Michael Dickson

Key factors in the rising cost of new drug discovery and development

The public desire for new therapies, their increasing cost and the increased role of government as a payer for innovative new drugs all converge on the issue of the rapidly rising cost of new drug development — now thought to be greater than US

Compliance with antihypertensive therapy in the elderly: a comparison of fixed-dose combination amlodipine/benazepril versus component-based free-combination therapy.

800 million — and highlight the necessity for an efficient use of resources. With this in mind, here we review studies on the cost of developing new drugs and consider how this cost has, and could be, affected by the changing environment for pharmaceutical research and development.

Pharmaceutical Reference Prices: How do They Work in Practice?

BackgroundTreatment regimens that require fewer dosage units and less frequent dosing to decrease the complexity and cost of care are among the strategies recommended to improve compliance with antihypertensive therapy. Simplifying therapy may be particularly important for elderly patients, who are more likely to have co-morbid conditions and to be taking multiple medications.ObjectiveTo determine rates of compliance with antihypertensive therapy and total costs of care among elderly Medicaid recipients treated with fixed-dose combination amlodipine besylate/benazepril versus a dihydropyridine calcium channel antagonist and ACE inhibitor prescribed as separate agents (free combination).Study designA longitudinal, retrospective, cohort analysis of South Carolina Medicaid claims for ambulatory services, hospital services, Medicare crossover, and prescription drug for the years 1997–2002. Follow-up was 12 months from the index date, defined as the first prescription dispensing date for a study drug.PatientsSouth Carolina Medicaid beneficiaries aged ≥65 years.Main outcome measureOutcomes variables included compliance defined as the medication possession ratio (MPR), which was the total days’ supply of drug (excluding last prescription fill) divided by the length of follow-up (with number of hospital days subtracted from the numerator and denominator). We hypothesized that elderly individuals receiving fixed-dose combination amlodipine besylate/benazepril HCl would be more compliant with therapy than those receiving a dihydropyridine calcium channel antagonist and ACE inhibitor as free combination.ResultsThere were 2336 individuals in the fixed-combination group and 3368 in the free-combination group. The mean age was 76.0 ± 7.2 years, and 82.6% were female. Compliance rates were significantly higher with fixed-dose versus free-combination therapy (63.4% vs 49.0%; p < 0.0001). The average total cost of care for patients receiving the fixed-dose combination was

Cross-Sectional Analysis of the Relationship Between National Guideline Recommended Asthma Drug Therapy and Emergency/Hospital Use Within a Managed Care Population

US3179 compared with

Medication possession ratio: implications of using fixed and variable observation periods in assessing adherence with disease-modifying drugs in patients with multiple sclerosis

US5236 (2002 values) for the free-combination regimen. In multivariate regression analyses on the log of total cost of care, average total costs increased by 0.5% for each 1-unit increase in MPR, and for each additional co-morbidity (measured by the chronic disease score) there was an increase of 10.4%. However, average total costs were reduced by 12.5% for patients using fixed-dose versus free-combination therapy (p < 0.003).ConclusionUse of fixed-dose amlodipine besylate/benazepril HCl by elderly Medicaid recipients was associated with improved compliance and lower healthcare costs compared with a dihydropyridine calcium channel antagonist and ACE inhibitor prescribed as separate agents.

An Empirical Reply to Empiricism: Protective Measurement Opens the Door for Quantum Realism

Reference pricing systems are reimbursement ceilings set by payers in an effort to constrain pharmaceutical expenditure for a private or public drug benefit. In recent years, many governments have adopted reference pricing either as a replacement or in addition to product specific price controls. Programme administrators should consider whether these policies are providing the intended benefits or whether there may be a more effective method.This article provides a review of reference pricing in Europe, North America and other countries. There are many similarities in the reference price policies but the markets to which they apply are more likely to be different. The European experience gives a ‘once-for-all’ lowering effect on pharmaceutical expenditure, often at the expense of compromises on prescribing. In Germany and The Netherlands, reference pricing has been relatively ineffective in lowering expenditure which has led to a succession of other interventions to achieve expenditure control goals.The US also has reference pricing, but it occurs in a very competitive market which may be responsible (at least in part) for the relatively modest growth in expenditure compared with European countries. The review of countries with reference pricing policies suggests that such policies are less effective than competitive markets in moderating pharmaceutical expenditure. Nonetheless, governments continue to pursue reference pricing strategies.

