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P&T Snapshot

A Survey on Managing Multiple Sclerosis

The Managed Care Perspective
Mari Edlin
Peter Sonnenreich MA

Teva Neuroscience, in cooperation with the National Multiple Sclerosis Society, surveyed 109 managed care organizations (MCOs), representing medical and pharmacy directors and clinical pharmacists from health maintenance organizations (HMOs) and preferred provider organizations (PPOs). The responses have been compiled into The Multiple Sclerosis Trend Report.1

The study explores pharmacy benefit design for managing multiple sclerosis (MS); cost and utilization-management strategies; the use of specialty pharmacy; and views on a variety of oral therapies for MS. The report also captures the opinions of pharmacy benefits managers, specialty pharmacies, neurologists, and employers. This P&T Snapshot focuses on MCOs.

The ever-increasing costs of biologic drugs have had an impact on MS treatment. A study of MS spending in 55 health plans, which appeared in Neurology a few years ago, found that drug costs accounted for approximately 50% of total per-patient treatment costs.2

Nicholas LaRocca, Vice President of Health Care Delivery and Policy Research for the National MS Society, says:

Even those with adequate insurance may have difficulty meeting cost-sharing for these expensive drugs. It may cause patients to skip doses or forgo other important drugs that MS patients take for symptoms, such as fatigue, lack of bladder control, and pain.

To keep those expenditures in check, health plans have introduced constraints for covering the six available MS disease-modifying drugs that were available at the time of the survey, namely interferon beta-1a (Avonex, Biogen Idec; Rebif, Serono/Pfizer); interferon beta-1b (Betaseron, Berlex; Extavia, Novartis); glatiramer acetate (Copaxone, Teva); and natalizumab (Tysabri, Biogen Idec/Elan). These restrictions are shown in Table 1. Some highlights follow:

  • 58% of MCOs, on average, utilize prior authorization.
  • 47% limit use to FDA-approved indications.
  • 38% set limits on quantity.
  • 14% do not place any restrictions on the six drugs.

Colorado Access, a not-for-profit, Denver-based health plan catering to Medicare beneficiaries and children, has phased out prior authorization but does apply step-therapy and quantity limits to MS drugs. Irene Girgis, Director of Pharmacy for Colorado Access, explains:

Step therapy allows us to funnel utilization to more effective products or to those that cause the fewest side effects. We think of ourselves as gatekeepers, the source of ultimate approval for what drugs are distributed, in order to avoid errors and drive appropriate adjudication.

Pharmacy benefits for MS patients are also attracting more attention with the recent approval of two oral drugs—dalfampridine (Ampyra, Acorda), which is used to improve the function of walking in MS patients, and fingolimod (Gilenya, Novartis), which received FDA approval in September 2010 to reduce relapses. MCOs were asked their opinions of fingolimod and oral cladribine (Litak, Merck KGaA); the latter awaits FDA approval until data on safety and a risk–balance profile are provided.

Seventy-five percent of respondents say they would welcome cladribine as an alternative to the injectable immunomodulators, whereas 86% support fingolimod; 65% anticipate that patients would demand cladribine and 74% would demand fingolimod, even if another therapy is a better option; and 54% and 63%, respectively, expect that cladribine and fingolimod will improve adherence because of their oral formulations (Figure 1). Both drugs elicit equal concern over safety.

James Kenney, pharmacy operations manager, Harvard Pilgrim Health Care, says: “The variability in responses points to the difficulties inherent in managing MS drugs and the need for further information on the efficacy of oral drugs and their potential side effects.”

Among the 76% of respondents who say they use specialty pharmacy providers for MS drugs, 29% mandate the use and 45% make the use voluntary; 27% say the decision whether to use specialty pharmacies depends on benefit design (Figure 2).

A free copy of the MS trend report may be ordered from www.mstrendreport.com.

Figures and Table

Opinions regarding fingolimod (Gilenya) and cladribine (Litak) for the treatment of multiple sclerosis (MS). (From The Multiple Sclerosis Trend Report, 2nd ed., 2011)

Use of the specialty pharmacy. (From The Multiple Sclerosis Trend Report, 2nd ed., 2011)

For the following immunomodulators, which restrictions are currently in place for the majority of your members?

Avonex Betaseron Copaxone Extavia Rebif Tysabri
Prior authorization 61% 58% 56% 53% 56% 66%
Limit use to FDA-approved indications 51% 47% 48% 40% 47% 48%
Quantity limits 42% 40% 42% 37% 39% 29%
Dosage limits 47% 46% 46% 35% 42% 30%
Restricted pharmacy network 31% 29% 30% 27% 30% 25%
Prescribing restricted to specialist 23% 24% 25% 23% 24% 31%
No restrictions 16% 16% 20% 11% 15% 6%
Step therapy 12% 19% 9% 19% 11% 19%
Not covered 5% 6% 2% 17% 6% 11%
Therapeutic interchange 2% 6% 2% 6% 2% 2%
Not applicable 2% 1% 2% 4% 4% 8%

Avonex = interferon beta-1a intramuscular injection; Betaseron = interferon beta-1b subcutaneous injection; Copaxone = glatiramer acetate injection; Extavia = interferon beta-1b subcutaneous injection; Rebif = interferon beta-1a subcutaneous injection; Tysabri = natalizumab.

From The Multiple Sclerosis Trend Report, 2nd ed., 2011.

References

  1. The Multiple Sclerosis Trend Report: Perspectives From Managed Care, Providers and Employers 2nd edTeva/National Multiple Sclerosis Society. 2011;
  2. Kobelt G, Berg J, Atherly D, Hadjimichael O. Costs and quality of life in multiple sclerosis: A cross-sectional study in the United States. Neurology 2006;66;(11):1696–1702.Available at: www.ncbi.nlm.nih.gov/pubmed/16769943.