NICE TA696 transformed NHS ATTR-CM access in 2021 — acoramidis’s pending appraisal and vutrisiran’s TA868/TA1115 access route now set the ceiling for UK amyloidosis spend.
NICE TA696’s Final Appraisal Determination (12 May 2021) recommended tafamidis (Vyndaqel/Vyndamax, Pfizer) for ATTR-CM patients with NYHA class I–II symptoms, a positive Tc-PYP scan or biopsy confirmation, and eGFR above 25. A confidential Patient Access Scheme, estimated at a 50–70% discount to WAC, brought the cost-effectiveness estimate within the standard £20,000–£30,000/QALY threshold, built on the ATTR-ACT trial’s 2.5-year mortality relative risk of 0.70 extrapolated to a 10-year survival benefit, with a modelled QALY gain of 0.7–1.2. NHS England Highly Specialised Cardiology services fast-tracked commissioning across 25 specialist centres, with an estimated 2,000 patients started within six months of publication and total annual NHS ATTR-CM spend projected at £80–120 million at peak of roughly 5,000 patients. NICE reappraised and updated the guidance as TA984 in 2024, reaffirming the same commercial terms.
Two further NICE decisions define the next phase of the UK ATTR market. Acoramidis (BridgeBio) showed composite-endpoint superiority over placebo in the ATTRibute-CM trial and is expected to enter NICE appraisal following EMA approval; because no head-to-head trial against tafamidis exists, BridgeBio’s positioning rests on indirect NT-proBNP and functional-improvement comparisons against historical tafamidis data, and at a WAC similar to tafamidis’s, NICE’s cost-effectiveness model will need to translate any incremental clinical benefit into an incremental QALY gain that justifies the additional cost. Separately, vutrisiran (Amvuttra, Alnylam) was recommended for ATTR-PN under NICE TA868 (published 15 February 2023) with a straightforward Patient Access Scheme discount, not a Managed Access Agreement, and NICE has since issued TA1115 (published 10 December 2025) recommending vutrisiran for ATTR-CM specifically, giving tafamidis its first head-to-head NICE-recommended competitor in the cardiomyopathy indication.
UK ATTR amyloidosis agent NICE and NHS status
| Drug (Brand / INN) | NICE HTA Route | NICE Recommendation & PAS/MAA | NHS Commissioning Channel | Cost-Effectiveness Position | Key Payer Risk |
|---|---|---|---|---|---|
| Vyndaqel/Vyndamax (tafamidis) | Standard Technology Appraisal (TA696, 2021; updated TA984, 2024) | Recommended with confidential PAS | NHS England Highly Specialised Cardiology — 25 centres | Within £20K–£30K/QALY threshold post-PAS (QALY gain 0.7–1.2) | Acoramidis entry on indirect comparison; no head-to-head trial exists |
| Amvuttra (vutrisiran) | Standard Technology Appraisal (TA868, 2023; extended TA1115, 2025) | Recommended with confidential Patient Access Scheme | NHS England Highly Specialised Cardiology — ATTR-PN and ATTR-CM | Recommended for both ATTR-PN (TA868) and ATTR-CM (TA1115) indications | First NICE-recommended competitor to tafamidis in the ATTR-CM indication |
Sources: NICE TA696 Final Appraisal Determination (tafamidis), 12 May 2021, updated as TA984, 2024; NICE TA868 Final Appraisal Determination (vutrisiran, ATTR-PN), 15 February 2023; NICE TA1115 (vutrisiran, ATTR-CM), 10 December 2025; NHS England ATTR-CM and ATTR-PN service commissioning documentation; ATTRibute-CM trial data (acoramidis), NEJM 2024; EMA acoramidis application timeline.
What this assessment answers
Every section answers a named commercial question your team is asking, scoped to your asset.
