CER Daily Newsfeed

Insights into ALZ-NET and Real-World Evidence Generation in Alzheimer’s disease: A Conversation with Rebecca Edelmayer, Alzheimer's Association

(6/2, The Evidence Base) reports “...[Edelmayer:] ALZ-NET was launched in 2022 and emerged following the recent approval of amyloid-targeting therapies by the US FDA, two of which are now in clinical use...It’s also important to note that ALZ-NET is not limited to amyloid-targeting therapies – it will include all newly-approved Alzheimer's treatments and diagnostic tools. It provides a platform to longitudinally follow patients and generate RWE to inform clinical practice and treatment decisions in Alzheimer’s and all other diseases that cause dementia.” Subscription Required

Real-World Evidence Informs Rare Disease Care, Guides New Rx

(6/3, Marcus A. Banks, Specialty Pharmacy Continuum) reports “...‘Health-system specialty pharmacies follow patients through the full continuum of care,’ [Tiffany Phung, PharmD, CSP] said. They can be particularly helpful in tracking rare diseases, where pharmacist’s roles include patient education, tracking adherence, monitoring adverse events, and securing financial assistance for patients. ‘Our pharma partners need to understand how their drug is doing in the real world. When rare disease programs are done right, they improve care and become a powerful engine of RWE.’” Full

Precision Medicine’s Privacy Problem

(6/3, Bella Pfeiffer, Health Affairs Forefront) comments “...To protect patients, Congress must amend 45 C.F.R. Section 164.512(f) to categorically prohibit law enforcement access to genetic health information and to prevent law enforcement acquisition of patient samples for forensic genetics. States must establish explicit retention limits for physical samples and genetic data, and they must stop exempting clinical genetic data when drafting privacy legislation. Without these reforms, patients will increasingly be forced to choose between life-saving treatment and the future of their family’s privacy. A medical system being exploited for surveillance cannot function as effective care.” Full

UK: Why Flexibility Is Built into Everything We Do at NICE Advice

(6/3, Andrew Walsh, NICE Blog) comments “...We designed our evidence gap analysis service for the healthtech market, but the concept adapts well to pharmaceuticals too. For pharmaceutical clients, we carry out a broad review of the evidence you submit, assess the volume of work involved, and agree a cost. It’s quicker and less resource-intensive than full scientific advice, making it a good option if you’re working to a tight deadline or budget, or if you have a focused set of questions and are already familiar with NICE appraisal requirements.” Full