September 1, 2023 Columns by Ed Tobias The 1st biosimilar OK’d as an MS DMT should save patients money The late August approval of Tyruko (natalizumab-sztn) by the U.S. Food and Drug Administration (FDA) is big news in the multiple sclerosis (MS) world. Tyruko is a biosimilar for Tysabri (natalizumab), and it’s the first biosimilar to gain FDA approval as an MS disease-modifying therapy…
August 26, 2022 News by Lindsey Shapiro, PhD Guidelines for Approval of DMT Biosimilars, Use In Europe Drafted Biosimilar, or āfollow-on,ā forms of disease-modifying therapies (DMTs) that have been approved in a highly regulated area can be considered as safe and effective as their reference medications, according to multiple sclerosis (MS) experts. A biosimilar is a medication that’s highly similar to an existing biological medication in…
May 17, 2022 News by Marisa Wexler, MS ‘Hidden’ Disabilities Fairly Common at RRMS Diagnosis, Study Finds Many people newly diagnosed withĀ relapsing-remitting multiple sclerosis (RRMS) experience substantial “hidden disabilities,” such as depression or fatigue, a study highlights. Findings indicate that treatment with disease-modifying therapies generally does not affect the severity of these problems, at least in the short term. “Considering the substantial impact that hidden…
April 21, 2022 News by Marisa Wexler, MS Data Is Lacking on Safety of MS Treatments During Breastfeeding There is minimal data available on the safety of most disease-modifying therapies for multiple sclerosis (MS) when used during breastfeeding, a new review indicates. The study “Disease-Modifying Drugs and Breastfeeding in Multiple Sclerosis: A Narrative Literature Review,” was published inĀ Frontiers in Neurology. Disease-modifying therapies, or DMTs,…
April 21, 2022 News by Lindsey Shapiro, PhD MSTOP Program in California Cuts DMT Costs and MS Relapse Rates A program aimed at optimizing the use of highly effective therapies successfully lowered treatment costs and relapse rates among people with multiple sclerosis (MS) in Southern California, according to a study. “Our novel physician-led approach simultaneously reduced MS DMT [disease-modifying therapy] expenditures and the frequency of MS relapses. We…
April 15, 2022 News by Marisa Wexler, MS Equal DMT Use Found in Norway Despite Socioeconomic Status: Study People newly diagnosed with multiple sclerosis (MS) in Norway have in recent years received disease-modifying therapies (DMTs) independent of their socioeconomic status, according to a new analysis. These findings do not support previous reports indicating that fewer DMTs are prescribed for the most socially deprived MS patients, the…
February 1, 2022 News by Marisa Wexler, MS Study: DNA Methylation in T-cells Affected by MS and Its Treatments Multiple sclerosis (MS) is characterized by changes in methylation ā a type of chemical modification in the DNA that changes how genes are read ā in immune cells called T-cells, according to a new study. The results also suggest that treatments for MS can help to normalize methylation…
November 9, 2021 News by Marisa Wexler, MS Ocrevus Still Top Therapy for Progressive MS Forms, Report Finds Ocrevus (ocrelizumab) continues to be the most commonly prescribed therapy for progressive forms of multiple sclerosis (MS), including primary progressive MS (PPMS) and secondary progressive MS (SPMS), according to an analysis from the market intelligence firm Spherix Global Insights. However, other therapies are “gaining traction” among…
September 1, 2021 News by Marisa Wexler, MS Early High-efficacy DMTs Linked to Better RRMS Outcomes in Sweden People with relapsing-remitting multiple sclerosis (RRMS) in Sweden have lower rates of worsening disability than those who live in Denmark, likely due to differences in treatment strategies in each country, according to a new study. “This study shows that, for the first time to our knowledge, differences in national…
July 13, 2021 News by Somi Igbene, PhD Patients Less Likely to Stop Taking Tecfidera Than Aubagio: Study Tecfidera has a lower risk of discontinuation due to treatment failure than Aubagio in people with multiple sclerosis (MS), a new observational study in Norway suggests. In the study, people receiving Tecfidera (dimethyl fumarate) were 38% less likely to experience treatment failure and stop use than those receiving…
