Opportunities for Pharma

EHR4CR CLINICAL RESEARCH SCENARIOS EXPECTED BENEFITS TO PHARMA
1. Improved protocol feasibility assessment
  • Improved clinical trial planning
  • Reduction of protocol amendments (estimated at 300,000€ each)
  • Increased probability of achieving the clinical trial objectives
  • Significant reduction of actual person-time and costs
2. Faster patient identification and recruitment
  • Reduction in clinical trial timelines
  • Precise patient targeting according to inclusion criteria
  • Increased probability of achieving the clinical trial endpoints
  • Significant reduction of actual person-time and costs
3. More efficient study conduct and reporting of serious adverse events (SAE)
  • Increased overall efficiency
  • Clinical trial seamless execution (less paper work)
  • High quality data and no data re-entry (reduced risk of error)
  • Improved patient safety
  • Significant reduction of actual person-time and costs
The pharma perspective, interview with Prof. Dipak Kalra [08/10/2014]

Transforming clinical research for faster access to innovative medicine

Establishing the Value of EHR4CR for Pharmaceutical Industry

Background

In the current healthcare environment, bringing a new drug to market requires not only to gain regulatory approval, but also a favourable decision from payers and health technology agencies. With the development of novel sophisticated health technologies and targeted therapies, clinical research has become more complex, time consuming, and costly. In parallel, there is a need to generate a larger amount of clinical evidence (including from the real world) to establish the safety, efficacy, and comparative effectiveness of innovative medicines for achieving regulatory approval and market access. Given the need to conduct more clinical trials, and more efficiently, the pharmaceutical industry has begun the modernization of its traditional model for drug development by integrating value-added innovative solutions to its clinical research platforms 1-4.

Cost Benefit Assessment

Assessing the Value of EHR4CR to Pharmaceutical Industry

To assess the value of EHR4CR scenarios (either used distinctively or sequentially) compared to current practices, a robust cost-benefit assessment (CBA) was conducted from the perspective of pharmaceutical industry.

Using a state-of-the-art methodological approach, advanced simulation modelling, and best practices in health technology assessment, the EHR4CR CBA was conducted jointly with a multidisciplinary expert panel composed of EFPIA partners, academic partners, and expert health economists.

The CBA model used robust data, including a resource utilization assessment specifically conducted by EFPIA partners to estimate the actual person-time and related costs for performing each clinical research scenario under current conditions, and with EHR4CR solutions, relevant to Phase II-IV clinical trials in oncology. To reflect the high priority for Europe and for pharmaceutical industry, oncology was selected as an example and reference case for the CBA.

To assess the potential incremental financial value of EHR4CR services for pharmaceutical industry compared to current practices, the model assumes that the efficiency gains realized under EHR4CR conditions would translate into delivering innovative medicines to healthcare faster.

To calculate the potential incremental global financial benefit that could be generated by the pharmaceutical sector from EHR4CR services in oncology, the distribution of the global market values of oncology products (2012) was used 5. Uncertainty was managed with robust probabilistic sensitivity analyses. Statistical analyses were carried out to show any potential differences between EHR4CR solutions and current practices.

PRELIMINARY FINDINGS

The EHR4CR CBA preliminary findings suggest that:

  • Compared to current practices, EHR4CR services appear more efficient, leading to a reduction in actual person-time and costs for performing protocol feasibility assessment, patient identification and recruitment, and clinical study conduct, including SAE reporting.
  • The efficiency gains (reduced time and costs) with each distinct EHR4CR scenario (1,2, or 3) appear to cumulate when EHR4CR scenarios are simulated sequentially (1,2, and 3) for a given clinical trial.
  • Assuming that more efficient clinical research processes with the EHR4CR platform would translate into delivering innovative medicines faster, this would generate substantial financial added value for the pharmaceutical industry.
  • The EHR4CR CBA model assumes a swift adoption of EHR4CR services at project completion, followed by a scalable market penetration in Europe thereafter.

COMPLEMENTARY ANALYSES

Further CBA analyses are planned to assess the full scope of EHR4CR benefits for the pharmaceutical industry.

In addition to the CBA which establishes the value of EHR4CR services compared to current practices, a budget impact analysis (BIA) will be developed to estimate the budgetary impact for the pharmaceutical industry of adopting EHR4CR services.

CONCLUSIONS

The EHR4CR CBA and BIA will provide useful tools to assist decisions relevant to the adoption of EHR4CR sustainable solutions at project completion.

DISSEMINATION STRATEGIES

A EHR4CR CBA scientific manuscript is planned for submission to a peer-reviewed scientific journal.