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Institute For Clinical And Economic Review
The Institute for Clinical and Economic Review (ICER) is a Boston-based independent nonprofit organization that seeks to place a value on medical care by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures. It was founded in about 2005 by physician-researcher Steven D. Pearson, MD, MSc, FRCP. Until 2014 it concentrated on assessing health care costs (rather than evaluating drugs). It evaluates the cost effectiveness of drugs in a similar way to the UK's NICE, and has come under some criticism from the drug industry. ICER has placed a monetary value on a number of prescription drugs since 2014. Those evaluations have been used by insurers to justify which drugs are approved or denied. The institution is funded by Arnold Ventures LLC (formerly the Laura and John Arnold Foundation), drug makers, insurers, and government grants. Threshold cost criteria ICER uses a “value assessment framework” to decide prices for select medical ...
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Steven Pearson
Steven Pearson is an American physician, bioethicist, and the Founder and President of the non-profit health policy and comparative effectiveness research organization Institute for Clinical and Economic Review in Boston, MA. He conducts research on cost-effectiveness analysis and healthcare technology assessment. He is also a lecturer in Harvard's Department of Population Medicine and a member of the National Institutes of Health (NIH) Comparative Effectiveness Research Steering Committee. Career and education Pearson founded the Institute for Clinical and Economic Review at the Massachusetts General Hospital's Institute for Technology Assessment in 2006. Prior to that, he was a fellow at America's Health Insurance Plans (AHIP). He also received an Atlantic Fellowship and was a Senior Fellow in the United Kingdom at the National Institute for Health and Care Excellence of the UK's National Health Service. Additionally he has been a member of the Coverage and Analysis Group at th ...
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Pembrolizumab
Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is given by slow injection into a vein. Common side effects include fatigue, musculoskeletal pain, decreased appetite, itchy skin (pruritus), diarrhea, nausea, rash, fever (pyrexia), cough, difficulty breathing (dyspnea), constipation, pain, and abdominal pain. It is an IgG4 isotype antibody that blocks a protective mechanism of cancer cells and thereby, allows the immune system to destroy them. It targets the programmed cell death protein 1 (PD-1) receptor of lymphocytes. It works by targeting the cellular pathway of proteins found on the body's immune cells and some cancer cells, known as PD-1/PD-L1. Pembrolizumab was approved for medical use in the United States in 2014. In 2017, the US Food and Drug Administration (FDA) app ...
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Organizations Established In 2005
An organization or organisation (Commonwealth English; see spelling differences), is an entity—such as a company, an institution, or an association—comprising one or more people and having a particular purpose. The word is derived from the Greek word ''organon'', which means tool or instrument, musical instrument, and organ. Types There are a variety of legal types of organizations, including corporations, governments, non-governmental organizations, political organizations, international organizations, armed forces, charities, not-for-profit corporations, partnership A partnership is an arrangement where parties, known as business partners, agree to cooperate to advance their mutual interests. The partners in a partnership may be individuals, businesses, interest-based organizations, schools, governments ...s, cooperatives, and Types of educational institutions, educational institutions, etc. A hybrid organization is a body that operates in both the publ ...
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Academy Of Managed Care Pharmacy
AMCP (Academy of Managed Care Pharmacy) is a professional organization representing the interests of pharmacists who practice in managed care The term managed care or managed healthcare is used in the United States to describe a group of activities intended to reduce the cost of providing health care and providing American health insurance while improving the quality of that care ("man ... settings. It publishes the '' Journal of Managed Care & Specialty Pharmacy''. References Pharmacy organizations in the United States Pharmacy-related professional associations Organizations established in 1988 1988 establishments in the United States {{Pharmacy-stub ...
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Psoriatic Arthritis
Psoriatic arthritis is a long-term inflammatory arthritis that occurs in people affected by the autoimmune disease psoriasis. The classic feature of psoriatic arthritis is swelling of entire fingers and toes with a sausage-like appearance. This often happens in association with changes to the nails such as small depressions in the nail (pitting), thickening of the nails, and detachment of the nail from the nailbed. Skin changes consistent with psoriasis (e.g., red, scaly, and itchy plaques) frequently occur before the onset of psoriatic arthritis but psoriatic arthritis can precede the rash in 15% of affected individuals. It is classified as a type of seronegative spondyloarthropathy. Genetics are thought to be strongly involved in the development of psoriatic arthritis. Obesity and certain forms of psoriasis are thought to increase the risk. Psoriatic arthritis affects up to 30% of people with psoriasis and occurs in both children and adults. Approximately 40–5 ...
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Brodalumab
Brodalumab, sold under the brand name Siliq in the US and Kyntheum in the EU, is a human monoclonal antibody designed for the treatment of inflammatory diseases. In February 2017, it received US FDA approval to treat moderate to severe plaque psoriasis in people who have not improved with other treatments. Mechanism of action Brodalumab binds to the interleukin-17 receptor and so prevents interleukin 17 (IL-17) from activating the receptor. This mechanism is similar to that of another anti-psoriasis antibody, ixekizumab, which however binds to IL-17 itself. History Brodalumab was developed by Amgen, Inc. as AMG 827. In 2013, it was in two phase III clinical trials for the treatment of moderate to severe psoriasis. In November 2014, Amgen and AstraZeneca reported encouraging results for the compound. The companies stated that the compound met the primary endpoint showing superior skin clearance in a Phase III trial when compared to ustekinumab and a placebo. However, in ...
