Epub: Slof & Gras. Sativex(®) in multiple sclerosis spasticity: a cost-effectiveness model. Expert Rev Pharmacoecon Outcomes Res. 2012 Jun 8.
Background: MS is a chronic, progressive disease that carries a high socioeconomic burden. Spasticity (rigidity and spasms) is common in MS and a key contributor to MS-related disability.
Objectives: This study evaluated the cost-effectiveness of Sativex(®), a 9-δ-tetrahydrocannabinol/cannabidiol-based oromucosal spray that acts as an endocannabinoid system modulator. Sativex was recently approved for the management of resistant MS spasticity as add-on medication.
Methods: A Markov model-based analysis was performed over a 5-year horizon from a German and Spanish healthcare payer perspective. The incremental cost of Sativex was low compared with current spasticity treatments, and provided a quality-adjusted life-year gain over the current standard of care.
Results: The base-case incremental cost-effectiveness ratio for Sativex was estimated at €11,214/quality-adjusted life-year in Germany, while the drug was the dominant option in Spain, providing savings of €3496/MSer over a 5-year period (year of costing: 2010). This was seen because the lower severity of spasticity in MSers who had improved led to reduced resource consumption (e.g., physiotherapy and medications).
Conclusion: Despite having a relatively high acquisition cost, Sativex was shown to be a cost-effective treatment option for MSers with MS-related spasticity.
Background: MS is a chronic, progressive disease that carries a high socioeconomic burden. Spasticity (rigidity and spasms) is common in MS and a key contributor to MS-related disability.
Objectives: This study evaluated the cost-effectiveness of Sativex(®), a 9-δ-tetrahydrocannabinol/cannabidiol-based oromucosal spray that acts as an endocannabinoid system modulator. Sativex was recently approved for the management of resistant MS spasticity as add-on medication.
Methods: A Markov model-based analysis was performed over a 5-year horizon from a German and Spanish healthcare payer perspective. The incremental cost of Sativex was low compared with current spasticity treatments, and provided a quality-adjusted life-year gain over the current standard of care.
Results: The base-case incremental cost-effectiveness ratio for Sativex was estimated at €11,214/quality-adjusted life-year in Germany, while the drug was the dominant option in Spain, providing savings of €3496/MSer over a 5-year period (year of costing: 2010). This was seen because the lower severity of spasticity in MSers who had improved led to reduced resource consumption (e.g., physiotherapy and medications).
Conclusion: Despite having a relatively high acquisition cost, Sativex was shown to be a cost-effective treatment option for MSers with MS-related spasticity.
“Interesting data; I wonder what the health economists at NICE would say about this model and data. As you may know already we are having major problems accessing Sativex in the UK for MSers under our care. The bottom line with Sativex is that it is not a drug for everyone; only about 40-50% of MSers respond and even then some can’t tolerate the drug because of side effects. Have any of you responded to the drug?”
Very interesting. As one of the team who showed unequivocally back in 2000 that cannabis can treat spasticity I'd like to see as many MSers who respond to it, get it as possible. Also despite the recent disappointing CUPID trial, I'm convinced that medications such as Sativex can play a role in slowing progression and the more people taking it, the more robust the data will become.
Only 40-50% response is not an argument against Sativex.How high is the reponse rate on Interferons? 20-30%?In my opinion one who has problms with spasticity or other things should try Sativex. And if it works it's okay if not, stop it.But I think that a lot of MSers get their green leafs from a trusted dealer. For EUR 500 you can have a "good time" for several months and not only 1 month.
MD2, what's your opinion on the following:http://jnnp.bmj.com/content/80/2/175.abstract"Patient ratings of spasticity during daily activities are only marginally associated with long-term surface electromyography"They say that the perception of spasticity amplitude differs from the objectively measured amplitude and that "Clinicians are therefore strongly advised to perform complementary objective assessments using long-term sEMG recordings."However, Sativex trials only used subjective measures, ie Visual Analog Scale and Numerical Rating Scale (both 0-10) where Sativex showed 1.3 points improvement while placebo showed 0.97 points.Don't you think that the simplest explanation for these poor results is just the pain relief properties of cannabinoids (in conjunction with placebo effect since the side effects are unmistakable)? The writers conclude:"It is likely that other factors such as pain and cognitions are also incorporated in these patient ratings."There is no fact or explanatory need to say anything about slowing down progression. Even the efficacy is standing on clay legs.
