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Filtering on: "topics reimbursement"

Showing 1 – 25  of 117

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

UK's NICE to Launch New Online Tool for Med Tech Developers Published 31 May 2017

The UK's National Institute for Health and Care Excellence (NICE), which often determines if the UK can afford to pay for certain treatments, will launch a new online tool in July to help developers of medical devices and diagnostics understand how to generate the evidence necessary to show their products are clinically and cost effective.

Categories: News, Europe, NICE, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: NICE, medical technologies, medical devices, cost effectiveness of medical tech

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

Biosimilars in the EU: New IMS Report Shows Savings Through Competition By Zachary Brennan - Published 09 May 2017

A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: biosimilars, biologic competition, anti-TNF, HGH

European Regulatory Roundup: EMA Reports Year-Long Shortage of BMS Kidney Transplant Drug; UK Rejects Indication-Specific Drug Pricing (23 March 2017) By Nick Paul Taylor - Published 23 March 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Reimbursement, Veterinary products

Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup

New House E&C Chairman to Consider Value-Based Drug Price Negotiations By Zachary Brennan - Published 02 February 2017

The newly minted chairman of the influential House Energy & Commerce Committee is looking to tackle pharmaceutical price gouging with a new bill and comments on how there need to be more negotiations to bring down prices.

Categories: News, US, Drugs, Reimbursement

Tags: Walden, House E&C, Schrader, Merck, CMS drug negotiations

NICE Halts Plans to Charge for Appraisals By Zachary Brennan - Published 16 January 2017

The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Reimbursement

Tags: Brexit, UK Life Sciences, ABPI, NICE

Senators Look to Halt Price Spikes of Off-Patent Drugs By Zachary Brennan - Published 21 December 2016

Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday released a 131-page report explaining the details behind specific price increases for off-patent drugs and ways Congress can combat such spikes.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Reimbursement

Tags: Valeant, Turing, Rodelis, Retrophin, Syprine, Cuprimine

Senate Democrats to Trump: Work With us to Lower Drug Prices By Zachary Brennan - Published 20 December 2016

Sens. Sherrod Brown (D-OH), Al Franken (D-MN) and 17 of their Democratic and Independent colleagues on Tuesday sent a letter to President-elect Donald Trump, urging him to combat the pharmaceutical industry’s “abusive tactics” that “price lifesaving drugs out of reach for those in need.”

Categories: News, US, Drugs, Reimbursement

Tags: Franken, Elizabeth Warren, Trump, CMS, drug prices

CMS Drops Medicare Part B Drug Payment Pilot By Zachary Brennan - Published 16 December 2016

The Centers for Medicare and Medicaid Services (CMS) late Thursday decided to abandon a pilot plan that aimed to lower Medicare pharmaceutical spending.

Categories: News, US, Drugs, Reimbursement

Tags: CMS Part B, Medicare drug costs, Medicare payment program, Medicare pilot

Bridging the Gap: Satisfying Payers in an Era of Expedited Regulatory Pathways  By Richard Macaulay, PhD - Published 16 December 2016

This article discusses the divergent evidentiary requirements of payers and regulators and the strategies companies can employ to help bridge this gap to ensure expedited regulatory approval effectively translates into reimbursement and patient access.

Categories: Features, Asia, Europe, US, EMA, FDA, NICE, Biologics and biotechnology, Drugs, Reimbursement

NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage By Zachary Brennan - Published 15 December 2016

The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to new medical devices, diagnostics and other health-related technologies.

Categories: News, Europe, US, CDRH, NICE, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: NICE, medical device insurer coverage, medical devices and approval

HHS Inspector General to Examine Medicaid Drug Rebate Program in Wake of EpiPen Fiasco By Zachary Brennan - Published 12 December 2016

In light of concerns over the misclassification of Mylan’s EpiPen and subsequent overcharging of the federal government for the life-saving allergy drug, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) late last week said it will review the Medicaid Drug Rebate Program.

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

Tags: CMS, EpiPen, Mylan, Andy Slavitt

Vermont Drug Price Transparency: New Law Calls Out Egregious Price Spikes By Zachary Brennan - Published 06 December 2016

Last June, Vermont Governor Peter Shumlin (D) signed into law a new pharmaceutical price transparency bill that sought to expose the companies and products seeing the largest price hikes.

