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.
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.
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.
NICE accepts a £100,000-300,000 QALY threshold for ultra-rare Pompe disease under its Highly Specialised Technologies pathway, five to fifteen times the £20,000-30,000 bar a standard technology appraisal applies. Avalglucosidase alfa's TA821 recommendation used that ceiling, 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.
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.
NICE built UK SMA access in sequence: 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, not an open field.
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.
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 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 Fabry disease is commissioned through three different NICE and NHS routes at once: no formal NICE technology appraisal for either enzyme replacement therapy, a Highly Specialised Technologies recommendation (HST4, 2016) for migalastat, and a standard technology appraisal (TA915, 2023) for pegunigalsidase alfa. A new entrant inherits no single reusable comparator or price benchmark.
NICE accepted an eGFR-slope-to-ESRD-delay model, not the headline proteinuria reduction, as the value basis for budesonide (TA937, expanded by TA1128) and sparsentan (TA1074) in IgA nephropathy. 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.
NICE has cleared four modern PNH anti-complement therapies (ravulizumab TA698, pegcetacoplan TA778, iptacopan TA1000 and crovalimab TA1019) through its standard £20,000-30,000 Technology Appraisal route, 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.
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.
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.
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.
Yes. You set the HTA bodies, market scope, and comparator set; the model is built to your scope and delivered editable.