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 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.
August 15, 2018 News by Patricia Inacio, PhD Long-term DMT Use Seen to Lower Likelihood of RRMS Progressing to SPMS in Study Long-term treatment with disease-modifying therapies (DMTs) appears to lessen the risk of disease worsening inĀ relapsing-remitting multiple sclerosis (RRMS) patients, an 18-year follow-up study suggests. But these therapies were not seen to benefit those who had progressed to secondary progressive multiple sclerosis (SPMS). The study, āOnset of secondary…
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…
April 30, 2018 News by Jose Marques Lopes, PhD #AAN2018 – New AAN Guideline Favors Advising Patients to Use DMTs Early in Disease Course A new American Academy of Neurology (AAN) guideline recommends that multiple sclerosis (MS) patients in general be counseled to start treatment with disease-modifying therapies (DMTs) as early as possible. Considerations on switching and stopping treatments are also presented in the guideline. The report, āPractice guideline recommendations…
April 18, 2018 News by Alice MelĆ£o, MSc #AAN2018 ā Early Treatment Delays MS Disease Progression But Does Not Affect Death Rate, Study Suggests Beginning treatment early with disease-modifying therapies is the most effective approach to prevent multiple sclerosis (MS) progression in patients, a large-scale study suggests. Data from the Danish study will be presented at the 2018 Annual Meeting of the American Academy of Neurology (AAN), taking place April 21-27…
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 9, 2018 News by Jose Marques Lopes, PhD #CMSC2018 – Closing Lecture to Focus on Best Use of DMTs When and how to best use disease-modifying therapies (DMTs) inĀ multiple sclerosisĀ depends on key treatment decisions that, partly because the number of DMTs available, can be as challenging for clinicians as they are for patients. DMTs and their optimal use will be covered in the closing lecture of the…
November 7, 2017 Columns by Ed Tobias Thinking About Stopping Your MS Treatments? Have you ever thought about stopping whatever MS treatment you’re using? I have. So has John Corboy. Corboy’s not an MS patient. Rather, he’s a researcher at the University of Colorado’s medical school. And he’s studying whether older patients, if they haven’t had a relapse for several…
October 30, 2017 News by Patricia Silva, PhD #MSParis2017 – Trial to See if Disease-modifying Therapies Not Necessary in Older MS Patients A clinical study now enrolling people with progressive or relapsing multiple sclerosis (MS) will examine the feasibility of older patients stopping use of disease-modifying therapies if they have had no relapses for a number of years. John Corboy,Ā with the University of Colorado School of Medicine, presented the study at…
July 6, 2017 News by admin Younger MS Patients Who Are Hospitalized May Be at Higher Risk of Quitting Treatment, Study Reports MS patients who start treatment at a younger age, and whose condition requires hospitalization, are more likely to stop treatment, a Canadian study reports. The research, published in the journal Dovepress, dealt with the main reasons Canadian patients quit first-line injected disease-modifying therapies, or DMTs. It was titled āPersistence to disease-modifying therapies for multiple sclerosis in a Canadian cohort.ā DMTs can reduce MS activity, but patients must stick with them in order for them to be effective. āThere is currently a paucity of clinical trial data on what happens to individuals when they discontinue DMT," the researchers wrote. "However, recent preliminary evidence from observational studies suggest increased relapses and disability in those who discontinue DMT." Researchers sought to identify MS patients at higher risk of discontinuing treatment. They looked at Manitoba Province's medical database to identify the types of drugs MS patients were taking, and for how long. The analysis covered 721 patients who received injected beta-interferons or Copaxone between 1996 and 2011, and whom doctors followed for at least a year. Teva manufactures Copaxone, whose generic name is glatiramer acetate. The mean age of the patients in the study was 37.6 years, and 74.2 percent were women. Researchers defined a discontinuation of a DMT as a 90-day or longer gap in treatment. A third of the patients were treated with beta-interferon-1b, either Bayer HealthCare's Betaferon/Betaseron or Novartis' Extavia. It was the first such therapy available in Manitoba. Twenty-three percent of patients received beta-interferon-1a, either Biogen's Avonex or Merck's Rebif. And 21 percent received Copaxone. The median time before a patient discontinued a DMT was 4.2 years. Although 62.6 percent of patients discontinued treatment at some point, 57.4 percent either reinitiated it or switched to a different DMT. Patients who were on DMT at least a year were more likely to stay with it than those who stopped in the first year. Importantly, patients who started a DMT at a younger age were more likely to stop taking it than older patients. āOur results are also consistent with previous work examining persistence for other chronic medication classes, including statins, antihypertensives, bisphosphonates, and oral antidiabetic agents, where the risk for discontinuing drugs declined in a linear fashion with age,ā the researchers wrote. The team also found that 16 percent of patients had to be hospitalized overnight, with 3 percent of the cases due to MS-related complications. And these hospitalized patients were more likely to stop their DMT treatment earlier, the researchers said. Summing up, the team said: "Subjects who were younger when starting a DMT, had prior MS-related hospitalizations, were more recently diagnosed with MS, or had a greater lag time between their MS diagnosis and DMT initiation were more likely to discontinue therapy." Although "not all of the factors identified with discontinuing DMT" can be modified, "they may help practitioners enhance MS care by identifying individuals who may be at particular risk for DMT discontinuation," the researchers concluded.
