Evidence
Surveillance decision
An update of the NICE guideline on neuropathic pain in adults, to reassess gabapentin and pregabalin across most types of neuropathic pain is not necessary. However, the roles of gabapentin and pregabalin for the treatment of sciatica need consideration but this would be most appropriate within an update to the NICE guideline on low back pain and sciatica in over 16s.
Reasons for the decision
Based on clinical- and cost-effectiveness evidence, the guideline on neuropathic pain in adults currently recommends: 'Offer a choice of amitriptyline, duloxetine, gabapentin or pregabalin as initial treatment for neuropathic pain (except trigeminal neuralgia)'. Concerns about dependence and misuse of gabapentin and pregabalin were discussed by the committee when the guideline was being developed. At that time, the committee had not experienced problems with dependence and misuse of these drugs in their patients. Warnings about misuse, dependence and withdrawal are clearly recorded in the summary of product characteristics for all preparations of gabapentin and pregabalin.
Overall, prescribing of gabapentin and pregabalin has increased, and alongside this, there has been increased incidence and awareness of problems of misuse and dependence with these drugs. In April 2019, the Medicines and Healthcare products Regulatory Agency published a Drug Safety Update notifying healthcare professionals that pregabalin and gabapentin are now controlled under the Misuse of Drugs Act 1971 as class C substances and scheduled under the Misuse of Drugs Regulations 2001 as schedule 3. Although a note to this effect was added to the guideline, the impact of the alert needed to be further explored in an exceptional surveillance review.
Topic experts suggested that the guideline had led to widespread prescribing of gabapentin and pregabalin for a very broad definition of neuropathic pain in non-specialist settings. They noted that more clinicians would now have direct experience with patients who had problems with dependence and withdrawal than when the guideline was developed.
The recommendation for initial treatment currently includes all forms of neuropathic pain (except for trigeminal neuralgia) but topic experts also indicated that many prescriptions of gabapentin and pregabalin are for treatment of sciatica, yet the evidence for this indication is very limited.
We noted that for sciatica, a common type of neuropathic pain, evidence for gabapentin and pregabalin appears to be insufficient, and topic experts were concerned about using these drugs in this condition. Therefore, we decided that an update to the guideline should focus on treating sciatica, particularly whether gabapentin and pregabalin are suitable treatments for this condition.
However, we concluded that an update of the guideline to reassess gabapentin and pregabalin in other forms of neuropathic pain was not necessary because:
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the evidence for gabapentin and pregabalin consistently indicates that these drugs are effective in most neuropathic pain
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the reclassification means that clinicians must prescribe in accordance with the more stringent requirements for schedule 3 controlled drugs
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the summaries of product characteristics already warn about misuse, dependence and withdrawal
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the guideline has already been amended to include a footnote covering the reclassification and actions to mitigate against dependence and abuse
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NICE has published a guideline on the safe use and management of controlled drugs and is also developing a new guideline on safe prescribing and withdrawal management of prescribed drugs associated with dependence and withdrawal.
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