STAT News: 8 Points to Note About Aduhelm Congressional Investigation
With the release of the US congressional report about the US Food and Drug Administration’s approval of Biogen’s ill-fated Alzheimer's drug Aduhelm, STAT News has published and article detailing 8 points to keep in mind going forward. The first is that the agency’s officials didn’t document communications with the manufacturer as required.
ICER Report Suggests Lower Price for Lecanemab Than Aduhelm
The Institute for Clinical and Economic Review (ICER) has issued a report evaluating the value and cost-effectiveness of two amyloid-targeted therapeutics for Alzheimer's disease. Biogen and Eisai’s lecanemab was deemed by the agency to be cost effective if priced between $9,000 and $21,000, whereas Eli Lilly’s donanemab was valued between $14,500 and $46,900, although evidence was limited regarding the latter.
ICER Releases Evidence Report Reviewing Multiple Sclerosis Therapeutics
The Institute for Clinical and Economic Review (ICER) has released a newly revised evidence report covering several therapies for multiple sclerosis, comparing their clinical efficacy and relative value. The treatments include five monoclonal antibody therapies and eight oral drugs. Although the analysis was unable to differentiate the value of individual monoclonal antibody treatments, they were collectively deemed cost-effective at annual prices ranging from $16,500 to $34,900.
Coalition for Health AI Lays Out Blueprints for Ethical Healthcare AI Usage
The recently launched Coalition for Health AI (CHAI) has released its framework for the ethical use of AI in healthcare and healthcare research. The framework, entitled the Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare, makes the case that the propensity for bias and perpetuation of existing systemic health inequities currently holds back the implementation of AI in healthcare settings.
Pharma and Payers Gear Up for 2023
Coming off the heels of an upset in the US mid-term elections, drugmakers and payers are preparing for what is set to be a tumultuous upcoming year. A major upcoming event on the minds of stakeholders is the beginning of Medicare negotiations with pharma to lower drug prices, a key provision of the Inflation Reduction Act. This only applies to a few drugs and with Medicare, but some fear it may portend future, more comprehensive legislation.
EMA and ECDC Collaborate on Vaccine Real-World Evidence Generation Efforts
Officials from the European Centre for Disease Prevention and Control (ECDC) and European Medicines Agency met earlier this month to begin a new collaboration intended to boost real-world evidence (RWE) generation for vaccine safety and efficacy trials. The collaboration, the Vaccine Monitoring Platform (VMP), will work to develop an RWE infrastructure for vaccines in the EU without outside industry funding.
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.
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.
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.
Pharma Skeptical of US FDA Plan for OTC Indications of Prescription Drugs
A group of pharma industry organizations have banded together and leveled their complaints and concerns at the US Food and Drug Administration’s recent plans to make a pathway for prescription drugs to receive over-the-counter (OTC) status for certain indications. A key sticking point was that insurers are likely to end coverage of prescriptions of these medications, complicating patient access and drugmakers’ earnings.
Achieving Better Health Outcomes with AI-Based Data Analytics – Interview with Richard Gliklich of OM1
Robert Gliklich, CEO and founder of OM1, recently sat down with Forbes to discuss how launched his company, which uses real-world data (RWD), big data analytics, and artificial intelligence (AI). Gliklich developed his interest in RWD and AI after his first major acquisition as a venture capitalist, noting that there was a wealth of data held by specialists that could be used to advance care for those with chronic conditions.
Canada and Australia to be Added to South Korea’s Drug Pricing Reference Countries
In a new announcement by the South Korean government, Canada and Australia will be added to the nation’s list of countries it uses as references for drug pricing purposes. Previously, the group of countries used for price-setting includes seven nations. The addition puts Canada and Australia into the cluster, which includes the UK, Germany, Japan, France, Italy, the US, and Switzerland
The Latest Shifts in the FDA Accelerated Approval Pathway
The US Food and Drug Administration (FDA) is actively retooling its accelerated approval pathway, with or without actions by Congress. GSK announced yesterday, November 22nd, that the agency asked it to pull a multiple myeloma drug based on negative post-confirmatory trial data. Unlike previous situations of the sort, the agency moved in just over two weeks.
WHO Draft Pandemic Rules Could Make Pharma Disclose Prices
New draft rules by the World Health Organization (WHO) may force pharma companies to reveal the prices of any drugs under public procurement contracts. This comes after criticism of the industry over a lack of pricing transparency regarding therapeutics like vaccines during the COVID-19 pandemic.
