Advancing AI Literacy in Health Sciences
Artificial intelligence (AI) is taking an increasingly prominent role in health sciences, allowing for quicker processing of massive, complex datasets to promote research, business decision-making, and patient health outcomes. However, a lack of understanding of AI hampers these efforts. A new PharmaPhorum article breaks down the role of AI in life sciences.
Insulin Manufacturers and PBMs Sued by State of California in Pricing Practices Dispute
The US state of California has filed suit against three major pharmacy benefit managers (PBMs) and the three largest insulin manufacturers over practices meant to spike the price of insulin. The pharma companies, including Novo Nordisk, Eli Lilly, and Sanofi, are accused of colluding, while the PBMs are accused of designing rebates to encourage manufacturers to raise list prices.
Improving Data Quality to Target Social Determinants of Health
Although increasing efforts have been made to address social determinants of health (SDoH) to improve health equity, poor or inconsistent data sources get in the way of progress. The American Medical Association (AMA) has put forward several initiatives to help address SDoH data standards that encourage interoperability.
HHS to Pick Drugs Subject to Medicare Price Negotiations by September
In an announcement this week, the US Department of Health and Human Services has revealed its schedule for the leadup to Medicare drug price negotiations, as granted by the Inflation Reduction Act. While negotiations don’t commence until 2026, the list of 10 drugs to be negotiated will be released in early September, with a public comment phase this spring.
Value-Based Contracts on the Rise
With the increasing adoption of high-price biologic therapies that offer potential long-term relief for small patient populations, other payment models like value-based contracts are being hotly debated by pharma, providers, and payers. These models account for the long-term benefits of the treatments and whether a given patient actually sees such effects.
CERSI Summit Attendees Discuss Barriers to Wider Real-World Evidence Adoption
At this years’ Innovations in Regulatory Science Summit, hosted by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), speakers talked about the hurdles faced in expanding the use of real-world evidence (RWE) and real-world data (RWD). Jeff Shuren of the FDA noted that collecting clinical evidence that meets regulatory standards will require a concerted effort by his and other federal agencies
North Carolina May See Last Medicaid Expansion in Some Time
The US state of North Carolina will soon vote on whether to expand Medicaid coverage within the state, thereby potentially leaving the ranks of states that have not expanded Medicaid to 10. Republican opposition to the expansion has shifted in the state legislature, with some top former opponents flipping sides.
A Slate of 10 Humira Biosimilars to Hit US Market in 2023
Abbvie’s 20-year competition-free history is set to end in 2023, with as many as 10 biosimilars for its notoriously expensive [...]
Real-World Data Study Finds Black and Hispanic Patients Receive Less Opioids During End-of-Life Care
A recently published study in the Journal of Clinical Oncology found that Black and Hispanic patients with cancer were significantly less likely to receive opioids during end-of-life care. In addition, the results, which came from nearly 320,000 Medicare patients 65 and older, also showed that Black and Hispanic patients were more likely to be urine screened for drug use.
APAC Therapeutic Access and Financing Trends to Watch in 2023
The market access and reimbursement landscape in APAC is set to shift in 2023, according to a new interview with Jeff Weisel, APAC managing director for PRMA Consulting. Weisel notes that global economic forces will play a significant role in payer decision-making in APAC, with inflation and the strengthening dollar being counterbalanced by the availability of biosimilars.
New Digital Health Solution by Molecular You Uses Blood Test to Recommend Interventions that Improve Outcomes in 100 Days
Molecular You has released a new digital health solution that generates actionable interventions based on the results of a blood test. The company’s recent real-world data (RWD) pilot study found that patients acting on these interventions had risk reductions of 50% in health metrics associated with cardiovascular health, diabetes, and cognitive function after 100 days of use.
Real-World Data Shows Bivalent Omicron COVID-19 Booster Reduces Hospitalization in Older Adults
Newly published research in Lancet finds that the bivalent Omicron COVID-19 booster shots substantially reduced hospitalization rates in people over the ages of 65. The study, which used real-world data of 85,000 older adults taking the Pfizer bivalent booster, showed that older adults taking it were 81% less likely to get hospitalized. The study showed it also decreased death rates.
Drug Pricing in 2023 – Five Key Issues to Look Out For
As the pharma industry leaves a tumultuous 2022 in terms of drug pricing, 2023 does not seem any less turbulent. Congress and the US Federal Trade Commission (FTC) are zeroing in on pharmacy benefit managers (PBM) while pharma prepares their legal rebuttals to the drug pricing reform included in the Inflation Reduction Act. In a new article by White and Case, learn about the 5 drug pricing trends you need to watch in this new year.
