Multiple sclerosis (MS) patients diagnosed in more recent years — specifically after 2017 — were more likely to start sooner on a first MS disease-modifying therapy (DMT) than were those diagnosed between 2014 and 2016, an analysis of data from three large MS registries found. However, starting with…

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…

Biosimilar, or “follow-on,” 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…

Many people newly diagnosed with 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…

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 in Frontiers in Neurology. Disease-modifying therapies, or DMTs,…

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…

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…

Multiple sclerosis (MS) is characterized by changes in methylation — a type of chemical modification in the DNA that changes how genes are read — in immune cells called T-cells, according to a new study. The results also suggest that treatments for MS can help to normalize methylation…

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…

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…

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…

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. “Our work adds to the body of literature detailing real-world outcomes in MS patients treated with [Ocrevus] and…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17–22. Go here to read the latest stories from the conference. Disease-modifying therapies (DMTs) that target CD20 are associated with worse outcomes from COVID-19 in multiple sclerosis (MS) patients, an…

Editor’s note: The Multiple Sclerosis News Today news team is providing in-depth and unparalleled coverage of the virtual ACTRIMS Forum 2021, Feb. 25–27. Go here 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…

Exposure to disease-modifying therapies does not increase 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…

Throughout 2019, Multiple Sclerosis News Today brought you daily coverage of the latest scientific findings, treatment developments, and clinical trials related to 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…

Age at disease onset is tightly linked to clinical outcomes in multiple sclerosis patients, a Swiss study in those on disease-modifying therapies (DMTs) reports. It found 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…

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 the University of Pittsburgh in a…

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…

The Cleveland Clinic Nevada is recruiting participants for DELIVER-MS, a clinical trial comparing two common treatment approaches for relapsing-remitting multiple sclerosis (RRMS). Results from the DELIVER-MS trial, titled “Determining the Effectiveness of Early Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis” (…

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. “It’s a dysfunctional market that lacks the typical incentives for most other consumer prices,” Daniel Hartung, the study’s lead author, said in an Oregon Health & Science University (OHSU) press release written by Erik Robinson. “Aside 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,” 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 the 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 — the four therapies available in 2007 — 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 9–13% per year. These include Novartis’ Extavia (interferon beta-1b) and Gilenya (fingolimod), Biogen’s Plegridy (peginterferon beta-1a) and Tecfidera (dimethyl fumarate), and Sanofi Genzyme’s 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 — Gilenya, Aubagio and Tecfidera — 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 Mylan’s 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 Copaxone’s 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 beneficiary’s total out-of-pocket spending, unlike what is mandated by the Affordable Care Act for brand-name therapies. “This is a pernicious effect of the release of a generic and an unfortunate effect of Medicare rules,” Dennis Bourdette, MD, one of the study’s 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 patient’s total out-of-pocket spending. Such strategy would reduce the disparity between brand-name and generic therapies, the researchers said. “In 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,” the researchers wrote. “There 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,” they concluded.

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 “Effect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression…

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…

African-Americans with relapsing–remitting multiple sclerosis (RRMS) show higher adherence and greater satisfaction when treated with oral Gilenya (fingolimod, by Novartis) than with injectable therapies, according to a new study. The research, “Treatment retention on fingolimod compared with injectable multiple sclerosis therapies in African-American patients: A…

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…

Genentech‘s Ocrevus (ocrelizumab), 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…

Cladribine treatment leads to a selective depletion of memory B-cells in patients with relapsing-remitting multiple sclerosis (RRMS), researchers report. The results are in the presentation “Cladribine for the Effective Control of Multiple Sclerosis via Memory B Cell Depletion” being given Friday, the final day of the 2018 Annual Meeting of the …

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…

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,…

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…