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  • Regulatory NewsRegulatory News

    UK's NICE to Launch New Online Tool for Med Tech Developers

    • 31 May 2017
    • By
    The UK's National Institute for Health and Care Excellence (NICE), which determines if the UK can afford to pay for certain medical 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. The Medtech Early Technical Assessment (META) tool, developed in partnership with NICE's Scientific Advice service and the Gre...
  • Regulatory NewsRegulatory News

    EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report

    The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the  Pediatric Regulation,  ten years after its implementation. The comments on the consultation, which is open until 20 February 2017, will help inform the EC's report, which is expected to be published in 2017 and will assess the regulation's impact on public health and the pharmaceutical industry. Background The Pediatric Regulation, known in the EU ...
  • Regulatory NewsRegulatory News

    NICE to Work Earlier With Industry to Speed NHS Adoption of New Drugs, Devices

    The UK's National Institute for Health and Care Excellence (NICE) on Tuesday officially launched its Office for Market Access (OMA) to collaborate more closely with industry to accelerate the adoption of new drugs, devices and diagnostics by the National Health Service (NHS). Specifically, OMA will give commercial stakeholders access to a dedicated team at NICE that they can approach for inquiries relating to health technology evaluation, as NICE is responsible for...
  • Regulatory NewsRegulatory News

    UK's NICE Rejects Roche's Breast Cancer Drug Kadcyla, Citing Major Cost Concerns

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance confirming its earlier rejection of Roche’s breast cancer drug treatment Kadcyla for National Health Service (NHS) coverage. Kadcyla (trastuzumab emtansine) treats women with m...
  • FDA Expresses Interest in Comparative Price of Drugs (But not in the way you Think)

    Watch a drug advertisement in the US-any one, really-and one thing you're unlikely to hear any mention of is the drug's cost. That's not always an accident, as the myriad of insurance companies, co-pays, state insurance programs, private assistance programs, coupons and other incentives mean that the true cost of a drug is rarely seen by consumers and is rarely the same for two people. But assume, for a moment, that such an instance existed-that a drug ("Drug A") cost ...
  • NICE: Novartis' Jakavi not Cost-Effective for Treating Myelofibrosis

    In final draft guidance released today, the UK's National Institute for Health and Care Excellence (NICE) has recommended against the use of ruxolitinib (Jakavi, Novartis) for the treatment of disease-related splenomegaly (enlarged spleen) or its symptoms in adults with primary myelofibrosis, post polycythaemia vera myelofibrosis, or post essential thrombocythaemia myelofibrosisi. Myelofibrosis is a rare blood cancer in which the bone marrow produces too many cells too...
  • Federal Agency Says FDA's Benefits Far Outweigh its Costs

    A new draft report out by the White House's Office of Management and Budget (OMB), the government's regulator of regulators, shows that the cost-benefit ratios of the US Food and Drug Administration (FDA) vastly outweigh its costs to industry and the public at large, potentially giving the regulator clout with legislators who are increasingly looking to make budget cuts. The Report The draft report was published in response to the Regulatory Right-to-Know Act of 2001,...
  • FDA Draft Guidance: When is it Acceptable to Charge for an Investigational Drug?

    What is an investigation drug worth? In a philosophical sense, an investigational drug may be priceless to a patient facing the prospect of certain death, offering them additional time, reduced suffering or a new chance at life. But for companies in the process of studying an investigational product, that drug has a very real cost. Now a new draft guidance published by the US Food and Drug Administration (FDA) wants to answer a basic question: Can a company charge a patie...
  • IOM Workshop Report Calls for FDA to Assess Products Based on Cost Effectiveness

    Even casual observers of US healthcare policy are aware of a common refrain: Costs are too high, unsustainable and a poor indicator for the quality US patients ought to be receiving. While the reasons for the high costs of healthcare are frequently and loudly debated, a new report out from the US Institute of Medicine (IOM), a venerable think tank of sorts that advises US agencies on matters of health, argues that at least some of those costs are the result of inefficient...
  • Report: Inefficient Clinical Trials Cost Industry Billions Each Year

    • 06 November 2012
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    Inefficient clinical trials are costing pharmaceutical development companies between $4 and $6 billion each year in unnecessary expenses, claims a new study just published by the Tufts Center for the Study of Drug Development (CSDD). The problem is widespread, the report explains, affecting roughly one in five (22.3%) trials for more than $1 million per trial. A greater percentage of Phase III trials collected extraneous data (24.7) than Phase II trials (17.7%) did. So ...
  • France Clarifies Its Health Technology Assessment Process

    • 22 October 2012
    • By
    France's cost containment agency, the National Authority for Health (HAS), recently released guidance  on the methods that it uses when it conducts "economic evaluations" of medicines and medical devices.  The document explains the basic methodology that HAS uses in the economic evaluations that allow health interventions to be compared on the basis of their health effects and costs. The methodology used is the "reference case analysis" that is adaptable to t...
  • IOM: Regulatory Holds Promise of Improving Healthcare Outcomes

    A new, landmark report just published by the US Institute of Medicines (IOM) says the US healthcare system spends more than $750 billion each year on wasteful and inefficient systems of healthcare, and calls for changes, including to the US Food and Drug Administration's regulatory system. The report, " Best Care at Lower Cost: The Path to Continuously Learning Health Care in America ," examines the burgeoning cost of healthcare, which IOM officials say, "Threaten the na...