May 24, 2021 News by Steve Bryson, PhD Antibody Levels, Age Linked to Infection Risk in Ocrevus-treated MS Lower antibody levels in the bloodstream and younger age are associated with a greater likelihood of infection in people with multiple sclerosis (MS) receiving Ocrevus (ocrelizumab) therapy, a study has found. āOur work adds to the body of literature detailing real-world outcomes in MS patients treated with [Ocrevus] and…
April 27, 2021 News by Marisa Wexler, MS #AANAM – Ocrevus, Rituximab Linked to More Severe COVID-19 Cases in Italy Editorās note: TheĀ Multiple Sclerosis News TodayĀ team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17ā22. GoĀ hereĀ to read the latest stories from the conference. Disease-modifying therapies (DMTs) that target CD20 are associated with worse outcomes from COVID-19 inĀ multiple sclerosis (MS) patients, an…
March 5, 2021 News by Marisa Wexler, MS #ACTRIMS2021 ā Taking Medication During Pregnancy Reduces Healthcare Costs Editorās note: TheĀ Multiple Sclerosis News Today news team is providing in-depth and unparalleled coverage of the virtual ACTRIMS Forum 2021, Feb. 25ā27. GoĀ hereĀ to see the latest stories from the conference. Women with multiple sclerosis (MS) who continue taking disease-modifying therapies (DMTs) throughout pregnancy accrue lower non-maternity healthcare…
July 1, 2020 News by Joana Carvalho, PhD Exposure to DMTs Does Not Increase Risk of Severe COVID-19 in MS Patients, Study Finds Exposure to disease-modifying therapies does not increaseĀ multiple sclerosis (MS) patients’ risk of developing a severe form of COVID-19, according to a registry-based study. However, MS patients who are older, obese, or have severe neurological impairments have a greater risk of developing a severe form of the disease. Findings…
January 2, 2020 News by Ana Pena PhD Top 10 Multiple Sclerosis Stories of 2019 Throughout 2019, Multiple Sclerosis News Today brought you daily coverage of the latest scientific findings, treatment developments, and clinical trialsĀ related toĀ multiple sclerosis (MS). We look forward to reporting more news to patients, family members, and caregivers dealing with MS during 2020. Here are the top 10 most-read articles of…
September 17, 2019 News by Jose Marques Lopes, PhD #ECTRIMS2019 – Age Seen as Crucial in MS Outcomes, with 40 Marking Shift from Relapses to Progression Age at disease onset is tightly linked to clinical outcomes in multiple sclerosisĀ patients, a Swiss study in those on disease-modifying therapies (DMTs) reports. It foundĀ a risk of continuous relapses more likely in pediatric MS, and that of disease progression in those with adult-onset MS. Patients at age 40…
August 29, 2019 News by Patricia Inacio, PhD Therapy Costs Increase More Than Sevenfold for MS Patients on Medicare, 10-Year Study Reveals The out-of-pocket costs for self-administered disease-modifying therapies (DMTs) for multiple sclerosis (MS) patients on Medicare increased more than sevenfold from 2006 to 2016, according to a new study. This was reported by researchers at theĀ University of Pittsburgh in a…
June 17, 2019 News by Alberto Molano, PhD Relative Cancer Risk is Higher in MS Patients Who Switch Disease-modifying Treatments More Frequently, Study Finds The relative risk of developing cancer was found to be higher in multiple sclerosis (MS) patients who more frequently switched between disease-modifying treatments, according to a study. In addition, researchers found an increased incidence of cancer in male MS patients from 20 to 50 years old, and in female…
March 15, 2019 News by Jonathan Grinstein Cleveland Clinic Nevada Joins DELIVER-MS Trial Assessing RRMS Treatments The Cleveland ClinicĀ Nevada is recruiting participants for DELIVER-MS, a clinical trial comparing two common treatment approaches for relapsing-remitting multiple sclerosis (RRMS). Results from theĀ DELIVER-MS trial, titled āDetermining the Effectiveness of Early Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosisā (…
