Implantable Penile Prosthesis for Erectile Dysfunction: Insurance Coverage in the United States.

INTRODUCTION: A manufacturer's benefit verification database was evaluated to ascertain United States health plan insurance coverage for implantable penile prostheses for erectile dysfunction. METHODS: All-payer and employer-sponsored health plan benefit verification databases were queried to determine implantable penile prosthesis approval status. For the all-payer analysis, data by payer were available and presented for 2019-2021 to assess approval status varied by payer and over time. For the employer-sponsored health plan analysis, data by payer were available from 2018-2021. RESULTS: Benefit verification records for the all-payer database were available for 3,167 patients in 2019, 3,016 in 2020, and 2,837 in 2021. Insurance type was preferred provider organization (27.5%), Medicare Advantage (26.9%), Medicare (15.9%), or point-of-service (10.5%). Most patients were approved or verified for implantable penile prosthesis coverage (79.4% in 2019, 79.6% in 2020, and 78.4% in 2021). Coverage was most extensive for government-based insurance (Medicare 98.7%, Medicare Advantage 97.1%, Tricare 100%, and Veterans Affairs 80.0%) but was also favorable for commercial insurance (75.0%). The most common reason for lack of coverage was employer exclusion; the proportion of patients with no coverage due to exclusion increased from 13.5% in 2019 to 17.5% in 2021. Analyses of the employer-sponsored health plan database (n=3,083 patients) showed that 63.1% of patients were approved or verified for coverage and 34.2% did not have coverage due to health plan exclusions. CONCLUSIONS: Approximately 80% of patients had implantable penile prosthesis coverage. Employer exclusion was the most common reason for lagging coverage; rates of employer exclusion increased 29.3% from 2019-2021.

Addressing Health-Care System Inequities in the Management of Erectile Dysfunction: A Call to Action.

Erectile dysfunction (ED) is a common, burdensome, and costly urologic condition strongly related to all aspects of general health, from physical to mental. ED has profound consequences as it may interfere physical well-being, quality of life (QoL), self-esteem, relationships, self-worth, and productivity. It is therefore important to ensure that all types of effective ED treatments are consistently accessible to patients. While federal and state mandates ensure access to treatment for women's breast health, female-factor infertility, and gender affirmation to ensure that these individuals do not experience a diminished QoL, there are no comparable mandates for men's sexual and reproductive health. The burden of ED necessitates a call to action to improve the accessibility of ED treatments. The call to action steps include: (a) coverage for pharmacological, surgical, and other ED treatments should be viewed in the same way as coverage for other health issues, whether male or female and regardless of the stages of treatment, physical dysfunction, or physical changes; (b) American Urological Association (AUA) guidelines for the management of ED should be followed, including implementation of templates in electronic medical records (EMRs) to support adherence to the guidelines; and (c) coverage criteria should explicitly state that the criteria are intended to support gender equity for sexual and reproductive health care and should not be used to prevent men from receiving medically necessary ED treatments. This call to action offers a pathway to support every man who seeks treatment for ED as a medically necessary intervention by removing systemic health-care barriers.

Pregnancy rates and outcomes in women with and without MS in the United States.

OBJECTIVE: To compare pregnancy prevalence and complications in women with and without multiple sclerosis (MS). METHODS: This retrospective US administrative claims study used data from January 1, 2006, to June 30, 2015. All data for women with MS were included. A nationally representative 5% random sample from approximately 58 million women without MS was used to compute the dataset. Annual pregnancy rates, identified via diagnosis/procedure codes and adjusted for covariates, were estimated via logistic regression. Claims for pregnancy and labor/delivery complications were compared using propensity score matching. RESULTS: From 2006 to 2014, the adjusted proportion of women with MS and pregnancy increased from 7.91% to 9.47%; the adjusted proportion without MS and with pregnancy decreased from 8.83% to 7.75%. The difference in linear trend (0.17% increase and 0.15% decrease in per-annum pregnancy rates) was significant (t statistic = 7.8; p < 0.0001). After matching (n = 2,115 per group), a higher proportion of women with MS than without had claims for premature labor (31.4% vs 27.4%; p = 0.005), infection (13.3% vs 10.9%; p = 0.016), cardiovascular disease (3.0% vs 1.9%; p = 0.028), anemia/acquired coagulation disorders (2.5% vs 1.3%; p = 0.007), neurologic complications (1.6% vs 0.6%; p = 0.005), sexually transmitted diseases (0.4% vs 0.1%; p = 0.045), acquired fetal damage (27.8% vs 23.5%; p = 0.002), and congenital fetal malformations (13.2% vs 10.3%; p = 0.004). CONCLUSIONS: Pregnancy rates in this population of women with MS have been increasing. High rates of claims for several peripartum complications were observed in women with and those without MS. Claims data provide knowledge of interactions patients have with the health care system and are valuable initial exploratory analyses.

