The ubiquitous adoption of electronic health records (EHR) has supported the explosion of real-world data (RWD) applications in clinical trials. RWD has the potential to accelerate and optimize clinical trials while expanding their reach. In a new Life Science Leader article, learn more about the […]
Looking at Real-World Data Supporting Durvalumab in NSCLC
In a new Targeted Oncology Case-Based Roundtable, clinicians discussed new real-world data (RWD) supporting the use of durvalumab in unresectable stage III non-small cell lung cancer (NSCLC). The clinicians discussed their use of the immunotherapy, noting that most of them continued the treatment […]
US FDA Fast Tracks Antithrombotic from BMS and J&J
Johnson & Johnson and Bristol Meyer’s Squibb’s (BMS’s) antithrombotic milvexian has been fast tracked by the US Food and Drug Administration for three indications, according to the companies. The drug received the designation for the drug for stroke, atrial fibrillation, and acute coronary […]
US FDA Approves Paxlovid for High-Risk Adults
The US Food and Drug Administration (FDA) approved Pfizer’s Paxlovid for patients at high risk of severe COVID-19 this week. The move is based on a randomized clinical trial that found that unvaccinated patients who had not been infected by COVID-19 before were 86% less likely to be hospitalized if […]
India’s NPPA Cuts Off-Patent Drug Ceiling Prices by Half
The National Pharmaceutical Pricing Authority (NPPA), India’s drug pricing agency, has announced it will cut the ceiling price of off-patent drugs by half to address profiteering in the pharmaceutical industry. The list of drugs covers much of the country’s National List of Essential Medicines […]
US CMS Announces New Strategy to Lower Medicaid Drug Prices
The US Centers for Medicare and Medicaid Services (CMS) has announced a new proposal to help lower prescription drug prices for Medicaid. The rule would establish a survey for drugmakers about drug manufacturing costs and would ensure that Medicaid payments for therapeutics, especially high-price […]
Yuhan Corp. Releases Real-World Data Supporting Leclaza in Lung Cancer
Researchers at Korea’s National Cancer Center have released new real-world data (RWD) supporting the use of Yuhan Corp’s Leclaza (lazertinib) in the treatment of a subset of non-small cell lung cancer (NSCLC). The study, basefd on data from 103 patients who used Leclaza as a […]
CMS Using Real-World Evidence in Medicare Drug Pricing Negotiations
The US Centers for Medicare and Medicaid Services (CMS) noted in a recent guidance that it will consider real-world data (RWD) and real-world evidence (RWE) as part of its upcoming Medicare drug pricing negotiations. However, the pharma industry is still awaiting clear guidance on the process, which […]
US House Members Call on FDA to Address Chemotherapy Shortages
A bipartisan group of US House representatives is calling on the Food and Drug Administration (FDA) to address ongoing shortages of key chemotherapy drugs. In a letter written by Debbie Dingell (D-MI) and Tim Wahlberg (R-MI), lawmakers highlight the current shortages of cisplatin and carboplatin and […]
US FDA Still Mulling Over Sarepta’s Duchenne’s Gene Therapy
The US Food and Drug Administration (FDA) has yet to make a call on Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, although it appears to be leaning towards a limited “yes”. As a result, the agency has pushed back its decision from May 29th to June 22nd. Deliberations will […]
FDA’s CDER Looking Towards Quicker Accelerated Approval Withdrawal Approach
The US Food and Drug Omnibus Reform Act (FDORA) empowered the Center for Drug Evaluation and Research (CDER) with the ability to expedite the withdrawal of drugs that were granted accelerated approval if confirmatory trials are not successful. The new process, which has yet to be rolled out, will be […]
Value in Health Regional Affairs: Developing Generic Drugs for Rare Diseases
Orphan drug development in the US and EU languished for years due to high development costs and low sales until it was bolstered by legislative action. While this has brought powerful therapeutics to patients, these drugs are still prohibitively expensive. In a new Value in Health: Regional Issues […]
US FDA Approves Gene Therapy for “Butterfly Children”
The US Food and Drug Administration (FDA) has approved Krystal Biotech’s Vyjuvek, the first gene therapy for dystrophic epidermolyis bullosa (DEB), a rare disease that leaves affected patients, dubbed “butterfly children” with skin that damages extremely easily and heals poorly. The treatment, which […]
Biden Admin Proposes CMS Rule to Make Drug Manufacturing Costs Transparent
The Biden administration and the Centers for Medicare and Medicaid Services (CMS) have put forward a new rule intended to bolster drug price transparency by highlighting drug manufacturing and transportation costs. This would be performed via a variety of tools, including a drug price verification […]
Orphan Drug Status Plays into Drug Pricing
Orphan drugs, treatments for rare diseases with limited therapeutic options, are usually less profitable for pharma companies due to high development costs and small patient populations. However, orphan drug designation (ODD) offers monetary incentives to companies developing drugs for rare […]
ISPOR Investigates HEOR Research in LMICs with New Report
