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Sunday 19 May 2019
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Bayer remains committed to supporting NHS with improved access to Sativex®

Bayer disappointed that guideline did not recommend Sativex® as a treatment option for moderate to severe spasticity
Sativex for MS

Bayer HealthCare announces it is pleased that the National Institute for Health and Care Excellence (NICE) clinical guideline for the management of Multiple Sclerosis (MS) in primary and secondary care (CG186) recognises the multi-faceted nature of the disease and the complex needs of people with MS. Bayer welcomes the recommendation that MS patients should have a single point of contact and a comprehensive annual review but are disappointed that the guideline did not recommend Sativex® as a treatment option for moderate to severe spasticity. (1)
 

Bayer encourages clinical commissioning groups (CCGs) in England to continue to consider patient access to Sativex® oromucosal spray despite the view within the guideline that it is not a cost effective treatment. (1) Although Sativex® was not recommended for use by the guideline development group (GDG), they did acknowledge that it is seen as a potential development in the management of MS symptoms; highlighting that there were clear clinically important benefits in a specific group of patients in terms of reduction in spasticity, carer, patient and physician global impression of improvement, and improvement in ambulation ability. (1,2)
 

NICE clinical guidelines cover the treatment and care of people with specific diseases and conditions within the NHS. They are inherently broad in scope and evaluate many interventions at different stages of the patient pathway and therefore do not undertake the type of in-depth analyses on which health technology appraisals (HTAs) are based.
 

In contrast to the broad nature of guidelines, HTAs examine a single or small number of technologies in-depth and consider a wider range of data than those considered by the GDG. The All Wales Medicines Strategy Group (AWMSG) recently undertook a technology appraisal of Sativex® in spasticity and reached the conclusion that it was cost effective. (3)
 

Dr Martin Duddy, Consultant in Neurology, Royal Victoria Infirmary, Newcastle, said: “It is disappointing that NICE has recommended that Sativex is not to be offered to people with MS with spasticity, in contrast to the decision by the All Wales Medicines Strategy Group. MS patients living with difficult to manage spasticity have very few treatment options available and it would have been beneficial to have ready access to Sativex, which we know from studies and experience can be very effective in some individuals. I am hoping that local commissioning groups will consider funding the drug outside the national guidelines to those where other treatment options have been exhausted.”
 

Bayer supports the NHS and covers the cost of the first pack of treatment meaning that the NHS does not have to pay for identifying those patients who respond to Sativex®. (4) The MS patient decides how many sprays they need in any one day to help with their symptoms, with a typical patient taking four sprays a day (daily limit of up to 12 sprays), (2,5) meaning the real-life daily cost of treatment with Sativex® is about £5.56. (2,5) The NHS price of Sativex® is £125 per 10 ml vial. (4) With the small group of patients eligible for continued treatment with Sativex® (five per 100,000 UK population), the budget impact on the NHS is small.

References:

  1. NICE. Management of multiple sclerosis in primary and secondary care. National Clinical Guideline Centre, 2014. October 2014 Available at: https://www.nice.org.uk/proxy/?sourceUrl=http%3a%2f%2fwww.nice.org.uk%2fguidance%2findex.jsp%3faction%3dfolder%26o%3d67512 Last accessed: September 2014
  2. Sativex® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/EMC/medicine/23262/SPC/Sativex+Oromucosal+Spray/ (Last accessed: September 2014)
  3. AWMSG, 2014. Sativex Preliminary Appraisal Recommendation. Available at: http://www.awmsg.org/awmsgonline/app/appraisalinfo/644. (Last accessed: September 2014)
  4. MIMS. Drug details: Sativex. Available at: http://www.mims.co.uk/Drugs/musculoskeletal-disorders/muscle-spasm/sativex/ (Last accessed: September 2014)
  5. Bayer, Data on File 2012. Sativex DOF 002.1

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