Value in Health Review: Applying Machine Learning to Wearable Data to Generate HEOR Insights
An article in the latest issue of Value in Health breaks down how machine learning can be applied to data from wearable devices to advance health economics and outcomes research (HEOR). Wearables are a font of real-world data (RWD) that can be analyzed by machine learning (ML). By addressing existing issues of data quality and effective usage, such a trove of information could accelerate research and decision-making process for payers, regulatory bodies, and pharma companies.
Advancing Rare Disease Drugs Through Real-World Evidence
Patients with rare diseases often suffer with few effective treatment options. Therapeutic development for these drugs targeting rare diseases increasingly depends on real-world evidence (RWE). In a new IQVIA blog, learn more about efforts in the UK to advance the development of drugs for rare diseases through the careful use of RWE.
CDC Launches Initiative to Accelerate Health Data Modernization Efforts
The US Centers for Disease Control and Prevention (CDC) has announced a new initiative to modernize its public health data infrastructure. The Initiative, announced today, February 27th, will be a cooperative public-private effort led by the agency, the National Coordinator for Health Information Technology (ONC), and the CDC Foundation, an independent non-profit started by Congress.
Sanofi and Sobi Score US Approval for Weekly Hemophilia A Therapeutic
Altuviiio, Sanofi and Sobi’s therapeutic for the blood disease hemophilia A, has just received regulator approval by the US Food and Drug Administration (FDA). The drug stands out in its class due to its dosage regimen; the therapy is delivered once a week versus every couple days with the current standard of care.
FDA Grants Breakthrough Status for Moderna and Merck’s Vaccine Combo Therapy for Skin Cancer
Moderna and Merck have secured a win with the US Food and Drug Administration (FDA) granting breakthrough therapy designation to the companies’ experimental therapy for skin cancer. The treatment combines a new mRNA vaccine with Merck’s existing drug Keytruda to help the immune system fight melanoma.
Senate Commerce Committee Holds PBM Hearing
The pharmacy benefit manager (PBM) industry is under the magnifying glass again, this time by the US Senate Commerce Committee. During the hearing, senators brought up anti-competitive actions taken by major players, as well as other practices that hurt the bottom line for pharmacies and patients alike.
FDA Pumps the Brakes on Fulcrum Sickle Cell Drug Trial
The US Food and Drug Administration (FDA) has put a damper on Fulcrum Therapeutics’ ambitions by placing a full hold on a clinical trial for the company’s new therapeutic, FTX-6058. The company says the FDA made the decision based on preclinical data, although the specific reason for the hold has yet to be reported.
The Far-Reaching Implications of the Potential Abortion Pill Ban
A court case that will determine the fate of nationwide access to the a pill used to induce abortions and treating miscarriage may trigger a sea change in the pharmaceutical industry in the US. If the far right-wing judge presiding over the case, a Donald Trump appointee, rules in favor of rescinding the approval of mifepristone, it will set a precedent that court cases can overrule drug approvals by the Food and Drug Administration (FDA).
US Senators Call for Expansion of Medicare Coverage for Amyloid Alzheimer’s Treatments
Following the controversial approval of the Alzheimer’s drug Aduhelm, the US Centers for Medicare and Medicaid Services (CMS) agreed to only pay for drugs in its class, amyloid-targeted therapies, when used in patients enrolled in clinical trials. A group of Senators have penned a letter to Xavier Becerra, Secretary of the Department of Health and Human Services (DHS) and the CMS Administrator Chiquita Brooks-Lasure.
Inflation Matters for Patients Considering Care Decisions
A recent survey of over 1,000 consumers found that 71% of participants said that inflation has affected their decision-making processes regarding healthcare. Results also show that one in ten people in the US owe at least 250 in medical debt. 43% of respondents said that the max amount they could comfortably spend on healthcare at the moment is just shy of that figure at $249.
Real-World Data Study Finds Remdesivir Lowers Mortality in All COVID Variants
A set of real-world data (RWD) studies finds that Veklury (remdesivir) treatment during hospitalization for all current variants of COVID-19 reduces mortality. The studies examined data from 500,000 patients, finding that the antiviral reduced mortality by 26% in patients undergoing mechanical ventilation, 19% in patients who did not take supplemental oxygen, and 21% in those receiving low-flow oxygen.
Eli Lilly Catches Up with Mounjaro Shortage
Eli Lilly announced it caught up on backorders for its obesity drug Mounjaro, drawing the end near for a shortage that’s persisted since last December. Some patients may still have to wait for the drug, but delays will likely drop to one to two days. The drug is still on the US Food and Drug Administration’s drug shortage supply list, which may change in the coming days.
