Guest author Edward Henry QC, of Mountford Chambers, examines current issues regarding access to medicinal cannabis, in particular as it relates to the treatment of children, in the United Kingdom (UK).
What’s the problem?
The battle for NHS prescriptions for the use of unauthorized cannabis medicines (CBMPs) in childhood epilepsies resistant to severe treatment continues to spark controversy.
Since the law was changed in November 2018 allowing the prescribing of CBMP, there has only been one prescription through the NHS, not three, as variously claimed. Indeed, in the case of Alfie Dingley and another child, access to CBMPs was resolved by a prescription from a general practitioner (GP) before cannabis reprogramming. Thus, the provisions that appeared after November 2018 stipulating that the prescriber must be entered in the register of specialists did not apply.
What is the explanation for this acute bottleneck, or block? The responsibility seems to lie with the British Pediatric Neurology Association (BPNA). In his March 2020 annual report, he stated the following:
The Association had to face particular challenges this year. The first concerns the issue of the use of unauthorized cannabis-based drugs in childhood epilepsies. The Association, at the request of the Chief Medical Officer and NHS England, has reviewed the clinical and scientific evidence in this area and issued interim guidance for clinicians. They have also actively participated in the development of NICE guidelines in this area. Both guidelines emphasized the need for further research, and the BPNA was actively involved in submitting requests for NIHR funding for research trials.
Given the compelling real-world evidence of many children who have seen remarkable improvement in their treatment-resistant severe epilepsy (“STRE”), as documented by the Drug Science charity, BPNA’s paradigm-based approach pharmaceutical development of evidence-based, double-blind, randomized clinical trials appears to have been too restrictive.
Their self-declared contribution to the development of the NICE guidelines, referenced above in their 2020 annual report, has been the subject of a legal challenge against NICE guideline NG144 regarding CBMPs. This legal action (settled out of court) was necessitated by the restrictive influence that the guidelines (borrowing from the already rigid BPNA approach) had had on prescribers. It was argued that the inflexible adherence to the double-blind model of RCTs, which then prevailed over the question of evidence, would have ignored many individual cases in which CBMPs had already had a beneficial impact. As a result, the amendment of the law of November 2018 to allow such requirements would have been hampered.
Unfortunately, before the challenge arose and was resolved, many clinicians weren’t ready to prescribe CBMPs that appeared to have had the above beneficial effect. They then claimed that they could not or should not do so because of the advice then made available to clinicians by NICE and / or BPNA.
So when, on March 22, 2021, NICE released the NG144 Guideline Clarification (“the Clarification”), many parents believed that a ray of hope would soon be seen in the distance.
The clarification, from NICE, however, would seem to have little impact over the past 8 months. So the question is why?
To understand, one must investigate the Clarification itself, and deduce how and why it remains to be implemented correctly and has been frustrated in practice.
The clarification was issued through an agreement between NICE and the parents of a child with STRE. His parents had initiated a judicial review of directive NG144. They argued that guideline NG144 was misinterpreted by clinicians, as clinicians viewed it as preventing them from prescribing CBMPs on the NHS. In response, NICE denied that directive NG144 was intended to have such an effect. As a matter of procedure, NICE issued the Clarification to remove the wrongdoing that parents had valiantly argued against.
It should never be forgotten that children with STRE very often die from seizures or suffer from irreversible brain damage, ruining their lives and their quality of life forever. The Clarification was therefore intended to provide authoritative guidance on this important (often painful) topic. It replaced and took precedence over any directive (issued by other bodies including the BPNA) to the contrary.
Drug Science, in a recent article, showed that in a cohort of children with STRE, there was a 96% chance that a child would improve significantly after receiving treatment with a spectrum CBMP. full. Since these children have so far been resistant to all licensed anticonvulsant drugs, often suffering hundreds of seizures per week and having a very poor quality of life combined with a statistically significantly increased risk of death, this was an article which deserved the most recognition by the medical profession.
