Management of the Multiple Sclerosis Category: An Increasing Focus for Payers

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As drug costs continue to outpace overall healthcare spending, private health insurers are seeking innovative ways to manage pharmacy utilization. In keeping with this trend, pharmacy management of specialty categories such as multiple sclerosis (MS) has begun to change in recent years.

When evaluating a therapeutic category from an economic perspective, payers evaluate overall spending trends, then drill down to identify specific cost drivers. Unlike many other disease states, the cost of prescription medications is responsible for the majority of healthcare spending in the MS category.1 As a result, there are limited opportunities for medical cost offset compared with other chronic conditions, such as cardiovascular disease and diabetes, where complications frequently result in hospitalization. A medical director at the roundtable stated, “I think [MS] is on everyone’s radar screen because of cost. In addition to disease-modifying therapies, symptom management agents are also being looked at, because they add to the cost.”

In the past, most drugs to treat MS were managed under the medical benefit. However, now most private payers manage drugs for MS via specialty pharmacy providers (SPPs). Some plans operate their own SPPs, whereas others carve out specialty pharmacy to independent SPPs.

As a result of an explosion in the cost of drugs to treat certain conditions, specialty drug spending is expected to continue rising more rapidly than the cost of traditional drugs.1 In the MS category, this increase is primarily a result of two factors. In 2010, the first oral disease-modifying drug, fingolimod, was introduced to the marketplace with premium pricing. In response, manufacturers of many existing injectable drugs took large price increases. These price increases among the disease-modifying therapies, along with the introduction of branded symptom management agents, resulted in a substantial increase in per-member per-month spending for MS by private payers.1

In response, some payers are changing the way they are managing drugs covered under the medical benefit, by implementing prior authorization (PA) and other utilization management approaches traditionally associated with pharmacy. Other payers have moved agents for the treatment of MS (including orals) to specialty pharmacy distribution, allowing far more control over tracking and utilization management.

In the MS category, PA is the utilization management tool of choice for most payers. To develop PA criteria, clinical staff prepare and review drug monographs, which are compilations of relevant clinical and product information needed to support payer decision-making. Clinical subcommittees typically provide these monographs along with their recommendations to the Pharmacy & Therapeutics committee. Payers may consult with network neurologists to review PA criteria, but neurologists are usually not involved in the criteria development process. Rather, they are asked to review the criteria to ensure that they are reasonable and that they meet acceptable medical standards. Based on information provided by subcommittee members, the payer determines the coverage criteria for a given drug or therapeutic category.

Payers contend that utilization management mea­sures are implemented to ensure appropriate utilization and not to arbitrarily penalize prescribers. Payers typically do not base coverage decisions on medical opinion; rather, they use empirical data as the basis for the development of objective, evidence-based criteria. Independent, peer-reviewed information is the preferred source. At the roundtable, a medical director stated, “In order to determine whether a drug works or doesn’t work, there should be some evidence-based measure, not some subjective evaluation to try and determine whether it works or not.”

The development of PA criteria for certain drugs for the treatment of MS has posed a considerable challenge to payers, and walking impairment provides a good representative example. Payers contend that the lack of universally acceptable clinical practice guidelines to measure walking impairment has hindered their ability to develop consistent PA criteria acceptable to the neurology community. In the absence of consensus, payers are forced to use product labeling for their PA criteria. However, product labeling is normally based on clinical trial data, and the measurement criteria used in clinical trials often differs from the criteria used in clinical practice. For example, in walking impairment, payers typically use the T25FW in their PA criteria, although payers and providers agree that it has significant limitations. Because of a floor effect, the T25FW is less sensitive for detecting differences in mildly disabled patients.2

Also, many community neurology offices do not have a walkway of sufficient length to conduct a T25FW. However, in the absence of a universally accepted, practical surrogate measure for walking, most payers default to the T25FW because of its use in the clinical trial setting. As a pharmacy director at the roundtable noted, “We don’t have a good surrogate, so we go back to the product label. In the clinical trials, the 25-foot time walk was used. It’s far from perfect, but it’s the best surrogate we have. Therefore, we accept the 25-foot timed walk along with physician attestation.”

Payers acknowledge that their PA criteria are developed in response to the standards identified and agreed on by the broader medical community. Therefore, they would consider revising their utilization management criteria if the neurology community agreed on consensus guidelines that were appropriately vetted. A medical director at the roundtable pointed out, “We don’t have anyone in the community to come to us and say, ‘You should be changing it to this.’ If there’s another methodology around to assess the patient for performance and evaluation, we will consider it. If [the neurology community] agrees on it, then we’ll consider adopting it.”

Therein lies the payers’ willingness to compromise—utilization management criteria are perceived as fluid and can be adapted to suit medical and community standards. However, in alignment with long-term federal policy initiatives supporting an evidence-based (and more recently, value-based) approach to developing medical standards, payers stand firm on the need for objective, measurable criteria that can be applied to everyone.

References

  1. Express Scripts, Inc. Drug Trend Report. 2011. www.drugtrendreport.com/specialty/specialty-drugs. Accessed September 2, 2012.
  2. Bethoux F, Bennett S. Evaluating walking in patients with multiple sclerosis. Int J MS Care. 2011;13:4-14.

Overview
Multiple Sclerosis Disease State Review
Treating Multiple Sclerosis: The Healthcare Provider Perspective
Management of the Multiple Sclerosis Category: An Increasing Focus for Payers
Achieving Consensus between Healthcare Providers and Payers

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Last modified: August 30, 2021
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