June 15, 2021 News by Marisa Wexler, MS FDA Rejects Expansion of Aubagio for Pediatric MS The U.S. Food and Drug Administration (FDA) has rejected an application requesting the expansion of Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, with relapsing forms of multiple sclerosis (MS). “The FDA deemed the data submitted were not sufficient to obtain approval of…
April 29, 2019 News by Santiago Gisler Relapsing MS Patients Highly Satisfied with Aubagio’s Efficacy and Ease of Use, Global Clinical Study Finds High levels of satisfaction with the efficacy and convenience ofĀ Aubagio (teriflunomide), an oral treatment for relapsingĀ multiple sclerosis (MS), were reported by patients across the U.S. and 13 other countries, a post-hoc analysis of data from a real-world Phase 4 study found. The study “Teriflunomide real-world evidence: Global…
April 25, 2019 News by Vijaya Iyer, PhD Aubagio Lowers Relapse Rate in RRMS Patients, Real-world Observational Study Shows In clinical practice, relapse events dropped by roughly half over a four-year period inĀ relapsing-remitting multiple sclerosisĀ (RRMS) patients treated withĀ Aubagio (teriflunomide), a real-world study reports. The study, āReal-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study,ā also examined patients’ perspectives in…
March 11, 2019 News by Alberto Molano, PhD Immunic Therapeutics Enrolls First Patient in Phase 2 Trial of IMU-838 for RRMS Immunic TherapeuticsĀ has enrolled the first patient in its Phase 2 clinical trial testing IMU-838, a potential oral therapy forĀ relapsing-remitting multiple sclerosis (RRMS). IMU-838 (vidofludimus calcium) is a next-generation selective modulator of the immune system. It works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which plays a role…
March 5, 2019 Columns by Ed Tobias Two Different Approaches to Providing Online MS Help I received an email recently from the National Multiple Sclerosis Society in the U.S. promoting a searchable database of “credible doctors and resources.” A few days later, I happened to run across another online multiple sclerosis (MS) information service hosted by the HealthCare Journey website. They call it…
March 5, 2019 News by Patricia Inacio, PhD #ACTRIMS2019 – TG Therapeutics’ Investigational Therapy Ublituximab Posts Positive Data in MS Phase 2 Clinical Trial Full results of a Phase 2 clinical trial testing TG Therapeuticsā lead candidate ublituximab (TG-1101) for relapsingĀ multiple sclerosisĀ (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…
February 26, 2019 News by Iqra Mumal, MSc Switching from Tysabri to Aubagio Can Help Lower Relapse Risk in MS Patients, Phase 4 Trial Shows Stable patients with multiple sclerosis (MS) who transition from Tysabri (natalizumab) treatment toĀ Aubagio (teriflunomide) have a lower relapse risk, a new study shows. The study, āReducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy,ā…
February 25, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Early DMT Use, Aubagio vs. Tecfidera, Lipoic Acid Study, MS Forums Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports The question of whether to start treating multiple sclerosis (MS) with an older, less effective disease-modifying therapy (DMT) and then move to a more effective one ā or use a heavy-hitting medication right…
February 22, 2019 News by Jonathan Grinstein Aubagio, Tecfidera Show Comparable Effectiveness in Relapsing MS, Real-world Phase 4 Trial Finds Aubagio (teriflunomide)Ā seems to be superior to Tecfidera (dimethyl fumarate)Ā in slowingĀ whole brain shrinkage in patients withĀ relapsing multiple sclerosis (MS), a new Phase 4 clinical trial shows. However, Aubagio and Tecfidera have similar beneficial effects in achieving other clinical goals and magnetic resonance imaging (MRI) parameters,…
February 20, 2019 News by Patricia Inacio, PhD Early Use of High-efficacy DMTs of Long-term Benefit to MS Patients, Real-world Study Reports Multiple sclerosis (MS) patients given intensive disease-modifying therapies early in their disease course have more favorable long-term outcomes than those treated with an escalating regimen, real-world data shows. The study, āClinical Outcomes of Escalation vs Early Intensive Disease-Modifying Therapy in Patients With Multiple Sclerosis,ā was published in the journalĀ …
February 15, 2019 Columns by Ed Tobias 4 Things I’ve Learned About Paying for MS Medications Are you having trouble paying for MS medications? If so, you’re not alone. People change or lose their insurance, and plans change the medications they cover from year to year. Your neurologist may change your medication without realizing that moving you from an injection to an oral med may…
February 8, 2019 Columns by Ed Tobias DMT Approvals for Medicare Users Decline While Costs Rise, Study Shows This probably won’t come as a surprise to you if you’re on Medicare: It’s getting harder to obtain approval for many of the disease-modifying therapies (DMTs) prescribed for people with multiple sclerosis (MS). I see complaints about this all the time on social media. Now, research reported in…
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.
