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Nov 28

Today, Medicare will cover anti-cancer drugs if one or more of the following is true: 1. the drug is FDA-approved, 2. the use of the drug is supported by one of the Medicare-approved compendia, and its use is not listed as "not recommended" in any of the compendia, or 3. the use is supported by clinical research that appears in peer-reviewed medical literature. Upon development or update of a tumor-specific guideline, the data and ratings are converted into the compendium. As such, manufacturers often provide resources regarding access coverage for both labeled and unlabeled uses. Through this process, experts may deem certain off-label uses as "acceptable" as a result of their review of the clinical data. It is not, however, a Medicare- or Medicaid-approved compendium. 2. DrugPoints is a summary of Thomson Micromedex DRUGDEX and a successor publication to USPDI. According to the final rule, as of January 1, 2010, each compendium must post listings evaluation processes to their websites, including disclosure of evidence considered and the review of evidence leading to the development of the recommendation. DrugPoints does not utilize its own ratings system, but, rather, references the DRUGDEX ratings. Wherever possible, manufacturers should compare listings for a product across two or more compendia. If conducted before the product comes to market, manufacturers can use information gleaned to help design the next round of clinical trials. Drug compendia are defined as summaries of drug information that are compiled by experts who have reviewed clinical data on drugs. In addition, manufacturers may want to consider surveying the payer and provider community on an ongoing basis to determine which compendia and guidelines are considered well-established and which are most respected in the industry. In addition to evaluating proxy products, it's important to review clinical trial literature to identify informational gaps for data or evidentiary support that may be needed for the compendia submission. In addition, the 2010 Final Medicare Physician Fee Schedule (MPFS) Rule finalized CMS' proposal requiring recognized and future compendia to have a publicly transparent process for evaluating therapies and identifying potential conflicts of interest, in order to improve regulatory safeguards. These data points then should be compared to the compendia benchmarks for the competitor proxy products. Compendia data fuels the systems that automatically checks for drug interactions and allergies. Once the gap analysis is complete, a summary should be developed that includes. Manufacturer strategies and tactical plans will continue to integrate and be incorporated earlier in the clinical trial phase to maximize the greatest patient access prior to launch. Ms Brown is senior vice president, Xcenda, a business unit of AmerisourceBergen Consulting Services. For example, many manufacturers have a reimbursement hotline to help providers and patients access therapies more affordably. Unlike disease treatment guidelines that are indexed by disease, these compendia should be indexed by drug or biologic. Strategies should be centered around disease states or be product specific. According to the Centers for Medicare and Medicaid Services (CMS), a compendium should include a summary of pharmacologic characteristics for each drug/biological that may include dosage and recommended uses. The analysis should evaluate compendia listings for the indication and listings that mention biomarkers or diagnostic testing. Manufacturers must work to determine the type and level of evidence, including end points and outcomes, needed for favorable listings. Regulatory agencies, such as CMS, continually implement changes to Medicare and Medicaid programs, including the appropriate use of compendia for drug coverage determinations. Drug compendia are defined as summaries of drug information that are compiled by experts who have reviewed clinical data on drugs. Approximately 90 editorial Micromedex staff members, trained in the identification of relevant literature and accepted literature evaluation techniques, participate in the multistep process to create and update the content within DRUGDEX. Because of this, it’s absolutely vital that you provide the Compendia with accurate, robust clinical information. AHFS-DI and Clinical Pharmacology don't have a standard review process, admission process, or timeline. This process involves reviewing many forms of drug/medical data from multiple resources and distilling them into usable and concise information. It might also be wise to consider which individuals on the manufacturer side are interfacing with the payers. Although FDA approval process may not always be a feasible option for additional indications, guidance is needed to determine which uses are medically appropriate. Facts & Comparisons, published by Wolters Kluwer Health, provides up-to-date, comprehensive drug information, including off-label uses. Occasionally, external data review requests will be honored. Regardless of timing, manufacturers should keep a finger on the pulse of the market and watch how payers respond to industry leaders. Therefore, a positive or negative listing can have a significant impact on whether or not a pharmaceutical product is covered, ultimately affecting prescribing decisions and patient access to medications. https://www.thefreedictionary.com/compendia, [C16: from Latin: a saving, literally: something weighed, from, [1575–85; < Latin: gain, saving, abridgment <, Where facts presented to an ALJ established that the use of dronabinol as prescribed to a patient under the Medicare prescription drug plan was supported by a citation to the Medicare-approved, a provider of SaaS solutions for property managers, residential homeowner associations and homebuilders, has completed its acquisition of homeowner web portals and manuals provider, M2 EQUITYBITES-February 11, 2016-Community Investors Expands Homebuilder Portal Provider, It is the tallest residential building in Texas and the luxurious and regal Austonian is, La tercera parte, sobre la caridad, debia tratar seguramente del Decalogo, que se, The report is the result of an analysis of over 100 evaluations of school and youth programs published in a series of, Supplementing Werner Paul Friederich's and Paget Jackson Toynbee's, THE EARLY DEVELOPMENT of engraved calligraphy, M2 EQUITYBITES-October 9, 2012-Life Technologies reports purchase of. Clinical Pharmacology is accessible online via a subscription ( http://www.clinicalpharmacology.com/) or through the purchase of a CD-ROM. Disclosure Information: The author reports no financial disclosures as related to products discussed in this article. According to the Centers for Medicare and Medicaid Services (CMS), a compendium should include a summary of pharmacologic characteristics for each drug/biological that may include dosage and recommended uses. NCCN guidelines are developed and updated by 44 individual panels, comprising more than 800 clinicians and oncology researchers from the 21 NCCN member institutions and their affiliates. Now, Medicare (both Parts B and D) relies on data from AHFS-DI, Clinical Pharmacology, DRUGDEX, and NCCN when making coverage decisions, while Medicaid utilizes only AHFS-DI and DRUGDEX. Recent changes in health policy as a result of healthcare reform do not currently impact Medicare and Medicaid's approach and use of compendia for off-label indications. Medical science liaisons, which work directly with payers, rather than account managers are most qualified to understand the payers' needs and have the ability to address off-label questions. CMS has even redesigned its process for determining medically appropriate indications and now allows for submission to be included as its proof compendium. First published in 1959, AHFS-DI is updated annually in hard copy format and provides frequent updates on its website ( http://www.ahfsdruginformation.com/). The Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals, more commonly known by its abbreviation CPS, is a reference book that contains drug monographs and numerous features which help healthcare professionals prescribe and use drugs safely and appropriately. These hotlines could also be utilized to assist physicians should they need support with off-label indications. Unlike disease treatment guidelines that are indexed by disease, these compendia should be indexed by drug or biologic.

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