Health services utilization with reference drug pricing of histamine(2) receptor antagonists in British Columbia elderly. The impact of reference pricing of nonsteroidal anti-inflammatory agents on the use and costs of analgesic drugs. Cardiovascular outcomes after a change in prescription policy for clopidogrel. Cost analysis of a provincial drug program to guide the treatment of upper gastrointestinal disorders. Effects of an evidence report and policies lifting reimbursement restrictions for acid suppressants: analysis of the Belgian national database. Effects of a prior-authorization policy for celecoxib on medical service and prescription drug use in a managed care Medicaid population. An evaluation of Oregon's evidence-based Practitioner-Managed Prescription Drug Plan. Plan-sponsor savings and member experience with point-of-service prescription step therapy. Retrospective assessment of Medicaid step-therapy prior authorization policy for atypical antipsychotic medications. Medicaid prior-authorization programs and the use of cyclooxygenase-2 inhibitors. Impact of Medicaid prior authorization on angiotensin-receptor blockers: can policy promote rational prescribing? The effects of mandatory prescribing of thiazides for newly treated, uncomplicated hypertension: interrupted time-series analysis. Impact of a criteria-based reimbursement policy on the use of respiratory drugs delivered by nebulizer and health care services utilization in Nova Scotia, Canada. Effect of a prior-authorization requirement on the use of nonsteroidal antiinflammatory drugs by Medicaid patients. Clinical and financial outcomes associated with a proton pump inhibitor prior-authorization program in a Medicaid population. Guidelines accompanied by changes in reimbursement rules. Effects on lipid-lowering drug prescribing. Impact of a limited fluoroquinolone reimbursement policy on antimicrobial prescription claims. Impact of administrative restrictions on antibiotic use and expenditure in Ontario: time series analysis. The effects of coxib formulary restrictions on analgesic use and cost: regional evidence from Canada. Antiulcer prescribing program in a state correctional system. Evaluation of an automated system for prior authorization: a COX-2 inhibitor example. Differential effect of early or late implementation of prior authorization policies on the use of Cox II inhibitors. Use of atypical antipsychotic drugs for schizophrenia in Maine Medicaid following a policy change. Switching statins in Norway after new reimbursement policy: a nationwide prescription study. A therapeutic substitution policy for proton pump inhibitors: clinical and economic consequences. Medicaid prior authorization and controlled-release oxycodone. Effect of prior authorization of second-generation antipsychotic agents on pharmacy utilization and reimbursements.
In October 1995, British Columbia introduced a reference pricing policy for five therapeutic classes of drugs, including histamine(2) receptor antagonists (H(2)RAs), for beneficiaries of its prescription drug program, Pharmacare.
                To evaluate utilization trends in consumption of health services in a cohort of Pharmacare beneficiaries to determine if a worsening of health outcomes could be detected after implementation of the reference pricing policy.
                Two cohorts, "control" (21 months before the reference pricing policy) and "exposed" (at risk for policy effects), were followed for 21 months. Using a longitudinal generalized linear model (Poisson), and controlling for age, sex, and prescriptions in unique drug classes, trend lines in each of these time series were compared for 3 periods: 9 months before policy implementation (or corresponding index date in the control cohort), 6 months after policy implementation, and a subsequent 6-month period.
                Two cohorts, each of size 10,000, were constructed by randomly sampling the population of Pharmacare beneficiaries exposed to H(2)RAs and other antisecretory drugs for 1993 through 1996.
                Prescriptions, physician office visits and associated transactions (ie, laboratory tests), emergency room visits, hospitalizations, hospital length of stay, and vital statistics.
                Differences between periods and between cohorts for health services utilization were not significant or decreased after imposition of the reference pricing policy.
                For these measures, there has been no worsening of health outcomes associated with implementing the reference pricing policy. To estimate the effect of reference pricing (RP) of nonsteroidal anti-inflammatory drugs (NSAIDs) on drug subsidy program and beneficiary expenditures on analgesic drugs.
                Monthly claims data from Pharmacare, the public drug subsidy program for seniors in British Columbia, Canada, over the period of February 1993 to June 2001.
                RP limits drug plan reimbursement of interchangeable medicines to a reference price, which is typically equal to the price of the lowest cost interchangeable drug; any cost above that is borne by the patient. Pharmacare introduced two different forms of RP to the NSAIDs, Type 1 in April 1994 and Type 2 in November 1995. Under Type 1 RP, generic and brand versions of the same NSAID are considered interchangeable, whereas under Type 2 RP different NSAIDs are considered interchangeable. We extrapolated average reimbursement per day of NSAID therapy over the months before RP to estimate what expenditures would have been without the policies. These counterfactual predictions were compared with actual values to estimate the impact of the policies; the estimated impacts on reimbursement rates were multiplied by the postpolicy volume of NSAIDS dispensed, which appeared unaffected by the policies, to estimate expenditure changes.
                After Type 2 RP, program expenditures declined by $22.7 million (CAN), or $4 million (CAN), annually cutting expenditure by about half. Most savings accrued from the substitution of low-cost NSAIDs for more costly alternatives. About 20 percent of savings represented expenditures by seniors who elected to pay for partially reimbursed drugs. Type 1 RP produced one-quarter the savings of type 2 RP.
