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1 MANAGED CARE CONSIDERATIONS IN TREATING MULTIPLE SCLEROSIS * Sheldon J. Rich, RPh, PhD ABSTRACT The lifelong treatment that is required for patients with multiple sclerosis (MS) presents numerous managed care considerations, such as ensuring proper diagnosis, making patient-specific treatment decisions, managing adverse effects, and making certain of timely follow-up. This article offers an extensive discussion of the practical treatment considerations in MS, some of which include monitoring of disease progression, management of progression-related symptoms, monitoring of treatment adherence, and management of breakthrough disease. Ensuring treatment adherence is a major issue in MS because 17% to 40% of patients who are prescribed a disease-modifying drug will discontinue treatment within 1 year of initiation, possibly as a result of a perceived lack of efficacy, adverse effects, or depression. Also included in this discussion are examples of treatment algorithms that can be used to help guide clinicians in stratifying patients, making evidence-based therapeutic decisions, and optimizing patient outcomes. A case study, intended to illustrate how pharmacists can help patients choose among the different disease-modifying therapies, is also presented. (Adv Stud Pharm. 2009;6(3):72-76) *Based on a presentation by Dr Rich from a Webcast series held May June President, SJR Associates, LLC, Palm Beach Gardens, Florida; Clinical Assistant Professor, University of Michigan, Ann Arbor, Michigan; Adjunct Assistant Professor, Wayne State University, Detroit, Michigan. Address correspondence to: Sheldon J. Rich, RPh, PhD, President, SJR Associates, LLC, 171 Sedona Way, Palm Beach Gardens, FL In considering the managed care perspective of multiple sclerosis (MS) diagnosis and treatment, it is essential to translate the available evidence-based medicine into practical considerations that may be readily applied in the day-to-day care of individual patients. Foremost, it is important to establish treatment goals, which include slowing accumulation of disability, improving patients quality of life, attaining a predictable and manageable adverse-event profile, slowing accumulation of cognitive dysfunction, and reducing progression of brain atrophy and inflammation. 1,2 Preventing or minimizing exacerbations is critical in slowing accumulation of disability because each successive relapse leads to additional disability that will affect patients quality of life. In managing adverse effects, it is important that patients understand the types of possible adverse effects and also the expected treatment course. Reducing inflammation will impact patients physical ability to function and reducing brain atrophy is crucial in preventing cognitive dysfunction, which disrupts patients from performing activities of daily living (eg, stringing thoughts together, counting, and working) and is considered a major factor in disability. Although it is difficult to determine which therapy would be most effective for MS because head-to-head comparison trials are not available, it is possible to evaluate current therapies based on their effects on sustained disability, relapse rate, lesion load, brain atrophy, and cognitive dysfunction. 3 Therapy selection should also be based on patient-specific issues because every patient is unique and should be managed individually. Understanding the patient s home life is vital, especially when considering whether the patient or a family member will be administering injections. All healthcare providers who treat patients with MS must actively plan for long-term management of the disease because therapy is lifelong and not curative. 72 Vol. 6, No. 3 September 2009

2 TREATMENT CONSIDERATIONS Comprehensive plans that assist with long-term patient management are essential and should include monitoring of disease progression, management of disease-modifying drug (DMD) side effects, management of progression-related symptoms, monitoring of treatment adherence, management of breakthrough disease, and consideration of medication cost and administration. In regard to monitoring disease progression, patients should be told when they are diagnosed or have a change in their disease course how often they will require magnetic resonance imaging (MRI) testing. The healthcare team should be knowledgeable about the appropriate number of required MRIs as well as issues related to financial coverage of this testing. Symptom management is especially critical in patients with progressive disease, who may require steroid therapy and/or hospitalization. In regard to treatment adherence, between 17% and 40% of patients who are prescribed a DMD will discontinue treatment within 1 year of initiation. The reasons are not entirely clear, but may be due to perceived lack of efficacy, side effects, adverse effects, or depression. 