Multiple Sclerosis Remains a Top Concern for Costly Disease Management

Boston—Multiple sclerosis (MS) is the most common chronic disease affecting the central nervous system in young adults, and it continues to be a costly burden on the healthcare system in terms of treatment options. During a satellite symposium presented at the AMCP meeting, a panel of speakers discussed implementing evidence-based treatment regimens, new care models, and strategies for managing patients with MS. The satellite symposium was supported by educational grants from Genzyme Corporation, a Sanofi company; Novartis Corporation; and Teva Pharmaceutical Industries Ltd.

Fred D. Lublin, MD, FAAN, FANA, Saunders Family professor of neurology, director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine, Mount Sinai, New York, opened the
session, noting that there are >2.5 million cases of MS worldwide and approximately 400,000 cases in the United States. Approximately 45% of MS cases present when the patient is between 20 and 50 years of age.

Dr. Lublin said MS is the most variable of the serious neurological diseases. “What we do not have yet is marker(s) to determine disease course,” said Dr. Lublin, stressing the importance of starting therapy at the first sign of MS activity rather than opting to wait for subsequent activity. “Treat early,” Dr. Lublin said. “We have the data to support that.”

Treatment Options and Selection Process
While 10 agents have been approved for MS and with many in the pipeline, Dr. Lublin said, “We do not have [a treatment algorithm for MS]. There is no 1 agent that everyone should start on,” thus recommending an individualized approach. Speaking as a physician, Dr. Lublin said the most important considerations for choosing a treatment course for patients with MS are efficacy, safety, side effects and tolerability, and costs—“In that order,” he said.

When selecting 1 treatment over another, comparative head-to-head trials are the best, but Dr. Lublin noted that those are lacking. He said mechanism of action is important in selecting a treatment option because comorbidities, prior therapies, and pregnancy all play a role in determining the best treatment for each patient. Dr. Lublin stressed that since women who are in their childbearing years are more often affected by MS, family planning needs to be discussed in order to prescribe the best course of treatment.

Dr. Lublin concluded by stressing the importance of collaboration between the physician and patient to discuss long-term adherence; drug safety, efficacy, and convenience; and medical monitoring for adherence. “All [MS] agents require monitoring,” he emphasized.

New Healthcare Initiatives Impacting MS Care
Bruce Sherman, MD, FCCP, FACOEM, consulting corporate medical director, Walmart Stores, Inc., medical director, Employers Health Coalition, continued the presentation, noting how the implications of the Patient Protection and Affordable Care Act have impacted MS care management. Through a shift to value-based care, Star rating systems emphasizing coordinated care, and patient-centered medical homes (PCMHs) and accountable care organizations, an emphasis has been placed on organizational structures that support proactive, patient-centered care, quality improvement, and clinical integration. “Love it or hate it, healthcare reform has changed delivery models,” said Dr. Sherman, emphasizing that MS requires a multidisciplinary approach to management involving all stakeholders.

Dr. Sherman noted that PCMHs enhance the benefits of primary care, and MS is among the top chronic conditions most often treated by primary care physicians (PCPs), with 77% of MS care being carried out by PCPs.

In the management of patients with MS, adherence is key. Between 17% and 40% of patients cease their disease-modifying therapies within 1 year of initiation. This can be due to a perceived lack of efficacy, adverse events, and depression, as 41% of patients had new or increased depression within 6 months of treatment initiation.

Dr. Sherman noted that depression is also a side effect of MS medications. He said cost is becoming another medication adherence barrier for patients.

Dr. Sherman said there are a number of factors related to patient adherence, including the following patient factors:
• Depression, anxiety, phobia
• Fatigue
• Cognitive status
• Patient attitude and beliefs (realistic therapeutic expectations)
• Active lifestyles
• Patient–physician relationship/teamwork

Physicians also impact patient adherence in ways such as:
• Lack of clear instructions from physicians
• Inappropriate patient education regarding expectations
• Lack of attention to side effects
• Limited access to care management support
• Reactive follow-up care

“Maybe there is a problem with the delivery system [and] we cannot just blame patients,” said Dr. Sherman.

A Payer’s Perspective
Jeffrey D. Dunn, PharmD, MBA, senior vice president, VRx Pharmacy Services, LLC, editorial advisory board member, First Report Managed Care, wrapped up the session with information from a payer’s standpoint. Dr. Dunn joked, “Hepatitis C is the best thing to happen to MS,” as recently approved costly hepatitis C medications have temporarily taken the focus off of MS treatment costs. Dr. Dunn said there have been significant price increases in MS therapies over the years, and it has become difficult to discuss the management of this disease state.

As the growth of specialty drug spending in commercial plans continues with coverage shifted out of the medical benefit, it is projected that by 2018, traditional and specialty drug spending will be split equally, with 50% in each. “Five percent of our members will be driving 50% of the spend,” said Dr. Dunn.

He cautioned that all stakeholders need to work together to manage this disease state, “Or our system will run out of money, quite literally.” In addition, he said, “Specialty is scaring us to death. If we do not manage this, we will be in trouble in the next 2 to 3 years.”

MS is second in terms of per-member, per-year (PMPY) pharmacy spending among specialty categories, with $37.98 PMPY costs, behind inflammatory conditions at $50.62 PMPY costs. Even more alarming, PMPY costs are expected to double in the next 4 years. “It is going to get worse before it gets better,” said Dr. Dunn.

According to the presentation, 78% of plans have prior authorizations for MS drugs, while 63% of plans have preferred drugs. In addition, 19% of plans have a National Drug Code (NDC) block, which means “1 in 5 [plans] block drugs,” said Dr. Dunn, who also warned that NDC blocks will continue to grow. Also, 36% of plans use online step-edits, and 27% of plans use cost-sharing and tiered copayments to cover MS costs.

“Right now payers have all the risk,” said Dr. Dunn, noting that pharmaceutical companies, patients, and providers have little to no risk when it comes to MS treatment and adherence. “What should we [be] asking our members to do in order for us to pay for the medications?” asked Dr. Dunn. He conceded, “We cannot push all of these costs back on patients. Benefit designs need to be addressed.”

Dr. Dunn listed the potential factors that contribute to decision-making for MS formularies:
• Efficacy
• Safety
• Productivity, satisfaction, and quality of life
• Physician support
• Budget impact
• Pharmacy benefit manager, physician, and
pharmacist contracts
• Discounts and rebates
• Cost-effectiveness
• Disease management programs
• Acquisition costs
• Willingness to pay
• Policies and public image

“This is why MS is a tough to control disease state,” said Dr. Dunn, noting that cost is not the only factor that should contribute to formulary decisions. Dr. Dunn said there should be goals implemented for specialty pharmacy management of MS drugs (Table).

Cost Containment
With a number of MS drugs in the pipeline, Dr. Dunn also said biosimilars would likely come to this disease state, though not for a few years. However, “We have to plan for [biosimilars now]; it takes years to change benefits,” said Dr. Dunn.

He presented a multifaceted benefit design approach that can lead to cost savings through specialty drug management. Drug dispensing can save 1% to 3%, utilization management can lead to 5% to 7% in savings, coordination of care can save 5% to 10%, and contracting activities can lead to 10% to 15% in savings. This collectively can lead to 10% to 20% in savings, “Which can lead us to gain or lose a customer [group],” said Dr. Dunn.

In conclusion, an integration of data, better planning for the future, examining benefits, and collaboration and communication between all healthcare stakeholders can help to improve cost and care management for MS.—Kerri Fitzgerald