Onasemnogene Abeparvovec Intravenous (Zolgensma®) Service & Onasemnogene Abeparvovec Intrathecal (OAV101 IT) Service

Notice summary

Spinal muscular atrophy (SMA) is a rare genetic disorder that causes muscle weakness and progressive loss of movement. The severity of SMA can vary greatly between individuals. Historically, the condition has been classified into different types, determined by clinicians at the time of diagnosis. This classification is based on both the age at which symptoms first appear, and the highest level of motor function achieved by the patient.

The types range from type 0, the most severe form, where symptoms are present before birth and most affected infants do not survive past 6 months, through to type 4, which develops in adulthood and is associated with mild motor impairment and a normal life span. However, because the disease presents so variably, consistently categorising patients into these types at the point of diagnosis can be challenging.

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.

This procurement is based on Lots with the intention to cover the population served by NHS England.

The objective is to allow Bidders to apply for different Lots that align best with their service capability and capacity.

Lot 1: Zolgensma only (if no positive NICE recommendation for OAV101 IT)

Lot 2: Positive recommendation for OAV101 IT for paediatric patients (in combination with Lot 1 for Zolgensma)

Lot 3: Positive NICE recommendation for OAV101 IT for adult patients (either standalone or in combination with Lots 1 and 2)

To express interest and participate in the Competitive Process, please register and apply via Atamis e-sourcing portal https://health-family.force.com/s/Welcome Should Tenderers have any queries, or problems using the portal, they should contact the Helpdesk at:

E-mail: [email protected]

The closing date for completed Competitive Process responses is 12:00pm (noon), on Wednesday 8 July 2026.

Atamis Project reference C449537.

The contract duration is for three (3) years with the Commissioners having the option to extend for up to an additional two (2) year(s) (maximum contract duration five (5) years).

This is a Provider Selection Regime (PSR) Contract Notice. The awarding of this contract is subject to

the Health Care Services (Provider Selection Regime) Regulations 2023. For the avoidance of doubt, the provisions of the Public Contracts Regulations 2015 do not apply.

Opportunity 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.

Contract and delivery

Lot 1: Zolgensma only (if no positive NICE recommendation for OAV101 IT)

Lot 2: Positive recommendation for OAV101 IT for paediatric patients (in combination with Lot 1 for Zolgensma)

Lot 3: Positive NICE recommendation for OAV101 IT for adult patients (either standalone or in combination with Lots 1 and 2)

Contracting authority

NHS England Wellington House, 133-135 Waterloo Rd, London, SE1 8UG, UKI, United Kingdom Contact: Surinder Kahlon Email: [email protected] Website: https://www.england.nhs.uk/

Procedure

Procedure: Open procedure Method: open Legal basis: 32014L0024

How to respond

Submissions and documents are handled via: https://atamis-1928.my.site.com/s/Welcome

CPV Classification

85100000 — Health services

Submission portal

https://atamis-1928.my.site.com/s/Welcome

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We can help you respond to Onasemnogene Abeparvovec Intravenous (Zolgensma®) Service & Onasemnogene Abeparvovec Intrathecal (OAV101 IT) Service with a specification-mirrored method statement, named operational evidence, and a 72-hour pre-submission review built in.