                Type 2 RP of NSAIDs achieved its goal of reducing drug expenditures and was more effective than Type 1 RP. The effects of RP on patient health and associated health care costs remain to be investigated. Drug-reimbursement policies may have an adverse effect on patient outcomes if they interfere with timely access to efficacious medications for acute medical conditions. Clopidogrel in combination with aspirin is the recommended standard of care for patients receiving coronary stents to prevent thrombosis. We examined the population-level effect of a change by a Canadian provincial government in a pharmacy-benefits program from a prior-authorization policy to a less restrictive, limited-use policy on access to clopidogrel among patients undergoing percutaneous coronary intervention (PCI) with stenting after acute myocardial infarction.
                We conducted a population-based, retrospective, time-series analysis from April 1, 2000, to March 31, 2005, of all patients 65 years of age or older with acute myocardial infarction who underwent PCI with stenting in Ontario, Canada. The primary outcome was the composite rate of death, recurrent acute myocardial infarction, PCI, and coronary-artery bypass grafting at 1 year, with adjustment for sex and age. The secondary outcome was major bleeding.
                The rate of clopidogrel use within 30 days after hospital discharge following myocardial infarction increased from 35% in the prior-authorization period to 88% in the limited-use period. The median time to the first dispensing of a clopidogrel prescription decreased from 9 days in the first period to 0 days in the second period. The 1-year composite cardiovascular outcome significantly decreased from 15% in the prior-authorization group to 11% in the limited-use group (P=0.02). Rates of bleeding in the two groups did not change.
                The removal of a prior-authorization program led to improvement in timely access to clopidogrel for coronary stenting and improved cardiovascular outcomes.
                2008 Massachusetts Medical Society Concerned with the rising costs of its drug programs for seniors and social-assistance recipients, the government of Newfoundland and Labrador requested physicians and pharmacists at the Memorial University of Newfoundland, and members of the Newfoundland and Labrador Medical Association and the Newfoundland Pharmaceutical Association to provide guidance to the health care community for the use of drugs to treat upper gastrointestinal disorders.
                Algorithms for the management of dyspepsia and gastrointestinal reflux disease were created and distributed to all physicians and pharmacists in the province in June 1996. On July 1, 1996, the provincial government implemented a program to restrict payment for proton-pump inhibitors through its drug programs to situations defined by the algorithms. Restrictions were not applied to the prescribing of cimetidine, ranitidine and prokinetic agents. The status of famotidine and nizatidine was changed from "open benefit" to "special consideration," which requires prescribers to request authorization of their use on a case-by-case basis.
                Between July 1 and Dec. 31, 1996, 973 of 1078 requests for a proton-pump inhibitor were approved (679 for gastroesophageal reflux, 186 for Helicobacter pylori eradication, 55 for ulcer treatment and 53 for other reasons). The program resulted in a sustained reduction in drug expenditures. Total drug expenditures, which had risen from $39.0 million in 1992/93 to $50.8 million in 1995/96, fell after implementation of the program to $46.4 million in 1996/97 because of a decrease of more than 80% in the use of proton-pump inhibitors. Expenditures on proton-pump inhibitors, which had increased from $0.7 million for the 6 months ending March 1993 to $1.6 million for the 6 months ending March 1996, decreased to $0.3 million for the 6 months ending March 1997. The use of H2-antagonists, but not prokinetic agents, increased concomitantly with the decline in proton-pump inhibitor use. Compared with the year preceding implementation of the program, annual combined expenditures in the subsequent 3 years for H2-antagonists, prokinetic drugs and proton-pump inhibitors were reduced by $1.6 million, $1.7 million and $1.0 million, respectively. Feedback from physicians and pharmacists was supportive for the clinical information and prescribing guidelines. Concerns were mostly limited to process issues.
                The program, designed by health care professionals, approved by health care associations and implemented by the province of Newfoundland and Labrador to guide the treatment of upper gastrointestinal disorders, has achieved a substantial reduction in drug expenditures. To explore the effect on prescribing of policies that lift reimbursement restrictions on selected H2-antihistamines and proton pump inhibitors (PPI) and of practice recommendations.
                Monthly claims based data for proton pump inhibitors (PPIs) and H2-antihistamines were obtained from the national health insurance database (Farmanet 1997-2005). Two policies were issued. In March 2001 two H2-antihistamines and in March 2003 two PPIs became available without restrictions. An evidence report was distributed in September 2004. Periods before and after implementation of the interventions were compared. Interrupted time series with segmented regression analysis was used to assess and compare time trends.
                The first policy resulted in an increase of volume (1.6 million DDDs; 95% CI 1.4-1.8 million; p < .001) and expenditure (euro 637,744; 95% CI 177 052-1 098 437; p = .026) for H2-antihistamines, but consumption of PPIs continued to grow. After the second policy use of selected PPIs also increased (4.7 million DDDs increase; 95% CI 3.9-5.5 million; p < .001), but more than the desired shift toward selected PPIs. Although total expenditure stabilized at a lower level, there was no significant change of trend. Publication of the evidence report did not have any impact on prescribing.
                Policies that lift reimbursement restrictions did not result in meaningful changes in utilization or cost saving. They may even have unintended effects. Collaboration between policymakers and guideline developers and linking policies to evidence-based guidelines could be a more effective way to pursue cost-containment and better quality of care.
                Copyright (c) 2008 John Wiley & Sons, Ltd. Prior authorization (PA) is a poorly studied but commonly employed policy used by health care payers to manage the rising costs of pharmacy benefits.
