High Cost, Low Access Still Plague Insulin Market at 100-Year Anniversary

Authors of a review of 100 years of insulin therapy for diabetes contend that manufacturers have systematically exploited the patent system and market to generate profits at the expense of patients, but they note progress in the development and availability of biosimilar insulin.

Semglee (insulin glargine), for example, was originally launched in 2020 as a standalone drug, but its status was changed to “interchangeable biosimilar” in 2021, potentially giving it access to a larger share of the market for reference product Lantus. The official relaunch of the product as a biosimilar was November 16, 2021, and this made Semglee the first official insulin biosimilar available in the United States.

In tandem with the redesignation of Semglee, which has an identical amino acid sequence to Lantus, the pharmacy benefit managers (PBMs) Prime Therapeutics and Express Scripts have announced intentions to give this product preferred formulary status, boosting access to patients and, potentially, savings.

Semglee was the first biosimilar to receive interchangeable status. An interchangeable can be dispensed at the pharmacy counter instead of higher-priced reference products without physician authorization. According to AmerisourceBergen, there are multiple rapid-acting and long-acting insulin biosimilars in development that could potentially complement the price-reducing effect of Semglee.

Insulin Promise and Disappointment

Insulin was discovered in 1921 in Toronto, Canada, and first used to treat diabetes in a human in January 1922. Recognizing insulin’s value for human health, its discoverers famously sold their patent rights for $1 each to keep insulin “accessible and affordable for everyone with diabetes”; yet after nearly 100 years of insulin, fewer than half of patients with diabetes worldwide can’t access or afford the drug, and up to 30% of individuals in the United States with diabetes report rationing or skipping insulin doses because of cost, according to authors of the review, which explores why insulin remains expensive and how its cost could be controlled.

“Insulin prices and expenditures have increased dramatically over the past decade in the United States, and high prices and out-of-pocket costs are barriers to insulin treatment for people with diabetes,” the authors wrote.

They cited several factors that are driving up the cost of insulin, including clinicians’ prescribing practices, price increases across all insulin products, regulatory and policy barriers, and a lack of transparency throughout the supply chain. They outlined strategies at clinical, policy, and regulatory levels to improve access to and affordability of insulin.

A Shift in Clinician Prescribing Practices

First, they noted increasing use of more expensive insulin analogs in place of human and animal insulins, which has “negatively affected the affordability of insulin for health systems and individuals around the world.”

Clinicians should weigh the benefits and costs of insulin analogs (laboratory grown and genetically modified to accelerate or control the drug’s effect), because less-expensive human insulins “may be appropriate alternatives” for some patients, the authors said. They cited research suggesting that insulin analogs did not reduce the risk of hypoglycemia or improve glycemic control compared with human neutral protamine Hagedorn (NPH; isophane) insulin in patients with type 2 diabetes.

Encourage Market Competition

The authors recommended regulatory changes, saying that “although patents and exclusivities serve to promote innovation, they can negatively impact competition.” For example, they recommended regulatory action to discourage manufacturers from applying for multiple patents on the same drug or making slight modifications in product to extend patent protection.

Additionally, they advised that manufacturer agreements that block the launch of generics or biosimilars (pay for delay) “should be curtailed,” and they said the 180-day exclusivity period for the first manufacturer to apply for a generic drug application “should be revised to close loopholes that limit competition beyond 180 days.” Plus, they said regulators should contemplate shortening the allowable period of market exclusivity for original biological products and removing market barriers to biosimilar entry.

Flexibility of Payers to Negotiate Drug Prices

The federal government’s limited flexibility to negotiate drug prices is another contributor to rising insulin costs, the authors said. Medicaid is permitted to negotiate drug prices “and by doing so is able to provide beneficiaries with an extensive choice of medications at low out-of-pocket costs,” but Medicare Part D is prohibited from negotiating drug prices. The authors recommended that “all federal drug benefit programs be given greater flexibility to negotiate medication prices with manufacturers and PBMs to capitalize on their market shares and volumes.”

Under the Build Back Better Act, currently under negotiation in Congress, Medicare Part D would be allowed to negotiate the prices of the highest cost drugs once they have been on the market for a certain length of time. The market exposure time for small molecule (generic) drugs would be 9 years, and the time limit for large molecule (biologics) would be 12 years. Medicare could negotiate up to 10 drugs per year in 2023, and in succeeding years the total could climb to 22 drugs negotiated.

Medicare Part D Senior Savings Model

The authors also discussed the Part D Senior Savings model, “a promising new model for pharmacy payment,” launched by the Center for Medicare and Medicaid Innovation in January 2021. This savings model offers beneficiaries “broad access to multiple types of insulin at a maximum copay of $35 per insulin per month.”

Implementing Value-Based Pricing

With value-based pricing, “the price paid for medication is based on the benefits to the patient as indicated by clinical or financial measures.” The authors encouraged the use of value-based pricing for insulin or alternatively, value-based insurance design (VBID), which is intended to promote cost-efficient health care and consumer choices, with the goal of lowering costs and improving health care quality. The authors noted that VBID principles are already in place in the Affordable Care Act, which requires health plans to cover certain preventive services with no patient co-pay.

Pharmaceutical Distribution Transparency

The authors noted the growing difference between the list price and the net price of insulin due to rebates and discounts, saying “for every $100 spent on retail drugs, $41 goes to parties in the distribution chain: wholesalers, pharmacies, pharmacy benefit managers, and insurers.” They urged “greater transparency and simplicity” in insulin pricing “to eliminate distortions that are currently beyond individual payers’ ability to address.”

Reference

Herman WH, Kuo S. 100 years of insulin: why is insulin so expensive and what can be done to control its cost? Endocrinol Metab Clin North Am. 2021;50(3 suppl):e21-e34. doi:10.1016/j.ecl.2021.09.001