J&J and Legend’s CAR-T Therapy Better Than Standard Care in Phase III Trial
J&J and Legend Biotech have announced new results from their CARTITUDE-4 trial that shows their new CAR-T therapy Carvykti is more effective at treating multiple myeloma than standard care. The companies say that the therapy, which many predict to be an upcoming blockbuster, has achieved the trials primary endpoint of progression-free survival.
Tidepool Pancreas App Wins FDA Approval
The US Food and Drug Administration (FDA) has approved the Tidepool “artificial pancreas” app. The prescription-only software connects continuous glucose monitors (CGMs) and insulin pumps to automate insulin delivery and blood sugar management in patients with Type I diabetes. The app will work with certain devices and provide a single place to find blood sugar and insulin dosage data.
Using the UK’s Innovative Medicines Fund to Accelerate Rare Disease Drug Development and Access
The UK’s Innovative Medicines Fund (IMF) was started in collaboration with the NHS England and National Institute for Health and Care Excellence (NICE) to provide novel medicines with unresolved uncertainties to patients with rare non-cancer diseases that have little treatment options. In doing so, the program is intended to incentivized development of drugs for rare diseases, or orphan drugs.
US Senators Blast Moderna for COVID Vaccine Price Hikes
Moderna is drawing heat from some US lawmakers and political leaders over its plans to spike prices of its COVID-19 vaccine to $110-130 per shot. The planned price hike, which is higher than the original price increases floated last fall, was lambasted by senators like Bernie Sanders (I-VT), Elizabeth Warren (D-MA), and Peter Welch (D-VT).
EMA Committee Announces Orphan Drug Application Changes to Improve Access to Rare Eye Disease Medications
Policies regarding orphan drug designations for a group of rare genetic eye diseases called inherited retinal dystrophies are changing, according to the European Medicines Agency (EMA). The changes would target terminology regarding the categories of disorders that are covered under the orphan drug designation, allowing drugs to be submitted into one or more of four subgroups.
US Sen. Warren Calls for March-In Rights for Prostate Cancer Drug
Elizabeth Warren (D-MA) and 25 other US senators wrote a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra requesting that the agency implements march-in rights for Astellas’ and Pfizer’s prostate cancer drug Xtandi. This would allow the federal government to take ownership of the drug’s license on the basis that government funding paid for part of its development.
Sonoma Pharma Seals Pricing and Distribution Arrangement, Spiking Share Prices
Sonoma Pharmaceuticals has announced that it has locked in a distribution and pricing deal with the Defense Logistics Agency. The announcement of the deal, which covers its Microcyn Rx products, was followed by Sonoma’s shares jumping in price by 82%. Products included in the deal are used for wound care, eye health, and dermatology.
Millions of Medicaid Beneficiaries Likely to Lose Coverage When Continuous Enrollment Ends
Medicaid enrollees must reapply every year in a complicated process fraught with hidden pitfalls that could sink one’s coverage. This [...]
Talking Real-World Evidence with Healthcore’s Co-Founders Mark Cziraky and Marcus Wilson
As Healthcore gears up for their impending brand transition to Carelon Research in the coming months, co-founders Mark Cziraky and Marcus Wilson discussed their insights into the importance of high-quality real-world evidence (RWE) generation methods and why they founded the company. The two worked together as pharmacists before starting Healthcore back in 1996.
New Venture Capital Firm Launches to Support Health Sciences Digitization
Cutting edge technology like big data analytics, artificial intelligence, and machine learning are poised to revolutionize life sciences and healthcare. Dimension, a new venture capital fund, has launched today in to support the digitization of life sciences. The fund is prepared to support new startups with a war chest of $350 million.
5 Takeaways for Practitioners to Promote Health Equity
Health equity efforts led by health impact assessment (HIA) and Health in All Policies (HiAP) professionals are helping to address [...]
Target RWE Releases 35 Disease Real-World Evidence Registries
Earlier this month, Target RWE announced the release of 35 observational disease state real-world evidence (RWE) registries. The disease fields covered by the registries include autoimmune disorders, neurological conditions, metabolic diseases, and more. The data will include patient reported outcome measures, clinical exam results, and tissue samples in a proprietary biobank.
Aetion Announces 5-Year Real-World Evidence Collab with FDA
Aetion has announced a new partnership with the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE) to promote oncology care and prevention through its real-world evidence (RWE) offerings. As part of the 5-year collaboration, the OCE will have access to the company’s Evidence Platform. This move adds another team-up for Aetion.
