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PubMedDate not supplied

Pharmacy benefit forecast for a new interferon Beta-1a for the treatment of multiple sclerosis: development of a first-line decision tool for pharmacy-budget planning using administrative claims data.

OBJECTIVE: To estimate the incremental change in pharmacy per-member-permonth (PMPM) costs, according to various formulary designs, for a new interferon beta-1a product (IB1a2) using administrative claims data. METHODS: Cross-sectional sex- and age-specific disease prevalence and treatment rates for relapsing, remitting multiple sclerosis (RRMS) patients were measured using integrated medical and pharmacy claims data from a 500,000- member employer group in the southern United States. Migration to IB1a2 from other drugs in the class was based on market-share data for new and existing RRMS patients. Duration of therapy was estimated by analyzing claims for current RRMS therapies. Daily therapy cost was provided by the manufacturer of IB1a2, adjusted for migration from other therapies, and multiplied by estimated volume to predict incremental and total PMPM cost impact. Market-share estimates were used to develop a PMPM cost forecast for the next 2 years. PMPM cost estimates were calculated for preferred (copayment tier 2) and nonpreferred (copayment tier 3) formulary designs with and without prior authorization (PA). One-way sensitivity analysis was performed to assess the influence of product pricing, duration of therapy, and other market factors. RESULTS: Annual incremental PMPM change was $0.047 for the scenario of third copayment tier with PA. The incremental change was greatest for those aged 55 to 65 years ($0.056 PMPM) and did not vary greatly by benefit design. Duration of therapy had the greatest impact on the PMPM estimate across benefit designs. CONCLUSION: IB1a2 will not cause a significant change in managed care pharmacy budgets under a variety of formulary conditions, according to this crosssectional analysis of current care-seeking behavior by RRMS patients. Economic impact may differ if IB1a2 expands RRMS patients. treatment-seeking behavior.

Adjuvants, Immunologic↗
PubMedDate not supplied

Alternate financial incentives in multi-tiered formulary systems to improve accountability for outcomes.

BACKGROUND: Drug manufacturer rebates paid to health plans and pharmacy benefit management companies have come under increased public scrutiny. Over the past several years, numerous articles have appeared in the literature encouraging a shift to a more quality-based decision-making process for health plan drug formularies. OBJECTIVE: To propose a new basis for formulary placement decisions that would include consideration of health-plan-specific measures (clinical outcomes, total cost, adherence, and appropriateness of care) and align incentives for health plans, physicians, pharmacists, and pharmaceutical companies to promote high-quality care. SUMMARY: The proposed approach builds on key components of the Pharmacy's Framework for Drug Therapy Management in the 21st Century and the Academy of Managed Care Pharmacy's Format for Formulary Submission, including a focus on patient outcomes and evidence-based decision making. The proposed approach would lessen the influence of drug manufacturer rebates on formulary placement by shifting the focus to appropriateness of care, clinical outcomes, patient adherence, and total cost of care. Pharmaceutical manufacturers would benefit from the focus on adherence to drug therapy and total cost of care. Health plans and pharmacy benefit management companies would gain in that they may be able to reduce efforts in drug utilization review as pharmaceutical manufacturers are given incentives to market their drugs more appropriately. Physicians and pharmacists would benefit because the rebate money would be used to provide quality-based financial incentives related to adherence and appropriate use of drugs. CONCLUSION: The implementation of this approach would be difficult and require cooperation from employers, pharmacists, pharmaceutical manufacturers, health plans, and pharmacy benefit management companies. Aspects of this approach could be incorporated into existing pharmacy benefit management processes to encourage the delivery of high-quality health care.

Cyclooxygenase Inhibitors↗
PubMedDate not supplied

Cost-effectiveness analysis and the formulary decision-making process.

BACKGROUND: Faced with high drug expenditures in an environment of cost containment, drug formulary systems, particularly in managed care, have become more dependent on pharmacoeconomic evaluations to assess the value of new products. Within pharmacoeconomics (PE), cost-effectiveness analysis (CEA) is the most commonly used method. However, current methodological concerns about CEA have limited its practical contribution to the formulary process. Advances in analysis are likely to improve the relevance of CEA over time. OBJECTIVE: The purpose of this paper is to review CEA, its limitations, and its applications in formulary decision making in order to promote greater utility of CEA for managed care pharmacists. SUMMARY: Enhancements to CEA, such as the development of modeling software, rank-order stability analysis, cost-consequence analysis (CCA), and budget impact analysis are discussed. A combined method of CCA-CEA and standardized guidelines are suggested to improve the impact of CEA in the drug formulary process. CONCLUSION: Along with advances in its methodology and relevant standardized guidelines, CEA will gain increased importance in formulary decision making, helping to assure the goal of cost containment while ensuring quality of care.