Real-World Evidence Studies Show Efficacy of COVID-19 Therapeutics
Two new real-world evidence studies exploring the efficacy of two treatments for COVID-19 have been published in the British Medical Journal (BMJ). The first study investigated real-world data (RWD) from fully vaccinated high-risk adult patients in England. Those taking sotrovimab had better COVID-19 outcomes than people taking molnupiravir, most notably a 46% reduction in severe COVID-19.
Study Highlights Barriers to Care for Disabled People in US Healthcare System
A newly published study in Health Affairs further characterizes significant physical and structural barriers to care. The survey found that many physicians felt uncomfortable taking on disabled patients, often denying care. Furthermore, many care delivery locations are not ADA compliant and inaccessible to some disabled people.
Study Finds Racial Health Disparities Negatively Impacted by Medicaid and Medicare DSH Payment Model
A recently published article in JAMA Network Open found that structural problems in Medicaid and Medicare DSH payment programs hurt the marginalized, low-income populations they are meant to benefit. Data was gathered from DSH programs in largely majority Black counties in all US states except Massachusetts. The results showed that payment models based on healthcare utilization underpay majority Black counties due to barriers of access to care.
New Data Reveals Burden of Oral Disease on Managed Care Plans
New research in Managed Care shows the burden of oral disease on managed care plans. The researchers looked at data from the IBM Watson Medicaid Marketscan data base, the IBM Dental Database, and the Medical Expenditure Panel Survey to ascertain the burden on Medicaid and commercial plans separately.
FDA Officials Point Out Interchangeability Essential to Biosimilar Competition
Despite a range of biosimilars entering the market, their ability to lower drug spending for patients is dependent on payer reimbursement, which is inconsistent and based on approved uses. According to FDA officials, one avenue to ease these issues is with interchangeables, drugs that can be substituted without a doctor’s permission. However, only a few of these drugs have been approved for interchangeable use. The market landscape is shaky, even for approved interchangeables like Semglee by Viatris, an insulin biosimilar.
Drug Pricing Reform on the Back Burner in Ramp-Up to US Mid-Term Elections
Although healthcare is front and center on tomorrow’s ballot in terms of abortion and Medicare, drug pricing reform has not been a key talking point in the lead-up to the US mid-term elections. This is in spite of the Democrats’ recent legislative win with the Inflation Reduction Act, which included major drug pricing reform. However, some Republicans hope to completely or partially repeal the act, including popular portions like price capping prescription costs for older adults.
Using Value-Based Payment to Support Health Equity Starts at Model Design
Although value-based payment (VBP) models offer the opportunity to advance health equity goals, doing so requires an intentional, carefully considered approach. Health equity must be centered in payment model design, according to newly published Health Affairs article in a recent series on VBPs. Patient attribution methods are critical but often overlooked.
FDA Panel Discusses Real-World Evidence Confirming Pulse Oximeters Inaccurate for People with Darker Skin Tones
The US Food and Drug Administration held a panel this week discussing “mounting real-world evidence” (RWE) that pulse oximeters do not work as well on people with darker skin tones. The topic, long discussed and highlighted by communities of color and patient advocacy groups, came to a head during the COVID-19 pandemic wherein inaccurate readings caused worse health outcomes among Black patients in the US.
San Diego Non-Profit and Managed Care Company Brings Free Healthcare to Unhoused People
A non-profit team of clinicians is providing comprehensive care to San Diego’s unhoused population in a partnership with Medi-Cal, a medical provider for low-income people in California, and Molina Healthcare of California, a managed care company. The team, called Healthcare in Action, is comprised of five clinicians who work five days a week to give unhoused people care for chronic conditions and, critically, mental illnesses.
ISPOR Releases Guidance on Reproducibility of Real-World Evidence Research
ISPOR has published a news guidance on using real-world evidence to determine efficacy and make healthcare decisions. The guidance puts forward a framework to address issues of data provenance, utilization, and analysis for researchers to follow in order to ensure reproducibility. This framework was designed in collaboration with the International Society for Pharmacoepidemiology (ISPE).
FDA Issues Final Guidance on Clinical Trials with Multiple Endpoints
Last week, the US Food and Drug Administration (FDA) released its final guidance on multiple endpoints in clinical trials. The goal of the guidance is to provide standardized strategies for clinical trials with multiple endpoints to avoid ambiguity in study findings that might have bearing on the regulatory approval process and patient outcomes.
