Comparative Effectiveness of Tofacitinib and Adalimumab in Axial Spondyloarthritis: A Real-World Clinical Context Multicenter Study.

INTRODUCTION: Tofacitinib, an oral Janus kinase inhibitor, is a putative choice in the treatment of axial spondyloarthritis (AxSpA). The objective of this study was to compare the effectiveness and tolerability of tofacitinib with adalimumab, in AxSpA, in a real-world clinical setting. METHODS: In this multicentric medical records review study, adult patients with active AxSpA treated with either tofacitinib 5 mg twice daily or adalimumab 40 mg subcutaneously fortnightly were recruited. Effectiveness was measured with Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Drug-cost analysis was calculated with Incremental Cost-Effectiveness Ratio (ICER drug ). RESULTS: Among the 266 patients, 135 were treated with tofacitinib and 131 with adalimumab (follow-up: 6.5 ± 1.6 months). Mean improvement of BASDAI (3.39 ± 0.09 vs. 3.14 ± 1.16, respectively) and that of ASDAS (1.78 ± 0.68 vs. 2.07 ± 2.08, respectively) were comparable between the adalimumab and tofacitinib groups. A higher proportion of patients achieved BASDAI50 response in the second (49.5% vs. 31.6%) and fourth month (83.9% vs. 62.8%) and ASDAS low disease activity in the fourth month (71.6% vs. 47.9%) in the adalimumab group. All disease activity measurements were similar by the sixth month in both groups. A higher proportion of patients in the tofacitinib group than in the adalimumab group required change in therapy (14.8% vs. 7.6%, respectively). ICER drug for adalimumab compared with tofacitinib was US $188.8 per patient in the adalimumab group for each person-month with BASDAI <4. CONCLUSIONS: Tofacitinib showed comparable effectiveness with adalimumab in patients with AxSpA at the sixth month, despite lesser response in the initial months, with favorable ICER drug .

Cost-effectiveness analysis and effectiveness of pharmacist-managed outpatient clinics in Helicobacter pylori eradication therapy.

BACKGROUND: Helicobacter pylori is involved in many upper gastrointestinal diseases such as peptic ulcers and gastric cancers. In this study, we compared the cost-effectiveness of lansoprazole and vonoprazan in H. pylori eradication therapy and examined the effectiveness of pharmacist-managed outpatient clinics. METHODS: We investigated the efficacy and cost-effectiveness of pharmacist-managed outpatient clinics in H. pylori eradication therapy at our hospital from January 2015 to December 2017. The subjects were classified into three groups: lansoprazole group; vonoprazan group; and the medication instruction group, which received instructions at the pharmacist-managed outpatient clinics (intervention group). We examined the eradication rate and cost-effectiveness ratio of each group. RESULTS: The eradication rate of primary eradication therapy was 75.2% in the lansoprazole group, 87.8% in the vonoprazan group and 91.4% in the intervention group. When mental component summary was used as quality of life score, cost-effectiveness ratio was 224.7 yen in lansoprazole group, 223.9 yen in vonoprazan group and 222.2 yen in intervention group. Setting up pharmacist-managed outpatient clinics increases the pharmacist labour cost necessary for eradication therapy. However, if the medication instructions provided by the pharmacist can lead to improved disinfection efficiency, improvement in cost efficiency can be expected. CONCLUSION: Although medication instructions provided at the pharmacist-managed outpatient clinics incur additional labour costs, they improve patient quality of life as well as disinfection rate in H. pylori eradication therapy. Therefore, pharmacist-managed outpatient clinics are useful from the viewpoint of pharmacoeconomics.

Budget impact of introducing tofacitinib to the public hospital formulary in Hong Kong, 2017-2021.

