Part 3: NICE Draft Guideline for CBMPs
Following on from Part 2: Barriers to accessing cannabis-based products for medicinal use on NHS prescription, this is a detailed analysis of The National Institute for Health and Care Excellence (NICE) Guideline for Cannabis-Based Medicinal Products (CBMPs)
We are happy about the inclusion of chronic pain and the broadening of scope for spasticity beyond Multiple Sclerosis but fail to understand the benefit in limiting “nausea and vomiting” to “intractable” and only related to “chemotherapy-induced” nor do we understand why epilepsy is limited to severe treatment-resistant types only? It seems to us and to all medical professionals we have consulted, as with spasticity, if there is the potential for a CBMP to work for a symptom, then that potential covers ALL conditions where the symptom is being experienced?
We are pleased to see that it has been made clear that prescribing is not limited to specialists so that under their supervision, other healthcare professionals such as GPs have the right to prescribe. Unlike the introduction of any other medicine into our healthcare system, cannabis has been consumed by many thousands of patients for many years and their expertise must be sought, accepted and explored. The most efficient way for this to happen will be where patients meet front line services such as nurses, pharmacists and GPs as that is where the most productive therapeutic conversations between patients and our health care system take place.
The guideline makes strong references to the potential impact on psychological, emotional and cognitive development and on structural and functional brain development, however, there is no quality evidence of any such impact from low THC dose CBMPs?
The recommendation that when prescribing CBMPs, patients should be advised to stop any non-prescribed cannabis, including over-the-counter, online and illicit products is reasonable but misses an opportunity to recommend that any such supplementing of their prescribed CBMPs, which many patients inevitably will, is recorded along with a measure of its impact on their well-being as this can help create valuable safety and efficacy data for our medical profession.
Great lengths have been taken to highlight that patients should be advised about the potential benefits, any potential harms, including any risk dependence or interaction with other medicines but we feel that in order to make sure that appropriate evidenced-based advice is being given by healthcare professionals there should be some guidance as to what those benefits and harms actually are so as to eliminate unevidenced opinions based on bad research and mainstream media scare stories over the last 40 years that along with the general public, our doctors have also been exposed. Surely we must adhere to the same standards for evidence to measure risks as we expect for measuring the benefits?
The guideline has also gone to the trouble to state that there was a lack of evidence on longer-term adverse events, such as dependence and the development of psychological disorders but again have not provided any rationale on why this considered such a special concern for CBMPs. There is no evidence that in balanced or moreover low doses of THC (which is found naturally in Hemp seed oil) has any associated risk and it is surely not standard practise to apply risks associated with chronic use of an illicit drug to that of a quality, standardised medicine under the supervision of a medical professional? We wouldn’t get very far with prescribing an opiate-based medicine if we based our risks profiles on the impact of illicit use of street heroin, would we?
The Guideline states that “some evidence showed that cannabis-based medicinal products reduce chronic pain, but the treatment effect was modest.” and adds, in spite of the overwhelming evidence to the contrary from around the world that the evidence did not show a reduction in opioid use in people prescribed medicinal cannabis.
Frankly, this is wrong and shockingly ill-informed. This relates only to limited RCT data which as already discussed is inappropriate for measuring the efficacy of CBMPs. If only one formulation of CBMP is trialled against placebo, the results will always be limited, however, where a range of balances has been offered in alternative trials, efficacy is seen to improve from ~20% to ~80%. There is also plenty of evidence from around the world that in places that have introduced medical cannabis opiate-related deaths and addiction have reduced by 24.8%. One producer we have spoken to in the US, Columbia Care, has data on over 40000 patients for whom 99% have successfully transitioned from opiates to CBMPs and are managing their pain more effectively and with significantly less unwanted side-effects. In fact, it is not that “the evidence did not show a reduction in opioid use” but truer to say that the evidence that shows said reduction was neither sought nor considered”. Does this seem like a “world-class” process?
The Guideline goes on to state that because the number of people who might benefit is large and the cost potentially high, an economic model was developed to compare benefits with the potential costs. In all cases, the potential benefits offered were small compared with the high and ongoing costs, and so “the products were not an effective use of NHS resources” and adds that “the evidence showed benefits of THC:CBD spray (licensed product in UK: Sativex®) for treating spasticity” but since Sativex® is nothing more than a 1:1 THC:CBD CBMP (it is made from full plant) – why not recommend one of the many other similar products at less than 1/5th of the price? Would that not radically change this recommendation? CPASS is currently in the process of producing an economic case for CBMPs with qualified health economists which we will publish and share with NICE in due course, but for now, as a most pertinent example:
In the US where Multiple Sclerosis (MS) patients, who constitute just 6% of those who report benefit, have access to cannabis, around 25% replace their existing suite of medications. The average MS patient costs ~£30k per year in medications alone and the cost of cannabis is ~£6k per year, representing a saving of £24k per patient per year. The UK has ~100k MS patients so represents a potential saving of (£24k * 25% of 100k) £600m per year to the NHS for prescription medications alone. Imagine what the saving might be if this included the other 94% of patients? Of course, when your existing processes only take a single symptom into consideration rather than looking at how cannabis can help manage multiple conditions simultaneously and if the only figures you use for costs are based on a product costing 5 to 10 times more than other similar and available products (Sativex®) it is going to be impossible to make this case.
CPASS strongly recommend to NICE that they review how these calculations are made and perform another review as soon as possible.
The Guideline goes on to state that other CBMPs should not be used to treat spasticity unless used in the context of a clinical trial. This recommendation was apparently needed to ensure that other products were not used as an alternative to THC:CBD spray (Sativex®) without sufficient evidence of their effects and associated costs. This is not a reasonable rationale and seems to us to be rather protective of a single product. There are many other products with almost exactly the same makeup as Sativex®. What is the rationale for treating this differently? Sativex® is simply a very expensive CBMP. The safety data will be identical in all the other identical products?
Finally, the guideline states that current research is limited and of low quality, making it difficult to assess just how effective these products are for people and as previously stated many times and by many experts in this field, we MUST move beyond our exclusive reliance on RCT data and given that this was raised with NICE many months ago during the scoping consultation, we are very disappointed that this fact is being completely ignored.
This Guideline from NICE highlights a fundamental issue of our medical systems which is an intransigent adherence to existing policies and procedures which can never be appropriate for the uniqueness of CBMPs and as such their recommendations should be reviewed carefully. It is critical that the expertise of patients, their voices, their issues, their pain and their priorities should be engaged, heard and seriously considered. If significant progress is ever to be made in making CBMPs accessible to patients through our NHS, we need more flexibility and innovation from our healthcare regulators and institutions with the priority, being the needs to patients as opposed to the following of our systems and rules that do not make adequate allowance for this new category of medicines.
CPASS will be providing all of this feedback and challenging NICE to review and respond, but we can only hope that our voice and those of patients are given significantly more priority than is apparent after the brief consultation on scope that we took part in, else we will have to conclude that it is little more than a box-ticking exercise. Patients with chronic and debilitating conditions deserve so much better than this and unless our healthcare system innovates appropriately for CBMPs then we are going to get left even further behind and will no longer be able to claim that they are world-class but far more importantly, the vast majority of the estimated 1.4 million patients already benefiting from their consumption of cannabis as medicine will have no choice but to continue to source the relief they seek for a better quality of life that is free from pain, from the criminal market and be exposed to all associated risks.
Jon Liebling – CPASS Co-Founding Director
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