Section one: Contracting authority
one.1) Name and addresses
NHS England - Specialised Commissioning
80 London Road
London
SE1 6LH
Contact
Anna Salt
Country
United Kingdom
NUTS code
UK - United Kingdom
National registration number
na
Internet address(es)
Main address
Buyer's address
https://uk.eu-supply.com/ctm/Company/CompanyInformation/Index/68205
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Services to deliver Onasemnogene abeparvovec/Zolgensma
two.1.2) Main CPV code
- 85000000 - Health and social work services
two.1.3) Type of contract
Services
two.1.4) Short description
NHS England is seeking to commission a service to deliver Onasemnogene abeparvovec/Zolgensma from four providers in England. It is currently anticipated that there may be one provider to cover the North of England, one to cover the Midlands, one to cover the South of England plus one other. The commissioner is by no means fixed on this geographical spread as the quality of the service provision is the most important factor.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £6,000,000
two.2) Description
two.2.2) Additional CPV code(s)
- 85100000 - Health services
- 85140000 - Miscellaneous health services
two.2.3) Place of performance
NUTS codes
- UK - United Kingdom
two.2.4) Description of the procurement
Spinal muscular atrophy, or SMA, is a rare genetic disorder that causes
muscle weakness and progressive loss of movement. It is most commonly
caused by defects in the gene SMN1.
Onasemnogene abeparvovec (Zolgensma, AveXis) is a single-use gene
replacement therapy made of a viral vector that has been modified to contain
the primary gene for the human survival motor neuron (SMN) protein, which is
lacking or mutated in people with SMA. When injected, the vector is expected
to carry the gene into the nerve cells, enabling production of sufficient
amounts of SMN. It is administered intravenously.
NHS England is seeking to commission a service to deliver Onasemnogene abeparvovec/Zolgensma from four providers in England. It is currently anticipated that there may be one provider to cover the North of England, one to cover the Midlands, one to cover the South of England plus one other. The commissioner is by no means fixed on this geographical spread as the quality of the service provision is the most important factor.
As well as having a neuromuscular MDT and experience in treating children with SMA, the successful providers will need to have the capability to safely manage the product itself in line with it being classified as ‘containment level 1’ and ensure that all elements of the patient pathway (pre-treatment, during treatment and post-treatment) can be put into place. The providers will also be expected to operate as a national-MDT to ensure that eligible patients can be treated within appropriate timescales. This will involve regular meetings/calls to discuss the appropriate treatment of individual patients and to share information on capacity to treat patients.
It is anticipated that the number of children requiring treatment each year is between 25 and 35, although this number may be subject to change, depending on the outcome of the NICE evaluation and, for example, if new-born screening for SMA was introduced.
Novartis Gene Therapies is the company who produce this gene therapy and providers will be required to comply with the company’s contractual documentation. This is currently in draft so providers will be expected to have contacted Novartis Gene Therapies prior to submitting a tender response to discuss their requirements in respect of providing a service to deliver Onasemnogene abeparvovec/Zolgensma.
Given the significant amount of preparatory work that needs to be undertaken to deliver a gene therapy service, it is not feasible for commissioners and providers to wait until NICE has made its recommendation. To do so would risk the NHS not being ready to provide access within the timeframe set out in the Mandate requirements on NICE approved treatments and not being able to make the treatment available as soon as possible after the NICE decision has been made. Providers are therefore submitting bids to deliver a service ‘at risk’ and it may be the case that the product does not receive a positive NICE recommendation. Bidders are responsible for their own costs incurred throughout each stage of the Procurement process.
two.2.5) Award criteria
Quality criterion - Name: Quality / Weighting: 100
Price - Weighting: 0
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
two.2.14) Additional information
All bidders must complete the Qualification Questionnaire and Technical Questions.
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.1) Previous publication concerning this procedure
Notice number: 2021/S 000-002051
Section five. Award of contract
Contract No
1
Title
Services to deliver Onasemnogene abeparvovec/Zolgensma
A contract/lot is awarded: Yes
five.2) Award of contract
five.2.1) Date of conclusion of the contract
28 May 2021
five.2.2) Information about tenders
Number of tenders received: 11
The contract has been awarded to a group of economic operators: Yes
five.2.3) Name and address of the contractor
Manchester University Hospitals Foundation Trust
Manchester
Country
United Kingdom
NUTS code
- UKD - North West (England)
The contractor is an SME
No
five.2.3) Name and address of the contractor
Guy’s and St Thomas’ NHS Foundation Trust
London
Country
United Kingdom
NUTS code
- UKI - London
The contractor is an SME
No
five.2.3) Name and address of the contractor
Sheffield Children’s NHS Foundation Trust
Sheffield
Country
United Kingdom
NUTS code
- UKE - Yorkshire and the Humber
The contractor is an SME
No
five.2.3) Name and address of the contractor
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol
Country
United Kingdom
NUTS code
- UKK - South West (England)
The contractor is an SME
No
five.2.4) Information on value of contract/lot (excluding VAT)
Total value of the contract/lot: £6,000,000
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
Arden & GEM Commissioning Support Unit
2nd Floor Cardinal Square, 10 Nottingham Road
Derby
DE1 3QT
Country
United Kingdom
six.4.2) Body responsible for mediation procedures
Arden & GEM Commissioning Support Unit
2nd Floor Cardinal Square, 10 Nottingham Road
Derby
DE1 3QT
Country
United Kingdom
six.4.4) Service from which information about the review procedure may be obtained
Arden & GEM Commissioning Support Unit
2nd Floor Cardinal Square, 10 Nottingham Road
Derby
DE1 3QT
Country
United Kingdom