A Patient-Centric Approach to “GLP-1s”

While there is a lot of attention around drugs like Ozempic® and Moujaro®, it is important to keep a patient-centric perspective. Positive clinical outcomes are only achieved when the therapy is matched to the right individual and the individual is able to tolerate the therapy.

Thumbnail of A Patient-Centric Approach to “GLP-1s”

The fervor around agents known affectionately as “GLP-1s” is not really a surprise.  The progressive advancement of the American Diabetes Association’s support behind GLP-1 receptor agonists (Ozempic® [semaglutide]) and GIP/GLP-1 receptor agonists (Moujaro® [tirzepatide]) for Type 2 diabetes and their cousins, FDA-indicated for weight management, (Wegovy® and Zepbound®, respectively) has continued to fuel demand alongside media of all kinds.[i]  Being a year out from Mounjaro’s FDA nod[ii] offers a time to reflect on this class of therapies and possibly think about them in new ways.

Why the GLP-1 hype?

Simply put – cost. Every few years we face budget busting therapies. Some might remember the launches of other drugs that hit the gate running and threatened budget upsets, such as PCSK9 inhibitors or Direct-Acting Antivirals for Hepatitis C.  Launched with surrogate endpoints (LDL lowering, viral load reductions), questions were abundant about whether the investment was worth it in the absence of clinical outcomes.

Penny wise or pound foolish?

If one focuses simply on direct drug spend, it is easy to acknowledge that GLP-1 therapy costs are unsustainable and risk putting self-funded groups into dicey territory financially.  A recent report from the Senate Committee on Health, Education, Labor and Pensions suggests that the US spend on GLP-1 agents could reach $1 trillion annually by early 2030.[iii]  Thus the imperative to ensure that when dollars are spent by Main Street USA on GLP-1 agents – for both diabetes and weight management – it comes with a return on investment.

The patient-centric perspective is the opportunity to reduce disability and death from major adverse cardiovascular events (MACE), such as heart attacks and strokes.  While Mounjaro® and Zepbound® await the FDA’s stamp of approval on cardiovascular outcomes benefits in its label, Ozempic has been enjoying the benefits of its supplemental NDA since January 2020 and Wegovy since March of this year.[iv],[v]  That said, the lack of labelled indication supporting cardiovascular benefits hasn’t dented the uptake of the tirzepatide-based therapies which boast strong glycemic control and weight-loss as a result of its dual-action.[vi],[vii],[viii]  The broad demand for GLP-1 agents continues to push an “all hands on deck” scenario due to shortages.[ix]

Positive clinical outcomes can only be achieved when the therapy is matched to the right individual and the individual is able to tolerate the therapy. A 30% persistence rate among weight management GLP-1 utilizers[x] is not powered to provide a return on investment and further underscores the need for smart management – high-touch service married with the identification of appropriate individuals for treatment. Clinician-led programs help individuals achieve the goals available from these treatments.  IPM is pleased to offer additional clinician-led programs to our members starting in July 2024.

A different view

It is no secret that chronic inflammation is a key driver of adverse cardiovascular heath, but it is equally important to ponder the contribution of a chronic inflammatory state manifesting as seronegative rheumatoid arthritis, ankylosing spondylitis, hidradenitis suppurativa, and others. As many of these conditions require advancement to specialty biologics to control symptoms and improve quality of life, identifying strategies to reduce chronic inflammation in a group’s population could have other indirect financial impacts.

The potential to reduce inflammation from hyperinsulinemia and excess adipose burden could have broader implications – maybe even reducing or avoiding increased specialty spend through the quelling of chronic inflammatory states.[xi],[xii],[xiii]

Achieving clarity

If anything is clear in this space it is that the path to the right answer is not linear – it is multifaceted.  Having a partner who can help you understand your unique population can help make that path more clear. Reach out to our team at (877) 846-3397; we’d love to schedule a time to talk.

 

 

[i] Standards of Care in Diabetes | American Diabetes Association

[ii] Drug Approval Package: MOUNJARO (fda.gov)

[iii] Weixel N. The Hill, 2024, May 15; https://thehill.com/policy/healthcare/4666461-wegovy-could-bankrupt-u-s-health-system-sanders-says-in-new-report/

[iv] Ozempic (semaglutide) Injection (fda.gov)

[v] Approval Letter_215256Orig1s011ltr.pdf (fda.gov)

[vi] DailyMed – MOUNJARO- tirzepatide injection, solution (nih.gov)

[vii] DailyMed – ZEPBOUND- tirzepatide injection, solution ZEPBOUND- tirzepatide injection, solution (nih.gov)

[viii] SURMOUNT-MMO, https://clinicaltrials.gov/study/NCT05556512

[ix] Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss | FDA

[x] Gleason PP, et al. J Manag Care Spec Pharm. 2024; doi: 10.18553/jmcp.2024.23332

[xi] Kolb H, et al. BMC Medicine. 2020, 18, 224; https://doi.org/10.1186/s12916-020-01688-6

[xii] Poznyak A, et al. Int J Mol Sci. 2020, 21, 1835; doi:10.3390/ijms21051835

[xiii] Wu KK, et al. Int J Mol Sci. 2020, 21, 4184; doi: 10.3390/ijms21114184