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Navigating the Landscape of Health Technology Assessments

Supporting you through your HTA journey, from initial strategy to reimbursement and launch

Early-stage HTA strategy

The power of early strategic advice to ensure high-quality trial designs.

OPEN Health can provide comprehensive, early strategic advice to ensure your trial meets HTA bodies’ requirements, maximizing chances of success.

Strategic advice can encompass:

  • PRO landscape assessment
  • PRO gap analysis
  • PRO measurement strategy (schedule of assessments, mode of administration, length of follow-up
  • Tailored advice on HTA requirements and timing of submissions
  • Determining the best approach for inclusion of utilities in your economic model
  • Support for HTA bodies’ early scientific advice submission
  • Support for UK NICE Innovative Licensing and Access Pathway (ILAP) submission
  • Early modeling using TPP (target product profile) and available trial data to ascertain EJP (economically justifiable price) as well as key data gaps affecting the cost effectiveness
  • Feasibility assessment of available RWD

End-to-end comprehensive HTA submission support and delivery

Our specialist teams in market access strategy and health economic modeling and meta-analysis work seamlessly together to support you, with a designated project manager to ensure clear communication and collaboration across the entire HTA process.

Case study: Secondary data research and machine learning in lysosomal storage disorders

Supplement clinical trial data during submissions to demonstrate differential value post launch.

OPEN Health offers a complete real-world evidence (RWE) solution, starting with a strong consultancy platform to support our clients to define potential data gaps and the most optimal solutions for RWE generation.

Click on each section to read more.


Challenges

Lysosomal storage disorders (LSDs) are a group of rare diseases with a wide range of symptoms. Diagnosis is often delayed due to variations in patient characteristics and access to specialist centers and testing.

The client needed an approach that yielded multiple outcomes. These included HTA submission, pathway analysis and burden quantification, and the development of an algorithm to identify patients with potentially undiagnosed LSDs.


Approach

Using the Clinical Practice Research Datalink and Optimum Patient Care Research Database plus Hospital Episode Statistics, an analysis was undertaken to determine the disease and natural history characteristics of LSD patients. Economic burden and disease pathways were described and quantified and validated with KOLs.

Using a variety of machine learning technologies, a patient-finding algorithm was developed. It was tested and validated with KOLs and provided to the NHS. In addition, a disease burden payer engagement model was developed, and a pathway and outcome analysis provided to NICE.


Outcomes

  • Data used for HTA submission
  • Diagnostic algorithm developed and deployed
  • Payer engagement toolkit
Learn more about our complete real-world data solution

Increasing the role of patients in the HTA decision-making process

Regulatory and HTA submissions require the integration of the patient voice to contextualize the results observed in clinical trials. 

Through decades of helping bring innovative therapies to market, we understand the patient’s perspective and how to develop patient-centric studies.

Learn more about including patients’ perspectives with these resources.

Making HEOR more accessible to patients

This whitepaper presents a cross-discipline review of how we can improve patient involvement and understanding across the HEOR process.

Read more
Effectively articulating burden for future

In this webinar, we address all facets of burden with patient advocates and experts in rare disease, health technology assessments and patient-centred outcomes.

View webinar

HTA and digital health technologies

As digital health becomes an increasingly common feature on the healthcare landscape, digital therapeutics have gained a lot of attention from both regulatory and HTA authorities.

Our market access expertise can guide you to the right digital tool to enhance your project.
View our white papers to learn more about the adoption of digital health technologies.

Digital Therapeutics Landscape In Europe 40 overlay
Digital Therapeutics Landscape In Europe
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Assessing Digital Health Technologies 40 overlay
Assessing Digital Health Technologies
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Get in touch

To learn more about our HTA capabilities and discuss what we could do for you, please get in touch.

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