PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-9 (9)
 

Clipboard (0)
None

Select a Filter Below

Journals
Authors
more »
Year of Publication
Document Types
1.  Impact of Prior Authorization on the Use and Costs of Lipid-Lowering Medications Among Michigan and Indiana Dual Enrollees in Medicaid and Medicare: Results of a Longitudinal, Population-Based Study 
Clinical therapeutics  2011;33(1):135-144.
Background
Some Medicaid programs have adopted prior-authorization (PA) policies that require prescribers to request approval from Medicaid before prescribing drugs not included on a preferred drug list.
Objective
This study examined the association between PA policies for lipid-lowering agents in Michigan and Indiana and the use and cost of this drug class among dual enrollees in Medicare and Medicaid.
Methods
Michigan and Indiana claims data from the Centers for Medicare and Medicaid Services were assessed. Michigan Medicaid instituted a PA requirement for several lipid-lowering medications in March 2002; Indiana implemented a PA policy for drugs in this class in September 2002. Although the PA policies affected some statins, they predominantly targeted second- line treatments, including bile acid sequestrants, fibrates, and niacins. Individuals aged ≥18 years who were continuously dually enrolled in both Medicare and Medicaid from July 2000 through September 2003 were included in this longitudinal, population-based study, which included a 20-month observation period before the implementation of PA in Michigan and a 12-month follow-up period after the Indiana PA policy was initiated. Interrupted time series analysis was used to examine changes in prescription rates and pharmacy costs for lipid-lowering drugs before and after policy implementation.
Results
A total of 38,684 dual enrollees in Michigan and 29,463 in Indiana were included. Slightly more than half of the cohort were female (Michigan, 53.3% [20,614/38,684]; Indiana, 56.3% [16,595/29,463]); nearly half were aged 45 to 64 years (Michigan, 43.7% [16,921/38,684]; Indiana, 45.2% [13,321/29,463]). Most subjects were white (Michigan, 77.4% [29,957/ 38,684]; Indiana: 84.9% [25,022/29,463]). The PA policy was associated with an immediate 58% reduction in prescriptions for nonpreferred medications in Michigan and a corresponding increase in prescriptions for preferred agents. However, the PA policy had no apparent effect in Indiana, where there had been little use of non-preferred medications before the policy was implemented (3.3%). The policies were associated with an immediate reduction of $24,548 in prescription expenditures in Michigan and an immediate reduction of $16,070 in Indiana.
Conclusions
The PA policy was associated with substantially lower use of nonpreferred lipid-lowering drugs in Michigan, offset by increases in the use of preferred medications, but there was less change in Indiana. Data limitations did not permit the evaluation of the impact of policy-induced switching on clinical outcomes such as cholesterol levels. The monetary benefit of PA policies for lipid-lowering agents should be weighed against administrative costs and the burden on patients and health care providers.
doi:10.1016/j.clinthera.2011.01.012
PMCID: PMC3980661  PMID: 21397779
drug expenditure; drug utilization; lipid-lowering drugs; Medicaid; prior authorization; statins
2.  Impact of Two Medicaid Prior-Authorization Policies on Antihypertensive Use and Costs Among Michigan and Indiana Residents Dually Enrolled in Medicaid and Medicare: Results of a Longitudinal, Population-Based Study 
Clinical therapeutics  2010;32(4):10.1016/j.clinthera.2010.04.007.
Background
In response to rising pharmaceutical costs, many state Medicaid programs have implemented policies requiring prior authorization for high-cost medications, even for established users. However, little is known about the impact of these policies on the use of antihypertensive medicines in the United States.
Objective
The aim of this longitudinal, population-based study was to assess comprehensive prior-authorization programs for antihypertensives on drug use and costs in a vulnerable Medicaid population in Michigan and Indiana.
