Q&A: Regulatory reform necessary to improve obesity drug access

Since the massive success of blockbuster diabetes and obesity drugs like Wegovy (semaglutide), and Mounjaro (tirzepatide), there have been several concerns surrounding drug shortages and reimbursement issues creating barriers that limit access. 

At the recent Obesity Update 2024 conference in London, Dr. Nicholas Finer, a former senior principal clinical scientist at Novo Nordisk, spoke about the potential of these drugs transforming obesity treatments. However, he highlighted that cost would continue to be a major issue, especially for state healthcare systems such as the UK’s National Health Service (NHS). 

Finer is also an honorary clinical professor in the National Centre for Cardiovascular Prevention and Outcomes, Institute of Cardiovascular Science at University College London. In an exclusive interview with Pharmaceutical Technology, conducted on the sidelines of the conference, he discussed issues with determining the cost-benefit of obesity drugs and barriers to patient access. 

This interview has been edited for length and clarity.

Nicholas Finer: Even though Saxenda (liraglutide), Wegovy, and Xenical (orlistat) have all been approved (to manage obesity) by the National Institute for Health and Care Excellence (NICE), you will find that there is virtually no funding for them, so doctors are basically not able to prescribe them. The access to newer, very expensive drugs like Wegovy is soon going to be trialed in half a dozen centres across the UK, funded by £40 million coming from the Department of Health (in a pilot programme). Otherwise, they are not yet available in the National Health Service (NHS). 

The issue comes down to cost effectiveness. As per NICE’s stringent criteria, they have found that these drugs are marginally better in terms of cost efficacy. I would personally argue that some of the models being used to evaluate cost efficacy have not taken into account all the potential benefits of these drugs. In particular, for Wegovy, the cost efficacy evaluation preceded the release of data from the Phase III SELECT trial (NCT03574597) that showed a 20% reduction in heart attacks and cardiovascular events. Clearly, that should be shifting the barrier in terms of favorability.

Nicholas Finer: In the UK, if you are paying taxes, a large part of which goes towards healthcare, there are not many people who can afford to also spend money on private healthcare. However, if you go to other parts of the world, the state system is very basic, and most people will be expecting to spend their money on their health.

In the NHS, what determines whether a drug can be prescribed, is whether NICE has approved the drug and then on top of that, even if NICE has approved a drug, there will be local formularies, both in hospitals and in integrated care boards, who will determine whether they will fund the drugs. The last thing is whether or not there is actually a supply, and that has been an issue with obesity drugs.

In the UK, there is virtually no government funding for weight loss drugs. There are very few centres that can prescribe Wegovy within their NHS services. Most UK Wegovy prescriptions are done privately, so it is up to the individual to pay the full cost of it.

Nicholas Finer: At the moment, the biggest challenge is this double standard with the regulatory process for getting an anti-obesity drug approved by European or US regulators; if you have a diabetes drug that also produces weight loss, you can put on the label “this drug treats diabetes and also produces weight loss". But if you produce a weight loss drug that improves diabetes, you cannot claim the diabetes benefits on your label. That is why there is this separate development.

The logic would be in the case of a drug like Mounjaro, which is approved for diabetics, many overweight people who have diabetes may see their diabetes improve on a very low dose. However, if they have diabetes, and they also have severe obesity, even though their diabetes has improved, you may want to push their dose up to treat their obesity. That is not something that is on the label at the moment.

Even though they— diabetes and obesity— are effectively the same disease, we are being forced to decide which we are treating. The regulatory process is now completely out of step with modern pharmacotherapy. It has been ten years since these regulations have been revised with this modern development.

It is also illogical that a patient will receive reimbursement for diabetes but not for obesity. Due to this, there is all this off-label prescribing going on which I see negatively.

Nicholas Finer: What we really need to do is have hard outcomes other than weight loss. Sceptical people still worry about the weight loss outcomes of these drugs, because patients might lose lean body mass or suffer from other effects. If you said— “Here is a drug that stops you from having a heart attack more effectively than statins, blood pressure control drugs, and best management, and you still get a 20% reduction in hard outcomes. Oh, and by the way, it produces weight loss.”—that ought to be a gamechanger. The SELECT trial did this with Wegovy—the primary outcome there was not weight loss but the reduction of cardiovascular events. This should drive things, but then you still come back to the cost benefit, for which state systems are always going to be an issue. 

We need to start asking more questions about these drugs. Do they prevent diabetes? Do they reverse fatty liver disease? Do they reduce heart attacks? Are they good for people with intracranial hypertension? One must assume that those benefits are not entirely dependent on weight loss. They may have other effects that have yet to be discovered.