DMT

Guidelines for Approval of DMT Biosimilars, Use In Europe Drafted

Biosimilar, or ā€œfollow-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…

‘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…

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,…

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…

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…

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…

#ACTRIMS2021 ā€“ Taking Medication During Pregnancy Reduces Healthcare Costs

Editorā€™s note: TheĀ Multiple Sclerosis News Today news team is providing in-depth and unparalleled coverage of the virtual ACTRIMS Forum 2021, Feb. 25ā€“27. 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…

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…

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 ā€œDetermining the Effectiveness of Early Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosisā€ (…

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. ā€œItā€™s a dysfunctional market that lacks the typical incentives for most other consumer prices,ā€ Daniel Hartung, the studyā€™s lead author, said in anĀ Oregon Health & Science University (OHSU) press release written by Erik Robinson. ā€œAside 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 9ā€“13% per year. These include Novartisā€™ Extavia (interferon beta-1b) and Gilenya (fingolimod), Biogenā€™s Plegridy (peginterferon beta-1a) and Tecfidera (dimethyl fumarate), and Sanofi Genzymeā€™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 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 Mylanā€™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 Copaxoneā€™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 beneficiaryā€™s total out-of-pocket spending, unlike what is mandated by the Affordable Care Act for brand-name therapies. ā€œThis is a pernicious effect of the release of a generic and an unfortunate effect of Medicare rules,ā€ Dennis Bourdette, MD, one of the studyā€™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 patientā€™s total out-of-pocket spending. Such strategy would reduce the disparity between brand-name and generic therapies, the researchers said. ā€œIn 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. ā€œThere 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.

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 ā€œEffect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression…

African-Americans Show Better Adherence and Satisfaction with Gilenya Than Injectable DMTs, Phase 4 Study Finds

African-Americans with relapsingā€“remitting 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, ā€œTreatment retention on fingolimod compared with injectable multiple sclerosis therapies in African-American patients: A…

#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 ā€œCladribine 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 …

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,…