                The aim of this study was to evaluate the intended and unintended effects of a PA policy for celecoxib on pharmacy and medical-service utilization in a Medicaid managed-care organization.
                This was a retrospective, interrupted time-series analysis of 22 monthly health-related utilization rates from January 1, 1999, to October 31, 2000. All Medicaid claims for CareOregon (a managed-care organization) and a fee-for-service program were reviewed. A model was constructed to evaluate changes in utilization of therapeutically related drug classes (eg, conventional nonsteroidal anti-inflammatory drugs [NSAIDs], gastrointestinal agents), office and emergency-department encounters, and hospitalizations before and after the PA policy was implemented on November 16, 1999. A secondary analysis evaluated these changes among a sample of prior NSAID users.
                After the PA policy was implemented, use of celecoxib was immediately reduced from 1.07 to 0.53 days' supply per person-year (58.9%; 95% CI, 50.0%-67.9%). The monthly rate of increase was also reduced (P < 0.001). Utilization changes were not observed in other drug classes. Similar changes were observed in the secondary analysis. An 18% (95% CI, 2.2%-33.9%) nonsignificant increase in emergency-department visits was observed in the entire sample after the PA policy was implemented. However, a similar change was not observed in the secondary analysis of prior NSAID users. No other changes in medical service encounters were noted after the PA policy was activated.
                This observational study found that celecoxib use was substantially reduced after the implementation of a PA policy. No important changes in use of other drug classes were detected. The overall increase in emergency-department visits--although not observed among previous NSAID users--should be explored on the individual level. This paper describes Oregon's implementation of its publicly developed, evidence-based, Practitioner-Managed Prescription Drug Plan (PMPDP). Oregon's PMPDP was initially self-enforced with a dispense as written (DAW) exception process, followed by an educational prior authorization (soft PA) method, and finally no active enforcement. Market-share trends indicate that the educational prior authorization process was most effective at increasing the use of preferred agents. Pharmacy costs decreased 9.1 percent and 17.7 percent after implementation of the DAW and soft PA policies, respectively. Data from nonenforced PMPDP classes showed no change; this suggests the need for effective methods to encourage PMPDP compliance. To examine the effect of prescription step-therapy programs in terms of plan-sponsor savings and member experience at the point of service.
                Plan-sponsor savings were measured using a quasi-experimental, case-control design. Member experience with step therapy was measured using a self-administered mailed survey.
                A 20,000-member plan implemented 3 step therapy programs in September 2002: proton pump inhibitors, selective serotonin reuptake inhibitors, and nonsteroidal anti-inflammatory drugs. Pharmacy claims from September 1, 2001, through June 30, 2003, were examined to compare changes in per-member-per-month (PMPM) net cost between the intervention group and a random sample of members from commercial plans without the step therapy programs. A mailed, self-administered survey was sent to members with a step edit from September 1, 2002 to December 31, 2002.
                The employer experienced a decrease of 0.83 dollars in net cost after implementing step therapy, while the comparison group had an upward trend of 0.10 dollars PMPM for these therapy classes. Member-reported outcomes indicated that approximately 30% of patients received a generic, 23% were granted a medical exception for the brand, 17% received no medication, and 16% paid the full retail price for the brand. If the pharmacist vs the patient contacted the physician, members were 8 times more likely to receive a medication covered by the health plan (OR, 8.10; 95% CI, 2.94-22.33 vs OR, 8.23; 95% CI, 3.11-21.93). Compared with those who received first-line therapy, those who paid out of pocket for the brand medication vs those who did not receive any medication were less likely to be satisfied with their pharmacy benefit (OR, 0.25; 95% CI, 0.08-0.80 vs OR, 0.12; 95% CI, 0.04-0.41).
                Step therapy produces significant drug savings. However, there appear to be opportunities to further members' and providers' understanding of these programs. Antipsychotic medications account for more prescription expenditures in Medicaid than any other therapeutic category. This has made them an attractive target for states hoping to curtail rising expenditures.
                The objective of this study was to document the effects of a step-therapy prior authorization (PA) policy for atypical antipsychotic medications on: (1) Medicaid prescription expenditures among all Medicaid beneficiaries and (2) prescription and health service expenditures among patients with schizophrenia.
                Prescription, inpatient, outpatient, and long-term care State Medicaid Research Files from Georgia and Mississippi from January 1, 1996, to December 31, 1997, were used to model an interrupted time-series analysis. We compared a step-therapy PA policy implemented in Georgia to a nonequivalent/no-treatment control group (Mississippi) over 10-month prepolicy, 11-month policy, and 3-month postpolicy periods. Segmented regression was used to estimate antipsychotic prescription expenditures among all eligible Medicaid beneficiaries. We used generalized estimating equations to model prescription and other health service expenditures with difference-indifference regressions among a cohort of patients with schizophrenia.
                Compared with Mississippi, Georgia saved approximately USD 7 million in atypical antipsychotic expenditures over the 11-month policy period. Among patients with schizophrenia, the PA policy was associated with a USD 19.62 per member per month (PMPM) decrease in atypical antipsychotic expenditures and a USD 2.20 PMPM increase in typical antipsychotic expenditures (both, P < 0.001). Among the same patients with schizophrenia however, the reduction in atypical antipsychotic expenditures was accompanied by a USD 31.59 PMPM increase in expenditures for outpatient services (P < 0.001).