Biosimilar Uptake on the Rise in Europe
A newly released report by IQVIA finds that the uptake of biosimilars is growing in 23 European countries. Spending on biologics grew in the past year, accounting for 35% of total drug spending. Biosimilars now directly compete with 18 original biologics in the region, with nearly 4 copycats per compound on average. However, this doesn’t mean that all patients are seeing the immediate benefits of said competition.
India’s NPPA Finalizes Price Caps on 128 Formulations
India’s National Pharmaceutical Pricing Authority has announced final price caps for 2023, affecting some 128 formulations. The list includes new ceiling prices for 97 formulations and revised prices for an additional 31. Included on the list are treatments for conditions like seizures, intestinal swelling, heart disease, HIV/AIDS, and more.
Moderna Eyes ~$120 COVID-19 Vaccine Price Tag
Moderna is looking to price its mRNA COVID-19 vaccine between $110 and $130 per shot, according Moderna CEO Stephane Bancel in an interview on Monday. The US government currently pays a discounted price of $26 per dose, but as the contract and the public health emergency comes to an end, most vaccine manufacturers are gearing up for price hikes.
Paxlovid Not on China’s Reimbursement List
As the nation phases out its zero-COVID strategy following major protests, China’s National Healthcare Security Administration has left Pfizer’s Paxlovid off its reimbursement list. This comes as cases spike in the nation, with many patients purchasing the drug off the internet through India. However, other COVID drugs did make the cut.
High Price of New Alzheimer’s Drug May Reduce Patient Access
With the successful accelerated US approval of lecanemab, Eisei and Biogen’s new Alzheimer’s drug, some worry the drug’s high price will limit access to many patients. The Institute for Clinical and Economic Review (ICER) estimated the drug’s value somewhere between $8,500 and $28,000 per biweekly treatment, well below the manufacturers’ estimated price of $26,000. Some worry it will go the way of the ill-fated Aduhelm.
FDA Makes Abortion Pill More Accessible Nationwide
In response to crackdowns on abortion rights in the US after Roe v. Wade was overturned, the Food and Drug Administration has changed risk evaluation and mitigation strategy (REMS) policies regarding Mifeprex, an abortion pill, that will increase patient access. The drug was formerly only available at registered clinics, but can now be dispensed at a pharmacy or by mail. It still requires a prescription, however, a potential barrier in many states.
Chiesi Acquires Amryt Pharma in $1.48B Deal to Broaden Rare Disease Efforts
Chiesi Farmaceutici S.p.A and Amyryr Pharma Plc have announced a new deal wherein the former will acquire the latter in an all-cash transaction topping $1.48 billion. The deal would provide Chiesi access to Amryt’s drug pipeline, with a focus on broadening its efforts in therapeutic development for treatments for rare diseases.
Patients Face Disparities in Access to Health Information
Although patients have the right to access their health-related information, many do not or are unable to take advantage of this resource. Health IT solutions have been developed to streamline these processes, but disparities still remain. Many patients are unaware of how to access their healthcare portal because their provider did not inform them of it, in particular, Black and Hispanic patients.
Interview with Patina CEO Jack Stoddard About AI in Healthcare
Forbes writer Arun Shastri recently sat down with Jack Stoddard, CEO of the healthcare AI company Patina. In the interview, the two discussed the state of AI in healthcare and how Patina leverages the technology to improve the health outcomes of older adults. He argues that the current system does not take older patients’ unique needs into account, especially in primary care.
Indian Pharma Industry Growth May Hit Drug Pricing and Regulatory Overhang Roadblocks
A report covered in Express Pharma predicts that growth in the Indian pharma market may be capped just shy of last year’s numbers. In its prediction, the report notes this may occur in response to pricing negotiations, ongoing supply chain disruptions, inflation, and regulatory pressure. However, the report is overall neutral-to-positive for the industry
Zack Scott of Norwest Venture Partners Talks Digital Health and Real-World Evidence
In a new Digital Health Business and Technology interview, Dr. Zack Scott of Norwest Venture Partners discusses digital health technologies, [...]
CMS Lets States Cover Nonmedical Services for Medicaid Beneficiaries
Social determinants of health (SDoH) like housing instability and food insecurity dramatically impact patient health outcomes. To address these factors, the US Centers for Medicare and Medicaid Services (CMS) has issued a new guidance that allows states to offer benefits for nonmedical services, under the classification of “in lieu of services and settings.”
