Specialty medications constitute the fastest-growing segment of drug spending under the pharmacy benefit. This study evaluated the impact of a specialty pharmacy prior authorization (PA) program on prescription drug costs for biologic response modifiers (BRMs) used in the treatment of persons with rheumatoid arthritis, juvenile rheumatoid arthritis, Crohn disease, ankylosing spondylitis, psoriatic arthritis, psoriasis, and other spondyloarthropathies. A retrospective, case-control, one-to-one matching approach based on patient age, sex, and client characteristics was used. Case clients were enrolled in the specialty pharmacy PA program from January 1 through December 31, 2005. The control group consisted of clients who were not enrolled in the program during this time. The average costs per eligible member per month (PMPM), for the total, plan, and member were $1.32, $1.29, and $0.03, respectively, in the case group, and $1.44, $1.41, and $0.03, respectively, in the control group. Clients who implemented the specialty pharmacy PA program for BRMs saved an estimated total cost of $0.12 PMPM. Implementing a specialty pharmacy PA program reduced BRM costs. (Drug Benefit Trends. 2008;20:26-31)
Specialty pharmaceuticals are costly and are typically administered by either injection or infusion to manage complex conditions, including multiple sclerosis (MS), rheumatoid arthritis (RA), hepatitis C, hemophilia, and some forms of cancer.1
Specialty medications constitute the fastest-growing segment of drug spending under the pharmacy benefit. They represent a relatively new area of prescription medications with generally smaller patient populations. 2 Although the percentage of persons taking specialty medications is less than 3%, these patients account for 25% to 30% of total medical costs for private health care payers.3
According to the Pharmaceutical Research and Manufacturers of America, the annual cost of specialty medications is "growing 2 times faster than traditional ambulatory drug products."4 Annual spending on these medications has exploded from $22 billion in 2001 to an estimated $40 billion in 2005 and is expected to reach as high as $1.7 trillion by 2030.5 With the introduction of more costly treatments, it is becoming increasingly important to manage these treatments effectively, especially in the ambulatory care setting. Payers are becoming alarmed by the expanding uses of specialty medications, which are increasingly being prescribed to manage more common conditions, such as RA, psoriasis, and even asthma, with prevalence estimates of 1%, 2.2%, and 6.7%, respectively.6-9
As more specialty medications become available and costs increase, plans and PBMs are implementing a variety of strategies to manage the use of specialty medications and control costs, including use of tiered formularies, step therapy, and prior authorization (PA). The high cost of specialty medications also puts patients at risk for increased cost-sharing and higher out-of-pocket payments. Ensuring appropriateness of therapy and access to medications is a challenge.10
Biologic response modifiers (BRMs) are among the most commonly used specialty medications. They are used mostly for the treatment of persons with RA.11 RA, a chronic autoimmune inflammatory disease associated with significant pain, joint destruction, and loss of mobility, typically follows a variable course characterized by exacerbations, remissions, and variable outcomes. Most patients require medical treatment to control disease flare-ups.
According to the Arthritis Foundation, RA affects more than 2 million US persons. The incidence of RA increases with age. This disease has significant economic consequences for patients and plans, with direct health care costs averaging 2 to 3 times more than costs for persons without RA.12,13 More than 9 million doctor visits and 250,000 hospitalizations per year are attributed to RA.14 The economic costs associated with RA are high, approximating those of coronary heart disease.15,16 The direct and indirect medical costs for RA in the United States were estimated at $26 billion to $32 billion per year (in 1998 dollars).17
BRMs have the potential to reduce inflammation and structural damage to joints by blocking the action of cytokines, proteins that trigger inflammation during a normal immune response.14,18 Generally, BRMs are recommended for use in patients with moderate to severe active RA who have failed to respond to an adequate trial of an oral disease-modifying antirheumatic drug (DMARD). BRMs, such as anakinra (Kineret) and adalimumab (Humira), can be added to DMARD regimens.14,18
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