Enacting value-based care payment models has been a priority of payer and provider organizations in recent years, but the implementation has been uneven, with care centers serving underprivileged or vulnerable populations being left in the lurch. Helping close the gap is pivotal to reaching the US Centers for Medicare and Medicaid Services (CMS) goal of transitioning to value-based payment models for the majority of Medicaid and Medicare reimbursements.
In 1983, the US Congress passed the Orphan Drug Act (ODA) that offers financial incentives for developing drugs for rare diseases that have limited, if any, approved therapeutics. A new study published in the Orphanet Journal of Rare Diseases explores the impact that the ODA has had on the field of rare diseases over the past 40 years.
With over 70% of Medicaid beneficiaries being enrolled in plans from managed care organizations (MCOs), managed care has become a major player in the American health insurance industry. A new article by the Kaiser Family Foundation (KFF) takes a look at five of the largest MCOs and how they are influencing the managed care landscape.
The Institute for Clinical and Economic Review has received industry backlash over changes to its value-assessment process it proposed in June. The changes, if implemented, would lower the threshold ranges for cost-effectiveness down to $50,000 to $100,000 a year, a net drop of $50,000 at each end of the range. The outgoing ICER president Steve Pearson noted that these changes are not going to be immediately implemented and are still under consideration.
The Biden administration and the US Department of Health and Human Services (HHS) have put forward a proposed rule that would set the limit for short-term health insurance to 4 months, reversing a Trump-era rule that gave them durations up to one year with the chance of renewal. Democrats derided these forms of insurance as “junk insurance,” noting that although they are cheap, they have poor coverage and are only meant to serve as a stop-gap measure.
A newly published study in the BMJ finds that almost 60% of drugs receiving new indications from the US Food and Drug Administration (FDA) do not add high therapeutic value to patients. As a result, the researchers argue that patients and providers should be aware and that prices should be set accordingly.
Eisai and Biogen’s Alzheimer’s treatment Leqembi (lecanemab) has received full approval by the US Food and Drug Administration (FDA). This marks the first full approval for an Alzheimer’s disease treatment in decades and clears the path to Medicare reimbursement, which previously required providers contribute data to a patient registry.
A panel of regulatory experts discussed how regulatory initiatives have advanced the use of real-world data (RWD) at this June’s Drug Information Association’s global meeting. The panelists, who came from the US Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA), and Amgen, highlighted initiatives like the EMA’s Data Analysis and Real World Interrogation Network (DARWIN EU).
A real-world evidence (RWE) study published in Nature Scientific Reports assessed the hepatotoxicity of several major biologics, such as adalimumab, trastuzumab, IF-Beta 1a, and insulin glargine. The study, which used real-world data (RWD) from over 2 million patients, found that many of these key biologics have some degree of hepatoxicity.
The Mayo Clinic, Mount Sinai, and around 150 other hospitals have joined other care centers in suing major drug manufacturers over inflated prices for generic medications. The lawsuit alleges that drugmakers like Pfizer, Sandoz, and Teva have illegally collaborated for over a decade to keep generic drug prices high.
According to a recent IQVIA report, clinical trial diversity is on the downswing despite recent efforts to the contrary. The research specifically identified significant under-representation for Black and Hispanic patients. Industry action is needed, according to IQVIA, as clinical trial under-representation is systemic and negatively impacts people from marginalized racial and ethnic backgrounds.
Samsung Biologics and Pfizer have announced they are expanding their current collaboration to ramp up production of biosimilars, bringing the agreement to a value of $897 million. The announcement comes as Pfizer and another branch of Samsung both prepare for US launches of their Humira biosimilars.
The UK’s NHS generates massive amounts of real-world data (RWD) every day, but recently data security has become a concern. However, a recent survey found that 59% of participants feeling comfortable with the agency storing their data, although most (89%) felt it was important that the data was stored in the UK. A majority, however, do not feel comfortable with their data being processed using artificial intelligence (AI).
US Senator Bernie Sanders (I – VT) is looking to include price caps on drugs developed with federal funding into a reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act. The proposal would place a ceiling price that matches the lowest price for a given drug in France, Germany, Japan, Canada, the UK, or Italy.
The Institute for Clinical and Economic Review (ICER) will perform a value-assessment on KarXT (xanomeline tartrate/trospium chloride), Karuna Therapeutics’ experimental therapeutic for schizophrenia. Public discussion of the assessment will take place next February at the 2024 New England CEPAC meeting.
Amicus Therapeutics has received approval from the European Commission (EC) for Opfolda (miglustat), its treatment for Pompe disease, a rare disorder that causes progressive muscle weakness. The approval specifically covers the drug in combination with Pombiliti (cipaglucosidase alfa). Results from a recent phase 3 study showing positive changes in mobility and breathing, both affected by the disorder, supported the EC’s decision.
A recently published abstract in the Journal of Clinical Oncology examined patient populations in clinical trials for advanced renal cell carcinoma (aRCC), finding that significant underrepresentation based on age, ethnicity, and racial backgrounds. The study examined data from multiple real-world evidence (RWE) and randomized controlled trials (RCTs) covering over 4800 patients.
Several new biosimilars to AbbVie’s Humira (adalimumab) have just hit the US market in the past week, bringing a new wave of competition for the expensive top-selling therapeutic of all time. The copycats come from companies like Organon, Samsung Bioepsis, Sandoz, and Boehringer Ingelheim. Hadlima, a product of Samsung and Organon, will retail for 85% less than brand name Humira.
In a recent interview with Clinical Leader, Harsha Rajasimha, PhD, of the Indo US Organization for Rare Diseases (IndoUSrare) talks about the challenges facing rare disease research and how the use of patient registries can accelerate research and clinical development. Patient registries allow the collection of real-world data (RWD) that can be used in research, but doing so requires collaboration between all stakeholders.
The US Food and Drug Administration (FDA) has approved Lantrida (donislecel), the first cell therapy for diabetes type 1. Celltrans’ treatment is now approved for use in adults with “brittle” diabetes type I, a rare form of the disease wherein patients have recurrent severe hypoglycemic episodes. The approval is based on two open-label clinical trials with 30 patients.
A recently published article in Clinical Psychology in Medical Settings finds that health disparities faced by children and youth with epilepsy (CYE) are poorly explored in the scientific literature. The authors of the paper noted that very few epilepsy studies actually focused on identifying health disparities, with even fewer focusing on CYE.
As the upcoming Medicare drug pricing negotiations approach, the US Centers for Medicare and Medicaid Services (CMS) have released a revised guidance that better outlines the process. Pharma companies and industry groups have been anxiously awaiting such clarification, but the new information has done little to quell their concerns.
Artificial Intelligence (AI) is increasingly being incorporated into every aspect of society, including healthcare. From diagnostics to reimbursement, AI is taking a foothold in healthcare and medicine from drug development to the clinic. However, significant barriers to realizing the potential of the technology still remain.
In response to a series of lawsuits from the pharma industry, the US Centers for Medicare and Medicaid Services (CMS) have announced changes to upcoming Medicare drug pricing negotiations. The agency dialed back a confidentiality policy associated with the negotiations, a sticking point for some plaintiffs who claimed it violated their First Amendment rights.
A report by PwC projects that healthcare costs will rise by 7% next year. The report was based on interviews with major payer organizations covering over 110 million patients in the US. Estimated increases in costs are attributed to labor shortages, rising drug prices, provider contracts, and more.