Multiple Sclerosis and Managed Care Pharmacy

San Francisco—With the costs associated with multiple sclerosis (MS) rising, health plans are having a difficult time managing the disease. Many plans are placing more of the financial burden on patients, which has led to decreased medication adherence.

According to speakers at the AMCP meeting, the conundrum could continue and even become more worrisome in the coming years as the FDA is expected to approve a few more expensive MS drugs. They spoke during a satellite symposium titled Toward Individualized, Patient-Centered Therapy for Multiple Sclerosis: The Role of Managed Care Pharmacy.

Robert P. Navarro, PharmD, president of Navarro Pharma, said approximately 400,000 people in the United States have MS, with the disease affecting 2 times as many women as men. MS is associated with $28 billion annually in direct medical and productivity cost.

Although the etiology of MS is unknown, Dr. Navarro said “this is a confusing disease” and “the exact cause is a mystery.” He added that drug therapy has been effective at treating episodes. Still, drug costs have increased 20% to 40% recently, and some are as high as $50,000 per year.

Dr. Navarro said managed care professionals must balance clinical and cost decisions, but he admitted “it’s always a challenge.”

“[MS] is a burden for health plans,” Dr. Navarro said. “It’s an expensive disease to treat.”

One way plans deal with growing MS costs, according to Dr. Navarro, is utilizing specialty pharmacies to manage the disease, partly because they typically provide patient-centric, outcomes-oriented therapy management programs. At approximately $40 per member per year, MS is already often the second most expensive specialty pharmacy category. In the next 5 to 8 years, Dr. Navarro predicted, specialty pharmacy will account for 50% of total pharmacy spending.

Plans are increasing their use of coinsurance for specialty drugs covered under the medical benefit. Dr. Navarro cited data from the EMD Serono Specialty Digest, 7th Edition that found 47% of commercial plans had no cost sharing for this class of drugs in 2010 compared with 63% in 2009 and 70% in 2008. In addition, 40% of Medicare Advantage plans had no cost sharing for specialty drugs covered under the medical benefit in 2010, compared with 48% in 2009 and 64% in 2008.

New MS drugs often cost as much as $3,000 to $4,000 per month. Thus, even if patients only pay 10% of the costs, it is still difficult for many of them.

“The ability to pay is often not possible,” Dr. Navarro said. “That’s a problem.”

However, Dr. Navarro said most manufacturers of MS drugs offer members financial assistance if cost sharing contributes to decreased medication adherence. He also mentioned the Partnership for Prescription Assistance, an organization that provides the uninsured or patients without prescription coverage access to 475 public and private patient assistance programs.

MS Treatment Options

Daniel Kantor, MD, medical director at Neurologique, followed with an overview of the FDA-approved therapies for MS. He said MS affects the central nervous system and is found in 1 out of 1000 people. When diagnosing the disease, patients undergo a physical exam, lumbar puncture, and a magnetic resonance imaging exam with gadolinium, and they are asked their family’s MS history. However, he added “most people live and die without even knowing they had multiple sclerosis.”

The following drugs are approved to treat the disease: interferon beta-1a (30 mcg administered intramuscularly weekly); interferon beta-1a (44 mcg administered subcutaneously [SC] 3 times per week); interferon beta-1b (250 mcg administered SC daily); glatiramer acetate (20 mg administered SC daily); natalizumab (300 mg administered intravenously monthly); and fingolimod (0.5 mg administered orally daily). The above-mentioned drugs are also approved as an auto-injection, according to Dr. Kantor. He said mitoxantrone is also FDA-approved, but the drug is not often used and has been associated with heart problems.

Dr. Kantor also discussed MS drugs that could soon gain FDA approval: BG-12, laquinimod, and teriflunomide, which are administered orally, and alemtuzumab, which is administered intravenously. In 2 phase 3 trials, patients taking BG-12 twice daily or 3 times daily had significant decreases in annualized relapse rates compared with placebo, and there were significant increases in the proportion of relapse-free patients. The incidence of serious infections was similar across the treatment groups, and there was no evidence of increased malignancy with BG-12.

Two phase 3 trials found patients taking alemtuzumab had significantly lower annualized relapse rates compared with interferon beta-1a administered SC. The drugs had similar serious adverse events (18.4% in alemtuzumab vs 14.4% in SC interferon beta-1a). Of the patients taking alemtuzumab, 99% had infusion reactions, but none were life-threatening or fatal. The reactions included headache, rash, nausea, hives, fever, itching, insomnia, and fatigue.

A pair of phase 3 trials also found laquinimod had a significantly lower annualized relapse rate compared with placebo as well as a significant decrease in 3-month and 6-month Expanded Disability Status Scale progression. Of the patients in the laquinimod group, 22.2% experienced serious adverse events compared with 16.2% in the placebo group.

Another phase 3 trial examined 1080 patients with relapsing-remitting MS or secondary progressive MS. The groups that took 7-mg or 14-mg daily doses of teriflunomide had significantly lower annualized relapse rates and fewer combined unique active lesions compared with the placebo group. Side effects associated with teriflunomide included nasopharyngitis, alopecia, nausea, and diarrhea.

Specialty Pharmacy Overview

Atheer A. Kaddis, PharmD, vice president of managed markets at Diplomat Specialty Pharmacy, concluded the session with an overview of specialty pharmacy. He said in 2011 there was >$100 billion in specialty pharmacy drug spending, with most coming under the medical benefit, although more could come under the pharmacy benefit in the future.

According to Dr. Kaddis, the amount of money health plans spent on traditional drugs in the past 5 years has remained consistent, and even declined in some cases, whereas specialty pharmacy spending has increased 15% to 25% in the same time period. Specialty drugs represent 25% of spending today, but Dr. Kaddis estimated they would represent 40% in 2015 and 50% in 2020.

Dr. Kaddis said managed care pharmacy would play an increasing role in MS in the coming years, particularly with more oral therapies expected to gain FDA approval. He cited a 2009 study that found the average cost of an MS relapse was $4682.

Some strategies Dr. Kaddis suggested for managing MS included screening for depression since it is a comorbidity of MS and can be exacerbated by some therapies; collaborating on case management programs; and providing the pharmacy and therapeutics committee with support on MS therapies and recommendations on utilization management.