Image-guided therapies improve health outcomes for patients, but greater pools of data are needed to support future development. Real-world data (RWD) can be used to provide a wealth of data related to image-guided therapies, supplementing classic randomized clinical trials (RCTs) and improving […]
Amgen Facing Stiff Resistance in US Supreme Court Patent Case
Amgen’s odds with the US Supreme Court are looking grim in its case against Sanofi-Regeneron regarding its “genus patent” over antibody-based PCSK9 inhibitors. Amgen maintains its patent covers a wide group of antibodies for the drug target and should be expanded to cover all possible permutations. […]
The Growing Impact of Health Economics
The field of health economics has existed for decades but has been brought to new prominence with recent policy decisions and the COVID-19 pandemic. In a new Health Tech Zone article, learn about the basics of health economics, how different stakeholders are leveraging it, and the growing impact the […]
Using Z Codes to Turn Social Determinants of Health Insights into Better Healthcare
Research in recent years has identified several non-medical factors that greatly influence health outcomes, referred to as social determinants of health (SDoH). However, health equity gains from these insights are held back, in part, by many providers not using the appropriate Z codes to record and […]
Study Finds Most Employers Provide Multiple Options for Health Insurance Plans
Results from Alight’s 2023 Benefits and Enrollment Trends report show that the vast majority of employers who provide health insurance give employees multiple options for plans. Over 90% offered more than one plan and three-quarters put money into employee health savings accounts for those with […]
NHS England Reveals Plan to Accelerate Diagnosis and Care for Rare Brain Disorders
NHS England has announced it is developing a new service to help fast-track diagnoses and care for people with a set of rare genetic brain diseases called inherited white matter disorders (IWMDs). Patients will be reviewed by a group of specialists and undergo genetic testing, getting […]
US House Energy and Commerce Committee Moves QALY Ban to Full House Vote
The US House Energy and Commerce Committee voted on Friday, March 24th, to advance a bill to a full House vote that would ban the use of quality adjusted life years (QALY) in therapeutic value-assessments. Some representatives argue that the bill is necessary, alleging the metric discriminates […]
US FDA Releases Draft Guidance on Oncology Clinical Trials Seeking Accelerated Approval
In a new draft guidance, the US FDA proposes two strategies to make clinical trials for cancer drugs better support accelerated approval applications for cancer drugs. Such applications are expected to be followed by confirmatory studies that often don’t materialize or yield negative results. The […]
Moving to Eliminate Health Inequities
Despite years of concerted efforts by providers and policy makers, patients from marginalized backgrounds still face significant health disparities. In a new Med Page Today article, Maulik S. Joshi, DrPH, lays out three ways that care systems can enact changes to make health inequity a “never […]
Provider Groups Call on US CMS for Hybrid Payment Model
Almost 30 provider groups have written a letter asking the US Centers for Medicare and Medicaid Services (CMS) to implement a hybrid system that mixes fee-for-service and prospective payments for primary care. According to the letter, doing so would incentivize primary care physicians […]
AMCP 2023 Panel Argues for Patient-Centered Prior Authorization
Prior authorization is a complex, lengthy process that stands between patients and the drugs they need. In a panel at the Academy of Managed Care Pharmacy 2023, Heather Odem, PharmD, of UnitedHealthcare and Richard Ogletree, PharmD, of Alliant Health Solutions spoke about the need to shift measures […]
NICE Recommends Novel Gene Therapy for Rare Genetic Brain Disorder
The UK’s National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending the approval of Upstaza, PTC Therapeutic’s gene therapy for aromatic L-amino acid decarboxylase (AADC) deficiency. The gene therapy, if approved, would cost £3 million and would be the only […]
Patient Advocacy Groups Decry NIH Refusing to Exert March-In Rights for Prostate Cancer Drug Xtandi
Patient advocacy groups are speaking out after the US National Institutes of Health (NIH) decided against exercising march-in rights, which allows the government to share patents developed with public funds, on Pfizer’s and Astella’s prostate drug Xtandi. The move would’ve lowered prices for the […]
India Shoots Down Application for J&J’s Tuberculosis Drug Patent Extension
Johnson & Johnson notched a loss today as India’s patent office refused to extend the patent on bedaquiline, a drug for treatment-resistant tuberculosis. The company was looking to extend the patent to 2027, but the patent office’s refusal means J&J will lose the patent by July, ending the […]
Improving Clinical Trials for Rare Disease Therapeutics
The decades old Orphan Drug Act helped spur a renaissance in rare disease research, incentivizing development therapeutics that may otherwise be deemed unprofitable. However, factors like small, spread-out patient populations and funding considerations make running clinical trials for rare diseases […]
