Importance of Adherence and Quality Measures for RA

Tampa—With the recent FDA approvals of new drugs to treat rheumatoid arthritis (RA) and updated guidelines, healthcare professionals have more information than ever about the disease. Still, speakers at a satellite symposium at the AMCP meeting noted that patient medication adherence remains a daunting challenge. This satellite symposium was supported by an educational grant from Genentech.

The consequences of poor adherence include reduced therapeutic benefits, poor health outcomes, decreased quality of life, and high costs, according to Babette Edgar, PharmD, partner, BluePeak Advisors. She added that adherence rates for RA drugs range from 30% to 80%.

Meanwhile, Gary Owens, MD, president, Gary Owens Associates, noted that if patients do not take their medications, they suffer from health complications, while payers must reimburse for relapses, readmissions, and other consequences of nonadherence. It is especially costly for chronic conditions such as RA and other inflammatory conditions, which accounted for 23% of the total specialty spending, according to the most recent Express Scripts drug trend report.

“The most expensive medication is the medication not taken,” said Dr. Owens, a former vice president of medical management and policy at Independence Blue Cross who now runs his own consulting firm in Pennsylvania.

In the United States, an estimated 1.3 million adults have RA, according to Dr. Owens. The disease is 2 to 3 times more common in women than it is in men. Patients with RA have a shortened life expectancy of 5 to 15 years and are twice as likely to have myocardial infarction or a cerebrovascular accident and 3 times as likely to have lymphoma than the general population.

Dr. Owens cited a study that estimated the direct costs associated with RA were $13,000 per patient in 2008, while indirect costs ranged from $1500 to $22,000 per patient. Furthermore, patients with the disease are 53% less likely to be employed, have 3.6 times as many sick days, and have an expected loss of $8957 in annual earnings. They also commonly have comorbid conditions, such as cardiovascular disease and depression.

Diagnosing and Treating RA Early

Mark Robbins, MD, MPh, rheumatologist, Harvard Vanguard Medical Associates, said it is important to diagnose RA early and treat the disease soon after diagnosis, because 50% to 70% of patients have radiographic damage within 2 years of symptom onset. However, he noted that it sometimes takes weeks or months for providers to diagnose RA.

Dr. Robbins mentioned the “treat-to-target” approach for dealing with RA, in which healthcare professionals monitor disease activity every 1 to 3 months until the pre-defined target is reached and then continue to keep track every 3 to 6 months. He said the treatment goal is typically remission or low disease activity.

There are several techniques to measure disease activity, including the Patient Activity Scale, the Routine Assessment of Patient Index Data 3, the Health Assessment Questionnaire, the Disease Activity Score in 28 Joints, and the Clinical Disease Activity Index. Dr. Robbins also mentioned the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) recently published guidelines on how to best treat the disease.  

The ACR recommends biologic disease-modifying antirheumatic drugs (DMARDs) as first-line options for early disease, while EULAR recommends DMARDs as second-line treatment. Both organizations recommend tumor necrosis factor inhibitors as first-line biologics.

The FDA has approved the following biologics as monotherapy for RA: adalimumab, etanercept, certolizumab, abatacept, tocilizumab, tofacitinib, and anakinra. New drugs for the disease include golimumab (an injectable medication that was FDA-approved in July 2013), tocilizumab (a subcutaneous medication that was FDA-approved in October 2013), and tofacitinib (an oral medication that was FDA-approved in November 2012).

Short-term studies of early RA suggest treatment with 3 DMARDs is as effective as taking a biologic and methotrexate, but Dr. Robbins warned that complex triple therapy regimens are associated with potential long-term adherence problems.

Comparative Effectiveness Research (CER) and Medicare Star Ratings

As of now, there are few head-to-head trials of RA drugs, but Dr. Edgar mentioned that the Patient Protection and Affordable Care Act (ACA) provided $1.1 billion to the National Institutes of Health, the Agency for Healthcare Research & Quality, and the Department of Health and Human Services (HHS) for CER.

The ACA also established the Patient-Centered Outcomes Research Institute (PCORI), an independent, nonprofit health research organization responsible for identifying priorities and establishing a research agenda for CER. Dr. Edgar noted that results of the PCORI-funded studies could not be used to determine or deny coverage or reimbursement for healthcare services.

Dr. Edgar said CER could be useful in RA because medical experts have a lack of data to make informed decisions on the best drugs for the disease. With CER, she said healthcare professionals could assess available evidence, compare benefits and harms of interventions, improve the formulary decision process, and potentially improve the quality of value of healthcare.

To improve quality and lower costs, the federal government has implemented a few initiatives such as the Medicare Star ratings that utilize the Healthcare Effectiveness Data and Information System (HEDIS) measures. All Medicare managed care plans are required to report on certain HEDIS measures. If plans fail to report or are judged to be deficient in certain areas, they could have their payments reduced or get terminated from Medicare.

The Medicare Star ratings are consistent with HHS’s National Quality Strategy, according to Dr. Edgar. They are in place to make care safer, ensure person and family centered care, promote the coordination of care, and make quality care more affordable through new healthcare delivery methods.

“We are on the right track [with quality initiatives], but we have a long way to go,” Dr. Edgar said.

Quality Demonstration Projects

Dr. Robbins mentioned that the Centers for Medicare & Medicaid Services established the Physician Quality Reporting System to encourage the reporting of quality measures. There are 6 measures specific to RA, and eligible healthcare professionals receive incentives and payments for participating in the program.

There are currently problems associated with treating the disease, according to Dr. Robbins. For instance, the use of DMARDs is often delayed, biologics are underutilized, disease assessment tools are not commonly used in clinical practice, and medication adherence is not assessed.

Meanwhile, Dr. Owens said challenges associated with RA include the high costs of specialty drugs, staying informed of new treatment approaches, and the disconnect between the pharmacy and medical benefits.