A newly-published real-world study in the Journal of the American College of Clinical Pharmacy finds new data supporting the use of Paxlovid in high-risk COVID-19 patients. The retrospective study followed patients administered the combination therapy at a single medical center, finding that the […]
Using Digital Twins to Accelerate Drug Development
Getting enough patients with the right characteristics for control arms in clinical trials is difficult and can be fraught with ethical concerns. A startup called Unlearn.ai hopes to address this issue using digital twins, simulated patients for control arms that are generated using real-world data […]
Interview with Nasim Asfar, Chief Health Officer of Oracle Health
Chief Healthcare Executive has published a new interview with Nasim Asfar, Oracle Health’s Chief Health Officer. Asfar is spearheading efforts to target health disparities to support health equity efforts and how Oracle Health is using tech to do so. She starts by touching on the outsized importance […]
FACILITATE Patient-Centered Framework Will Boost Repurposing of Clinical Trial Data
The Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem (FACILITATE) is a project supported by a coalition of EU and Non-EU nations to help support the re-use of clinical trial data. This will allow increased access to existing pools of […]
Biden Executive Order to Lower Drug Prices May Have Outsized Impact
An executive order issued last month by the Biden Administration could have far-reaching consequences on drug pricing efforts, according to a new article in MedCity News. The order commands officials to explore value-based payment models. These methods may help reduce drug prices by tying payouts to […]
FDA Approves Hemophilia Gene Therapy with Highest Drug Price on Market
A newly approved gene therapy for Hemophilia B tops the charts as the most expensive therapy in the US. A round of the therapeutic, which provides substantial protection against bleeds with a single treatment, comes with a price of $3.5 million. The drugmaker CSL says that the steep price is […]
Medicaid Directors Tell US Congress That Uncertainty around Public Health Emergency Status is Too Much
The uncertainty building around the COVID-19 public health emergency (PHE) in the US is becoming too much for Medicaid to bear, according to a coalition of Medicaid directors. The association told congress that the tenuous status of the Medicaid continuous enrollment requirement during the PHE is […]
Access to Therapeutics in Northern Ireland in Jeopardy According to Teva
A representative for Teva Pharmaceuticals told members of the UK House of Lords that the impending end of a grace period in the North Ireland Protocol portends reduced access to medicines in Northern Ireland. The Protocol allowed the transportation of certain goods, including medications, into the […]
EU Announces Launch of ONCOVALUE Real-World Data Artificial Intelligence Initiative
A new initiative has been launched by the European Commission to promote the collection and use of real-world data (RWD) via artificial intelligence (AI). The project, called ONCOVALUE, will use these resources to help examine the performance and safety of new oncology drugs to support applications […]
Telemedica Boosts Real-World Evidence Platform with New Funding Round
Telemedica has announced a new funding round to help support its real-world evidence (RWE) and real-world data (RWD) offerings. The funding round netted the company almost $26 billion, bringing Telemedica’s total funds raised to $43.4 million. The company’s plans to integrate its Permia RWE platform […]
Pharmaphorum Speaks Smart Reviewing with EY Consulting
At last month’s Reuters Pharma 2022, speakers from EY Consulting spoke to pharmaphorum. Kornelia Lencz about her company’s EY Smart Reviewer Platform. The software suite uses artificial intelligence (AI) and machine learning-based techniques to help review promotional materials. Alice Blezat spoke […]
Supplementing HTA Submissions with Burden of Illness Studies Adds Value
Burden of illness (BoI) data measures the impact of an illness on a patient and caregivers and is derived from patient-reported outcomes (PRO). New attention has been paid to BoI studies in recent years, especially in the context of health technology assessment (HTA) decision-making, wherein BoI […]
Study Finds Infant CHD Outcomes Negatively Affected by Racial and Educational Isolation
A newly presented study at this month’s American Heart Association (AHA) Scientific Sessions 2022 found that certain social determinants of health (SDoH) play an outsized role in health outcomes of infants with congenital heart disease (CHD). The study pulled real-world data (RWD) from the US Center […]
Congress Still has Pharmacy Benefit Managers on the Mind After Midterms
After a mid-term election in the US that saw the Democrats unexpectedly maintaining control of the Senate, legislative action and congressional hearings into the practices of pharmacy benefit managers (PBMs) will still be on the docket in coming months. The industry has faced increasing scrutiny in […]
Canada and Australia to be Added to South Korea’s Drug Pricing Reference Countries
In a new announcement by the South Korean government, Canada and Australia will be added to the nation’s list of countries it uses as references for drug pricing purposes. Previously, the group of countries used for price-setting includes seven nations. The addition puts Canada and […]
