Full Submissions Support – Pharma

YHEC has a proven track record of creating all of the materials for health technology assessment (HTA) submissions across multiple countries, as well as preparing the submission documents. As such, we can seamlessly integrate the following into the submission dossier:

  • Systematic literature review of clinical efficacy and safety
  • Evidence synthesis (mixed treatment comparison, conventional meta-analysis)
  • Systematic literature reviews of published economic models, resource use and health related quality of life
  • Burden of illness reviews
  • Economic modelling (cost-effectiveness and budget impact)
  • Patient reported outcomes

YHEC regularly prepares dossiers for submission to all major UK based agencies (The National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC), All Wales Medicines Strategy Group (AWMSG)) as well as other major international agencies (National Centre for Pharmacoeconomics (NCPE), Canadian Agency for Drugs and Technologies in Health (CADTH), Pharmaceutical Benefits Advisory Committee (PBAC), The Dental and Pharmaceutical Benefits Agency (TLV), Belgian Health Care Knowledge Centre (KCE)).

YHEC will support you from beginning to end with your dossier preparation covering:

  • Preparation of an outline including key messaging for each section
  • Creation of content for all sections of the dossier
  • Section specific, as well as whole document review in order to streamline the review process and have key people critique key sections of the document at the right time
  • Overall editorial control
  • Highlighting text that is commercial in confidence or academic in confidence
  • Preparation of reference packs
  • Rapid post-submission support and reanalyses if needed
  • Organisation of mock appraisal committee meetings
  • Attendance at committee meetings

Examples of recent HTA submissions include:

  • SMC submission for a woman’s sexual health product
  • NICE submission for a new product in plaque psoriasis
  • NICE, SMC and NCPE submissions for an immuno-oncologic in urothelial cancer
  • NICE submission for a paediatric ultra-orphan product to treat a genetic disorder
  • NICE submission for a product in emphysema
  • KCE submission for a novel product in uveitis

YHEC can provide all elements needed for a successful HTA submission in house

 

Contact us today if you would like to enquire about this service

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