HSCT UK criteria

Patient Eligibility Criteria Adopted by the London MS-AHSCT Collaborative Group

The England (Wales, Scotland and NI don’t currently fund HSCT on the NHS) National Health Service criteria for HSCT treatment is largely looking for evidence that a patient's MS is in the inflammatory stage, rather than the degenerative phase.

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What is the availability and methodology behind NHS London HSCT treatment?

1. Full referral criteria

2. Inclusion criteria

3. Exclusion criteria

What is the availability and methodology behind NHS London HSCT treatment?

Currently HSCT is only available in England on the NHS, in Scotland, Wales and NI patients have yet to be accepted due to funding issues. The non-profit Scottish HSCT Network is working to change this situation in Scotland.

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The NHS is primarily trying to ensure that a patient's MS is in the inflammatory stage, rather than the degenerative phase. A patient must have: -

• Primary Progressive MS: oligoclonal bands in cerebrospinal fluid (lumbar puncture) 

• Secondary Progressive MS: activity shown on gadolinium contrast MRI (enhancing /active lesion), or two new T2 / flair lesions in space of past 12 months. Check both brain and spine in a gadolinium contrast MRI. 

• Relapsing Remitting MS: must ALSO have failed higher efficacy drugs Tysabri (natalizumab) or Lemtrada (alemtuzumab / CAMPATH) over 6 months of treatment minimum, with a relapse / MRI activity/ EDSS progression 

• age 18 – 65 

Full NHS London referral criteria

• Diagnosis of MS made by a neurologist

• Able to walk, needing at most bilateral assistance to walk 20 metres without resting

• In relapsing MS (RMS), failed one licensed disease modifying drug of high efficacy (currently including alemtuzumab and natalizumab) because of demonstrated lack of efficacy

• New MRI activity within last 12 months

NHS London inclusion criteria

•  Age 18 to 65 years

• Disease duration ≤15 years from diagnosis of MS

• Diagnosis of MS according to McDonald’s criteria

• For PPMS: CSF OCB+

• For RMS: failed at least one licensed disease modifying drug of high efficacy (‘Category 2’ as defined by Scolding N, Barnes D, Cader S, et al. Pract Neurol 2015;15:273–279; currently including alemtuzumab and natalizumab) because of demonstrated lack of efficacy (as evident from relapse, MRI activity as defined below at Point 7, or EDSS increase) after being on DMT for at least 6 months

• EDSS score 0-6.5 (see the EDSS scale in our FAQ answer No.13 here )

• Inflammatory active MS as defined by 1 Gd+ (>3mm) lesion (off steroids for one month) or 2 new T2 lesions in MRI within last 12 months

• Approved by the MDT (The HSCT Multi-Disciplinary Team)

Source – London MS-AHSCT Collaborative Group – Patient Eligibility Criteria Final V.3. – 8/12/2015

NHS London exclusion criteria

• Eligible for an ethically approved clinical trial where AHSCT is offered as one of the treatment arms

• Unable to adequately understand risk and benefits of AHSCT and give written informed consent

• Prior treatment with total lymphoid irradiation and autologous or allogeneic hematopoietic stem cell transplantation

• Contraindication to MRI including but not limited to metal implants or fragments, history of claustrophobia or the inability of the subject to lie still on their back

• Poorly controlled depression or recent suicide attempt

• Presence of any active or chronic infection

• Unable to walk 20 metres with or without support, or wheelchair dependent

• Any significant organ dysfunction or co-morbidity that the Investigators consider would put the subject at unacceptable risk
   

Source – London MS-AHSCT Collaborative Group – Patient Eligibility Criteria Final V.3. – 8/12/2015