Cost-Benefit Analysis↗
PubMedDate not supplied

Clinical monograph for drug formulary review: systemic agents for psoriasis/psoriatic arthritis.

BACKGROUND: Significant advances in the pharmacologic treatment of psoriasis, most notably the introduction of the biologic agents efalizumab and alefacept, have occurred recently. In addition, another biologic agent, etanercept, was recently approved for the treatment of psoriasis and psoriatic arthritis, thus adding to the list of biologic agents approved for the treatment of these disease states. A review was conducted by the Drug Information Service of a pharmacy benefits manager (PBM) to determine the relative merits and place in therapy of commonly used systemic agents for the treatment of psoriasis and psoriatic arthritis. OBJECTIVE: To provide readers with a comprehensive clinical monograph on psoriasis and psoriatic arthritis agents, written with a managed care perspective, as used in actual drug formulary decision making by a PBM. METHODS: The drug formulary of this PBM is designed to provide health plans with an evidence-based review of drugs, therapeutic classes, and disease states with a managed care focus. For each therapeutic class or disease review, an extensive and thorough literature search of MEDLINE is conducted for efficacy, safety, effectiveness, and humanistic and economic data. Drug/disease-state databases (UpToDate online, MICROMEDEX), U.S. Food and Drug Administration clinical reviews, key Internet sites, medical/pharmacy-related news sites, clinical guidelines, and AMCP dossiers are also reviewed. Formulary drug monographs produced by the Drug Information Service of the PBM include a critical analysis and summary of disease-oriented and patient-oriented clinical outcomes, effectiveness, and humanistic data. Additional data considered and included in the formulary review process are clinical attributes, patent expirations/generic competition, off-label or pending indications, and pharmacoeconomic data. RESULTS: The biologic agents do not appear to be as efficacious as traditional systemic therapies but are associated with fewer long-term toxicities that often limit treatment duration with traditional systemic agents. Although no head-to-head comparisons between alefacept and efalizumab exist, efalizumab appears to offer slightly higher efficacy rates, while alefacept has a longer duration of action. Etanercept at the higher approved dose appears more efficacious compared with efalizumab or alefacept for the treatment of psoriasis, and it is the only biologic currently approved for the treatment of psoriatic arthritis. Efalizumab and alefacept are generally well tolerated, but rebound flare of psoriasis is associated with efalizumab, thus requiring continuous treatment to avoid a flare in disease. Efalizumab and etanercept can be self-administered by the patient, while alefacept and infliximab require administration by a health care professional. CONCLUSIONS: Systemic therapy is reserved for patients with moderate-to-severe psoriasis or patients with psoriatic arthritis. The biologic agents are not as efficacious as traditional therapies but, due to better tolerability, are gaining acceptance in the treatment of psoriasis and psoriatic arthritis. The biologic agents differ in efficacy rates and are generally well tolerated. Clinical attributes, overall efficacy, and economic costs associated with the biologic agents will be significant factors in selecting agents for the treatment of psoriasis and psoriatic arthritis.

Arthritis, Psoriatic↗
PubMed2005

Clinical monograph for drug formulary review: erectile dysfunction agents.

