Multiple Sclerosis: The Central Nervous System Destroyer

Multiple Sclerosis (MS) is an immune-mediated chronic disease that affects the central nervous system (CNS) and, according to the National Multiple Sclerosis Society, it affects more than 2.3 million people worldwide. The CNS is made up of the brain, spinal cord, and optic nerves.

In MS, the body’s immune system mistakenly attacks myelin, the protective sheath covering nerve fibers, in the CNS. Damaged or destroyed areas on the myelin or nerve fibers cause a variety of neurological symptoms.

Cause

The cause of MS is unknown, but it is thought to have a genetic component, as well as abnormalities in the immune system and environmental factors that could trigger the disease. Risk factors for the development of MS include gender, genetics, age, geography, and ethnic background.

MS is at least 2 to 3 times more common in women than men. This suggests that hormones play a significant role in susceptibility to MS.

Most patients are diagnosed between 20 and 50 years old; however, MS has been in seen in young children and older adults. MS is more common in areas farthest from the equator.

Symptoms

The symptoms of MS vary greatly among patients in type and severity and can be categorized as primary, secondary, and tertiary. MS is very difficult to diagnose because of the broad scope of symptoms and there is not a definite diagnostic tool.

Some common primary symptoms include:

• fatigue
• numbness or tingling of the face/body/extremities
• weakness
• dizziness and vertigo
• sexual problems
• pain
• emotional changes
• walking difficulties
• spasticity
• vision problems
• bowel and bladder problems
• cognitive changes
• depression

Numbness or tingling is often the first symptom experienced by those who are eventually diagnosed with MS.

Primary symptoms can develop into secondary symptoms if not treated properly. For example, bladder dysfunction can lead to urinary tract infections and immobility can lead to pressure sores.

Tertiary symptoms are “trickle down” effects, meaning the symptoms affect an individual’s social, vocational, and psychological state. For example, a patient may be no longer able to walk or drive and cannot work anymore.

Diagnosis

There are no specific or independent symptoms, physical findings, or lab tests to diagnose a patient with MS. The provider must be a sleuth and put all of their clues together, typically requiring the expertise of a neurologist. A detailed health history, a neurologic exam, blood tests, MRI, and other tests are all vital in trying to determine what is wrong with the patient.

In order to diagnose MS, according to the National MS Society, the physician must find the following:

• Find evidence of damage in at least 2 separate areas of the CNS.
• Find evidence that the damage occurred at different points in time.
• Rule out all other possible diagnoses.

Using the McDonald Criteria for the Diagnosis of MS is the gold standard to hasten a patient’s MS diagnosis so that they can begin the treatment they need as quickly as possible.

Types or Phenotypes of MS

People with MS typically experience 1 of 4 disease courses developed by the International Advisory Committee on Clinical Trials of MS in 2013. These include:

Clinically isolated syndrome (CIS): the first episode of neurologic symptoms lasting for 24 hours, which is caused by inflammation and demyelination in the CNS; however, this does not meet criteria for diagnosing the patient with MS.

Relapsing-remitting MS (RRMS): the most common disease course with approximately 85% of people initially diagnosed. The patient alternates between relapses or exacerbations of new or increasing neurologic symptoms followed by periods of remissions.

Secondary progressive MS (SPMS): follows an initial relapsing-remitting course and most people who are diagnosed with RRMS progress to SPMS.

Primary progressive MS (PPMS): characterized by worsening neurologic function and disability. Fifteen percent of people with MS have PPMS.

Treatment

There is no cure for MS currently, but there are more than a dozen treatment options to aid in lessening the severity of the disease. Symptoms can be managed with medication, rehabilitation, and other strategies. According to Rebecca Spain, MD, MSPH, the best evidence shows that “early MS therapy delays onset of MS for CIS patients, reduces MS clinical attacks, and reduces long-term disability in MS.”

Treatments for MS are continuing to evolve as researchers and manufacturers race to find a cure. Early on when traditional treatments such as beta interferon were the mainstay of therapy, they were found to be notably harsh on patients.

While taking beta interferon to treat their MS, patients also began taking other medications to treat the adverse effects it was causing. Fast forward to present day and there are now more treatment options, most of which provide a better tolerability profile for patients.

No longer are patients limited to only injectable medications to treat their MS. There are currently oral formulations available for patients who are unable to tolerate injectable medications due to adverse effects of the medication, they are unable to inject themselves, or due to injection site reaction.

Oral MS therapies include:

• Dimethyl fumarate (Tecfidera) is a twice-daily oral medication indicated for the treatment of relapsing forms of MS.
• Fingolimod (Gilenya) is a once-daily oral medication indicated for the treatment of relapsing forms of MS.
• Teriflunomide (Aubagio) is a once-daily oral medication indicated for the treatment of relapsing forms of MS.

