Addressing the Growing Storage Burden of Life Sciences Data
The use of big data in healthcare and life sciences is contributing to a growing data storage demand that is outstrips the supply of storage media. Without addressing this pressing issue, the depletion of data storage resources could slow research and healthcare IT development. In a recent Pharmaceutical Online article, Thomas Armel, PhD, of EY-Parthenon discusses this problem and ways to address it moving forward.
US Department of Health and Human Services Releases Medicare Hospital Ownership Data
The US Department of Health and Human Services Secretary Xavier Becerra announced that the agency will be releasing ownership data for all hospitals that are Medicare-certified. The data will be available for the public and contains information regarding over 7,000 hospitals. The move is intended to promote transparency and accountability.
US Department of Defense Announces TRICARE Managed Care Contracts Totaling $136 Billion
The US Department of Defense (DoD) has awarded $136 billion in TRICARE managed care support contracts. These T-5 contracts are scheduled to initiate in 2024 and will shift 6 states from the East region to the West Region. The transfer will move around 1.5 million patients, although it is not expected to have a major immediate impact on patients’ existing care plans.
Managed Healthcare Executive: Top Predictions for 2023
As 2023 nears, industry leaders look toward the new year. In a new Managed Healthcare Executive article, industry leaders offer up their top 10 predictions for healthcare in 2023. Brandon Clark, chief strategy officer of Equality Health, says that 2023 is going to be a watershed year for value-based care.
FDA Accelerated Approval Reforms Makes the Cut on US Congress Government Spending Bill
The US Food and Drug Administration (FDA) got a win in the just-passed $1.7 trillion government spending bill. The bill includes provisions that would allow the agency to ask applicants start confirmatory studies before they are granted accelerated approval. In addition, companies receiving accelerated approval would need to provide data from confirmatory studies every six months.
Spanish Agency for Medicines and Health Products Expedites Drug National Code Application Process
The Spanish Agency for Medicines and Health Products (AEMPS) has implemented changes to the application process for national code (NC) of centrally authorized medicinal products. Applicants may now send their NC application once they and the relevant regulatory agencies finalized texts. This and other changes are intended to speed up the application process.
Young Adult Cancer Patients May Have Higher Survival Rates with Medicaid Expansion
A newly published study in the Journal of Clinical Oncology found that a Medicaid expansion could help improve survival rates [...]
ICER Report Suggests Lower Price for Lecanemab Than Aduhelm
The Institute for Clinical and Economic Review (ICER) has issued a report evaluating the value and cost-effectiveness of two amyloid-targeted therapeutics for Alzheimer's disease. Biogen and Eisai’s lecanemab was deemed by the agency to be cost effective if priced between $9,000 and $21,000, whereas Eli Lilly’s donanemab was valued between $14,500 and $46,900, although evidence was limited regarding the latter.
Mark Cuban Plans to Address High US Insulin Prices
Mark Cuban, an American entrepreneur who has advocated for lower drug prices in recent year, is looking to address high insulin prices for US patients. The billionaire intends to offer the life-saving drug for patients with diabetes through his online prescription drug company, the Mark Cuban Cost Plus Drug Co., at rates much lower than the hundreds of dollars per month that many patients pay out of pocket.
ICER Cuts Price Recommendation for Paxlovid
The Institute for Clinical and Economic Review has issued a change to its suggested US price for Paxlovid, Pfizer’s antiviral drug for COVID-19, dropping it to between $563 and $906. The institute formerly recommended a price range of $3,600 to $5,800 for a round of treatment. The change was made based on new evidence regarding the drug’s ability to reduce hospitalizations among more widespread immunity to the virus in the nation.
FDA Updates Real-World Data-Based Medical Device Adverse Event Reporting
The US Food and Drug Administration (FDA) has issued an update to its Exemptions, Variances, and Alternative Forms of Adverse [...]
Unaffordable Medical Expenses Are a Key Social Determinant of Health
Race, ethnicity, socioeconomic status, and geographical location are all widely recognized as primary social determinants of health (SDoH). However, unaffordable medical bills are often overlooked as a critical SDoH. A recently published paper in JAMA Network Open explored this concept and found that ~20% of US households have medical debt.
ICER Releases Evidence Report Reviewing Multiple Sclerosis Therapeutics
The Institute for Clinical and Economic Review (ICER) has released a newly revised evidence report covering several therapies for multiple sclerosis, comparing their clinical efficacy and relative value. The treatments include five monoclonal antibody therapies and eight oral drugs. Although the analysis was unable to differentiate the value of individual monoclonal antibody treatments, they were collectively deemed cost-effective at annual prices ranging from $16,500 to $34,900.
