Search Results for HTA

Showing 1 – 25  of 40

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

The Value of Health Technology Assessment Scientific Advice By Amina Udechuku, PhD, Matthew William Bending, PhD, MSc - Published 23 August 2017

In recent years, particularly in Europe, a paradigm shift in the regulatory and Health Technology Assessment (HTA) environment has led to an increase in multi-stakeholder acceptance of integrated scientific advice. This article discusses how using integrated scientific advice can support companies in optimizing their product development programs and generate evidence relevant to regulators, HTA bodies and payers.

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

Tags: Health Technology Assessment, HTA

EU Health Tech Assessments: Majority Favor Continuing Beyond 2020 By Zachary Brennan - Published 15 May 2017

A majority of respondents to a European Commission questionnaire says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: HTA, health technology assessments, European Commission report

EU Parliament Committee Backs Report to Increase Access to Medicines By Zachary Brennan - Published 01 February 2017

The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Tuesday backed a draft report calling on the commission to analyze the impact of intellectual property on pharmaceutical access, as well as review the regulatory framework for orphan medicines, among other provisions.

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

Tags: ENVI committee, EFPIA, HTA, medicines access

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

NICE to Charge up to £282,000 for Each New Drug Assessment By Zachary Brennan - Published 03 October 2016

The UK’s National Institute of Health and Care Excellence (NICE) plans to charge pharmaceutical companies new fees of up to £282,000 for each cost-effectiveness assessment for a new medicine beginning next year.

Categories: News, Europe, EMA, NICE, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices

Tags: NICE assessment, NICE fees, EMA and HTA parallel assessment

European Regulatory Roundup: UK to Increase Regulatory Oversight of Antibiotics (22 September 2016) By Nick Paul Taylor - Published 22 September 2016

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

Categories: News, EC, EMA, MHRA, Biologics and biotechnology, Drugs

Tags: EU, antibiotics, HTA, marketing authorisation

European Regulatory Roundup: Clinical Trial Delays Prompt EMA to Consider Revising Guidance (18 August 2016) By Nick Paul Taylor - Published 18 August 2016

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: European Regulatory Roundup, clinical trial guidance, EFPIA, Novo Nordisk, HTA

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

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

EMA to Continue Parallel Scientific, HTA Advice Following Successful Pilot By Michael Mezher - Published 31 March 2016

The European Medicines Agency (EMA) says its pilot project for delivering scientific advice to sponsors in parallel with health technology assessment (HTA) bodies has been successful in helping to design efficient clinical development plans and speeding access to new drugs.

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Preclinical, Research and development

Tags: HTA advice, EMA pilot project, scientific advice

European Drug Prices: New Commission Report on What Policies Work and What Could Work By Zachary Brennan - Published 25 February 2016

The complicated world of drug pricing presents an array of challenges for keeping costs low in the US and EU, though European countries are increasingly employing new policies to keep price gouging in check.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Reimbursement, Research and development

Tags: European Commission, EU drug pricing, HTA, external price referencing, differential pricing, pricing policies

The Key to EU Market Access for Pharmaceutical Companies: Early Engagement By Michael Mezher - Published 18 March 2015

The path to regulatory approval can be long and arduous. It can also be especially difficult for smaller companies to navigate. But a new report finds that early input from health authorities can help make the process more straightforward.

Categories: News, Europe, EMA, NICE, Biologics and biotechnology, Clinical, Communication, Drugs, Government affairs, Regulatory strategy, Reimbursement, Research and development, Submission and registration

Tags: HTA, Health Technology Assessment, scientific advice

German Price Watchdog Says ‘No’ to 3 Cancer Drugs By Michael Mezher - Published 23 January 2015

The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month.

Categories: News, Europe, Clinical, Prescription drugs, Reimbursement

Tags: IQWiG, Health Technology Assessment, HTA, G-BA, Federal Joint Committee, AMNOG

EMA, Payors Team up to Speed up Assessments of Medicines By Alexander Gaffney, RAC - Published 25 June 2014

In the EU, a product must clear two hurdles before it can reach patients. First, it must be approved by regulators, such as the European Medicines Agency (EMA), which determines if a product is safe and effective. Thereafter, the product is evaluated by health technology assessment (HTA) bodies, which determine if the product is suitable for reimbursement according to the standards of various countries.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs

Tags: HTA, EUnetHTA, EPAR, EPARs, Payors, HTA

European Commission Establishes Framework for EU-Wide HTA Network By Alexander Gaffney, RF News Editor - Published 27 June 2013

Categories: EC

Tags: HTA, CER, EU

NICE: Novartis' Jakavi not Cost-Effective for Treating Myelofibrosis By Louise Zornoza, RegLink - Published 26 June 2013

Categories: NICE

Tags: HTA, Novartis, CER, cost, UK, EU

MHRA wants to be a World-Class Regulator, Plans to Use Clinical Data to Assist HTA Assessments By Alexander Gaffney, RF News Editor - Published 12 April 2013

Categories: MHRA

Tags: HTA, Latest News, UK, plan, regulatory

NICE Green Lights Two IVDs Intended to Detect Lung Cancer By Louise Zornoza, RegLink - Published 10 April 2013

Categories: NICE

Tags: HTA, CER, UK

IOM Workshop Report Calls for FDA to Assess Products Based on Cost Effectiveness By Alexander Gaffney, RF News Editor - Published 11 February 2013

Categories: FDA

Tags: Cost Effectiveness, HTA, IOM, Report, CER, cost, Latest News, value, workshop

UK's NICE Finds Roche's Avastin Not Cost-Effective for Ovarian Cancer By Louise Zornoza, RegLink - Published 18 December 2012

Categories: Regulatory Update, EMA, NICE, Reimbursement

Tags: Ovarian Cancer, HTA, Roche, Payor, Oncology, CER, UK

Should Regulatory and Reimbursement Be Linked? By Charles A. Stevens, JD, MBA - Published 17 December 2012

The functions of determining regulatory approval and reimbursement for a product traditionally have been at opposite ends of the development process. Historically, any product that received regulatory approval was reimbursed by payers. This is no longer the case in today's global market.

Categories: Features, Reimbursement

Tags: Payors, Payments, HTA, CER, regulatory

NICE Announces Appointment of New Chairman By Alexander Gaffney, RF News Editor - Published 13 December 2012

Categories: NICE

Tags: Rawlins, HTA, CER, UK

The Need for More Certainty in Reimbursement Strategies By Ursula Benter, MSc - Published 12 December 2012

For drug developers, getting a treatment to market with regulatory approval is proving to be only half the battle. Regulatory approval, once considered the gold standard, is no longer good enough in a therapeutic market where inadequate reimbursement status essentially blocks product usage for a considerable volume of patients.

Categories: Features, Reimbursement

Tags: Payors, Health Economics, Money, HTA, Payment, CER, value

Reimbursement Hurdles Focus of EU Consultation on Post-Authorization Studies By Louise Zornoza, RegLink - Published 29 November 2012

Categories: EMA, Reimbursement

Tags: Hurdle, Post-Authorization, HTA, CER, Latest News, studies, EU