Categories: News, US, Biologics and biotechnology, Business and Leadership, Drugs, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: pharmaceutical price transparency, drug prices, increases in drug prices, Vermont pharmaceuticals, Medicaid

Mylan CEO Defends EpiPen Price Increases By Zachary Brennan - Published 01 December 2016

Mylan CEO Heather Bresch on Thursday defended the more than 400% price increase for its life-saving EpiPen, saying the company has made the device “more ergonomic” and that patients “never see the needle.”

Categories: News, US, Business and Leadership, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: EpiPen, Mylan, Heather Bresch, generic drug price gouging

CMS Updates Drug Pricing Dashboard, Calls for Affordable and Accessible Pharmaceuticals By Zachary Brennan - Published 14 November 2016

As the rising prices of pharmaceuticals continue to hurt Americans' pockets, the US Centers for Medicare & Medicaid Services (CMS) are using transparency to highlight some of the steepest price spikes that are costing Medicare and Medicaid the most.

Categories: News, US, Drugs, Postmarket surveillance, Reimbursement

Tags: CMS, drug spending dashboard, pharmaceutical prices

EMA Recommends Nine Drugs for Approval By Zachary Brennan - Published 11 November 2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: EMA CHMP, marketing authorisation in EU, Gilead, Sanofi, Novo Nordisk

UK Report Calls for Streamlining to Accelerate Access to Drugs by Four Years By Michael Mezher - Published 24 October 2016

The UK government on Monday released a new report on accelerated access, claiming the UK's National Health Service (NHS) could speed access to new drugs and devices by streamlining regulatory, health technology assessment (HTA) and reimbursement mechanisms.

Categories: News, Europe, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory strategy, Reimbursement

Tags: National Health Service, NHS, Accelerated Access Pathway

FDA and CMS Parallel Reviews of Devices to Continue By Michael Mezher - Published 21 October 2016

A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday.

Categories: News, US, FDA, Clinical, Medical Devices, Reimbursement, Submission and registration

Tags: Parallel review, National coverage determination, Centers for Medicare & Medicaid Services, CMS

European Commission Explores the Future of HTA Cooperation By Zachary Brennan - Published 21 October 2016

The European Commission on Friday opened a consultation to consider the views of a number of different stakeholders on the future of health technology assessments (HTAs) across the EU member states.

Categories: News, Europe, EC, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: HTA cooperation, health technology assessment

ICER on PD-1 Immunotherapies to Treat Lung Cancer: Lower the Prices By Zachary Brennan - Published 03 October 2016

In a new report on non-small cell lung cancer (NSCLC) treatments, the Institute for Clinical and Economic Review (ICER) found that for PD-1 immunotherapies, which are also often used to treat melanoma, the cost may be too high in terms of lengthening progression-free and overall survival.

Categories: News, US, Biologics and biotechnology, Due Diligence, Ethics, Regulatory strategy, Reimbursement, Research and development

Tags: NSCLC, lung cancer, ICER

WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable By Zachary Brennan - Published 30 September 2016

The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, WHO, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: WHO, prequalification of vaccines, prequalification of medicines, WHO funds

GAO Report: 315 Generics More Than Doubled in Price Since 2010 By Michael Mezher - Published 13 September 2016

A new report by the US Government Accountability Office (GAO) found that the price for generic drugs under Medicare Part D fell significantly since 2010 despite some "extraordinary" increases for 315 generics.

Categories: News, US, Generic drugs, Reimbursement

European Regulatory Roundup: EU Council Presidency to Prioritize Drug Availability; Eisai, IQWiG Clash Over Halaven (8 September 2016) By Nick Paul Taylor - Published 08 September 2016

The Slovak presidency of the EU Council of Ministers has identified improvements to the availability of drugs as a top priority for its time at the head of the organization. Slovakia is setting the agenda at the Council until the end of the year, giving it several months in which to advance its ambitions.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Reimbursement

Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup

What Drugs Really Cost: GAO Wants CMS to Find Out By Zachary Brennan - Published 02 August 2016

In order to help ensure the accuracy of Medicare Part B drug payment rates, the US Government Accountability Office (GAO) on Monday urged Congress to require all manufacturers of Part B drugs paid at average sales price (ASP) to submit sales price data to the Centers for Medicare & Medicaid Services (CMS). 

Categories: News, US, Biologics and biotechnology, Drugs, Government affairs, Reimbursement

Tags: GAO, CMS drug prices, Part B, drug pricing, ASP