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Friday, October 11, 2019

June Halper Describes the Team-Based Approach Underlying the Consortium of MS Centers

August 2019

The Consortium of Multiple Sclerosis (MS) Centers is unique in that it places physicians and other healthcare professionals on a level playing field while elevating the patient’s voice to be the most important on the team, explained June Halper, MSN, APN-C, MSCN, FAAN, chief executive officer, Consortium of Multiple Sclerosis Centers.

Click to listen to June Halper as she describes a Team-based approach to care




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Tuesday, October 8, 2019

Pharmacy Benefit Managers and Their Role in Drug Spending - Are they the Good Guys or Bad Guys

April 2019

Pharmacy benefit manager have a significant behind-the-scenes impact in determining drug costs and patients’ access to medications. Some experts think pharmacy benefit managers need to move their business model away from securing rebates from drugmakers and toward encouraging better value in pharmaceutical spending.


What are pharmacy benefit managers?

Pharmacy benefit managers, or PBMs, are companies that manage prescription drug benefits on behalf of health insurers, Medicare Part D drug plans, large employers, and other payers. By negotiating with drug manufacturers and pharmacies to control drug spending, PBMs have a significant behind-the-scenes impact in determining total drug costs for insurers, shaping patients’ access to medications, and determining how much pharmacies are paid.1 PBMs have faced growing scrutiny about their role in rising prescription drug costs and spending.
What role do PBMs play in how much we spend on prescription drugs?
PBMs operate in the middle of the distribution chain for prescription drugs. That’s because they:
  • develop and maintain lists, or formularies, of covered medications on behalf of health insurers, which influence which drugs individuals use and determine out-of-pocket costs
  • use their purchasing power to negotiate rebates and discounts from drug manufacturers
  • contract directly with individual pharmacies to reimburse for drugs dispensed to beneficiaries.2
The federal Centers for Medicare and Medicaid Services found that PBMs’ ability to negotiate larger rebates from manufacturers has helped lower drug prices and slow the growth of drug spending over the last three years. But PBMs may also have an incentive to favor high-priced drugs over drugs that are more cost-effective. Because they often receive rebates that are calculated as a percentage of the manufacturer’s list price, PBMs receive a larger rebate for expensive drugs than they do for ones that may provide better value at lower cost. As a result, people who have a high-deductible plan or have copays based on a drug’s list price may incur higher out-of-pocket costs.3

What’s the controversy over the rebates PBMs receive from drug companies?   Click here to read


 Role of a Pharmacy Benefit Manager in Providing Services and Flow of Funds for Prescription Drugs
           Click here to continue reading

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Monday, October 7, 2019

Association Between Serum Neurofilament Light Chain Levels and Long-term Disease Course Among Patients With Multiple Sclerosis Followed up for 12 Years

Question  Can serum neurofilament light chain measurements serve as a reliable biomarker of disease worsening for patients with multiple sclerosis?
Findings  In this cohort study of 607 patients with multiple sclerosis, serum neurofilament light chain levels increased significantly faster in those experiencing disability worsening than in those who remained clinically stable. Serum neurofilament light chain level was associated with brain fraction loss, whereas this was less the case for clinical outcomes such as relapses or EDSS worsening.
Meaning  The association of serum neurofilament light chain level with changes in relevant clinical and neuroimaging outcomes in multiple sclerosis was confirmed, strengthening the potential of this biomarker as a measure of disease activity in multiple sclerosis; however, the clinically useful prognostic value of serum neurofilament light chain level for the individual patient was limited.
Abstract
Importance  Blood sample–based biomarkers that are associated with clinically meaningful outcomes for patients with multiple sclerosis (MS) have not been developed.
Objective  To evaluate the potential of serum neurofilament light chain (sNFL) measurements as a biomarker of disease activity and progression in a longitudinal MS data set.
Design, Setting, and Participants  Single-center, ongoing, prospective observational cohort study of 607 patients with MS from the longitudinal EPIC (Expression, Proteomics, Imaging, Clinical) study at the University of California, San Francisco from July 1, 2004, through August 31, 2017. Clinical evaluations and sample collection were performed annually for 5 years, then at different time points for up to 12 years, with a median follow-up duration of 10 (interquartile range, 7-11) years. Serum NFL levels were measured using a sensitive single molecule array platform and compared with clinical and magnetic resonance imaging variables with the use of univariable and multivariable analyses.
Main Outcomes and Measures  The main outcomes were disability progression defined as clinically significant worsening on the Expanded Disability Status Scale (EDSS) score and brain fraction atrophy.
Results  Mean (SD) age of the 607 study participants at study entry was 42.5 (9.8) years; 423 (69.7%) were women; and all participants were of non-Hispanic European descent. Of 3911 samples sequentially collected, 3904 passed quality control for quantification of sNFL. Baseline sNFL levels showed significant associations with EDSS score (β, 1.080; 95% CI, 1.047-1.114; P < .001), MS subtype (β, 1.478; 95% CI, 1.279-1.707; P < .001), and treatment status (β, 1.120; 95% CI, 1.007-1.245; P = .04). A significant interaction between EDSS worsening and change in levels of sNFL over time was found (β, 1.015; 95% CI, 1.007-1.023; P < .001). Baseline sNFL levels alone were associated with approximately 11.6% of the variance in brain fraction atrophy at year 10. In a multivariable analysis that considered sex, age, and disease duration, baseline sNFL levels were associated with 18.0% of the variance in brain fraction atrophy at year 10. After 5 years’ follow-up, active treatment was associated with lower levels of sNFL, with high-potency treatments associated with the greater decreases in sNFL levels compared with platform therapies (high-potency vs untreated: β, 0.946; 95% CI, 0.915-0.976; P < .001; high-potency vs platform: β, 0.972; 95% CI, 0.948-0.998; P = .04).

