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  • Regulatory NewsRegulatory News

    Not Just Mylan: Misclassifications May Have Cost Medicaid More Than $1B

    The US Department of Health and Human Services' (HHS) Office of Inspector General (OIG) released a report this week finding that drugmakers may have caused the Medicaid program to lose out on $1.3 billion for 10 potentially misclassified drugs from 2012 to 2016. The release of the report follows a settlement between Mylan and the Department of Justice from August in which the drugmaker agreed to pay $465 million to settle claims relating to the misclassification ...
  • Regulatory NewsRegulatory News

    CMS Shift on Biosimilar Reimbursement Under Part B: What to Expect

    The Centers for Medicare and Medicaid (CMS) last week announced a major shift in how it will reimburse for biosimilars under Medicare Part B, and though the agency and market might not see the full impact of the decision for another decade, experts explained to Focus what the change will likely mean in the near and long term. And though the predictions are largely hypothetical (since there are not currently multiple biosimilars for any reference biologic on the mar...
  • Feature ArticlesFeature Articles

    France Reimbursement Profile

    This profile summarizes the reimbursement process, presents key stakeholders in France and highlights complexities to be considered early in the development process. Introduction Obtaining regulatory approval for medicines is the first major hurdle of most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are approved by regulatory agencies, such as Haute Autorité de la Santé (HAS), is...
  • Feature ArticlesFeature Articles

    England Reimbursement Profile

    This profile summarizes the reimbursement process in England, presents key stakeholders and highlights what should be considered early in the development process. Obtaining regulatory approval for medicines is the first major hurdle for most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are approved by regulatory agencies (e.g., MHRA) is a separate and crucial process without which ...
  • Feature ArticlesFeature Articles

    Italy Reimbursement Profile

    This profile summarizes the reimbursement process in Italy, presents key stakeholders and highlights what should be considered early in the development process. Obtaining regulatory approval for medicines is the first major hurdle of most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are approved by regulatory agencies (e.g., AIFA) is a separate and crucial process without which pat...
  • Feature ArticlesFeature Articles

    Drug Reimbursement in Canada

    This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place. The Regulatory–Reimbursement Interface Community (out-patient) drug reimbursement is usually considered after a drug has received regulatory approval from Health Canada. Regulatory proces...
  • Feature ArticlesFeature Articles

    Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices

    This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy. Introduction Bringing new and innovative medical technologies to the US market has numerous challenges, including market identification, product development, regulatory and quality requirements, and demonstrating both clinical and economic effectiveness. In recent years, adequate reimbursement has beco...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: New Pressure to Reverse Brexit Regulatory Split (13 July 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Drug Supply Fears Prompt Politicians to Pressure PM to Reverse Brexit Regulatory Split Politicians have begun pressuring United Kingdom Prime Minister Theresa May to reverse her decision to leave the European nuclear energy regulator. Interest in the UK’s planned exit from Euratom surged after newspapers published long-standing fears about the effect of the split on the...
  • Regulatory NewsRegulatory News

    Congress Calls on HHS to Reverse Biosimilar Reimbursement Policy

    Sen. Pat Roberts (R-KS), and Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA) as well as 52 other representatives and nine senators sent letters to Tom Price, Health & Human Services secretary, and Seema Verma, administrator for the Centers for Medicare & Medicaid Services (CMS) with concerns about the biosimilar reimbursement policy from a recently issued final rule. The final rule, issued by CMS on 30 October 2015, stipulates that each biosimilar of the same refere...
  • Regulatory NewsRegulatory News

    Researchers Propose Framework to Validate Surrogate Endpoints

    A team of researchers and health officials, including European Medicines Agency (EMA) Executive Director Guido Rasi, are proposing a three-step validation process to enhance the use of surrogate endpoints in regulatory and reimbursement decision-making. The issue, they say, is that poorly validated surrogate endpoints can lead to products being approved or reimbursed that have little or no benefit, and in some cases even harm patients. In recent years, drugmakers have i...
  • Regulatory NewsRegulatory News

    FDA Draft Guidance to Assist CMS With IDE Coverage Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS). While an agreement has been in place between the two agencies for more than two decades, FDA says it has run into issues with some devices not easily fittin...
  • Feature ArticlesFeature Articles

    Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps

    This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers who would like to enter this geographical market. In addition, solutions to maximize the product development strategy are discussed with the intention of bridging regulatory and market access gaps. The rapid diffusion of health technologies has presented governments with unprecedented challenges to provide high quality an...