Search Results for

Filtering on: "topics reimbursement"

Showing 1 – 25  of 141

FDA, CMS: Second Parallel Review Decision Ever for NGS Test By Michael Mezher - Published 01 December 2017

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test.

Categories: News, US, FDA, In vitro diagnostics, Reimbursement, Submission and registration

Tags: Parallel Review, CMS, FoundationOne CDx, Breakthrough Device

Updated: House Passes GOP Tax Overhaul With Orphan Drug Tax Credit Repeal Included By Zachary Brennan - Published 16 November 2017

The US House of Representatives on Thursday passed a bill to reform the US tax code by a vote of 227 to 205, with all Democrats voting against it and all but 13 Republicans voting for it.

Categories: News, US, FDA, Clinical, Reimbursement, Research and development

Tags: orphan drug tax credit, tax reform

Trump: Former Eli Lilly Exec to be Nominated as Next HHS Secretary By Zachary Brennan - Published 13 November 2017

President Donald Trump on Monday morning announced via Twitter his intention to nominate Alex Azar, former senior vice president at Eli Lilly and deputy HHS secretary under President George W. Bush, to be the next HHS secretary.

Categories: News, US, Drugs, Reimbursement

Tags: Azar, HHS Secretary, Eli Lilly

EMA, EUnetHTA Sign Off on Three-Year Work Plan By Michael Mezher - Published 13 November 2017

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Reimbursement, Submission and registration

Tags: EUnetHTA, HTA, Health Technology Assessment, Parallel Advice

Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition By Zachary Brennan - Published 08 November 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition.

Categories: News, US, FDA, FTC, Generic drugs, Government affairs, Reimbursement

Tags: generic drug competition, REMS, shared REMS, pay-for-delay

CMS Shift on Biosimilar Reimbursement Under Part B: What to Expect By Zachary Brennan - Published 06 November 2017

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.

Categories: News, US, FDA, Biologics and biotechnology, Reimbursement

Tags: biosimilars, Medicare Part B, biosimilar reimbursement

CMS Shifts Coding and Payment Policy for Biosimilars Under Medicare Part B By Zachary Brennan - Published 02 November 2017

The Centers for Medicare and Medicaid Services (CMS) late Thursday announced that it would finalize a policy to separately code and pay for biosimilar products under Medicare Part B, signaling a win for industry.

Categories: News, US, Biologics and biotechnology, Reimbursement

Tags: CMS, biosimilars

Greek Health Minister Takes Issue With Roche's Withdrawal of Cancer Medicine Due to Mandatory Discount By Zachary Brennan - Published 31 October 2017

Drug prices are not just a US problem. Greece's minister of health on Tuesday expressed dismay over Roche's decision to withdraw a cancer medicine because of a new mandatory discount imposed by the country.

Categories: News, Europe, Drugs, Reimbursement

Tags: Greece, Roche, Cotellic

How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss By Zachary Brennan - Published 18 October 2017

Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales.

Categories: News, India, US, MHLW, Government affairs, In vitro diagnostics, Medical Devices, Reimbursement

Tags: stents, knee implants, India price ceilings, medical devices in india

Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System By Zachary Brennan - Published 17 October 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay.

Categories: News, US, Drugs, Reimbursement

Tags: pharmaceutical pricing, Senate HELP committee, PhRMA

340B: Health System Execs Push Back on Narrowing of Drug Discount Program By Zachary Brennan - Published 11 October 2017

The House Energy & Commerce's subcommittee on Oversight and Investigations on Wednesday discussed the federal 340B drug discount program, which provides participating hospitals and other medical providers deep discounts on outpatient drugs. 

Categories: News, US, Drugs, Government affairs, Reimbursement

Tags: 340B program, drug discounts, pharmaceutical companies

Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods By Gloria Hall - Published 04 October 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in October.