Conclusions and Relevance  This study found that statistically significant associations of sNFL with relevant clinical and neuroimaging outcomes in MS were confirmed and extended, supporting the potential of sNFL as an objective surrogate of ongoing MS disease activity. In this data set of patients with MS who received early treatment, the prognostic power of sNFL for relapse activity and long-term disability progression was limited. Further prospective studies are necessary to assess the assay’s utility for decision-making in individual patients.


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Learn about Neurofilament light polypeptide

Neurofilament light polypeptide (NFL), also known as neurofilament light chain, is a neurofilament protein that in humans is encoded by the NEFL gene.[5][6] Neurofilament light chain is a biomarker that can be measured with immunoassays in cerebrospinal fluid and plasma and reflects axonal damage in a wide variety of neurological disorders.[7][8] It is a useful marker for disease monitoring in amyotrophic lateral sclerosis,[9] multiple sclerosis,[10] Alzheimer's disease,[11][12] and more recently Huntington's disease.[13]

Read more


MS & Socializing: A Few Things to Remember

#MS&Socializing

By Devin Garlit · September 17, 2019

While a disease like multiple sclerosis has a different effect on everyone it afflicts, universally it has an impact on your ability to socialize. Perhaps you are disabled and can’t drive, so you are unable to leave the house much. Maybe you are still doing fairly well, but fatigue still ends your day early. Maybe you can even hold down a job and survive but you aren’t well enough to actually thrive. When it comes to MS, there are many scenarios that can inhibit our ability to socialize with others. Like many things I write about, I struggle in this area as well, however, I do have some tips to help improve your chances of experiencing that crucial time with other human beings.

MS &#038; Socializing: A Few Things to Remember

Remember it’s important
You’ve probably heard the phrase “humans are social creatures” a number of times in your life.  There’s a lot of truth to it, humans have evolved to be around other humans. Even the most introverted among us require time with other people. The psychological effects of not allowing humans to interact with others can be severe (you can simply Google “solitary confinement” and see how it is often viewed as cruel and unusual punishment). I could go into depth about why you need to see and interact with other human beings, but if I did, this article would be way too long. Besides, I’m pretty sure most people will agree on its importance. No matter how introverted you are, you have to remember that it’s beneficial to be amongst other people. No matter how different you feel they may be from them. People with chronic illness have a tendency to isolate themselves, and you have to consciously fight against that. It’s important to think back to the times you have been around people that it felt good, focus on those moments to help get yourself over the hump.

Plan!

I’ve written before how I tend to thrive more when I follow a routine and go to familiar places. Getting out is difficult for me, so I often set aside a standard day every week to get out. I have a set plan to go to a local bar and play trivia with a group of friends. I know I’m doing it every week, so my body is prepared for it.  It’s also at the same place each time, so I’m familiar with it, I know how the temperatures run, I know where the bathrooms are, etc. Familiarity makes getting out with a chronic illness much easier.  Even if you aren’t going to a set event every week, simply going to a place you know well can be of huge comfort, whether you realize it or not. If someone suggests meeting at one place, and you are uneasy, suggest somewhere you know a bit better. To go along with the planning theme, budget the appropriate rest time before and after activities. Knowing you have that time set aside can be very helpful.

