Barriers to receipt of novel oral oncolytics: A single-institution quality improvement investigation.

INTRODUCTION: Novel oral oncolytic agents have become the standard of care and first-line therapies for many malignancies. However, issues impacting access to these drugs are not well explored. As part of a quality improvement project in a large tertiary academic institution, we aim to identify potential barriers that delay treatment for patients who are prescribed novel oral oncolytics. METHODS: This was a retrospective review of adults who were newly prescribed a novel oral oncolytic for Food and Drug Administration-approved indications at a single tertiary care center. Patients were identified via electronic prescription data (e-Scribe). Demographics, insurance information, and prescription dates were extracted from the electronic medical record and pharmacy claims data. Statistical analyses were performed to determine whether time-to-receipt was associated with insurance category, pharmacy transfers, cost assistance, and drug prescribed. RESULTS: Of the 270 successfully filled prescriptions, the mean time-to-receipt was 7.3 ± 10.3 days (range: 0-109 days). Patients with Medicare experienced longer time-to-receipt (9.1 ± 13.1 days) compared to patients with commercial insurance (4.4 ± 3.3). Uninsured patients experienced the longest time-to-receipt (15.7 ± 7.8 days) overall. Pharmacy transfers and cost assistance programs were also significantly associated with longer time-to-receipt. Ten prescriptions remained unfilled 90 days after the study period and were considered abandoned. CONCLUSION: Insurance has a significant effect on the time-to-receipt of newly prescribed novel oral oncolytics. Pharmacy transfers and applying for cost assistance are also associated with longer wait times for patients. Our retrospective analysis identifies areas of improvement for future interventions to reduce wait times for patients receiving novel oral oncolytics.

Canada's New Generic Pricing Policy: A Reasoned Approach to a Challenging Problem.

Alberta, quickly followed by other Canadian provinces, has introduced a new pricing model for generic drugs, in which prices are inversely related to the number of generic manufacturers of the drug. This paper examines the rationale for the new policy.

National evaluation of prescriber drug dispensing.

OBJECTIVE: To describe the legal, professional, and consumer status of prescribers dispensing legend and over-the-counter drugs in the United States. METHODS: Legal and academic databases were searched to identify those states that permit prescribers to dispense medications to patients and any limitations on such practice. In addition, prescribers and patients-consumers were surveyed to learn about the prevalence and perceptions of such practice. The use of drug samples was explicitly excluded from the study. MAIN RESULTS: Surveys were obtained from 556 physicians, 64 NPs, and 999 patient-consumers of drugs dispensed by prescribers. Forty-four states authorize prescriber dispensing. Midlevel practitioners (i.e., NPs and physician assistants) are authorized to dispense in 43 states. Thirty-two states do not require dispensing prescribers to compete additional registration to dispense medications, and 30 states require some level of compliance with pharmacy practice requirements. Prescriber dispensing is common, independent of patient age or insurance coverage. Prescriber dispensing appears driven by physician and patient perceptions of convenience and cost reductions. Future dispensing is likely to increase due to consumers' satisfaction with the practice. Consumer self-reported adverse drug reactions (ADRs) were equivalent between pharmacist- and physician-dispensed drugs, but urgent and emergency clinic ADR consultations were slightly lower with physician dispensing. CONCLUSIONS: Prescriber dispensing is firmly entrenched in the U.S. health care system, is likely to increase, does not appear to increase ADRs, and may reduce urgent care and emergency department visits. The reduction in urgent care and emergency department visits requires further study to confirm these preliminary findings.

State generic substitution laws can lower drug outlays under Medicaid.

To stem the rising costs of medications provided to patients enrolled in Medicaid, states have implemented varying policies about generic substitution. These policies differ in the extent to which pharmacists or patients can influence which medications they choose. Using national Medicaid data, we evaluated the relationship between different generic substitution policies and the use of generic simvastatin, a cholesterol-lowering drug, after the patent for the brand-name equivalent, Zocor, expired. States that implemented policies requiring patients' consent prior to generic substitution experienced rates of substitution that were 25 percent lower than those of states that did not require patient consent. By eliminating patient consent requirements, state Medicaid programs could expect to save more than $100 million in coverage for three top-selling medications that are nearing patent expiration. Although these consent requirements are probably intended to increase patient autonomy, policy makers should consider the sizable opportunity costs.

