = 0.048) and after matching (82.8% vs. 78.0%; P = 0.002). CONCLUSIONS: In-hospital treatment of CAP with IV moxifloxacin 400 mg or IV levofloxacin 750 mg was associated with similar hospital LOS and costs in propensity-matched cohorts.

Relative strength of relationships of nasal congestion and ocular symptoms with sleep, mood and productivity.

BACKGROUND: Nasal congestion associated with allergic rhinitis has been shown to be the most bothersome symptom. Ocular symptoms may be troublesome to patients as well. OBJECTIVE: To estimate the relative strength of relationships of nasal congestion and ocular symptoms associated with allergic rhinitis with patient-reported outcomes of sleep quality; practical problems; somnolence; impairment at work, class, activities; and mood. METHODS: Patients (n = 404) presenting with symptoms of allergic rhinitis completed five patient-reported outcomes that assessed the effect of morning allergic rhinitis symptoms on patients' reports of sleep, work and activity impairment, and mood. Multiple regression analyses were used to compare the relative strength of relationships of congestion and ocular symptoms with the patient-reported outcomes. RESULTS: The majority of patients had both nasal congestion and ocular symptoms at baseline. A single nasal congestion item and a 3-item ocular symptom score were significantly related to the patient-reported outcomes: those with more severe congestion or ocular symptoms reported more negative scores on the patient-reported outcomes. Nasal congestion had the stronger relationship with patient-reported outcomes total scores or subscales in 14 of 20 regressions. CONCLUSION: Although nasal congestion is generally more strongly related to the patient-reported outcomes, ocular symptoms have a significant negative effect on patients' lives. Study limitations include: (1) only baseline data were used because of greater severity and variability of symptoms scores; we are unable to establish causal relationships or discuss change, only correlation/covariation; (2) recruitment took place from September through November, thus different patients might have been recruited if sampling took place during the spring; (3) patients were screened for nasal congestion not for ocular symptoms, though there was high co-occurrence of each. These limitations aside, congestion and ocular symptoms are troublesome to patients and typically co-occur. Evaluating and treating these symptoms are key to managing allergic rhinitis and improving patient-reported outcomes.

Retrospective claims study of fluticasone propionate/salmeterol fixed-dose combination use as initial asthma controller therapy in children despite guideline recommendations.

BACKGROUND: According to current asthma treatment guidelines, single-entity inhaled corticosteroids (ICSs) should be used as initial controller therapy in children with mild to moderate persistent asthma. Long-acting beta(2)-agonists (LABAs) can be added to therapy for those patients whose asthma is not well controlled with a single-entity ICS. OBJECTIVES: The goal of this study was to examine whether the claims history for children in a US insured population indicate proper fluticasone propionate/ salmeterol (FPS) fixed-dose combination use in accordance with recommended asthma guidelines and a US Food and Drug Administration (FDA) advisory and black box warning regarding LABA use. A comparison of study-drug charges was also conducted. METHODS: Data from a US commercial insurance database were used in this retrospective study to evaluate pharmacy and medical claims for children between October 2004 and September 2006 (ie, the index period). An index date corresponding to the date of the first FPS claim was assigned to each patient. Eligible patients were aged 4 to 11 years and had >/=1 pharmacy claim for FPS during the index period. Those patients receiving 1 FPS prescription dose strength on the index date who were continuously enrolled for benefits during the preindex period (ie, the 365 days before the index date) were included in the study. Disease severity was assigned based on asthma-related pharmacy (frequency and/or incidence of oral corticosteroid, LABA, montelukast, and >365 doses of a short-acting beta(2)-agonist) and medical (asthma-related urgent care clinic or emergency department visits or hospitalizations) claim histories during the preindex period. RESULTS: A total of 13,306 patients between the ages of 4 and 11 years on the index date were included in the study; their mean (SD) age was 8.9 (1.9) years. The majority of the patients were male (60.7%). Of the total FPS claims, 55.2% were for patients with no evidence of pharmacy or medical claims in the 365 days before the first FPS claim that would warrant ICS/LABA combination therapy according to asthma treatment guidelines. There were no large changes in preindex ICS claims over the course of the study in response to an FDA-issued advisory and black box warning regarding the use of LABAs. Median drug charges for single-entity ICS use were $98 compared with $168 for FPS therapy. CONCLUSIONS: ICS/LABA combination treatment was used as initial therapy in 55.2% of children with mild to moderate asthma in this claims database population, contrary to the recommendations of current asthma treatment guidelines. The FDA advisory and black box warning for LABA use had little observed impact on the number of single-entity ICS claims.

