Why has the Welsh government approved Sativa for multiple sclerosis and not NICE in England?

Sativa is a nasal spray based on a cannabis extract which is used for painful muscle cramps in multiple sclerosis. There doesn’t seem much doubt that it works, and in its most recent draft guidance on MS, NICE has based it’s decision on cost effectiveness grounds – the benefit came out at £49,300 per QALY from studies published in the peer reviewed literature, based on eight sprays of the drug a day. This is above the NICE threshold of £30,000 per QALY.

The Welsh appraisal seems to have taken into account additional data provided by the company which included a cost benefit analysis based on four sprays a day (rather than the eight that NICE had used in its calculations). The Welsh report comes out with a range of QALYs from £10,891 to £49,300 depending on the assumptions made. The process that they actually used to decide that the drug was cost effective is unclear, but some of the methods would bring the drug within NICE’s QALY thresholds (if NICE had used company data)

So the difference between England and Wales in the assessments seems to be that England relied on data in the peer reviewed literature, whereas Wales included data from the company some of which was based on a lower (and hence cheaper) dose of the drug. And who’s right and who’s wrong? NICE is right if the cost effectiveness needs to be based on data in the peer reviewed literature. Wales is right if a wider range of types of data can be used, including data on cost-effectiveness from the company.

If I had MS, I think I’d feel pretty perplexed (and maybe cross) at the different methodologies being used.


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