Additional compliance requirements for submissions to health technology assessors and insurance appraisers:
✅
Clear Labelling: Ensure the document is clearly labelled as "For submission to [HTA/insurer name]" and not distributed outside that context.
✅
Data Substantiation: Claims and economic arguments must be substantiated with robust data (peer-reviewed or accepted HTA modelling standards).
✅
Objective Language: Avoid superlatives ("best," "first," "only") and any marketing tone. Stick to objective, factual language.
✅
No Promotional Branding: Do not include promotional branding, slogans, or imagery. Company/product identification should be functional only.
✅
Pre-licence Products: For pre-licence products, restrict content to factual, non-promotional information (e.g., mechanism of action, study design).
✅
Value Transfer Compliance: If the submission includes value transfer or joint working arrangements with the NHS or insurers, ensure contracts and ABPI disclosure obligations are met.
⚠️
Audit Trail: Keep an audit trail — submissions may be scrutinised later in a complaint.
Comments & References
No compliance issues detected