Aligning Cancer Therapeutic Evidence Between EMA and EU HTAs
Many of the health technology assessment agencies (HTAs) of EU member nations have evidence requirements for cancer drugs that are different than those of the European Medicines Agency (EMA). This disparity often delays patient access. In a new article in Value in Health, authors break down these different requirements to highlight the need for alignment between EMA and EU HTA requirements.
Will Global Drug Price Transparency Improve Access for Patients?
With conversation building worldwide about growing drug prices, many have recommended efforts to increase global drug price transparency. This allows countries to make comparisons when negotiating prices with drug manufacturers. However, easy comparisons are not always possible, and the problem of high drug prices goes far beyond manufacturers.
NHS Launches Digital Home Health Check-Up Trial
The UK’s National Health Service (NHS) is launching a trial to test its new Digital Health Check service for patients with underlying health conditions. The 2,000+ participant trial would provide patients with at-home blood test kits and have them get their blood pressure checked at a nearby pharmacy, reporting that data online to their provider. In doing so, the NHS hopes lower the pressure on clinics while expanding access to preventative care to more patients.
Oura for Business Launched to Monitor Employee Wellness Trends
The makers of the Oura Ring have launched their newest branch, Oura for Business to provide employers with employee sleep and wellness trends from aggregated, anonymized real-world data. The opt-in program will, in essence, create closed data ecosystems at the employer level that could give insights into burnout and general fitness to guide scheduling and fitness programming.
Pharmacy or Medical Benefit? Specialty Pharmacy Weighs In
The reimbursement and dispensing of specialty pharmacy drugs is made complicated by inconsistencies in coverage, wherein different plans will categorize the same treatment as a pharmacy benefit or a medical benefit. This can determine coverage and therefore where patients will go for medications. In a recent article in Pharmacy Times, Bill Bolgar discusses a comprehensive pharmacy services approach that lets specialty pharmacies categorize drugs into medical or pharmacy benefits.
Enzyvant Merges with Altavant to Advance Treatments for Rare Diseases
Enzyvant and Altavant have announced plans for a merger, which will take on the name of the former. The new company will have a facilities to manufacture regenerative medicines for rare diseases, particularly in immunology and cardiopulmonology. The combined Envyzant intends to build on its track record in the rare disease therapeutics space.
FDA Extends Aetion’s COVID-19 Real-World Data Contract
Aetion announced that the US Food and Drug Administration (FDA) has renewed its contract regarding real-world data (RWD) and COVID-19 treatment. As part of the collaboration, Aetion will continue to advance data standardization for RWD sources related to COVID-19. In doing so, the data resources will be evaluated to examine whether data standardization affected RWD sources not originally generated for research.
Researchers Propose Novel Real-World Evidence Observational Study Design to Investigate Surgical Transfusion Complications
Observational evidence suggests that surgical transfusions are associated with increased complication risk, but randomized clinical trials (RCTs) have yet to identify such a phenomenon. In a newly published study in BMC Medical Research Methodology, researchers introduce an observational study design that uses real-world evidence to achieve results that mirror those found in parallel RCTs.
Alzheimer’s Association Launches ALZ-NET Real-World Data Network
The Alzheimer's Association has announced a new collaboration to advance research and care for people living with Alzheimer's disease. The Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) will help researchers collect and analyze real-world data (RWD) that comes from newly FDA-approved Alzheimer's therapeutics. The network will also include resources to promote clinical readiness for new therapies
OMNY Health Scores $17 million Series B Round to Support Real-World Data Offerings
OMNY Health has announced it has been awarded $17 million in a Series B funding round. The company, which equips provider organizations and other healthcare stakeholders with real-world data (RWD) and real-world evidence (RWE), will use the funding to help support the company’s continued growth and RWD/RWE offerings.
New CMS Rule Proposal to Improve Access to Health Information and Streamline Prior Authorization
The US Centers for Medicare & Medicaid Services (CMS) has announced a rule proposal to streamline the prior authorization process and increase access to health information for patients and providers. The rule would require payers to share data with other payers when patients change plans. In addition, it would mandate that payers establish systems and policies that would expedite the prior authorization process.
EMA Emergency Task Force Recommends Bivalent COVID-19 Vaccines for Initial Inoculations
An Emergency Task Force (ETF) of the European Medicines Agency (EMA) has announced that it supports the use of bivalent mRNA COVID-19 vaccines for primary inoculations. The vaccines, which contain mRNA from the original SARS-CoV-2 and the Omicron BA.4/BA.5 strains, were previously only used as boosters for those who have already been vaccinated with one of the original versions of the shots.
