Device Companies

YHEC regularly prepares dossiers for submission to all major UK based agencies (National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC), All Wales Medicines Strategy Group (AWMSG)) and has good experience of preparing submissions to 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
• Commercial and academic in conference highlighting
• 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 health technology assessment (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
• NICE submission for treating liver cancer

YHEC ensures that all NICE dossier chapters are aligned to optimise the likelihood of a positive outcome