December 1, 2016 News by Patricia Silva, PhD ICER Releases Draft Report on Disease-modifying Therapies for MS, Welcomes Comment The Institute for Clinical and Economic Review (ICER) has released aĀ Draft Evidence ReportĀ evaluating the comparative clinical effectiveness and value of disease-modifying therapies (DMTs) for patients with relapsing-remitting and primary-progressive forms of multiple sclerosis (MS). Through Dec. 21, patients, the public, and other stakeholders can accessĀ the 82-page report and…
October 21, 2016 Columns by Ed Tobias MS Drugs – Who’s Using What? Most of us who live with multiple sclerosis also live with a disease modifying therapy (DMT) ā a drug that, we hope, will positively modify the course of our disease. One of the earliest of these was Avonex, a weekly injection into the muscle. I was one of those…
September 19, 2016 News by Patricia Inacio, PhD #ECTRIMS2016 – Poor Medication Adherence in Pediatric MS Patients Linked to Fatigue, Lack of Routine Children with multiple sclerosis (MS) inĀ North America identified a number ofĀ challenges inĀ adhering to disease-modifying therapies ā a potential first step to devising Ā therapeutic approaches that mightĀ improve adherence to MS medications among young patients and, subsequently, disease outcomes in these children. The results were presented in the talk, āMedication adherence in…
July 18, 2016 News by Charles Moore Closer Look at ICER, Group Now Weighing Efficacy and Benefits of RRMS Therapies The Institute of Clinical and Economic Review (ICER), the nonprofit organization thatĀ released a preliminary draft last week intended to shapeĀ the Institute’s forthcoming report onĀ the effectiveness and benefits of therapies for relapsing-remitting multiple sclerosis (RRMS), is made up of experts in healthcare policy from across the U.S. who, through the…
July 12, 2016 News by Patricia Inacio, PhD Cognitive Skills Maintained in RRMS Patients Treated with Gilenya or Tysabri in Yearlong Study Disease-modifying therapies, a groupĀ of treatments for peopleĀ withĀ relapsing-remitting multiple sclerosis (RRMS), work to stabilize patients’ cognitive functionsĀ just as they do their physical symptoms. Research, conducted over the course of a year, also reportedĀ no differences between two types of DMTs,Ā Gilenya (fingolimod) andĀ Tysabri (natalizumab). The study, ā…
July 8, 2016 Columns by admin Have Your Say About Disease Modifying Therapies for RRMS You have just one week from today to have your say about the effectiveness of various disease modifying therapies (DMT) used to treat relapsing remitting multiple sclerosis (RRMS). Public comments are welcome in response to an early draft paper that is planned to be the basis for…
July 6, 2016 News by InĆŖs Martins, PhD ICER Draft Report Evaluating Therapies for RRMS Now Open for Public Comment TheĀ Institute of Clinical and Economic Review (ICER)Ā released the early draft of a paper intended toĀ informĀ a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called aĀ draft scopingĀ document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and…
November 23, 2015 News by Patricia Silva, PhD MS Society Supports 2 Projects Advancing MS Care, Services The United Kingdom basedĀ Multiple Sclerosis Society (MS Society) recently announced Ā£1.98 million in grants toĀ new MS research projects in different disease-related areas. A panel of experts carefully selected 16 projects to be funded through the MS Societyās 2015 grant round, totaling Ā£1,979,879. All selected projects fulfill the requirements of…