Summary
- Price & reimbursement: Practices can buy inclisiran from AAH at a £45 nominal charge and claim it as a personally administered (PA) item at a Drug Tariff reimbursement of £60 per injection from 1 April 2025. NHS England
- Secondary care: Prior-approval (e.g., Blueteq) has been removed from 1 April 2025, aligning secondary-care processes with primary care. NHS England
- Contracting: Delivery in general practice is not a core GMS/PMS requirement.
- BMA position: Given workload, liability and still-evolving long-term outcomes evidence, practices should not prescribe/administer inclisiran without an adequately funded locally commissioned service
Funding and claiming
Supply route & prices
- Order from AAH at £45 nominal charge (+ VAT); 30-day end-of-month payment terms. NHS England
Claiming
- Claim as a Personally Administered (PA) item at £60 per injection (from 1 Apr 2025), listed in Drug Tariff Part VIIIC. NHS England
- Discount deduction (clawback) does not apply to this Part VIIIC(ii) item for GP practices (from 1 Oct 2024). NHS England
- VAT allowance is added to claims. NHS England
Required paperwork
- Include inclisiran on the FP34PD submission document (not the “high-volume vaccines” appendix) and submit an individual FP10 per injection to trigger the fee and drug reimbursement. NHS England
Income components (per injection)
- Non-dispensing practices - price differential (“practice profit”): £60 – £45 = £15. NHS England
- Dispensing practices - price differential (“practice profit”): £18 (dispex)
Practice workload implications
Delivery of inclisiran within practices creates workload and governance considerations:
- Register, call/recall, and tracking of a twice-yearly schedule after loading.
- Ordering, cold-chain storage and stock control (do not freeze; 3-year shelf-life). NHS England
- Clinical responsibility (patient selection per NICE TA 733 cohort and local pathways; documentation; adverse drug reaction reporting).
- Administration (trained staff, observation, documentation).
- Staff Training & Standard Operating Procedures (injection, cold chain, claims workflow).
- Demand/Capacity mismatch: especially with targeted CVD screening programmes.
Contracting and comparators
- Non-core service: Inclisiran administration is not mandated in core GMS/PMS; participation requires suitable funding. Some ICBs (e.g., Hampshire & IOW) have commissioned an LCS/LES to recognise workload and liability. Wessex LMC scpsc.org.uk
- Comparators: Other injections delivered in general practice (e.g. joint injections) may attract reimbursement profit but are typically delivered under a Direct Enhanced Service (DES), commissioned for administration and clinical responsibility. (There is no national DES for inclisiran administration.)
BMA advice
Do not proceed without an adequately funded locally commissioned service that covers call/recall, admin time, premises/overheads, training, governance, stock/cold-chain, clinical risk, and claims processing.
Safety and efficacy: what we know and what we don’t
Safety
- Pooled/longer-term analyses (up to 3–4 years exposure across programmes) report favourable tolerability with no new safety signals, aside from higher rates of mild/moderate injection-site reactions. JACCOxford Academic
Efficacy (lipids)
- Pivotal ORION trials show 50% LDL-C reduction vs placebo sustained over 18 months; reductions of ~48–52% across ORION-9/10/11. NICEPMC
- Durability of LDL lowering maintained in longer-term open-label extensions. The Lancet
Critical evidence gap: cardiovascular outcomes
- No completed hard-outcome (MACE) trials yet. Large outcomes trials (ORION-4, VICTORION-2 PREVENT) are ongoing, with read-outs expected 2026–2027. Until then, long-term efficacy on events remains unconfirmed. tctmd.comPMC
Implications for practice
- While LDL-C lowering is robust and durable, real-world effectiveness on CVD outcomes and very long-term safety beyond trial horizons are still evolving. These uncertainties should be reflected in shared decision-making and local commissioning terms.
BMA recommendations to LMCs and practices
1. Do not implement inclisiran clinics without an adequately funded locally commissioned service that explicitly covers workload, training, governance, and clinical risk.
2. Insist on written ICB terms covering call/recall admin, stock & cold-chain costs, premises time, staff training, indemnity, and claims processing steps (FP34PD + FP10).
3. Use strict eligibility criteria aligned to NICE TA733 and national lipid pathways.
4. Counsel on uncertainties: explain the absence (to date) of completed CVD outcomes data and discuss ongoing trials. tctmd.com
5. Monitor and code: re-check LDL-C after the second dose and maintain robust Adverse Drug Reactions (ADR) reporting (black triangle).
6. Audit claims monthly to ensure the fee has been correctly paid; escalate discrepancies to NHSBSA/ICB.