Economic benefit of a 1-day reduction in hospital stay for community-acquired pneumonia (CAP)

BACKGROUND Nationally recognized clinical guidelines provide recommended therapies for the treatment of asthma. Research demonstrating the impact of guideline recommended drug therapy on utilization [emergency department (ED) and hospitalizations] is beneficial when considering these guidelines for managing asthmatics within a managed care setting. OBJECTIVE The purpose is to determine the relationship between ED/hospital claims and selected asthma drug therapies as recommended by the National Asthma Education Program Expert Panel and the National Heart, Lung, and Blood Institute/ World Health Organization Workshop. METHODS The analysis is a retrospective, cross-sectional study within a managed care organization (MCO), serving 359,464 patients in the state of Florida. Asthma patients from all lines of business (Medicaid, Medicare, commercial) were stratified into subgroups based on the type of drug therapy utilized. Members included were those identified as having at least one prescription filled for an asthma medication between January 1, 1995 and June 30, 1995 and at least six consecutive months of enrollment within the health plan. Pharmacy and medical claims data were collected over a 1.5-year study period (January 1, 1995 through June 30, 1996) to assure follow-up on utilization was at a minimum 6 months and maximum 1.5 years. Outcomes were measured based on patient utilization of tertiary medical services (asthma-related ED and hospital visits) through claims. RESULTS Total membership within the Florida MCO, reflected 359,464 members of whom 5.2% were identified as asthmatic. The asthma members were reviewed based on pharmacy claims data, identifying 26.2% of the members utilizing inhaled corticosteroids concomitantly with a short-acting beta2-agonist. Upon further review of this subset, 85% were utilizing short-acting beta2-agonists in quantities at or below recommended dosages. Patients not utilizing the beta2-agonist therapy according to the recommended dosing guidelines had a significantly higher incidence (P = .001) of ED and hospital use. The remaining asthma population was reviewed, identifying 33.2% of the members utilizing short-acting beta2-agonists alone. This subset revealed 97.6% were utilizing therapy according to the beta2-agonist dosing guidelines. Patients not utilizing the beta2-agonist therapy according to dosing guidelines had a significantly higher incidence (P = .016) of ED and hospital use. CONCLUSION Assessment of asthma therapy in a managed care population demonstrates that there is a lower proportionate use of the ED and hospital in those patients treated in accordance to the asthma guideline recommendations.

Potential drug–drug interactions with antiepileptic drugs in Medicaid recipients

Background The purpose of this study was to compare two methods of adherence calculation using administrative data for patients with multiple sclerosis (MS) who are prescribed disease-modifying drugs. Methods Pharmacy-billed disease-modifying drug prescription claims were selected from the 2007–2008 LifeLink™ Health Plan Claims Database. The index date was the first disease-modifying drug prescription claim. Two cohorts were created: all patients with a disease-modifying drug claim in 2007 and a subset with continuous eligibility for 12 months post-index. Adherence was calculated across all disease-modifying drugs for 12 months post-index. Medication possession ratios (MPRs) with variable (start to end of therapy) and fixed (365 days) duration denominators were calculated. Variable MPR was calculated by summing days supply from the first to the last prescription (inclusive) divided by time between the last prescription date plus days supply and the first prescription date. Variable MPR was evaluated for all patients and the continuously eligible cohort. Fixed MPR used the same numerator but divided by 365 days of follow-up and evaluated only for the continuously eligible cohort. Results There were 3405 patients with MS and a disease-modifying drug claim in 2007 and 2145 in the continuously eligible cohort. Means for variable MPR ranged from 87.5% ± 16.6% for the continuously eligible cohort to 90.5% ± 16.0% for the 2007 cohort. The comparable value for fixed MPR was 78.0% ± 28.2% for the continuously eligible cohort. Fixed MPR gave a consistently lower rate of adherence than variable MPR at an 80% adherence threshold. Conclusion Different adherence measures can yield different outcomes, especially when using different eligibility criteria. These results demonstrate the importance of full disclosure of methods used for calculations and specification of the study population.

Quantum Logic Is Alive ∧ (It Is True ∨ It Is False)

Quantum mechanics has sometimes been taken to be an empiricist (vs. realist) theory. I state the empiricists argument, then outline a recently noticed type of measurement--protective measurement--that affords a good reply for the realist. This paper is a reply to scientific empiricism (about quantum mechanics), but is neither a refutation of that position, nor an argument in favor of scientific realism. Rather, my aim is to place realism and empiricism on an even score in regards to quantum theory.

Trends in Neutropenia-Related Inpatient Events

Abstract Objective: As a component of healthcare reform, payers, hospital administrators, and physicians are looking for ways to reduce hospital expenditures and improve efficiency. The economic benefit of a reduced hospital stay must be weighed against the cost of the treatment or process necessary to achieve the reduced length of stay (LOS). The objective of this paper was to estimate the potential economic benefit of a reduction in inpatient hospital LOS for a common type of admission, community acquired pneumonia (CAP). Research design and methods: Data for this study were from the CAP hospital admissions selected from the 2006 Healthcare Cost and Utilization Project (HCUP) National Inpatient Sample (NIS). Potential savings associated with a 1 day reduction in CAP LOS were estimated using three methods: (1) average cost, (2) weighted-average incremental cost of an additional day, and (3) weighted-average predicted mean costs from regression models which were used to estimate incremental cost adjusting for hospitalization characteristics. Main outcome measures: Cost per day of CAP hospitalization. Results: A total of 1,471,295 CAP admissions qualified for the analysis. The cost for each day of reduction in LOS in 2009 US dollars was