INTRODUCTION: As the first approved oral kinase inhibitor, tofacitinib is effective and well-tolerated, but more expensive than conventional treatments for uncontrolled rheumatoid arthritis. Public formulary listing typically exerts a positive impact on the uptake of new drugs. We aimed to assess the budgetary impact of introducing tofacitinib into the Hospital Authority Drug Formulary as a fully subsidised drug in Hong Kong. METHODS: We applied a population-based budget impact model to trace the number of eligible patients receiving biologics or tofacitinib treatment, then estimated the 5-year healthcare expenditure on rheumatoid arthritis treatments, with or without tofacitinib (2017-2021). We used linear regression to estimate the number of target patients and compound annual growth rate to estimate market share. Competing treatments included abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, and tofacitinib. Retail price was used for drug costs, valued in Hong Kong dollars (HK$) in 2017 and discounted at 4% per year. RESULTS: The annual treatment cost of tofacitinib was HK$74 214 per patient, and the costs of biologics ranged from HK$64 350 to HK$115 700. Without tofacitinib, the annual government health expenditures for rheumatoid arthritis treatment were estimated to increase from HK$147.9 million (2017) to HK$190.6 million (2021). The introduction of tofacitinib to the formulary would reduce healthcare expenditures by 17.3% to 20.3% per year, with cumulative savings of HK$192.8 million; this change was estimated to provide consistent savings (HK$66.4 million to HK$196.8 million) in all tested scenarios. CONCLUSION: Introduction of tofacitinib to the formulary will provide 5-year savings, given the current drug price and patient volume.

Estimated medical expenditure and risk of job loss among rheumatoid arthritis patients undergoing tofacitinib treatment: post hoc analyses of two randomized clinical trials.

Objectives: RA causes high disability levels and reduces health-related quality of life, triggering increased costs and risk of unemployment. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. These post hoc analyses of phase 3 data aimed to assess monthly medical expenditure (MME) and risk of job loss for tofacitinib treatment vs placebo. Methods: Data analysed were from two randomized phase 3 studies of RA patients (n = 1115) with inadequate response to MTX or TNF inhibitors (TNFi) receiving tofacitinib 5 or 10 mg twice daily, adalimumab (one study only) or placebo, in combination with MTX. Short Form 36 version 2 Health Survey physical and mental component summary scores were translated into predicted MME via an algorithm and concurrent inability to work and job loss risks at 6, 12 and 24 months, using Medical Outcomes Study data. Results: MME reduction by month 3 was $100 greater for tofacitinib- than placebo-treated TNFi inadequate responders (P < 0.001); >20 and 6% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾16%, and risk of future job loss decreased ∼20% (P < 0.001 vs placebo). MME reduction by month 3 was $70 greater for tofacitinib- than placebo-treated MTX inadequate responders (P < 0.001); ⩾23 and 13% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾31% and risk of future job loss decreased ⩾25% (P < 0.001 vs placebo). Conclusion: Tofacitinib treatment had a positive impact on estimated medical expenditure and risk of job loss for RA patients with inadequate response to MTX or TNFi.

Analysis of the cost-effectiveness of using vonoprazan-amoxicillin-clarithromycin triple therapy for first-line Helicobacter pylori eradication.

BACKGROUND: Vonoprazan (VPZ)-based triple therapy has been reported to have greater efficacy than a proton pump inhibitor (PPI)-based triple therapy for Helicobacter pylori (H. pylori) eradication. However, because VPZ is more expensive than PPIs such as rabeprazole (RPZ), economic evaluation is essential. METHODS: We performed a retrospective study on 209 patients who underwent first-line eradication of H. pylori infection in Fuyoukai Murakami Hospital from 1 March 2015 to 31 March 2016. Patients who received VPZ, amoxicillin (AMPC) and clarithromycin (CAM) were assigned to the VPZ/AC group (n = 111) and patients who received RPZ, AMPC and CAM to the RPZ/AC group (n = 98). We compared the patients' backgrounds, including age, gender, use of high-dose CAM, past history of peptic ulcer, smoking and drug-related adverse events between the two groups. We defined cost as direct medical costs per patient and effectiveness as the first-line eradication rate in the intention-to-treat (ITT) analysis and analyzed the cost-effectiveness using the cost-effectiveness ratio (CER) and incremental cost-effectiveness ratio (ICER). RESULTS: There was no significant difference in the patients' backgrounds. The ITT analysis revealed an eradication rate of 94.6% for VPZ/AC and 86.7% for RPZ/AC. VPZ/AC cost 1155.4 Japanese yen (JPY) higher than RPZ/AC (34063.4 vs. 32908.0, JPY). CER of VPZ/AC was less than that of RPZ/AC (360.1 vs. 379.4, JPY per percent) and ICER of VPZ/AC was 147.0 JPY (1.28 Euro (EUR), 1 EUR =115 JPY) per percent. CONCLUSIONS: VPZ/AC was more cost-effective than RPZ/AC as first-line therapy for H. pylori eradication.