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Sunday, October 6, 2019

MS Symptoms - Learn to recognize and manage the possible symptoms of MS, which range from mild to severe.

MS Keywords:
   Fatigue; Pain; Gait (Walking), Cognition; Bladder, Bowel, Vision, Sexual Problems and Depression

MS symptoms are variable and unpredictable. No two people have exactly the same symptoms, and each person’s symptoms can change or fluctuate over time. One person might experience only one or two of the possible symptoms while another person experiences many more.

Explore the list below to find more information about the symptoms you or someone you care about may experience. Most of these symptoms can be managed very effectively with medication, rehabilitation and other management strategies. 
Effective symptom management by an interdisciplinary team of healthcare professionals is one of the key components of comprehensive MS care.
click to see more




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Pregnancy & MS - Considerations before starting a family

Pregnancy and MS
When I was diagnosed with multiple sclerosis (MS), I was 26 years old and newly married. I was working full time and had just started graduate school. I remember wondering early on in my diagnosis if I would ever be able to have a child. Some of the things that ran through my mind were:
    • Could I have a baby?
    • Should I have a baby?
    • Would I be a good parent?
    With so much going on in my life, my husband and I decided that we would hold off on having a child until I was almost finished with graduate school. We used this time to seek out answers to the questions that I had.
    It took a little bit of searching, but I was able to connect with someone who had a baby after her diagnosis of MS. Finding this person was not easy. I started by emailing support group leaders and asking them if they knew anyone. I had to put myself out there and ask, but I am so thankful that I did. Connecting with someone who understood my concerns and knew what I was going through was extremely helpful.
    After doing some research, I found an MS specialist who was able to address some of my concerns. The first question I asked him was whether I could have a baby. He was very helpful and willing to answer all my questions. Some of the other questions I asked were:
      • How will my current therapy affect my ability to get pregnant?
      • Will my MS symptoms affect my pregnancy?
      • What happens if I have an MS relapse immediately after my pregnancy?
      Being Pregnant With MS
      In my final semester of graduate school, I became pregnant. My husband and I were overjoyed. My pregnancy was very positive. I embraced the emotions and moments of that time. We took pictures every week of my growing belly and settled on the name Jacob when we found out we were having a boy.
      Nine months later, my husband and I welcomed Jacob into the world. We were so happy. We finally had the little family we planned.

      Below are some tips based on my experience:

      • Planning : My husband and I talked a lot about what parenting would be like and how we could do it together. A lot of these conversations were discussed before I got pregnant and during my pregnancy. Planning early helped alleviate some of our concerns
      • Co-parenting : My husband and I decided early on that we would be 50/50 parents. This meant we would alternate diaper changes, baths, etc. Sometimes we would do these things together, but it helped that we were sharing responsibilities. Going into parenting this way was very important for us.
      • Addressing MS symptoms: I was worried that my symptoms would get in the way of my parenting duties. But having a strong support system was helpful and made me feel very comfortable. At times, my husband would do extra things so I could manage my fatigue. We knew if I addressed my fatigue, I might have more energy to do some of the things with our son that I really wanted to do
      • My husband and I also came up with a feeding schedule. He is a night owl, and I need extra sleep. I fed our son any time up to 9:30 PM . He would feed our son any time after that until 4 AM . I would then feed Jacob in the early hours of the morning. I cannot express how helpful this system was for us
      • Working with your healthcare team: My healthcare team was there to help me before, during, and after my pregnancy. I made sure that I shared any concerns I had with my healthcare provider. For example, my neurologist was very helpful with giving me information about starting back on my relapsing MS medication. In addition, I made sure to regularly touch base with him after having Jacob. My OBGYN was very helpful to talk with when I was worried about not being able to breastfeed. Jacob’s pediatrician even became a part of my team too. He gave me good advice on parenting, and provided tips for taking care of a baby while living with a chronic illness. Find tips for connecting your healthcare team here
      • Breastfeeding : When I had Jacob, I was advised that I should not breastfeed when starting back on my treatment a few weeks after delivery. I was sad that I would miss out on breastfeeding, but I felt so thankful to be having a baby. Formula feeding offered a positive opportunity for my husband as he was able to help out quite a bit. This helped with their bonding as my husband settled into becoming a new dad. Breastfeeding is a personal choice. Be sure to talk to your healthcare provider about whether breastfeeding may be right for you and your child
      Keep in mind, everyone's situation is different and this is just my own personal experience. Pregnancy may not be appropriate or possible for everyone. Please talk to your healthcare provider if you have any questions relating to pregnancy and MS. He or she will help you make a decision based upon your specific condition and weigh the potential benefits and risks.
      Starting a Family With MS

