Exploring Treatments for Diabetes

^{By Julie Gould} 

In response to a recent study, Michael Attanasio, DO, and Megan Santanna, MA, PCMH CCE, discuss the high costs associated with guideline-based diabetes treatments and why this is a deterrent, and share thoughts on the future of diabetes treatments.

Michael:  I'm Michael Attanasio, I am an independent family physician and my practice is located in South Philadelphia. I am still the physician that practices across the continuum of care. I practice at my office, round at a community hospital, nursing home, and also hospice.  I try to be that doctor that still sees patients in many, many areas and across the cycle of life.  In my primary care office we focus on the Patient Centered Medical Home model and over the previous five years, have invested heavily into the transformation to Population Health.

Megan:  Hi, my name is Megan Santanna, I am the Director of Practice Optimization at our practice I have been working with Dr. Attanasio in primary care for about five years. Previous to this, I worked at large health plan is western PA developing ACO and PCMH programs in the primary care setting. In my spare time I am an adjunct professor at Cabrini University teaching Sociology and Public Health. I have a master's degree in applied sociology with a concentration in medical sociology.

My primary focus is looking at population health management within primary care.

Can you briefly discuss why GLP-1s are superior for HbA1c reduction?

Michael:  If you look at randomized clinical trials, you see A1c reductions that are more than what you would typically see in other diabetic monotherapy trials. You'll see A1c reductions of 1.2-1.4 %.

In real-world studies, when you're able to look at data across systems, you also see that the GLP-1 class has very robust A1c reduction, especially compared to other classes.

It’s known that they are very, very potent. We see it clinically too. It's important clinically to see that match of real-world study mimicking randomized trials. 

There aren’t many head-to-head trials across classes. However, the real-world studies are very beneficial in seeing trends in patient populations. It’s a positive to see the real-world data mimicking what we see in the randomized controlled trials. It’s an indication that these are very strong A1c-reducing group of medications.

Can you discuss the high costs associated with guideline-based treatments and why this is a deterrent? How should this be addressed in order to help treat more patients?

Michael:  In our practice, we focus on evidence-based medicine. In diabetes, I believe that the American Association of Clinical Endocrinologists, AACE guidelines, have a clear and effective way to examine a paradigm of treatment.

The guideline begins with metformin, which most guidelines on diabetes start with because it's an older, inexpensive medication. Following metformin is 3 categories are GLP-1s, SGLT-2s, and DPP-4s, all of which are all-branded medications.

What's below that and what's our secondary choices are older medications, which are much more affordable because they're all generic now, but have many, many risks associated with them. Definite reasons not to use them in comorbidities like coronary artery disease.

So, if you treat using evidence-based guideline treatments, you're choosing medications that are branded and expensive, but have some definite benefits to the patient vs older medications.

Megan:  First, costs from a population health perspective can we challenging. It’s a dichotomy.  Do we save costs today by using generic and cheaper drugs but not provide the most (potentially) effective treatment for the patient in controlling A1C; OR do we utilize the branded GLP-1’s and SGLT2’s where the patients A1C is lower and more controlled which could avoid ER utilization and potentially avoidable hospitalizations?

 Second issue with costs is trying to get patients with active coverage the medications. Often, these classes of medications are step therapies requiring prior authorization. This means the patient must fail other mechanisms of therapy to be eligible to use these higher cost medications.

In those trials and failures or inabilities to get patients medication, patients may live their lives on samples, which is really difficult to manage, especially if we have a population that can't afford the medications that would benefit them. 

Patients who remain on older therapies we see going to the ER more frequently or experience potentially avoidable admissions because we can't control their diabetes. We need to consider the total cost of care including hospitalization and ER, not just looking at the pharmacy benefit costs.

We are willing to jump through the hurdles of prior authorizations based on the evidence from trials, patient positive experiences on the medications, and the other noted health benefits in addition to A1C reduction. 

Michael:  When you look at the GLP-1 and SGLT-2’s in diabetes, the thoughts that I sent in response to the article really expand across other classes of medications as well.

We’ve progressed in medicine to outcomes-based studies. We've shifted away from intermediary markers. As providers we don't just look at LDL anymore. We don't just review hemoglobin A1c either. We consider newer medication therapies that have multiple benefits to the patients. We critically evaluate the impact on heart attack, stroke, mortality and death.

For example, GLP-1 and SGLT-2 outcomes-based studies show a slowing of decline in kidney function. There is evidence of reduced heart failure hospitalizations, even in people that weren't known to have heart failure as a diagnosis in those cohorts which is remarkable for this patient population. So, this population-based study hasn't really correlated yet to population-based treatment.