BACKGROUND: Significant advances in the pharmacologic treatment of erectile dysfunction (ERD) have occurred in recent years, most notably the introduction of sildenafil, the first oral selective phosphodiesterase type 5 (PDE5) inhibitor, in 1998. Sildenafil quickly gained acceptance by the medical community and the public because of its broad efficacy for different types of ERD and its ease of use. Two PDE5 inhibitors, vardenafil and tadalafil, have since joined sildenafil to compete in the ERD market. A review was conducted by the Drug Information Service of a pharmacy benefits manager (PBM) to determine the relative merits and place in therapy of commonly used ERD drugs as part of drug formulary management process and decision making by the Pharmacy & Therapeutics (P&T) committee. OBJECTIVE: To provide readers with a comprehensive clinical monograph on ERD drugs written from a managed care perspective. METHODS: The PBM clinical monograph is designed to provide health plans with an evidence-based review of drugs, therapeutic classes, and disease states with a managed care focus. For each therapeutic class or disease review, an extensive and thorough literature search of MEDLINE is conducted for efficacy, safety, effectiveness, and humanistic and economic data. Drug/disease-state databases (UptoDate online, MICROMEDEX), U.S. Food and Drug Administration clinical reviews, key Internet sites, medical/pharmacy-related news sites, clinical guidelines, and AMCP dossiers are also reviewed. Formulary drug monographs prepared by the Drug Information Service of the PBM include a critical analysis and summary of disease-oriented and patient-oriented clinical outcomes, effectiveness, and humanistic data. Additional data considered and included in the formulary review process are clinical attributes, patent expirations/generic competition, off-label or pending indications, and pharmacoeconomic data. RESULTS: Despite the lack of head-to-head comparative studies, all 3 PDE5 inhibitors appear to have equivalent efficacy in the treatment of general ERD and ERD associated with diabetes and postprostatectomy. Sildenafil has additional efficacy data in the management of ERD associated with spinal cord injury and antidepressant medications. Tadalafil has the longest duration of action (up to 36 hours); this feature can be both beneficial (greater sexual spontaneity) or possibly detrimental (greater exposure to drug, delayed adverse events). All 3 PDE5 inhibitors appear to be generally well tolerated and have similar contraindications and warnings. However, vardenafil is the only PDE5 inhibitor with a cardiac conduction precaution. Alprostadil products are recommended in current ERD guidelines as second-line therapy for those who have not responded or cannot take the oral PDE5 inhibitors. Overall, higher clinical efficacy rates are achieved with intracavernous than with transurethral administration. CONCLUSION: A large amount of clinical efficacy and safety data has been published since the market launch of sildenafil in 1998. Sildenafil has the greatest body of efficacy and safety evidence. No comparative studies have been conducted with any of the PDE5 inhibitors. Differences in study populations, primary end points, and measurement tools make comparisons difficult. However, all PDE5 inhibitors appear to be roughly equivalent in efficacy, with minor differences in adverse event profiles. Until more comparative data are available, economic considerations will be a significant factor in choosing ERD products for formulary inclusion.

Carbolines↗
PubMed2005

The role of pharmacoeconomic modeling in evidence-based and value-based formulary guidelines.

OBJECTIVE: To review evidence-based medicine (EBM) in the context of pharmacoeconomic (PE) decision making by health care organizations. SUMMARY: Pharmacoeconomics involves processes similar to EBM, but it deals with decisions on the population rather than the patient level. The overall goal of PE is to provide the most efficient use of resources, taking into account both the cost and the value derived from a given technology. These evaluations assist health care decision making because both cost and effectiveness are considered. New therapies are increasingly complex in terms of administration, effects, and cost. As a result, PE models are likely to become more complex as well. At present, there is no standard threshold for what constitutes cost-effective therapy, so each organization is likely to have its own criterion for acceptance. CONCLUSION: Clinical trial results define the safety and efficacy of therapy but cannot determine whether a given technology represents a good buy for a specific organization. This requires PE analysis.

Cost-Benefit Analysis↗
PubMed2005

Effects of electronic prescribing on formulary compliance and generic drug utilization in the ambulatory care setting: a retrospective analysis of administrative claims data.

OBJECTIVE: Electronic prescribing (e-prescribing) provides formulary information at the point of care. The objective of this study was to assess the effects of e-prescribing on formulary compliance and generic utilization. METHODS: This was a retrospective analysis of pharmacy claims data from a large national managed care organization. A sample of 95 providers using predominantly e-prescribing was randomly selected (e-prescriber group). A matched sample of 95 traditional prescribers was selected (traditional prescriber group), matched to the e-prescriber group by zip code and medical specialty. A total of 110,975 paid pharmacy claims, for the 12 months from August 1, 2001, through July 31, 2002, were analyzed to assess the effect of e-prescribing on formulary compliance and generic utilization. All paid pharmacy claims were examined for each group; for the e-prescriber group, this included all claims, not just those prescribed using an e-prescribing device. A written qualitative survey was distributed to physicians and office managers to assess e-prescribing usage, sources of formulary information, and effects of e-prescribing on office resources. RESULTS: Both predominantly e-prescribers and traditional prescribers demonstrated high levels of formulary compliance, 83.2% versus 82.8%, respectively (P=0.32). Formulary compliance for these groups did not differ from the overall prescriber population (82.0%). There was not a difference in generic drug utilization rates between e-prescribers and traditional prescribers (absolute rates 37.3% versus 36.9%, P=0.18). Qualitative survey responses supported previously reported research indicating reductions in calls both to and from pharmacies for prescription orders. CONCLUSIONS: An examination of paid pharmacy claims from a large, national managed care organization demonstrated no differences between predominantly e-prescribers and traditional prescribers in measures of formulary compliance or generic drug utilization. Future studies should examine keystroke data at the point of care to observe more detail about drug selection methods.