Services provided by community pharmacies in Wayne County, Michigan: a comparison by ZIP code characteristics.

OBJECTIVE: To document the availability of selected pharmacy services and out-of-pocket cost of medication throughout a diverse county in Michigan and to assess possible associations between availability of services and price of medication and characteristics of residents of the ZIP codes in which the pharmacies were located. DESIGN: Cross-sectional telephone survey of pharmacies coupled with ZIP code-level census data. SETTING: 503 pharmacies throughout the 63 ZIP codes of Wayne County, MI. MAIN OUTCOME MEASURES: The out-of-pocket cost for a 30 days' supply of levothyroxine 50 mcg and brand-name atorvastatin (Lipitor-Pfizer) 20 mg, availability of discount generic drug programs, home delivery of medications, hours of pharmacy operation, and availability of pharmacy-based immunization services. Census data aggregated at the ZIP code level included race, annual household income, age, and number of residents per pharmacy. RESULTS: The overall results per ZIP code showed that the average cost for levothyroxine was $10.01 ± $2.29 and $140.45 + $14.70 for Lipitor. Per ZIP code, the mean (± SD) percentages of pharmacies offering discount generic drug programs was 66.9% ± 15.0%; home delivery of medications was 44.5% ± 22.7%; and immunization for influenza was 46.7% ± 24.3% of pharmacies. The mean (± SD) hours of operation per pharmacy per ZIP code was 67.0 ± 25.2. ZIP codes with higher household income as well as higher percentage of residents being white had lower levothyroxine price, greater percentage of pharmacies offering discount generic drug programs, more hours of operation per week, and more pharmacy-based immunization services. The cost of Lipitor was not associated with any ZIP code characteristic. CONCLUSION: Disparities in the cost of generic levothyroxine, the availability of services such as discount generic drug programs, hours of operation, and pharmacy-based immunization services are evident based on race and household income within this diverse metropolitan county.

Trends in statin consumption and cardiovascular mortality in Croatia 2004-2012.

Prescribing of statins showed an increasing trend in all developed countries, during the last two decades. The aim of this study was to research the trends in statin consumption in the period from 2004 to 2012 as well as trends of cardiovascular mortality during the 1990 to 2012 period, and to compare them between Croatia and several neighbouring countries. Data on statin expenditures and consumption expresed in defined daily doses per 1000 inhabitants per day (DDD/TID), were taken from annual reports of Croatian Agency for Medicinal Products and Medical Devices (HALMED). Data on crude mortality rates and standardized cardiovascular mortality rates, were taken from the Croatian Health Statistics Yearbooks. The utilization of statins increased by 196.7% during the observed period, with the highest consumption of atorvastatin and simvastatin. Financial expenditure of statins expanded at much faster rate in comparison with overall drug costs. Cardiovascular mortality rates decreased slightly, while maintaining higher level in comparison with some neighbouring countries.

Cost analysis of S1 and XELOX as adjuvant therapy for gastric cancer.

Both S1 and XELOX (capecitabine+oxaliplatin) have been recommended as an adjuvant treatment for gastric cancer according to the guidelines of the National Comprehensive Cancer Network (NCCN). This study compared the two regimens in terms of monetary costs, assuming equal efficacy of both regimens. Chemotherapy cost data of 188 patients were collected from the medical records, 91 for the S1 group and 97 for XELOX. Costs were classified as direct costs (chemotherapy, hospitalization, venous access, and tests), adverse event-related treatments costs, and societal (travel and time) costs. The total direct costs of S1 and XELOX per cycle per patient were $1938±236 and $2317±315, respectively. S1 cost $27 and $9 less than XELOX on total adverse event-related costs and societal costs, respectively. The total costs of S1 and XELOX were $1994±322 versus $2410±391 per cycle per patient, respectively. The total cost of S1 was 17.3% less than that of XELOX for the average patient. All the differences were statistically significant. S1, compared with XELOX, could be a more affordable option as an adjuvant treatment for gastric cancer when all healthcare resources are taken into account in China.

