Worth the Device — HTA of a High-Cost Cardiac Implant

Advanced healthcare-management simulation that puts you in the HTA Analyst seat at Azienda Ospedaliera San Gerardo, a 720-bed regional teaching hospital in Lombardy whose adoption verdicts set a precedent for all of Lombardy. MedTech vendor CardioNova has filed a market-access dossier for VentriGuard, an implantable heart-failure monitor priced at €22,000 per patient, against an uncommitted devices envelope of only €2.4M. Across four rounds — Appraise the Evidence and set the WTP/QALY threshold; Run the HTA (ICER, sensitivity, and budget-impact at hospital and regional scale); issue the Adoption Recommendation, eligibility sub-group, and reimbursement tier; then Defend & Negotiate against the cardiology chief, the vendor's confidential discount, and a patient-access demand — you set explicit evidence standards, build a real ICER and budget-impact model, and design value-based reimbursement that ties spend to value. The engine computes incremental cost, QALYs, ICER versus your threshold, hospital and regional budget impact, access coverage and an equity score, so that approving on cost-effectiveness alone bankrupts the system, swallowing the sponsor's 0.6-QALY claim fails the pessimistic case, rejecting outright leaves real benefit on the table, and a toothless tier lets volume blow the envelope. Anchored in Tarricone's MedtecHTA / value-based-access framework, ICER-versus-willingness-to-pay logic, budget-impact analysis, the cost-effectiveness plane, and managed-entry / outcomes-based agreements.