Good research practices for measuring drug costs in cost effectiveness analyses: an industry perspective: the ISPOR Drug Cost Task Force report--Part V.

OBJECTIVES: The industry perspective on drug costs should be framed by the need for decision-makers to use actual and relevant costs, and to inform real-world decisions regarding medication selection and use. The objective of this report is to provide guidance and recommendations on how manufacturers should approach the use of drug costs. METHODS: The Task Force was appointed with the advice and consent of the ISPOR Board of Directors. Members were experienced developers or users of drug cost information working in academia and industry, and came from several countries. Following the core assumptions developed and outlined by the Task Force, a draft report was prepared. Comments were solicited on the outline and several draft reports both from a core group of external reviewers and more broadly from the ISPOR membership of ISPOR via the ISPOR Web site. RESULTS: The industry should always strive for: 1) a focus on drug value and not just cost; 2) credibility-that is correct and consistent costs; 3) transparency-by disclosing the prices and costs, and ensuring that they reflect the actual cost of the drug whenever possible; and 4) providing actionable results that help customers comprehend the value offered by a drug therapy and to use products more efficiently and effectively. CONCLUSIONS: Understanding and accounting for all costs and consequences of the use of a medical treatment is in the best interests of all parties involved in the prescribing, consuming, reimbursement, selling, and manufacturing of bio/pharmaceuticals. Transparency, consistency, and clear communication of costs and value are essential for appropriate decision-making and should be important goals for all parties.

Good research practices for measuring drug costs in cost-effectiveness analyses: a societal perspective: the ISPOR Drug Cost Task Force report--Part II.

OBJECTIVES: Major guidelines regarding the application of cost-effectiveness analysis (CEA) have recommended the common and widespread use of the "societal perspective" for purposes of consistency and comparability. The objective of this Task Force subgroup report (one of six reports from the International Society for Pharmacoeconomics and Outcomes Research [ISPOR] Task Force on Good Research Practices-Use of Drug Costs for Cost Effectiveness Analysis [Drug Cost Task Force (DCTF)]) was to review the definition of this perspective, assess its specific application in measuring drug costs, identify any limitations in theory or practice, and make recommendations regarding potential improvements. METHODS: Key articles, books, and reports in the methodological literature were reviewed, summarized, and integrated into a draft review and report. This draft report was posted for review and comment by ISPOR membership. Numerous comments and suggestions were received, and the report was revised in response to them. RESULTS: The societal perspective can be defined by three conditions: 1) the inclusion of time costs, 2) the use of opportunity costs, and 3) the use of community preferences. In practice, very few, if any, published CEAs have met all of these conditions, though many claim to have taken a societal perspective. Branded drug costs have typically used actual acquisition cost rather than the much lower social opportunity costs that would reflect only short-run manufacturing and distribution costs. This practice is understandable, pragmatic, and useful to current decision-makers. Nevertheless, this use of CEA focuses on static rather than dynamic efficacy and overlooks the related incentives for innovation. CONCLUSIONS: Our key recommendation is that current CEA practice acknowledge and embrace this limitation by adopting a new standard for the reference case as one of a "limited societal" or "health systems" perspective, using acquisition drug prices while including indirect costs and community preferences. The field of pharmacoeconomics also needs to acknowledge the limitations of this perspective when it comes to important questions of research and development costs, and incentives for innovation.

Good research practices for measuring drug costs in cost-effectiveness analyses: Medicare, Medicaid and other US government payers perspectives: the ISPOR Drug Cost Task Force report--Part IV.

