One more hurdle to overcome

Given the increasing commodization of their insulin franchise Novo Nordisk increasingly has relied on their GLP-1 portfolio to drive sales and profits. With the oral version of semaglutide now at the FDA and approval expected before the end of the year many have projected blockbuster potential for this first ever orally delivered GLP-1. As we have noted in past writings on this drug, we anticipate a strong start but are concerned over the longer term given the drugs rather complex dosing regimen.

As it turns out the drug may have another hurdle to overcome as according to a report from The Institute for Clinical and Economic Review (ICER) the drug only offers an “incremental” benefit when compared to other drugs such as Jardiance from Lilly. ICER concluded that oral Ozempic plus background therapy would underperform Jardiance in cost effectiveness, as measured by quality-adjusted life years gained.

A few points to consider before making any rash judgements – the ICER estimated the cost of the new drug at $6,520 annually which is the cost of the injectable version. Second given the drug isn’t approved yet Novo has not publicly disclosed what they plan on charging but has in public comments indicated they would be aggressive. Third Novo has bet the farm on this drug and understands what’s at stake here.

Using a combination of rebates and discounts we anticipate payors providing wide formulary access when the drug receives approval. The key then will get back to how Novo handles informing physicians about the drugs’ dosing regimen. Given that GLP-1 usage has been steadily increasing and this being the first orally administered GLP-1 there is already a high level of physician awareness about the drug. However the majority while familiar with it are clueless to how it’s dosed hence the delicate tightrope Novo must walk on.

Being an oral medication many if not most just assume the patient takes the pill each morning and goes about their day. They are unaware that the pill can only be taken with a specific amount of water nor are they aware that the patient cannot eat anything for at least 30 minutes after taking the drug. Should the patient violate either one of these two protocols the drug does not work.

This is why we are so concerned with the longer-term results as once this dosing regimen becomes more well-known physicians and patients could opt for the injectable once-weekly option. Simply put it’s easier to inject just once a week then it is to follow this dosing regimen each and every day.

Let’s be very clear here we have no concerns about the drug working or not, when dosed correctly it works very well. The issue as we see it is one of patient adherence will they follow this complex dosing regimen consistently. History tells us they won’t.