Subcutaneous injection of weight loss drug.
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Eli Lilly’s weight-loss drug, tilzepatide, has shown considerable potential in a large phase 3 trial, with results reported on Thursday, April 28.
Tirzepatide is a combination of GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist in a single novel molecule. The drug is given once a week by subcutaneous injection.
The investigational drug is the first such drug in a phase 3 study to result in an average weight loss of 20% or more compared to placebo. As the dose of the active ingredient increased, the average weight loss increased.
The overall safety and tolerability profile of tyrzepatide was similar to other incretin-based therapies approved for the treatment of obesity. This was a significant side effect reported, especially as dose levels increased. The most common adverse events were nausea (~ 30%), diarrhea (~ 20%), constipation (~ 15%), and vomiting (~ 10%).
If tyrzepatide is approved, it could be a blockbuster drug. However, this is not certain. It will have to overcome the pricing and reimbursement obstacles that have plagued obesity treatment for decades.
The drug also competes directly with Novo Nordisk’s Wegoby (semaglutide). Last June, the Food and Drug Administration (FDA) approved Wegovy, a GLP-1 receptor agonist, a Novo Nordisk obesity drug. It is also given once a week by subcutaneous injection. Wegovy is a high-dose version of the diabetes drug Ozempic.
At that time, Wegovy became the most effective weight loss drug on the market because it helped reduce an average of about 15% of a patient’s weight. This is almost twice as much as previous prescription drugs.
Wegovy represents a turning point in the pharmacological treatment of obesity. In the past, obesity drugs have suffered from negative adverse event profiles and relatively low efficacy. Therefore, weight loss drugs have historically struggled to gain traction. Not only did they not find many subscribers, but they also tended to be very difficult to get insurance coverage. For example, Medicare excludes all medications prescribed for obesity. And unlike the vast majority of other outpatients, weight loss medications are not an essential benefit of the Medicaid program. In addition, obesity medications, coupled with step-by-step editing, often make heavy use of pre-approval when covered by the Medicaid program. Finally, the coverage of commercial payers of weight loss drugs is highly variable.
With Wegovy, insurers have clearly changed their tone, at least to some extent. With the exception of Medicare, which still bans obesity drug compensation, many commercial and Medicaid payers are compensating for Wegoby, albeit with a lot of variability. The relatively favorable efficacy profile probably helped the product to be lucky with some payers.
In 2021, Novo Nordisk achieved approximately $ 1.2 billion in sales of Wegovy and its old weight loss treatment, Saxenda (liraglutide). The company does not provide an accurate breakdown of sales. But now it’s no wonder Wegovy is outselling Saxenda. Indeed, according to Novo Nordisk, the number of doctors prescribing Wegoby has recently surpassed Saxender.
Wegovy’s demand actually exceeds supply, supporting the idea that there are fewer reimbursement issues than previous obesity medications. Perhaps the big hurdle for Wegovy was the quality of manufacturing. This is blocking the supply. Once this is resolved, Novo Nordisk hopes to be on the road to achieving its 2025 sales target for all $ 3.7 billion in obesity treatments.
Tirzepatide is poised to compete directly with Wegoby. Its effectiveness seems to be even better than Wegovy. The question related to the payer will be the net price of tilzepatide (after rebate). Obviously, at this stage it is not known what tilzepatide will sell for if approved. It is more cost effective than Wegovy, assuming the net prices of tilzepatide are equal. On the other hand, in the eyes of the payer, the higher net price will have to be justified by a proportionally larger profit. It is everyone’s guess that premium payers are willing to pay.
Further complicating the issue of all obesity medicines, regardless of efficacy, is the fact that payers can be short-sighted when it comes to cost and efficacy assessments. In a way, this reflects churn. Every year, about 25% of the US population switches health insurance. This means that many payers do not necessarily take a long-term view of the cost-effectiveness of medicines.
Ideally, all payers will take a longer-term perspective. It’s unlikely because there are so many churn. In addition, some payers continue to put together obesity medicines along with lifestyle medicines. It is difficult to get rid of this mysterious view.
The benefits of weight loss go beyond fat loss. Correspondingly, weight loss can lead to a reduced prevalence of diabetes, a reduced heart attack and stroke, and a reduced joint pain.
When combined with diet and exercise, a new generation of obesity medicines can certainly contribute to weight loss. The problem remains, and payers will do so entirely, especially in the public sector. Medicare and Medicaid-Are you paying sufficient attention to provide a consistently favorable coverage?
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