Balancing Biologics With Managed Care Considerations: Advancing Therapeutic Strategies for Chronic Diseases

Thursday morning at the AMCP Annual Meeting & Expo featured an educational session entitled "Biologic Therapies for Chronic Diseases: Factors Influencing Treatment Decisions," that was hosted by Robert P. Navarro, PharmD, a clinical professor at the University of Florida College of Pharmacy in Gainesville, FL. Along with his colleagues on stage, James T. Kenney, Jr., RPh, MBA, the pharmacy operations manager of Harvard Pilgrim Health Care, Inc, and Gary M. Owens, MD, the president of Gary Owens Associates, Navarro introduced his presentation, "Review of Different Types of Biologics Including FDA Approved Indications and Expanded Indications Across Multiple Disease." Biologicals, he began, are "novel, life-altering and -saving therapies" that are now a growing portion of today's drug pipeline. The disease states that have benefited from the use of biologicals include cancer, hepatitis C virus infection , HIV/AIDS, multiple sclerosis, autoimmune diseases such as rheumatoid arthritis (RA), and orphan/rare diseases. However, he said, new biologic therapies are often very expensive with major safety considerations, and therefore, appropriate utilization and cost-containment are primary concerns for plan sponsors and insurers.

Navarro continued by saying that biologicals are increasing in availability and targeting novel indications, but are simultaneously contributing to substantial healthcare expenditures. Statistics published in 2012 indicate that biologic agents constitute 40% of total pharmacy costs, 70% of total drug trend, and an estimated 50% of medical benefit costs. Navarro indicated that in the years following the initial FDA-approval of several biologicals, such as adalimumab and etanercept, many of those biologicals were able to receive FDA approval for multiple indications. Furthermore, the clinical successes of biologicals have driven a flourishing drug pipeline, with numerous agents in development for chronic disorders, such as RA, psoriatic arthritis, and Crohn's disease. Consequently, clinical management strategies have adjusted to appropriate the use of biologic agents, drive medication adherence, promote safety monitoring, and share costs between patients and payers.

Taking the podium next was James T. Kenney, Jr., whose presentation, "Discussion of Recent Clinical Data on Current and Emerging Biological Therapies: Evaluate Their Clinical Relevance Including Key Risks/Benefits and Costs Associated with Biologic Therapy," began with a discussion of RA as a model for appropriating the utilization of biologicals in disease management. The goals of autoimmune treatment, Kenney stated, are to target the appropriate patients, treat earlier in the disease course, inhibit disease progression, delay structural damage, induce remission/prevent relapse, and maximize dosing options. In the case of RA, Kenney pointed out that the American College of Rheumatology recommends early therapeutic intervention to improve clinical outcomes and reduce the accrual of joint damage and disability, thereby preventing patients with RA from reaching a chronic and erosive disease state. Furthermore, according to an analysis of international biologics registries and the US claims database, an estimated 30% of patients with RA are treated with biologic monotherapy. In an effort to combat the high costs associated with biologic therapies, management strategies for specialty drugs have been implemented, such as pharmacy prior authorization, clinical care management, 30-day supply limits, preferred products and formulary, pharmacy step therapies, cost-sharing tiers, restricted medical benefit coverage, and tracking outcomes. Medication nonadherence is always a concern in the management of chronic illnesses because it is associated with increased out-of-pocket costs, comorbidities, and adverse effects, and decreased drug efficacy. As a larger number of specialty and biologic drugs continue to be developed, achieving the lowest levels of disease activity and remission has become increasingly more feasible; however, specialty drug utilization must be done in a cost-effective manner.

Up next was Gary M. Owens, MD, whose presentation was titled, "Case Scenarios: Evaluate Emerging Management Strategies That Have Been Shown to Improve Long-term Patient Outcomes and Minimize Adverse Effects." The current environment for payers and providers has witnessed an increased government presence, as well as an increased emphasis on outcomes and quality that may ultimately drive patient decisions and choices of health plans in the coming future. In regards to specialty pharmaceuticals, as treatments for autoimmune diseases and inflammatory bowel disease are often the largest specialty spending category, many plans are looking to optimize patient outcomes in a cost-effective manner. Evolving concurrently are treatment guidelines, and as an example, Owens noted that 2012 guidelines for RA now recommend more aggressive and earlier treatments with biologics and/or combination therapy in contrast to the traditional disease-modifying antirheumatic drugs. A discussion from the treat-to-target (T2T) expert committee for the treatment of RA revealed that the evidence-based approach is a shared decision between the patient and rheumatologist with a primary goal of maximizing long-term health-related quality of life through symptomatic control, the prevention of structural damage, normalization of daily function, and social participation. With validated measures and assessment metrics, the adoption of T2T protocols may offer an opportunity to strengthen the optimal management of specialty drugs and biological utilization.