Ambulatory Care Information Systems↗
PubMedDate not supplied

Consumer understanding and satisfaction associated with a 3-tier prescription drug benefit.

OBJECTIVE: The purpose of this research was to investigate consumer understanding and satisfaction associated with a 3-tier prescription drug benefit among users of the prescription drug benefit. METHODS: This study involved a self-administered postal questionnaire and the use of prescription drug claims to evaluate utilization of prescription medications. Fifteen hundred subjects were randomly selected based on the following inclusion criteria. Each subject had to (1) be enrolled in a 3-tier copayment ($10 generic, $20 formulary brand, $35 nonformulary brand) prescription drug benefit; (2) be the primary beneficiary (cardholder); (3) be >18 years of age; (4) have received at least 1 prescription medication using his or her prescription drug insurance; and (5) have a mailing address on file. RESULTS: A total of 479 usable responses were returned (35% response rate). The mean (SD) understanding score was 2.22 (1.54) (range: 0 to 6). Fewer than 1% of respondents correctly answered all 6 items used to measure the level of understanding. The mean (SD) satisfaction score was 54.32 (19.69) (range: 0 to 100). Experience with purchasing a medication within a particular copayment tier was predictive of correctly answering the item related to that tier.s copayment amount. Multiple regression analysis revealed a relationship between the amount of use of the drug benefit and the degree of satisfaction with the drug benefit. There was no significant relationship between the level of understanding and the degree of satisfaction with prescription drug insurance. CONCLUSION: The average level of beneficiary understanding of the 3-tier copayment prescription drug benefit was very low, and the average degree of respondent satisfaction appeared to be near neutral. There was no significant relationship between the level of understanding and the degree of satisfaction with prescription drug benefits. The level of understanding was proportional to the amount of drug benefit use, but the degree of satisfaction was not related to the amount of drug benefit use.

Adolescent↗
PubMedDate not supplied

Effect of patient notification of formulary change on formulary adherence.

OBJECTIVE: To evaluate the impact of patient notification of impending formulary changes on formulary adherence. METHODS: This pilot program in a large, Midwest-based health insurer utilized a randomized controlled trial research design. A list of 30 chronic-use medications that were to change formulary status were selected for the pilot. A review of adjudicated pharmacy claims records was performed to identify patients receiving one or more of the formulary change medications on the list. Members of 112 individual health plans of this large health insurer, all of whom were subject to the same drug formulary, were randomized to either the intervention (letter) or control arm. Patients in the intervention arm were sent a targeted communication that described the patient.s formulary change medication(s) and provided therapeutic option(s) for the formulary change medication(s). Pharmacy claims for patients in both arms were examined at 110 days after the date of the mailing to determine if there was a switch to a formulary alternative. Multivariate regression modeling was performed to adjust for baseline differences between the arms. RESULTS: A total of 7,247 unique formulary change medication regimens were identified (3,817 in the control arm and 3,430 in the letter arm) for 6,518 subjects (3,387 in the control arm and 3,131 in the letter arm). A higher proportion of formulary change medication regimens in the intervention arm were switched to a formulary alternative compared with the control arm (19.2% vs. 12.0%, P<0.001). After adjustment for baseline differences, regression modeling indicated that subjects in the intervention arm were 1.33 times more likely to switch to a formulary alternative (P<0.001). CONCLUSION: A letter-based, formulary change notification program is a pragmatic and effective strategy to increase drug formulary adherence. Such a program does not restrict access to medications but, rather, provides education and personalized information that may allow patients to participate more actively in their pharmacotherapy decision making.

Female↗