Applying health technology assessment requirements to your global value dossier

Apr 16, 2021

 Written by Pip White, Senior Medical Writer

  

The global value dossier (GVD) is an essential tool used to internally align the global strategy and externally communicate the value of a product.

The GVD presents evidence-based messaging to convey the product value story and is a primary resource for affiliates. Unlike a Health Technology Assessment (HTA) submission, the GVD is strategic, bespoke, and not confined by restrictive templates and requirements. However, whilst GVDs and HTA submission dossiers are distinct materials with independent purposes, the application of common HTA agency requirements can create a powerful GVD with greater scientific rigour. See below…

Relevance to the scope

HTA agencies require that submissions contain evidence relevant to the scope of the assessment (1-11). Whilst not a formal requirement of the GVD, presentation of only the most relevant information provides rationale for selected messaging to support a powerful and concise value story. For example, trial populations (or subgroup/s), comparators, trial endpoints, and economic model inputs should all be reflective of the scope.

Rigorous systematic literature reviews

Some HTA agencies require the systematic identification of clinical and cost-effectiveness evidence (1-11). Synthesising evidence from a rigorous, up-to-date systematic literature review to meet HTA requirements creates a stronger evidence base to support messaging within the GVD. A clear search strategy can also ensure that only the strongest evidence is presented to avoid the GVD from becoming an evidence repository.

Comprehensive clinical efficacy and safety results

Presentation of clinical efficacy and safety results is essential for HTAs and GVDs; however, HTA agencies typically require considerably more detail (1-12). Ensuring that the GVD contains all relevant results and analyses with sufficient detail is essential. Comprehensive results support strategy alignment, affiliate understanding, and external communication. Key efficacy and safety results are reported in the main body of the dossier, with lower-priority results/additional analyses presented in appendices to maintain a streamlined dossier.

Robust economic analyses

Most HTA agencies request some form of budget impact and/or cost-effectiveness analysis (10-11). Presenting economic analyses within the GVD to the same standard as HTA submissions enables the reader to better understand the cost of the intervention versus standard of care. With increasing focus on resource allocation due to finite health budgets, robust economic analyses are vital to communicating the overall value of a technology.

If you would like to learn more about communicating the value of your product, please contact the Market Access and Value Communication team at Source Health Economics, an independent consultancy specialising in evidence generation, health economics, and communication.

 

References

  1.  European Network for Health Technology Assessment (EUNETHTA). HTA core model. Available at: https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf [accessed February 2021].
  2. All Wales Medicines Strategy Group (AWMSG). Available at: https://awmsg.nhs.wales/files/appraisal-process/guidance-on-appraisal-structure-and-evidence-considered-pdf-780kb/ [accessed February 2021].
  3. Canadian Agency for Drugs and Technologies in Health (CADTH). Available at: https://cadth.ca/sites/default/files/Drug_Review_Process/CADTH_Drug_Reimbursement_Review_Procedures.pdf [accessed February 2021].
  4. French National Authority for Health (HAS). Available at: https://www.has-sante.fr/jcms/c_2035649/en/assessment-of-medicinal-products [accessed February 2021].
  5. Italian Medicines Agency (AIFA). Available at: https://www.aifa.gov.it/web/guest/negoziazione-e-rimborsabilit%C3%A0 [accessed February 2021].
  6. National Institute for Health and Care Excellence (NICE). Single technology appraisal: User guide for company evidence submission template. Available at: https://www.nice.org.uk/process/pmg24/chapter/instructions-for-companies [accessed February 2021].
  7. Scottish Medicines Consortium (SMC). Available at: https://www.scottishmedicines.org.uk/making-a-submission/ [accessed February 2021].
  8. Sweden Dental and Pharmaceutical Benefits Agency (TLV). Available at: https://www.tlv.se/lakemedel/halsoekonomi.html [accessed February 2021].
  9. National Centre for Pharmacoeconomics (NCPE). Available at: http://www.ncpe.ie/submission-process/hta-guidelines/ [accessed February 2021].
  10. Pharmaceutical Benefits Advisory Committee (PBAC). Available at: https://pbac.pbs.gov.au/ [accessed February 2021].
  11. Der Gemeinsame Bundesausschuss (G-BA) Institute for Quality and Efficiency in Health Care (IQWiG). Available at: https://www.g-ba.de/english/benefitassessment/ [accessed February 2021].
  12. National insitute for Health and Care Excellence (NICE). Medical technologies evaluation programme methods guide. Available at: https://www.nice.org.uk/process/pmg33/resources/medical-technologies-evaluation-programme-methods-guide-pdf-72286774205893 [accessed February 2021].

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