Petition update

Scotland Confirms Position on Lifesaving NurOwn for Treatment of Motor Neurone Disease (MND/ALS)

Sam B
Oxford, United Kingdom

Feb 16, 2020 — 

The Scottish Medicines Consortium (SMC) this week confirmed its position on NurOwn. The announcement provides some interesting information as listed below. In many respects this is a positive development simply as it is more than most government organisations, possibly including US FDA, have confirmed to date. Many countries have no announced formal position concerning NurOwn or are unaware of the treatment or are simply not intending to address the issue until US FDA approval or thereafter, despite the lives likely to be lost as a consequence of such a delay.

The MND / ALS community including its advocates are of the opinion that progress in any jurisdiction is positive news for all MND / ALS sufferers as any country approving NurOwn early or otherwise puts pressure on others to follow suit. Therefore, SMC’s confirmation concerning NurOwn is welcome news.

The key points from the SMC announcement are listed below

1-      Formal confirmation of the position concerning NurOwn for Scotland.

2-      An acknowledgment of NurOwn as treatment for MND / ALS.

3-      SMC engages UK PharmaScan for information on new medicines in the pipeline.

4-      SMC is willing to contact Brainstorm Cell Therapeutics to enquire about NurOwn.

5-      SMC issues regular reports to health boards and National Services Scotland concerning new treatments including NurOwn.

6-      SMC's confirmation concerning NurOwn is early notification in support of financial and service planning within NHS Scotland.

A notable mistake in its confirmation, that has been raised with SMC in an ongoing discussion, is the below statement. It should be noted that NurOwn is not in early clinical trials but is in the final months of phase 3 of the clinical trial.

“NurOwn is a complex investigational therapy in early clinical trials that involves injecting stem cells into patients with the condition. However, as this complex therapy is in early development I am not able to indicate if and when this may become available in the UK.”

The initial announcement and full text of SMC's letter can be found at the following link and on RareConnect.org / EURODIS.org.

https://twitter.com/CureMND/status/1228286657348153345 .

Amyotrophic Lateral Sclerosis (ALS) - Community on RareConnect.org

A new MND / ALS community was approved this week by Rare Connect / EURODIS.  Please join the community to support efforts to establish a patient group for future representations to the European Medicines Agency (EMA) concerning NurOwn and other MND / ALS drugs. The community pages are multilingual in an effort to attract MND / ALS advocates, sufferers and others from non-English speaking countries to increase what is currently a relatively small number of advocates working towards approval of NurOwn and other MND / ALS drugs.

Please join RareConnect.org and then subscribe to the Amyotrophic Lateral Sclerosis (ALS) community.

https://rareconnect.org/en/community/als

UK and EU lucrative markets for Brainstorm Cell Therapeutics

Another fact that may prove interesting from the point of view of Brainstorm and other companies developing MND / ALS drugs is that Scotland has approximately 500 MND / ALS sufferers whose treatment would be funded by NHS Scotland while the UK has approximately 5,000 MND / ALS sufferers and similarly, their treatment would be funded by the NHS. The 5,000 UK MND / ALS sufferers that could potentially be treated with NurOwn may be comparable to the number of US MND / ALS sufferers that might seek NurOwn treatment. To some extent this depends on varying estimates for the number MND / ALS sufferers in the US. Brainstorm’s future revenue from NurOwn in the US compared with that in the UK may be somewhat similar. Therefore, the main difference between Brainstorm providing NurOwn in the US and UK is that in the former the individual / health insurance pays while in the latter the state / NHS funds treatment.

The UK position is repeated in many EU countries making the UK and EU lucrative markets for NurOwn. In addition to the above, any one from the following; Scottish Medicines Consortium (SMC), Medicines and Healthcare Products Regulatory Agency (MHRA), Human Tissue Authority (HTA), National Institute for Health and Care Excellence (NICE) and European Medicines Agency (EMA), could potentially approve NurOwn early before US FDA.

Furthermore, as demonstrated by the recent Novartis / NHS Inclisiran clinical trial for over 50,000 UK patients prior to EMA, MHRA and NICE approval of the drug similarly, there is the possibility of treating all 5,000 UK MND / ALS sufferers with NurOwn within a clinical trial setting or as part of an existing platform trial such as MND-Smart. This is made possible due to the fact that the state, through the NHS / NHS Scotland, would fund such treatment.

Working towards early approval of NurOwn and other drugs

Finally, for organisations that could have done more in the past to advance early approval of lifesaving drugs such as NurOwn for treatment of MND / ALS please do not stand in the way of efforts being made or promote the idea that there is no available treatment to justify past inaction. Let bygones be bygones and work with the MND / ALS community for early approval of NurOwn and other drugs. At the very least step aside and let the process proceed without hindrance. 

NurOwn and other MND / ALS drug approval decision makers for Scotland

Following SMC's statement, requests have been made seeking clarification of the parties engaged in the decision-making process for Scotland. Some of the key people/organisations are listed below using their Twitter accounts

@BrainstormCell @Cylebo @MNDScotland @lacowan @MNDoddie5 @JillADouglas @DoddieWeir5 @ScottHastings13 @sweirz @EuansCentre @AnneRowlClinic #MNDSmart #ScottishMedicinesConsortium #UKPharmaScan

@MattHancock @NicolaSturgeon @JeaneF1MSP @JoeFitzSNP @Jeremy_Hunt @NHSScotland @NHSScotlandRBLX @online_his

@EMA_News @MHRAgovuk @NICEComms @NHSEngland

@MicMac650  @st_psy @UKDRI @CathyAbbottLab @MMECEdinburgh @MRC_IGMM @EdinUniNeuro @UoE_Psychology @JNewton_MND @suvankarpal @CMHenstridge @GillingwaterLab @SchoolofPPLS @lyons_lab @justthevax @EdinUniBrainSci @NCMlab @NEAnatomist @TSpiresJones @EdinUniMedicine @crm_edinburgh @crm_edinburgh @AnnaWilliamsLa1 @EdinUni_IRR @BleedingStroke 

Media on Twitter

@BBCJohnBeattie @VickyLeeMid @MacNicol_BBC @BBCHughPym @BBCScotlandNews @BBCScotland @BBCNews @BBCWorld @sallynugent @BBCBreakfast @BBCSport @BBCRadio4 @bbcrugbyunion @BBCrugbyleague @BBCBreaking @bbc5live @BBCHughPym @bbc @SkyNews @RachelSkyNews @DrChidiMD @Doctor_Monah @joepike @MWilliamsHT @Martin1Williams

 


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