Playbook

What could be done, in what order, and where to stop and re-test the strategy

DEMO | Fictional asset | Illustrative outputsVelantra (fictional)Systemic lupus erythematosusOral, once daily

This illustrative playbook demonstrates how the analysis could be translated into sequenced actions. Timings, thresholds and market choices would require validation for a live asset.

The principle
Illustrative strategic judgement
Establish the evidence strategy, target price corridor and launch-sequencing governance before committing to visible market prices. Early price decisions may affect subsequent negotiations elsewhere.
1
Define the comparator strategy and quantify convenience

Illustrative timing

Months 0 to 6 | Evidence and framing before any authority sees a price

Illustrative strategic judgement
  • Consider early scientific advice with G-BA and HAS to explore whether the comparator can be framed as the treated refractory pathway rather than generic mycophenolate alone
  • Build the cost offset model that converts oral dosing into avoided infusion visits, travel, and monitoring
  • Explore a single European list corridor of 17,200 EUR, the illustrative German list price input used in the reference cascade simulator, and consider making confidentiality of net price a launch precondition
  • Map every referencing basket and rank the eight markets by assumed referencing influence

Illustrative decision checkpoint. Reassess the target corridor and value proposition if the intended comparator strategy is not accepted.

2
Consider initial entry in more price-tolerant markets

Illustrative timing

Months 6 to 12 | Sweden, the Netherlands, and the UK

Illustrative strategic judgement
  • Consider filing and launching in Sweden and the Netherlands at the corridor list price
  • Consider taking the UK appraisal early, where cost effectiveness may reward the adherence and offset case
  • Start a prospective adherence and flare registry from the first patient treated
  • Keep net price out of the public domain, and assess carefully any arrangement requiring a visible discount, considering its potential wider-market implications

Illustrative decision checkpoint. Three defensible prices on the record and around twelve months of adherence data would be a useful position before the German dossier is filed.

3
Prepare for negotiation in the anchor markets

Illustrative timing

Months 12 to 20 | Germany and France

Illustrative strategic judgement
  • Consider using the German free pricing window at the corridor list rather than above it, so any negotiated step down stays small
  • Bring the Nordic and UK price record and the registry data into the AMNOG and CEPS discussions
  • Explore volume commitments and outcome guarantees in place of visible price cuts
  • Model the referencing spillover of any offer received in advance, and consider delaying or restructuring offers where the modelled wider-market impact exceeds local value

Illustrative decision checkpoint. Illustrative decision threshold, not the expected German achievable net price: if the German net price were to land above 12,500 EUR the corridor would remain viable in the model, while the separately modelled net under the preferred scenario is 13,522 EUR. Below that threshold, the sequencing decision would be worth reopening.

4
Assess entry into the more price-sensitive markets

Illustrative timing

Months 20 to 30 | Italy, Spain, and Poland

Illustrative strategic judgement
  • Consider entering Italy and Spain only under confidential managed entry agreements
  • Consider later entry in Poland if suitable confidential or risk-sharing arrangements are unavailable that keep the list price at the corridor
  • Consider early access or named patient supply where reimbursement is still open, to support patients without setting a price

Illustrative decision checkpoint. If a confidential net price is unavailable, delaying entry may be preferable to accepting a visible cut, with the position revisited periodically.

5
Monitor and manage the European price corridor

Illustrative timing

Ongoing | Governance

Illustrative strategic judgement
  • Review the reference cascade regularly and re-run the sequencing model before every new market decision
  • Track parallel trade volumes and consider adjusting supply quotas where arbitrage appears
  • Feed real world outcomes back into each market at reassessment, and use them to help resist erosion

Illustrative decision checkpoint. A single owner for the global price corridor, able to consider delaying or restructuring any country deal where the modelled wider-market impact exceeds local value.

Illustrative strategic conclusion
Under the illustrative assumptions used here, a company in this position could consider treating Europe as one price corridor supported by evidence rather than as eight separate prices. Defensibility could be assessed pillar by pillar, recognising that convenience and clinical gain, rather than the generic price, would need to carry most of the premium. Each market could then be assessed on the price likely to survive HTA, the volume realistically treatable, the expected time to reimbursement, and the modelled effect its visible price may have on other markets. Sequencing could follow that assessment: more price-tolerant markets first to build a price record and real world data, the anchor markets next with that evidence in hand, and the more price-sensitive markets later and preferably behind confidential net prices. Where a market appears unable to clear the corridor floor, later entry may be worth considering, since the revenue protected elsewhere could outweigh the value of the market forgone. Each of these judgements would need validation for a live asset.