February 8, 2019 News by Jose Marques Lopes, PhD Medicare Rules, Higher Cost-sharing Load Increase Out-of-pocket Spending for MS Therapies, Study Reports Restrictive access policies by Medicare and a rising cost-sharing burden lead to an increased price of disease-modifying therapies for multiple sclerosis patients, according to new research. The findings also revealed that Medicare beneficiaries without a low-income subsidy may spend on average $6,894 for their MS treatments in 2019, with generic versions of Copaxone representing the highest burden. Approximately 25-30% of patients with MS are covered by Medicare through disability. In 2013, MS Medicare beneficiaries with MS and without low-income subsidies averaged $4,389 a year in out-of-pocket expenses, second only to hepatitis. Despite a greater number and diversity of DMTs for MS treatment, their price has increased substantially over the past two decades. In fact, expenses related to DMTs for MS are among the highest by class in the Medicare market. āItās a dysfunctional market that lacks the typical incentives for most other consumer prices,ā Daniel Hartung, the studyās lead author, said in anĀ Oregon Health & Science University (OHSU) press release written by Erik Robinson. āAside from the public optics, there are few incentives for companies not to raise prices. Most intermediaries in the drug distribution channel, including drug companies, benefit from higher prices,ā Hartung said. These high prices may lead to reduced access, as insurance companies can restrict coverage or manage use through prior authorization or step-therapy policies, and high deductibles or cost-sharing components in health plans that increase the financial burden for patients. Now, a team at OHSU and theĀ Oregon State University College of Pharmacy used prescription drug plan formulary files to analyze changes in coverage policies from 2007 to 2016, and to estimate out-of-pocket spending for DMTs for MS within Medicare Part D program, through which outpatient prescriptions are financed. Eleven DMTs available during the study period were analyzed. Tysabri and Lemtrada were not part of the analysis because they are delivered via intravenous infusion in the clinic setting, and are typically covered through Medicare Part B. Results revealed that the price for Betaseron , Copaxone 20 mg , Rebif, and Avonex ā the four therapies available in 2007 ā quadrupled over the 10-year study period. Except for Copaxone 40 mg and its 20 mg generic formulation (Glatopa, by Sandoz), prices for the other DMTs introduced after 2007 increased by 9ā13% per year. These include Novartisā Extavia (interferon beta-1b) and Gilenya (fingolimod), Biogenās Plegridy (peginterferon beta-1a) and Tecfidera (dimethyl fumarate), and Sanofi Genzymeās Aubagio (teriflunomide). In 2007, 99-100% of plans covered the four available medications, with the exceptions being Rebif (88%). These percentages fell to 54-89% in 2016. Coverage of the other DMTs varied between 21% (Extavia) to 92% for Copaxone 40 mg. In turn, coverage for the three oral options ā Gilenya, Aubagio and Tecfidera ā generally increased or was maintained over time, ranging from 46% for Aubagio to 83% for Gilenya. The use of prior authorization increased from 61-66% in 2007, to 84-90% in 2016. Also, the share of plans with at least one DMT available without limitations declined from 39% to 17%. The average projected out-of-pocket spending for 2019 across DMTs was $6,894. The highest projected out-of-pocket expenses ($8,219) are associated with generic glatiramer acetate, both Glatopa and Mylanās 20 mg/mL and 40 mg/mL generic formulations, approved by the U.S. Food and Drug Administration in 2017. This is more than with any of Copaxoneās formulations. According to the team, this is the result of a higher coinsurance payment (37% vs. 25%) expected for generic medications compared to brand-name options, as well as the fact that manufacturers of generics do not provide discounts toward a beneficiaryās total out-of-pocket spending, unlike what is mandated by the Affordable Care Act for brand-name therapies. āThis is a pernicious effect of the release of a generic and an unfortunate effect of Medicare rules,ā Dennis Bourdette, MD, one of the studyās co-authors, said. A proposal by U.S. President Donald Trump's administration addresses this by eliminating manufacturer discounts from the calculation to determine a patientās total out-of-pocket spending. Such strategy would reduce the disparity between brand-name and generic therapies, the researchers said. āIn this study we found that Medicare beneficiaries with MS who require a [DMT] face considerable policy-related access restrictions and high out-of-pocket spending,ā the researchers wrote. āThere is an urgent need for policies that slow the growth of drug prices, improve access, and shield patients from excessively high out-of-pocket spending,ā they concluded.