High Deductibles Discourage Follow-Up Testing After Abnormal Mammogram Results
A recent study found that 20% of women who receive abnormal results from a mammogram will not seek additional screening if their deductible is too high. 932 patients who received mammograms at Boston Medical Center were surveyed. The results showed that ~60% of respondents who had to pay a deductible would still go in for testing, while another 20% were undecided. Social determinants of health (SDoH) like low income, Hispanic ethnicity, and uninsured status were associated with decreased follow-up testing
Childhood Cancer Survivors on Public Insurance Face Barriers to Care
A recent study found that childhood cancer survivors face significant barriers of access to care when insured on public plans. The study followed patients who received care for cancer at a pediatric cancer center between the ages of 15-19. The risk of follow-up effects after transitioning to adult care are dependent on a variety of factors, so researchers employed a Transition Readiness Inventory (TRI).
2023: Upcoming Drug Pricing Developments to Look Out For
With the passage of the US Democrats’ Inflation Reduction Act and increased scrutiny over the practices of pharmacy benefit managers (PBMs), 2023 is set to be a year defined by drug pricing for pharma. In a new Law360 article, learn about 5 key upcoming issues related to drug prices to keep an eye on in the upcoming year. One key issue are Medicare price negotiations.
Entering the Dual Eligible Market? 5 Things for Payers to Consider
Changes in the US dual eligible landscape, patients who qualify for both Medicare and Medicaid, have complicated things for payers looking to crack into the market. In a new article on Health Payer Intelligence, Kelsey Waddill discusses 5 important things for payers interested in the dual eligible market to consider beforehand to ensure market success. The first is the increasingly picky dual eligible special need plan enrollment process.
Evaluating Real-World Data: Best Practices
Real-world data (RWD) and the real-world evidence (RWE) generated from it are increasingly being used by biopharma companies for a range of applications. However, the quality of RWD is inconsistent, potentially limiting its utility. In a new Clinical Leader article, RWD experts from Merck lay out best practices when evaluating RWD sources for relevance and quality.
Biopharma CEOs Talk Public Image and Pricing
With criticisms and praises levied at the industry from all sides, biotech companies occupy a precarious place in the public discourse. Leaders in biopharma have to account for this to achieve success moving forward. In a recent Life Science Leader article, three biopharma CEOs were asked about the relationship between the public and their industry.
Market Analysts Eye Rare Disease Drug Development as the FDA Asks for Public Comments on Rare Disease Cures Program
The US Food and Drug Administration (FDA) released a request for public comments last week on its Accelerating Rare Disease Cures Program, signaling growing market interest to Wall Street analysts. The announcement comes as therapeutics for rare diseases account for over half of novel drug approvals in the US. Comments must be submitted to the agency before January 31st, 2023.
Real-World Data Shows Bivalent COVID-19 Boosters Reduce Hospitalizations and Urgent Care Utilization for Older Adults
Two recently published studies have found that inoculation with the new bivalent COVID-19 mRNA boosters by Moderna and Pfizer reduce the rate of hospitalization and urgent care visits. Older adults were particularly protected by the shots, which boasted an efficacy against hospitalization of 83% and 73% compared to unvaccinated older adults and those only receiving two or more doses of the original vaccines, respectively
Real-World Data Study Finds Rise in Mental Health Hospitalization Among Teens in US and France
A newly-published study in JAMA Network Open found that hospitalizations for mental health crises in adolescents spiked during the COVID-19 pandemic. The real-world data (RWD) study examined electronic health records (EHR) from 8 pediatric health centers in the two nations from February 2019 to April 2021, finding that the number of hospitalizations per month rose by 0.60% during the pandemic.
Coalition for Health AI Lays Out Blueprints for Ethical Healthcare AI Usage
The recently launched Coalition for Health AI (CHAI) has released its framework for the ethical use of AI in healthcare and healthcare research. The framework, entitled the Blueprint for Trustworthy AI Implementation Guidance and Assurance for Healthcare, makes the case that the propensity for bias and perpetuation of existing systemic health inequities currently holds back the implementation of AI in healthcare settings.
French Early Access Programme Drugs Experience 16% Price Drop
France initiated its temporary authorization system (ATU) to help expedite access to therapeutics for conditions with limited treatment options. A report by GlobalData found that drugs released under this early access program had price reductions of 16% after negotiations. Half of the drugs investigated were in the oncology field and seven were considered orphan drugs.
Pharma and Payers Gear Up for 2023
Coming off the heels of an upset in the US mid-term elections, drugmakers and payers are preparing for what is set to be a tumultuous upcoming year. A major upcoming event on the minds of stakeholders is the beginning of Medicare negotiations with pharma to lower drug prices, a key provision of the Inflation Reduction Act. This only applies to a few drugs and with Medicare, but some fear it may portend future, more comprehensive legislation.