Methods
A prior-authorization policy for anti-hypertensives was implemented in Michigan in March 2002 and in Indiana in September 2002; Indiana also implemented an antihypertensive stepwise-therapy requirement in July 2003. Our study cohort included individuals aged ≥18 years in Michigan and Indiana who were continuously enrolled in both Medicaid and Medicare from July 2000 through September 2003. Claims data were obtained from the Centers for Medicare and Medicaid Services. We included all antihypertensive medications, including diuretics, angiotensin-converting enzyme inhibitors, calcium channel blockers, β-blockers, α-blockers, and angiotensin II receptor blockers. We used interrupted time-series analysis to study policy-related changes in the total number and cost of anti-hypertensive prescriptions.
Results
Overall, 38,684 enrollees in Michigan and 29,463 in Indiana met our inclusion criteria. Slightly more than half of our cohort in both states was female (53.29% in Michigan and 56.32% in Indiana). In Michigan, 20.23% of patients were aged ≥65 years; 77.44% were white, 20.11% were black, and the remainder were Hispanic, Native American, Asian, or of other or unknown race. In Indiana, 20.07% were aged ≥65 years; 84.93% were white, 13.64% were black, and the remainder were Hispanic, Native American, Asian, or of other or unknown race. The implementation of both policies was associated with large and immediate reductions in the use of nonpreferred medications: 83.33% reduction in the use of such drugs in Michigan (−84.30 prescriptions per 1000 enrollees per month; P < 0.001) and 35.76% in Indiana (−64.45 prescriptions per 1000 enrollees per month; P < 0.001). As expected, use of preferred medications also increased substantially in both states (P < 0.001). Overall, antihypertensive therapy immediately dropped 0.16% in Michigan (P = 0.04) and 1.82% in Indiana (P = 0.02). Implementation of the policies was also associated with reductions in pharmacy reimbursement of $616,572.43 in Michigan and $868,265.97 in Indiana in the first postpolicy year.
Conclusions
Prior authorization was associated with lower use of nonpreferred antihypertensive drugs that was largely offset by increases in the use of preferred drugs. The possible clinical consequences of policy-induced drug switching for individual patients remain unknown because the present study did not include access to medical record data. Further research is needed to establish whether large-scale switches in medicines following the inception of prior-authorization policies have any long-term health effects.
doi:10.1016/j.clinthera.2010.04.007
PMCID: PMC3844690  PMID: 20435243
prior authorization; Medicaid; anti-hypertensive; drug utilization; costs
3.  Association Between Prior Authorization for Psychiatric Medications and Use of Health Services Among Medicaid Patients With Bipolar Disorder 
Background
Prior authorization policies are commonly used by Medicaid programs to control psychotropic drug expenditures. This study examined the association of a prior-authorization policy for atypical antipsychotic and anticonvulsant agents with medication discontinuation and use of health services among patients with bipolar disorder.
Methods
A pre-post-with-historical-comparison-group design was used to analyze Maine Medicaid and Medicare claims data. Newly treated patients were identified during the policy (Jul 2003–Feb 2004; N=946) and a comparison group from the pre-policy period (Jul 2002–Feb 2003; N=1,014). Patients were stratified according to their pre-initiation visits to community mental health centers (CMHCs) that target those with the most serious mental illness: CMHC-attenders (at least 2 visits) and non-attenders (fewer than 2 visits). Changes in rates of medication discontinuation, outpatient, emergency room and hospital visits before and after drug initiation were estimated.
Results
CMHC-attenders had substantially higher rates of comorbidity and use of medications and health services than non-attenders. The policy was associated with increased medication discontinuation in both groups; reductions in psychiatric visits after discontinuing medication among CMHC-attenders (−64/100 patients/month; p<.05); and increases in emergency room visits after discontinuing medication among non-attenders (16/100 patients/month; p<.05). During the 8-month follow-up, the policy had no detectable impact on risk of hospitalization.
