Need to Replace EpiPens Regularly Adds to Cost Concerns

Device has shelf life of 12 to 18 months

As controversy about the pricing of EpiPens reverberates across the country, one recurring complaint from consumers is that the high cost is magnified because the drug expires quickly, forcing users to regularly bear the cost of replacing the medication, according to a report from Kaiser Health News.

The EpiPen injects epinephrine, which causes a series of physiological changes, including tightening blood vessels and opening airways.

Epinephrine is a generic medication and is not expensive, but Mylan Pharmaceuticals has a patent on the design of the autoinjector that is the key component of the EpiPen. The injector allows users to administer epinephrine more quickly than do other options on the market. Under its patent, Mylan has progressively raised the cost of the EpiPen since 2007 to the current price of approximately $600 for a pack of two.

Because the medication generally expires every year, the cost to replace EpiPens adds up quickly, especially for consumers who do not have insurance or who have high-deductible plans in which they must spend money out of pocket before the coverage kicks in, the Kaiser article notes.

In addition to epinephrine, the EpiPen solution contains fillers needed to help stabilize the drug. These compounds also break down over time, affecting the drug’s potency.

According to Julie Knell, Director of Specialty Communications at Mylan, the EpiPen expires every 12 to 18 months, but that period includes the time it takes to distribute the product and reach the patient’s hands.

Consumers can purchase a cheaper generic alternative to the EpiPen that contains the same medication. That product lasts 18 months—the maximum length of time for the EpiPen. Both the generic and EpiPen autoinjectors are designed with a viewing window to check the solution for cloudiness and particulate matter. Unlike the EpiPen, however, the generic autoinjector requires the user to remove an endcap before injecting the epinephrine. The generic product has a price tag of $395 for a two-pack––almost half the cost of the EpiPen.

Under intense scrutiny, Mylan announced several initiatives to reduce the cost of EpiPens for their users. Among them is the release of their own generic version, which, according to the company’s website, will be identical to their brand-name device at half the cost. In addition, Mylan will provide a direct-ship option, which allows consumers to buy the product directly from the company.

Mylan’s announcement drew sharp criticism last week at a hearing of the House Oversight and Government Reform Committee, with many members claiming the company would profit more from the generic drug than from the brand-name drug because it cut costs by eliminating the distributor. Mylan CEO Heather Bresch denied the accusations.

In addition, Bresch announced that the company is “days away” from submitting a proposal to the FDA for an EpiPen that expires every 24 months––double the shelf life of the current product.

Source: Kaiser Health News; September 30, 2016.