A retrospective study of the use of fluticasone propionate/salmeterol combination as initial asthma controller therapy in a commercially insured population.

BACKGROUND: Asthma management guidelines state that a low-dose inhaled corticosteroid (ICS) is the preferred treatment for mild persistent asthma and that coadministration of a long-acting beta(2)-agonist (LABA) should be reserved for patients whose asthma is uncontrolled by single-entity ICS. However, it appears that many patients in the United States with mild persistent asthma are initially treated with combinations of fluticasone propionate/salmeterol (FPS). OBJECTIVE: The aim of this study was to examine whether use of FPS was consistent with asthma management guidelines. METHODS: A commercial insurance database was analyzed retrospectively to identify patients aged 12 to 62 years who had >or=1 pharmacy claim for FPS between October 1, 2004, and September 30, 2006. An index date corresponding to the date of the first FPS pharmacy claim was assigned to each patient. Medical and pharmacy claims data were analyzed for the 365-day period before the index date (preindex period). The severity of patients' asthma was inferred from their history of claims. Patients were identified as having more severe asthma if, during the preindex period, they either received >365 doses of short-acting beta(2)-agonists (SABAs), an oral corticosteroid (OCS), or an emergency department (ED) asthma visit with an OCS prescription, or were hospitalized for their asthma. RESULTS: Among 87,459 patients with new FPS claims, 60.8% were female, and the mean age was 37.3 years. Of these patients, 60,453 (69.1%) had no preindex ICS pharmacy claim or claims that would indicate moderate or severe asthma. In the preindex period, only 6.3% had received an ICS, 7.4% had >365 SABA doses, 22.7% had used an OCS, 1.1% had an ED visit with an OCS prescription, and 1.5% had been hospitalized. CONCLUSION: More than two thirds of the patients who initiated FPS treatment had neither received an ICS prescription before their first FPS pharmacy claim nor had evidence of asthma severity that would appear to warrant the use of an ICS/LABA combination.

Using the congestion quantifier seven-item test to assess change in patient symptoms and their impact.

Generally, nasal congestion is reported to be the most troublesome symptom of allergic rhinitis and has been shown to have negative effects on sleep, productivity, work, and school performance. A new patient-reported outcome (PRO) tool called the Congestion Quantifier Seven-Item Test (CQ7) was developed and shown to be a reliable and valid screening tool for nasal congestion. The purpose of this study was to assess the CQ7 as a tool for clinical use that can monitor changes in nasal congestion or determine if patients are showing meaningful improvement in symptoms. This study examined the responsiveness of the CQ7 to changes in nasal congestion and changes in relevant PRO to explore whether the CQ7 can serve as a monitoring tool and a valid screening tool for nasal congestion using latent growth curve models. Results showed that the CQ7 is sensitive to changes in patients' symptoms and their impact. Change in the CQ7 from baseline to day 15 was highly related to the change in symptom scores from baseline to day 15 (beta = -0.99); and regression coefficients for the relationships between the CQ7 and changes in the other PRO subscales also were very high (betas ranged from -0.79 to -0.95), lending evidence to support the use of the CQ7 as a monitoring tool. The large sizes of the coefficients suggest that the efficient, seven-item monitoring tool captures change in congestion very well. Analyses of responsiveness to change suggest that a three- to four-point improvement is meaningful to patients.

Improving patient and nurse outcomes: a comparison of nurse tasks and time associated with two patient-controlled analgesia modalities using delphi panels.

