Onasemnogene Abeparvovec Intravenous (Zolgensma®) Service & Onasemnogene Abeparvovec Intrathecal (OAV101 IT) Service
NHS EnglandEstimated Value
Up to £26,136,000
Deadline
8 July 2026
Published
4 June 2026
Type
services
Overview
Onasemnogene abeparvovec intravenous (Zolgensma®) is a one-time, in vivo gene replacement therapy, for use in babies aged 12 months and under, that utilises an adeno-associated virus serotype 9 (AAV9) vector, modified to contain a functional copy of the human SMN1 gene. It is administered intravenously, allowing the vector to deliver the gene into motor neurones and peripheral tissues, enabling the sustained expression of survival motor neuron (SMN) protein, which is deficient or mutated in individuals with SMA.
Onasemnogene abeparvovec intrathecal (OAV101 IT) is a one-time in vivo gene replacement therapy for patients with SMA, proposed to treat individuals with SMA aged 2 years and over. This intrathecal injection will be used to treat a distinct cohort of SMA patients to Zolgensma. It will be assessed via NICE’s technology appraisal programme, with an expected final guidance publication date in late 2026.
Lots (3)
- Lot 1Zolgensma only (if no positive NICE recommendation for OAV101 IT)
- Lot 2Positive recommendation for OAV101 IT for paediatric patients (in combination with Lot 1 for Zolgensma)
- Lot 3Positive NICE recommendation for OAV101 IT for adult patients (either standalone or in combination with Lots 1 and 2)
AI Analysis
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The NHS is seeking to commission two gene therapy services for treating Spinal Muscular Atrophy (SMA): Zolgensma® for babies under 12 months (intravenous injection) and OAV101 IT for older children and adults aged 2+ (intrathecal injection into the spine). This is a highly specialised medical service requiring expertise in administering one-time genetic treatments that replace a faulty gene with a working copy.
Requirements
- Ability to deliver intravenous gene therapy (Zolgensma®) to infants aged 12 months and under
- Ability to deliver intrathecal gene therapy (OAV101 IT) to patients aged 2 years and over
- Expertise in managing adeno-associated virus (AAV9) vector-based gene therapies
- Capacity to monitor sustained expression of survival motor neuron (SMN) protein post-treatment
- Compliance with NICE technology appraisal guidance (expected late 2026 for OAV101 IT)
- Specialist staff trained in administering one-time in vivo gene replacement therapies
- Infrastructure to store, handle, and administer AAV9-based treatments safely
- Experience managing SMA patient cohorts and monitoring long-term outcomes
Key Tasks & Deliverables
- Administer Zolgensma® intravenously to babies aged 12 months and under with SMA
- Deliver intrathecal OAV101 injections to SMA patients aged 2 years and older
- Monitor patients post-treatment for sustained SMN protein expression and clinical outcomes
- Manage distinct patient cohorts (infants receiving Zolgensma versus older children/adults receiving OAV101 IT)
- Implement NICE-approved treatment pathways once guidance is published (late 2026 for OAV101 IT)
- Provide ongoing specialist clinical support and follow-up care after gene therapy administration
How to Read This Tender
- 1This tender has three separate 'Lots' (contract options) — Lot 1 is Zolgensma only, Lot 2 adds OAV101 IT for children, and Lot 3 adds OAV101 IT for adults. You may be asked to bid for one, two, or all three depending on your capacity. Check which Lot(s) apply to you.
- 2The approval status of OAV101 IT is conditional on NICE's final guidance (expected late 2026) — Lot 1 stands alone regardless, but Lots 2 and 3 depend on a positive NICE recommendation. Understand that timescales may shift based on NICE's decision.
- 3This is 'gene therapy' — a highly specialist field. The tender expects you to understand AAV9 vectors, intrathecal and intravenous administration routes, and long-term patient monitoring. If this is new territory, partner with a specialist provider or subcontractor.
- 4Look carefully at the full tender documents for: patient eligibility criteria, staffing and training requirements, storage/handling conditions for the therapy, and performance metrics for monitoring outcomes post-treatment.
- 5SMA (Spinal Muscular Atrophy) is rare, so patient numbers will be small. Focus on quality, safety, and specialist expertise rather than scale. Highlight any existing experience with rare genetic conditions or specialist therapies.
Tips for Small Businesses
- If you're not a large NHS trust, consider forming a consortium with a specialist gene therapy centre or hospital with existing infrastructure for rare disease management. Many SMEs win by subcontracting specialist delivery to experienced partners while providing other support services (e.g., patient coordination, monitoring, allied health support).
- Emphasise any track record with rare paediatric conditions, genetic disorders, or specialist intravenous/intrathecal therapies. Even if you haven't delivered gene therapy before, highlight relevant experience with complex infant care or spinal injections — this demonstrates capability in high-risk clinical environments.
- Social value scoring may favour providers who commit to patient support services (e.g., genetic counselling, family support networks, transition pathways from paediatric to adult care). Building these into your bid can differentiate you, especially as this affects small patient cohorts who benefit from holistic care.
Likely incumbents
Suppliers who won similar work from this buyer in the last 5 years.
- 1
HCRG Care Services Limited
1 contract wonlatest 14 Aug 2026 - 2
Practice Plus Group Health and Rehabilitation Services Limited
- 3
Rape Crisis South London
1 contract wonlatest 15 Jul 2026 - 4
University Hospitals Plymouth NHS Trust
1 contract wonlatest 22 Jun 2026
HCRG Care Services Limited is the most likely incumbent based on recency and category match. To win, bidders typically need a clearly differentiated proposition or a price advantage.
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Buyer Profile
NHS EnglandKey Dates
Published
4 June 2026
Submission deadline
8 July 2026
Notice type
tender
Source
find a tender
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