4-7 Essentially, the intent of using DMDs is to decrease the number of white-matter lesions and the number of relapses and long-term disability, but because this outcome is difficult to monitor, patients may not perceive therapy to be effective. Patients must be counseled that DMDs begin to work 3 to 12 months after starting on therapy. The patient should be told that his or her walking is not going to improve immediately after starting the injections but they will decrease the chance of developing further disability. An individual might experience a relapse while on treatment and conclude that the drug is not effective, but it is likely that the relapse episode is less severe or occurs less frequently as a direct result of treatment. New or increased depression affects more than 40% of patients within 6 months of treatment initiation, and may be related to treatment (particularly to interferons [IFNs]) and/or being diagnosed with MS. 6 Because depression is significantly associated with decreased adherence, it is important to identify this problem and recommend appropriate treatment when necessary. Monitoring the degree of compliance is vital and, as such, pharmacists should examine refill data and question patients who, for example, refill a 1-month supply of medication 3 months later. These patients might have suffered a relapse, been hospitalized, or simply may not have been confident in their administration technique. Pharmacists may be particularly helpful in resolving the latter issue. Patients should be able to identify symptoms of exacerbations and have realistic expectations about management of breakthrough disease. Cost of medication is another significant issue and should be determined up front for DMDs, as well as for ancillary medications. Pharmacists may be particularly helpful by contacting pharmaceutical manufacturers to inquire about patient assistance programs for those with difficulty affording treatment. In addressing administration issues, patients should be comfortable in handling syringes and capable of administering correct doses. Because many patients do not have a good understanding of their disease state and do not fully realize that these medications are used for life, education is critical and should be centered on realistic expectations (specifically regarding the non-curative nature of therapy), good administration techniques, coping with adverse effects, proper medication storage (especially when traveling), and timely follow-up. One common administration error that patients make is using the same needle to dilute the medication and to inject it, which may cause skin dystrophy as a result of medication remaining on the lumen. Thus, it is important that patients be told to change needles after diluting medication (when applicable), prior to administering it. TREATMENT ALGORITHMS In developing treatment plans, it is important to identify how the differences (eg, route and frequency of administration, expected side effects) among the available therapies will impact treatment decisions for individual patients. Natalizumab, for example, should only be used as secondary therapy after the patient has failed treatment with other DMDs, and the patient must be compliant with the frequent follow-up that is necessary to monitor for the potential associated risk of multifocal leukoencephalopathy (TOUCH program). Treatment algorithms can help guide clinicians in stratifying patients, making evidence-based therapeutic decisions, and optimizing patient outcomes. In following the MS algorithm outlined in Figure 1, patients with clinically isolated syndrome should have proper diagnostic testing (ie, MRI) to confirm the presence of MS, and then be given a therapeutic plan and platform therapy (either one of the IFN agents or glatiramer acetate). 8 Treatment considerations include evidence-based efficacy supporting the individual University of Tennessee Advanced Studies in Pharmacy 73

3 Figure 1. Treatment Algorithm for MS Clinically isolated syndrome + MRI to support diagnosis Patient education Setting expectations Care management plan Patient meets diagnostic criteria for MS Develop therapeutic plan and select platform therapy : Glatiramer acetate *Wait at least 30 days after last steroid treatment if patient is being treated with steroids. IFN = interferon; IM = intramuscular; MRI = magnetic resonance imaging; MS = multiple sclerosis; NAb = neutralizing antibody; SC = subcutaneous. Adapted with permission from Rich et al. J Manag Care Pharm. 2004;10(3, suppl B): S26-S32. 