In a newly released report, ISPOR breaks down the state of health economics and outcomes research (HEOR) in low- and middle-income countries (LMICs). The report, entitled “Advancing HEOR in Low- and Middle-Income Countries” covers the need to better implement HEOR research in LMICs and ways to do so […]
Data Book Podcast: Collecting Better Data on LGBTQ+ Patients to Improve Health Outcomes
LGBTQ+ patients experience significant discrimination in healthcare settings and face disproportionate barriers to care, worsening health outcomes. In the latest episode of the Data Book podcast by Chief Healthcare Executive, C.K. Wang of COTA talks about issues facing LGBTQ+ patients in healthcare […]
Indian Pharma Group Petitions NPPA to Establish Prospective Batch Pricing
When India’s National Pharmaceutical Pricing Authority (NPPA) sets ceiling prices for drugs, pharma companies can be fined if even one pharmacist charges higher. As a result, the Indian Drug Manufacturer’s Association (IDMA), should put in place prospective price batching that would apply the new […]
Transgender Adults Stripped of Transition Care in Florida
Florida governor Ron DeSantis recently signed a bill into law that, at least for now, strips transgender adults of their right to access gender transition care, including all hormones, gender transition appointments, and surgical operations. The law only allows adults to maintain their transition […]
HHS Awards $65 Million in Funding to Fight Maternal Mortality
Despite spending the most on healthcare per capita in the world, the US has much higher maternal mortality rates than other wealthy nations, especially among Black and Indigenous patients. To address this long-standing problem, the US Department of Health and Human Services (HHS) and its Health […]
Only Some US Prescription Drug Prices are 10X Higher than Other Countries
A common talking point in US drug pricing discussions is that US residents pay 10 times as much for prescription medicines than people in other nations. While this is true for many drugs, the picture is more complex. Making such an analysis is complicated by the comparator nations, the drugs […]
Price of Multiple Sclerosis Disease Modifying Therapies Keeps Creeping Up
Disease modifying therapies (DMTs) for multiple sclerosis (MS) have a significant positive impact on patient outcomes but are often expensive. A recent report by GlobalData finds that prices for MS DMTs are on a steady increase, with drugs like Tysabri by biogen or Gilenya by Novartis increasing by […]
Making Narcan OTC Doesn’t Go Far Enough
Earlier this year, the US Food and Drug Administration (FDA) approved over-the-counter (OTC) use of Narcan (naloxone), a drug that rapidly reverses opioid overdoses. However, making the drug available OTC does not eliminate barriers to access to those who want it. One key barrier is price, as it […]
Patients Regularly Switch Between Psoriasis Biologics
A recent real-world data study published in the Journal of Dermatological Treatment finds that patients with psoriasis change up their biologic therapeutics. Claims data from nearly 8,000 patients taken revealed that, on average, 14.4% of patients changed biologics within 12 months of the study’s […]
Older US Adults Skipping Meds Because of Price
A recently published study in JAMA Network OPEN found that at least 20% of adults 65 and up skipped their medication, cut back their dose, or took drugs intended for other patients due to financial reasons in 2022. The figure is a jump from 2016, when one in seven older patients reported skipping […]
Talking 340B with Sara Hearn of RxBenefits
The US 340B program requires drugmakers to provide certain medications at a significant discount to safety-net care centers that provide care for patients in economically disadvantaged areas through Medicaid and Medicare Part B. In a new BenefitsPRO interview with Sarah Hearn of RxBenefits, learn […]
FDA Adcomm Tentatively Recommends Sarepta’s Duchenne Muscular Dystrophy Gene Therapy
An advisory committee for the US Food and Drug Administration (FDA) has voted 8 to 6 to recommend accelerated approval for Sarepta Therapeutics Duchenne muscular dystrophy gene therapy. The narrow vote comes despite concerns from several regulators about the treatment’s benefit-risk profile and data […]
Real-World Evidence Study Finds Lifescan Blood Glucose Meter and App Improves Diabetes Symptoms
Two real-world evidence (RWE) studies published in Diabetes Therapy and Diabetes Technology and Therapeutics found that 2 daily blood glucose measurements with Lifescan’s OneTouch Verio Reflectt® glucose monitoring device and accompanying OneTouch Reveal® app are associated with improved glycemic […]
NICE Recommends Expanding Approval for AstraZeneca’s Heart Failure Med
The UK’s National Institute for Health and Care Excellence (NICE) has recommended that Astrazeneca’s heart failure med Forixga (dapagliflozin) should have its indication expanded to adults regardless of the degree of their left ventricular ejection fraction (LVEF). The drug was previously indicated […]
Real-World Data Backs SPRINT® PNS System for Pain Relief
Real-world data (RWD) published in Pain Physician found that SPR Therapeutics’ percutaneous peripheral nerve stimulation (PNS) device significantly reduced pain in patients. The data, which came from over 6,100 patients, showed that more than 70% of patients saw a 50% or greater reduction in their […]
