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02 · Sizing & Access · Analysis type · 11 published

HTA Strategy Model

A 9-sheet HTA submission-strategy model: authority landscape, PICO framework, comparator defence, value-dossier self-assessment, HEOR gap register, and submission timeline — built before the dossier is written, not after.

Every HTA Strategy Model analysis

HTA · Oncology · Medical Affairs · Heor UK Breast Cancer HR+/HER2- HTA Strategy Model NICE accepts palbociclib, ribociclib, and abemaciclib as comparators for each other. No trial has ever tested any of them head-to-head against exemestane plus everolimus, the older endocrine-based comparator regimen they effectively replaced. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK Myasthenia Gravis HTA Strategy Model NICE has never modelled a cost-per-QALY for a myasthenia gravis biologic. Eculizumab's appraisal (TA636) closed before a dossier was submitted; efgartigimod's (TA1069) closed on evidence gaps, not a quantified ICER breach. A new entrant inherits no reusable comparator or price benchmark from either. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK Dravet Syndrome HTA Strategy Model Both existing Dravet therapies cleared NICE's standard Technology Appraisal, not the ultra-rare Highly Specialised Technology route. A new entrant's WAC, PAS, and stakeholder-engagement calendar all need to be built against that lower cost-effectiveness bar, with soticlestat's 2026-27 appraisal setting the clock. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK Pompe Disease HTA Strategy Model NICE accepts a £100,000-300,000 QALY threshold for ultra-rare Pompe disease, five to fifteen times the standard appraisal bar. That Highly Specialised Technologies ceiling is what avalglucosidase alfa's TA821 recommendation used, but only with a substantial confidential commercial arrangement. A new entrant without that leverage should build a standalone case for the antibody-positive inadequate-responder subgroup instead. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK ATTR Amyloidosis HTA Strategy Model NICE recommends both ATTR-CM stabilisers, tafamidis (TA984) and acoramidis (TA1121), and directs clinicians to the cheaper one. Acoramidis cleared on indirect comparison alone. A third entrant must beat an invisible, PAS-discounted floor, with no published price target. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK Spinal Muscular Atrophy HTA Strategy Model NICE built UK SMA access in sequence, not as an open field. Gene therapy took the pre-symptomatic subgroup first (HST15, HST24), then TA1162 moved chronic therapy to routine funding behind it. A new entrant inherits a fixed subgroup hierarchy and a comparator that shifts by population. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK Sickle Cell Disease HTA Strategy Model NICE recommended crizanlizumab (TA743) via managed access in 2021, then withdrew it in 2023 after the confirmatory trial failed. Casgevy (TA1044) cleared only by restructuring its £1.65M price into managed access. A new entrant inherits no reusable ICER benchmark from either. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK Hereditary Angioedema HTA Strategy Model Three completed NICE standard technology appraisals already fund HAE prophylaxis in England (TA606, TA738, TA1101). Every one cleared at the ordinary £20,000 to £30,000 per QALY bar and is held behind a confidential Patient Access Scheme, so a new entrant inherits a comparator-dense field in which garadacimab's £20,625 list pen is the only transparent price. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK IgA Nephropathy HTA Strategy Model NICE accepted an eGFR-slope-to-ESRD-delay model, not headline proteinuria reduction, as the value basis in IgA nephropathy. That covers budesonide (TA937, expanded by TA1128) and sparsentan (TA1074). The mandatory ACEi/ARB and SGLT2 inhibitor optimisation gate narrows the UK's 10,000 to 15,000 patients to a 3,000 to 5,000 novel-agent-eligible pool before that pricing math applies. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK Fabry Disease HTA Strategy Model UK Fabry disease is commissioned through three different NICE and NHS routes at once. No formal technology appraisal for either enzyme replacement therapy, a Highly Specialised Technologies recommendation (HST4, 2016) for migalastat, and a standard appraisal (TA915, 2023) for pegunigalsidase alfa. A new entrant inherits no single reusable comparator or price benchmark. UK · In-Market · 24–32 pp · PDF · Excel · PPT HTA · Rare Disease · Medical Affairs · Heor UK PNH HTA Strategy Model NICE has cleared all four modern PNH anti-complement therapies through its standard £20,000-30,000 Technology Appraisal route. Ravulizumab TA698, pegcetacoplan TA778, iptacopan TA1000 and crovalimab TA1019, each contingent on a confidential commercial arrangement, never the Highly Specialised Technologies threshold. A new submission inherits an unbroken standard-STA precedent it must be built to clear from the first dossier decision. UK · In-Market · 24–32 pp · PDF · Excel · PPT

HTA Strategy Model — frequently asked

What formats are included?

An editable 9-sheet Excel HTA strategy model and a PDF methodology brief, with a 45-minute analyst call included. No PowerPoint deck — this deliverable is built to be worked in directly.

How is the HTA evidence verified?

Every HTA body requirement, comparator claim, and evidence gap is cited to a primary regulatory or HTA source — no assumption is carried from model memory.

Can I scope this to a specific HTA body or market set?

Yes. You set the HTA bodies, market scope, and comparator set; the model is built to your scope and delivered editable.