                Although PA of atypical antipsychotics was associated with significant prescription savings to the Georgia Medicaid program, among a vulnerable cohort of patients with schizophrenia, an increase in outpatient expenditures was associated with overall savings. Over the past five years, selective cyclooxygenase-2 inhibitors (coxibs) have accounted for a growing proportion of prescriptions for nonsteroidal antiinflammatory drugs (NSAIDs). To control these expenses, many state Medicaid programs have implemented prior-authorization requirements before coxibs can be prescribed. We evaluated the effect of such programs on the use of coxibs by Medicaid beneficiaries.
                We surveyed state Medicaid agencies to determine whether prescription of coxibs required prior authorization and, if so, the criteria for authorization. For each program, we compared these criteria with evidence-based recommendations for prescribing of coxibs. Using data for all filled prescriptions in 50 state Medicaid programs from 1999 through the end of 2003, we calculated the proportion of defined daily doses of NSAIDs accounted for by coxibs. Time-series analyses were used to measure the changes in prescription patterns after the implementation of each prior-authorization program.
                By 2001, coxibs accounted for half of all NSAID doses covered by Medicaid. This proportion varied widely according to the state in 2003, from a low of 11 percent to a high of 70 percent of all NSAID doses. Twenty-two states implemented prior-authorization programs for coxibs during the study period. Overall, the implementation of such programs reduced the proportion of NSAID doses made up by coxibs by 15.0 percent (95 percent confidence interval, 10.9 to 19.2 percent), corresponding to a decrease of 10.28 dollars (95 percent confidence interval, 7.56 dollars to 13.00 dollars) in spending per NSAID prescription. The effect of such programs was not influenced by the degree to which a prior-authorization program incorporated evidence-based prescribing recommendations.
                The use of coxibs and spending on NSAIDs varies widely by state and declined substantially after the implementation of prior-authorization programs. Determining whether these reductions are clinically appropriate will have important implications for the development of rational drug-reimbursement policies.
                Copyright 2004 Massachusetts Medical Society. Prescription drug cost containment is a key health policy priority. State Medicaid programs have implemented policies requiring prior authorization before paying for angiotensin-receptor blockers (ARBs), a costly class of blood pressure medications. We examined the impact of these policies on drug use. We found that policies using a stepped-therapy approach reduced ARB use by 1.6 percent when first implemented and decreased the subsequent trend in ARB use by 1.3 percent per quarter; alternative approaches were unsuccessful. These findings have important implications for the development of rational drug reimbursement policy under Medicare Part D and other health insurance plans. The purpose of our study was to evaluate the effects of a new reimbursement rule for antihypertensive medication that made thiazides mandatory first-line drugs for newly treated, uncomplicated hypertension. The objective of the new regulation was to reduce drug expenditures.
                We conducted an interrupted time-series analysis on prescribing data before and after the new reimbursement rule for antihypertensive medication was put into effect. All patients started on antihypertensive medication in 61 general practices in Norway were included in the analysis. The new rule was put forward by the Ministry of Health and was approved by parliament. Adherence to the rule was monitored only minimally, and there were no penalties for non-adherence. Our primary outcome was the proportion of thiazide prescriptions among all prescriptions made for persons started on antihypertensive medication. Secondary outcomes included the proportion of patients who, within 4 mo, reached recommended blood-pressure goals and the proportion of patients who, within 4 mo, were not started on a second antihypertensive drug. We also compared drug costs before and after the intervention. During the baseline period, 10% of patients started on antihypertensive medication were given a thiazide prescription. This proportion rose steadily during the transition period, after which it remained stable at 25%. For other outcomes, no statistically significant differences were demonstrated. Achievement of treatment goals was slightly higher (56.6% versus 58.4%) after the new rule was introduced, and the prescribing of a second drug was slightly lower (24.0% versus 21.8%). Drug costs were reduced by an estimated Norwegian kroner 4.8 million (0.58 million Euros, US$0.72 million) in the first year, which is equivalent to Norwegian kroner 1.06 per inhabitant (0.13 Euros, US$0.16).
                Prescribing of thiazides in Norway for uncomplicated hypertension more than doubled after a reimbursement rule requiring the use of thiazides as the first-choice therapy was put into effect. However, the resulting savings on drug expenditures were modest. There were no significant changes in the achievement of treatment goals or in the prescribing of a second antihypertensive drug. In February 2000, the Nova Scotia Seniors' Pharmacare Program announced a change in the reimbursement of respiratory drugs that added specific reimbursement criteria for wet nebulization therapy. Policy implementation coincided with multifaceted interventions to assist patients and providers with the change.
                To assess the impact of the new policy and associated interventions on the use of wet nebulization and portable inhaler delivery systems of respiratory drugs and on the utilization of health services.
                The administrative claims database identified all beneficiaries (age > or = 65 yrs) who received at least one respiratory drug prescription in the 12 months before the study. These patients were then grouped into the wet nebulization cohort or the control cohort receiving a metered-dose or a dry-powder inhaler. The study period was from April 1998-February 2002. Use of respiratory drugs, physician visits, and hospitalizations were compared between study cohorts using an interrupted time-series design.