Increased demand on nursing time may adversely affect nurse satisfaction and patient outcomes. Technologies to reduce nursing time and burden may improve patient care. Two Delphi panels assessed the perceived nursing time of fentanyl iontophoretic transdermal system (ITS) and intravenous patient-controlled analgesia (IV PCA) for postoperative pain management. The panels were asked to estimate the time spent on individual nursing tasks from a list. The Clinical Trial panel (n = 14) was composed of nurses who participated in two clinical trials, and data for both PCA modalities were collected from this panel. The routine practice panel (n = 13) was composed of nurses from various hospital units, and only data for IV PCA were collected from this panel. From the Clinical Trial panel, the estimated total average task time was 251 minutes for IV PCA and 210 minutes for fentanyl ITS. From the Routine Practice panel, the estimated total average task time was 163 minutes for IV PCA. Thirteen extra tasks were identified by the Clinical Trial panel to be associated only with IV PCA, and these eliminated steps primarily explained the estimated total nursing time difference between IV PCA and fentanyl ITS. According to the two Delphi panels, the perceived nursing time consumed was less and the number of tasks was lower for fentanyl ITS than for IV PCA. This benefit associated with fentanyl ITS may lead to other positive outcomes, such as improved nurse satisfaction and improved patient outcomes.

Economic evaluation of etoricoxib versus non-selective NSAIDs in the treatment of osteoarthritis and rheumatoid arthritis patients in the UK.

INTRODUCTION: The objective of this study was to evaluate the potential economic implications of using etoricoxib versus non-selective NSAID alternatives in the treatment of patients with osteoarthritis (OA) or rheumatoid arthritis (RA) in the UK. STUDY DESIGN: Decision-analytical modelling was used to calculate the expected costs and consequences of the use of etoricoxib compared with non-selective NSAIDs alone, NSAIDs plus proton pump inhibitors (PPIs), NSAIDs plus histamine H2 receptor antagonists and NSAIDs plus misoprostol over a continuous treatment period of 1 year. METHODS: The model considered direct medical costs from the perspective of the UK National Health Service (NHS) and used data from phase IIb and III clinical trials of etoricoxib to determine probabilities of gastrointestinal (GI) events. Model outcomes were defined as resource-consuming GI-related events, including clinically evident gastroduodenal perforations, symptomatic gastroduodenal ulcers, or upper GI bleeding (collectively, PUBs ['perforation, ulcers and/or bleeding']). Resource utilisation and costs (2002 values) for the treatment of OA and RA as well as GI events were based on published literature and information available from UK-specific sources. MAIN OUTCOME MEASURES AND RESULTS: The model suggests that etoricoxib is cost saving compared with non-selective NSAIDs plus PPIs or non-selective NSAIDs plus misoprostol. The model also suggests that etoricoxib is cost effective in terms of the incremental cost per QALY gained for non-selective NSAIDs alone (pound 19,766) and for non-selective NSAIDs plus H2 antagonists (pound 9350). The incremental cost of etoricoxib per PUB avoided was pound 12,446 versus non-selective NSAIDs alone and pound 6438 versus NSAIDs co-prescribed with H2 antagonists. For patients without the presence of specific GI risk factors (history of GI event, corticosteroid use or disability), etoricoxib may be cost effective for patients over age 56 years, assuming a cost-effectiveness threshold of pound 30,000 per QALY gained. Etoricoxib may also be cost effective in patients of all ages who had at least one specific GI risk factor. CONCLUSIONS: The model suggests, with its underlying assumptions and data, that etoricoxib is a cost-effective alternative to therapeutic regimens involving non-selective NSAIDs for OA or RA, from the UK NHS perspective. Etoricoxib may be cost saving and dominant over non-selective NSAIDs used together with a PPI or misoprostol. When compared with non-selective NSAIDs alone or non-selective NSAIDs co-prescribed with H2 antagonists, the incremental cost per QALY gained with use of etoricoxib was within the generally accepted threshold for cost effectiveness (less than pound 30,000 per QALY gained).

Update on the use of patient reported functional status and HRQOL measures in low back pain.

Disease-specific functional status and generic health-related quality of life instruments used in low back pain studies are reviewed. A variety of instruments are available and many have been demonstrated to be valid and reliable. The Roland-Morris Disability Index and Oswestry Disability Index are the most commonly used low back pain-specific measures, while the Short Form-36 is the most commonly used generic quality of life tool. The Short Form-36 is valid and reliable in back pain but not necessarily intended to replace disease-specific measures. Studies have been inconsistent in their efforts to demonstrate a relationship between self-reported functioning and task performance.