I have been taking Sativex for about six months. The spasticity in my glutes and calves that was affecting my walking and made standing in line (at checkouts etc) terribly painful has been relieved and my quality of sleep has greatly improved. I already took Baclofen to try to relieve the spasticity but found it had diminishing efficacy.I take a low dosage of Sativex and only in the evening. Going beyond that I found the side effects – which would have been great if I was 20 and at a party – were hampering me.As for the health economics angle, I look upon it as one of the cocktail of drugs that keeps me working and being a taxpayer.
Re: "But I think that a lot of MSers get their green leafs from a trusted dealer. For EUR 500 you can have a "good time" for several months and not only 1 month."The £4,000 per year is paying for the development costs of the drug, which includes quality control, and so that the company can make a profit. Hopefully, some of the profits are going back into R&D. I assume the shareholder, whoever they are, are happy to see a return on their investment. With street cannabis you have no idea how clean the product is or what dose you are getting. Despite this a lot of MSers with spasticity and pain use street cannabis with good effect. The problem is that sourcing it is an illegal activity and therefore cannot be recommended.
VV You seem to be saying that what the MSers think is irrelevant in terms of what the neuros are monitoring. That is when we are talking about spasticity. However, when you are talking about CCSVI you then expect us to take a different view, so when neuros cannot see any effect and MSers are saying it works you expect us to believe the Msers.We have no control of what researchers do, is it great? is it rubbish? Can you avoid side-effects, surely not if you are getting enough drug…The study you mention is 2008 and in 2010 Sativex was approved for use in Spasticity.You say "There is no fact or explanatory need to say anything about slowing down progression"What MD2 is saying is based on a logical biology. We have so many ways of making the point. Much of this is unpublished. So we say there may be no fact in your eyes, but you do not know what we know.Your snipes, which is exactly what they are, are unhelpful.
VV You seem to have already formed your own opinion so I suggest that mine is superfluous (as frequently seems to be the case) ;-)As MD points out, we actually know a lot more about this than you do but your pontifications are always welcome for a little light relief.
"You seem to be saying that what the MSers think is irrelevant in terms of what the neuros are monitoring."Regarding self measurement of spasticity, this is the writers opinion, not mine.I say that 1.3 points improvement on Sativex versus 0.97 points on placebo (in 0-10 integer scale) is no big deal, especially since Sativex comes with recognizable side effects that break down the blinding on patient side."The study you mention is 2008 and in 2010 Sativex was approved for use in Spasticity."What is your point exactly? Approval is not an efficacy certificate, it's a trading license.
Re: "What is your point exactly? Approval is not an efficacy certificate, it's a trading license."Incorrect; a trading license would only be granted if the drug was effective and safe. It implies a favourable benefit:risk ratio. Licenses are usually revoked if the drug is shown not to be safe and occasionally if new data emerges that it is not effective. The same level of scrutiny will be applied to devices and procedures; hence the recent FDA ruling on CCSVI procedures. There is no class 1 or even 2 evidence of efficacy and safety remains a concern. The good thing is that rules are rules and if you want to prescribe off license you need a very good case to do so.
Could you do a post about how spasticity works? I have tried to read about this, but am still confused. http://www.msaustralia.org.au/documents/MS-Practice/spasticity.pdf makes it sound like the underlying mechanism is not known and suggests that it might have something to with proprioception. Do you agree? Thank you.PS Would also be interested in your thoughts on measuring spasticity. Prof G doesn't seem to think much of the Ashworth Scale. VV brings up electrophysiological measures. I have only ever heard of one person having spasticity measured this way in a normal appointment. Do you think this a practical and more accurate way to measure spasticity? When I asked a neuro why my calves sometimes get superhard, the neuro thought it due to "silent cramps," which I guess don't show up on EMG so maybe EMG doesn't work for everything. I can see how patient reports can be unreliable, though. For example, I am not really sure what's tightness from spasticity and what is paresthesias that feel like tightening around the outside of my skin (I'm not describing that very well, but my point is that it's not always clear to me how to map my experiences to the causes). How do you think spasticity should be measured?
"a trading license would only be granted if the drug was effective and safe"So it really is a trading license after all. A conditional one, as most trading licenses, but a trading license in the first place."It implies a favourable benefit:risk ratio."I agree. It implies, it does not certifie. In any case, there is no threshold for how low the efficacy level may be. Little efficacy is only a commercial disadvantage, not a true obstacle against approval. So a drug approval is not a proof of drug efficacy, the same way that a driving licence is not a proof of visual acquity.