Categories: Features, Canada, Europe, US, FDA, Health Canada, MHRA, NICE, Advertising and Promotion, Labeling, Nutritional and dietary supplements, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

Canada Reimbursement Profile By Matthew Brougham, MSc, William O'Neil, PhD, Dima Samaha, MAS, PharmD - Published 04 October 2017

This profile summarizes reimbursement processes in Canada, presents information for key stakeholders and highlights what should be considered early in the development process.

Categories: Features, Canada, Health Canada, Drugs, Medical Devices, Reimbursement

Tags: CADTH, Health Canada, INESSS, pCPA, PMPRB

Germany Reimbursement Profile By Elvira Müller, PhD, MPH - Published 03 October 2017

This profile summarizes the reimbursement process in Germany, presents responsibilities for key stakeholders and highlights issues for consideration early in the development process.

Categories: Features, Europe, Drugs, Medical Devices, Reimbursement, Submission and registration

Tags: G-BA, IQWiG, GKV-SV, InEK

New Developments in Payor Communications: Are 20 Years of Uncertainty Over? By Glenn Byrd, MBA, RAC - Published 29 September 2017

This article discusses the state of FDA guidance relating to the US Food and Drug Administration Modernization Act (FDAMA-114), particularly in the area of Healthcare Economic Information (HCEI), and looks at the questions requiring clarification in order for industry to be able to effectively change how economic and other clinical information is communicated to payors and similar groups. The author also evaluates elements of FDA's 2017 Draft Guidance.

Categories: Features, US, FDA, Communication, Drugs, Reimbursement

Tags: Healthcare Economic Information, HCEI, Payor Communications, FDAMA

Spain Reimbursement Profile By Jesús Cuervo, PhD, Carlos Crespo, MBA, MHE, PhD, Jenifer Ehreth, MHA, PhD - Published 27 September 2017

This profile summarizes the reimbursement process in Spain, presents key stakeholders and highlights what should be considered early in the development process.

Categories: Features, Europe, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement

Tags: Spain, AEMPS, Agencia Española de Medicamentos y Productos Sanitarios

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

House Reps Seek More Transparency on Novartis-CMS Pricing Deal for Newly Approved CAR-T Therapy By Zachary Brennan - Published 14 September 2017

Rep. Lloyd Doggett (D-TX) and other House Democrats on Wednesday sent a letter to Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS), seeking to find out more information about an outcomes-based payment approach for Novartis’ newly approved chimeric antigen receptor T-cell (CAR-T) treatment Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

Categories: News, US, Compliance, Reimbursement

Tags: CAR-T, outcomes-based deal, Novartis

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

Preparing for Market: Reimbursement Strategies for Cell and Gene Therapies Published 08 September 2017

In this interview with Regulatory Focus, Ted Slocomb and Michael Werner, two leaders from the Alliance for Regenerative Medicine (ARM), provide insight into future challenges and opportunities for ensuring market access and value-based reimbursement for gene and cell therapies.

Categories: Features, US, FDA, Biologics and biotechnology, Human cell and tissue, Reimbursement

Tags: Regenerative Medicine, ARM, Michael Werner, Ted Slocomb

Health Technology Assessment, Reimbursement, Scientific Research, Risk Management, Generic Drug Legislation and a Preview of September By Gloria Hall - Published 06 September 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in September.

Categories: Features, FDA, Health Canada, Biologics and biotechnology, Generic drugs, Medical Devices, Regulatory strategy, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

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

NICE, Roche Reach Deal on Breast Cancer Drug By Michael Mezher - Published 15 June 2017

Patients in the UK could soon get access to Roche's targeted breast cancer drug Kadcyla (trastuzumab emtansine) through the National Health Service (NHS) as early as next month, the National Institute for Health and Care Excellence (NICE) said on Thursday.

Categories: News, Europe, NICE, Biologics and biotechnology, Reimbursement

Tags: NICE, Roche, Kadcyla, Herceptin, Trastuzumab