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Supplements Cost-Effectiveness of Disease- Modifying Therapies in Multiple Sclerosis: A Managed Care Perspective
Overview and Diagnosis of Multiple Sclerosis
Samuel F. Hunter, MD, PhD
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Economic Burden of Multiple Sclerosis and the Role of Managed Care Organizations in Multiple Sclerosis Management
Gary M. Owens, MD
Cost-Effectiveness of Disease- Modifying Therapies in Multiple Sclerosis: A Managed Care Perspective
Cost-Effectiveness of Disease-Modifying Therapies in Multiple Sclerosis: A Managed Care Perspective

Economic Burden of Multiple Sclerosis and the Role of Managed Care Organizations in Multiple Sclerosis Management

Gary M. Owens, MD
Multiple sclerosis (MS) is disease that has an early age of onset and may intensify and subside with disease relapses or exacerbations interrupted by periods of stability. Because of this, patients, their families and caregivers, employers, and the entire healthcare system carry substantial clinical and economic burdens associated with the disease over of a period of many years. Although most patients with MS are covered by health insurance, the management landscape has become increasingly complex over the past decade with the introduction and approval of several new disease-modifying therapies that, while remarkably effective and well tolerated, usually come with a very high cost. Whereas the main goal of treating patients with MS is to prevent disease progression and disability, healthcare and benefit providers are faced with an ever-tipping balance point between effectively managing the disease and maximizing the value of high-cost disease-modifying therapies in an already overburdened healthcare system. Treatment of MS should be individualized, and shared decision making between patients and healthcare providers must be preserved. Healthcare providers and payers need to collaborate to ensure that resources are used optimally and not wasted, reducing both the clinical and economic burdens related to this complex chronic disorder.
Am J Manag Care. 2016;22:S151-S158
Current Health Insurance/Medicare Utilization Landscape for Patients With MS
      
In the United States, multiple sclerosis (MS) affects approximately 400,000 individuals, and worldwide, the disease affects 2.5 million individuals, varying greatly by geographic region.1 Patients with MS utilize healthcare services considerably more than those without chronic illnesses.2 A patient who is newly diagnosed with MS will visit their physician an average of 8 times annually, approximately 3 times as often as an individual without the disease.2,3 It is also important to note that the frequency with which patients with MS require medical care usually increases with disease progression, adding to substantial pharmacy costs that increase over time.
      Data suggest that most patients with MS have health insurance coverage.2 The results of a survey report compiled by the National Disability Institute (NDI) and the Multiple Sclerosis Association of America (MSAA) in 2012 showed that actual access to health insurance is not a significant barrier to care for the patients with MS who responded to the survey. Data demonstrated that 53.9% of patients with MS had private health insurance and almost 39% received federally funded healthcare, namely Medicare (32.5%) and Medicaid (6.0%). A total of 7.7% of participants were uninsured at the time of the survey.4
      
While data such as that from the NDI and the National Multiple Sclerosis Society (NMSS) highlight that the majority of patients with MS are covered by some form of health insurance, the landscape for actual coverage of MS treatment and management can be highly variable and potentially inaccurate. For example, while accurate data are not available on the number of patients
with MS receiving Medicaid benefits (because these programs are administered by individual states instead of through a single federal program), the NMSS currently estimates that approximately 25% to 30% of patients with MS receive Medicare.5,6 However, the cost of specialty drugs for the treatment of complex disorders such as MS can be very high, even with Medicare Part D enrollment
and coverage; this is especially true when the costs that must be covered by patients are taken into consideration.7
     
Specialty-tier drugs, defined by Medicare as drugs that cost more than $600 per month for an individual patient, represent a limited number of Part D drugs used by a small proportion of enrolled patients.8,9 An analysis of such specialty-tier drug use and cost was performed by researchers at Georgetown University and the Kaiser Family Foundation and was published in December
2015; it covered 12 specialty drugs used to treat 4 specific disease areas: hepatitis C, MS, rheumatoid arthritis, and cancer. Results demonstrated that approximately 2% of patients enrolled in Medicare Part D used these agents and other specialty-tier drugs, according to the Centers for Medicare & Medicaid Services (CMS).

     Recent data suggest that out-of-pocket costs for patients with complex conditions, such as cancer, may reach as high as $11,538 for a single current drug, with estimates for patient out-of-pocket costs for 3 sample MS agents ranging from $5979 to $6448 annually. For the 3 MS drugs studied, an average of 34.7% of out-of-pocket costs were incurred by Part D enrollees after their spending
reached the catastrophic coverage phase of the Part D benefit. The data demonstrated that a substantial share of the out-of-pocket costs for these specialty-tier drugs can be incurred even after enrollees’ drug spending reaches the drug benefit’s catastrophic threshold, which was intended to protect against high costs, but not established as an absolute limit on actual out-of-pocket spending.9
      
Catastrophic limits vary depending on the insurance plan, and may be limited to a specific event or illness.10 Although Medicare Part D has set that limit at $4850 for Medicare beneficiaries, the limit is not an absolute limit on out-of-pocket cost, because Medicare still requires enrollees to pay an additional 5% of the specialty drug’s cost even after the catastrophic limit is reached. In addition,
if Medicare enrollees take a drug that has been excluded from the formulary for their particular insurance plan, their costs for care can be extremely high, and the out-of-pocket cost of treatments, even for lower-priced drugs, can vary widely from plan to plan.7 However, each patient has the right to request that his/her plan provide or pay for a drug they believe should be covered, provided, or continued. Patients also have the right to request an appeal if they disagree with their plan’s decision regarding whether or not to provide or pay for a drug.11 Such data show that while the insurance landscape demonstrates substantial coverage for care, individual coverage can vary significantly and may not be enough for optimal management of the overall disease and symptoms for patients with MS.

