Prescribing Sativex for spasticity in MS – how to establish shared care in your local health system

Aim of the webinar:

To provide prescribers, service managers and other relevant clinical stakeholders with guidance and support to established shared care protocols for Sativex. To explore the benefit of prescribing Sativex for eligible patients with MS and having clear shared protocols.

Dr Rachel Farrell, Consultant Neurologist, National Hospital for Neurology and Neurosurgery, Queen Square, London will share her experience of MS spasticity, the indications for Sativex and service model. She will discuss the NICE guideline recommendations and the NHNN experience in establishing Shared Care Guidelines (SCGs) across North Central London and how this might be adopted nationally. She will highlight the importance of working with clinical colleagues in pharmacy, rehabilitation services and primary care to ensure eligible patients can access Sativex and effective care protocols are in place.

Joela Mathews, Lead Neuro Science Pharmacist at Barts will talk about her experience attempting to establish a SCG for Sativex, the barriers to this and the important role primary care plays.

The NCL group have published the SCG and it has been shared widely to enable colleagues in other parts of the country to progress Sativex prescribing within their systems.

Resources:

• SCG: www.ncl-mon.nhs.uk/wp-content/uploads/Interface_prescribing/SCG_Sativex.pdf
• Cannabis and Sativex resources: www.mssociety.org.uk/...
• Experts in MS: Professional network: www.mssociety.org.uk/professionals

Summary

With the 2019 NICE approval of Sativex for the treatment of spasticity in MS, teams across England are working to realign pathways and enable access to the drug. This session offered some practical advice on making that happen.

The story so far

A framework to identify and diagnose spasticity is a key first step to designing spasticity pathways, said Dr Rachel Farrell, pointing to the official definition:

“A motor disorder characterised by a velocity-dependent increase in tonic stretch reflexes, with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex, as one component of the UMN syndrome… Disordered sensorimotor control, resulting from an upper motor neurone lesion, resulting in intermittent or sustained involuntary muscle activity.” (REF)

The velocity dependent element of this definition was extremely important, said Rachel.

“When you start moving somebody's limb slowly, you might feel a little bit of resistance. But if when you move more quickly the resistance increases, that tells you there's a neural component that can be modulated through pharmacological means,” she said.

It is important to differentiate between spasticity and stiffness caused by other symptoms – such as changes in the connective tissue, drop foot, and muscle shortening, for example – because treatment options are different.

MDT approach

Spasticity affects around 70 to 80% of people with MS at some point, but treatment should only be offered if the symptom is “causing a problem for them”, said Rachel. (ref)

Moderate to severe spasticity can:

• reduce upper limb function
• be associated with pain
• lead to secondary complications such as:
  • contractures
  • pressure ulcers
  • interrupted sleep
  • fatigue exacerbation
  • overactive bladder

Rachel advised a multidisciplinary approach to management that involved:

• a doctor, either a neurologist or a rehabilitation specialist with an interest in spasticity
• an MS nurse or a spasticity nurse
• a physiotherapist
• an occupational therapist

The key considerations, she went on, are:

• is something driving the spasms?
• does it happen at a particular time of day or night?
• is it associated with movements or transfers?
• is it associated with passing urine or bowel movements?

“We think about all of these triggers and try to modulate them,” said Rachel. “It’s working with the individual to optimise self-management so they know if they stretch, follow their exercise programme, and avoid or treat urinary tract infections early, maybe their spasticity will not be as severe.”

Pharmacological intervention

Even with this holistic approach, many people will need pharmacological intervention. In most cases, the MDT would work with patient to try to first- and second-line treatments, said Rachel, before adding Sativex if needed.

“It's also really key to know if there is a complex specialist spasticity service nearby, because if they don't respond to Sativex, which happens in about 50% of people, we need to think about what happens after that.” (REF)

Cannabinoids

Sativex contains the cannabinoids cannabidiol (CBD) and tetrahydrocannabinol (THC). These interact with the endocannabinoid system, modulating anxiety, relaxation, appetite, sleep, memory, and stress regulation.

“While cannabinoids are highly expressed, for example, in the cerebellum and through the temporal lobes, there are very few cannabinoid receptors in the brainstem. Therefore, respiratory depression is not really associated with cannabinoids,” said Rachel.

Rachel divided the cannabis products patients have access to four groups:

• regulatory approved cannabis-based medicines, such as Sativex, which have been through clinical trials and approved for use;
• non-regulatory approved products, often referred to as “medical cannabis”. These are used for medical purposes and are available on prescription, but have not been approved by regulators;
• CBD-containing consumer products and foods, which are sold to people direct. They are unregulated and produced in line with food, rather than medical grade, standards;
• Recreational cannabis use. About 20% of people with MS use cannabis in this way (ref)

Only category one, she reiterated, was evidence based.

NICE guidelines

Despite being licenced in the EU as an add-on therapy in 2010, Sativex was deemed not cost effective by NICE soon after. However, in 2019, the body’s Cannabis-based medicinal products guidelines approved its use for moderate to severe spasticity in MS.

Rachel’s service, however, has been using Sativex since 2011 to ascertain if it could reduce the need for invasive procedures. They have found that around 60% of people responded to the treatment (ref).

“This is not going to work for everybody, and it won’t be effective enough for everybody, but a cohort of people respond really nicely and can stay on it long-term”, she said.

The 2019 NICE guidelines recommend Sativex be prescribed under Shared Care, meaning responsibility is split between services, and provides a framework for building such arrangements.

Looking to the future of Sativex services, Rachel said: “For people who are prescribers and treating MS spasticity, it's really key to move with this and support your local patients. For people with MS, even though it's frustrating, a little bit of patience is going to be required before we can roll this out on a national level.”

Setting up Shared Care

Joela Mathews said it was important to manage expectations, both among patients and the clinicians working within the Shared Care arrangement. People think it will cure all spasticity from “day one”, but people need to be aware that not everyone responds and that there is a drop-off rate.

Different models

Explaining how services not on the NHS England Specification can access the drug for their patients, she said Shared Care could be established between neurology centres or on a hub and spoke basis.

“The specialist centre can look after the spasticity, but the prescribing can go back to the local centre – it doesn’t always have to be from GP to specialist, which can be harder to implement,” she said.

“Or you could have a couple of GPs who have an interest in spasticity who take on the prescribing for their locality. It’s about what works in your geography.”

Setting up pathways and joining up care

Joela’s tip tips for setting up Shared Care were:

• speak to the specialist pharmacy team
• engage with the CCG / ICS pharmacy team early on
• look at the whole pathway for spasticity, rather than focus on a single drug

“You need physios, you need to be able to measure response, you need occupational therapy, and you need a named clinician who wants take on the interest in spasticity,” she said.

Other considerations include:

• don’t forget community rehabilitation colleagues
• conversations will take some time, so start early
• changing how financing of secondary care services works will require the negotiation of a new block contract, so ensure commissioning, pharmacy, service, and general managers are all involved in the talks
• don’t reinvent the wheel: use Rachel’s team’s Shared Care agreement as a basis (see ‘resources’)
• Sativex is a schedule four drug, meaning treatment initiation must come from a medical consultant rather than an independent prescriber

Ultimately, Joela said, patients were currently travelling from all over the country to UCL to access Sativex. It is now the responsibility of MS teams to ensure they can be treated locally.

Podcast

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