Since my story on Sunday about James Coates, who has Secondary Progressive MS, having HSCT free of charge on the UK’s National Health Service (NHS), I have been inundated with enquiries.
Most have been concerned about whether they can qualify for treatment and, so, today I am going to set out the latest criteria that I can find but must point out that the requirements may have been modified since this was produced by the London MS-AHSCT Collaborative Group.
It must be noted that to be considered for this treatment, a patient must be living in the UK with MS that must be ‘active’. The group has also stressed that this as an exceptional therapy for some people with MS, rather than a standard treatment; neither the National Institute for Health and Care Excellence (NICE) nor NHS England have given the go-ahead for this therapy to be used routinely to treat any form of MS.
This is the Patient Eligibility Criteria Adopted by the London MS-AHSCT Collaborative Group.
The eligibility criteria are overall aimed at selecting patients who have failed approved treatments of high efficacy or have none available to them and have recently presented evidence of inflammatory CNS disease activity; and who could undergo AHSCT with an acceptable estimated level of risk of adverse events. Justification for each of criteria is supported by evidence from AHSCT trials and observational studies.
- Diagnosis of MS made by a neurologist
- Able to walk, needing at most bilateral assistance to walk 20m 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
- 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
- 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
- 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 London MS-AHSCT Collaborative Group – Patient Eligibility Criteria Final V.3. – 8/12/2015
- 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 suicidal attempt
- Presence of any active or chronic infection
- Unable to walk 20mt 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
And they are the criteria in their entirety to the best of my knowledge and belief.