AHF Hits Apexus for Not Conducting 340B Drug Pricing Negotiations
The AIDS Healthcare Foundation (AHF) has announced a new lawsuit against Apexus, LLC, a company contracted to negotiate 340B price discounts for qualifying non-profit healthcare organizations that serve at-risk populations. The AHF alleges that Apexus has failed to negotiate prices for life-saving […]
Bivalent COVID-19 Boosters Bolster Efficacy of Original Versions, Real-World Data Study Finds
Newly released data from the US Centers for Disease Control and Prevention (CDC) show that patients vaccinated with the new wave of bivalent COVID-19 boosters had better protection than those that have only taken the original versions. Moreover, results from the real-world data (RWD) study show that […]
ICER Announces Plans to Assess Sickle Cell Gene Therapy
Two sickle cell gene therapies will be assessed for value and efficacy by the Institute for Clinical and Economic Review (ICER), according to an announcement today, November 23rd. The institute will investigate lovotibeglogene autotemcel (“lovo-cel”, bluebird bio) and exagamglogene autotemcel […]
Gamida Cell Gets Short PDUFA Setback from FDA
The US Food and Drug Administration (FDA) gave Gamida Cell a short setback on its therapeutic omidubicel. The agency issued an information request in the review of the stem cell transplant therapy and set back the PDUFA for the treatment by three months. Although the delay is short, it has had an […]
The Latest Shifts in the FDA Accelerated Approval Pathway
The US Food and Drug Administration (FDA) is actively retooling its accelerated approval pathway, with or without actions by Congress. GSK announced yesterday, November 22nd, that the agency asked it to pull a multiple myeloma drug based on negative post-confirmatory trial data. Unlike previous […]
CMS Meena Seshamani – Central Player in US Drug Pricing Legislation
A new article in Bloomberg Government highlighted the role of Meena Seshamani, director of the US Centers for Medicare & Medicaid Services (CMS), in developing the drug pricing reform. Seshamani is working to ensure that the Inflation Reduction Act actually reduces drug prices. Her efforts are […]
US Drug Pricing Laws on the Mind of Bristol Myers CEO
Giovanni Caforio, CEO of Bristol Myers Squibb, adds his name to the growing list of C-suite members that say looming US drug pricing laws are causing them to reassess their strategies. In a recent interview, Caforio said that he expects to cancel some drug development programs as the company […]
Japan’s Drug Pricing Policies Cool Pharma’s Ambitions
A new report by the Office of Pharmaceutical Industry Research, a part of a major pharma industry group in Japan, showed that over a quarter of member companies think of Japan as a lower investment priority in recent years. The majority of companies, which are nearly evenly split between overseas […]
Commentary Highlights Ways for Medicaid to Tackle High Drug Prices
The law mandates that Medicaid must pay for any drugs approved by the US Food and Drug Administration (FDA). This includes high-price drugs approved through accelerated processes, which come with limited data that often negatively impacts reimbursement decisions with other payers. In a recent […]
Accession Digital Platform Hits 7-Year Development Milestone
Accession has announced that its digital platform pathwaypro® has hit 7 years of product development, completing a major goal set by the company 7 years ago. The platform allows healthcare organizations and decision-makers to model drug optimization and value-assessment. In a recent annual ranking […]
AJMC Study: Improving Risk Stratification Using AI and Social Determinants of Health
A recently published paper in AJMC explored a risk prediction model based on artificial intelligence (AI) that allowed the researchers to efficiently identify high-cost members. The study pulled claims data from a Medicaid care organization, covering nearly 62,00 patients. Researchers also analyzed […]
Mid-Terms Change Pharma’s Prospects to Change Drug Pricing Legislation
With the expected “red wave” failing to materialize and the Democratic party likely maintaining majority rule in the US Senate, the pharma industry is reassessing their prospects in challenging looming drug pricing reform. Pharma companies were basing their ambitions on which party controlled […]
WHO Draft Pandemic Rules Could Make Pharma Disclose Prices
New draft rules by the World Health Organization (WHO) may force pharma companies to reveal the prices of any drugs under public procurement contracts. This comes after criticism of the industry over a lack of pricing transparency regarding therapeutics like vaccines during the COVID-19 […]
Eli Lilly’s Copycat Insulin Gets Interchangeability Nod from FDA
Eli Lilly has received approval for the interchangeable use of its insulin biosimilar with Sanofi’s Lantus. Patients will now be able to ask for Lilly’s biosimilar at the pharmacy as a substitution for Landus, which runs $300 dollars for a 10 mL bottle out of pocket. The move comes as public furor […]
Cash-Only Pharmacy Offers Novel Model to Reduce Drug Prices for Patients
The small-town pharmacy Honest Rx explicitly does not take health insurance, a practice the owner says helps his patients save money on their medicines. The Virginia pharmacist says that dealing with pharmacy benefit managers (PBMs) and payer organizations slows down his practice and separates him […]