OBJECTIVES: Public programs finance a large share of the US pharmaceutical expenditures. To date, there are not guidelines for estimating the cost of drugs financed by US public programs. The objective of this study was to provide standards for estimating the cost of drugs financed by US public programs for utilization in pharmacoeconomic evaluations. METHODS: This report was prepared by the ISPOR Task Force on Good Research Practices-Use of Drug Costs for Cost-Effectiveness Analysis Medicare, Medicaid, and other US Government Payers Subgroup. The Subgroup was convened to assess the methodological and practical issues confronted by researchers when estimating the cost of drugs financed by US public programs, and to propose standards for more transparent, accurate and consistent costing methods. RESULTS: The Subgroup proposed these recommendations: 1) researchers must consider regulation requirements that affect the drug cost paid by public programs; 2) drug cost must represent the actual acquisition cost, incorporating any rebates or discounts; 3) transparency with respect to cost inputs must be ensured; 4) inclusion of the public program's perspective is recommended; 5) high cost drugs require special attention, particularly when drugs represent a significant proportion of health-care expenditures for a specific disease; and 6) because of variations across public programs, sensitivity analyses for actual acquisition cost, real-world adherence, and generics availability are warranted. Specific recommendations also were proposed for the Medicare and Medicaid programs. CONCLUSIONS: As pharmacoeconomic evaluations for coverage decisions made by US public programs grows, the need for precise and consistent estimation of drug costs is warranted. Application of the proposed recommendations will allow researchers to include accurate and unbiased cost estimates in pharmacoeconomic evaluations.

Effects of the German reference drug program on ex-factory prices of prescription drugs: a panel data approach.

This paper examines effects of the German social health insurance system's reference drug program (RDP) for prescription drugs on ex-factory prices. Moreover, we analyze whether manufacturers adapt prices of their products that are not subject to reference pricing as a consequence of changes in reference prices of their products that are subject to reference pricing. We use econometric panel data methods based on a large panel data set of nearly all German prescription drugs on a monthly basis between October 1994 and July 2005. They provide information on ex-factory prices, reference prices, manufacturers, type of prescription drug, and market entries and exits. Our results show that there is no full price adjustment: A 1%-change in reference prices leads to a 0.3%-change in market prices. Price adjustment, however, is fast - it mostly happens in the first month. Furthermore, the first introduction of a reference price reduces market prices of the affected products by approximately 7%. Finally, we observe a significant time effect that is positive in the market without reference prices and negative in the market with reference prices.

AMCP Guide to Pharmaceutical Payment Methods.

The methods by which the U.S. health care system pays for prescription drugs have been subject to much attention and increased scrutiny in recent years. In particular, ground-breaking legislation has been enacted and regulations implemented that have changed the basis for payment for prescription drugs in the Medicare and Medicaid programs, and a number of precedent-setting court cases are likely to result in further modifications to drug payment methods used by public and private payers. These developments will have significant implications for many stakeholders beyond public and private payers; they will affect consumers' access to drugs, payment to pharmacists and other providers of drugs, and spending for the health care system as a whole. Recent debate centers on determining the most appropriate basis for calculating how payers, including government, employers, and health plans, should pay pharmacists and other providers for drugs. Historically, payment for prescription drugs has been based on benchmark prices that do not necessarily reflect the actual acquisition costs paid by providers, primarily pharmacists, physicians and hospitals. This has led policymakers to believe that Medicare and Medicaid have paid more than is necessary for prescription drugs, contributing to excess spending in public programs. Thus, in an effort to reform the payment system and reduce drug expenditures, policymakers have made changes to the benchmarks used by public programs to pay for drugs. Private payers are beginning to follow their lead by changing their own payment methods and benchmarks. However, the drug purchasing and distribution system within the United States is highly complex and involves multiple transactions among myriad stakeholders, including drug manufacturers, distributors, third-party payers, pharmacists, physicians, and patients. Any change in payment methods or benchmarks has significant implications for all stakeholders, affecting the payments and prices to and from each of these groups. Knowledge of the intricate distribution and payment systems for prescription drugs is essential in order to ensure that payment reform results in desired outcomes such as fair and equitable payment to providers while avoiding unintended consequences such as reduced access to drugs. The Academy of Managed Care Pharmacy (AMCP) recognized the need to help stakeholders and policymakers better understand, evaluate and navigate the profound changes occurring in payment for prescription drugs in the United States. This AMCP Guide to Pharmaceutical Payment Methods offers a comprehensive examination of the methodologies and price benchmarks that have been used in the public and private sector to pay for pharmaceuticals in the U.S., the changes that have occurred or are likely to occur in the future, and the forces that are behind these changes. AMCP has made every effort to make the Guide an unbiased presentation of information, issues, and implications.

