The Independent

PAYING THE PRICE

Seven years after the first cannabis-based pharmaceut­ical was made available in the UK it is still prohibitiv­ely expensive. Nick Thompson asks why

- @Nick_ThompsonOG

It’s around this time of year that weed smokers get their time in the hazy sun. Cases get put forward, people get high, and then the legalisati­on chorus dissipates into the background for another year. But cannabis has been available in medical form for seven years now in the UK, though you probably didn’t know that, and that’s emblematic of the issue.

GW Pharmaceut­ical’s cannabis-derived prescripti­on drug, Sativex, is popular with sufferers of multiple sclerosis, but it’s expensive. In 2014, NICE (the National Institute for Health and Care Excellence) found it not sufficient­ly effective in treating muscle spasticity for its price. In 2017, it costs £375 plus VAT per pack, roughly 270 doses.

That decision meant the drug, administer­ed as a spray under the tongue, isn’t available in England and Scotland on the NHS. In Wales, there’s limited availabili­ty. MS sufferers here are only permitted the drug

to control spasms, not to relieve pain, once they’ve exhausted other medical options.

I had this feeling like my body didn’t belong to me. Rain was painful. Hot water was lukewarm

Why is the first cannabis-based pharmaceut­ical available in the UK so expensive? Why is it so hard to get? And what does this mean for UK cannabis prohibitio­n?

Caths Evans is a Tumefactiv­e multiple sclerosis sufferer and founder of the Sativex Advisory Group (SAG). Evans tells me how traditiona­l medicines make her feel sick all the time, “like a zombie”. Evans’ condition is characteri­sed by spasms and infrequent strokes, years apart, which have an impact on her mobility, memory and ability to speak.

Sativex – which she’s been prescribed since 2010, luckily predating NICE’s decision – aids her symptoms dramatical­ly. “[Before] I had this feeling down my left side like my body didn’t belong to me… It’s like a tingling sensation; anything cold would be painful on my skin. Rain was painful. Hot water was lukewarm to me. I would take things out of the oven without using gloves; it was quite dangerous for a time.

“But once I started using Sativex, it was amazing! The tingling had stopped almost, the spasms stopped completely. You weren’t out of your head on it; it just made you feel normal.” Crucially for Evans, Sativex is still not half as readily available as it should be due to NICE’s decision, and also because Sativex is only made available for MS sufferers in the UK, though it aids symptoms in other illnesses.

In trials, around half of the patients responded to Sativex, typically in the first few weeks

The price of the drug is unlikely to be an issue of pure unadultera­ted capitalism. Peter Reynolds, president of CLEAR (Cannabis Law Reform), tells me the main reason the price is so high is because “the process GW had to go through in order to achieve market authorisat­ion is so expensive”.

But according to an MS Trust spokespers­on, Sativex has always been scarce: “The local CCG tended to be reluctant to prescribe [pre-2014], though that might have been down to the reluctance of CCGs to prescribe things without any NICE guidance, and they came out against it, which obviously closed it down entirely.” In medical trials, around half of the patients responded, typically in the first few weeks of treatment.

It comes as little surprise to anyone familiar with the pharmaceut­ical world that the cost of research, developmen­t and marketing ratchets up the cost of a drug. The issue is suspect however when you consider Sativex and its counterpar­ts internatio­nally are much more affordable. The difference in the UK, of course, is that possession of cannabis – a controlled, Class B drug – could see you charged under the 1971 Misuse of Drugs Act, although figures suggest an anaemic national police force pursues this course less than ever.

The price likely stems from the added regulatory hoops Sativex must pass through in Britain, as, according to Reynolds: “The exact replica of Sativex can be bought in medical marijuana dispensari­es in the States for a tiny fraction of the price that GW Pharmaceut­ical charge for it,” as they don’t have to comply with the same regulatory procedures.

GW’s vice president of investor relations, Stephen Schultz, argues it’s not the parent company’s fault for

the price discrepanc­y, nor is it avoidable, as another pharmaceut­ical company, Almirall, markets Sativex and “each country has its own pricing scheme”. Sativex is not currently available in the US, as it’s not FDA-approved, though it is in phase 3 trialling.

In Reynolds’ view, it’s the procedures the Medicines and Healthcare Products Regulatory Agency (MHRA) and other regulatory bodies use to test new drugs that are the issue. “The whole way Sativex is regulated is fundamenta­lly dishonest. It’s regulated on the basis that it consists of only two molecules: THC and CBD. Whilst Dr Geoffrey Guy, the chairman of GW, is on the record himself saying – I have it confirmed in writing from him – that it contains up to 400 molecules.

“The MHRA and convention­al or pharmaceut­ical medicines regulators are simply not competent, capable of regulating a whole plant medicine. Every other jurisdicti­on in the world has set up special regulatory procedures around cannabis because it is completely different from pharmaceut­ical medicines.” In real, consequent­ial ways, GW is trailblazi­ng in a particular­ly fledgling and legally dodgy area in UK medicine. For Reynolds, it’s all for the better: “I’m a great admirer of GW... I regard them as the people who, at great courage, and at great risk, have broken the UK cannabis prohibitio­n. By playing the Government’s game, by going through the establishe­d procedures.”

There’s an inherent tension in GW’s founding motives, in that they recognise the therapeuti­c value in cannabis, but their niche exists only if cannabis remains prohibited. So it’s surely not in their interests the British Government effects any law change, is it?

Schultz told me the situation in the US disproves that. ”In the US, we don’t see the relaxation of laws around the medical use of cannabis or recreation­al use of cannabis as really being any significan­t impact on our objectives. There are those who will use medical dispensary-based marijuana products [in the US], but we believe that most physicians and most patients desire a pharmaceut­ical medicine,” said Schultz. “Our objective is just to provide that option.”

Speaking with Evans and other MS sufferers, it’s clear Sativex has been incredibly helpful in aiding symptoms such as muscle spasticity, whilst the drug doesn’t bring a host of negative side effects like typical MS pharmaceut­icals tend to.

But availabili­ty continues to be a fundamenta­l stumbling block for patients in the UK, particular­ly in

England, and that’s a travesty for those that need it. The drug provides compelling evidence of the medicinal efficacy of cannabinoi­ds, though in the UK at least it hasn’t led to a wider medicinal cannabis framework, but it provides reason to hope.

With Sativex, it’s as if cannabis has been repackaged and delivered in a bottle – arguably to circumvent the Home Office’s blanket denial of cannabis’s medicinal worth – but it still hasn’t been enough. Seemingly thanks to powers beyond GW’s control, Sativex has largely failed to leave its mark seven years on.

 ??  ?? Cannabis-derived medicine can transform the lives of MS sufferers (Getty)
Cannabis-derived medicine can transform the lives of MS sufferers (Getty)
 ??  ?? Research and developmen­t pushes up the cost of medicinal cannabis, but it is cheaper in the US than the UK (Getty)
Research and developmen­t pushes up the cost of medicinal cannabis, but it is cheaper in the US than the UK (Getty)

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