Natalizumab (originator and biosimilar) for treating highly active relapsing–remitting multiple sclerosis after disease-modifying therapy [ID6369]

Status:

In progress

Technology type:

Medicine

Decision:

Selected

Reason for decision:

Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources

Further information:

Scoping

Process:

MTA Standard

ID number:

6369

Project Team

Project lead

Thomas Feist

Email enquiries

If you have any queries please email [email protected]

External Assessment Group:

Bristol Technology Assessment Group, University of Bristol

Stakeholders

Companies sponsors

Biogen (natalizumab)

 

Sandoz (Tyruko (natalizumab biosimilar))

Others

Department of Health and Social Care

 

Health Technology Wales (HTW)

 

NHS England

Patient carer groups

Multiple Sclerosis Society

 

Multiple Sclerosis Trust

Professional groups

Association of British Neurologists

 

Royal College of Physicians

Associated public health groups

Public Health Wales

 

UK Health Security Agency

Comparator companies

Juvise Pharmaceuticals (confidentiality agreement signed, participating)

 

Merck Serono (cladribine, interferon beta-1a) (confidentiality agreement signed, participating)

 

Novartis Pharmaceuticals (fingolimod, interferon beta-1a, interferon beta-1b, ofatumumab) (confidentiality agreement signed, participating)

 

Amarox (fingolimod) (confidentiality agreement not signed, not participating)

 

Bayer (interferon beta-1a, interferon beta-1b) (confidentiality agreement not signed, not participating)

 

Biocon Pharma (fingolimod) (confidentiality agreement not signed, not participating)

 

Biogen Idec (interferon beta-1a) (confidentiality agreement not signed, not participating)

 

Dr. Reddy's Laboratories (fingolimod) (confidentiality agreement not signed, not participating)

 

Glenmark Pharmaceuticals (fingolimod) (confidentiality agreement not signed, not participating)

 

Juvise Pharmaceuticals (ponesimod) (confidentiality agreement not signed, not participating)

 

Mylan (fingolimod, glatiramer acetate, teriflunomide) (confidentiality agreement not signed, not participating)

 

Roche Products (ocrelizumab) (confidentiality agreement not signed, not participating)

 

Sandoz (fingolimod) (confidentiality agreement not signed, not participating)

 

Sanofi Genzyme (alemtuzumab) (confidentiality agreement not signed, not participating)

 

Sun Pharma (fingolimod) (confidentiality agreement not signed, not participating)

 

Teva (fingolimod, glatiramer acetate) (confidentiality agreement not signed, not participating)

 

Tillomed Laboratories (fingolimod) (confidentiality agreement not signed, not participating)

 

Zenvita (fingolimod) (confidentiality agreement not signed, not participating)

General commentators

All Wales Therapeutics and Toxicology Centre

 

British National Formulary

 

Department of Health - Northern Ireland

 

Healthcare Improvement Scotland

 

Medicines and Healthcare products Regulatory Agency

 

NHS Wales Joint Commissioning Committee

 

Scottish Medicines Consortium

 

Welsh Government

Relevant research groups

Brain Research UK

 

Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group

 

Cochrane UK

 

Genomics England

 

MRC Clinical Trials Unit

Timeline

Key events during the development of the guidance:

For further information on our processes and methods, please see our CHTE processes and methods manual