Response to NHSE Review & NICE CBMP Guideline – Part 2: NHS England Review

Part 2: Barriers to accessing cannabis-based products for medicinal use on NHS prescription

Following on from our Part 1: Overview yesterday, this is a more detailed analysis of the NHS England and NHS Improvement’s report on the Barriers to accessing cannabis-based products for medicinal use on NHS prescription. 

The Good

The creation of a specialist clinical network is an excellent idea which will help cascade knowledge across the medical profession efficiently, but why should this be limited to the paediatric space alone? CPASS feel the scope should be broadened to include all indicated disciplines that can service the entire medical profession and all patients. 

 

The recommendation that NHS England (NHSE) and the Department of Health and Social Care (DHSC) should work together to develop clear information for patients on cannabis-based medicinal products is another good idea. CPASS will be publishing a guide for patients built on over 20 years of medical and patient experiences from abroad in the Autumn. We look forward to sharing this and working with them on progressing this as we have with Health Education England’s e-learning tool for doctors, due to be published shortly. 

 

Another welcome recommendation is for NHSE and The National Institute for Health Research (NIHR) to work together on alternative trial design(s) for CBMPs to include patients who cannot be enrolled into a standard RCT due to having consumed this medicine before.  RCT’s are inappropriate for CBMPs as different patients require different cannabinoid balances for best effect. We encourage them to look carefully at the timely proposals from The Centre for Medicinal Cannabis: Breaking The Embargo 

 

Whilst we agree that NIHR should support research into the NICE Guideline five priority research areas they should be encouraged to broaden scope into areas where the highest proportion of patients are reporting benefits such as depression (17%), anxiety (16%), insomnia (9%). In addition, the qualification criteria for research awards need to be relaxed to encourage more research into these areas. 

 

Finally, on the positive side, CPASS look forward to helping NHSE and DHSC on building a national UK patient registry across all indications, though not just for patients prescribed a CBMP,  as there will be a great deal of good data to be gained from extending this to those who currently have no choice but to self medicate from the criminal market. 

The Bad

The report states that the use of cannabis with a high concentration of THC has harmful effects on mental health which is untrue. The evidence suggests an increased risk for a very limited proportion of people and for which causation has never been established. In fact, the single evidence example given in the report has been thoroughly challenged in the Lancet and elsewhere so we ask why has this not been referred to? Does this reflect a lack of thoroughness or a biased selection of evidence? It should be noted that this evidence is based on the self-reported illicit use of street cannabis for which the levels of THC/CBD and presence of other impurities such as pesticides and heavy metals remains unknown. This cannot be considered quality evidence which reflects very badly on the credibility of this review. 

 

We have major concerns over the lack of explanation for why Sativex® and shortly Epidyolex® should be treated as exceptions to all other CBMPs by being given their own schedule (4ii) in the MDA:

 

  • Sativex® is a blend of full plant extracts to make a 1:1 THC:CBD product and is no different to other available similarly balanced products. 
  • Epidyolex® is purified CBD and little more. As an isolated compound, CBD is already available at less than 100th of the price online or on the high street. 

 

There is no scientific or medical basis for these exceptions and we challenge our authorities to properly justify this or change it. If all CBMPs were placed into Schedule 4ii, it is likely that doctors would find it easier and as such be more willing to prescribe them 

 

Whilst it is pleasing that over 100 young patients have access to Epidyolex® through an early access programme, no reference has been made to how patients are progressing. We are aware of concerning reports by parents, that the medicine is causing unpleasant side effects and a few reports that patients are plateauing and their seizures returning after a few months. Surely, this needs proper investigation before it is approved for wider use? Specifically, we would like to understand why so many patients are reportedly requiring the maximum recommended dose of CBD which is about 10x the dose of CBD than in other effective products from around the world which contain small amounts of THC along with other cannabinoids?

 

The focus on intractable paediatric epilepsy is also of concern to the vast majority of patients. Whilst recognising the urgency for this patient group, they only constitute around 1% of all epilepsy patients and epilepsy represents only 1% of patients with chronic conditions who could benefit from CBMPs. Focusing only on 1 in 10000 patients cannot possibly give anyone a true picture of the challenges being faced nor the benefits being experienced by patients in the UK. 

