• Regulatory NewsRegulatory News

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

    • 31 May 2017
    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

    ICER to Re-Evaluate How to Assess Value and Comparative Clinical Effectiveness

    The Institute for Clinical and Economic Review (ICER), an independent nonprofit research institute, on Thursday opened a national call for suggestions on how to improve its value assessment framework, which assesses the comparative clinical effectiveness and value of health care tests, treatments and delivery systems. The call for comments, which are expected to come before 12 September, will help inform ICER’s 2017 update to the methods that underpin its evidence repo...
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    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

    FDA Releases Final Guidance on Integrated Summary of Effectiveness

    More than seven years since unveiling the draft document, the US Food and Drug Administration (FDA) on Wednesday finalized its guidance on how an Integrated Summary of Effectiveness (ISE) should be prepared for new drug applications (NDAs) and biologics license applications (BLAs). In terms of the changes between the draft and final versions, FDA has revised the definition of integrated analyses, clarified the components that constitute integrated analyses, defined poole...
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    Does FDA Need New Authority to Regulate Complex Generic Drugs?

    New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority. Background The bill, the Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 , was introduced on 24 March 2015 by Rep. Michael Burgess (R-TX), a former physician and member of the House Energy a...
  • PCORI Giving $68 Million to Build a National Comparative Effectiveness Research Network

    The US' Patient-Centered Outcomes Research Institute (PCORI), a budding comparative effectiveness research (CER) organization formed under the Patient Protection and Affordable Care Act (PPACA) of 2010, has announced its plans to spend as much as $68 million to develop a new clinical research network that it says will bolster the US' capacity to compare treatments. Background PCORI's 2010 founding under the PPACA -better known as "Obamacare" by some-was rife with con...
  • Looking to Change US Approach to Comparative Effectiveness Research, PCORI Staffs Advisory Panels

    The US Patient-Centered Outcomes Research Institute's (PCORI) Board of Governors announced on 26 March 2013 that it had selected 84 people to serve on its first four advisory panels, staffing the agency with crucial experts it will need in its attempts to re-define how patients are treated in the US. PCORI was founded by the 2010 Patient Protection and Affordable Care Act (PPACA), better known as Obamacare. The legislation called for an entity that could, somewhat like...
  • 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...
  • PCORI Board Adopts CER Standards

    The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) at its 19 November 2012 meeting in Boston, MA adopted 47  revised methodology standards  that are intended to guide the comparative effectiveness research (CER) funded by PCORI.  The Board also authorized at the meeting the development of three new CER funding announcements: Treatment options for uterine fibroids, the safety and benefits of treatment options for severe asthm...
  • UK: Two Breast Cancer Drugs not Recommended by NICE in Latest Draft Guidance

    The National Institute for Health and Clinical Excellence (NICE) will not recommend lapatinib (Tyverb, GlaxoSmithKline) or trastuzumab (Herceptin, Roche) with aromatase inhibitors for a particular type and stage of breast cancer, the agency said in a final draft guidance issued 26 April. The proposal notes that it is unclear how much either drug can improve overall survival compared to existing treatments and that the drugs do not appear t...
  • NICE Denies Avastin Indication for Breast Cancer

    The UK's National  Institute for Health and Clinical Excellence (NICE) announced in a draft guidance it will not approve Roche's breast cancer drug Avastin (bevacizumab) due to "too many uncertainties" about the drug's cost effectiveness, writes In Pharm . "The draft guidance, which is out for consultation, has not recommended Avastin as first line treatment for metastatic breast cancer in combination with chemotherapy drug capecitabine," wrote In Pharm . NICE's ...
  • PCORI Moves to Advance New CER-Centered Agenda

    • 17 April 2012
    The Patient-Centered Outcomes Research Center (PCORI) announced in the Journal of the American Medical Association (JAMA) its impending focus on five areas of clinical effectiveness research (CER). In two spate articles in the 18 April issue of JAMA , PCORI said it was looking to establish a "new, methodologically rigorous focus on patients' needs in CER." "Such an approach, along with more actively engaging clinicians and other stakeholders in all aspects of the re...