Medicaid payments for all types of insulin skyrocketed between 1991 and 2014, new research finds.
Over the 25-year period examined there was a "near-exponential upward trend" in Medicaid payments per unit of insulin regardless of formulation, duration of action, or patent status.
While reimbursement increased more rapidly for newer, patent-protected insulin analogs than for older insulins, increases were seen for all insulin products, report Jing Luo, MD, of the program on regulation, therapeutics, and law division of pharmacoepidemiology and pharmacoeconomics, department of medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, and colleagues in the October issue of JAMA Internal Medicine.
The data suggest a lack of price competition for insulin products in the United States, they say, noting that "If these trends continue without price controls from robust generic competition, patients, physicians, and public and private insurers will find it increasingly difficult to pay for this specialized class of essential medicines."
Principal investigator Aaron S Kesselheim, MD, JD, from the same institution, told Medscape Medical News, "It's possible that greater competition could lower prices, which is why we suggested setting down a definite path for getting follow-on insulin products approved."
Clinically, he said, "It's important to recognize that prescription drug costs can lead patients to stop their medications, even medications as important as insulin, so it's important to identify which insulin products are covered by patients' insurance."
Asked to comment, Kasia J Lipska, MD, an endocrinologist at Yale University, New Haven, Connecticut, agrees. "I'm very worried about patients who require insulin for their treatment these days. Many simply can't afford [it].
"Moreover, not all will necessarily tell their physician about the financial hardships they face due to insulin costs," she stressed, adding, "I ask all of my patients whether they have financial worries about the cost of their medications. Many are relieved to have the question asked.
"We try to brainstorm about ways to obtain insulin more cheaply," she told Medscape Medical News.
"Near-Exponential Upward Trend"
Dr Luo and colleagues used the Medicaid State Drug Utilization Database and accounted for different formulations by reporting reimbursements per unit, with each unit representing 1 mL (100 IU) of standard-strength insulin. They reported 2014 US dollar values, adjusted for inflation.
For all insulins, quarterly Medicaid reimbursements to pharmacies have risen steadily, from $2.36 to $4.43 per unit in the 1990s to $9.64 per unit for short-acting and $9.24/unit for intermediate-acting insulins in 2014. For premixed insulins, average reimbursement in 2014 was $14.79 per unit.
Medicaid reimbursement for rapid-acting insulin analogs (lispro, aspart, and glulisine) have increased from $3.69 per unit when lispro — the first of the class — appeared on the US market in 1996 to $19.81 per unit in 2014.
By 2014, the amount reimbursed for long-acting analogs (glargine and detemir) was about the same, at $19.78.
Reimbursement for patent-protected insulin analogs increased at a higher rate than did non–patent-protected insulins (P < .001). In 2001, when the first long-acting analog (glargine) was introduced, the rate of reimbursement for patient-protected insulins was 76% higher than for those that were not patent protected. By 2014, that difference had risen to 111%.
Total reimbursements by Medicaid for insulin increased from $10.7 million in the first quarter of 1991 to $178.5 million in the fourth quarter of 2005.
And since 2010, quarterly reimbursements have achieved record highs every quarter until the second quarter of 2014, where it topped out at $407.4 million.
Assuming an average daily insulin dose of 40 units, the annual inflation-adjusted cost to Medicaid for medication and dispensing fees was $370 for premixed insulin in 1991 and $2852 for rapid-acting insulin in 2014.
As these trends continue, state Medicaid programs are likely to continue to use prescription management strategies to reduce spending, which will disproportionately affect the newer, more expensive analogs and may make it more difficult for physicians to prescribe them, the authors note.
The findings suggest that the insulin market in the United States lacks competition, despite the presence of three companies.
"It appears not to be enough, because insulin prices are skyrocketing over the past few decades, as we showed," Dr Kesselheim told Medscape Medical News.
He and his coauthors note that there are no generic insulins in the United States, in contrast to Europe where a generic formulation of Sanofi's insulin glargine, marketed by Lilly/Boehringer Ingelheim, has been available since September 2014.
The US Food and Drug Administration (FDA) did tentatively approve this product, with the provisional trade name Basaglar in August 2014, but the approval was subject to an automatic "stay" of up to 30 months as a result of litigation filed by Sanofi claiming patent infringement.
However in the past 2 weeks, Lilly and Sanofi have announced that they have resolved their dispute, with the result that Lilly/Boehringer Ingelheim will have the ability to launch Basaglar in December 2016. With this resolution, Lilly said it plans to request final approval of Basaglar from the FDA.
Nevertheless, say Dr Kesselheim and colleagues, the data from their study suggest that generic alternatives alone may not be sufficient to keep down the costs of insulin products.
On a practical level, Dr Kesselheim told Medscape Medical News, "I think which products people use will probably mostly depend on their insurance and what the copays are. We are not advocating for rethinking the use of analogs, just pointing out their escalating costs."
Cheaper Insulins Clinically Reasonable in Many Cases
Dr Lipska and colleagues previously published a study that called into question whether the newer analog insulins are worth their higher cost.
She said that although insulin analogs are associated with slightly less nocturnal hypoglycemia and more flexible dosing, "For many patients, human insulin may work just as well. I do switch those patients to these cheaper alternatives when it's clinically reasonable."
However, she added, "some patients prefer insulin analogs. I see a lot of older patients who are in the doughnut hole [Medicare coverage gap] and struggle with this. For these patients, I really wish there were generic insulin options."
Dr Luo and coauthor Jerry Avorn, MD, report no relevant financial relationships. Dr Kesselheim is supported by a Harvard Program in Therapeutic Science Ignition Award and a Greenwall Faculty Scholarship in Bioethics. He also reports receiving research funding from the FDA Office of Generic Drugs. Dr Lipska has received grant support from the National Institutes of Health and some support from the Centers for Medicare and Medicaid Services to develop and maintain publicly reported quality measures.
JAMA Intern Med. 2015;175:1681-1686. Abstract
Medscape Medical News © 2015 WebMD, LLC
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Cite this: US Medicaid Reimbursements for All Insulins Have Skyrocketed - Medscape - Oct 14, 2015.