Cost-consequence analysis of antibiotic-impregnated shunts and external ventricular drains in hydrocephalus.

OBJECT: Despite multiple preventive strategies for reducing infection, up to 15% of patients with shunt catheters and 27% of patients with external ventricular drains (EVDs) may develop an infection. There are few data on the cost-effectiveness of measures to prevent hydrocephalus catheter infection from the hospital perspective. The objective of this study was to perform a cost-consequence analysis to assess the potential clinical and economic value of antibiotic-impregnated catheter (AIC) shunts and EVDs compared with non-AIC shunts and EVDs in the treatment of hydrocephalus from a hospital perspective. METHODS: The authors used decision analytical techniques to assess the clinical and economic consequences of using antibiotic-impregnated shunts and EVDs from a hospital perspective. Model inputs were derived from the published, peer-reviewed literature. Clinical studies comparing infection rates and the clinical and economic impact of infections associated with the use of AICs and standard catheters (non-AICs) were evaluated. Outcomes assessed included infections, deaths due to infection, surgeries due to infection, and cost associated with shunt- and EVD-related infection. A subanalysis using only AIC shunt and EVD Level I evidence (randomized controlled trial results) was conducted as an alternate to the cumulative analysis of all of the AIC versus non-AIC studies (13 of the 14 shunt studies and 4 of the 6 EVD studies identified were observational). Sensitivity analyses were conducted to determine how changes in the values of uncertain parameters affected the results of the model. RESULTS: In 100 patients requiring shunts, AICs may be associated with 0.5 fewer deaths, 71 fewer hospital days, 11 fewer surgeries, and $128,228 of net savings in hospital costs due to decreased infection. Results of the subanalysis showed that AICs may be associated with 1.9 fewer deaths, 1611 fewer hospital days, 25 fewer surgeries, and $346,616 of net savings in hospital costs due to decreased infection. The rate of decrease in infection with AIC shunts was shown to have the greatest impact on the cost savings realized with use of AIC shunts. In 100 patients requiring EVDs, AICs may be associated with 2.7 fewer deaths and 82 fewer hospital days due to infection. The relative risk of more severe neurological impairment was estimated to be 5.33 times greater with EVD infection. Decreases in infection with AIC EVDs resulted in an estimated $264,069 of net savings per 100 patients treated with AICs. Results of the subanalysis showed that AIC EVDs may be associated with 1.0 fewer deaths, 31 infection-related hospital days averted, and $74,631 saved per 100 patients treated with AIC EVDs. As was seen with AIC shunts, the rate of decrease in infection with AIC EVDs was shown to have the greatest impact on the cost savings realized with use of AIC EVDs. CONCLUSIONS: The current value analysis demonstrates that evidence supports the use of AICs as effective and potentially cost-saving treatment.

The role of decision analytic modeling in the health economic assessment of spinal intervention.

STUDY DESIGN: Narrative review. OBJECTIVE: To review the common tenets, strengths, and weaknesses of decision modeling for health economic assessment and to review the use of decision modeling in the spine literature to date. SUMMARY OF BACKGROUND DATA: For the majority of spinal interventions, well-designed prospective, randomized, pragmatic cost-effectiveness studies that address the specific decision-in-need are lacking. Decision analytic modeling allows for the estimation of cost-effectiveness based on data available to date. Given the rising demands for proven value in spine care, the use of decision analytic modeling is rapidly increasing by clinicians and policy makers. METHODS: This narrative review discusses the general components of decision analytic models, how decision analytic models are populated and the trade-offs entailed, makes recommendations for how users of spine intervention decision models might go about appraising the models, and presents an overview of published spine economic models. RESULTS: A proper, integrated, clinical, and economic critical appraisal is necessary in the evaluation of the strength of evidence provided by a modeling evaluation. As is the case with clinical research, all options for collecting health economic or value data are not without their limitations and flaws. There is substantial heterogeneity across the 20 spine intervention health economic modeling studies summarized with respect to study design, models used, reporting, and general quality. There is sparse evidence for populating spine intervention models. Results mostly showed that interventions were cost-effective based on $100,000/quality-adjusted life-year threshold. Spine care providers, as partners with their health economic colleagues, have unique clinical expertise and perspectives that are critical to interpret the strengths and weaknesses of health economic models. CONCLUSION: Health economic models must be critically appraised for both clinical validity and economic quality before altering health care policy, payment strategies, or patient care decisions. LEVEL OF EVIDENCE: 4.