                A sharp decrease was noted in use of wet nebulization after the policy announcement, along with an increase in use of short-acting beta2-agonists and anticholinergic agents delivered by metered-dose or drypowder inhaler. From December 1999 to December 2001, in the heavy wet nebulization cohort (a subset of the wet nebulization cohort), wet nebulization use dropped from 100% to 35%; in the wet nebulization cohort, wet nebulization use decreased from 67% to 20%. Rates of spacer device use were 42%, 31%, and 17% in the heavy wet nebulization, wet nebulization, and control cohorts, respectively, in December 2001. Rates of general practitioner visits and hospitalizations for respiratory conditions did not increase in the intervention cohorts after the policy announcement. In fact, relative to the control cohort, health services use in response to the policy and interventions in the wet nebulization cohort decreased.
                The reimbursement policy resulted in decreased use of respiratory drugs delivered by wet nebulization without a negative impact on general practitioner visits and hospitalizations for respiratory conditions. Prior authorization--mandatory advance approval for the use of expensive medications--is now the primary method by which Medicaid programs control expenditures for drugs. However, whether this policy reduces expenditures for specific drugs without causing the unwanted substitution of other drugs or medical services has been largely unstudied. We evaluated the effects of a prior-authorization policy involving nongeneric nonsteroidal antiinflammatory drugs (NSAIDs) in the Medicaid program in Tennessee.
                We compared monthly Medicaid expenditures that were potentially affected by the policy change during the year before and the two years after its implementation. We studied prescriptions for NSAIDs, other analgesic or antiinflammatory drugs, and psychotropic drugs, as well as outpatient services and inpatient admissions for the management of pain or inflammation.
                At the midpoint of the base-line year, 495,821 people were enrolled in Medicaid. During that year, mean annualized Medicaid expenditures for NSAID prescriptions amounted to $22.41. Expenditures decreased by 53 percent (95 percent confidence interval, 48 to 57 percent) during the next two years, for an estimated savings of $12.8 million. The reduction in expenditures resulted from the increased use of generic NSAIDs, as well as from a 19 percent decrease in overall NSAID use (95 percent confidence interval, 13 to 25 percent). There was no concomitant increase in Medicaid expenditures for other medical care. Regular users of nongeneric NSAIDs, those most affected by the policy change, had similar reductions in NSAID expenditures and use, with no increase in expenditures for other medical care.
                Prior-authorization requirements may be highly cost effective with regard to expenditures for NSAIDs, drugs that have very similar efficacy and safety but substantial variation in cost. To examine the clinical and financial outcomes associated with a proton pump inhibitor (PPI) prior-authorization policy.
                Interrupted time-series analyses of antisecretory prescription drug claims. Separate 6-month retrospective cohort analyses were conducted to estimate the clinical and financial effects of the policy.
                More than 1.2 million Medicaid enrollees, with subgroup analyses of 5965 continuously eligible, potential antisecretory medication users. Measures included antisecretory drug expenditures, proportions of patients with at least 1 gastrointestinal diagnosis and gastrointestinal-related ambulatory and inpatient medical service visit, and subsequent gastrointestinal-related and total medical service expenditures.
                There was a 90.9% decrease in PPI per-member-per-month expenditures and a 223.2% increase in histamine2-receptor antagonist (H2A) per-member-per-month expenditures in the month immediately following the implementation of the policy (P < .001 for both). A greater proportion (80.7%) of prior-authorization eligible enrollees who received a PPI had at least 1 diagnosis for a gastrointestinal condition than enrollees who received an H2A (64.1%) or no antisecretory drugs (48.4%) (P < .001 for both). Two-part, finite mixture regression analyses indicated that the enrollees who received an H2A or no antisecretory drugs were no more likely to have incurred greater total medical care expenditures than enrollees who received a PPI.
                Prior authorization for PPIs had the effect of reducing use of high-cost PPIs, while encouraging use of lower costing H2As without evidence of adverse medical consequences. To analyse the effect of guidelines accompanied by changes in reimbursement rules for the prescription of lipid-lowering drugs (LLDs).
                Observational study focusing on LLD use before (1994-98) and after an intervention (1999).
                Guidelines were developed by the Danish College of General Practitioners and focused on prevention of cardiovascular heart disease (CHD). Guidelines were sent out and changes in reimbursement took place in December 1998. Prescriptions for LLDs were extracted from a population-based prescription database (Odense University Pharmacoepidemiological Database, OPED) covering 10% of the Danish population (470,000 inhabitants).
                Incidence rate and 1 year prevalence rate (annual prevalence) of LLD use.
                The incidence of LLD use increased significantly in the year following the intervention. Incidence rate ratio (after/before) was 1.43 (CI 1.35-1.52). The annual prevalence of LLD use in the population increased by 0.4% after the intervention (0.2% before). The corresponding figure for patients with diabetes mellitus (treated with insulin or oral anti-diabetics) was 2.3% after the intervention (1.2% before), and for patients with CHD (treated with vasodilators) 8.1% after the intervention (5.0% before).
                Guidelines accompanied by a change in reimbursement rules had a significant influence on the prescribing of lipid-lowering drugs. To examine the influence on administrative pharmacy claims of a policy that limited the reimbursement of the fluoroquinolones and other antimicrobials in the senior population within Nova Scotia, Canada.
                The administrative claims database of the Nova Scotia Seniors' Pharmacare Program was used to identify all prescription claims for orally administered antibiotics and urinary antiinfectives. The number of beneficiaries receiving antimicrobials and the number, duration, and cost of prescriptions for antimicrobials were measured monthly. Descriptive time-series plots were used to compare antimicrobial use for two 12-month periods before the institution of the policy (December 1, 1994-November 30, 1995, and December 1, 1995-November 30, 1996) and the 12 months after the policy took effect (January 1, 1997-December 31, 1997).
