Evaluation of a possible predictor for Federal Joint Committee decisions on early benefit assessments according to the German act on the reform of the market for medicinal products.

OBJECTIVES: As of 1st January 2011 the German drug market is regulated by the act on the reform of the market for medicinal products (AMNOG). Since then the normal procedure for reimbursement of a new pharmaceutical is a benefit assessment by the joint federal committee (G-BA) which determines one of six additional benefit levels. METHODS: In order to evaluate a possible predictor of G-BA decisions, the 'evaluation of pharmaceutical innovations (EVITA)' score was calculated for 40 out of 63 dossiers and compared with published G-BA appraisals. RESULTS: Univariate ordinary least squares (p<0.001) and ordered logit regression (p=0.008) analyses show statistically significant correlations between EVITA scores and the G-BA additional benefit levels. Moreover, for the prediction of an additional benefit level of at least 'minor', an EVITA score cutpoint of ≥3 is associated with a sensitivity of 100% and a specificity of 80%. For the prediction of an additional benefit level of at least 'considerable', an EVITA score cutpoint of ≥7.5 is associated with a sensitivity of 100% and a specificity of 93.1%. CONCLUSION: The present investigation indicates that the EVITA score may have some potential to act as a possible predictor of G-BA decisions related to AMNOG early benefit assessments.

Drug coverage insurance as a novel element of private health insurance in Poland.

In recent years, there have been observed increased costs of health care in Poland. The patient's out of pocket expenses on drug have grown too. To the above, the insurance companies have offered patients drug coverage insurance policies since recently. Drug insurance policy covers the cost of purchasing pharmaceutical products not reimbursed by the National Health Fund is a modern product on the Polish health insurance market. The aim of the article is to characterize drug coverage insurance policies on the health insurance market in Poland. The Polish insurance market and entities offered these types of insurance are also presented.

Orals in the bundle: a policy framework.

Oral prescription drugs for treatment of bone and mineral disorders (phosphate binders and calcimimetics) in patients undergoing dialysis (i.e., those with ESRD) will be integrated into the Medicare Part B ESRD bundled payment system in 2016. Payment will be denied under Medicare Part D. Integrating Part D drugs into Part B payment at this level of scale lacks any policy precedent. Providers and patients have serious concerns about the potential for inadequate funding, and the Centers for Medicare & Medicaid Services (CMS) has been silent about the methods and other critical policy used to guide its decisions. We believe an adequate policy framework to support valuation of the targeted oral drugs depends on use of the most recent available Medicare Part D data, measurement of mean utilization for all target drugs based on a minimum of 6 months of complete data for prescriptions and dialysis treatments, use of appropriate price proxies to monetize drug volume to dialysis provider acquisition cost, adjustment to account for change in adherence due to change in patient out-of-pocket expenses, inclusion of valuation for dispensing and administrative cost, and a mechanism for adjusting payment to future changes in adherence.

The redistributive effect of the move from age-based to income-based prescription drug coverage in British Columbia, Canada.

OBJECTIVES: To explore the redistributive impact of two different pharmaceutical financing policies (age-based versus income-based pharmacare) on the distribution of income in British Columbia (B.C.), Canada. METHODS: Using household-level data on all payments that are used to finance prescription drugs in B.C. (including taxation and private payments), we performed a redistributive analysis to indicate how much income inequality in the province changed as a result of payments made for prescription drugs. We also illustrated changes in vertical equity (different treatment according to ability-to-pay) and horizontal equity (equals, according to ability-to-pay, being treated equally) between the two years separately through a pre-post policy examination. RESULTS: We found that payments made to finance prescription drugs increased overall income inequality in the province. This negative impact was larger after the move to income-based pharmacare. Our results also show increasing horizontal inequity after the policy change, and suggest that the increased reliance on out-of-pocket payments was a major source of the negative impact on the B.C.'s overall income distribution. We also show that the consequences of the move to income-based pharmacare would have been less severe had the level of public financing not decreased substantially between the two years. CONCLUSIONS: The increase in income inequality in B.C. following the policy change was an unintended consequence of the move to income-based pharmacare. This finding is worth consideration as countries and jurisdictions weigh pharmaceutical policy alternatives.

PBS reform - a missed opportunity?