      Focus on what matters most

      Having a family has always been a dream of mine. And for me, deciding to have Jacob was one of the best decisions that my husband and I ever made. I am thankful that we decided to have a baby regardless of my MS. Since having Jacob, my condition is not the only focus of my life. Being a mom with MS has motivated me to make the most of every moment spent with my family. Being a good mom was something that I aspired to be. Now I am one, and I just happen to have MS too.
      Article source: AboveMS



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      Medical management during pregnancy, delivery, and postpartum

      None of the current disease-modifying medications — Aubagio®Avonex®Betaseron®, Copaxone®Extavia®Gilenya®, Glatopa®, Lemtrada®, Novantrone®Ocrevus™, Plegridy®, Rebif®Tecfidera® Tysabri®, or Zinbryta® — are approved for use during pregnancy. Women who are taking any of these medications should discuss their plan to become pregnant with their prescribing physician. 
      For more information about treatment considerations in women and men in their reproductive years, refer to the MS Coalition's Consensus Paper -- the Use of Disease-Modifying Therapies in Multiple Sclerosis: Principles and Current Evidence.

      Women with MS usually need no special gynecologic care during pregnancy. Labor and delivery are usually the same as in other women and no special management is needed. All forms of anesthesia are considered safe for women during labor and delivery and.seem to be well tolerated.

      The disease-modifying drugs are not recommended during breastfeeding because it is not known if they are excreted in breast milk. A woman should also review any other medications she is taking with her neurologist and obstetrician in order to identify those that are safe during pregnancy and breastfeeding.
      Studies have indicated no increased risk of relapse of MS associated with breastfeeding.

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      Treating pediatric MS

      In 2018 the U.S. Food and Drug Administration approved the expansion of the use of the oral MS therapy Gilenya® (fingolimod, Novartis AG) to include the treatment of children and adolescents 10 years of age or older with relapsing MS.  In addition, many of the disease modifying therapies that are FDA approved for adults are also prescribed off-label for pediatric MS.

      Other oral therapies for MS, including dimethyl fumarate (Tecfidera®) and teriflunomide (Aubagio®), are currently under study in clinical trials for the treatment of pediatric MS.  An observational study of natalizumab showed that the safety and efficacy in children were similar to that in the adult MS population.  Smaller retrospective studies, case studies and unblinded controlled trials have demonstrated safety and efficacy of the self-injected MS disease modifying therapies.

      In addition to the FDA approved therapies used for pediatrics, another treatment, that is not FDA approved for MS, known as rituximab (Rituxan®), has been studied in small trials of pediatric patients and showed that it was safe and effective.

      Ultimately, starting or switching a disease modifying therapy in children and adolescents requires that the provider, child and family have an in-depth discussion. This discussion should include the goals and expectations of the child and family, how the drug is expected to control the MS, the side effects, the risks and any monitoring (blood tests, MRI and other tests) after the therapy is started. In this way, providers, patients and families can participate in a shared decision-making process to determine the therapy that best meets individual needs.

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      Coping with dual diagnoses -- How to prioritize when MS is only one of your health concerns.

