NASP: As RA Specialty Drug Use Rises, Technology and Collaboration Will Be Key to Management

By 2018, the sale of specialty drugs is expected to surpass the sales of traditional agents.

Inflammatory disease, including rheumatoid ar­thritis (RA), is the most expensive specialty category under the pharmacy benefit, Jeffrey Dunn, PharmD, MBA, chief clinical officer and senior vice president of Veridicus Health/VRx Pharmacy Services, LLC told attendees at the 2015 NASP Annual Conference. Currently, 1.3 million Americans are living with RA, which carries a total annual excess direct cost of $22.3 billion in the United States.

Standard treatment for RA consists of disease-modifying antirheumatic drugs (DMARDs), including methotrexate, while newer therapies include biologic agents such as etanercept and abatacept. However, current practice is often suboptimal—patients are often delayed in treatment or are undertreated, which may contribute to uncontrolled inflammation and irreversible tissue damage. Patients who are not referred to a rheumatologist are less likely to receive DMARD therapy within 12 months of symptom onset.

The increasing number of biologic agents have created additional challenges, including a need for standardized outcome measures used in clinical practice; additional understanding of the cause of variation of drug efficacy between patients; and guidelines on how biologics should be compared to optimize RA treatment outcomes. Additional­ly, physicians, patients, and plan managers need better data to compare effectiveness. The importance of understanding the optimal use of these agents is magnified by their high cost.

Specialty pharmacists may be able to provide solutions to some of these challenges by confirm­ing  patients are seen by a rheumatologist, provid­ing education to patients and practitioners, and participating in disease management programs. Specialty pharmacists can also obtain prior authoriza­tions, ensure step-by-step therapy, determine dose and regimen limits and make appropriate changes, assess for comorbidities, and monitor patients for treatment safety and efficacy.

RA is a prime target for comparative effectiveness research (CER), largely because of the high budget impact and lack of clear clinical superiority among biologic alternatives. The best way to use CER in formulary and benefit design and evaluate without head-to-head trials, Dr Dunn explained, is to identify key trials, evaluate the drug benefit minus the pla­cebocebo benefit over a defined timeframe of appropriate outcome measures, determine appropriate costs, divide cost into the drug benefit, and compare the cost to achieve a predefined response, such as “How much do we pay for an outcome with all of the drugs?” Currently, this is not the reality of CER in formulary and benefit design. 

The impact of drug formulary or benefit design decisions on health outcomes is generally not measured and patients are not currently part of the formulary decision-making chain. Reassessments of drugs for inclusion, exclusion, or change in position are infrequently performed, Dr Dunn said. Evaluation of the real-world ability of drugs to improve outcomes requires technology that effectively integrates all stakeholders.

“We have to do things differently in order to man-age these significant specialty trends,” Dr Dunn said.  “Initiatives that we should be evaluating now include novel benefit designs, including value-based, which includes patient assistance programs and multiple specialty tiers; channel management; site of care; and integrated care management, including specialty medication therapy management (MTM). Specialty MTM should be multifactorial and focus on appropriate utilization and concomitant use of DMARDs. Biosimilars potentially play an important role in managing RA.  If they are priced attractively, it will allow us to contract the category differently (ie, by disease state rather than by drug), which would allow us to prefer and cover more cost-effective medications.  Information technology, shared risk, and collaboration among all stakeholders will be the keys to successfully managing specialty drugs in the future.”—Mary Mihalovic