BOSTON, Massachusetts—Newly available data from the pilot project used as a model for the Medicare Part D drug benefit suggests that “specialty tiering” allowed in the Medicare drug program may slam rheumatoid arthritis (RA) patients with unexpectedly high costs for biologics. Although designed to reduce financial barriers and improve health outcomes, the cost shifting provisions in Medicare Part D plans may be having the opposite effect, according to the new analysis in the June issue of Arthritis Care & Research.¹

“As more biologic DMARDS are approved and used for RA and more plans use the specialty tier system, both beneficiaries and Medicare face costs that they may be increasingly unable to afford,” conclude researchers who were led by Jennifer M. Polinski, MPH, MS, of Brigham and Women’s Hospital in Boston.

“Specialty tiering” likely to leave RA biologics out of reach for many

In 2003, Congress created the Medicare Replacement Drug Demonstration (MRDD) to provide temporary drug insurance until the start of Medicare Part D in 2006. The MRDD targeted Medicare patients who did not have comprehensive drug insurance coverage. This program had similar cost-sharing arrangements to Medicare Part D. Analyses of MRDD found that it reduced costs and improved health outcomes.

Unfortunately, Medicare Part D plans can place costly biologics in a specialty tier, where they are subject to higher patient cost sharing and thus may be too expensive for many patients.

The researchers followed almost 15,000 patients who were enrolled in the MRDD as they transitioned into Part D in 2006. Patients were grouped into three drug coverage options: enrollment in a Part D plan (which was further stratified by a Medicare Advantage or stand-alone plan), other creditable coverage, or unknown coverage. They examined the benefit design of each plan, as well as potential differences in beneficiaries’ annual out-of-pocket costs for biologic DMARDs under these three coverage scenarios.

Overall, 81% of Medicare beneficiaries with RA who participated in the MRDD program had enrolled in Part D plans by July 2006. Medicare Advantage plans offered lower deductibles, lower premiums, and were more likely to require fixed copayments, when compared with stand-alone Part D plans. Medicare Advantage plans also placed significantly fewer restrictions on reimbursement for biologics.

Most RA patients enrolled in plans that placed biologics on high-cost specialty tiers, and about 75% of plans required copayments for these drugs.  

Part D plans that require coinsurance shift the financial burden of biologics from the plan to the patient and to Medicare. “Patients assume up to 28 percent and Medicare assumes more than 58 percent of the costs of biologic DMARDs in our scenarios, yet neither is in a position to sustain such financial burden,” the authors conclude.

This can have dire consequences on health outcomes, they write. In plans where cost sharing is high, patients may delay or not even begin therapy due to the high cost and in plans with cost sharing that is steep but manageable, RA patients may begin therapy only to discontinue it. “Neither scenario is optimal for patients who may benefit from biologic DMARDs,” the authors point out.

Translating research into practice: MDs should advocate for RA patients

Rochelle Rosian, MD, a rheumatologist at Cleveland Clinic Foundation in Cleveland, Ohio is all too familiar with the high cost of biologics and the shrinking patient populations that can afford to pay for these potentially life-saving drugs.

“Drug companies are coming up with creative ways to help, but most of the time our patients are going on and off their medications and not taking them the way that they are supposed to,” she told MSKreport.com. “We are seeing more of [this behavior] this year.”

Rheumatologists can help by discussing all treatment options with their patients and letting them know about any cost-saving opportunities such as grants from pharmaceutical companies or the benefits of opening a medical savings account. “Try and make sure your staff is knowledgeable on helping patients work with pharmaceutical companies,” she added.

“As a physician, you always want to treat your patients the best they can be treated,” she said. “Let them know their options and tell them what medications you think they should be on and within reason, you should help them obtain those medications,” she said. “We can’t make assumptions that a drug is too expensive.”

Reference

1. Polinski JM, Mohr PE, Johnson L. Impact of Medicare Part D on access to and cost sharing for specialty biologic medications for beneficiaries with rheumatoid arthritis. Arthritis Care & Research. 2009;61:745-754.