Limited options to manage specialty drug spending

Research brief 04/2012;
Source: PubMed


Spending on specialty drugs—typically high-cost biologic medications to treat complex medical conditions—is growing at a high rate and represents an increasing share of U.S. pharmaceutical spending and overall health spending. Absence of generic substitutes, or even brand-name therapeutic equivalents in many cases, gives drug manufacturers near-monopoly pricing power and makes conventional tools of benefit design and utilization management less effective, according to a new qualitative study from the Center for Studying Health System Change (HSC). Despite the dearth of substitutes, cost pressures have prompted some employers to increase patient cost sharing for specialty drugs. Some believe this is counter-productive, since it can expose patients to large financial obligations and may reduce patient adherence, which in turn may lead to higher costs. Utilization management has focused on prior authorization and quantity limits, rather than step-therapy approaches--where lower-cost options must first be tried--that are prevalent with conventional drugs. Unlike conventional drugs, a substantial share of specialty drugs--typically clinician-administered drugs--are covered under the medical benefit rather than the pharmacy benefit. The challenges of such coverage--high drug mark-ups by physicians, less utilization data, less control for health plans and employers--have led to attempts to integrate medical and pharmacy benefits, but such efforts are still in early development. Health plans are experimenting with a range of innovations to control spending, but the most meaningful, wide-ranging innovations may not be feasible until substitutes, such as biosimilars, become widely available, which for many specialty drugs will not occur for many years.

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    ABSTRACT: Objectives Novel specialty biopharmaceuticals hold promise for patients living with complex and chronic conditions. However, high research and development costs, special handling, and other necessary enhancements to patient support programs all contribute to frequently higher prices for these products. This study sought to assess the value of specialty pharmaceuticals through an examination of the clinical, functional, and economic benefits of these treatments for the top 3 disease areas by pharmaceutical spend: rheumatoid arthritis (RA), multiple sclerosis (MS), and breast cancer (BC). Study Design Systematic literature review. Methods A systematic review of market research and cost-effectiveness articles was conducted for each disease area to assess clinical, functional, and economic outcomes associated with specialty medicine treatments versus the previous standard of care. Results All RA clinical (American College of Rheumatology) and functional (Health Assessment Questionnaire) outcome articles were classified as positive. The median cost-effectiveness ratio was $38,900 per quality-adjusted life year (QALY). All MS clinical outcome (relapse rate) articles were positive. The MS functional outcome (Expanded Disability Status Scale) findings were less conclusive. The median cost-effectiveness ratio was $248,000 per QALY. The majority of BC articles yielded statistically inconclusive results for survival. All functional outcome (Quality of Life Questionnaire- Core 30) articles were positive. The median cost-effectiveness ratio was $51,900 per QALY. Conclusions Novel specialty therapies hold promise for arresting disease progression and improving quality of life for the 3 conditions associated with the highest specialty pharmaceutical spend. These findings demonstrate a strong value proposition for specialty pharmaceuticals, and suggest even greater potential individual patient benefit with consideration of patient heterogeneity.
    No preview · Article · Jun 2014 · The American journal of managed care
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    ABSTRACT: With increased innovation and development of specialty pharmaceuticals, the US and global healthcare industries are looking to implement appropriate management strategies to control both utilization and costs. Specialty pharmaceuticals are high-cost medications that treat complex, chronic, rare, and difficult-to-manage conditions. These drugs require special drug handling, appropriate clinical outcomes monitoring, and effective cost controls. The primary scope of this article is to discuss various strategies being implemented for specialty pharmaceutical utilization and cost management and correlated outcomes in the USA; these outcomes include enhanced health insurance plan benefit designs with formulary modifications and greater patient cost burden. Additional methods to manage specialty pharmaceuticals include the use of specialty pharmacies for drug distribution, increased emphasis on coordination of care and evidence-based medicine, as well as healthcare reform and regulations. Healthcare spending, both in the US and globally, continues to increase, with a rising proportion of drug spend towards specialty pharmaceuticals. Continued specialty pharmaceutical innovation and introduction of biosimilar products will evolve the currently utilized management strategies for these drugs.
    Preview · Article · Aug 2014 · PharmacoEconomics
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    ABSTRACT: Objectives: At the University of Illinois Hospital and Health Sciences System (UI Health), patients with chronic gastrointestinal conditions receive outpatient care through a clinical practice model integrated with a pharmacist working both in the clinic and specialty pharmacy call center. The pharmacist performs routine efficacy and safety monitoring, provides patient education, ensures medication insurance coverage and acquisition, and optimizes adherence. The objective of this paper was to describe the pharmacist’s multiple roles within the gastroenterology clinic, with a focus on self-injectable biologic therapies used for patients with inflammatory bowel disease. Study Design: This is a descriptive paper with adherence data. Methods: A retrospective chart review was conducted from January 1, 2008, to December 31, 2013 to assess the pharmacist’s impact on medication adherence. Patients 18 years or older initiated on self-injectable biologic therapy with a minimum of 4 consecutive prescription refills at UI Health pharmacy for each calendar year were included. Refill history data was collected. Adherence was determined through medication possession ratio (MPR) and data was analyzed using SAS software. Results: The MPR for patients who receive prescriptions for self-injectable biologics at UI Health averaged 90%. In addition to optimizing adherence rates, the pharmacist provides patient education, assists with acquisition of biologics, and provides close monitoring for the efficacy and safety of biologic therapy. Conclusions: Within the integrated clinical practice model, the pharmacist provides comprehensive optimal patient care. Meaningful clinical outcomes data are warranted in future studies to further evaluate the pharmacist’s impact.
    No preview · Article · Sep 2015