The threshold rate of oral atypical anti-psychotic adherence at which paliperidone palmitate is cost saving.

OBJECTIVE: To identify, estimate, and compare 'real world' costs and outcomes associated with paliperidone palmitate compared with branded oral atypical anti-psychotics, and to estimate the threshold rate of oral atypical adherence at which paliperidone palmitate is cost saving. METHODS: Decision analytic modeling techniques developed by Glazer and Ereshefsky have previously been used to estimate the cost-effectiveness of depot haloperidol, LAI risperidone, and, more recently, LAI olanzapine. This study used those same techniques, along with updated comparative published clinical data, to evaluate paliperidone palmitate. Adherence rates were based on strict Medication Event Monitoring System (MEMS) criteria. The evaluation was conducted from the perspective of US healthcare payers. RESULTS: Paliperidone palmitate patients had fewer mean annual days of relapse (8.7 days; 6.0 requiring hospitalization, 2.7 not requiring hospitalization vs 17.8 days; 12.4 requiring hospitalization, 5.4 not requiring hospitalization), and lower annual total cost ($20,995) compared to oral atypicals (mean $22,481). Because paliperidone palmitate was both more effective and less costly, it is considered economically dominant. Paliperidone palmitate saved costs when the rate of adherence of oral atypical anti-psychotics was below 44.9% using strict MEMS criteria. Sensitivity analyses showed results were robust to changes in parameter values. For patients receiving 156 mg paliperidone palmitate, the annual incremental cost was $1216 per patient (ICER = $191 per day of relapse averted). Inclusion of generic risperidone (market share 18.6%) also resulted in net incremental cost for paliperidone palmitate ($120; ICER = $13). Limitations of this evaluation include use of simplifying assumptions, data from multiple sources, and generalizability of results. CONCLUSIONS: Although uptake of LAIs in the US has not been as rapid as elsewhere, many thought leaders emphasize their importance in optimizing outcomes in patients with adherence problems. The findings of this analysis support the cost-effectiveness of paliperidone palmitate in these patients.