Delivers
- TA696 cost-effectiveness modelling breakdown (QALY gain 0.7–1.2
- PAS discount estimate 50–70%)
- NHS commissioning rollout data (25 centres
- ~2,000 patients in 6 months)
- annual spend projection at peak (£80–120M)
- TA984’s 2024 reappraisal terms
Delivers
- Indirect comparison methodology analysis (NT-proBNP, functional endpoints)
- expected NICE appraisal timeline post-EMA approval
- competitive positioning scenarios vs tafamidis at PAS-adjusted price
Delivers
- TA868 Patient Access Scheme terms for ATTR-PN
- TA1115 (December 2025) extension into ATTR-CM
- competitive positioning against tafamidis now that vutrisiran has a NICE-recommended cardiomyopathy indication
Custom assessment delivered in 72 hours.
Commission This AssessmentWhat's inside
- How NHS England Highly Specialised Cardiology services commission ATTR-CM care across 25 specialist centres following NICE's tafamidis recommendation
- The scale of NHS ATTR-CM treatment to date: roughly 2,000 patients started within six months of TA696's May 2021 publication
- How a confidential Patient Access Scheme discount of 50-70% off WAC brought tafamidis within the standard £20,000-£30,000 per QALY threshold
- Why TA984's 2024 reappraisal reaffirmed the same commercial terms, with peak NHS spend projected at £80-120 million across roughly 5,000 patients
- Why acoramidis's NICE case rests on indirect NT-proBNP and functional-improvement comparisons against historical tafamidis data, with no head-to-head trial
- What incremental QALY gain BridgeBio must demonstrate to justify a WAC similar to tafamidis's once NICE appraisal begins post-EMA approval
- TA868's February 2023 recommendation of vutrisiran for ATTR-PN under a straightforward Patient Access Scheme, not a Managed Access Agreement
- How TA1115's December 2025 extension into ATTR-CM gives tafamidis its first NICE-recommended head-to-head competitor in cardiomyopathy
- Projected peak NHS annual spend of £80-120 million across roughly 5,000 ATTR-CM patients under tafamidis's confidential PAS pricing
- How vutrisiran's recommendation across both ATTR-PN (TA868) and ATTR-CM (TA1115) indications compounds the combined NHS ATTR programme budget
- How Scotland's SMC and Wales's AWMSG assess ATTR agents separately against NICE's TA696/TA868 precedent, creating a divergence risk
- What a devolved-nation deviation from NICE's tafamidis and vutrisiran recommendations would mean for UK-wide access planning
Included with every brief
How AXLRx builds this assessment
Prepared by MoatRx analysts.
This assessment is built from NICE’s published Technology Appraisal documentation, NHS England Highly Specialised Cardiology commissioning specifications, and the ATTRibute-CM trial evidence supporting acoramidis’s pending NICE review.
Key sources: NICE TA696 Final Appraisal Determination (tafamidis), 12 May 2021, updated as TA984, 2024; NICE TA868 Final Appraisal Determination (vutrisiran, ATTR-PN), 15 February 2023; NICE TA1115 (vutrisiran, ATTR-CM), 10 December 2025; NHS England ATTR-CM service commissioning and ATTR-PN registry specifications; ATTRibute-CM trial results, NEJM 2024; EMA acoramidis application timeline. Devolved-nation positions (Scotland’s SMC, Wales’s AWMSG) are assessed separately against NICE’s TA696/TA868 precedent.
- NICE TA696 recommendation, PAS structure, and cost-effectiveness parameters verified against the NICE TA696 Final Appraisal Determination, 12 May 2021, and the TA984 update, 2024
- NHS commissioning rollout (25 centres; ~2,000 patients in 6 months) verified against NHS England ATTR-CM service commissioning documentation
- Vutrisiran’s Patient Access Scheme terms verified against the NICE TA868 Final Appraisal Determination, 2023, and the NICE TA1115 Final Appraisal Determination for ATTR-CM, 10 December 2025
- Acoramidis trial data verified against ATTRibute-CM published results, NEJM 2024, and the EMA acoramidis application timeline
Frequently asked questions
Commission this assessment
AXLRx ATTR Amyloidosis Payer & HTA is built for market access, HEOR, and pricing teams navigating NICE TA696/TA984’s tafamidis commissioning, vutrisiran’s TA868/TA1115 access route, and acoramidis’s pending NICE comparison in the UK. Custom assessment in 72 hours.
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