Conclusion
The Maine prior-authorization policy was associated with increased medication discontinuation and subsequent changes in use of health services. Though small, these unintended policy effects raise quality of care concerns for a group of very vulnerable patients. Long-term consequences of prior-authorization policies on patient outcomes warrant further investigation.
doi:10.1176/appi.ps.62.2.186
PMCID: PMC3053119  PMID: 21285097
prior authorization; bipolar disorder; policy evaluation; Medicaid; health services research
4.  Access to high cost medicines in Australia: ethical perspectives 
Access to "high cost medicines" through Australia's Pharmaceutical Benefits Scheme (PBS) is tightly regulated. It is inherently difficult to apply any criteria-based system of control in a way that provides a fair balance between efficient use of limited resources for community needs and equitable individual access to care. We suggest, in relation to very high cost medicines, that the present arrangements be re-considered in order to overcome potential inequities. The biological agents for the treatment of rheumatoid arthritis are used as an example by which to discuss the ethical issues associated with the current scheme. Consideration of ethical aspects of the PBS and similar programs is important in order to achieve the fairest outcomes for individual patients, as well as for the community.
doi:10.1186/1743-8462-5-4
PMCID: PMC2412887  PMID: 18489760
5.  Interventions designed to improve the quality and efficiency of medication use in managed care: A critical review of the literature – 2001–2007 
Background
Managed care organizations use a variety of strategies to reduce the cost and improve the quality of medication use. The effectiveness of such policies is not well understood. The objective of this research was to update a previous systematic review of interventions, published between 1966 and 2001, to improve the quality and efficiency of medication use in the US managed care setting.
Methods
We searched MEDLINE and EMBASE for publications from July 2001 to January 2007 describing interventions targeting drug use conducted in the US managed care setting. We categorized studies by intervention type and adequacy of research design using commonly accepted criteria. We summarized the outcomes of well-controlled strategies and documented the significance and magnitude of effects for key study outcomes.
Results
We identified 164 papers published during the six-year period. Predominant strategies were: educational interventions (n = 20, including dissemination of educational materials, and group or one-to-one educational outreach); monitoring and feedback (n = 22, including audit/feedback and computerized monitoring); formulary interventions (n = 66, including tiered formulary and patient copayment); collaborative care involving pharmacists (n = 15); and disease management with pharmacotherapy as a primary focus (n = 41, including care for depression, asthma, and peptic ulcer disease). Overall, 51 studies met minimum criteria for methodological adequacy. Effective interventions included one-to-one academic detailing, computerized alerts and reminders, pharmacist-led collaborative care, and multifaceted disease management. Further, changes in formulary tier-design and related increases in copayments were associated with reductions in medication use and increased out-of-pocket spending by patients. The dissemination of educational materials alone had little or no impact, while the impact of group education was inconclusive.
Conclusion
There is good evidence for the effectiveness of several strategies in changing drug use in the managed care environment. However, little is known about the cost-effectiveness of these interventions. Computerized alerts showed promise in improving short-term outcomes but little is known about longer-term outcomes. Few well-designed, published studies have assessed the potential negative clinical effects of formulary-related interventions despite their widespread use. However, some evidence suggests increases in cost sharing reduce access to essential medicines for chronic illness.
doi:10.1186/1472-6963-8-75
PMCID: PMC2323373  PMID: 18394200
6.  The views of stakeholders on controlled access schemes for high-cost antirheumatic biological medicines in Australia 
Background
In Australia, government-subsidised access to high-cost medicines is "targeted" to particular sub-sets of patients under the Pharmaceutical Benefits Scheme to achieve cost-effective use. In order to determine how this access system could be improved, the opinions of key stakeholders on access to biological agents for rheumatoid arthritis were explored.
Methods
Thirty-six semi-structured interviews were conducted with persons from relevant stakeholder groups. These were transcribed verbatim, and analysed thematically.
Results
Controlled access to expensive medicines was considered to be equitable and practical; however, there was disagreement as to the method of defining the target patient populations. Other concerns included timeliness of access, excessive bureaucracy, and the need for additional resources to facilitate the scheme. Collaboration between stakeholders was deemed important because it allows more equitable distribution of limited resources. The majority considered that stakeholder consultation should have been broader. Most wanted increased transparency of the decision-making process, ongoing and timely review of access criteria, and an increased provision of information for patients. More structured communication between stakeholders was proposed.
