Can Real-World Evidence Be Used To Remove LPAD's Limited Population Designation?
(7/10, Michael Cipriano, Pink Sheet) reports “...Can real-world evidence be sufficient to support a supplemental application for lifting the restrictions of the 21st Century Cures Act's limited population antibacterial drug pathway? Or would a clinical trial be required? These are among the many questions industry has raised about LPAD as the US Food and Drug Administration readies for a 12 July public meeting on the subject.” Paid Subscription Required
Trump Calls For Artificial Kidney Development In Executive Order
(7/11, David Roza, InsideHealthPolicy) reports “...HHS says the information FDA collects also will be used by device makers, patients, providers, payers and other researchers to inform the development of new treatments. ‘The patient preferences survey will be an important example of how patient engagement can contribute to building infrastructure for expanded patient-centered outcomes research and how patient input can be used in FDA's review processes,’ HHS says.” Paid Subscription Required
UF Health Joins Research Network Developing a Data Repository on Infectious Diseases
(7/11, Florida Trend) reports “With funding from a five-year, $6.7 million National Institutes of Health grant, researchers at UF Health have joined the University of Pittsburgh Graduate School of Public Health and other academic centers to form a collaborative research network focused on improving global knowledge of infectious diseases.” Full
The National Health Council Announces the Release of a Rubric to Capture the Patient Voice
(7/11, Silke Schoch, National Health Council Blog) comments “...The purpose of the NHC Rubric to Capture the Patient Voice (Rubric) is to provide a tool the patient community or any other health care stakeholder can use to evaluate attributes of patient centeredness and to guide them on meaningful patient engagement throughout any activity they might undertake. It is an all-purpose tool to assist users across the health ecosystem. Potential uses might include, but are not limited to, patient engagement in health care policy, quality-measure development, shared decision-making, value assessment, product development, etc.” Full
UK: NICE Recommends gammaCore for Cluster Headaches
(7/11, Anna Smith, PharmaTimes) reports “In a new draft guidance, The National Institute for Health and Care Excellence has recommended that using gammaCore in addition to standard care (sumatriptan, zolmitriptan and oxygen) could save the NHS £450 per patient in the first year compared to standard care alone.” Full
No Evidence of Added Benefit for Most New Drugs, Say Researchers
(7/10, BMJ Press Release) “...Between 2011 and 2017, IQWiG assessed 216 drugs entering the German market following regulatory approval, they explain. Almost all of these drugs were approved by the European Medicines Agency for use throughout Europe. Yet only 54 (25%) were judged to have a considerable or major added benefit. In 35 (16%), the added benefit was either minor or could not be quantified. And for 125 drugs (58%), the available evidence did not prove an added benefit over standard care in the approved patient population.” Full
Aimmune Statement on Institute for Clinical and Economic Review (ICER) Final Report on AR101 for Peanut Allergy
(7/11, Aimmune Therapeutics Press Release) “Aimmune Therapeutics...cautions stakeholders against drawing conclusions from the Institute for Clinical and Economic Review's final report on emerging desensitization treatments for peanut allergy, released yesterday. In its review, ICER fails to incorporate available data on both long-term outcomes and quality-of-life. ICER's analysis and the public meeting discussion discounted patient and community perspectives on the physical, social and psychological benefits of desensitization.” Full
ACO Model Delivers Improved Health Care to Rural Areas and $48M Savings to Medicare
(7/11, Abt Associates Press Release) “...Financing and inadequate capital for information technology have been cited by rural providers as significant infrastructure obstacles to ACO participation. Under [the CMS ACO Investment Model], up-front and ongoing payments to ACOs enabled them to overcome those initial operational barriers. CMS recoups the payments from the ACOs' subsequent savings. ACOs also receive bonuses from CMS if their savings exceed the payments they've received from CMS and their quality of care is robust.” Full
New Drugs: Where Did We Go Wrong and What Can We Do Better?
Beate Wieseler, et al.
July 10, 2019, BMJ