The clarification was important in two significant ways. He made it clear that NICE’s view was not, and is not, that CBMPs should not or should never be prescribed in individual cases where it is clinically appropriate. This NG144 had not been spelled before.
The clarification, very helpfully, also explicitly explained when, in an individual case, prescribing a CBMP would be clinically appropriate. The key phrase is the last of paragraph 3.2:
“Patients in this population may be prescribed cannabis-based medicines if the healthcare professional considers it appropriate on the basis of a benefit / risk balance, and in consultation with the patient, their families and caregivers. or tutors ”(emphasis added).
This phrase means that healthcare professionals, when deciding whether or not to clinically support the prescribing of a particular CBMP, should actively look to:
(a) what benefits do they think this will or could bring; and
(b) what risk do they think this will or could create?
If the healthcare professional considers that the benefit outweighs the risk in all the circumstances of the case, and the parents support the use (i.e., knowingly consent), there is no there is no reason for them, clinically or on the basis of the recommendations, not to support the prescription of the CBMP in question.
What if, rhetorically, a clinician who has performed this risk / reward exercise, which results in a tilted balance in favor of prescribing, subject to obtaining valid informed consent from the parent, but then decides not to do so? , based on his own point of view (according to the BPNA) that there needs to be more pharmacological evidence first, on a population-wide study? If they considered that the actual or potential benefits outweighed the actual or potential risks, but did not clinically support the prescription, then the clinician would act, in our opinion, at odds with the clarification and not in the best interests of the physician. patient. The purpose of the clarification was to emphasize that the state of the research evidence on CBMP to treat STRE, although currently limited, cannot be a reason for refusing prescribing in an individual case.
Unfortunately, in a display of apparent disregard for clarification, the BPNA issued updated guidelines in October 2021, which were either designed to overturn the clarification released by NICE or create such obstacles in its implementation in one case. individual that it would become impractical. As an example, this can be seen in the following paragraphs of the current BPNA guideline:
5.13 If a pediatric neurologist is considering prescribing an unlicensed CBMP in private practice, he or she should:
5.13.1 inform the NHS pediatric neurologist who normally cares for the child and
5.13.2 Provide comprehensive and ongoing care for a child with complex epilepsy, including appropriate psychological, developmental and physical assessment / therapy, with 24 hour support.
5.13.4 If a pediatric neurologist prescribes unauthorized CBPM in a private practice, he or she should also be certain that the family can bear the cost of the ongoing private prescriptions. We consider it unethical to initiate treatment in private practice for which funding is not available in the longer term. The NHS is unlikely to cover the cost of future prescriptions for an unlicensed drug that has no Level 1 evidence of efficacy and safety.
From our reading, paragraph 5.13 could be interpreted as a veiled threat that the NHS pediatric neurologist will wash the patient’s hands if he receives a private prescription for CBMP. As for 5.14, this is an intrusive element, and totally outside the specialist’s remit.
The research recommendations in paragraph 6 of the BPNA offer show that it is still committed to the double-blind RCT model, completely forgetting the importance of clarification, in which NICE said:
3.1 “The (original) guideline made research recommendations for the use of unauthorized cannabis-based drugs for severe treatment-resistant epilepsy. The committee considered, based on the evidence available at the time, that there was insufficient evidence of safety and efficacy to support a population-wide practice recommendation (i.e. i.e. a recommendation relating to the entire population of people with severe resistance to treatment). epilepsy).
3.2 The fact that NICE has not made any population-wide recommendations, however, should not be interpreted by healthcare professionals to mean that they are precluded from considering the use of non-cannabis-based medicines. permitted when clinically appropriate in an individual case. Patients in this population may be prescribed cannabis-based medicines if the healthcare professional considers this to be appropriate on the basis of a benefit / risk balance, and in consultation with the patient, family, caregivers or others. his tutor.
3.3 There is no recommendation against the use of cannabis-based medicines ”.
It appears, in view of the clear divergence from the proposed clarification by NICE cited above, that the BPNA is sticking to its rigid, orthodox and conventional approach to CBMPs, and therefore there is no real change. in sight for families.