On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022, which includes U.S. drug pricing reform that, among other things, requires the federal government to negotiate prices for some high-cost drugs covered under Medicare. In our recent webinar, Vice President of Value and Access Anna Forsythe discusses the effect that a strong HEOR strategy can have to help sponsors navigate this space for the benefit of all parties.
The Living Model Approach for Systematic Literature Reviews
When building a disease model or an economic model, the assumption has been that updates to such models should only occur once sufficient evidence has been gathered. A “living model” approach, however, aspires to treat models as always evolving, with new evidence continuously incorporated into its parameters.
Systematic literature reviews (SLRs) are essential for proving product value to health authorities but struggle to stay current with the rapid pace of scientific knowledge. Guidance published by PRISMA, Cochrane, and other thought leaders in establishing standards for SLRs indicates that living models for SLRs are the future of the industry. Such living models can benefit clinicians who are weighing treatment strategies for patients and are essential to demonstrate product value based on the most updated evidence.
To learn more about the living model approach for SLRs
Overcoming the Shared Effect Modifier Assumption with Network Meta-Interpolation
Commonly used methods to handle the complexities of effect modification in indirect treatment comparisons (ITCs) often rely on the shared effect modifier (SEM) assumption, that is, that the effect modifiers impact a set of treatments in the evidence network in the same way. However, it has been argued that this assumption is limiting and often unreasonable to make.
The solution, argues Senior Research Consultant, Statistics, Caitlin Daly, is Network Meta-Interpolation, a new method that takes advantage of reported subgroup analysis results — which are often available but rarely used in ITCs — to overcome this and other limitations.
Read more »
Quantifying Uncertainty in RWE Studies with Quantitative Bias Analysis
Missing data and unmeasured confounding are common challenges for researchers, particularly in observational studies and those involving real-world data, jeopardizing the validity of study conclusions. Here, we introduce a useful tool — quantitative bias analysis (QBA) — to address these challenges.
Real-Life Data-Sharing and EU Joint Clinical Assessments: Is Closing this Chasm a Mission Impossible?
Written by Grammati Sarri, David Smalbrugge, Andreas Freitag, and Evie Merinopoulou
The vision of a single, centralized system for the comparative joint clinical assessments (JCA) of health technologies in the European Union (EU) is now a reality, with corresponding guidance that supports EU member state cooperation and increases transparency in clinical assessments. However, oversight by the European Network for Health Technology Assessment (EUnetHTA) 21 will cease in September 2023, leaving stakeholders (pharmaceutical companies, local decision-makers) uncertain about next steps for the EU JCA guidance, particularly regarding the use and weight of real-world evidence (RWE) and its opportunities in decision-making.
Read more »
Reflections on the RCT DUPLICATE Study and Increasing Confidence in Real-World Evidence
With input by Alind Gupta, Louis Dron, and Jason Simeone.
Randomized clinical trials (RCTs) have long been considered the gold standard for assessing the efficacy of medical treatments, but real-world evidence (RWE) is often more representative of routine clinical care. The RCT DUPLICATE study makes great strides in comparing the two, but the study has its limitations: notably, the lack of quantitative bias analysis. Read more »
Retrospective Claims Data Analysis Unlocks Discovery in Multiple Sclerosis Research
One of the lesser-known complications associated with Multiple Sclerosis is a higher risk of serious infections (SIs). Cytel’s RWE experts conducted a retrospective analysis of claims data to determine the incidence of SIs among people with various types of MS. Let’s take a closer look at this method:
Read more »
Navigating Comparative Effectiveness in the Inflation Reduction Act: Methodological Approaches for Healthcare Challenges
The Inflation Reduction Act (IRA), passed in August 2022, marks a significant shift in the US healthcare landscape, particularly for Medicare. The IRA introduces reforms to Medicare’s prescription drug program (Part D), inflationary caps in Medicare (Part B), and Medicare price negotiation. To effectively navigate these changes, pharmaceutical companies must develop robust evidence-generation programs that support evolving value requirements throughout a drug’s life cycle. Read more »
Network Meta-Interpolation: Effect Modification Adjustment in Network Meta-Analysis Using Subgroup Analyses
When conducting network meta-analysis (NMA) – that is, a technique that involves comparing multiple treatments simultaneously in one analysis by combining both direct comparisons of treatments trialed against each other in randomized control trials and indirect comparisons, based on a common comparator – bias can be caused by effect modification, potentially leading to inaccurate conclusions.