Generic atorvastatin, the Belgian statin market and the cost-effectiveness of statin therapy.

PURPOSE: This study examines how the market entry of generic atorvastatin influences the Belgian statin market and the cost-effectiveness of statin therapy. METHODS: Using IMS Health data, the Belgian 2000-2011 statin market was analyzed in terms of total expenditure, annual price of statin treatment, and patient numbers. A simulation analysis projected statin market shares from 2012 to 2015 following market entry of generic atorvastatin. This analysis was based on three scenarios regarding the number of patients taking specific statins. Savings associated with an atorvastatin price reduction of 50-70 % were calculated. A literature review of economic evaluations assessed the cost-effectiveness of generic atorvastatin. RESULTS: Statin expenditure increased from €113 million in 2000 to €285 million in 2011 due to higher expenditure on atorvastatin and rosuvastatin. Although the number of patients treated with simvastatin increased by nearly 800 %, the resulting increase in expenditure was partially offset by price reductions. Atorvastatin is projected to become the dominant product in the Belgian statin market (market share of 47-66 % by 2015). Annual savings would attain €108.6-€153.7 million for a 50 % reduction in the atorvastatin price and €152.0-€215.2 million for a 70 % price reduction. The literature suggests that generic atorvastatin is cost-effective as compared to simvastatin. The limited evidence about the cost-effectiveness of rosuvastatin as compared with generic atorvastatin is inconclusive. CONCLUSIONS: Generic atorvastatin is cost-effective as compared to simvastatin, is projected to become the dominant product in the Belgian statin market and is expected to generate substantial savings to health care payers.

The STAR trial protocol: a randomised multi-stage phase II/III study of Sunitinib comparing temporary cessation with allowing continuation, at the time of maximal radiological response, in the first-line treatment of locally advanced/metastatic renal cancer.

BACKGROUND: Over recent years a number of novel therapies have shown promise in advanced renal cell carcinoma (RCC). Internationally the standard of care of first-line therapy is sunitinib™, after a clear survival benefit was demonstrated over interferon-α. Convention dictates that sunitinib is continued until evidence of disease progression, assuming tolerability, although there is no evidence that this approach is superior to intermittent periods of treatment. The purpose of the STAR trial is to compare the standard treatment strategy (conventional continuation strategy, CCS) with a novel drug free interval strategy (DFIS) which includes planned treatment breaks. METHODS/DESIGN: The STAR trial is an NIHR HTA-funded UK pragmatic randomised phase II/III clinical trial in the first-line treatment of advanced RCC. Participants will be randomised (1:1) to either a sunitinib CCS or a DFIS. The overall aim of the trial is to determine whether a DFIS is non-inferior, in terms of 2-year overall survival (OS) and quality adjusted life years (QALY) (averaged over treatment and follow up), compared to a CCS. The QALY primary endpoint was selected to assess whether any detriment in terms of OS could be balanced with improvements in quality of life (QoL). This is a complex trial with a number of design challenges, and to address these issues a feasibility stage is incorporated into the trial design. Predetermined recruitment (stage A) and efficacy (stage B) intermediary endpoints must be met to allow continuation to the overall phase III trial (stage C). An integral qualitative patient preference and understanding study will occur alongside the feasibility stage to investigate patients' feelings regarding participation or non-participation in the trial. DISCUSSION: The optimal duration of continuing sunitinib in advanced RCC is unknown. Novel targeted therapies do not always have the same constraints to treatment duration as standard chemotherapeutic agents and currently there are no randomised data comparing different treatment durations. Incorporating planned treatment breaks has the potential to improve QoL and cost effectiveness, hopefully without significant detriment on OS, as has been demonstrated in other cancer types with other treatments. TRIAL REGISTRATION: Controlled-trials.com ISRCTN 06473203.