Clinical Trials Must Include Diversity Plan in FDA Applications
Many patients from rural areas and marginalized backgrounds are severely underrepresented in many clinical trials. To address this problem, the US Food and Drug Administration (FDA) has announced that in the near future, all clinical trials registered through the agency must contain a plan to ensure diversity in the participant population. The plan will take time, however, as the agency must issue a final guidance and wait for public input.
High-deductible Insurance Plans Harm Patients
To cope with the cost of health insurance, over half of patients in the US with private insurance sign up for high-deductible plans that leave them paying list price for most of their medications and care. While some payer orgs tout the benefits of these plans, researchers are finding that these plans worsen health outcomes for members.
Medicaid Preps for Glut of Expensive New Gene Therapies
Patients, providers, and payers alike are anticipating the release of new gene therapies for conditions like cancer and sickle cell disease. The US Centers for Medicare and Medicaid Services (CMS) released an experimental outcomes-based payment model to help manage the high prices of these therapies. Payouts would be based on patient outcomes, like symptom reduction or remission.
NIH Funds Project to Use Digital Twins to Advance Health Equity
A group of researchers at the Cleveland Clinic have been awarded a grant from the US National Institutes of Health totaling $3.14 million. The project will look at advancing health equity efforts using digital twins, simulated patients built from pools of real-world data (RWD) whose details, like social determinants of health (SDoH) mirror participants in trials.
Pharma Preps for Major Exclusivity Losses
As biosimilars for blockbuster drugs like Humira and Keytruda begin to enter the market, pharma giants are preparing for major potential losses. A swath of high-priced therapeutics is also facing the ends of their patents and exclusivity, but biosimilars are not interchangeable like generics, so companies may not take the massive hit they are anticipating.
Most Healthcare Organizations Behind on SDoH Data
The American Health Information Management Association (AHIMA) has released a white paper detailing the state of social determinants of health (SDoH) data collection and usage. The authors surveyed 2,637 members, finding that the majority of healthcare organizations are collecting SDoH data but have issues analyzing and using it.
Harvard Study Finds LGB People Face Significant Barriers to Care and Poor Health Outcomes
Health equity received a boost of attention during the COVID-19 pandemic, bringing increased awareness of the health impact of social determinants of health (SDoH) like race and location. A recent study found that exposure risk was highly affected by a variety of SDoH. Likewise, access to care and quality of care are far from equally distributed.
Exploring the Intersection of Health Equity and Infectious Disease
Health equity received a boost of attention during the COVID-19 pandemic, bringing increased awareness of the health impact of social determinants of health (SDoH) like race and location. A recent study found that exposure risk was highly affected by a variety of SDoH. Likewise, access to care and quality of care are far from equally distributed.
India’s Department of Pharmaceuticals Holds Up NPPA Pricing Decision for Acetazolamide
Sun Pharma’s request to change the price cap set by India’s National Pharmaceutical Pricing Authority (NPPA) for acetazolamide 500 mg, a drug for glaucoma, has been rejected by the Department of Pharmaceuticals (DoP). The manufacturer had argued that the NPPA had based its pricing decision based on the 2021 price cap for the 250 mg capsule, not the increased price set in 2022.
Cystic Fibrosis Patients Stuck with Exorbitant Drug Costs Due to Vertex Feud with Payers
Many patients with cystic fibrosis have been shocked to find that the price of Orkambi, a key drug for the chronic disease, has skyrocketed, with some facing a +200X increase in yearly co-pays. This comes as payers, pharmacy benefit managers (PBMs), and Vertex, the drug’s manufacturer duke it out over reimbursement, copay assistance programs, and a new insurance tool called a copay accumulator.
Abarca CEO: Drug Pricing to Follow Model Set by Medicare Drug Negotiations Going Forward
With the impending Medicare drug pricing negotiations in the next few years, the future of drug pricing is uncertain in the US. According to Jason Borschow, CEO of the pharmacy benefit manager (PBM) Abarca Health, thinks that the pricing model will be the default for the pharma and biotech industries going forward.
Four Projections for Value-Based Drug Pricing Landscape in 2030
Panel speakers at the Abarca Forward pharmacy conference discussed their outlooks for value-based drug pricing models by the end of the decade, coming up with four main predictions going . The first prediction, from Lyfegen’s CEO Girisha Fernando, is that the healthcare industry will have largely adopted a value-based pricing approach to drug formularies.
Real World Data Study Breaks Down Data Quality Assessment for COVID-19 Therapeutics
There is a significant pool of electronic health records (EHR) that could be used to generate real-world evidence (RWE) exploring COVID-19 therapeutics, but data quality and interoperability varies between sources. A newly published study in BMC Medical Research Methodology examines data assessments for COVID-19 therapeutic real-world data (RWD) sources.