      by Aviva Patz
      Lisa Emrich and her husband, Rob Osberg.
      Lisa Emrich, a musician, with her husband, Rob Osberg, manages the coexisting health conditions of multiple sclerosis and rheumatoid arthritis. Photo courtesy of Lisa Emrich
      Just two years after being diagnosed with multiple sclerosis, 47-year-old Lisa Emrich, a professional musician in Falls Church, Virginia, suddenly was unable to play the piano. “My fingers on both hands curled into fists, and I cried during the night because of the excruciating pain,” she recalls. “I fantasized that someone would chop off my arms just so I might get some relief.”
      Emrich, who had already lost control of two fingers on her left hand the previous year due to MS, figured the new symptoms were just the next chapter in her struggle with the disease. But after several months and referrals to many other medical professionals, her finger issues turned out to be due to a whole other diagnosis—rheumatoid arthritis (RA).
      “I was devastated,” Emrich says. “As if it wasn’t bad enough that I had previously lost my vision, lost the use of my left arm, even lost strength and dexterity, all due to MS, now I was faced with the possibility of further pain and disability from the RA.” Once her RA was diagnosed, however, Emrich worked with her team of physicians to pursue a course of treatment and learn strategies for managing it alongside her MS.
      Dr. David E. Jones
      Dr. David E. Jones says it’s important to identify the condition that may be causing new symptoms in
      someone with MS.
       Photo courtesy of Dr. David E. Jones
      Untangling the web
      Like Emrich, many people with MS develop other seemingly unrelated health conditions such as cancer or diabetes, another autoimmune disease such as psoriasis or RA, or a potentially temporary issue like headaches or anemia.
      “More than 50 percent of people with MS are estimated to have another chronic health condition,” says Dr. Ruth Ann Marrie, professor of medicine and community health sciences at the University of Manitoba, Canada, and director of the Multiple Sclerosis Clinic at the Health Sciences Centre in Winnipeg.
      However, like Emrich, many people with more than one health condition may simply blame the new or worsening symptom on their MS—especially if the symptom is consistent with MS, like pain or weakness. “Part of the problem is that MS is different for different people, so you can’t just pick up a book and say, ‘This is exactly what you’ll have,’” says Dr. David E. Jones, assistant professor of neurology at the University of Virginia and chair of the MS section at the American Academy of Neurology. Attributing new symptoms to MS may also provide some sense of comfort, Dr. Jones says. “People may think, ‘Phew—it’s just my MS and not another diagnosis.’ ”
      But as awareness of dual diagnoses grows, it’s becoming increasingly clear that for people with MS, any new symptoms should be evaluated through a wider medical lens. “If there’s another condition that’s causing the [new] symptoms, it will not be treated successfully unless it’s identified,” Dr. Marrie says.
      Dr. Ruth Ann Marie
      Dr. Ruth Ann Marrie has found that depression and anxiety are common disorders that occur alongside MS. Photo courtesy of Health Sciences Centre Winnipeg
      Common comorbidities
      Dr. Marrie recently led an international committee of MS experts in an investigation into which coexisting health conditions, known medically as “comorbidities,” are most common among people with MS. The goal of the ongoing research, called The Comorbidities Project (which is supported by the National MS Society and the European Committee for Treatment and Research in MS), is to understand how other health conditions may affect the course and treatment of MS, and how best to manage all of the various symptoms.
      After reviewing 249 earlier studies on MS and other medical conditions, Dr. Marrie’s team published seven papers in the MS Journal in 2015. Key findings include:
      • The five most prevalent disorders that occur alongside MS are depression, anxiety, high blood pressure, high cholesterol and chronic lung diseases like asthma. Depression and anxiety are so common, in fact—affecting about 24 and 22 percent of people with MS, respectively, per Dr. Marrie’s analysis—that researchers are beginning to suspect they may actually be caused by the disease process itself. “In some cases, structural and functional changes in the brain due to MS likely play a role, and inflammation may also play a role,” explains Dr. Marrie. But she’s quick to add that depression should not automatically be attributed to MS. “Any of the stressors and circumstances that increase the risk of depression in people without MS—divorce, illness in family members, financial difficulties—can also cause depression in people with MS, and genetic factors are likely relevant in other cases.”
      • Some autoimmune disorders—in which the immune system attacks its own body rather than predatory invaders like viruses—appear to be more common among people with MS. According to Dr. Marrie’s findings, more than 7 percent of people with MS have psoriasis, over 6 percent have thyroid disease and nearly 3 percent have RA. In the general population, only a total of 5 to 8 percent of people have any type of autoimmune condition.
      • On the whole, cancer is less common in people with MS than in the general population. However, certain types of cancer may occur more often in people with MS—including cervical and digestive-system cancers.
      • Heart disease, congestive heart failure, stroke, arthritis, inflammatory bowel disease, irritable bowel syndrome (IBS), seizure disorders, bipolar disorder, sleep disorders and alcohol abuse are found more often in people with MS. 
      Click here to read the complete article 


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