scholarly journals PNP6: THE USE OF DISEASE-ALTERING NEW DRUGS FOR MULTIPLE SCLEROSIS TREATMENT

2003 ◽  
Vol 6 (3) ◽  
pp. 273
Author(s):  
RJ Ozminkowski ◽  
W Marder ◽  
K Hawkins ◽  
S Wang ◽  
S Stallings ◽  
...  
2017 ◽  
Vol 33 (S1) ◽  
pp. 111-111
Author(s):  
Andrea Brígida de Souza ◽  
Avila Vidal ◽  
Pollyanna Gomes ◽  
Vania Canuto ◽  
Clarice Petramale

INTRODUCTION:In Brazil, the pharmaceutical sector has requested an individual incorporation in the Brazilian public health system (SUS) for each new drug for multiple sclerosis that receives sanitary authorization for marketing. Horizon Scanning within Brazilian Ministry of Health has played a key role in the recommendations made by the National Committee for Health Technology Incorporation (CONITEC). Horizon Scanning seeks to predict which technologies have potential to impact health care in SUS, before their formal request. This study aims to present the impact of horizon scanning in two assessments made by CONITEC on drugs to treat Multiple Sclerosis.METHODS:Grey literature was searched to find new and emerging drugs for multiple sclerosis treatment. Regulatory agencies were also searched: European Medicines Agency (EMA), Food and Drug Administration (FDA) and Brazilian Regulation and Health Surveillance Agency (Anvisa). A pre-defined standardized form was used. Information extracted about each drug was identified as: drugs name, mechanism of action, indication, administration route, finished phases of clinical trial and registration in other countries.RESULTS:In 2014, horizon scanning identified seven drugs while CONITEC was assessing Fingolimod for multiple sclerosis. In this case, the drug's administration route was a differential, as only three new drugs identified were also orally administrated. Thus, Fingolimod received a positive recommendation for incorporation. In 2016, horizon scanning identified fourteen drugs while Teriflunomide was under assessment. At this moment, the orally administrated Fingolimod was already available and it was identified other eight new drugs with the same route. Therefore, the initial recommendation was against its incorporation.CONCLUSIONS:Horizon scanning has proved to be of major importance for assisting recommendation-making process of the committee. In the two cases presented, horizon scanning information could predict which technologies were being developed and could be registered in Brazil. These new technologies had influenced the recommendations made by CONITEC's members. As a result, a horizon scanning section in all CONITEC's reports became mandatory.


2004 ◽  
Vol 26 (8) ◽  
pp. 1341-1354 ◽  
Author(s):  
Ronald J. Ozminkowski ◽  
William D. Marder ◽  
Kevin Hawkins ◽  
Shaohung Wang ◽  
Sarah C. Stallings ◽  
...  

2018 ◽  
Vol 74 (5) ◽  
pp. 663-670 ◽  
Author(s):  
Irene Eriksson ◽  
Joris Komen ◽  
Fredrik Piehl ◽  
Rickard E. Malmström ◽  
Björn Wettermark ◽  
...  

2019 ◽  
Vol 12 ◽  
pp. 175628641983657 ◽  
Author(s):  
Luisa Klotz ◽  
Joachim Havla ◽  
Nicholas Schwab ◽  
Reinhard Hohlfeld ◽  
Michael Barnett ◽  
...  

In recent years, there has been a paradigm shift in the treatment of multiple sclerosis (MS) owing to the approval of a number of new drugs with very distinct mechanisms of action. All approved disease-modifying drugs primarily work directly on the immune system. However, the identification of an ‘optimal choice’ for individual patients with regard to treatment efficacy, treatment adherence and side-effect profile has become increasingly complex including conceptual as well as practical considerations. Similarly, there are peculiarities and specific requirements with regard to treatment monitoring, especially in relation to immunosuppression, the development of secondary immune-related complications, as well as the existence of drug-specific on- and off-target effects. Both classical immunosuppression and selective immune interventions generate a spectrum of potential therapy-related complications. This article provides a comprehensive overview of available immunotherapeutics for MS and their risks, detailing individual mechanisms of action and side-effect profiles. Furthermore, practical recommendations for patients treated with modern MS immunotherapeutics are provided.


2019 ◽  
pp. 56-62
Author(s):  
N. V. Khachanova

Clinical trials confirm alemtuzumab efficacy for multiple sclerosis treatment in terms of both conventional measures and combined criteria such as NEDA (no evidence of disease activity). However, established drug efficacy and convenient dosing schedule are balanced by the risk of serious adverse events. Therefore, it is necessary to inform physicians about the benefits of alemtuzumab therapy along with the pattern of its safety profile.The present review provides the analysis of alemtuzumab real-world studies in Europe, USA and other parts of the world. The information obtained can help physicians to prescribe and administer the drug properly and to perform effective safety monitoring for early detection of adverse events and saving the maximum treatment benefit for the patient.


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