ABSTRACT
Over the past decade, we have witnessed unprecedented, groundbreaking innovation in pharmaceuticals. This has been particularly true in oncology, where new therapies have increased survival and at times offered clinical cure. However, the impact of these promising treatments has been attenuated by persistent access and cost challenges that may limit their effect. A narrative has emerged that many of these so-called breakthroughs are not priced according to the value they provide. Traditional cost-effectiveness analyses would appear to support these doubts, often suggesting that innovative therapies do not represent value for money. However, there is a case to be made that innovative therapies require equally innovative value assessments. To explore this emerging viewpoint, this article provides a brief introduction to the current value debate and oncology-specific considerations when assessing elements of value. We offer a brief background on the nature and development of quality-adjusted life-years as a part of cost-effectiveness analyses and some of their key limitations; a primer on "novel" elements of value, which capture specific aspects of patient and societal preferences not included in quality-adjusted life-years; and their applicability to oncology including discussion on areas where further thought and research might be needed. We conclude with a potential checklist of novel elements of value that should be considered. DISCLOSURES: This Viewpoints article was funded by Novartis, Inc., which also provided funding to COVIA Health Solutions for manuscript development. The sponsor was involved in developing the manuscript. Kamal-Bahl and Puckett are employees of COVIA Health Solutions, a consulting firm that provides services to biopharmaceutical clients, trade organizations, and foundations. Kamal-Bahl holds stock in Merck and Pfizer. Singh is an employee of Novartis Pharmaceuticals. Willke received personal fees from COVIA Health Solutions for work on the manuscript.
Subject(s)
Medical Oncology , Cost-Benefit Analysis , Humans , Quality-Adjusted Life YearsABSTRACT
BACKGROUND: Linezolid is a novel oxazolidinone antibiotic that is effective for the treatment of gram-positive bacterial infections. The oral formulation has the potential to reduce length of stay (LOS) when used as a substitute for parenteral glycopeptide antibiotics. In a recent multinational trial comparing linezolid (i.v. followed by oral administration) with teicoplanin (i.v. alone or switched to i.m. administration), linezolid was found to have better efficacy (P = 0.005) and similar safety for treating serious gram-positive infections. OBJECTIVE: The purpose of this study was to compare hospital resource use (primarily LOS) and cost of treatment between linezolid and teicoplanin for hospitalized patients with serious gram-positive infections in South America and Mexico using data from the multinational trial. METHODS: In a multinational, Phase IIIb, open-label, comparator-controlled trial, data were collected from hospitalized patients in centers in 6 South America can countries and Mexico with suspected or confirmed serious gram-positive infections. Patients were randomly assigned to receive i.v. linezolid 600 mg BID (for the entire treatment period [7-28 days] or switched to oral linezolid 600 mg BID) or i.v. teicoplanin (for the entire treatment period or switched to i.m. teicoplanin) dosed per approved prescription information. Data on direct medical resource utilization were collected for each patient, including duration and doses of study medication, location of hospitalization and LOS, comedications, tests and procedures, and outpatient service usage. Unit costs for the medical resources were obtained from secondary sources. RESULTS: A total of 203 patients (97 treated with linezolid and 106 treated with teicoplanin) were enrolled from these 7 countries. The unadjusted results showed that compared with teicoplanin, patients treated with linezolid had a 3.1-day shorter mean i.v. antibiotic treatment duration (P < 0.001), a 2.0- to 2.2-day shorter median and mean LOS (P = 0.03), and a 311 US dollars lower mean total cost of treatment (P = NS). After controlling for age, race, sex, site of infection, inpatient location when the antibiotic treatment started, number of historical and current comorbidities, and whether the patient had a diagnosis of systemic inflammatory response syndrome or sepsis, the multivariate adjusted results were similar to the unadjusted results. The linezolid group had a 1.6-day shorter adjusted LOS or 66% greater odds of early discharge (P = 0.049) and a 335 US dollars lower adjusted mean total cost of treatment (P = NS). CONCLUSION: Linezolid was associated with shorter LOS and duration of IV antibiotic treatment than teicoplanin for serious gram-positive infections in the population studied. Linezolid therapy has the potential to reduce the total cost of treatment.