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 […]
Folding Patient Experience into EU Real-World Data Studies
The use of real-world data (RWD) and real-world evidence (RWE) into clinical research and regulatory decision making is growing in the EU. However, patient experience data is yet to be incorporated, for a variety of reasons. The European Medicines Agency (EMA) held a panel last year to discuss […]
Embracing Patient-Centered Clinical Trials to Facilitate More Representative Recruitment
Despite recent efforts, patient recruitment for clinical trials is expensive, difficult, and time-consuming. Moreover, the vast majority of clinical trials are far from representative of real patient populations, often severely lacking in people from marginalized ethnic and racial backgrounds. In a […]
Patient-Reported Data Collection to Grow Through Medicare Drug Pricing Negotiations
A recent guidance from the US Centers for Medicare and Medicaid Services (CMS) stated that patient experiences will be factored into the upcoming Medicare drug pricing negotiations. As a result, patient-reported data collection is set to grow significantly. However, significant uncertainty surrounds […]
FDA Releases Guidance on Patient-Centered Drug Development
A final draft guidance regarding patient-focused drug development (PFDD) has been issued by the US Food and Drug Administration (FDA). The guidance covers data collection methods about patient care experiences and how they can be used in regulatory decision-making processes, […]
How New Advancements in Pharmacy are Shifting the Managed Care Landscape
Pharmacies are changing, sending ripples into the managed care landscape. In a new Managed Healthcare Executive article, Joe Johnson, Todd Clark, and Brendan Mitchell of LEK Consulting discuss new disruptive pharmacy models and how they are affecting managed care and other payers. The first such […]
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 […]
Transparency, Oversight, and Opt-in Consent Makes Patients More Open to Sharing Data
A newly published paper in JAMA Network Open found that patients are more likely to participate in patient data sharing programs if certain conditions are met. Survey data from 3,500 hundred patients showed that patients valued transparency, opt-in informed consent, oversight mechanisms, and […]
Talking Remote Care and Reimbursement with Bronwyn Spira of Force Therapeutics
The US Centers for Medicare and Medicaid Services (CMS) introduced new CPT codes last year, reducing barriers via remote care. In a new video by Managed Healthcare Executive, Force Therapeutics’ Bronwyn Spira talks about how these new codes affected outcomes and why outcomes-based reimbursement […]
ISPOR Task Force – Good Practices for Patient Preference Studies
Healthcare decision-makers have increasingly recognized the importance of patient health preferences, incorporating results from patient preference studies into a wide range of deliberative processes. ISPOR has published a set of good practices to enhance the impact of these studies in a newly […]
