South east coast policy recommendation committee

Recommendation

The East Kent Prescribing Group has agreed the Kent and Medway Policy Recommendation and Guidance Committee (PRGC) recommendation that: Sativex is not funded within the local NHS for the treatment of spasticity due to Multiple Sclerosis, further details are provided overleaf. Approved by: East Kent Prescribing Group (Representing Ashford CCG, Canterbury and Coastal CCG,
South Kent Coast CCG and Thanet CCG)
Date: November 2013
Address: c/o Canterbury and Coastal CCG, Brook House, John Wilson Business Park, Whitstable, CT5 3DD
Contact: T: 01227 791267 | E: [email protected]
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Kent and Medway Policy Recommendation and Guidance Committee
Policy Recommendation
PR 2013-19: Sativex® for spasticity due to multiple sclerosis (MS)
Issue date:
November 2013
Review date:
November 2016
The Kent and Medway Policy Recommendation and Guidance Committee (PRGC) has considered national policy, available evidence of clinical and cost effectiveness, information on prevalence, activity and expenditure, and views and opinions of local stakeholders. Taking these into account, the PRGC recommends that:  Sativex1 is not funded within the local NHS for the treatment of spasticity due to MS This policy recommendation will be reviewed in light of new evidence or national guidance. Commissioners in Kent and Medway will always consider appropriate individual funding requests (IFRs) through their IFR process. 1Sativex is not a PbR excluded drug.

Supporting documents
Health Care Intervention Appraisal and Guidance (HCiAG) team (2013) Sativex® for the
management of moderate to severe spasticity due to multiple sclerosis (MS) – Final report


Key points and rationale

Why does the policy on Sativex need to be reviewed?
The routine prescribing of Sativex is not currently recommended in Kent and Medway. Since the
original policy recommendation was issued, the company has introduced a patient access scheme
whereby responders can be identified at no cost.

What is multiple sclerosis (MS) and spasticity?
MS is thought to be an acquired chronic immune-mediated inflammatory condition that affects the
central nervous system. Spasticity is a common symptom of MS. It is usually associated with
muscle spasms, immobility, disturbed sleep and pain.
How is spasticity due to MS currently treated?
According to NICE clinical guideline 8 (2003), initial drug treatments are baclofen and gabapentin
(not licensed for this indication). If these drugs are unsuccessful or are not tolerated, tizanidine,
diazepam, clonazepam (not licensed for this indication) or dantrolene may be given; other
medicines, such as anticonvulsants, should only be used after further specialist advice.
What is Sativex?
Sativex is a cannabinoid-based medicine comprising the two main active ingredients of Cannabis
sativa. It is formulated as an oromucosal spray and licensed for symptom improvement in adult
patients with moderate to severe spasticity due to MS, who have not responded adequately to
other anti-spasticity medication and who demonstrate clinically significant improvement in
spasticity related symptoms during an initial trial of therapy. Sativex is intended to be used in
addition to the patient's current anti-spasticity medication.
NICE CG8 does not offer advice regarding the use of Sativex as treatment for spasticity, while a
planned technology appraisal has been discontinued. However, Sativex will be reviewed as part of
an update of NICE CG8, due for publication in October 2014.
What is the prevalence of moderate to severe spasticity due to MS in Kent and Medway?
It is estimated that around 100,000 people in the UK have MS, and that 34% have moderate,
severe or total (17%, 13%, 4% respectively) spasticity. Of these, an estimated 35% with moderate
spasticity and 46% with severe or total spasticity use combination therapy with more than one oral
agent, and of these 50% are not adequately managed. This would equate to around 145
individuals in Kent and Medway who would be eligible for Sativex, with approximately 69 of these
being ‘responders’ who would continue Sativex therapy after the initial four week period.
What is the evidence base for Sativex?
Sativex, used according to its license, has been evaluated in one short-term RCT. The study used
an enriched design to assess the benefit of continued treatment in patients who achieved an initial
response (≥20% reduction in baseline patient-reported 11-point numerical rating scale [NRS]
score). In the initial 4-week single-blind phase (n = 572) the mean change in NRS score was
3.0±1.4 from baseline (6.9±1.3). In the following 12-week randomised double-blind phase (n =
241), the mean NRS score reduced by a further 0.04 points in the Sativex group, and increased by
0.81 in the placebo group, giving a mean treatment difference of -0.84 (95% CI -1.29 to -0.40). Of
participants who entered the second phase, 74% of Sativex patients achieved a ≥30% reduction in
NRS from pre-treatment baseline, compared to 51% of placebo patients. The overall adverse event
rate was similar in both groups.
These results suggest Sativex may benefit some MS patients with spasticity, but uncertainty still
exists over how closely the observed improvements in NRS score correlate with functional
improvement, and whether any benefit is maintained long-term. Also, it was not documented
whether study participants were titrated to the maximal tolerated/ therapeutic doses of their original
anti-spasticity drugs before using Sativex.
How cost-effectiveness is Sativex?
[Type text] According to a UK cost-effectiveness study, Sativex was unlikely to be cost-effective compared to standard treatment (oral medicines alone or combined with botulinum toxin injections or a baclofen intrathecal pump), using a willingness-to-pay threshold of £30,000 per QALY. Sativex is unlikely to be cost-effective after adjusting for the patient access scheme proposed by the company.

Source: http://www.kentlpc.org.uk/userfiles/files/sativex_for_spasticity_associated_with_ms,_ekpg_nov_2013.pdf