The robust market and pipeline for multiple sclerosis treatment means patients and pharmacists, have more options than ever.
Multiple sclerosis (MS) is defined as a chronic, often progressive and disabling disease that attacks the body’s central nervous system. People affected by this condition may experience a variety of symptoms based on the disease progression and their own unique characteristics. The etiology is unknown, but patterns and theories are actively being studied by the academic community for trending and predisposition. Symptoms can be mild, such as numbness in the appendages, or more severe, such as loss of vision or partial/full paralysis. Symptoms can occur (if even noticed by the patient) once in a lifetime or, more likely, with increasing frequency over time.
Professional consensus has allowed general stratification into various categories1:
1. Relapsing-Remitting MS (RR-MS): Individuals with RR-MS are typically defined as having attacks (exacerbations/ flare-ups/relapses) of worsening neurologic function. After an exacerbation, there is typically a partial or complete recovery period (remission) in which the disease is absent (does not progress). Approximately 85% are initially diagnosed with RR-MS.
2. Primary-Progressive MS (PP-MS): PP-MS is characterized by a slow decline of neurologic function from the initial diagnosis but with no distinct relapses or remissions. Individuals may have minor improvements or occasional plateaus. Approximately 10% to 15% are diagnosed with PP-MS, and it is the most common category for people diagnosed over the age of 40 years.
3. Secondary-Progressive MS: Typically following an initial period of RR-MS, some patients develop a secondaryprogressive stratification, in which the disease worsens steadily with or without exacerbations, remissions, or plateaus. This may lead into a more progressive disease category.
4. Progressive-Relapsing MS: The least common form of the disease is characterized by steadily worsening disease from the beginning, but with clear exacerbations of worsening neurologic function progressively. Individuals may or may not present any recovery following the relapses. The disease continues to progress without remissions. Although the rarest stratification, approximately 5% are affected.
Currently there is no known cure for MS, but fortunately there are treatment choices and many products in the pipeline that will assist in the management of the disease’s effects (Table 1). As biotech products first emerged, pharmacists initially were trained to know their “ABCs”— Avonex, Betaseron, and Copaxone. Fortunately, new products and versions steadily emerged that allowed physicians and patients options in products, enhanced delivery systems, and support services. As these products became available on the market, disease progression, life expectancies, and quality of life improved.
Table 2 lists some primary MS therapies on the market today and the associated product/patient/caregiver support service information.
As pharmacists, we need to be informed to help manage the uniqueness of each patient. I have found that the MS population is extremely well educated and very passionate. Fortunately for all involved in the therapeutic space, there are amazing support systems and educational resources in place for patients with MS. After many years of working with specialty pharmacy products and advocacy organizations, I can easily say that the MS space has some of the best solutions in the marketplace for patients, caregivers, physicians, and payers. These support and advocacy systems are in place on national, regional, and local/chapter levels and include the National MS Society (www.nationalmssociety. org) and the Multiple Sclerosis Association of America (www.msaa.com), as well as pharmaceutical manufacturer programs. Both advocacy organizations and manufacturers offer a variety of perspectives, information, and services. As a pharmacist, I signed up years ago for e-mails from the National MS Society. I frequently get information about programs, services, and meetings that help me keep current on trends. The manufacturers also have wonderful opt-in services for patients looking for knowledge and assistance in the complex maze of insurance. Patients can get a variety of support services from most manufacturers, including but not limited to:
• Case management/reimbursement support
• Compassionate care support: patient assistance programs, copay assistance programs
• Injection training: in the home or physician’s office
• Adherence support services
• Insurance gap coverage/services
• Ancillary supplies/materials: needles, coolers for transportation, educational information
Each manufacturer has different programs based on their product and its specific regimen nuances.
Primary MS products are in the “expensive/ specialty” category. Both self-injected and oral MS products typically fall under a well-managed pharmacy benefit. Infused MS products may also fall under the pharmacy or medical benefit. It is important to understand that it is not best practice to simply do a test claim or adjudicate an MS prescription. We need to dive deeper to see if there is a preferred pharmacy or copay assistance program. Fully understanding the benefit options for the patients and allowing them to be part of the decision-making process will build strong loyalty.
There is huge opportunity for those pharmacists who make the effort, do the research, and find solutions for their customers. Managing MS is much more than traditional pharmacy and a business opportunity. It is providing extra care and attention to those patients who need our help the most in their time of need—a time of expensive drugs, complex clinical regimens, multiple doctors, complex insurance navigation, family worries, and a lot of stress. A single motivated pharmacist can make such a difference in so many lives! PT
David M. Suchanek, RPh, is senior vice president of biotech and specialty services at D2 Pharma Consulting, LLC, a consulting firm which focuses exclusively on pharma services in the life sciences industry. Mr. Suchanek is a member of the Specialty Pharmacy Times editorial board.
1. National MS Society, www.nationalmssociety.org.
2. Ness S.Significant advances in multiple sclerosis treatment. Specialty Pharmacy Times, February 2011. With permission.