January 09, 2020
This Benefit Manager Guide is a a summary of employer recommendations and new evidence related to Multiple Sclerosis (MS), as well as a discussion of its impact on employers and what they can do to help employees and caregivers with MS.
- New disease-modifying therapies (DMTs) are approved for both relapsing and progressive forms of multiple sclerosis (MS), providing treatment options for populations of MS patients for whom previously only off-label therapies were available.
- Recently released clinical guidelines attempt to strike a balance between newer therapies’ increased efficacy at preventing flare-ups and increased risk of serious adverse events: employers should review their formulary and utilization management programs to best meet the needs of their employees.
- More patients living with MS are active in the workforce due to innovations in pharmacological treatments, coinciding with increased costs over time. The high costs of medications, as well as the fact that treatment is ongoing, place the disease among the top most expensive conditions for many employers.
- Copay assistance programs and cards are available for many MS therapies. Implementation of copay accumulator programs, where manufacturer assistance no longer applies to the deductible and out-of-pocket maximums, may result in members with MS being disproportionately impacted financially. This can lead to a decrease in treatment adherence.
MS is a chronic inflammatory condition that affects the central nervous system and may cause significant disability over time.1 Although symptoms and the course of the disease vary by patient, common symptoms include fatigue, loss of balance, problems with walking, vision loss and cognitive impairment.2 Women are twice as likely to be affected, and there is no known cause or cure.3
While there is no one diagnostic test for MS, clinicians rely on presentation of symptoms, clinical examinations, MRIs and spinal taps to identify the disease. Because prompt initiation of treatment is usually most beneficial to the patient, there is pressure to make MS diagnoses as early as possible. This increases the risk of overinterpretation of test results, leading to misdiagnosis. A 2016 survey of MS specialists found that virtually all 122 respondents had incorrectly diagnosed patients with MS over the past year, while a survey of MS patients found that 42% were initially misdiagnosed with another condition.4,5 Given the cost of treatment and the drug tolerance challenges, the price of an incorrect diagnosis is high, but the health impact of not being diagnosed promptly is arguably greater.
Specialty pharmacy products, called disease-modifying therapies (DMTs), are the primary MS treatments available. Designed to prevent and/or delay relapses, these drugs tend to be very expensive, with potentially severe side effects. While the majority of DMTs are available only for treatment of relapsing-remitting MS (RRMS), therapies aimed at treatment of the more progressive forms of MS – primary progressive MS (PPMS) and secondary progressive MS (SPMS) – have begun entering the market. The Food and Drug Administration (FDA) includes those who continue to experience periods of relapses and remissions in its definitions of both RRMS and PPMS to ensure patient access to treatment, as patients with the latter form would otherwise be left without FDA-approved treatment options.6 Ocrevus, approved in March 2017, is the first therapy approved for treatment of PPMS; it is expected that therapies aimed to treat SPMS will enter the market as soon as 2019.
Reasons Why Employers Should Care About MS and its Effects
Major Cost Driver
The cost of treatment for MS was the eighth highest in drug spending among U.S. therapeutic classes in 2016.7 Over the past 20 years, the cost of MS treatment has risen at a rate five to seven times higher than that of prescription drugs overall. Worldwide, the MS market is estimated to be about $19 billion a year.8 Since MS progresses over time, spending is concentrated among the top percent who are the most severely afflicted.7 Spending on pharmaceuticals accounts for between 70% and 75% of the cost of MS treatment.7 Although there are no treatments that can reverse the neurodegenerative effects of MS, multiple treatments are available for managing the disease and its related symptoms. In addition, all disease types are likely to have a treatment option in the short-term future. As a result, employers can expect to see costs rise consistently year after year.
Productivity Reduction for Affected Employees
The life expectancy for a person living with MS does not vary significantly from the general population, with rare exceptions.9 Due to the early average age of onset and chronic symptoms, MS is considered a “prime-of-life” disease. Common symptoms like fatigue, vision loss, chronic pain, loss of bladder control and cognitive impairment can restrict the ability of people living with MS to function in the workplace.
