Real-World Data Study Examines the Past Decade of Biomarker Testing for Lung Cancer
A real-world data study presented at this year’s ISPOR meeting showed that biomarker testing for early-stage non-small cell lung cancer (NSCLC) increased steadily over the past ten years. Data from over one thousand patients with early-stage NSCLC from 2011 to 2021, finding that 74.1% of patients had biomarker testing performed within the first six months after being diagnosed with the disease.
Challenges Bringing Drugs to All EU Member States Worry Pharma
As the European Commission prepares for a major revamp to drug legislation, pharma executives and thought leaders worry that even with the new laws, rolling out new drugs to all 27 member states in a short timeframe will be a difficult task to achieve. The proposed law would offer pharma companies an additional years of data protection if new drugs reach all EU markets within 2-3 years of launch, which will be complicated if reimbursement decisions must be made in that period.
WHO: The COVID-19 Pandemic Is Over
The World Health Organization (WHO) has announced the end of the COVID-19 public health emergency (PHE). The move comes after reported deaths and hospitalizations for the disease have plummeted in recent months. PHE status as declared by the WHO won’t immediately rescind healthcare policy changes in all nations, but countries are already set to end their own PHEs, triggering massive changes to Medicare enrollment in the US.
FDA On the Fence About OTC Birth Control
The US Food and Drug Administration (FDA) recently met to discuss whether to approve Opill, Perrigo’s hormonal contraceptive, for over-the-counter (OTC) use. Although reproductive rights advocates contend that the move would expand access to contraceptives to people who don’t have a primary care clinician, some religious advocates and committee members argued against it.
Real-World Data Study Investigates HER2-Low Vs HER2-Zero Triple-Negative Breast Cancer
A newly published real-world data (RWD) study in Breast Cancer: Targets and Therapy takes a look at the clinical factors and sociodemographics of patients with HER2-low and HER2-zero triple-negative breast cancer at the Brazilian National Cancer Institute. Analysis shows that that there were no significant differences between the two groups in terms of sociodemographic traits, survival outcomes, and clinical behavior.
Addressing Asthma Care Gaps with Patient Assistance Programs
The majority of Americans living with asthma sit firmly in the poverty range, making it difficult or impossible to get lifesaving care. Fortunately, nonprofit patient assistance programs (PAP) are stepping up, connecting uninsured or underinsured low-income patients access asthma care. However, the programs don’t just offer care, according to Accessia Health CEO Gwen Cooper.
The CARE Act Is Improving Patient Health Outcomes
A total of 42 states have adopted laws called the Caregiver Advise, Record, and Enable (CARE) Act, which promotes increased clinician communication with patients and caregivers during care delivery and at the point of discharge from care centers. A newly published paper in JAMA Network Open finds that these policies are having positive real-world impacts on patient health outcomes.
CMS Issues Final Rule on Medicare Advantage Prior Authorization Requirements
The US Centers for Medicare and Medicaid Services (CMS) has issued its final rule on prior authorization requirements for Medicare Advantage (MA) plans. The rule changes ensure that prior authorization approvals last as long as medically necessary, that plans must only use prior authorization policies to check diagnoses, and that plans must give beneficiaries a 90-day transition period when changing plans.
India Negotiating Generic Export Prices with UAE
The Indian government is currently negotiating drug external reference pricing (ERP) with the United Arab Emirates (UAE). To cap drug prices, the UAE uses an ERP based primarily on wealthy European nations and the US. Officials contend that this practice and vaccine import rules that exclude Indian generics barriers to exporting generics and vaccines.
Advisory Committee Changes May Be on the Horizon for Orphan Drug Approval
The US Food and Drug Administration (FDA) relies on recommendations from its several advisory committees when weighing whether to approve a drug. However, Congress is placing extra scrutiny on the composition of these committees when debating orphan drugs, as laid out in an explanatory statement in the 2023 FY Consolidated Appropriations Act. Currently, they are expected to be populated with experts in the general field, but there is no provision to make sure rare disease experts are on the panel.
Lung Cancer Detection AI Accurately Identifies Pre-Cancerous Growths
An artificial intelligence (AI) model developed by UK researchers identified abnormal lung growths that would later become cancerous with a high degree of accuracy. The AI model was developed in the LIBRA study using lung imaging data from 500 patients with large abonormal lung nodules. 82% of the tumors the AI model identified as high-risk were later found to be cancerous.
Responding to Next Public Health Emergency With Real-World Data
The COVID-19 pandemic spurred a sea change in the real-world data (RWD) landscape, bolstering its utilization and recognition. Eventually, another public health crisis will emerge, and by continuing to support the development of RWD resources and utilization, we can rise to the challenge even more quickly. Learn more about how The MITRE Corporation helped during the pandemic and how it is planning for the next public health emergency.
How to Overcome Challenges When Backing Regulatory Submissions with Real-World Data
Clinical developers and regulatory approval agencies are increasingly relying on real-world data (RWD) and the real-world evidence (RWE) generated from it in decision-making. However, clinical research organizations (CROs) often run into significant pitfalls when using RWD, complicating the process and driving up expenses. In a new Applied Clinical Trials article, learn what these challenges are and how to overcome them.