Impact of reference-based pricing for histamine-2 receptor antagonists and restricted access for proton pump inhibitors in British Columbia.

BACKGROUND: Two programs to reduce expenditures for common gastrointestinal drugs were introduced simultaneously by British Columbia (BC) Pharmacare in 1995. Reference-based pricing restricted reimbursement for all histamine-2 receptor antagonists (H2RAs) to the cost of the least expensive H2RA available, generic cimetidine. Special authority restricted reimbursement for proton pump inhibitors (PPIs) to patients who met certain eligibility criteria. We evaluated the effect of reference-based pricing for H2RAs and special authority for PPIs on dispensing and reimbursement for senior citizen beneficiaries of BC Pharmacare. METHODS: Itemized monthly claims data for upper gastrointestinal drugs were obtained from BC Pharmacare for all beneficiaries 65 years of age or older. Periods before and after implementation of reference-based pricing and special authority were compared with respect to defined daily doses dispensed per 100,000 beneficiaries, BC Pharmacare reimbursement per 100,000 beneficiaries, BC Pharmacare reimbursement per defined daily dose and beneficiary contributions per defined daily dose. We used regression models to project forward trends in expenditures observed before implementation of the new policies and hence to estimate accrued cost savings. RESULTS: Before reference-based pricing and special authority, the numbers of defined daily doses that were dispensed and total BC Pharmacare reimbursements for H2RAs appeared to be declining gradually, whereas those for PPIs were rising. With reference-based pricing, the monthly defined daily dose of cimetidine dispensed increased more than 4-fold, to 116,257 per 100,000 beneficiaries, while those of other restricted H2RAs decreased by more than half, to 50,927 per 100,000 beneficiaries. Special authority immediately reduced the dispensed volumes of PPIs by one-fourth, but growth in volume then appeared to resume at its previous rate. The estimated annualized cost savings achieved by reference-based pricing and special authority were $1.8 million to $3.2 million for H2RAs (depending on the estimation method used) and $5.5 million for PPIs. However, beneficiary contributions for H2RAs increased from negligible amounts to approximately 16% of total drug expenditures. INTERPRETATION: Reference-based pricing and special authority appear to have been successful in altering prescribing habits and reducing provincial expenditures for upper gastrointestinal drugs, but they have increased the financial burden on senior citizen beneficiaries.

Outcomes of reference pricing for angiotensin-converting-enzyme inhibitors.

BACKGROUND: In January 1997, reference pricing for angiotensin-converting-enzyme (ACE) inhibitors for patients 65 years of age or older was introduced in British Columbia, Canada. For medications within a specific class, insurance covers the cost up to the reference price, and patients pay the extra cost of more expensive medications. Although reference pricing may reduce the costs of prescription drugs, there is concern that patients may switch to less effective medications or stop treatment. METHODS: We analyzed data from the Ministry of Health on all 37,362 residents of British Columbia who were 65 or older and were enrolled in the provincial health insurance program, received ACE inhibitors priced higher than the reference price of $27 a month in 1996, and were potentially affected by the new policy. We identified 5353 residents who switched to an ACE inhibitor not subject to cost sharing during the first six months and compared them with 27,938 residents who received only ACE inhibitors subject to cost sharing. RESULTS: Reference pricing for ACE inhibitors was not associated with changes in the rates of visits to physicians, hospitalizations, admissions to long-term care facilities, or mortality. The probability of stopping antihypertensive therapy decreased as compared with the probability before the change in policy (relative risk, 0.76; 95 percent confidence interval, 0.65 to 0.89). Eighteen percent of patients who had been prescribed ACE inhibitors subject to cost sharing switched to lower-priced alternatives. As compared with patients who did not switch, those who did had a moderate transitory increase in the rates of visits to physicians (rate ratio, 1.11; 95 percent confidence interval, 1.07 to 1.15) and hospital admissions through the emergency room (rate ratio, 1.19; 95 percent confidence interval, 0.99 to 1.42) during the two months after switching, but not subsequently. CONCLUSIONS: We found little evidence that when reference pricing for ACE inhibitors was introduced in British Columbia, patients stopped treatment for hypertension or that health care utilization and costs increased.