More Providers Looking to Bill for Patient Messaging
After a recent health system implemented a plan to bill patients for patient-provider messaging, what was before a free service, some providers and care systems are eyeing similar moves. The Cleveland Clinic started charging patients $50 dollars for messages that require medical expertise. Many patient groups worry that more care providers will adopt the practice, as several already have.
ICER Releases List of Top Drugs with Unsubstantiated Price Hikes in 2021
A new report published by the Institute for Clinical and Economic Review (ICER) lays out a list of the top 10 therapeutics that had unsupported price hikes last year. Among the top ten were several high-price drugs that contributed significantly to US drug spending. Seven of the top 10 list were hiked without any new evidence.
NICE Calls for Real-World Evidence on Parkinson’s Disease Medical Devices
The UK’s National Institute for Health and Care Excellence (NICE) recently recommended that the National Health Service (NHS) collect real-world evidence (RWE) regarding a series of medical devices used in the management of Parkinson’s disease. The devices all serve to record information about the wearer’s Parkinson’s-related motor symptoms.
EMA Leans into Push to Improve Real-World Data Sources for Regulatory Decision-Making
Officials from the European Medicines Agency (EMA) and member state national health technology assessment (HTA) agencies recently announced they were going forward with plans to improve the quality of real-world data (RWD) resources for use in regulatory decision-making. The EMA and HTA bodies established a Big Data Steering Group, which has already endorsed documents that will go through a phase of public consultation.
Using Real-World Evidence Enterprise-Wide
Biopharma companies have turned to real-world evidence (RWE) and the real-world data (RWD) it is generated from to support clinical trials and market access efforts, especially as health technology assessment (HTA) bodies increasingly encourage its use in regulatory decision-making. In a recent article in Deloitte, industry leaders discuss how RWE use has extended enterprise-wide and across all stages of drug life-cycles.
How Will FDA Real-World Data Guidances Affect Patient Advocacy Groups?
With the US Food and Drug Administration’s (FDA) growing focus on the use of real-world data (RWD) and real-world evidence (RWE) in decision-making, patient advocacy groups must adapt to the new regulatory landscape. Fortunately, the guidances contain information to guide advocacy organizations in setting up and managing their patient registries.
Managing the Implementation of Patient-Centered Care
At the recent R&D and Quality Summit, hosted by Veeva Systems, industry experts broke down the moving parts underlying patient-centered care. One requirement is consolidate data sources so that different parties can work together from the same playing field in risk management. In addition, stakeholders must tease out the important variables found in disparate data sources.
Drug Price Reductions for Medicare Patients to Come Next Month
New drug price decreases of the Inflation Reduction Act will go into effect next month. The first drug to be affected by the legislation is insulin, which will be capped at $35 a month for Medicare recipients. In addition, the changes this coming month will remove insulin deductibles. Next July, the cost of insulin pumps will also be capped at $35.
PTC Therapeutics Nets Brazilian Approval for Familial Partial Lipodystrophy Drug
ANVISA, Brazil’s health regulatory body, has approved PTC Therapeutics’ Waylivra for the treatment of family partial lipodystrophy (FPL). The approval marks the first of its kind worldwide for the disease. The drug is already approved in Brazil and the EU for the treatment of patients living with Familial Chylomicronemia Syndrome.
Senate Committee Unveil Draft Legislation to Make Medicare Advantage Directories for Mental Healthcare Accurate
The US Senate Finance Committee has released a draft of new legislation intended to make Medicare Advantage plans update and make available certain information to patients. This information includes provider contact details and availability for new patient intake. In addition, the draft would help target pay parity in mental healthcare.
Discovery CORE Launched by RetinAI to Advance Opthalmology with RWE
RetinAI Medical AG has announced the launch of their Discovery CORE™ software suite. The software uses artificial intelligence (AI) models to help speed retinal fluid and layer segmentation analysis by automatically measuring volumes and layer thickness across large datasets automatically. In addition, it consolidates data into a centralized source.
Engaging Patients and Improving Outcomes through Self-Driven Healthcare
The UK agency Innovate UK established the idea of self-driven healthcare (SDH), a broad term covering strategies to help engage patients in their own healthcare. In a newly published paper in the Journal of the Royal Society of Medicine, authors lay out a framework for SDH that would use digital health technologies like medical devices and apps to deliver healthcare information to patients and their providers.
DARWIN EU Real-World Evidence Studies Begin
The first real-world evidence (RWE) studies have begun in the DARWIN EU initiative of the European Medicines Agency (EMA). The project is a collaboration between the European Commission and the health technology assessment bodies of 27 member countries. Through the project, members hope to support and optimize the use of RWE in regulatory decision-making.
