{"title":"FDA's Gottlieb Aims To End Biosimilars Groundhog Day.","authors":"Richard Mark Kirkner","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The FDA commissioner has an 11-step \"action plan\" to get biosimilars out of a repeat mode of unrealized potential. But issues like interchangeability still need clarifying if biosimilars are to have a major effect on drug expenditures.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"28 1","pages":"5-6"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37067435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Conversation with Gary Lyman, MD: Biosimilars and the Search for the Cure To Cancer Treatment's Financial Toxicity.","authors":"Peter Wehrwein","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Lyman has emerged as an important voice about biosimilars and their potential for corralling cancer costs. It's personal because Lyman is all too aware of how the price of medications can ruin patients financially. We need more biosimilars on the market, he contends.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"28 1","pages":"12-15"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37067438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Why Biosimilars Can Never Be Identical To Originators-and Why They Don't Need To Be.","authors":"Thomas Reinke","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The FDA's approval criteria require a biosimilar to be highly similar to its original biologic and show \"no clinically meaningful differences.\" But mere similarity is not close enough for many clinicians and some patients; it makes biosimilars seem riskier than the original biologics.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"28 1","pages":"10-11"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37067439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bringing Humira (Its Price) Down a Peg.","authors":"Susan Ladika","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>It's the best-selling drug by revenue worldwide and manufacturer AbbVie has worked hard to fend off competition. Very hard. Humira faces competition in Europe, but it will probably take years before its market share is challenged in the United States.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"28 1","pages":"7-8"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37067436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Show Us (the U.S.) the Savings.","authors":"Thomas Reinke","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Companies with originator biologics on the market have used a variety of regulatory and legal tricks to fend off biosimilars and keep the revenue generated by their products pouring in. The most common approach has been for the \"originators\" to take legal action to assert or defend the patents attached to their products.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"28 1","pages":"9-10"},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37067437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Why the ACA is 'not dead yet' and lives on in 2019.","authors":"Robert Calandra","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The ACA-and more specifically, the individual ACA exchange market-is doing quite well these days, thank you very much. ACA premium prices have stabilized and even gone down for many plans. In October, CMS announced that the average premium for the second-lowest-cost silver plans for 2019 had decreased by 1.5%.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"27 12","pages":"20-21"},"PeriodicalIF":0.0,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36844116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Why the new opioid bill won't really change the way insurers approach the epidemic.","authors":"Frank Diamond","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Not that plans won't be taking a close look at some innovative approaches such as addiction recovery medical homes. One model includes bundled payments and performance bonuses, nationally recognized quality metrics, and the placement of treatment and recovery providers close to where patients with substance use disorder live.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"27 12","pages":"29-30"},"PeriodicalIF":0.0,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36844117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Population Health Service Organizations: Managed Care Gets a New 4-Wheel Drive Vehicle To Navigate the Value-based Terrain.","authors":"Richard G Stefanacci, Terri Schieder","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Population health service organizations (PHSOs) are supplanting management service organizations that gained popularity in the '90s. PHSOs are emerging as the organizations within health systems that can improve the clinical and financial outcomes of the populations the health systems serve.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"27 12","pages":"38-39"},"PeriodicalIF":0.0,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36844125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Why marijuana is headed for the mainstream.","authors":"Thomas Reinke","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The credibility of cannabis as a source of a legitimate pharmaceutical ingredient in prescription medications took a major step forward in 2018 when the FDA approved Epidiolex (cannabidiol) for two types of severe seizures. Epidiolex was a stellar candidate for approval. It reduced convulsive seizures by about 40% and has a good safety profile.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"27 12","pages":"31"},"PeriodicalIF":0.0,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36844121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Why Medicare Advantage enrollment will keep on growing, whatever the politics.","authors":"Timothy Kelley","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In 2019, a record 36% of Medicare beneficiaries will be getting their benefits in a Medicare Advantage plan. CMS has broadened the services such plans can provide-services that may reduce expensive treatments and injuries. Insurers continue to see the market as a business opportunity. Critics see a slow-motion privatization of the entitlement.</p>","PeriodicalId":39329,"journal":{"name":"Managed Care","volume":"27 12","pages":"16-17"},"PeriodicalIF":0.0,"publicationDate":"2018-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36844111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}