Conclusion
The Pharmaceutical Benefit Scheme is adapting to meet the changing needs of patients. Provision of subsidised access to high-cost medicines in a manner that is affordable for individuals and society, and that is equitable and efficiently managed is challenging. The views of stakeholders on targeted access to anti-rheumatic biological medicines in Australia acknowledged this challenge and provided a number of suggestions for modifications. These could serve as a basis to inform the debate on how to change the processes and policies so as to improve the scheme.
doi:10.1186/1743-8462-4-26
PMCID: PMC2231358  PMID: 18096055
7.  The funding and use of high-cost medicines in Australia: the example of anti-rheumatic biological medicines 
Background
Subsidised access to high-cost medicines in Australia is restricted under national programs (the Pharmaceutical Benefits Scheme, PBS, and the Repatriation Pharmaceutical Benefits Scheme, RPBS) with a view to achieving cost-effective use. The aim of this study was to examine the use and associated government cost of biological agents for treating rheumatoid arthritis over the first two years of subsidy, and to compare these data to the predicted outcomes.
Methods
National prescription and expenditure data for the biologicals, etanercept, infliximab, adalimumab, and anakinra were collected and analysed for the period August 2003 to July 2005. Dispensing data on biologicals sorted by the metropolitan, rural and remote zones and by prescriber major specialty were also examined.
Results
A total of 27,970 prescriptions for biologicals was reimbursed. The government expenditure was A$53.1 million, representing only 19% of that expected. Almost all prescriptions were reimbursed by the PBS (98%, A$52 million) and the remainder by the RPBS. Approximately 62% of the prescriptions were for concessional patients (A$32.9 million). There was considerable variability in the use of biologicals across Australian states and territories, usage roughly correlating with the per capita adjusted number of rheumatologists. The total number of prescriptions continued to increase over the study period. Etanercept was the most highly prescribed agent (74% by number of prescriptions), although its use was beginning to plateau. Use of adalimumab increased steadily. Use of infliximab and anakinra was considerably lower. The resultant health outcomes for individual patients are unknown. Prescribers from capital cities and other metropolitan centres provided a majority of prescriptions of biologicals (89%).
Conclusion
The overall uptake of biologicals for treating rheumatoid arthritis over the first two years of PBS subsidy was considerably lower than expected. Long-term safety concerns and the expanded clinical uses of these drugs emphasise the need for evaluation. It is essential that there is comprehensive, ongoing analysis of utilisation data, associated expenditure and, importantly, patient outcomes in order to enhance accountability, efficiency and equity of policies that allocate substantial resources to subsidising national access to high-cost medicines.
doi:10.1186/1743-8462-4-2
PMCID: PMC1828161  PMID: 17331230
8.  Recent developments in targeting access to high cost medicines in Australia 
Background
In Australia, the Pharmaceutical Benefits Scheme (PBS) has developed a set of arrangements to control access to high-cost medicines to ensure their use is cost-effective. These medicines include the tumour necrosis factor-alpha inhibitors (TNFIs) for the treatment of rheumatoid arthritis. The aim of this first phase of a qualitative study was to explore basic views on the restricted access to TNFIs in order to confirm where further investigation should take place in the next phase.
Methods
Semi-structured interviews were conducted in 2004 with a member of the four relevant stakeholder groups. Participants were asked their opinions about features of the establishment, process and effects of the system of restricted access to TNFIs. Views on the collaboration between stakeholder groups in the decision-making process were also collected.
Results
The principle of 'controlled access' to TNFIs was supported in general. There were concerns regarding some of the specific eligibility criteria. Wider and more transparent stakeholder consultation was judged desirable. Some flexibility around prescribing of TNFIs by physicians, and regular review of the arrangements were proposed. These themes will inform the next phase of the study.
Conclusion
This first phase highlighted a range of issues associated with the PBS arrangements restricting access to TNFIs. Timely review and report of issues and concerns associated with such policy developments that arose in practice are essential. There is a need for a more comprehensive exploration across a wide range of stakeholders with different perspectives that will in turn be helpful in guiding policy and practice around national arrangements to manage access to high-cost medicines.
doi:10.1186/1743-8462-2-28
PMCID: PMC1325248  PMID: 16305742
Access to medicines; tumour necrosis factor inhibitors; pharmaceutical benefits scheme; drug reimbursement

Results 1-9 (9)