McKesson Reaches $141 Million Settlement with Shareholders in Generic Price Fixing Lawsuit
McKesson Corp. has indicated it reached a settlement with shareholders to the tune of $141 million in a lawsuit over price fixing claims regarding generic medications. The plaintiffs argued that the company lied when it said that it was raising prices due to supply disruptions, instead doing so for anti-competitive reasons.
Atropos and Syntegra Team Up to Bring Synthetic Data to Real-World Evidence Offerings
Atropos will work synthetic data into their offerings with their newly announced partnership with Syntegra. The pool of synthetic data, generated by Syntegra using real datasets and machine learning techniques, will supplement the real-world evidence (RWE) in Atropos Health’s Green Button Informatics Consult and Evidence Platform. Synthetic data helps by covering gaps in information with data free from privacy concerns.
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.
US Could Save Nearly $4 Trillion by Addressing Health Equity
New data released by the Partnership to Fight Chronic Disease (PFCD) shows that the US could save $3.8 trillion by addressing health equity in people with chronic health issues. On a more granular level, the study found that the nation would cut healthcare costs by $2.7 trillion and recoup another $1.1 due to lost work hours in 10 years.
Verge Genomic’s AI-Designed ALS Drug Hits the Clinic for Testing
Verge Genomics has announced that the first patient in a phase I clinical trial has taken the company’s experimental small molecule drug VRG50635 for amyotrophic lateral sclerosis (ALS). The drug is the first for the company, as its early development was primarily performed using its ConVERGE artificial intelligence (AI) platform.
Alkermes Eyes Gains with Oncology Spinoff Thanks to Inflation Reduction Act
The Irish biotech Alkermes announced it will spin out its oncology division as it pivots to biologics development. The move is one made by several pharma and biotech giants in recent weeks due to rules surrounding price capping. While small molecule drugs can be negotiated by Medicare after 9 years on the market, the wait period for biologics is 13 years.
Indian Pharma Industry Fares Well Amid Inflation and Pricing Concerns
An ICRA analysis of 16 leading Indian pharma companies finds the industry doing well in spite of concerns regarding inflation and drug pricing. The selected companies reported an average revenue growth of 4.9%, driven in part by market growth in the US and abroad. However, the report also noted a reduction in the European market.
Advancing Disability Research via Harmonized Data
Recent efforts to advance disability research, healthcare, and policymaking have been held back by a lack of large, high-quality sources of real-world data (RWD) regarding disabled people. In a newly published article in Health Affairs, authors discuss how harmonizing disability-related RWD sources could help address this pressing issue.
ICER Publishes Revised Hemophilia Gene Therapy Evidence Report
A revised evidence report has been published by the Institute for Clinical and Economic Review (ICER) detailing the effectiveness and value of two gene therapies for hemophilia A and B. The gene therapies offer nearly complete remission of bleeds for a period of time without the need for prophylactic factor replacement.
Supporting the Social Determinants of Health Infrastructure with Federal Funding
The growing public focus on social determinants of health (SDoH) spurred by the COVID-19 pandemic has outstripped the infrastructure in place to address issues of health equity. According to several stakeholders, increased federal funding is key to advancing these goals and developing a tech infrastructure that can support SDoH-related efforts
Norstella and Citeline Announce Complete Merger
Norstella, a biotech that provides end-to-end services for therapeutic development has merged with Citeline, a leader in pharma intelligence. The acquisition brings the value of Norstella up to $5 billion, ranking among the largest in the industry. Norstella will use Citeline’s range of services and assets to help improve the company’s drug development support services.
Improving Cancer Outcomes with Value-Based Care and Reimbursement
At last month’s Community Oncology Alliance Payer Exchange Summit, a panel of speakers discussed how improving cancer outcomes and spending through value-based care and reimbursement requires a plethora of different strategies. The panel, entitled “New Strategies for Insurance Benefit Designs: From the Simple to the Complex,” noted that a one-size-fits-all approach can leave smaller practices behind.
Eli Lilly and US HHS at Odds Over 340B Program in Federal Court
The US Department of Health and Human Services (HHS) and Eli Lilly butted heads in a recent federal appeals court hearing over the agency’s 340B drug discount program, which requires that drugmakers give discounts on certain drugs to pharmacies that serve underprivileged communities. Lilly has refused to sell discounted drugs to several pharmacies that have contracts with the 340B program. The pharma giant, which has reported record profits in recent years, says that the law doesn’t require them to serve all such pharmacies.
