Forum Topics RMD RMD Tirzepatide (Eli Lilly) Phase

Pinned straw:

Added 6 months ago

As @Arizona said, the Resmed price fall was the market reaction to the release of the Phase 3 endpoint results for Eli Lilly’s drug Tirzepatide. As is detailed in the abstract linked below the results showed significant effectiveness in reducing AHI (apnea-hypopnea index) which Resmed’s CPAP product addresses.

Bad news no doubt… or maybe – As was the reaction to Ozempic, the initial first order thinking was CPAP would no longer be needed and Resmed’s market would evaporate as the new drug “solved” the problem. But the high cost of Ozempic and the increased awareness of the problem of sleep aponia lead to increased interest in CPAP and a positive correlation when Ozempic customers also used CPAP, which Resmed announced data supporting last results announcement.

Now we have Tirepatide, as per the links below, it is also expensive, US$13k, especially compared to A$2k a CPAP machine costs as @Bear77 has informed us.

So, I think we are a long way from a terminal issue for Resmed. That said – I wouldn’t consider Resmed a bottom draw stock either. In the medium term the expansion of the market is likely to offset any impact drug treatments may have as alternatives. But in the long run, the price of the treatments will drop (as they come off patent and scale) and probably improve to a point the cost benefit equation is in their favor. In fact, if you live in China, it’s pretty close already!

 

Phase 3 results abstract:

·        The New England Journal of Medicine (21/6/24): Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity | New England Journal of Medicine (nejm.org)

Annual cost of Tirzepatide of US$13,410 ($2,247 per 1% reduction in A1c and $237 per 1 kg weight lost more cost effective than Semaglutide)

·        National Library of Medicine (29/3/23): Short-term cost-effectiveness analysis of tirzepatide for the treatment of type 2 diabetes in the United States - PMC (nih.gov)

Tirepatide annual cost in China of around US$2,000:

·        National Library of Medicine (13/5/24): Cost-utility analysis and drug pricing for tirzepatide for type 2 diabetes in the Chinese market compared with semaglutide - PubMed (nih.gov)

Disc: I own in RL

Mujo
Added 6 months ago

ResMed CEO response to the trial. Biased, but points to small trial, different types of OSA, takes 12 months to get to desired outcome on the drugs.


A closer look at what the latest GLP-1 data could mean for those with OSA

Carlos Nunez

Physician, Large Cap C-suite #MedTech / #Digital Health executive and Corporate Board Member, with two decades of proven medical, scientific, public policy and business leadership. #sleep #science #technology #medicine

June 26, 2024

Nearly 40% of the adult population in the US has obesity [1]. Nearly a billion people in the world have sleep apnea [2]. And the numbers are increasing [3]. ResMed has always done what’s best for patients, encouraging all patients to live healthier lives through sleep, diet and exercise. The recent SURMOUNT-OSA clinical trial results are good news for individuals with obesity and sleep apnea. GLP-1 medications will give physicians more options in how they treat patients; GLP-1s will likely be used concomitantly with positive airway pressure (PAP) therapy.

As Douglas Kurz, a 20-year CPAP user on Ozempic, put it: “These GLP-1 agonists are indeed miracle drugs when it comes to weight loss, and that helps with OSA. But for me the miracle treatment for sleep apnea was the CPAP machine, not a drug.”

Having attended the American Diabetes Association’s Scientific Sessions last week, I’m pleased that the importance of sleep in cardiometabolic health was a focal point at the symposium on the SURMOUNT-OSA trial results. The panel of leaders in obesity and sleep health highlighted the positive impact of PAP therapy on OSA severity indices and cardiometabolic markers and discussed the multiple subtypes of OSA.

GLP-1 medications, like Eli Lilly’s tirzepatide, are an emerging option for people with obesity-related sleep conditions, and the 52-week trial demonstrated positive results on reduction of OSA severity and key secondary outcomes such as sleep-related patient-reported outcomes and cardiometabolic markers. This is something that I believe all of us in the medical community should celebrate.

However, it’s important we also revisit some key points:

OSA is a heterogenous disorder

  • It is important to note that the SURMOUNT-OSA trial included only a small sub-set of patients with OSA: patients with obesity and moderate-to-severe OSA without diabetes.
  • Why does this matter? There are multiple subtypes of OSA, so it would not be appropriate to generalize the results of this study to a broader OSA population. SURMOUNT-OSA excluded people who have excess weight (but not considered obese (BMI <30>


"Disease Resolution” needs more context

  • Some of the reactions to the trial that I have read have focused on the term “disease resolution.” This term is not commonly used in the field of sleep medicine, nor is it mentioned in the NEJM scientific article. Instead, the article includes a discussion of the patients who did achieve the secondary endpoints of an Apnea-Hypopnea Index (AHI) <5>
  • When the authors of the NEJM article state that “these thresholds represent a level at which PAP therapy may not be recommended,” they are referencing the CMS requirements for PAP therapy coverage, which for AHI 5-14 lists 7 different qualifying symptoms and comorbidities, only one of which is sleepiness. Hypertension is another qualifying condition that was present in >75% of the SURMOUNT-OSA trial population. It’s important that we consider these qualifying conditions as the number of patients for whom PAP therapy may not be recommended is much smaller than perceived.
  • If reduction in AHI is achieved using weight loss medications, then the medications must be continued (unless the weight loss can be maintained by other means such as lifestyle changes) to avoid the well-documented rebound in weight and a return of the underlying OSA back to baseline levels. OSA is a condition which in the vast majority of patients can be effectively managed, but true resolution is rare, because when you stop the therapy, the OSA typically returns.
  • Another point that cannot be ignored is that treatment for OSA with PAP has an immediate and typically complete effect, on day 1 of therapy, while weight loss that can potentially lower AHI takes a year or more as reflected in the results of the SURMOUNT-OSA trial itself. Untreated sleep apnea has been shown to increase all-cause mortality in just the first year after diagnosis, by nearly 40%. It’s important to treat both OSA and obesity on day one, because no patient should wait for the therapy they deserve.

Combination therapy is the optimal approach

  • Dr. Louis Aronne, M.D., from Weill Cornell Medicine, closed the symposium by saying, “It’s possible that combination therapy with tirzepatide plus CPAP is optimal for treatment of OSA and obesity-related cardiometabolic risk.” I couldn’t agree more.
  • The panelists/investigators involved in the SURMOUNT-OSA trial also emphasized that patients who meet the AHI threshold for mild OSA would still be assessed and in most cases treated with PAP therapy, and agreed that the combination of tirzepatide and PAP therapy is optimal for the treatment of OSA and obesity-related cardiometabolic risk.
  • Published literature has shown that in patients with moderate-to-severe obesity-related sleep apnea, the combination of PAP therapy and weight loss has been shown to be more beneficial than either treatment in isolation [4].


GLP-1s are a welcome and important tool in helping people diagnosed with OSA to meet their weight challenges in order to achieve better health, but they are only one piece of the puzzle when it comes to OSA. As an OSA patient, Douglas Kurz, says it best:

“I feel quite strongly about the benefits of both CPAP therapy and the new class of drugs. But I am quite clear in my thinking that neither serves as a replacement for the other. Both are valuable tools in the war against obesity as well as OSA.”

For further insights into ResMed’s perspective on the link between obesity and sleep health, the SURMOUNT-OSA trial and our dedication to sleep health, please visit www.resmed.com/emerging-therapies.

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