January 18, 2019 News by Patricia Inacio, PhD Blood Stem Cell Transplant Better than DMTs at Reducing Risk of Disease Progression in RRMS Autologous hematopoietic stem cell transplant is better than disease-modifying therapies (DMT) at reducing the risk of disease progression in patients with relapsing-remitting multiple sclerosis (RRMS), results from the MIST clinical trial show. The study āEffect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression…
January 15, 2019 News by Alice MelĆ£o, MSc UK Experts Propose New Guidelines to Treat Women with MS Before, During, After Pregnancy Multiple sclerosis (MS) experts in the United Kingdom have proposed consensus guidelines for the management and treatment of pregnant women with the disease, and couples affected by MS who are planning a pregnancy. The new guidelines are expected to reduce uncertainty about treatments that are considered to be safe and…
July 30, 2018 News by Jose Marques Lopes, PhD African-Americans Show Better Adherence and Satisfaction with Gilenya Than Injectable DMTs, Phase 4 Study Finds African-Americans with relapsingāremitting multiple sclerosis (RRMS) show higher adherence and greater satisfaction when treated with oralĀ Gilenya (fingolimod, by Novartis) than with injectable therapies, according to a new study. The research, āTreatment retention on fingolimod compared with injectable multiple sclerosis therapies in African-American patients: A…
July 27, 2018 News by Alice MelĆ£o, MSc Oral DMTs Still Common 1st Therapy for New MS Patients but Ocrevus Having Impact, Market Report Says Oral disease-modifying therapies (DMTs) are the most common first choice of treatment for people newly diagnosed with multiple sclerosis (MS) in the United States, an analysis reports. Antibody-based DMTs like Ocrevus, however, are emerging competitors. Spherix Global Insights, a market research and analysis company, states that 1 in every…
June 27, 2018 News by Patricia Inacio, PhD After Ocrevus Approval, New Therapies May Become Available for MS, Report Suggests Genentech‘s OcrevusĀ (ocrelizumab),Ā approved in March 2017, has fueled a sea change in the treatment of multiple sclerosis (MS) patients in the U.S., leading to an increased interest in disease-modifying therapies (DMTs) for progressive forms of MS. Now, other potential treatment choices for progressive MS forms will likely…
April 26, 2018 News by Patricia Inacio, PhD #AAN2018 – CladribineĀ Injections Deplete Number of Memory B-cells in RRMS, Study Shows CladribineĀ treatment leads to a selective depletion of memory B-cells in patients with relapsing-remittingĀ multiple sclerosisĀ (RRMS), researchers report. The results are in the presentation āCladribine for the Effective Control of Multiple Sclerosis via Memory B Cell Depletionā being given Friday, the final day of the 2018 Annual MeetingĀ of theĀ …
April 12, 2018 News by Stacy Grieve, PhD First Generation Disease-modifying Therapies Pose Low Infection Risk in MS, Study Finds A large group study showed that first-generation disease-modifying therapies (DMTs) do not increase the infection risk in multiple sclerosis (MS) patients. Many of the DMTs used to reduce the risk of relapse in MS target the immune system and cause a suppression of the inflammatory response. Although helpful in…
April 10, 2018 Columns by Ed Tobias Lemtrada Round 2: My Drip Stops Here As you read this, I likely will be in the middle of, or finished with, my second round of Lemtrada (alemtuzumab). Hopefully, this will be the final round of this disease-modifying therapy (DMT), and the final MS treatment of any kind, for me. Though some have required more,…
February 6, 2018 News by Alice MelĆ£o, MSc #ACTRIMS2018 – Prior Therapies Don’t Affect Gilenya’s Benefits, Study Shows Changing from injectable disease-modifying therapies (DMTs) to Gilenya (fingolimod) can benefit people with relapsing multiple sclerosis (MS), regardless of prior therapy regimens. The PREFERMS Phase 4 trial (NCT01623596) concluded that Gilenya, marketed by Novartis, reduces annualized relapse rates (ARR) and brain volume loss (BVL) in both…
January 17, 2018 News by Ana Pena PhD Majority of RRMS Patients in Swedish Study Seen to Stop Using Tecfidera Within 2 Years A majority of relapsing-remitting multiple sclerosis (RRMS) patients at a Swedish clinic who initiated treatment with Tecfidera (dimethyl fumarate; DMF) either stopped or switched to another therapy within two years, a study reports. Researchers in the observational study were not able to determine exact reasons for discontinuation. But, they wrote,…