                Following the implementation of the fluoroquinolone reimbursement policy, the number of patients using antimicrobials decreased by 2.2% and the number of prescriptions for antimicrobials decreased by 3.4%. Fluoroquinolone prescriptions decreased by 80.2%; prescriptions for sulfonamides and trimethoprim increased by 34.9%, cephalosporins by 17.0%, and macrolides and lincosamides by 16.5%. The only prescription duration to change was the fluoroquinolones, which increased by 25%. The average cost per antimicrobial user/year decreased from $35.24 during prepolicy period 2 to $27.51 during the postpolicy period.
                Prescription claims for fluoroquinolones in seniors decreased following the introduction of the policy. Total antimicrobial use also decreased, although this may be related to other factors. The effect of this policy change on patient outcomes requires further study. In a potential attempt to guide antibiotic prescribing based on current clinical evidence and mitigate the spread of antibiotic resistance, in March 2001 the Ontario Drug Benefit programme restricted reimbursement of two fluoroquinolone antibiotics--ciprofloxacin and ofloxacin--to its beneficiaries. Our objective was to determine the impact of this policy on the volume and cost of antibiotic prescribing.
                Weekly administrative data on antibiotic prescribing volumes and expenditures were analysed between January 1999 and September 2002 to estimate the effect of the policy changes using time series analysis.
                The policy changes were associated with a statistically significant shift downwards for the fluoroquinolones as a category (1905 fewer prescriptions each week, representing a saving of Can$105,707 a week), driven by a decrease in prescriptions for ciprofloxacin (2084 fewer prescriptions a week, saving Can$129,421 a week). Nitrofurantoin (200 more prescriptions a week, costing an extra Can$2082 a week) and trimethoprim-sulphamethoxazole (532 more prescriptions a week, costing an extra Can$1473 a week) demonstrated a statistically significant shift upwards. The latter also showed a decrease in trend and nitrofurantoin an increase in trend during the time period. There was no statistically significant change in either the total number of antibiotic prescriptions or expenditures associated with the policy of limiting their use.
                Although no direct cause and effect can be shown with these observational data, the results suggest that the change in reimbursement policy to restrict prescribing of fluoroquinolones decreased their use and associated expenditures. These decreases were offset by increases in the use of other antibiotics. The balance of consequent benefit and harm of these shifts in prescribing patterns needs to be examined carefully. Alternative solutions to encourage appropriate use of antibiotics deserve exploration. Public insurance plans for pharmaceuticals in Canada differ substantially across provinces in the conditions under which pharmaceuticals are reimbursed. Coxibs provide a good example. Québec had no restrictions on reimbursement for these drugs. Ontario required physicians to submit the clinical indications for their use on the prescription. British Columbia required physicians to seek and receive prior authorisation from the drug plan.
                This study compares the effects of different reimbursement policies on coxib, non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs), and gastro-protective agent (GPA) use and cost.
                Analysis of retrospective time series analysis of all NSAID and GPA administrative claims data from April 1997 through December 2002.
                Administrative claims data from April 1997 through December 2002 for each of the publicly funded drug plans in Québec, Ontario, and British Columbia. In addition, we obtained data from BC PharmaNet, which records all dispensed prescriptions in British Columbia.
                Senior beneficiaries (>or= 65 years).
                We compared the projected total NSAID utilisation in the absence of coxib reimbursement restriction with actual utilisation by province and drug category. Projected utilisation was based on ARIMA modelling and reported as the number of defined daily doses (DDDs) per 100 senior (>or=65 years) beneficiaries/month.
                In Ontario, under its "limited use" policy, uptake and steady-state use of coxibs was similar to that in Québec, where there were no restrictions. In British Columbia, publicly funded use of coxibs was 6% of that in Ontario and Québec. Despite a shift to private reimbursement, total coxib use in BC was only 50% of use in Ontario and Québec. The use of all NSAIDS (nsNSAIDS plus coxibs) increased for all provincial drug plans except for BC. The increase and overall rate of total NSAID use was greatest in Ontario. Neither Ontario's nor BC's policies had an impact on use of nsNSAIDs or GPAs.
                Only BC's policy effectively limited publicly funded coxib use. However, there was substantial cost-shifting to out-of-pocket and third party insurance plans in BC. To describe a formulary antiulcer agent prescribing program developed as the result of a drug use evaluation (DUE). Program implementation, methods, cost impact, and results of a follow-up DUE are provided.
                The institution is a 51,000-bed correctional system consisting of 40 separate units each containing an ambulatory care clinic. Medication orders are transmitted via mainframe computer system to one of four pharmacies, which collectively dispense an average of 4000 medication orders (30 days' supply) per day.
                Results from the antiulcer agent (cimetidine, ranitidine, sucralfate) DUE revealed that the agents studied were prescribed in dosages and durations exceeding criteria developed by the Pharmacy and Therapeutics Committee. A program designed to reduce dosages to maintenance therapy after eight weeks at treatment dosage was developed by the Pharmacy and Therapeutics Committee with staff physician input. Antiulcer agent use and expenditures were followed and a follow-up DUE was completed seven months after program implementation. Antacid use and frequency of upper gastrointestinal studies that were ordered were followed.