Compliance among pharmacies in California with a prescription-drug discount program for Medicare beneficiaries.

BACKGROUND: Several states have developed prescription-drug discount programs for Medicare beneficiaries. In California, Senate Bill 393, enacted in 1999, requires pharmacies participating in the state Medicaid program (Medi-Cal) to charge customers who present a Medicare card amounts based on Medi-Cal rates. Because Medicare beneficiaries may not be accustomed to presenting their Medicare cards at pharmacies, we assessed the compliance of pharmacies with Senate Bill 393. METHODS: Fifteen Medicare beneficiaries who received special training and acted as "standardized patients" visited a random sample of pharmacies in the San Francisco Bay area and Los Angeles County in April and May 2001. According to a script, they asked for the prices of three commonly prescribed drugs: rofecoxib, sertraline, and atorvastatin. The script enabled us to determine whether and when, during their interactions with pharmacists or salespeople, the discounts specified in Senate Bill 393 were offered. Pharmacies at which the appropriate discounts were offered were considered compliant. RESULTS: The patients completed visits to 494 pharmacies. Seventy-five percent of the pharmacies complied with the prescription-drug discount program; at only 45 percent, however, was the discount offered before it was specifically requested. The discount was offered at 91 percent of pharmacies that were part of a chain, as compared with 58 percent of independent pharmacies (P<0.001). Compliance was higher in the San Francisco Bay area than in Los Angeles County (84 percent vs. 72 percent, P=0.004) and was higher in high-income than low-income neighborhoods (81 percent vs. 69 percent, P=0.002). A Medicare beneficiary taking all three drugs would have saved an average of $55.70 per month as compared with retail prices (a savings of 20 percent). CONCLUSIONS: Discounts required under California's prescription-drug discount program for Medicare beneficiaries offer substantial savings. Many patients, however, especially those who use independent pharmacies or who live in low-income neighborhoods, may not receive the discounts.

Impact of reference-based pricing of nitrates on the use and costs of anti-anginal drugs.

BACKGROUND: Reference-based pricing limits reimbursement for a group of drugs that are deemed therapeutically equivalent to the cost of the lowest-priced product within that group. We estimated the effect of reference-based pricing of nitrate drugs used for long-term prophylaxis on prescribing of and expenditures on nitrates and other anti-anginal drugs dispensed to senior citizens in British Columbia. METHODS: We assessed trends in the monthly volume of prescriptions of anti-anginal drugs and the associated drug ingredient cost paid by the province's publicly funded drug subsidy program, Pharmacare, and by the patients themselves for the period April 1994 to May 1999. Trends in monthly rates of nitrate expenditures per 100,000 senior citizens before the introduction of reference-based pricing were extrapolated to infer what expenditures would have been without the policy. RESULTS: During the 3 1/2 years after reference-based pricing was introduced, Pharmacare expenditures on nitrates prescribed to senior citizens declined by $14.9 million (95% confidence interval $10.7 to $19.1 million). Most of these savings were due to the lower prices that Pharmacare paid for sustained-release nitroglycerin tablets and the nitroglycerin patch, which were the 2 most frequently prescribed nitrates before the introduction of reference-based pricing; $1.2 million (8%) of the savings represented expenditures by senior citizens who purchased drugs that were only partially reimbursed. There were no compensatory increases in expenditures for other anti-anginal drugs. Use of sublingual nitroglycerin--a marker for deteriorating health in patients with angina--did not increase after the introduction of reference-based pricing. The nitroglycerin patch is now the most frequently prescribed nitrate, owing to the fact that Pharmacare resumed the provision of full subsidies for the drug after its manufacturers voluntarily reduced retail prices. INTERPRETATION: Evidence to date suggests that reference-based pricing of nitrates has achieved its primary goal of reducing drug expenditures. The effects of this policy on patient health, associated health care costs and administrative costs remain to be investigated.