Self-injectable medications indicated for the treatment of MS include:

• Beta interferons (Avonex) is a subcutaneous or intramuscular self-injection and is arguably the most commonly prescribed medication to treat MS; however, they are not as well tolerated. It is indicated for the treatment of relapsing forms of MS to decrease the number of flare-ups and slow the occurrence of physical disability. Also approved for patients who have their first attack and have brains lesions consistent with MS. Common adverse effects include flu-like symptoms and injection site reaction.
• Glatiramer acetate (Copaxone) is a subcutaneous self-injection indicated for the treatment of relapsing forms of multiple sclerosis.

Office-infused medications for the treatment of MS include:

• Natalizumab (Tysabri) is an infusion medication administered for 2 hours every 28 days authorized by the TOUCH Prescribing Program (1-hour infusion, 1-hour to watch for any infusion-related reaction). It is indicated to treat patients with relapsing forms of MS and to slow down the symptoms and decrease the number of relapses. Tysabri has an increased risk of developing a rare brain infection-progressive multifocal leukoencephalopathy, which leads to death or severe disability.
• Alemtuzumab (Lemtrada) is a prescription infusion medication to treat relapsing MS in people who have tried 2 or more MS medicines that has not controlled their relapses. Medication is administered 8 times over 2 years (round 1 is infused 5 days in a row and round 2 is infused 3 days in a row). After the first treatment, patients will be monitored monthly over the next 4 years or longer for adverse effects. Monthly blood and urine tests, self-checks, and yearly skin checks will be required to monitor for possible adverse effects, including autoimmune disorders or some cancers, such as melanoma.

The Role of Specialty Pharmacy: Beyond the Medication

MS is a prime example of a complex, lifelong condition that requires continual care management. While managing the primary disease, there are many signs and symptoms that require management as well, such as depression, fatigue, muscle weakness, and mobility. Although additional medications may be needed to help counteract these symptoms, the care continuum should not end there.

This is where the model of specialty pharmacy really shines. However, specialty pharmacies haven’t always taken the all-inclusive approach in caring for its patients. But in recent years, specialty pharmacies have done an incredible job at creating a patient experience that not only treats MS, but also manages the patient holistically.

We are continuing to see the incorporation of integrated services by some of the larger specialty pharmacies, which is good news for patients. Furthermore, some of the biggest pharmacies are expanding through vertical integration.

When services are integrated through vertical integration, for example a health insurer buying a pharmacy, the promise is better outcomes and a more seamless health care experience for patients. Take MS for example, in which a patient would visit a neurologist and then the pharmacy.

The neurologist provides services to the patient that include comprehensive exams, diagnosis, etc. The pharmacy provides medication management, counseling, medication reconciliation, etc.

Although the premise of this health care team synchronization will remain the same, new models are looking to enhance this. Piggy-backing off the previous scenario of the patient seeing the neurologist and pharmacy, think about how much more of a seamless experience this would be for the patient if a physician had access to their pharmacy records and a pharmacist had access to the physician’s patient records.

This type of model aims to address any remaining gaps in care that will help optimize a patient’s outcome while promoting safety. Furthermore, we are seeing the incorporation of nursing services within specialty pharmacies for select complex conditions, such as MS. These nurses have clinical expertise and are subject matter experts in MS.

The scope of these nurses is to provide more than just additional medication management. They provide services such as injection training and proper education around disease management.

Additionally, these nurses are helping patients with services such as assisting in finding transportation to their appointments, getting wheelchairs or other medical equipment as needed, and even helping patients find financial assistance if needed. The nurses are also offering lifestyle tips to help patients gain control over their disease.

One example of a lifestyle tip that the nurse could recommend to a patient with MS is to not have their office desk near a window because if it’s warm or sunny outside, this could cause the patient to have a flare due to the heat. Nurses are becoming a crucial part of the integrated care model within specialty pharmacies and their role is to improve the quality of life for patients by providing disease management recommendations.

References

National Multiple Sclerosis Society. 2017. https://www.nationalmssociety.org.

Spain, R. 2010. Diagnosing Multiple Sclerosis Using the McDonald Criteria. https://www.va.gov/MS/Professionals/diagnosis/Diagnosing_MS_Using_the_McDonald_Criteria.asp

Important Safety Information. https://www.avonex.com/?cid=PPC-GGL-AV.HCP.Avonex_HCP_Branded_Exact.Exact-SUP-106664&gclid=CKjUwvHoz9wCFSSDswodVDoNSA&gclsrc=ds

About Lemtrada. https://www.lemtrada.com/about/how-lemtrada-is-given

About the Author

Mark Thomas earned his Doctor of Pharmacy degree from Lake Erie College of Osteopathic Medicine (LECOM) and is currently enrolled in the Master of Science in Pharmacy Business Administration (MSPBA) program at the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Mark spent the past 4 years as a clinical pharmacist in a specialty pharmacy working on high profile initiatives to expand his organization’s national footprint, as well as directly coordinating with patients, prescribers and other healthcare providers to educate and promote the utilization and uptick of generic specialty medication. In his current role as a clinical advisor in the managed care setting, he works directly with clients to help manage and develop strategies that promote optimal health outcomes in the most cost-effective manner.