 

This is justified, in the report, by citing intractable paediatric epilepsy as having the “Strongest arguments” for progression but offers nothing as to why. What evidence is this based on? We suspect that it is a mixture of political and public pressure which are surely not good bases for prioritisation? Chronic Pain is clearly and by some margin “stronger” with 28 million sufferers in the UK today according to the British Pain Society and with potential efficacy in 80% of patients. It is of great concern that “The vast majority of the clinicians” told the inquiry that the lack of good quality RCT data demonstrating adequate safety and clinical-cost effectiveness of CBPMs for all indications is a major hurdle to prescribing. 

 

The Royal College of Physicians have repeatedly stated that on the basis of the evidence they have reviewed, there is only a 24% efficacy which is roughly equivalent to placebo, but there are two glaring issues drawing any conclusions from this: 

 

Firstly, out of the 20000 available studies, only 20 were selected for review, dismissing the other 99.9%. Secondly, RCT’s of a single CBMP versus placebo can never measure true effectiveness as individual patients require different ratios of the main active ingredients, THC and CBD for the most benefit. Where variable trials have been undertaken around the world, efficacy is in excess of 80%, making it orders of magnitude more effective than other currently available pain medications.  Not only that but with significantly less unwanted side-effects. 

 

The next issue of concern is that “Most clinicians told us that products containing THC would not be prescribed in their trusts, primarily because of the lack of evidence, knowledge about the products and long-term safety data.” Several clinicians referenced the higher risk of impaired mental health from long term exposure to THC and the need to “proceed with caution”.

 

Whilst we would expect all areas of medicine to “proceed with caution” there is no evidence that low doses of THC are associated with any risk and such unevidenced opinion should not be included in an evidence-based review. The standards for evidence for both the benefits and the risks must match if we are to achieve the best analysis. All the evidence that highlights potential and increased risks are based upon anecdotal reports of illicit consumption of very high THC, zero CBD street weed and cannot be applied to the use of a quality and prescribed CBMP under the supervision of a medical professional. Perhaps this argument would benefit from the knowledge that THC at up to 10mg/kg has been consumed by the UK public for many years in Hemp Seed Oil products, ironically, all of which are in breach of the 2001 Misuse of Drugs Act. There have been no reported instances of anyone ever having had any negative consequences from consuming hemp seed oil during the decades that it has been available on every high street store or supermarket. Is this not evidence?

 

In addition, when assessing risk vs benefit, surely it is wrong not to include the fact that any decision not to prescribe a CBMP to a patient is, in effect, a decision to send the patient back to the criminal market for their medicine prolonging their exposure to all the associated risks. Surely, every patient who is already acquiring and consuming street cannabis to alleviate their symptoms would be at less risk if they were prescribed a quality controlled CBMP under the supervision of a medical professional? 

 

We need to be efficient in producing efficacy and safety data as many CBMPs will have an identical safety profile and could be grouped into two or three “product groupings” such as: 1: High THC, 2: Low THC, 3: 1:1 and surely we can use the safety data gathered from Sativex® over the last few years since it was approved as it is a 1:1 CBMP whose results could be applied to ALL similar products? 

 

It is another concern that Healthcare Trust costing boards are making decisions based on the price of Sativex®, which is 5-10 times more expensive than other similar and available CBMPs.

 

Pharmacists raising concerns around the difficulty in knowing which products are of good quality and consistency is an education issue rather than a practical or logistical or as there are many CBMPs available right now that qualify. The recommendation that DHSC and MHRA should work to provide access to information on good quality products can be fixed very quickly through proper engagement with Licensed Producers (LPs) and by looking again at the product marketing regulations that apply to the specials category of medicines. CPASS already have good working relationships with many LPs and would be happy to help gather this information together.

 

In summary, there is room for optimism with some of these recommendations as long as they are accepted and implemented, however, if access for patients is to be improved significantly, then there is still too much reliance being placed on our existing “world-class” systems which are simply inappropriate for the approval and prescribing of CBMPs. Healthcare providers have a moral obligation to support the well-being of patients, whom, without access will continue to expose themselves to the inherent risks of the criminal market to source low-quality medicine. CPASS believe that this review would have benefited more from hearing much more from the voices of all patients and patient groups and recommend that a further review take place. We shall be raising all of these points with the inquiry team directly and will report back on any responses we get.

Jon Liebling – CPASS Co-Founding Director

Read Part 3 here: NICE Guideline for Cannabis-Based Medicinal Products

 

Register your interest in CPASS here: http://cannpass.org/

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