Productivity Reduction for Employees with Dependents Affected by MS
Employees who serve as caregivers for family members living with MS may experience fear, guilt, anxiety, grief, anger and exhaustion as they cope with taking care of a loved one with a serious illness.10 Many families affected by MS face financial hardships, increasing stress and potential feelings of helplessness. These stress factors can have a significant impact on productivity and contribute to employee caregivers’ own health conditions, like high blood pressure, insomnia and depression.
Treatment Options for Multiple Sclerosis
A neurologist should determine the appropriate treatment for MS, but effective disease management requires a team of providers. Treatments seek to address one or more of five different goals:
- Slow the progress of the disease;
- Treat symptom flare-ups;
- Manage ongoing symptoms;
- Promote function through rehabilitation; and
- Address mental health issues that often accompany an MS diagnosis.11
Do People with MS Stay in the Workforce?
Many people living with MS drop out of the workforce due to inability to cope with the stress and physical or mental demands of their job; and 40% of people living with MS in the United States receive some form of disability payments. Still, an estimated 40% of people who have had an MS diagnosis for 10 years or more continue working.3
Clinicians typically use imaging tests to monitor inflammatory activity in the early stages of the disease, particularly lesions in the brain that drive many of the complications associated with MS. Clinicians may recommend imaging at least annually along with close follow-up for people with relapsing forms of MS who are not on a DMT, have not had relapses in the preceding two years and do not have active new MRI lesion activity on recent imaging.12 However, in progressive disease courses, functional decline associated with the neurodegenerative component of MS is not easily detected by MRIs or other imaging techniques, thereby complicating the development of effective treatment strategies.
Currently available DMTs can prevent disease progression and flare-ups of symptoms, albeit without repairing existing damage. DMTs should be offered as soon as an MS diagnosis is made and confirmed. It is unclear which treatments will work for each patient, so switching treatments early on after diagnosis is common.13 DMTs can be administered orally, via self-injection into the skin or muscle, or by infusion. Patients should be monitored closely when beginning treatment, as all DMTs carry the risk of side effects, some of which can be severe. Analyses of DMT efficacy suggest that those most often successful in slowing disease progression also have the highest risk of severe side effects.14
Low Adherence for Lifetime DMT Treatment
Once individuals with MS find a DMT that is effective and has manageable side effects, they will likely take the drug indefinitely, or until it is no longer effective.15 Because different DMTs have varying modes and frequency of administration, clinicians must have the flexibility to prescribe the therapy that is working or they believe will best fit the lifestyle of their patients. Patients should not be overly burdened with prior authorizations, narrow formularies, step- therapy programs and other administrative requirements. People who are adherent to their medications are far less likely to visit the emergency room, have lower out-of-pocket medical spending and have slower disease progression.16 Still, studies suggest that long-term adherence to DMTs ranges only between 41% and 88%.17 Low adherence may be due to high out-of-pocket costs of the drugs, potentially severe side effects and the fact that dosing schedules for DMTs vary widely.
Additional and Alternative Therapies
Other common treatments and procedures related to MS that may appear in an employer’s claims include the following:
- Brain and spine imaging tests to assess the progression of the disease for those who have recently had flare-ups;
- Administration of clinically-infused DMTs;
- Cognitive behavioral therapy for anxiety, depression and stress associated with MS;
- Prescription-strength painkillers for common symptoms; and
- Occupational and physical therapy (PT) to rehabilitate lost function, which may include the need for durable medical devices.
Alternative therapies include fish oil, acupuncture, bee sting treatment, yoga and magnetic therapy. However, the evidence is mixed for each of these treatments.18,19 Medical marijuana may be used to relieve pain, overactive bladder and muscle stiffness, if other treatments are ineffective.20
Several drugs have also entered the market specifically to address MS symptoms, such as difficulty walking and movement of the upper and lower extremities. For example, generic versions of Ampyra, used to improve walking in adults with MS, are now available.21 Due to the types of physical therapy likely required by MS patients, including twice daily stretching therapy among other treatments, virtual PT solutions can play a role in care for MS patients.