Insurers, pharmacy benefit managers, people that manage the medication, I might have gotten a little overzealous when I said “refused” because I'm just passionate about it. What I really intended to say is that our health system is so complex with competing pressures to reduce the cost of care that we often see misaligned goals from each of these entities that in the end it is a detriment to the patient.

Let's cut the cost of medication for Type 2 Diabetics to the patient and see the downstream savings from decreased hospitalizations, decreased myocardial infarctions and decreased ischemic strokes.

Therefore, the overall total cost of care is less even with investing in these higher-cost medications versus inexpensive therapies that lack A1c control.

My opinion is that we're still in, "Let's reduce the cost of medications to try and reduce the cost of care," mindset rather than looking at true population-based and outcome-based studies in treating populations in which we all practice. 

It could be South Philadelphia, it could be southeastern Pennsylvania, it could be a state, or nation-wide. We could trial it with a specific insurer, PBM, or health system but as practitioners its imperative that we apply these guidelines and monitor the real-world outcomes to observe if   the study data correlates to our patients the way we’d expect.

Megan:  One thing that I'll add onto that is, it's the mindset of invest today or pay later. If we're investing in the treatments that are really going to benefit patients today, we're not paying for hospitalizations later because we're controlling their diabetes now and investing in medications that can help preserve kidney function and help preserve their life.

It's important to think, when we're looking at prescribing medications that would really benefit the patient, to think about the long-term impacts if they're not on this medication today. What is the quality of life for the patient—will this therapy fit into their daily regimen?

Something that we've had conversations about and something that I'm always interested in is what's happening internationally. If cost was not a barrier to care, how is that impacting patient lives in other countries?

If you're looking at the UK, or you're looking at countries that have socialized medicine, if they're receiving these treatments, what is their long-term impacts for quality of life and cost of care?

Why do you believe insurers refuse to lower the cost barriers to allow access to superior care, which will also lower hospitalizations and organ damage and overall costs?

Michael:  I want to reiterate what I’ve said before—“refusing” was an overzealous statement, however the frustrated sentiment remains.  The health system is too complex and siloed.  Even within the same payer, there are conflicting methods to reach the same goal—how do we reduce the cost of care?  The pharmacy teams (including the PBM’s), population health teams, policy teams, member teams, and provider teams at health plans must work together on this common goal and align methodologies so we can truly achieve at cutting the cutting the cost of diabetes medications to reap the benefits of their efficacy.

For example, the population health aspect of the insurer says, "We have this therapy that will reduce Myocardial Infarctions by 30 percent," doesn't really have influence over the same person who's working with the pharmacy benefit manager and is still just trying to work on overall cost of medication.

I think that goes across the systems too. Megan and I have many, many conversations where we're talking to population health departments. We're talking to insurers. We're talking to Pharma. We're talking to the health systems where we treat, but we can't get everybody together to truly collaborate and meaningfully test the evidence-based medicine in a real-world setting we will never see the implementation outcomes. This is a major focus of implementation science.

We have this great medicine, this great therapy. How does it get implemented? How does it get applied across the people that need it most?

What are your thoughts on the future of diabetes treatments? Do you think cost will continue to be a standard or a regular barrier to treatment?

Michael:  I think costs are going to continue to be a large part of it. I don't see in any near future the types of programs I'm talking about widespread implementation. I think that the cost of medications will still be a target for insurers and pharmacy benefit managers, versus the overall cost of care across the population.

More frequently I see the cost of medications increasing and the cost-share shifted to patients. Patients can’t afford $600 per month for medications—but they also can’t afford the unintended consequences for missing work due to a hospitalization for complications resulting from uncontrolled diabetes –not to mention the costs incurred with that hospitalization. 

As the medications are kept in a high cost tier, and the insurers are not taking a higher burden.  They're shifting more and more cost to the patients, I think it's going to become a bigger problem unless we have more study on the overall cost to care across populations.

Is there anything else that you would like to add?

Michael:  I would just implore everyone that no matter what stakeholder you are in this, that we need to consider these advanced therapies. It's not just in type 2 diabetes—its also complications stemming from diabetes. Heart failure therapies, for example. There's a fish oil, a prescription fish oil that's been shown to reduce cardiovascular disease by 30 percent in people with elevated triglycerides.

There are so many important therapies that require increased access to the patient by reducing the cost, maybe having more cost sharing by the payers in order to achieve the expected outcomes. I think that if we can successfully implement this into our delivery systems, then we can realize the total cost of care is reduced overall, which benefits all.

The triple aim is a priority across the industry, where we want to reduce costs, improve healthcare of the patient, and improve the patient experience. Increasing accessibility and decreasing the costs of these important therapies aids in that triple aim goal.

If we don't have that mindset, where we get all the stakeholders in together and looking at the overall data, it's not going to happen.