8 Figure 2. Treatment Algorithm for MS (Based on Stages) Treatment Selection Ongoing Disease Management Symptom management MRI monitor disease After therapy Stage I Maintenance At 12 mos and on breakthrough disease IFNβ-1a IM IFNβ-1a SC IFNβ-1b Glatiramer acetate Test for NAbs* High titer (>20) Low titer (<20) Consider long-term implications and repeat NAb test in 6 mos; if persistent, alter therapy Check patient compliance Symptomatic Asymptomatic Asymptomatic Symptomatic Possibly do not alter therapy Stage II Breakthrough disease Follow-up and further evaluate; possibly alter therapy plus Pulsed corticosteroids as needed Glatiramer acetate Breakthrough disease Switch to an IFN Consider Natalizumab or combination therapy Stage III Continued breakthrough disease plus Maintenance pulsed corticosteroids and/or Stage IIIA: Oral immunosuppressant and/or Stage IIIB: IV immunosuppressant IFN = interferon; IM = intramuscular; IV = intravenous; MS = multiple sclerosis; SC = subcutaneous. Reprinted with permission from Stuart. J Manag Care Pharm. 2004;10(3, suppl B):S19-S25. 9 agents, patient s lifestyle as it relates to likelihood of compliance with the dosing and administration regimen, potential for immunogenicity, and ability of the patient to tolerate long-term treatment. In discussing ongoing management of MS, patients who stop responding to therapy and experience breakthrough disease should be questioned regarding compliance and correct administration technique. In addition, they should be tested for neutralizing antibodies (NAbs), especially if treated with subcutaneous (SC) IFNβ-1a or 1b. Those with persistently high NAb titers and increasing MS symptoms will likely require alterations in therapy. Patients with low NAb titers who continue to experience breakthrough disease while being treated with lowdose IFNs should be considered for high-dose IFN therapy or change to glatiramer acetate, or monotherapy with natalizumab. Figure 2 exemplifies another type of algorithm, which categorizes treatment recommendations based on stages of MS (stage I [maintenance], stage II [breakthrough disease], and stage III [continued breakthrough disease]). 9 Platform therapy is initially chosen as it is in the Figure 1 algorithm, then stepped up to include pulsed corticosteroids and/or additional immunosuppressive therapy for breakthrough disease. 8 CASE STUDY: PATIENT WITH NEWLY DIAGNOSED MS Patient LM, who is a regular visitor at a local pharmacy, asked the pharmacist for a consultation. She stated that she had been experiencing left-sided weakness and also complained of intermittent headaches, difficulty with memory and visual function, and was easily fatigued. She asked for the pharmacist s advice regarding these symptoms and he suggested that she first see her primary care physician for a general physical examination (to rule out any obvious cause for her symptoms) and then inquire about a referral to a neurologist. LM returned several weeks later and told the pharmacist that she was diagnosed with relapsingremitting multiple sclerosis (RRMS) and was treated by a neurologist with a 3-day course of intravenous (1000 mg/day) regimen of methylprednisolone. LM s neurologist then gave her some videos describing several DMDs (IFNβ-1a SC, IFNβ-1a intramuscular, and IFNβ-1b) that may be used for initial treatment of RRMS and allowed her to make the treatment choice. She asked for the pharmacist s help in deciding which agent to start with. 74 Vol. 6, No. 3 September 2009

4 The pharmacist pointed out that all of the aforementioned therapies were equally effective for her type of MS, and that none were inferior to the other. He further explained that the major differences between the products were in side effects and dosage form (Table), and also emphasized the importance of beginning therapy early to try and prevent additional attacks. He made certain that LM had realistic expectations, explaining that therapy will not cure MS, but rather minimize the frequency and severity of relapses. After further conversation regarding LM s home life and concerns, the pharmacist learned that she had a fear of needles and, because she lived alone with her young children, an adult caregiver was unavailable to help administer injections. In discussing the different formulations, the pharmacist explained that although IFNβ- 1a intramuscular is given infrequently compared to the other agents, it is not recommended for LM because it must be given intramuscularly and, therefore, the injection may be more painful and the needle size is larger (compared to SC formulations). The pharmacist reassured LM that SC formulations have smaller needle sizes and are relatively simple to inject once proper injection technique is mastered. After the pharmacist reviewed with LM the expected adverse effects of the various treatments, the patient expressed concern about the possibility of flu-like symptoms (associated with IFNs) preventing her from being able to care for her children. The pharmacist explained to LM that these symptoms usually decrease or disappear after 2 to 3 months of therapy and, in the meantime, they can be minimized through preventive techniques, such as administering the injection at bedtime in hopes of sleeping through the majority of symptoms, increasing