Many questions remain to be answered
By: Bill Zolis
I don’t think I can remember any new prescription medication hitting the market that created anywhere near the excitement that the new weight-loss drugs have caused over the last few years.
It stands to reason. A great many people, through – let’s face it – no real fault of their own, have struggled with obesity for years, often their whole lifetimes. They’ve tried this diet, and that miracle cure advertised on television and no end of fad “solutions.” And the one thing most of those things had in common was that they often didn’t work, were too demanding to be maintained in the long term or resulted in temporary progress followed by all the weight coming back. Even the people who worked hard at eating right and exercising found that it was always a struggle.
So when a new diabetes medication, indicated for controlling blood sugar, started adding a line to their TV commercials that said something like, “some patients have experienced weight loss,” a lot of people sat up and took notice.
That drug – we all know the name, Ozempic – had been clinically trialed, found to be safe and effective, and was approved by Health Canada as a doctor-prescribed medication. But just for the indication that had been studied – helping to control blood sugar in some diabetic or pre-diabetic patients.
That didn’t stop patients from going to their doctors and asking to be prescribed Ozempic for weight loss. Interestingly, doctors are able to prescribe “off label,” which means that they can prescribe a drug for a purpose other than the one for which it was approved by Health Canada, if they believe it is appropriate for their patients.
A great many doctors and patients decided that this was the way to go, based on the patient’s degree of excess weight and other factors. Many prescriptions were written, even though patients had to pay out-of-pocket, and even though the costs ran to the high hundreds per month.
Off-label use of the drug took off spectacularly, to the point that widespread shortages were reported. Now it seems like everyone knows someone who is using it. And the public consciousness, perhaps the social media buzz, seemed to agree that that it was effective in driving weight loss and that the always-lurking possibility of serious side-effects emerging over time did not seem to be happening.
However, benefits plans, private insurance and government drug plans did not – and still do not — cover Ozempic for weight loss. Some offered coverage if prescribed for its approved purpose of helping manage Type 2 Diabetes, but generally only with prior authorization and approval.
However, the makers of Ozempic and other pharmaceutical companies have moved quickly to develop and trial versions of the drug indicated specifically for weight loss. Two of these medications – Wegovy and Mountjaro – have now been approved. Several others, including oral versions that do not require injections, are in the pipeline and may become available in the future.
The newer drugs, even though they are specifically indicated for weight loss, are also not at this time covered by drug plans. There are a number of reasons.
– Cost. These drugs are quite expensive – hundreds of dollars per month – and would add significantly to the total costs for drug benefits plans. No one knows for sure how much it would average out to for all employees, but I’ve seen estimates that suggest it could be around $100 per employee per month – and note that this means all employees, not just those using the drugs. I also know from experience that it could rise significantly higher than that over time. (Ozempic, the first of the drugs to emerge, is covered by patents until December 2031, so the first lower-cost generics are still more than six years away.)
– Track record. Insurers and governments – who run the largest drug plans in the country – tend to move slowly and carefully. The argument is made that weight-loss drugs have not yet established a track record of reliable effectiveness in the long term.
– Lack of evidence regarding co-morbidities. It seems like a no-brainer that significant and sustained weight loss would improve the general health of the patient as well as helping to prevent or control specific, obesity-related health issues such as diabetes, cardiovascular health and osteoarthritis, to name just a few. That assumption – and it’s just an assumption at this point – would suggest a possible reduction in other health care costs that could make weight-loss drugs effectively pay for themselves.
However, in the world of evidence-based medicine, there is simply no evidence to support this assumption. The studies that have been done have been fairly short-term – two years in the case of safety and efficacy studies – and have not specifically studied long-term co-morbidities. (Long-term studies are underway but, by definition, will take years to produce hard evidence.)
So that’s pretty much where we stand today. First- and second-generation versions of the drug are out there. They have created a great deal of excitement among patients. They are very expensive. And they are not covered by drug plans.
So where do we go from here? Well, I’m certainly not going to try to make any predictions, but I would pose a number of questions that need to be answered before a clearer picture emerges.
– With many, if not most, of the big pharma companies working to develop new and perhaps better versions of weight-loss drugs – the market for them being so huge – will the price come down before the generic version become available in six to 10 years? If so, will this make them affordable for drug plan sponsors?
– Will the long-term research establish that, as many believe, weight-loss drugs will help reduce other health care and drug costs by addressing co-morbidities?
– Will the current picture of smooth sailing with regard to safety and effectiveness continue?
– Will some plan sponsors at some point bite the bullet and offer coverage? Coverage can always be added to plans – it’s just a matter of cost, and costs at this point would be quite high.
Finally, when we look at an issue as big and fast changing as this, we always have to ask: Are there any more surprises in store, and is another game-changer just around the corner?
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I really appreciate comments, ideas, suggestions or just observations about the blog or any other topics in benefits management. I always look forward to hearing from readers. If there’s anything you want to share, please email me at bill@penmorebenefits.com.
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