France Reimbursement Profile
By Jenifer Ehreth, MHA, PhD -
Published 20 September 2017
This profile summarizes the reimbursement process, presents key stakeholders in France and highlights complexities to be considered early in the development process.
Categories: Features, Europe, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement
Tags: ANSM, ACAM, CEESP, CEPS, Reimbursement, France
England Reimbursement Profile
By Vishal Patel -
Published 18 September 2017
This profile summarizes the reimbursement process in England, presents key stakeholders and highlights what should be considered early in the development process.
Categories: Features, Europe, MHRA, NICE, Biologics and biotechnology, Drugs, Reimbursement
Tags: NICE, NHS, Reimbursement
Italy Reimbursement Profile
By Patrizia Berto, PharmD, MBA -
Published 14 September 2017
This profile summarizes the reimbursement process in Italy, presents key stakeholders and highlights what should be considered early in the development process.
Categories: Features, Europe, EMA, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement
Tags: AIFA, Agenzia Italiana del Farmaco, Reimbursement
Drug Reimbursement in Canada
By George Wyatt, MBA -
Published 01 September 2017
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.
Categories: Features, Canada, Health Canada, Biologics and biotechnology, Drugs, Reimbursement
Tags: Reimbursement, Coverage, Health Technology Assessment, HTA, Common Drug Review
Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices
By Mark Domyahn -
Published 21 August 2017
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.
Categories: Features, US, FDA, Medical Devices, Reimbursement
Tags: Reimbursement, Centers for Medicaid & Medicare Services, CMS, Payers, Coverage
European Regulatory Roundup: New Pressure to Reverse Brexit Regulatory Split (13 July 2017)
By Nick Paul Taylor -
Published 13 July 2017
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Categories: News, Europe, EC, EMA, NICE, Biologics and biotechnology, Drugs, Medical Devices
Tags: European Regulatory Roundup, Brexit, reimbursement
Congress Calls on HHS to Reverse Biosimilar Reimbursement Policy
By Zachary Brennan -
Published 12 May 2017
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.
Categories: News, US, FDA, Biologics and biotechnology, Reimbursement
Tags: biosimilar reimbursement, HCPCS, reimbursement code, CMS
Researchers Propose Framework to Validate Surrogate Endpoints
By Michael Mezher -
Published 08 June 2016
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.
Categories: News, Europe, EMA, NICE, Clinical, Drugs, Regulatory strategy, Reimbursement
Tags: surrogate endpoints, reimbursement decisions, HTA, cancer drugs
FDA Draft Guidance to Assist CMS With IDE Coverage Decisions
By Michael Mezher -
Published 31 May 2016
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).
Categories: News, US, FDA, Clinical, Medical Devices, Reimbursement
Tags: CMS, Reimbursement, Investigational Device Exemption, IDE, Early feasibility studies, EFS, Category A, Category B, Medicare
Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps
By Daniel Muscionico, PharmD, MPH, MBA, Paloma Grasser, MTIM, BSc, Rosa Mouchotte, MSc, RAC, Anne Rambaud -
Published 29 April 2016
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.
Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Drugs, Regulatory strategy, Reimbursement
Tags: Health technology assessment, HTA, Reimbursement, Market access, EUnetHTA, Target product profile
FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings
By Michael Mezher -
Published 23 February 2016
The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices.
Categories: News, US, CDRH, Clinical, Communication, Medical Devices, Reimbursement, Submission and registration
Tags: Parallel Review Pilot Program, National Coverage Decision, NCD, Reimbursement
Experts Call for New Regulatory Pathways for Antibiotics
By Michael Mezher -
Published 15 December 2015
Faced with the increasing threat of antimicrobial resistance (AMR), experts are calling for more incentives to boost investment in new antibiotics.
Categories: News, US, FDA, Drugs, Regulatory strategy, Reimbursement
Tags: Antimicrobial Resistance, Reimbursement, Limited Population Antibacterial Drug, LPAD, Qualified Infectious Disease Product, QIDP
RAPS Switzerland Chapter to Host 2015 EU Medtech Reimbursement Roundtable
By Zachary Brousseau -
Published 04 June 2015
The elements of market access in Europe will be examined in depth at the 2015 EU Medtech Reimbursement Roundtable, taking place 25 June in Zurich, and hosted by the RAPS Switzerland Chapter.
Categories: HTML, Articles, Under RAPS, RAPS Events, Europe, Switzerland Chapter, RAPS, Medical Devices, Reimbursement
Tags: MedTech Roundtable, medtech, medical device, device, market access, reimbursement, pricing, coverage policy, Europe, EU
Scottish Regulators Decline to Reimburse COPD Treatments From GSK, Boehringer
By Alexander Gaffney, RAC -
Published 11 August 2014
Scotland's health technology assessment body, the Scottish Medicines Consortium (SMC), has not recommended reimbursement for five medicines, including two chronic obstructive pulmonary disease (COPD) drugs manufactured by GlaxoSmithKline and Boehringer Ingelheim.
Categories: News, Europe, Prescription drugs, Reimbursement
Tags: SMC, Scotland, COPD, Reimbursement, Scottish Medicines Consortium