Cidara’s Anti-Fungal Receives Approval with Priority Review from US FDA
Rezzayo, Cidara Therapeutics’ newest anti-fungal drug, has received the nod from the US Food and Drug Administration (FDA) for approval under priority review for two kinds of candida infections, candidemia and invasive candidiasis. The drug is currently being reviewed by the EMA, which has already […]
Real-World Evidence Explores Inpatient and Outpatient Delivery of CAR T-Cell Therapy
Real-world evidence (RWE) presented at the 2023 Transplantation and Cellular Therapy Meeting compared and contrasted outcomes for patients receiving inpatient vs. outpatient CAR T-cell therapy for mantle cell lymphoma (MCL) and follicular lymphoma (FL). Patients with FL fared better with outpatient […]
Rare Skin Cancer Drug by Incyte Receives Accelerated Approval
Incyte notched a win today, March 23rd, with accelerated approval for retifanlimab, its treatment for a rare, aggressive skin cancer called Merkel cell carcinoma. The approval comes after patients single-arm study achieved a 52% response rate, with 18% seeing a complete response. These responses […]
Improving Clinical Trials for Rare Disease Therapeutics
With millions worldwide living with rare diseases that have few or no current therapeutic options, clinical trials are essential in treating the conditions faced by this diverse patient population. However, running these trials are expensive, hard to recruit for, and often require novel trial […]
Biogen’s ALS Drug Receives Unanimous Recommendation Accelerated Approval from FDA Adcomm
Tofersen, Biogen’s ALS Drug, has received a unanimous 9-0 recommendation for accelerated approval by the US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee. The move comes in spite of results from a Phase III trial in which the drug failed to meet its […]
Value-Based Care as a Solution for Healthcare Workforce Shortages
Widespread healthcare workforce shortages and high employer-sponsored health insurance costs are impacting health systems and increasing healthcare costs. One potential solution for this problem is value-based care (VBC), which bases reimbursement on quality of care and patient outcomes. According […]
CMS Approves Coverage for VR Pain Relief Solution
In the first approval of its kind, the US Centers for Medicare and Medicaid Services (CMS) have approved AppliedVR’s RelieVRx immersive virtual reality (VR) platform as a durable medical device. This opens up funding for not only RelieVRx, but also other therapeutic immersive VR programs. With the […]
FTC Says Parkinson’s Drug Patent Fight is Major Case for Patients
A case between Supernus and Sage Chemical over the Parkinson’s disease drug Apokyn has far-reaching implications for patients, according to the US Federal Trade Commission. Sage’s generic version of the drug was approved in 2022, but patients could not access it because approval does not cover the […]
HHS Shoots Down Call to Use March-In Rights for Xtandi
In a win for Pfizer and Astellas, the US Department of Health and Human Services decided against using march-in rights to lower the price of Xtandi, a blockbuster prostate cancer drug. Exercising march-in rights would the government to share patents made using public funds with third-party […]
Questioning the Detrimental Impacts of QALY in Health Policy
While disability advocates and lawmakers have decried the use of quality-adjusted life years (QALY) in recent years, some argue that it is an indispensable measure that is unfairly maligned. For example, patient advocates argue that the focus on quality of life devalues the lives of disabled people […]
Study Offers Recommendations for China’s Biosimilar Regulations
A recently published paper in Frontiers in Pharmacology examines the regulatory framework surrounding biosimilars in China. The researchers noted that the regulatory system is not “clearly formed” and is ill suited to support the nearly 400 biosimilars in development in the country. The paper offers […]
Eisai CEO Not too Worried About Leqembi After CMS Keeps Anti-Amyloid Rule
Eisai’s CEO Ivan Cheung told Fierce Pharma he is not too worried about the long-term success of Leqembi in light of the US Centers for Medicare and Medicaid Services (CMS) declined to change its rule about reimbursement for drugs in its class. The rule states that drugs targeting amyloid, a key […]
Takeda Reveals Pricing for Dengue Vaccine
Fresh off approval of its dengue vaccine in Brazil, Takeda has announced its pricing strategy for the shot. Prices will be determined by endemic status of the disease in a given country. Indonesia, where the virus is endemic, will see the vaccine priced at $40 per dose, while travel markets like […]
Exploring the Systemic Causes of Maternal Mortality in the US
A 2022 report by the US Centers for Disease Control and Prevention (CDC) explored the underlying causes of high maternal mortality in the US. Over 75% of maternal deaths happen after returning from the hospital after delivery and 80% were preventable. A new article in Health Affairs, explains how […]
Ozempic and Mounjaro Back on Shelves
Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, both diabetes drugs used off-label for weight loss, have been on a backlog for months due to an explosion of popularity. According to the US Food and Drug Administration, most doses of the two drugs are back in stock. This excludes the higher doses of […]