February 1, 2019 Columns by Ed Tobias Why Aren’t You Using an MS Medication? I see a lot of answers to the question about why people stop, or refuse to start, an MS medication. “Thinking of stopping the…meds. Sick of the shots and how they hurt to take them” “I stopped all of them….all multiple times. It…
January 30, 2019 News by Jonathan Grinstein Canadian RRMS Patients Less Likely to Discontinue Treatment with Oral Gilenya, Compared to Injectable or Infusible Therapies Multiple sclerosisĀ (MS) patients in Canada are more likely to comply with their treatment plan and less likely to discontinue the use of the oral disease-modifying treatment Gilenya (fingolimod), compared to injectable or infusible treatment options, new research shows. The research article with that finding, āA…
January 29, 2019 News by Patricia Inacio, PhD Gilenya Better at Lowering Relapse Rate than Tecfidera or Aubagio, Study Suggests Gilenya is linked to significantly lower annualized relapse rates in relapsing-remitting multiple sclerosis (RRMS) patients compared to Tecfidera orĀ Aubagio, a study suggests. All three therapies showed similar effects on disability outcomes. Oral immunotherapies ā including Novartisā Gilenya, Biogenās Tecfidera, and Sanofi Genzymeās Aubagio ā are currently standard therapies for RRMS treatment. But while these therapies are highly effective at modulating MS activity, studies comparing their efficacy on relapse and disability are missing. This is an important point for MS patients, so that if a change in oral therapies is needed (due to lack of tolerance, for example), the decision on a more suitable therapy is based on scientific evidence. To address this matter, a group of researchers used the MsBase, an international observational MS cohort study, to identify RRMS patients who had been treated with Gilenya, Tecfidera, or Aubagio for at least three months. The team compared Tecfidera versus Aubagio, Gilenya versus Aubagio, and Gilenya versus Tecfidera, specifically for the therapyās impact on relapse activity, six-month disability worsening or improvement, and persistence of treatment. Relapse was defined as the occurrence of new symptoms or exacerbation of existing ones for a period of over 24 hours, at least 30 days after a previous relapse. Disability was assessed using the Expanded Disability Status Scale (EDSS); the six-month disability worsening or improvement were defined as an increase or a decrease by one value in EDSS. The study included 614 patients treated with Aubagio, 782 with Tecfidera, and 2,332 with Gilenya. Patients were followed over a median of 2.5 years. Patientsā characteristics at baseline differed among the three groups. Aubagio-treated patients tended to be older, with longer periods of disease, fewer relapses, and lower EDSS scores compared to the other two groups. Patients treated with Gilenya had higher EDSS and more relapses during the prior year, compared to those treated with Tecfidera. The majority of the patients had been treated with other immunotherapies prior to being given one of these three oral treatments. Results showed that Gilenya-treated patients had significantly lower annualized relapse rates than those treated with Tecfidera (0.20 versus 0.26) or Aubagio (0.18 versus 0.24), while patients taking either Tecfidera or Aubagio had a similar rate. However, during the 2.5-year period analyzed, researchers found no differences in disability accumulation or disability improvement among the three therapies. Regarding treatment persistence, Tecfidera and Aubagio were more likely to be discontinued than Gilenya. Overall, the results suggest that treatment with Gilenya may have a greater impact on relapse frequency in RRMS patients compared to Tecfidera and Aubagio, although the "effect of the three oral therapies on disability outcomes was similar during the initial 2.5 years on treatment," researchers said. āChoosing a therapy in individual patients remains a complex task that requires thorough and individualized evaluation of disease prognosis, and the corresponding risks and benefits of the increasing number of available therapies,ā they concluded.
