Since a new law took effect a year ago, England’s National Health Service (NHS) has reimbursed patients on only 18 occasions for “unlicensed” cannabis-based products that have not undergone clinical trials, according to government data.
In the case of private prescriptions – which are paid out of pocket by patients – the number of prescriptions reached 104.
The data – which covers November 2018 through August 2019 – relates only to prescriptions in England. Health-care authorities in England, Scotland, Wales and Northern Ireland operate independently.
In the United Kingdom, only Epidiolex, nabilone and Sativex are licensed medical cannabis medicines.
All other cannabis-based medicines are unlicensed. They’re also known as “specials,” meaning they did not go through clinical trials to be granted a license to be marketed.
Unlicensed medicines can be prescribed only to meet the “special needs” of an individual patient if no equivalent licensed medicine can do that.
Though NHS prescriptions of unlicensed cannabis-based medicines are allowed, they are expected to be available in rare instances for the foreseeable future.
So companies hoping to capitalize on such products in the United Kingdom face an uphill battle and will have to find ways to boost private prescriptions. A private prescription is one that is not covered by the NHS.
The data includes the number of prescriptions that were “prescribed and submitted to NHS Business Services Authority (NHSBSA).”
Private prescriptions are also submitted to England’s NHSBSA, but they are only for reporting and monitoring purposes and not reimbursed.
“Prescribing an unlicensed product should be considered third and only if an individual patient has exceptional clinical needs that cannot be met by a licensed or off-label medicine,” according to a Q&A on the NHS England website.
Recent guidelines from England’s National Institute for Health and Care Excellence (NICE) recommended NHS coverage of licensed medicines Epidiolex, nabilone and Sativex for certain conditions.
The NICE recommendation likely will lead to an increase in NHS prescriptions for those pharmaceutical products.
That, in turn, will likely put unlicensed medical cannabis at a competitive disadvantage, because medical professionals are much more likely to prescribe licensed medical marijuana products over unlicensed ones.
Alfredo Pascual can be reached at firstname.lastname@example.org