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 high-deductible plans.
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 referred to neurologists if an IWMD is expected.
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 against people with disabilities. Other representatives argue the bill overreaches and would complicate upcoming drug price negotiations.
US FDA Releases Draft Guidance on Oncology Clinical Trials Seeking Accelerated Approval
In a new draft guidance, the US FDA proposes two strategies to make clinical trials for cancer drugs better support accelerated approval applications for cancer drugs.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 first suggestion is to move to a single trial for accelerated approval that also confirms potential health benefits.
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 event.” It begins with appropriate goal setting and a sea change in how health systems view care.
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 (PCPs) to serve rural areas. The letter is, in part, in response to a push from the agency to get PCPs in rural and underserved areas to move to value-based care models.
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 used in prior authorization decision-making to benefit patients.
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 treatment for the ultra-rare disorder.
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 drug, but the agency ruled that the effort involved was not justified based on the remaining length of the patent.
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 company’s monopoly of the drug and opening the door for cheaper generics.
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 granted its marketing authorization approval.
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 treatment, but those fighting MCL had slightly more adverse events (AEs) with outpatient infusions.
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 were durable out to almost 25 months in some patients.
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 formats to account for small participant pools. Regardless, hope is on the horizon for patients.
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 primary outcome of reducing disease activity from baseline at 6 months. It did, however, reduce levels of a key protein in ALS pathophysiology, which the committee believes may impart long-term benefits.
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 to a new article in Benefits Pro, this can keep employees healthier and happier while reducing organizational health insurance costs.
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 move, AppliedVR expects other payers to eventually follow suit.
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 injector pen, which is still patented by Supernus.
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 manufacturers if a drug is difficult to access and is priced too high.
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 and patients with chronic illness. Writers from the Center for the Evaluation of Value and Risk in Health (CEVR) contend this is a misunderstanding.
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 recommendations for improvement in several areas, including labeling.
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 protein in Alzheimer’s disease, can only be covered for patients in clinical trials.
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 Germany will pay $115 a shot.
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 the underlying design of our maternal care systems contributes to the problem
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 Ozempic, however.