Comparing the cost-effectiveness of disease-modifying drugs for the first-line treatment of relapsing-remitting multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) is an inflammatory autoimmune disorder of the central nervous system that primarily afflicts young adults. Approximately 400,000 people in the United States are affected by MS. Although several forms of MS exist, the most common course is known as relapsing-remitting MS (RRMS), which affects about 85% of MS patients. This form of MS is characterized by relapses of neurologic symptoms followed by periods of recovery. Progression of disease can lead to increasingly severe disability. Since the introduction of immunomodulatory biologic agents, such as interferon betas and glatiramer acetate, treatment has helped to change the course of the disease. Under budgetary constraints, health services payers are challenged to differentiate the economic value of these agents for formulary selection and/or placement. OBJECTIVE: The primary objective of this analysis was to evaluate the 2-year cost-effectiveness of 4 disease modifying drugs (DMDs) used as first-line treatment of RRMS: glatiramer acetate, interferon (IFN) Beta-1a IM injection, IFN Beta-1a SC injection, and IFN Beta-1b SC injection. METHODS: An Excel-based model was developed to compare the relative effectiveness and cost components of relapses, disability progression, and DMDs in the treatment of RRMS over a 2-year time horizon. The relative risk reduction (RRR) method was used to compare reduction in relapse rates and disease progression data from pivotal randomized double-blind placebo-controlled clinical trials of the DMDs. RRRs for relapses and disability progression, respectively, were calculated as the relative difference (treatment vs. placebo) in relapse rates and disease progression rates from placebo-controlled clinical trials. These RRRs were applied to the weighted average rates of relapse and number of disability progression steps seen in the placebo arms of the pivotal studies. The evaluation was conducted from the perspective of a U.S. health care payer (only direct medical costs considered). Medical savings were calculated as costs saved due to relapses avoided and prevention in disability progression steps. In the base case analysis, we assumed 89.4% persistence, a cost per relapse of $4,682, and a cost per disability progression step of $1,788. Monthly cost of therapy was defined as wholesale acquisition cost ($0 contractual discounts and $25 patient copayment assumed in the base case analysis) plus routine monitoring costs as assessed by an expert panel. The primary economic endpoint was cost per relapse avoided. Costs and outcomes occurring in the second year were discounted 3% to bring to 2008 present values. Oneway and multiway probabilistic (Monte Carlo) sensitivity analyses were conducted on key input variables to assess their impact on cost per relapse avoided. RESULTS: Without DMD treatment, patients were predicted to experience 2.55 relapses and 0.44 disability progression steps over a 2-year period (discounted values). The 2-year reductions in clinical relapses for treatment with glatiramer acetate, IFN Beta-1a IM injection, IFN Beta-1a SC injection, and IFN Beta-1b were 0.66, 0.42, 0.74, and 0.70, respectively. The 2-year reductions in disability progression steps for treatment with glatiramer acetate, IFN Beta-1a IM injection, IFN Beta-1a SC injection, and IFN Beta-1b were 0.05, 0.15, 0.12, and 0.11, respectively. In the base case analysis, IFN Beta-1a SC injection, IFN Beta-1b SC injection, and glatiramer acetate had the most favorable costs per relapse avoided ($80,589; $87,061; and $88,310; respectively) and IFN Beta-1a IM injection had the least favorable cost-effectiveness ratio ($141,721 per relapse avoided). Sensitivity analyses showed that these results were robust to changes in key input parameters, such as the number of relapses and disease progression steps in untreated patients, the RRR in clinical relapse and progression rates, the rate of persistence, the average cost of relapse, and the average cost of a disease progression step. CONCLUSION: This evaluation suggests that IFN Beta-1a SC injection, IFN Beta-1b SC injection, and glatiramer acetate represent the most cost-effective DMDs for the treatment of RRMS, where cost-effectiveness is defined as cost per relapse avoided, assuming that (a) the RRR in relapses and disease progression steps calculated from multiple DMD placebo-controlled clinical trials reflect real differences among DMDs over 2 years; and (b) resource unit costs derived from published sources reflect economic consequences of relapses and disease progression.

One-year clinical and economic consequences of oral atypical antipsychotics in the treatment of schizophrenia.

OBJECTIVE: To assess the clinical and economic consequences of oral atypical antipsychotic treatment (aripiprazole, olanzapine, paliperidone ER, quetiapine, risperidone, and ziprasidone) in schizophrenia over one-year from a US healthcare system perspective. METHODS: The decision model captured rates of discontinuation, symptom response, frequency and duration of relapse, adverse events (extrapyramidal symptoms and weight gain), resource utilization, and unit costs. Published randomized, double-blind, placebo-controlled clinical trial data were used to obtain response rates for comparators. Published clinical trial data from long-term effectiveness trials reflective of typical clinical settings were used for time on therapy, rates of discontinuation, likelihood of switching, relapse rates, and adverse event rates. Drug costs were based on Wholesale Acquisition Cost weighted by Wolters Kluwer Retail and First Databank Pricing drug utilization data. PharMetrics Patient-Centric database was utilized for length of stay, frequency of relapse, and unit cost of healthcare resource data. A clinical expert panel provided resource-use information not available in published literature or healthcare databases. To test the robustness of the findings, sensitivity analyses were performed using plausible ranges of key model input parameters. RESULTS: The model estimated that, over 1 year, clinical outcomes of patients administered oral atypical antipsychotics would not vary considerably. This is partly due to differences 'washing out' because of frequent switching and discontinuation of medication. Economic outcomes did vary among pharmacotherapies: paliperidone ER was associated with cost savings in direct medical costs per patient per year compared to risperidone (cost savings using paliperidone ER vs. risperidone: $793), quetiapine ($1191), olanzapine ($1259), ziprasidone ($2159), and aripiprazole ($2204)). Limitations of this analysis include the absence of direct head-to-head long-term comparative data for antipsychotics. However, the results of the decision analysis held true when tested through a multitude of sensitivity analyses. CONCLUSION: This modeling study showed that paliperidone ER had the most favorable clinical and economic outcomes compared to other oral atypical antipsychotics for patients with schizophrenia. The analysis supports the notion that frequent discontinuation of medication is a problem with all oral antipsychotic treatments for schizophrenia.

