Amid growing scrutiny of pharmacy benefit managers (PBMs) at the public and congressional level, a PBM industry group has launched an ad campaign pointing the blame back at pharma for high drug prices. The group argues that the pharmaceutical industry has spent millions of dollars on advertising and […]
Building an Effective Real-World Evidence Strategy
Real-world evidence (RWE) is a key part of a successful product launch or indication expansion, but doing so requires a careful strategy to maximize efficiency and minimize costs. In a new article by Richard Hallquist of IQVIA, learn about how to build an evidence strategy that maximizes the odds of […]
Medicare Drug Price Negotiations Will Include Patient Perspectives and Real-World Evidence
According to Medicare Director Meena Seshamani, upcoming drug pricing negotiations will take the patient perspective and real-world evidence (RWE) into account. The agency wants to incorporate information about how high prices of key therapeutics impacts patients, as well as how the drugs are used […]
A Look at How Medicare Advantage Affects Providers
Although Medicare Advantage (MA) has been greatly beneficial for participating payer organizations, the picture is less rosy for providers, according to an analysis from the Kaiser Family Foundation (KFF). Providers must deal with a more complex policy framework when working with MA plans, resulting […]
First Lawsuit Against US Medicare Drug Pricing Negotiations Filed by Merck
The pharma giant Merck & Co has filed a lawsuit against the US government over upcoming Medicare drug pricing negotiations included in the Inflation Reduction Act passed last year. The company argues that the negotiations would violate their 5th Amendment rights by forcing them to provide drugs […]
AstraZeneca Looking Toward Early Full Approval for Anticoagulant Reversal Medication
Following positive results in a phase IV clinical trial, Astrazeneca is making moves to apply for full approval for its anticoagulant reversal drug Andexxa earlier than expected. Data from the trial, which is being ended early based on outside recommendations, showed that the drug was effective in […]
Inflation Reduction Act R&D Cost Request May Prove Problematic
The US Inflation Reduction Act requires drugmakers to justify new drug prices based on the R&D costs needed to develop a therapeutic during drug pricing negotiations. However, this policy may be short-sighted, according to some experts, as it doesn’t account for the lost investments in failed […]
Bristol Myers Squibb’s Heart Medication Camzyos Receives NICE Recommendation
Bristol Myers Squibb (BMS) has received a recommendation for approval from the UK’s National Institute for Health and Care Excellence (NICE) for its heart drug Camzyos (mavacamten). The recommendation covers the use of the drug as a adjunct treatment for symtompatic obstructive hypertrophic […]
Real-World Data Study Finds Two Year Immunotherapy Regimens Appropriate for Advanced Lung Cancer
A real-world data (RWD) study published in JAMA Oncology finds that administering immunotherapy to patients with advanced non-small cell lung cancer (NSCLC) is appropriate. The study, which followed 1091 patients at Penn Medicine’s Abramson Cancer Center, found that patients whose cancer hasn’t […]
CMS Drug Price Negotiations Complicated by Therapeutic Alternatives Clause
As part of the upcoming drug pricing negotiations from the Inflation Reduction Act, drugmakers will need to justify high US drug prices by comparing efficacy and value with therapeutic alternatives. The problem, according to industry leaders, is that the definition of therapeutic alternatives is […]
EMA Calls for Novartis’ Sickle Cell Treatment to Lose Market Authorization
Novartis took a hit this week as the European Medicines Agency (EMA) has recommended that its market authorization for Adakveo, a sickle cell medication, be revoked. Although initial data suggested the drug could help reduce pain crises in patients 16 and older, the agency argues that […]
Better Employee Health Through Specialty Rx Carve-Outs
Specialty Rx carve-outs allow for dedicated management of high-cost specialty medications by bypassing traditional pharmacy benefit managers (PBMs). Doing so, according to a new article in Corporate Wellness Magazine, can help improve employee health by applying specialized expertise to coverage […]
Using Real-World Evidence to Accelerate Medical Device Development
Korea’s Ministry of Food and Drug Safety is now accepting real-world evidence (RWE) as clinical data for medical device approval decision-making. This opens up a pathway for medical device manufacturers to accelerate development with real-world data (RWD) resources like clinical data from devices, […]
Working with Pharma to Advance NHS Health Equity Efforts
A key priority in the UK’s National Health Service (NHS) Operational Planning Guidance 2023/2024 is improving health outcomes for the poorest 20% of patients in the nation. Partnerships between NHS systems and the pharmaceutical industry represent one way to help address health disparities. Doing […]
Targeting Health Equity at the Neighborhood-Level
A person’s living environment is an important social determinant of health (SODH), affecting access to care and employment, exposure to environmental hazards, and financial pressures. As a result, health equity efforts need to zoom down to the neighborhood level to improve health outcomes. In a new […]