Amazon Launches RxPass Service for $5 Generic Drugs
Amazon has announced the launch of its RxPass service, a subscription-based prescription drug service that will ship certain generic medications to patients for $50 a month. The program includes over 50 generics and is integrated into existing Amazon Prime subscriptions. Drugs can be delivered monthly or once every three months, as requested.
DiaCarta Monkeypox Test Kit Issued Emergency Use Authorization by FDA
Earlier this month, the US Food and Drug Administration (FDA) issued an emergency use authorization for DiaCarta’s QuantiVirusTM MPXV test kit. The kit is a PCR test for monkeypox virus (MPXV) that tests for two separate regions of the MPXV genome to account for the chance of future mutations that would otherwise render the test void.
Optum Rx Launches Tool to Match Patients with Cheapest Generic Drug Prices
The massive pharmacy benefit manager (PBM) Optum Rx has launched its Price Edge tool that promises to lower generic prescription drug prices to patients. Price Edge scans through prices and pairs patients with the most affordable generic that matches their prescription. Purchases will apply to patients’ deductibles and out of pocket maximums, the company says, and will be applied to members automatically.
Exploring Value-Based Drug Pricing Models
Value-based care, a kind of payment model that determines reimbursement based on patient care outcomes, has become more prevalent in recent years. Such a change has not been seen in prescription drug prices, despite the advent of multi-million dollar therapies that can radically change a patient's course of care. In a new Med City News article, learn how value-based payment models for prescription medications may be a path towards more affordable drug prices.
Uncertainty Surrounds Payment Models for World’s Priciest Therapeutic
With the US Food and Drug Administration’s (FDA’s) approval last year of Hemgenix, a hemophilia B gene therapy by CSL Behring and most expensive drug in history, insurers are looking to the Centers for Medicare and Medicaid Services (CMS) for new payment models. The agency has long been used as a model for pricing decision-making, especially for novel, expensive medications.
End of the X Waiver for Buprenorphine
Patients seeking buprenorphine, a partial opioid used to successfully treat opioid dependency and reduce overdoses, have classically had to get an waiver to get the drug in the US. This requirement, which effectively limited access to the lifesaving medication, is being lifted today as part of the Mainstreaming Addiction Treatment (MAT) act that was included in December’s omnibus bill.
Sanofi Sets Up Warranty Program for Discontinued Rare Disease Treatment
Sanofi has set up a warranty program to pay back some medical institutions who administered Cablivi, an antibody-based treatment for a rare clotting disease. The company will reimburse healthcare institutions the cost of 6 doses for patients who do not see improvements and 12 doses for patients whose conditions worsen during treatment
Oncology Telehealth Cuts Costs for Some Patients
A newly published paper in JAMA Network Open shows that some cancer patients saved significantly on travel costs by using telehealth oncology services. The study looked at completed telehealth visits from 11,688 adult patients up to 65 years of age and analyzed travel costs and loss of productivity due to an in-person visit.
Pharma Bro Martin Shkreli in Hot Water with FTC Over Lifetime Industry Ban
Martin Shkreli is once again in trouble with the FTC, this time over a potential violation of his lifetime ban from the pharma industry. Shkreli, who famously jacked the price of a niche malaria medicine from $18 to $750 per pill, appears to the agency to be side-skirting his industry ban for securities fraud charges by starting up a new drug discovery company within weeks of leaving prison.
In-Person Care and Telehealth Private Insurer Payments Similar in 2020
A new analysis by the Kaiser Health Foundation finds that reimbursements from private insurance plans were similar for in-person and telehealth appointments during 2020. The researchers analyzed data from over 90 million claims. The average cost for telehealth visits covering serious evaluation and management cases for established patients was $143, whereas in-person services were, on average, only a few dollars cheaper at $137.
JAMA Network Study Shows Quality of Care Doesn’t Mitigate High Out-Of-Pocket Healthcare Costs
A newly published study in JAMA Network has found that no matter whether the quality of care for emergency general surgery (EGS) is good or subpar, the out of pocket (OOP) costs are uniformly high. The researchers looked at 23,450 patients admitted for several common causes of EGS at over 600 facilities from 2016 to 2019.
NAHC President Tells Home Care Providers to Keep an Eye on Medicare Advantage
At a webinar this week, the president of the National Association for Home Care & Hospice (NAHC) Bill Dombi said that Medicare Advantage plans are on the rise and that home care providers should pay attention. Dombi noted that there is a huge marketing force driving the boom, with big celebrity names behind it.