FDA Approves First Ever RSV Vaccine by GSK
For the first time ever, a vaccine for respiratory syncytial virus (RSV) has been approved by the US Food and Drug Administration (FDA). GSK’s vaccine, named Arexvy, is now approved for adults over 60 years of age based on strong data showing it reduced infections and severe cases of the disease. The move comes as an RSV candidate from Pfizer faces an imminent decision.
Inspire RWE Launched to Empower Patient-Centered Healthcare Research
Inspire has launched its new real-world evidence (RWE) platform Inspire RWE. The platform provides research organizations with a large pool of patient-reported real-world data (RWD) and powerful analytical tools to drive evidence generation that focuses on patients and their healthcare experiences to advance patient-centered care.
FDA Guidance on RWD and Externally Controlled Trials Leaves Stakeholders Confused
A recent draft guidance by the US Food and Drug Administration (FDA) on the use of real-world data (RWD) and externally controlled trials has many stakeholders asking for further clarification on several key points. In particular, many left public comments asking for specific examples of how handle issues when using real-world evidence (RWE).
Flatiron Showcases Oncology Real-World Data at ISPOR 2023
Experts from Flatiron Health will share the latest in oncology real-world data (RWD) research at this year’s ISPOR 2023 Conference in 10 presentations and 6 posters. The presenters will discuss how RWD and real-world evidence (RWE) are changing the oncology landscape. One poster presentation will show how characteristics of different practices affects multiple myeloma outfcomes, while the other investigates the effects of racism on metastatic breast cancer patient outcomes.
The End of the COVID-19 PHE Draws Near
The COVID-19 public health emergency (PHE) is set to expire in the US next week, leaving much up in the air. The pandemic-era pause on Medicare redeterminations will hit patients soon, kicking millions off of healthcare coverage. In addition, vaccines and treatments for COVID will hit the private market, although uninsured Americans will still have access to the drugs free of charge.
PRMA Launches MALCOM HEOR and Market Access E-Learning Platform
Health economics and outcomes research (HEOR) and market access experts require in-depth knowledge and a finger on the pulse of the latest trends to keep up in this constantly shifting field. To this goal, PRMA Consulting has launched the Market Access Learning Compendium (MALCOM), an e-learning platform packed with educational resources that cover all aspects of HEOR and market access, from core concepts to industry-shaping current events.
Negative Makena Confirmatory Data Didn’t Affect Reimbursement
Negative confirmatory data for the preterm birth drug Makena did not affect payers’ decisions to reimburse the drug, according to an analysis published in Health Affairs Forefront. The drug was granted accelerated approval by the US Food and Drug Administration (FDA) back in 2011 based on a small sample size. It was then recommended to be pulled from the market last October by the FDA Center for Drug Evaluation and Research advisory committee based on larger pools of post-market data showing no reduction in pre-term births. The agency finalized Makena’s approval withdrawal in early April this year.
US Inflation Reduction Act Places More Financial Liability on Insurers and Drugmakers
Speakers at a panel at the 2023 Specialty Pharmacy Summit in Las Vegas, Nevada discussed how provisions in the Inflation Reduction Act, passed in the US last year, would pass more liability onto drugmakers and payers. One reason for this are inflation-based rebates that drugmakers must pay if they raise the price of drugs higher than inflation for Medicare Part B and D plans.
US PBM Bill Markup Hearing Postponed Until May 11th
US Senators were geared up for a hearing to markup a bill targeting practices of the pharmacy benefit manager (PBM) industry that are alleged to be anticompetitive and drive up drug prices. However, this meeting has been delayed until May 11th so that the markup can occur after a May 10th hearing featuring testimony from major pharma and PBM leaders.
External Reference Pricing Doesn’t Lower High Drug Launch Prices
A recently published paper in Health Policy OPEN finds that external reference pricing (ERP) policies don’t result in lower drug launch prices. The study, which investigated 100 high-priced drugs, also reported that ERP policies slowed the launch of new drugs, lowering the odds of them hitting the market within 9 months of approval by 73%. ERP policies were, however, associated with decreases in annual cost.
Biogen’s ALS Drug Qalsody Price Tag Set at Over $14,000
Biogen has announced that its new amyotrophic lateral sclerosis (ALS) drug Qalsody will launch with a list price of $14,230 per dose. The drug was just granted accelerated approval by the US Food and Drug Administration (FDA) based on data showing that it reduced levels of neurofilament, a hallmark of the drug that drives disease pathology.
New Real-World Data Supports Genentech’s Faricimab for DME
At this year’s annual ARVO conference, Genentech’s David Tabano, PhD, discussed new real-world data supporting the use of the company’s faricimab in the treatment of diabetic macular edema (DME), a progressive vision disorder affecting patients with diabetes. The data shows that patients taking faricimab maintained their vision over a 6 month period with 4 injections of the drug.
