Glossary

Food for Special Medical Purposes. EU regulatory category covering medical nutrition products used under medical supervision, including hypoallergenic infant formulas.

UK route for FSMP listing. The Advisory Committee on Borderline Substances reviews medical foods for NHS prescribability; products appear in Part XV of the Drug Tariff.

Health Technology Assessment. National bodies (NICE in UK, HAS in France, G-BA in Germany, AIFA in Italy) that evaluate clinical and economic value before listing.

Country-level reimbursement list - LPPR (France), Lista (Italy), Nomenclator (Spain), GVS (Germany), Drug Tariff (UK).

Competitive procurement at national or regional level. Italy (regional), Spain (CCAA), Sweden (regions) and Poland (NFZ) run tender-driven access.

Reimbursement decided by statutory sickness funds or insurers rather than a central HTA list. Common in Germany (GKV) and the Netherlands.

How a prescribed pack actually gets paid for - retail prescription, hospital supply, social security reimbursement, etc.

Clinical and reimbursement requirement to trial eHF before AAF is funded. Heavily influences volume mix between Aptamil/Cow & Gate Pepti (eHF) and Neocate (AAF).

Amino Acid Formula and extensively Hydrolysed Formula. eHF is typically prescribed first-line for cow's milk protein allergy; AAF is escalated to when eHF fails or in severe cases.

Cow's Milk Protein Allergy. Primary clinical indication for the Aptamil Pepti, Cow & Gate Pepti and Neocate ranges.

Extensively Hydrolysed Formula with a built-in anti-reflux thickener (typically carob bean gum). Used for CMA infants with regurgitation, removing the need for an add-on thickener such as Carobel. Currently a category-of-one held by Novalac Allernova AR (United Pharmaceuticals); no equivalent SKU exists in Aptamil Pepti or Cow & Gate Pepti.

Composite score of regulatory steps, payer fragmentation and tender intensity. 1 = single national pathway, 5 = highly fragmented regional access requiring per-region engagement.

VISFO analyst confidence in the documented pathway. High = primary-source verified. Moderate-High / Moderate = directionally correct, spot-check recommended. Low-Moderate = verify per region or SKU before action.

Estimated months from dossier submission to first reimbursed dispense in market. Includes HTA review, listing and any tender cycles.

Count of in-scope Danone SKUs across Aptamil, Neocate and Cow & Gate that map to the market's pathway. Drives commercial prioritisation.

Invoice price after contracted discounts, rebates and tender concessions. The true realised price per pack, distinct from list price.

Erosion of net price vs benchmark, typically caused by over-discounting, off-contract sales or unmanaged tender concessions.

Share of in-market volume governed by an active commercial contract vs. spot / open-market purchases.

Scored view of clinical, health-economic and real-world evidence per SKU. Used to identify dossier gaps before HTA submission.

Share of tenders won vs. participated in over the trailing 12 months, by market and competitor.

Relative share of HCP-directed promotional activity (congress, digital, field) vs. tracked competitors.

Formal review point between programme phases. Phase 1 to Phase 2 transition requires evidence, pricing, competitive and access workstreams to clear defined readiness criteria.

Phase 1: intelligence and baseline mapping across pricing, competitors, evidence and access. Phase 2: activation - pricing playbooks, dossier upgrades and market-access execution.

Danone extensively hydrolysed formula (eHF) range for CMPA. SKU prefix APT-PEP. First-line in step-up protocols.

Danone amino acid formula (AAF) range via Nutricia. SKU prefix NEO-. Second-line where eHF fails or in severe / multi-allergy cases.

Danone eHF range positioned alongside Aptamil Pepti in the UK and selected EU markets. SKU prefix CG-.

APT- = Aptamil, NEO- = Neocate, CG- = Cow & Gate. Suffix encodes format and pack size, e.g. APT-PEP1-800 = Aptamil Pepti 1, 800 g tin.