You’re Making Decisions Based on 20% of the Data. Here’s Why.

Back in the day, our team at TrialHub used to compose manual reports for clients. Reports on how the patients in certain countries were treated, what their journey was from disease onset to treatment, which drugs were reimbursed for them, and so on. We were looking into different sources of data and realized that most providers of Drug Reimbursement data rely solely on Health Technology Assessments (HTAs). Most of our clients didn’t even know that.

So what are HTAs?

HTAs are evaluations conducted to assess the clinical effectiveness, cost-effectiveness, safety, and broader impact of health technologies (like drugs, medical devices, and procedures) — they inform healthcare policy and decision-making by providing evidence-based analysis to support the adoption, reimbursement, and use of new medical technologies.

What HTAs Contain and What They Don't:

HTAs can vary between different countries but typically contain clinical trial data, cost-effectiveness analyses, safety profiles, and patient-reported outcomes, offering a broad perspective on the value of health technologies.

However, a staggering 80% of the content in HTAs is not published.

This raises concerns about the completeness and transparency of the information that decision-makers rely on. Let’s explore why this content is hidden, what information is available in the remaining 20%, and why this limited data can be misleading. 

We’ll also address how to identify better, more accurate sources for Standard of Care (SoC) and patient treatment pathway insights. And importantly, how to make sure the reimbursement status of the drugs you’re interested in is accurate.

Why 80% of the Content is Hidden?

The primary reasons for the non-publication of 80% of HTA content are multifaceted:

1. Confidentiality and Proprietary Information: Much of the data in HTAs involves proprietary information from pharmaceutical and medical device companies, including detailed clinical trial results and economic evaluations. Companies are reluctant to disclose this data publicly due to competitive and intellectual property concerns.
2. Regulatory and Legal Constraints: Legal and regulatory frameworks often protect sensitive information until regulatory decisions are finalized. This includes clinical trial data that may still be under review.
3. Incomplete or Preliminary Data: HTAs frequently incorporate preliminary findings that have not yet been validated or peer-reviewed, making them unsuitable for public dissemination.
4. Resource Limitations: HTA bodies may lack the resources to publish comprehensive reports, and formatting data for public consumption can be resource-intensive.

What is the Actual Information You Get from the Other 20%?

The 20% of HTA content that is published typically includes:

1. Summary Findings: Overviews of the clinical and economic evaluations of the health technology.
2. Clinical Effectiveness Data: Results from systematic reviews and meta-analyses of clinical trials.
3. Cost-Effectiveness Analyses: Basic economic evaluations and budget impact assessments.
4. Safety Profiles: Information on adverse effects and safety concerns.
5. Patient-Reported Outcomes: Limited data on the impact of the technology on patient quality of life.

Why This Limited Data Can Mislead You

Relying solely on the published 20% can be misleading because it often lacks the depth and context needed for informed decision-making. Key data points, such as comprehensive economic evaluations, detailed clinical trial results, and nuanced patient pathway insights, are typically omitted.

And when it comes to decisions to do with reimbursement, you should be aware that approval and/or proof of effectiveness does not equal reimbursement – which might increase your costs when it turns out you have to cover the price of your comparator in your countries of choice.

We’ve even worked with companies that made decisions for their trial based on data from platforms that rely solely on HTAs. These companies’ trials ended up delayed because of amendments, issues with recruitment, and rescue country selection.

What is the Alternative?

To overcome the limitations of HTAs, you should consider the following sources, which offer more accurate and comprehensive data:

1. National Health Agencies: Databases from agencies like the FDA, EMA, and national health services provide extensive regulatory and reimbursement information. These databases are often more transparent and up-to-date than HTAs. Since different countries have different reimbursement systems, sourcing information directly from the national agencies gives you the most accurate view of the local landscape.
2. Clinical Trial Registries: Platforms like ClinicalTrials.gov and the EU Clinical Trials Register offer detailed trial data, including patient recruitment insights and comprehensive study results.
3. Electronic Health Records (EHRs): EHR databases provide real-world patient data, treatment outcomes, and disease prevalence, offering a more accurate reflection of the SoC and patient experiences.
4. Patient Advocacy Groups: Engaging with patient advocacy groups can provide valuable insights into real-world patient experiences, unmet needs, and access to care, offering perspectives that may be overlooked in HTAs. These groups often collect data directly from patients, providing a richer understanding of treatment pathways and the impact of healthcare interventions on quality of life.
5. Medical and Scientific Publications: Peer-reviewed journals and systematic reviews offer comprehensive clinical effectiveness and economic evaluations, often including the detailed data omitted from HTAs. These publications can shed light on the discrepancies between local healthcare systems, which influence the patient pathway.

Why These Alternatives Are Not Used En Masse

Despite their advantages, these alternative sources are not universally adopted due to several blockers:

1. Access and Cost: Accessing comprehensive EHR databases can be costly and logistically challenging.
2. Data Integration: Integrating data from various sources into a cohesive analysis requires sophisticated data management and analytical capabilities.
3. Regulatory Hurdles: Navigating the legal and regulatory landscape to access certain types of data can be complex and time-consuming.
4. Standardization Issues: Data from different sources often lack standardization, complicating comparisons and combined analyses.

Precisely because we understand these challenges, we no longer provide manual reports. Instead, we developed Standard of Care. We automate standard of care and reimbursement research by providing you with insights pulled directly from local reimbursement authorities. Our in-house medical team then double-checks for accuracy so you can get actionable insights on:

• Reimbursement;
• Drug prices;
• Subpopulations and limitations.

Let me know if you’d like to know more about the process.

Conclusion

While HTAs remain an industry standard for decision-making, their reliance on only 20% of the available data limits their utility. By leveraging alternative sources such as national health agencies, clinical trial registries, EHRs, patient advocacy groups, and medical publications, researchers can access more accurate and comprehensive data. 

Overcoming the barriers to using these sources en masse will require concerted efforts to address access, cost, data integration, regulatory hurdles, and standardization issues. By doing so, the clinical research industry can make more informed decisions, ultimately improving patient outcomes and the success of new health technologies.