Clinical consequences following regulatory changes in respect to reimbursement of statins cost by the Icelandic Social Insurance Administration.

INTRODUCTION: On 1 March 2009, a new reimbursement system was introduced by the Ministry of Health of Iceland regarding drugs to treat hyperlipidaemia. The Social Insurance Administration was only authorised to reimburse 10 and 20 mg simvastatin unless patients were eligible to receive a medical card from the Social Insurance Administration. The purpose of this study was to evaluate the influence of this reimbursement regulation on the clinical outcome. MATERIALS AND METHODS: Patients that received hyperlipidaemia treatment and were admitted to the cardiac ward were enrolled. The criteria were that the patients had been admitted 1 year prior to the regulation change and were using other statins than simvastatin. RESULTS: Out of 233 eligible patients 170 (73%) reached the treatment goal before the switch. After the switch, only 126 (54%) reached their goal (p<0.05). Total cholesterol was found to be increased after the switch by a mean of 0.48 mmol/l (range 3.90-5.53 mmol/l, p<0.001). Low-density lipoprotein cholesterol increased by a mean of 0.48 mmol/l (range 1.62-3.11, p<0.001). The level of triglycerides did not change significantly. Before the introduction of the new regulations, 73% of subjects were well controlled, but after 1 March 2009, this figure dropped to 46% (37% decrease). CONCLUSIONS: In order to lower costs for subsidising drugs, a switch to simvastatin from other cholesterol-lowering drugs was implemented (by the Ministry of Health of Iceland). The result was a significant and unwanted increase in cholesterol levels among patients with heart disease. The reason seems to be inaccurate prescriptions due to lack of competence among physicians and pharmacists. The use of "one drug fits all" does not comply here.

Impact of out-of-pocket expenses on discontinuation of statin therapy: a cohort study in Finland.

WHAT IS KNOWN AND OBJECTIVE: Out-of-pocket expenses of drug therapy may negatively affect adherence. We aimed to analyse 1-year discontinuation rates between cohorts initiating therapy with either generic simvastatin or non-generic atorvastatin. METHODS: Statin-naìve initiators of atorvastatin and generic simvastatin in April-June 2003, and corresponding cohorts in 2005, were identified through the nationwide Finnish prescription register. Persistence with statin therapy was followed for 365 days, considering the treatment to have been discontinued when the tablet-free gap between two consecutive refills exceeded 90 days. Using multivariate-adjusted logistic regression, odds ratios (OR) for discontinuation associated with initiating with simvastatin vs. atorvastatin were estimated separately for each year. RESULTS AND DISCUSSION: In the year 2003, 5838 persons initiated treatment with atorvastatin and 5644 with generic simvastatin. In the year 2005, the respective numbers were 5228 and 10 987. Soon after the introduction of generic substitution in 2003, there was no difference in the risk of discontinuation between the comparator groups [OR 0·97, 95% confidence interval (CI) 0·89-1·05]. Two years later, persons initiating with generic simvastatin were 20% less likely to discontinue statin therapy (OR 0·80; 95% CI 0·74-0·83). Among persons whose medicinal costs were almost completely reimbursed towards the end of the initiation year, the OR was 1·14 (95% CI 0·76-1·64, P = 0·033 for interaction). WHAT IS NEW AND CONCLUSIONS: We found that lower out-of-pocket expenses associated with the initiating statin had a positive impact on persistence with therapy. The finding does not seem to apply to persons with minor copayments towards the end of the initiation year.

Economic evaluation of new targeted therapies for the first-line treatment of patients with metastatic renal cell carcinoma.