                The follow-up DUE showed the mean daily dosage for prescribed histamine2-receptor antagonists decreased (cimetidine from 694 to 454 mg, ranitidine from 280 to 183 mg) and the mean duration of therapy decreased from 14 to 10 months. The percentage of patients with potentially significant drug interactions decreased from 14.2 to 6.5 percent. The mean number of antiulcer agents dosage units dispensed per month decreased by 24,461 units, resulting in a projected annual savings of $327,273. There were no identifiable clinically important changes in the use of antacid products or prescribing of upper gastrointestinal studies.
                A cost-savings program sponsored by the pharmacy and therapeutics committee decreased costs, corrected prescribing to more closely meet preset criteria, and produced no discernable unfavorable effect on patient care. To evaluate the effectiveness of an automated prior authorization (PA) system (SmartPA) in reducing use of and expenditures for cyclooxygenase-2 (COX-2) inhibitors.
                Before and after with control group.
                After implementation of SmartPA in Missouri, changes in use of and expenditures for COX-2 inhibitors, COX-2 substitutes (traditional nonsteroidal anti-inflammatory drugs [NSAIDs] and other products for pain), and gastrointestinal (GI) protective agents were compared between the Medicaid program of Missouri and that of a state with no PA program for COX-2 inhibitors. Subjects were continuously enrolled for the 24-month study period and had a claim for a COX-2 inhibitor in the 12-month baseline period. Analyses included comparison of means and linear regression. Regressions controlled for age, sex, risk for GI complications, severity of illness, and the interaction between state and risk.
                Changes in expenditures for COX-2 inhibitors, NSAIDs, other pain drugs, and GI-protective drugs were $256 higher, $56 lower, $21 higher, and $198 higher, respectively, in the control state among low-risk patients. Changes in expenditures were $102 higher, $12 lower, $21 lower, and $185 higher, respectively, in the control state among high-risk patients. Results were similar for drug utilization.
                Implementation of SmartPA resulted in reduced use of and expenditures for COX-2 inhibitors and reduced net expenditures for all pain and GI-protective medications. These effects were greatest for patients at low risk for GI complications. State Medicaid programs introduce many types of prescribing restrictions to manage pharmaceutical use and expenditure. Little is known about the differential effect of implementing prior authorization (PA) policies at market entry versus waiting until several years later when prescribing behavior may already be established.
                We sought to examine the impact on overall use of Cox II inhibitors of PA policies implemented at market entry versus at least 2 years after market entry.
                We quantified Cox II inhibitor and nonselective nonsteroidal anti-inflammatory drug (NSAID) utilization for state Medicaid programs from January 1996 to September 2003. We used generalized estimating equations, Tukey's studentized range test and segmented linear regression on state Medicaid programs to determine the significance of changes in medication use.
                The primary end point was the number of defined daily doses (DDD) per 1000 population per day.
                Six states implementing prescribing restrictions for Cox II inhibitors at market entry had the lowest rates of uptake, averaging 10.9 DDD/1000/d. Twelve states adopting restrictions more than 2 years after market entry experienced declines in use from 23.0 DDD/1000/d before to 13.9 DDD/1000/d after the restrictions (P < 0.01). The 17 states that had never restricted access had the highest utilization, averaging 29.0 DDD/1000/d.
                Implementing prescribing restrictions at market entry of Cox II inhibitors was effective in restricting uptake. Despite the difficulty in changing well-established prescribing patterns, utilization in states implementing policies 2 years after market entry approached that of the early adopting states within 1 year. Clinical outcomes of such policies remain unknown. More than one-third of Medicaid programs and Medicare Part D plans use prior authorization (PA) policies to control the use of atypical antipsychotics (AAs). We used Medicaid and Medicare claims data to investigate how Maine's PA policy affected AA use, treatment discontinuities, and spending among schizophrenia patients initiating AA therapy. Patients initiating AAs during Maine's policy experienced a 29 percent greater risk of treatment discontinuity than patients initiating AAs before the policy took effect; no change occurred in a comparison state. AA spending was slightly lower in both states. Observed increases in treatment discontinuities without cost savings suggest that AAs should be exempt from PA for patients with severe mental illnesses. To assess the changes in prescribing of statins in Norway after implementation of the new reimbursement regulations for statins in June 2005.
                Data were retrieved from the Norwegian Prescription Database covering the total population in Norway (4.6 million). Outcome measures were the proportion of atorvastatin users switching to simvastatin and changes in the proportion of new statin users receiving simvastatin. Based on retail costs for all statin prescriptions dispensed in Norway, expenditure was measured in Norwegian currency.
                One-year prevalences of statin use increased from 6.3 to 6.8% for women and from 7.5 to 8.1% for men from the year before to the year after the new statin regulations. Of atorvastatin users (N = 131,222), 39% switched to simvastatin during the 13-month period after the implementation. The proportion of switching was higher in women (41%) than in men (36%). In May 2005, 48% of the new statin users received simvastatin. The proportion of new users receiving simvastatin increased rapidly after implementation of the new regulations to 68% in June 2005 and reached 92% in June 2006. Expenditure was reduced from 120 million to 95 million Euro when comparing the year before with the year after the new statin regulations.
