What does Off Label mean?
Off-label is a term used when a medicine is prescribed for any reason other than what’s stated on its product license. A product license dictates what the medicine can be used for, at what dosages, and who it should be prescribed to, so prescribing outside of these guidelines included with the license of any medicine means that it is being used “off-label”.
Off-label prescribing is fairly common, and is a safe practice as long as the patient’s condition, medical history, allergies and current medicines are taken into consideration, often alongside family history due to certain side effects that some medicines can cause.
Being prescribed a medicine off-label doesn’t mean that the drug is unlicensed – these two terms mean very different things and shouldn’t be confused with each other. An unlicensed medicine usually refers to a medication that hasn’t received a UK license at all but is prescribed to patients regardless of this, as long as it is suitable for them. An off-label medicine is simply a medicine that does have a UK license, but not for the purpose that it’s being used for.
Semaglutide (Ozempic, Rybelsus) is often prescribed off-label to adults with a BMI of over 30 that struggle to lose weight conservatively with diet and exercise. Whilst it isn’t a first line treatment for weight loss, if your prescriber believes that it would be safe and effective for you, it can still be prescribed to you despite the product license – it just means that there’s more responsibility for the prescriber as they need to justify their decisions for prescribing a medicine for any use other than what it’s licensed for.
Are there any greater risks associated with using this as its off label?
All medications carry risks whether they’re used off-label or not. However, if a medicine is prescribed to you for any purpose other than what it is licensed for, then there are certain things that you need to be aware of. Your prescriber should provide you with all of the information you need for any medicines you take that haven’t been specifically licensed for your condition.
One risk of taking an off-label medicine is the fact that the patient information leaflet is unlikely to have any specific information regarding the reasons why you’re taking it, especially with semaglutide as the information is aimed at adults with type 2 diabetes mellitus (T2DM). However, as long as you stick to the dosing schedule that’s been given to you by your prescriber, and you read all of the information that you’re provided with, there shouldn’t be much of an additional risk to you if you have been prescribed any medicine for a condition that it isn’t licensed for.
You may find that it might be a little more difficult to find information online about the medicine you’re taking for your condition if it has been prescribed off-label, but your doctor, consultant or prescriber should be able to answer any questions you might have about it.
It’s also worth noting that most of the time, drug trials are carried out with the groups of people that they’re intended to treat. With semaglutide, initial studies were carried out in adults with T2DM, and a license was granted accordingly. It’s only recently that studies have been conducted with adults who don’t have T2DM but do have a BMI of over 30. This means that if you don’t have T2DM and are taking the medication, you may be more susceptible to side effects or adverse reactions, but all information relating to this should be given to you by your prescriber.
Generally, there isn’t a huge risk to your health by taking an off-label medicine – if it’s been prescribed to you by your GP, consultant or independent prescriber, they will already have evaluated whether or not it’s safe for you to take. With off-label medicines, this is generally done on a case-by-case basis due to the added responsibility for the prescribers.
When is this expected to be approved in the UK?
Semaglutide and Rybelsus have already received approval for use in the UK – just not for weight loss at the moment. Unfortunately it’s not easy to tell if or when it may receive a separate license for weight loss (much like what happened with Victoza/Saxenda), but it’s likely that if semaglutide does receive a license for the treatment of obesity, it may be rebranded or be indicated at a different dosage to current semaglutide medications that are available.
Studies are underway to review how efficient semaglutide can be for the treatment of obesity, and so far, the studies look promising, with many participants taking semaglutide achieving a significantly greater weight loss than those on a similar medication or placebo. Currently, side effects don’t seem to severely affect many people, but until the studies are finished and Novo Nordisk files for a new license, we’re unable to predict when semaglutide might become licensed for weight loss.
Until then, if your prescriber is comfortable with giving you Ozempic or Rybelsus to help you with your weight loss, then you can continue taking it, but it’s important to keep in regular contact with your GP and prescriber, particularly if you experience any side effects or adverse reactions.
Will this be available on the NHS?
Unfortunately, this is another question that can be difficult to answer, as many medications do hold a product license within the UK, but aren’t available on the NHS due to cost issues or other reasons.
Broadly speaking, the National Institute of Health Care and Excellence (NICE) decide which medications will be made available on the NHS. However, there are a host of reasons why it may be rejected, and many of them aren’t related to the safety of the medication.
Ozempic and Rybelsus are already available on the NHS for those with T2DM. However, it isn’t available for those wanting to take it for weight loss purposes. This is because licensed anti-obesity drugs already exist which are more cost-effective than semaglutide. However, we’ve already seen Saxenda become approved for use on the NHS in October 2020 after several years of holding a product license within the UK for weight loss. This is a promising step for people that need to access weight management treatment within the NHS.
If semaglutide is approved for a license as an anti-obesity medication, then it would be up to NICE to decide whether or not it will be available on the NHS, or whether patients seeking treatment will have to pay privately for it.