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High Costs of Pancreatic Enzyme Replacement Therapy Barrier to Medicare Beneficiary Drug Access

January 20, 2021

 

Arjun Gupta, MD, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (Baltimore, MD), discusses results from a study assessing out-of-pocket and total spending on pancreatic enzyme replacement therapy under Medicare Part D.

These results were presented at the virtual 2021 ASCO Gastrointestinal Cancers Symposium.

Follow Dr Gupta on Twitter: @guptaarjun90

Transcript

Hi, my name is Arjun Gupta. I'm a medical oncology fellow at the Johns Hopkins Cancer Center. This year, at the ASCO Gastrointestinal Cancers Symposium, we presented our work on the costs of pancreas enzyme replacement therapy. I'm here to talk about that.

Patients with pancreatic disorders including pancreatic cancer, chronic pancreatitis, and cystic fibrosis can often suffer from pancreatic insufficiency, which is the inability of the body to produce adequate amounts of digestive enzymes required to digest and absorb food.

These patients can have very bothersome symptoms such as flatulence, diarrhea, and malabsorption. This can limit their quality of life, and it's also been associated with reduced survival.

Patients with pancreatic insufficiency often have to take daily pills with every meal. This is what's called as supplemental pancreatic enzymes. We know from clinical practice that there's very few brand name prescriptions available in the US for pancreatic enzymes. The costs of these enzymes are a major barrier to their access by patients.

In fact, we as clinicians, often under‑prescribe pancreatic enzymes in clinical practice. Because of this, our research team wanted to look at what are the estimated out‑of‑pocket costs for patients directly when they're prescribed an optimal regimen of pancreatic enzymes.

We looked at 2020 Medicare plans that covered pancreatic enzyme replacement therapy. These capsules come in different doses, ranging from 3000 lipase units to up to 40,000 lipase units. To give you just an idea, a good-sized meal often requires 80,000 units of lipase or 2 of the very largest pills. Of note, these pills need to be taken meal after meal every meal throughout a patient's life.

What we found was that there was wide variation in the costs of these pancreatic enzymes. If someone was to just try to go to a pharmacy and attempt to purchase these pancreatic enzymes, a 1‑month supply would cost them between $2000 to $4800. Remember, this is just for a 30‑day supply.

For Medicare beneficiaries, the out‑of‑pocket costs for a 30‑day supply, depending on the formulation, ranged depending on which phase of the Medicare plan they were in. For example, in the standard benefit design, which is at the start of the out‑of‑pocket costs on average for a 30‑day supply was $999.

With a 25% coinsurance for the second phase of the Medicare benefits, the out‑of‑pocket costs were over $600 a month. In the last fees, the catastrophic fees, the out‑of‑pocket costs for more than $130 per month. Remember, these are just the out‑of‑pocket costs for a 30‑day supply.

We know from clinical practice that patients are often under‑prescribed these bills. Patients, because they're unable to fill these pills, often resort to cheaper, over‑the‑counter, non‑formulary pancreas enzyme products available at your local CVS or Walgreens.

The trouble with those formulations is that they are not regulated. The enzyme content in them is miniscule in the range of 100s of units instead of the 50,000 units needed per meal. Patients end up spending way more for not too much benefit.

In summary, our findings show that these high out‑of‑pocket costs serve as a barrier to Medicare beneficiary drug access and also are a major cause of financial toxicity to these patients. We all recognize the financial toxicity imposed by novel chemotherapy drugs, CT scans, imaging, and hospitalizations.

I think it's easy to forget that sometimes the simplest supportive care interventions may be causing the most financial toxicity. Thank you.

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