Epic’s Johnston Thayer Discusses New Real-World Data Platform
Epic’s director of clinical informatics and population health Johnston Thayer, MBA, RN, sat down with Healthcare Innovation to talk about the company’s new real-world data (RWD) tool. Best Care, as the platform is called, will pull data from Epic’s large electronic health record (EHR) database to help clinicians make healthcare decisions.
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.
OptumRX Settles Ohio Lawsuit for $15 Million
OptumRX has reached a settlement with the US state of Ohio to the tune of $15 million. The suit centered around claims the pharmacy benefit manager (PBM) giant was over-billing the state’s Bureau of Workers’ Compensation. Andrew Krejci, a spokesperson for OptumRX, initially argued that negotiations were ongoing after the settlement was announced by Ohio Attorney General Dave Yost.
UICC and WHO to Negotiate Prices for Cancer Generics and Biosimilars
Cancer drug price negotiations with the World Health Organization (WHO) and the Union for International Cancer Control (UICC) will center around biosimilars and generics. The goal is to increase access to life-saving medications for people living in low and low-middle income countries (LMICs). Negotiations will begin with drugs on the WHO’s Essential Medicines List.
Efficacy of Combination Therapy for Metastatic Breast Cancer Confirmed in Real-World Data Study
A new real-world data (RWD) study published in NPJ Breast Cancer has found that a combination therapy for a form of metastatic breast cancer (MBC) is more effective than monotherapy. The study investigated the use of palbociclib and an aromatase inhibitor (AI), comparing it to AI monotherapy. Data came from 2,888 patients in the Flatiron Health Analytic Database.
Call for Nominations: STAT Madness 2023
STAT has opened nominations for its 2023 STAT Madness competition. Every year for the past seven years, STAT has invited readers to nominate research leaders who are advancing biomedical innovation. Select a research team who published novel research in 2022 and nominate them by January 17th, 2023. The competition begins March 1st, 2023.
Group Practices Rate Prior Authorization as Worst Regulatory Burden
The 2022 Annual Regulatory Burden Report by MGMA found that prior authorizations were the largest source of regulatory headaches for executives of group practices. Almost 82% of respondents stated that prior authorizations exacted a high burden on their practices and 89% said that their regulatory burden increased from the previous year. However, this is not the only pressing issue on respondents’ minds.
Real-World Evidence-Based Regulatory Decision-Making Requires Collaboration
Advancing remote patient monitoring depends on the use of connected medical devices that generate large amounts of real-world data (RWD). To leverage these resources to generate usable real-world evidence (RWE), manufactures must work with firms specializing in digital health infrastructure, according to a new MedCityNews article. The RWE gleaned from these devices can be used to validate or expand their approved uses.
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).
New Real-World Data Program for Personalized Oncology Care Revealed by Tempus
The artificial intelligence (AI) company Tempus has announced its new precision medicine oncology real-world data (RWD) platform Tempus+. The program is a collaboration between several cancer centers across the US. Over five million electronic health records (EHR) will be organized and made available to researchers through Tempus’ existing Lens software platform.
Alnylam Blames New US Drug Pricing Laws for Shelving of Rare Eye Disease Therapeutic
Alnylam is setting aside a clinical trial of its therapeutic Vutrisiran for a rare eye disease due to the looming US drug pricing reforms, according to the company. The RNA-based treatment for Stargardt disease is currently used in another rare disease but would not face Medicare pricing negotiations because the law only targets newly approved drugs. Approval of the treatment for Stargardt would allow the government to negotiate the price of Vutrisiran for that indication.
AJMC “What We’re Reading” – Uninsured Children, HIV and Monkeypox, and Health Outcomes by US State
In the latest edition of “What We’re Reading,” the AJMC staff cover several breaking stories. A recent study found that people living in conservative US states have lower life expectancies than more liberal ones. The researchers’ anaysis shows that over 170,000 lives could be saved if certain liberal policies were enacted nationwide. In other news, new data shows a striking comorbidity between monkeypox and HIV.