Molecular Templates’ Multiple Myeloma Trial Partial Hold Lifted
Molecular Templates’ clinical trial for MT-0169, its experimental multiple myeloma therapeutic, is back on, following the US Food and Drug Administration (FDA) lifting a partial hold. The hold was placed on the trial following two adverse events experienced by patients, who both recovered. The move […]
Addressing Barriers to Care in Rural America
Rural US residents face significant barriers to care that significantly worsen health outcomes. Addressing these barriers is a complex task due to the underlying reasons behind them. In a new Becker’s Hospital Review article, Karen Joynt-Maddox, MD, MPH, associate professor at the Washington […]
Pfizer’s RSV Vaccine Gets FDA Approval
The US Food and Drug Administration (FDA) has given approval for the use of Pfizer’s respiratory syncytial virus (RSV) vaccine in older adults. The move comes shortly after the agency approved another RSV vaccine from GSK. This sets up a marketplace standoff between the two, competing over a market […]
Over 500,000 Disenrolled from Medicaid After COVID-19 PHE Ends
Shortly following the end of the COVID-19 public health emergency, pandemic-era restrictions on Medicaid redetermination ended. In that time, over 500,000 people have been disenrolled, interrupting their coverage and impacting their access to healthcare. Some states have kicked off more […]
CMS Opens Up Coverage of Alzheimer’s Drugs
Once Lequembi, Easai’s amyloid-targeting Alzheimer's drug, is potentially approved by the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) have announced they will expand coverage for the class of drugs. Previously, CMS only covered amyloid therapies in […]
US Congressional Research Service Asks When Pharma Can Challenge Drug Pricing Reform
The Congressional Research Service (CRS), a nonpartisan public policy research institute, released a report asking for more clarity on when lawsuits over upcoming Medicare drug pricing reform can commence. The report comes as industry groups also seek more transparency on time windows as they […]
Incorporating Value-Based Care into Nursing Homes with the Payvider Model
As nursing homes increasingly look for ways to incorporate value-based care into their practices, some are moving towards payvider models, wherein they partner with a Medicare Advantage insurer and play the roles of payer and provider together. A panel of experts spoke about this strategy in a […]
Eli Lilly Reaches $13.5 Million Settlement in Insulin Pricing Case
Eli Lilly has settled a case with patients using insulin, who accused the company and others of artificially inflating prices of the lifesaving drug. Lilly will pay out a total of $13.5 million and will maintain their $35 a month out-of-pocket price cap for four years at minimum. The company, which […]
Canadian Health Officials Tried to Hide Evidence Health Minister Stalled Drug Pricing Reform
Recently released emails show that Health Canada officials tried to hide a letter from Health Minister Jean-Yves Duclos to the Patented Medicines Prices Review Board (PMPRB), Canada’s independent drug pricing agency, asking them to delay drug pricing reform last year. The letter mirrored the pharma […]
Real World Data Study Finds Comprehensive Genomic Profiling Improves Cancer Outcomees
Real-world data (RWD) to be presented at this year’s upcoming American Society of Clinical Oncology’s Annual Meeting shows that comprehensive genomic profiling (CGP) improves cancer patients’ outcomes. The study, which covered 1,423 advanced cancer patients who received CGP from 2019 to 2021, showed […]
Patients Turning to Illegal Pharmacies for Essential Medications
US patients are increasingly turning to illegal pharmacies due to high prescription drug prices and shortages of essential medications. The issue has grown in recent years, catching the eyes of officials at the US Food and Drug Administration. It is especially concerning for the attention deficit […]
Real-World Data Backs Dolutegravir Combo Therapies for HIV
A real-world data study published in AIDS found that three two-drug dolutegravir combination therapies were as effective in managing HIV as commonly used three-drug treatment regimens. The study covered over 3,000 patients from 2015 and 2021 taking dolutegravir in combination with lamivudine, […]
Speaking with the Person Behind the Inflation Reduction Act Drug Price Negotiations
The US drug pricing reform in the Inflation Reduction Act was concocted by John Barkett of the Berkely Research Group. In a new interview, Politico’s Ben Leonard spoke to Barkett to talk about the process and the next steps for the Centers for Medicare and Medicaid Services (CMS). Barkett first […]
Expiration of Temporary Provisions Set to Change Up Insurance Coverage for People Under 65
COVID-era policies expanded access to Medicaid and Marketplace plans for millions of people in the US, resulting in the lowest rates of uninsured status ever. However, these policies are set to expire soon, resulting in many people under 65 losing their coverage. In a new Health Affairs article, […]
Part D Out-of-Pocket Prescription Drug Price Cap Will Help New Part D Recipients
A newly published study in JAMA Health Forum found that new Medicare Part D price caps on out-of-pocket prescription drug costs will help new beneficiaries switching from commercial plans. The study found that the $2000 price cap in the provision, included in the Inflation Reduction Act, would save […]
