Treatment to adult patients who have 5Q Spinal Muscular Atrophy (SMA) with the Drug Nusinersen (2)

NHS Arden and Greater East Midlands CSU (AGCSU) on behalf of NHS England Specialised Commissioning is inviting suitably qualified and experienced providers to deliver Treatment to adult patients who have 5Q Spinal Muscular Atrophy (SMA) with the Drug Nusinersen under the Compliance Process specified in Document 1 - Process Overview of process documentation.

On 24 July 2019, NICE published Technology appraisal guidance on the use of the drug Nusinersen to treat patients with 5q Spinal Muscular Atrophy (SMA). This is a rare, genetic, neuromuscular disease, characterised by spinal motor neuron loss, muscle atrophy and motor impairment. SMA is debilitating for all patients and fatal for the worst affected; patients and their families can experience extremely high levels of burden.

NHS England has agreed a 'Managed Access Agreement (MAA)' for the drug nusinersen for the treatment of eligible patients with spinal muscular atrophy (SMA). The NICE guidance sets out that the drug should only be made available to people who meet the criteria for treatment under the associated MAA.

The key objectives of the Compliance Process are: to commission the service(s) to serve adult patients eligible to receive the treatment nationally. It is estimated that 600 patients (adults and children) will be treated in England over the lifetime of the contract. Patients' eligibility and population covered are described in section 4 of the Managed Access Agreement. This may include treating patients from the devolved nations.

The Commissioner is seeking to appoint providers who have expertise in the treatment of adults with SMA (from 16-18 years of age, depending on local agreements) and who have the infrastructure both to be able to treat patients with nusinersen (which is given by intrathecal injection) and to collect detailed monitoring information about eligible patients. Providers will need to demonstrate that they are suitably qualified and can meet the agreed service requirements.

In 2019, NHS England ran a compliance process to appoint providers to deliver the service and was able to appoint several suitably qualified and experienced providers. Since then, the Commissioners have assessed patients' needs and have identified service gaps nationally. In order to address these gaps, the Commissioners are re-issuing the opportunity.

Further information about scope and qualification requirements can be found in the process documentation published on the EU Supply eTender/Procurement portal (Quote/tender 39295). All communications regarding this opportunity will be managed via the EU Supply messaging service.

Additional information: An agreement will be established with the successful applicants for a period of 3 (three) years with the Commissioner having the option to extend the contract until the end of the Managed Access Agreement (24 July 2024). To apply please visit https://uk.eu-supply.com/login.asp?B=UK Quote/tender 39295 - NHS England Spec. Commissioning - Treatment to adult patients who have 5Q Spinal Muscular Atrophy (SMA) with the Drug Nusinersen (2).