the dose gradually, making sure the drug is at room temperature, rotating the injection sites, and taking acetaminophen or a nonsteroidal antiinflammatory drug before and after the injection. Table. Disease-Modifying Therapies for MS LM continued to exhibit apprehension regarding having to manage flu-like symptoms, stating, colds always wipe me out for weeks, and I m tired as it is. At that point, the pharmacist recommended that she start with glatiramer acetate, which is not associated with flu-like symptoms and is available as an SC injection. LM was then counseled on adverse effects associated with glatiramer acetate, which commonly include injection site reactions that are more sensitive, painful, and longer lasting than those associated with IFNs. Glatiramer acetate is also (less commonly) associated with post-injection systemic reactions, which may present as chest tightness and panic-type symptoms. LM agreed to try this treatment, despite the likelihood of painful injection site reactions, stating, as long as I don t have to deal with flu-like symptoms. LM was then counseled extensively on proper injection technique, which is pertinent in reducing injection site reactions. She was encouraged to rotate between all available injection sites on both sides of the body and also within each site, use clean injection technique, warm medication to room temperature, Drug Dose and Route of Administration Common Adverse Effects IFNβ-1a IM 30 µg (1 ml) Flu-like symptoms IM weekly Injection site reactions IFNβ-1a SC 44 µg (0.5 ml) Laboratory abnormalities SC 3 times weekly Menstrual abnormalities IFNβ-1b 0.25 mg (1 ml) Depression SC every other day Palpitations Dyspnea Glatiramer acetate 20 mg (1 ml) Injection site reactions SC every day Post-injection systemic reaction Depression Natalizumab 300 mg IV infused over 1 hour, Headache every 4 weeks Fatigue Hypersensitivity Infections Progressive multifocal leukoencephalopathy (rare) Mitoxantrone 12 mg/m 2 IV infusion every Nausea/vomiting 3 months (lifetime dose 140 mg/m 2 ) Alopecia Amenorrhea Myelosuppression Cardiac dysfunction IFN = interferon; IM = intramuscular; IV = intravenous; MS = multiple sclerosis; SC = subcutaneous. University of Tennessee Advanced Studies in Pharmacy 75

5 avoid partial intradermic injection by ensuring complete skin penetration, use auto-injectors (which may aid in skin penetration), apply hydrocortisone cream (15 30 minutes prior to injection) only if necessary, and ice injection sites. The pharmacist then asked LM to demonstrate her injection technique, in order to make certain that she was competent in self-administration. He also encouraged LM to call any time with questions regarding her therapy and referred her to the National Multiple Sclerosis Society ( for additional information and support. CONCLUSIONS In summarizing treatment considerations in MS, it is important to understand that therapy should be tailored to the individual patient based on factors such as home life and the degree of potential support from family and friends. Other considerations include the route of administration and cost of therapy, the patient s acceptance of education, and potential adherence with maintenance therapy. Treatment goals should be realistic, in that the patient should understand that medication will not cure the disease, but is expected to reduce the number of relapses, which may ultimately reduce MS-associated disability. Patients should be educated on side effects and ways to mitigate them, the importance of follow-up, and possible reasons for treatment failure. REFERENCES 1. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002;58: Whitaker JN, McFarland HF, Rudge P, Reingold SC. Outcomes assessment in multiple sclerosis clinical trials: a critical analysis. Mult Scler. 1995;1: Andersson PB, Goodkin DE. Outcome measures in multiple sclerosis clinical trials. Baillieres Clin Neurol. 1997;6: Río J, Porcel J, Téllez N, et al. Factors related with treatment adherence to interferon beta and glatiramer acetate therapy in multiple sclerosis. Mult Scler. 2005;11: Daugherty KK, Butler JS, Mattingly M, Ryan M. Factors leading patients to discontinue multiple sclerosis therapies. J Am Pharm Assoc. 2005;45: Mohr DC, Goodkin DE, Likosky W, et al. Treatment of depression improves adherence to interferon beta-1b therapy for multiple sclerosis. Arch Neurol. 1997;54: Clerico M, Barbaro P, Contessa G, et al. Adherence to interferon-beta treatment and results of therapy switching. J Neurol Sci. 2007;259: Rich SJ, Coleman IC, Cook R, et al. Step-care approach to treating MS: A managed care treatment algorithm. J Manag Care Pharm. 2004;10(3, suppl B):S26-S Stuart WH. Clinical management of multiple sclerosis: the treatment paradigm and issues of patient management. J Manag Care Pharm. 2004;10(3, suppl B):S19-S Vol. 6, No. 3 September 2009

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