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If you think a HTA submission cannot successfully be completed in a weekMore case studies

REWRITING AN HTA SUBMISSION IN JUST 7 DAYS


  • A global pharmaceutical company engaged FIECON for HTA submission support following a failed submission which had not undergone an internal approval process.
  • Rescue work was required to ensure an optimal outcome on re-submission.
CHALLENGE
  • The original submission had several gaps in the value story, strategic alignment, and clinical and economic evidence.
  • With just 7 days to present a re-submission to HTA, major re-working and additions to the submission were required.
Action
Respecting the technical:
  • The base case for the CUA was amended to increase robustness through re-selecting survival curves to better reflect the clinical plausibility of the long-term extrapolations.
  • FIECON accuracy-checked clinical sections, wrote up key studies missing in the clinical evidence sections and produced the clinical SLR appendix.
  • Document A was updated to ensure consistency throughout the submission.
Delivering the practical:
  • Conference calls to fully understand the decision problem and strategic goals of the client were organised.
  • Internal communications to allow simultaneous work on clinical and economic sections were carried out.
  • Determining the base case for economic analyses, to allow time for running lengthy sensitivity analyses and defining scenarios was prioritised.
result
  • The HTA submission was completed in a week (only 7 days); a consistent, high-quality, strategically aligned product value evidence package.
  • FIECON provided ongoing consultancy support post-submission to ensure HTA reimbursement.

    Acronyms: CLL, Chronic Lymphocytic Leukaemia; CMA, Cost Minimisation Analysis; CUA, Cost Utility Analysis; NICE, National Institute for Health and Care Excellence; SLR, Systematic Literature Review; TBC, To Be Confirmed.