The Pharmaceutical Benefits Scheme (PBS) reform package was announced in 2006 and was designed to save the government significant expenditure on the PBS through mandatory price cuts and price disclosure arrangements for multi-brand products. Perhaps most significantly, the formulary was spilt in two with no linkages between the formularies on either price or therapeutic outcome. This article examines the potential impact of these changes on the PBS and pharmaceutical policy in Australia more broadly.

Pricing and reimbursement of pharmaceuticals in the Czech Republic and Sweden.

OBJECTIVES: To describe and compare price regulation and reimbursement in the Czech Republic and Sweden. METHODS: Legal documents, government reports, statutory information, annual reports and scientific articles were searched using the keywords: pharmaceutical market regulation, drug policy, drug pricing, drug reimbursement and patients' participation in costs concerning both countries. Approaches to regulation and regulatory steps concerning prices were compared between the countries. MAIN OUTCOME MEASURE: (i) Institutional responsibilities in pricing and reimbursement of pharmaceuticals; (ii) principles of patients' participation in costs on pharmaceuticals. RESULTS: Substantial differences were found in terms of pricing. In the Czech Republic, the Ministry of Finance sets maximal prices for pharmaceuticals whereas in Sweden there is a process of price regulation combined with reimbursement decisions taken by the Pharmaceutical Benefits Board. Together with a system of state-owned pharmacies, this ensures that drug prices in Sweden are fixed at the same level throughout the country. In the Czech Republic, prices may differ, since only maximal price levels are set. In both countries, decisions about reimbursement are taken at the national or state level whereas insurance funds or county councils are responsible for covering costs. The private share of pharmaceutical expenditures is substantially lower in the Czech Republic, even though there is no maximal level for patient's co-payment, as there is in Sweden. CONCLUSION: Differences in price setting and some other regulations of the pharmaceutical market were found. Both systems are designed to promote rational use of pharmaceuticals; and are based on social solidarity.

Ley de garantías y uso racional de los medicamentos y productos sanitarios. 1. Comentarios generales / Garanties Law and rational use of drugs and medical devices. 1. General comments

Se inicia una serie de comentarios sobre la Ley de garantías y uso racional de los medicamentos y productos sanitarios que empieza con una introducción que incluye el sumario o índice general comparativo con el de la anterior Ley del medicamento de 1990 y su estructura general

It is initiated a series of commentaries above the Guaranties Law and rational use of drugs and medical devices to begin by a introduction with the summary either general index comparative with the previous Drugs Law 1990, and the structure

Impact of administrative restrictions on antibiotic use and expenditure in Ontario: time series analysis.

OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSIONS: 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.

Reference pricing for drugs: is it compatible with U.S. health care?

To control spending on prescription drugs, health insurance systems abroad have experimented in recent years with a novel form of patient cost sharing called "reference pricing." Under this approach, the insurer covers only the prices of low-cost, benchmark drugs in therapeutic clusters that are deemed to be close substitutes for one another in treating specific illnesses. Patients who desire a higher-price substitute in a cluster must then pay the full difference between the retail price of that drug and the reference price covered by the insurer. This paper explores the difficult trade-offs that policymakers must make in designing such a system, drawing where relevant from experience abroad.

Medicaid and indigent care issue brief: Medicaid: benefits and services: year end report-2003.

Medicaid provides health care insurance for low-income children, some parents who meet income thresholds, pregnant women, the elderly and the disabled. In order to receive federal funds for Medicaid, each state must offer coverage for the following health care services: inpatient and outpatient hospital services; physician services; medical and surgical dental services; nursing facility services; home health care services; family planning services; rural health clinic services; laboratory and x-ray services; pediatric and family nurse practitioner services; federally qualified health center services; nurse-midwife services; and early and periodic screening, diagnosis and treatment (EPSDT) services for individuals under age 21. States can also choose to cover certain additional services under their Medicaid plans, and these often include prescription drugs, dental services (nonmedical or surgical), clinic services, and vision and hearing services. It is up to each state to decide what optional services to include with the mandated services to create their Medicaid benefit package.

Medicaid and indigent care issue brief: Medicaid: provider reimbursement: year end report-2003.

Medicaid provider reimbursement rates have been a hot topic for the last several years. Thirty states, including California, Hawaii, Indiana, Maryland, Mississippi, New York and Wisconsin, addressed the issue in the 2001 legislative session while 33 states enacted legislation dealing with provider reimbursement in 2002.