                The new reimbursement policy for statins has had a great impact on physicians' prescribing of statins in Norway. Physicians in Norway acknowledge the importance of contributing to cost containment. With the growing need to provide prescription drug benefits to older patients and to contain costs, it will be necessary to direct that coverage so as to make expenditures as efficient as possible. We evaluated the clinical and economic consequences of coverage restriction for 3 leading proton pump inhibitors (PPIs) in a large-scale natural experiment.
                The study design was a time-trend analysis in the setting of a provincial drug benefits program in British Columbia, Canada. We studied all British Columbia residents aged 66 or older (N = 501,104) using linked data on all prescription drug dispensings, physician services, and hospitalizations between January 2002 and June 2004. The new policy restricted coverage to rabeprazole and required treatment failure with a histamine H2 blocker. More widely used PPIs (omeprazole, pantoprazole, and lansoprazole) had to be paid for out of pocket, unless the physician requested an exemption. The main outcome measures were utilization of PPIs, drug discontinuation rates, gastrointestinal hemorrhage rates, and drug expenditures.
                Utilization of the restricted PPIs declined sharply after the policy change (-14,850 daily doses per month per 10,000 residents, P < .0001), whereas use of the covered PPI increased sharply (+19,300, P < .0001), with 45% of all PPI users switching to the covered agent within 6 months. We found no increased use of H2 blockers or stopping of gastroprotective drugs. There was no increase in the monthly rate of hospitalization for gastrointestinal hemorrhage after the PPI restriction (P = .35) even though the study had the power to detect increases of 24 events per 10,000 residents with 95% confidence. There was a slight increase in physician visits 3 months after the policy change (P = .01) for a 2-month period when 9% of new rabeprazole users were switched back to a restricted PPI. In the first 6 months of the policy change, the provincial health plan saved at least 2.9 million Canadian dollars as a result of the policy change.
                Coverage restriction of 3 leading PPIs led to substantial utilization changes and savings, without increased noncompliance or clinical complication. Since its introduction in 1996, controlled-release (CR) oxycodone use has increased steadily despite its high cost. To control use and expenditures, many Medicaid programs have implemented CR oxycodone prior authorization (PA) policies. Few studies evaluate Medicaid policies or compare lenient and strict policies in multiple states.
                To estimate the impact of PA on CR oxycodone use by Medicaid beneficiaries.
                Secondary data analysis of 50 states' aggregate Medicaid prescription dispensing records,1996-2005. PA details were systematically collected. Regression and random effects meta-analyses estimated impact of strict and lenient PA policies on CR oxycodone use and expenditures.
                Change in rate of CR oxycodone use, proportion of long-acting opiates accounted for by CR oxycodone and average long-acting opiate dose expenditure.
                In 2004, CR oxycodone accounted for 12.4% of all opiates and 32.2% of long-acting opiates dispensed to Medicaid beneficiaries. Over the study period its use increased, on average, 109% annually, and 21 states implemented PA. PA was associated with state-specific use changes ranging from -76% to 9%. In aggregate, PA was associated with a nonsignificant decrease in CR oxycodone use, a significant 8% decrease in CR oxycodone as a proportion of long-acting opiate doses, and a small but significant change of -$0.31 in average cost per long-acting opiate dose. Strict policies were associated with greater changes.
                PA impact varied by state and was less dramatic than previously described Medicaid PA effects, suggesting CR oxycodone is relatively refractory to PA. A refined measure of such policies is needed to identify effective prescription management strategies. Medicaid expenditures for antipsychotic medications have risen rapidly, from under $1.0 billion in 1995 to over $5.5 billion in 2005. In response, at least ten states have implemented prior-authorization programs that restrict access to particular second-generation antipsychotic agents (aripiprazole and olanzapine). Twenty-two states restrict particular dosing forms (injections). This study examined the impact of such restrictions.
                The authors used interrupted time-series analysis of quarterly state-level drug utilization data to examine the impact of prior authorization for particular agents in West Virginia and Texas. Changes in market share of nonpreferred medications and total pharmacy costs were compared with changes in states without similar prior-authorization requirements.
                The West Virginia policy led to an immediate 3.5% reduction in market share level (p<.01) and a 1.3% decrease in trend per quarter in market share (p<.001) for nonpreferred antipsychotics, leading to a 13.9% reduction after two years. In Texas, prior authorization reduced the market share level of nonpreferred agents by 2.6% (p=.055). However, prior authorization did not lead to a significant decrease in pharmacy reimbursements in either state.
                Current prior-authorization policies for second-generation antipsychotics do not appear to reduce pharmacy reimbursement, probably because alternative medications are costly. These findings suggest that any cost savings from prior-authorization policies would accrue largely through supplemental rebate agreements with manufacturers, which are likely reduced by the transfer of dually eligible Medicaid enrollees to Medicare Part D plans. Further evaluation of the clinical consequences resulting from such policies is urgently needed to determine whether the minimal cost savings outweigh the potential clinical risks.
Implementing restrictions to coverage and reimbursement of selected medications can decrease third-party drug spending without increasing the use of other health services (6 studies). Relaxing reimbursement rules for drugs used for secondary prevention can also remove barriers to access. Policy design, however, needs to be based on research quantifying the harm and benefit profiles of target and alternative drugs to avoid unwanted health system and health effects. Health impact evaluation should be conducted where drugs are not interchangeable. Impacts on health equity, relating to the fair and just distribution of health benefits in society (sustainable access to publically financed drug benefits for seniors and low income populations, for example), also require explicit measurement.