January 23, 2019 News by Jose Marques Lopes, PhD Favorable Efficacy and Similar Safety with Ocrevus in Relapsing MS, Study Finds Treatment with Ocrevus (ocrelizumab) has superior or comparable effectiveness and a similar safety profile to other available disease-modifying treatments (DMTs) for treating relapsing multiple sclerosis (MS), according to a new review study. The research, āSystematic review and network meta-analysis comparing ocrelizumab with other treatments for…
January 17, 2019 News by Jose Marques Lopes, PhD Fewer RRMS Patients Relapse, Discontinue Treatment with Gilenya, Study Finds Relapsing-remitting multiple sclerosis (RRMS) patients on Gilenya (fingolimod) have fewer relapses and stay on treatment longer than those takingĀ Tecfidera (dimethyl fumarate) or Aubagio (teriflunomide), according to a new study. The research, āComparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis,ā was published…
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…
December 21, 2018 Columns by Ed Tobias Shots, Infusions, or Pills for Your MS? There are more than a dozen disease-modifying therapies available to treat MS. Some are shots, some are infusions, and some are pills. Some are more effective than others. The marketing intelligence company Spherix Global Insights regularly surveys which of these treatments are being used by neurologists and…
December 7, 2018 News by Jose Marques Lopes, PhD Aubagio Becomes 1st Once-daily Oral DMT for Relapsing MS Patients in India AubagioĀ (teriflunomide) has become the first once-a-day, oral disease-modifying therapy (DMT) for multiple sclerosis (MS) to be approved for use inĀ India. Sanofi Genzymeās therapy is indicated for first-line treatment of relapsing MS. It should be taken each day with or without food, and patients in India will have…
November 20, 2018 News by Alice MelĆ£o, MSc FDA Approves Generic Version of Aubagio to Treat Relapsing MS, Glenmark Pharma Says The U.S. Food and Drug Administration (FDA) has approved a generic version of Ā Aubagio (teriflunomide) tablets at the 7 mg and 14 mg doses marketed by Sanofi, according to the generic’s manufacturer,Ā Glenmark Pharmaceuticals. The FDAās decision to approve the company’s application for teriflunomide tablets at two…
October 16, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Two European Studies Compare Tecfidera, Aubagio Effectiveness Treatment of relapsing-remitting multiple sclerosis (RRMS) patients with Tecfidera (dimethyl fumarate)Ā is associated with fewer new brain lesions at two years, lower relapse rates, increased time to first relapse, and reduced treatment discontinuation than with Aubagio (teriflunomide), according to a nationwide study from France and a real-world, population-based…
October 15, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Plasma Neurofilament Light Levels Linked to Treatment Effects in RRMS, Study Finds Levels of proposed biomarker neurofilament light chain (NfL) are associated with therapeutic effects of disease-modifying treatments (DMTs) inĀ relapsing-remitting multiple sclerosisĀ (RRMS) patients, according to a real-world study. Study findings also revealed that treatment with either Lemtrada (alemtuzumab, marketed byĀ Sanofi Genzyme),Ā Gilenya (fingolimod, marketed by Novartis), Tecfidera (dimethyl fumarate, marketed…
October 10, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Switching to Tysabri Leads to Fewer Relapses and Disability than Gilenya, Study in RRMS Patients Finds Patients with relapsing-remitting multiple sclerosis (RRMS) who switch to Tysabri (natalizumab) after relapses on first-line treatment with other medications show greater relapse reduction and less disability progression than those switching to Gilenya (fingolimod), according to a real-world study. The research, āComparative effectiveness of switching…
October 5, 2018 Columns by Ed Tobias Could Government Probe Threaten Pharma Patient Assistance Programs? Many of us have received help to pay for our MS medications. Now there’s a chance that assistance could be threatened. A recent article in the The Wall Street Journal reports that U.S. government prosecutors are looking into whether some pharmaceutical companies’ patient assistance programs are on the wrong…
September 28, 2018 News by Jose Marques Lopes, PhD #ECTRIMS2018 – Ublituximab Markedly Reduces Lesions, Promotes B-cell Depletion, Halts Disability Progression in Phase 2 Trial A 48-week treatment of relapsing multiple sclerosis (MS) with TG Therapeuticsā investigational compound ublituximab led to a marked reduction of brain and spinal cord lesions, massive depletion of relapse-associated immune B-cells, and significantly halted disability progression, according to results from a Phase 2 clinical trial. The data…
August 24, 2018 Columns by Ed Tobias Your MS Med’s Copay Could Be More Expensive than Paying Cash I get my medications the old-fashioned way. When I need to fill a prescription, I either go to the drug store or use a mail-order pharmacy ā and usually, I have a copay. Sometimes the copay is just a few dollars, but sometimes it can be a few hundred.
August 13, 2018 Columns by Ed Tobias MS News That Caught My Eye Last Week: MMJ Chewing Gum, Hair Loss, Botox for Bladder Problems, MS Progression Prediction Hair Loss Seen in RRMS Patients Using Aubagio Often Temporary and Mild, Study Says I read a lot of questions on multiple sclerosis (MS) social media groups from people who are worried about hair loss caused by their disease-modifying therapy (DMT). Aubagio (teriflunomide) is one DMT with…
August 10, 2018 News by Jose Marques Lopes, PhD Hair Loss Seen in RRMS Patients Using Aubagio Often Temporary and Mild, Study Says Hair thinning in relapsing-remitting multiple sclerosis (RRMS) patients usingĀ AubagioĀ is usually mild and temporary, and does not require stopping treatment, a small real-world study reports. The research, āReal-World Observational Evaluation of Hair Thinning in Patients with Multiple Sclerosis Receiving Teriflunomide: Is It an Issue in Clinical…