OBJECTIVE: • To assess the economic value of targeted therapies as first-line metastatic renal cell carcinoma (mRCC) treatment in the US and Sweden by indirect comparison of survival data. METHODS: • A Markov model simulated disease progression, adverse events and survival with sunitinib vs sorafenib in the US and bevacizumab plus interferon-α (IFN-α) in both countries. • Results, in life-years (LYs), progression-free LYs (PFLYs), quality-adjusted LYs (QALYs) gained and treatment costs (2008 USD) were obtained through deterministic and probabilistic analyses over the patient's lifetime. RESULTS: • Sunitinib was more effective and less costly than sorafenib (gains of 0.52 PFLYs, 0.16 LYs and 0.17 QALYs and savings/patient of $13,576 in the US) and bevacizumab plus IFN-α (gains of 0.19 PFLYs, 0.23 LYs and 0.16 QALYs in both countries and savings/patient of $67,798 and $47,264 in the US and Sweden, respectively). • Results were most influenced by hazard ratios for progression-free and overall survival and treatment costs, making results generalizable across other countries if relative costs were to fall within the ranges of those in the US and Sweden. CONCLUSION: • The present analyses suggest that first-line mRCC treatment with sunitinib is a cost-effective alternative to sorafenib and bevacizumab plus IFN-α.

[Analysis of cost-effectiveness of simvastatin versus atorvastatin in the secondary prevention of cardiovascular events within the Brazilian public healthcare system]. / Análise de custo-efetividade da sinvastatina versus atorvastatina na prevenção secundária de eventos cardiovasculares no Sistema Único de Saúde Brasileiro.

OBJECTIVE: The objective of this study is to perform an economic evaluation analyzing the treatment with atorvastatin and simvastatin in comparison to placebo treatment, within the Brazilian Public Healthcare System (SUS) scenario, for patients with high risk of cardiovascular disease; analyzing if the additional cost related to statin treatment is justified by the clinical benefits expected, in terms of cardiovascular event and mortality reduction. METHODS: Cardiovascular event risk and mortality risk were used as outcomes. Statin efficacy at LDL-c and cardiovascular events levels lowering data was obtained from a systematic review of literature. A decision analytic model was developed to perform a cost-effectiveness analysis comparing atorvastatin 10mg/day and simvastatin 40 mg/day to placebo treatment in patients with dyslipidemia in Brazil. The target population of this study was a hypothetic cohort of men and women with a mean age of 50 years old and high risk of cardiovascular disease. The model includes only direct costs obtained from Ambulatory and Hospital Information System and Price Database of Brazilian Ministry of Health. The comparative cost-effectiveness analysis itself was done through Excel spreadsheets covering a 5 -years time horizon. RESULTS: The result shows that atorvastatin 10mg/day in comparison to placebo has higher cost with higher effectiveness in the time horizon of 5 years (Incremental Cost Effectiveness Ratio of R$ 433.065,05 per life year gained). In this scenario atorvastatin is not cost effective in comparison to placebo. The simvastatin 40 mg/day appears to be a strategy with lower cost and higher effectiveness in comparison to placebo, in the time horizon analyzed (5 years). In the multivariate probabilistic sensitivity analysis, simvastatin showed 53% of the results in the quadrant with greater effectiveness and lower cost. CONCLUSIONS: This study is an important tool for public decision makers. The study can be used in the decision process of increasing cardiovascular disease treatment access with budgetary sustainability for Ministry of Health. In comparison to placebo, the results show that sinvastatin is a cost saving strategy while atorvastatin is not cost effective.

Cardiovascular and economic outcomes after initiation of atorvastatin versus simvastatin in an employed population stratified by cardiovascular risk.

The relative effects of atorvastatin and simvastatin among higher- and lower-risk patients are not well characterized. This study compared cardiovascular (CV) risk and direct and indirect costs among higher- and lower-risk employees initiating atorvastatin vs. simvastatin. Using a large employer claims database (1999-2006), employees were stratified as 1) high-risk employees with prior CV events, diabetes, or renal disorders; and 2) low- to intermediate-risk employees without these conditions. Propensity score matching was used, and 2-year outcomes were compared between matched cohorts. Indirect costs included disability payments and medically related absenteeism. Drug costs were imputed with recent prices to account for availability of generic simvastatin. Among 4167 matched pairs of high-risk employees, atorvastatin use was associated with a numerically lower risk of CV events (17.6 versus 18.4%, P = 0.37), higher direct medical costs ($17,590 versus $17,377, P = 0.002), numerically lower indirect costs ($4830 versus $4989, P = 0.29), and higher total costs by $54 ($22,420 versus $22,366, P = 0.034). The majority of high-risk employees (62%) received low initial statin doses (atorvastatin = 10 mg or simvastatin = 20 mg). Among 9326 matched pairs of low- to intermediate-risk employees, atorvastatin use was associated with a lower risk of CV events (3.1% versus 3.7%, P = 0.030), lower direct medical costs ($8400 versus $8436, P < 0.001), numerically lower indirect costs ($2781 versus $2807; P = 0.12), and lower total costs by $61 ($11,181 versus $11,243, P < 0.001). These results suggest that formulary policies reserving atorvastatin for higher-risk patients may not be cost-saving from the employer perspective.