     The Affordable Care Act (ACA) was designed to improve access to healthcare and health insurance coverage through the adoption of changes at the federal, state, and employer levels. The ACA was created to provide new consumer protections surrounding healthcare, increase access to affordable healthcare options, and standardize benefit offerings of healthcare insurance companies. Aspects of this law are of particular interest: the potential benefits for patients with MS include prohibiting insurance companies from denying coverage based on preexisting conditions, eliminating annual or lifetime coverage benefit limits, offering Medicare donut hole relief and prescription drug discounts, providing healthcare access to uninsured individuals with preexisting conditions, allowing states to cover more individuals with Medicaid, and increasing Medicaid eligibility and access, among other provisions.5,12

     
However, the long-term effects of the ACA related to specialty pharmacy (which encompasses the bulk of the current disease-modifying therapies [DMTs] for MS) have yet to be fully determined.5 MS is an expensive and very individualized disease to manage, and patients with MS must consider a substantial number of factors related to their individual cost of care when determining appropriate
healthcare coverage. Because of this, the MSAA has created an acronym for patients to consider when applying for coverage: “PLAN” stands for prepare, look, analyze, name. Specific questions for patients to consider when enrolling include13:
  • Are their medications covered and what are the costs for them?
  • Are there any “step” requirements for accessing their drugs?
  • Which plans offer the most flexibility relating to access to drugs, doctors, etc?
  • If a medication must be changed due to the plan chosen, what alternative drugs are available?
     Even with health insurance, a substantial number of patients with MS still have plans that may challenge their ability to pay for prescription drugs, as well as limited networks of hospitals and MS providers.14 However, in addition to current insurance options, several programs are now available to help patients better afford and pay for their MS medications. Because of the often high out-of-pocket costs for patients with MS, assistance programs are important in the management of patients with MS. For example, the co-pay relief program of the Patient Advocate Foundation has added new prescription coverage designed to benefit patients with MS. This new source of funding is available to financially eligible patients with MS, with health insurance coverage to assist in supporting the costs of needed treatment medications. Originally launched in 2004, this program now approves qualified patients with MS for up to $8000 in assistance per award-year. It offers individualized services for patients, including technology tools for patients and their healthcare providers, in addition to financial assistance.15 Assistance programs are also available to patients with MS from the Patient Access Network Foundation.16

Economic Burden of MS
Costs of MS for the Patient: Disease State, Progression, Comorbidities, and Disability
     Overall, MS is a very costly chronic disease, with direct costs of prescription drugs and indirect costs being the most significant cost drivers, according to available data.17 The disease usually has an early age of onset and symptoms that intensify and subside with disease relapses and remissions. Because of this, patients, their families, and caregivers carry an extreme disease burden.18 Along with the high costs of therapies for the disease, the common sequelae of MS also contribute substantially to the total cost of care and economic burden of this chronic disease. A study
of commercially insured patients with MS by Carroll et al found that mean MS charges were significantly higher for patients with common disease sequelae, including malaise/fatigue, paresthesia, depression, and development of gait abnormalities.19 These conditions were found to be additional cost drivers in the management of MS.
     As patients with MS age and their disabilities progress, so do the costs of managing the disease.20 Compared with healthy individuals, patients with MS are substantially more likely to utilize healthcare services. Newly diagnosed patients are 3.5 times more likely to be hospitalized, 2 times more likely to have 1 or more emergency department visits, and 2.4 times more likely to have 1 or
more visits for physical, speech, or occupational therapy.6,20 The economic burden of MS includes the cost of diagnostics, interventions, and monitoring, and the loss of patient productivity and employment.
    Meta-analyses have shown that MS ranked second behind congestive heart failure in direct all-cause medical costs for chronic conditions.17 The total lifetime cost per patient with MS is estimated to be $4.1 million (in 2010 dollars).18 For patients using DMTs to manage their MS, approximately 75% of total MS-related healthcare costs in 2011 was for DMT monotherapy, and this percentage
was similar to that previously reported in 2004. It must also be noted that cost of managing the sequelae of MS contributed extensively to the total cost of care.19 This utilization of healthcare services increases with increasing disability, with an average yearly healthcare cost of $30,000 for those with mild to moderate disability; $50,000 for those with moderate disability; and $100,000 or more for those with more severe disability, such as those confined to a wheelchair or bed/chair.
     As a patient’s disability level progresses with increasing disease burden, as measured using the Expanded Disability Status Scale (EDSS), total MS costs rise significantly. The average cost for a patient with an EDSS score of 3.0 to 3.5 (mild to moderate disability) is $30,000 per year. For patients with a score between 3.5 (moderate disability) and 6.5 (walking assistance is required), the
average cost increases markedly to $50,000 annually. For patients with an EDSS score of 6.5, who are confined to wheelchair or bed/chair, need help to perform self-care, are completely dependent on a caregiver, or die from complications associated with MS, the average cost is at least $100,000 per year.20,21
     Actual MS spending and cost growth are driven by several factors, including that MS presents in different forms and multiple phases of disease, and each patient’s experience with MS varies in complexity. While the greatest proportion of spending for MS is attributed to DMTs, other medical costs include the requirement for multiple clinical interventions (eg, diagnostics and monitoring).22 Data reported by the IMS Institute for Healthcare Informatics in 2012 documented that the average costs for all privately insured patients with MS were $30,000 annually. However, because MS varies in severity, health spending is likely disproportionately concentrated on a smaller number of patients with more severe disease, with 25% of spending used for just 1% of the total number of patients covered in a health plan. Taking just that 1% into consideration, the per-patient cost can exceed $66,000 per year, with the average cost of the disease elevated markedly by that small number of
seriously ill patients, although many other patients with MS will have lower expenses.22,23

 
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