Cost-effectiveness model of long-acting risperidone in schizophrenia in the US.

BACKGROUND: Schizophrenia is a devastating and costly illness that affects 1% of the population in the US. Effective pharmacological therapies are available but suboptimal patient adherence to either acute or long-term therapeutic regimens reduces their effectiveness. The availability of a long-acting injection (LAI) formulation of risperidone may increase adherence and improve clinical and economic outcomes for people with schizophrenia. OBJECTIVE: To assess the cost effectiveness of risperidone LAI compared with oral risperidone, oral olanzapine and haloperidol decanoate LAI over a 1-year time period in outpatients with schizophrenia who had previously suffered a relapse requiring hospitalisation. PERSPECTIVE: US healthcare system. METHODS: Published medical literature, unpublished data from clinical trials and a consumer health database, and a clinical expert panel were used to populate a decision-analysis model comparing the four treatment alternatives. The model captured: rates of patient compliance; rates, frequency and duration of relapse; incidence of adverse events (bodyweight gain and extrapyramidal effects); and healthcare resource utilisation and associated costs. Primary outcomes were: the proportion of patients with relapse; the frequency of relapse per patient; the number of relapse days per patient; and total direct medical cost per patient per year. Costs are in year 2002 US dollars. RESULTS: Based on model projections, the proportions of patients experiencing a relapse requiring hospitalisation after 1 year of treatment were 66% for haloperidol decanoate LAI, 41% for oral risperidone and oral olanzapine and 26% for risperidone LAI, while the proportion of patients with a relapse not requiring hospitalisation were 60%, 37%, 37% and 24%, respectively. The mean number of days of relapse requiring hospitalisation per patient per year was 28 for haloperidol decanoate LAI, 18 for oral risperidone and oral olanzapine and 11 for risperidone LAI, while the mean number of days of relapse not requiring hospitalisation was 8, 5, 5 and 3, respectively. This would translate into direct medical cost savings with risperidone LAI compared with oral risperidone, oral olanzapine and haloperidol decanoate LAI of USD 397, USD 1742, and USD 8328, respectively. These findings were supported by sensitivity analyses. CONCLUSION: The use of risperidone LAI for treatment of outpatients with schizophrenia is predicted in this model to result in better clinical outcomes and lower total healthcare costs over 1 year than its comparators, oral risperidone, oral olanzapine and haloperidol decanoate LAI. Risperidone LAI may therefore be a cost saving therapeutic option for outpatients with schizophrenia in the US healthcare setting.

Cost effectiveness of long-acting risperidone injection versus alternative antipsychotic agents in patients with schizophrenia in the USA.

The availability of long-acting risperidone injection may increase adherence and lead to improved clinical and economic outcomes for individuals with schizophrenia. The objective of this study was to assess the cost effectiveness of long-acting risperidone, oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot in patients with schizophrenia over 1 year from a healthcare system perspective. Published medical literature, unpublished data from clinical trials and a consumer health database, and a clinical expert panel were utilized to populate a decision analytical model comparing the seven treatment alternatives. The model captured rates of patient compliance, the rates, frequency and duration of relapse, incidence of adverse events, and healthcare resource utilization and associated costs. Primary outcomes were expressed in terms of percentage of patients relapsing per year, number of relapse days per year (number and duration of relapses per patient per year), and total direct 2003 medical cost per patient per year. On the basis of model projections, the proportions of patients experiencing a relapse requiring hospitalization in 1 year were 66% for haloperidol depot, 41% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 26% for long-acting risperidone, whereas the proportions of patients with an exacerbation not requiring hospitalization were 60% for haloperidol depot, 37% for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 24% for long-acting risperidone. The mean number of days of relapse requiring hospitalization per patient per year were 28 for haloperidol depot, 18 for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and 11 for long-acting risperidone, whereas the mean number of days of exacerbation not requiring hospitalization were eight for haloperidol depot, five for oral risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole, and three for long-acting risperidone. This would translate into direct medical cost savings with long-acting risperidone compared with oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot of US dollars 161, 1425, 508, 259, 1068, and 8224, respectively. These findings were supported by sensitivity analyses. The utilization of long-acting risperidone is predicted to result in better clinical outcomes and lower total healthcare costs than its comparators, oral risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and haloperidol depot. Long-acting risperidone may therefore be a cost saving therapeutic option for patients with schizophrenia.