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Ixekizumab
Ixekizumab, sold under the brand name Taltz, is an injectable medication for the treatment of autoimmune diseases. Chemically, it is a form of a humanized monoclonal antibody. The substance acts by binding interleukin 17A and neutralizing it, reducing inflammation. The most common side effects include upper respiratory infections, injection site reactions and fungal (tinea) infections. The drug was developed by Eli Lilly and Co. and is approved for the treatment of plaque psoriasis in the European Union and the United States. Medical uses In the United States, ixekizumab is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, active psoriatic arthritis, active ankylosing spondylitis, and active non-radiographic axial spondyloarthritis with objective signs of inflammation. In the European Union it is indicated for the treatment of moderate-to-severe plaque psoriasis and as a second-line therapy ...
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Daclizumab
Daclizumab (trade name Zinbryta) is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab works by binding to CD25, the alpha subunit of the IL-2 receptor of T-cells. In March 2018, it was voluntarily withdrawn from the market by Biogen and Abbvie after reports of autoimmune encephalitis in Europe. Medical uses Daclizumab was used to treat adults with relapsing forms of multiple sclerosis.FDBLA Approval letterMay 27, 2016 It is administered subcutaneously. In clinical trials, decreases of 45% in annualized relapse rate have been reported, as well as a 41% reduction in the proportion of patients who relapsed, and a 54% reduction in the number of new lesions. A 2013 Cochrane systematic review concluded that there was insufficient evidence to determine the efficacy of daclizumab relative to placebo in people with relapsing-remitting MS and, prior to its being discontinued, the need to inv ...
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Alemtuzumab
Alemtuzumab, sold under the brand names Campath and Lemtrada among others, is a medication used to treat chronic lymphocytic leukemia (CLL) and multiple sclerosis. In CLL, it has been used as both a first line and second line treatment. In MS it is generally only recommended if other treatments have not worked. It is given by injection into a vein. It is a monoclonal antibody that binds to CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived. After treatment with alemtuzumab, these CD52-bearing lymphocytes are targeted for destruction. Alemtuzumab was approved for medical use in the United States in 2001. (Mab)Campath was withdrawn from the markets in the US and Europe in 2012, to prepare for a higher-priced relaunch of Lemtrada aimed at multiple sclerosis. Medical uses Chronic lymphocytic leukemia Alemtuzumab is used for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in people who hav ...
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Teriflunomide
Teriflunomide, sold under the brand name Aubagio, is the active metabolite of leflunomide. Teriflunomide was investigated in the Phase III clinical trial TEMSO as a medication for multiple sclerosis (MS). The study was completed in July 2010. 2-year results were positive. However, the subsequent TENERE head-to-head comparison trial reported that "although permanent discontinuations f therapywere substantially less common among MS patients who received teriflunomide compared with interferon beta-1a, relapses were more common with teriflunomide." The drug was approved for use in the United States in September 2012 and for use in the European Union in August 2013. Mechanisms of action Teriflunomide is an immunomodulatory drug inhibiting pyrimidine de novo synthesis by blocking the enzyme dihydroorotate dehydrogenase. It is uncertain whether this explains its effect on MS lesions. Teriflunomide inhibits rapidly dividing cells, including activated T cells, which are thought t ...
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Dimethyl Fumarate
Dimethyl fumarate (DMF) is the methyl ester of fumaric acid and is named after the earth smoke plant (''Fumaria officinalis''). Dimethyl fumarate combined with three other fumaric acid esters (FAEs) is solely licensed in Germany as an oral therapy for psoriasis (trade name Fumaderm). Since 2013, it has been approved by the U.S. Food and Drug Administration (FDA) as a treatment option for adults with relapsing multiple sclerosis (brand name Tecfidera). In 2017, a new oral formulation of dimethyl fumarate (trade name Skilarence) was approved by the European Medicines Agency (EMA) for use in the European Union as a treatment for moderate-to-severe plaque psoriasis. Dimethyl fumarate is thought to have immunomodulatory properties without causing significant immunosuppression. Dimethyl fumarate has also been applied as a biocide in furniture or shoes to prevent growths of mold during storage or transport in humid climates. However, due to cases of allergic reactions after skin cont ...
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Fingolimod
Fingolimod, sold under the brand name Gilenya, is an immunomodulating medication, mostly used for treating multiple sclerosis (MS). Fingolimod is a sphingosine-1-phosphate receptor modulator, which sequesters lymphocytes in lymph nodes, preventing them from contributing to an autoimmune reaction. It has been reported to reduce the rate of relapses in relapsing-remitting multiple sclerosis by approximately one-half over a two-year period. Medical uses Fingolimod is used in the treatment of the relapsing form of multiple sclerosis. Its effect in those with primary progressive MS is not clear. It may also be used in chronic inflammatory demyelinating polyneuropathy. Adverse effects The most common side effects of fingolimod have been head colds, headache, increased gamma-glutamyl transfer (≤15%), diarrhea (13%), nausea (13%), abdominal pain (11%) and fatigue. A few cases of skin cancer have been reported, which has also been reported in patients taking natalizumab (Tysabri) ...
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