Does bargaining affect Medicare prescription drug plan reimbursements to independent pharmacies?

OBJECTIVE: To examine how pharmacy bargaining activities affect reimbursement rates in Medicare Part D prescription drug plan (PDP) contracts, controlling for pharmacy quality attributes, market structures, and area socioeconomic status. DESIGN: Cross-sectional study. SETTING: Six Medicare regions throughout the United States between October and December 2009. PARTICIPANTS: Random sample of 1,650 independent pharmacies; 321 returned surveys containing sufficient responses for analysis. INTERVENTION: Pharmacies were surveyed regarding PDP reimbursement rates, costs, and cash prices of two popular prescription drugs (atorvastatin calcium [Lipitor-Pfizer] and lisinopril, 1-month supply of a common strength), as well as pharmacy bargaining activities and quality attributes. Data also were used from the National Council for Prescription Drug Programs pharmacy database, the 2000 U. S. Census, and the 2006 Economic Census on local market structures and area socio-economic status. MAIN OUTCOME MEASURE: PDP reimbursement rates. RESULTS: For the brand-name drug atorvastatin calcium, the PDP reimbursement was positively related to a pharmacy's request for a contract change (ß = 0.887, P < 0.05), whereas other bargaining activities were not significantly related to PDP reimbursement. However, for the generic drug lisinopril, no bargaining activities were found to be significantly related to the PDP reimbursement. CONCLUSION: Pharmacy request for a contract change was associated with higher reimbursement rates for the brand-name drug atorvastatin calcium in PDP contracts, after controlling for pharmacy quality attributes, local market structures, and area socioeconomic status; this finding likely applies to other brand-name drugs because of the structure of the contracts. Our results suggest that independent pharmacies are more likely to acquire higher reimbursement rates by engaging in active bargaining with third-party payers.

Impact of restricted reimbursement on the use of statins in Finland: a register-based study.

OBJECTIVES: New and expensive medicines are a driving force behind growth in medicine costs, and policies promoting use of less expensive products have been widely introduced. This study investigated the short-term consequences of the restricted reimbursement of expensive statins (atorvastatin and rosuvastatin) on the use of statins in Finland. METHODS: Data on patients purchasing atorvastatin, rosuvastatin, or simvastatin in 2002-2007 were retrieved from the nationwide Prescription Register. Outcome measures included the time trend in the numbers of purchasers and initiators of different statins, the morbidities of new users before and after the new policy, and the proportion of users of expensive statins switching to other statins. RESULTS: After the restriction, the numbers of purchasers of atorvastatin and rosuvastatin dropped, and atorvastatin and rosuvastatin were seldom prescribed as first-line therapy. Before the restriction, 20.9% of new users of atorvastatin and 18.4% of those of rosuvastatin had either coronary artery disease or familial hyperlipidemia. After the restriction the corresponding figures were 28.7% and 26.8%. After the restriction new users of atorvastatin and rosuvastatin were also more likely to use other cardiovascular medicines or antidiabetics or to have previous statin purchases. A total of 57.6% of those using atorvastatin and 49.2% of those using rosuvastatin before the restriction switched to a less expensive statin. CONCLUSIONS: Restricted reimbursement of expensive statins decreased their use. It seems that after the policy new statin treatments have channeled appropriately. Although it is likely that the cost-containment aim of the policy was reached, health and long-term effects are not known.