As controversy about the pricing of EpiPens reverberates from Capitol Hill to school districts 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 medicine that saves lives in the event of a severe allergic reaction.
So what exactly determines its longevity? It turns out storage and distribution can play as important a role in the drug’s shelf life as the chemical compounds.
The EpiPen works by injecting into the body the drug epinephrine. That causes a series of physiological changes, including tightening blood vessels and opening airways.
Epinephrine is a generic medication and not very costly, but the drug maker Mylan has a patent on the design of the auto injector that is the key element of the EpiPen. That injector allows users to administer the medication more quickly than other options on the market. Under that patent, the company has progressively raised the cost of the drug since 2007 to about $600 for a pack of two today.
Since the medicine generally expires every year, the cost to replace EpiPens adds up fairly quickly, especially for consumers who do not have insurance or have high-deductible plans in which they must spend money out of pocket before the coverage kicks in.
“This is just a lifesaving medicine,” said Robert Glatter, an emergency room physician at Lenox Hill Hospital in New York. “You can’t let it expire.”This KHN story also ran on Money. It can be republished for free (details).
Environment plays a role the in the EpiPen’s lifespan. The medicine can be stored in areas fluctuating between 59 and 86 degrees, but it should not be exposed to extreme heat or cold. Mylan also advises users to protect the drug from light and not store it in a glove compartment.
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.
Glatter said that is similar to the time that hospitals keep vials of epinephrine in stock, too.
Aside from the active ingredient, the EpiPen solution also contains fillers needed to help stabilize the drug. These compounds also break down over time, affecting the drug’s potency. Glatter said EpiPen users should look out for cloudiness or small pieces of matter in the liquid, as that indicates degradation.
Still, he pointed out that a study in 2000 found EpiPens can remain without apparent signs of deterioration for up to 90 months — seven and a half years — after the expiration date.
While he strongly discourages patients from allowing their EpiPens to expire, Glatter said using an expired one is better than none at all.
“They’re willing to take a chance, unfortunately,” he said.
Glatter said he’s seen a rise in people holding onto expired EpiPens because they cannot afford a new dose. And according on FDA standards, no other drug on the market is as effective.
Despite its dominance, consumers can purchase a cheaper alternative that contains the same medication: Adrenaclick’s generic option. That product lasts 18 months — the maximum length of time for the EpiPen — and can withstand the same temperatures as its competitor. Both the generic and EpiPen auto-injectors are designed with a viewing window to check the solution for cloudiness and particle matter.
Unlike the EpiPen, the generic auto-injector requires the user to remove an endcap before injecting the epinephrine. The alternative also stands out from its brand name competitor with its price tag: $395 for a two-pack.
Under intense scrutiny, Mylan announced several initiatives to reduce the cost of EpiPens for its 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 drug at half the cost. In addition, the manufacturer 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 the brand name drug because it cut costs by eliminating the distributor. Mylan CEO Heather Bresch adamantly denied the accusations.
In addition, Bresch also announced the company is “day’s away” from submitting a proposal to the FDA for an EpiPen that expires every 24 months, double the shelf life of the current product.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
Most hospitals offer palliative care services that help people with serious illnesses manage their pain and other symptoms and make decisions about their treatment, while providing emotional support and assistance in navigating the health system. But hospital programs vary widely, and the majority fail to provide adequate staff to meet national guidelines, a recent study found.
A growing body of research has shown that palliative care can improve the quality of life for patients with serious illnesses and complex, long-term needs. In one study, patients with advanced cancer who had discussions with their doctor about their wishes were less likely to die in the intensive care unit, be put on a ventilator or have cardiopulmonary resuscitation, for example.Insuring Your Health
KHN contributing columnist Michelle Andrews writes the series Insuring Your Health, which explores health care coverage and costs.
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Although many people, including medical professionals, continue to associate palliative care only with end-of-life care, it is appropriate for many people in many settings who are living with debilitating long-term illnesses.
In 2013, two-thirds of hospitals with at least 50 beds reported having a palliative care program. At hospitals with 300 beds or more, the figure was 90 percent, according to a study published in the Journal of Palliative Medicine earlier this year.
But not all programs provide the same level of service. In the September issue of Health Affairs, an analysis of 410 palliative care programs found that only 25 percent funded teams in 2013 that included a physician, an advanced practice or registered nurse, a social worker and a chaplain, the four positions that are recommended by the Joint Commission, which sets hospital standards, including those for accreditation. If “unfunded” staffers were counted, those who were on loan from other units, for example, the figure rose to 39 percent.
Study coauthor Diane Meier, a professor of geriatrics and palliative medicine at the School of Medicine at Mount Sinai in New York and director of the Center to Advance Palliative Care, said she wasn’t surprised by the low numbers.
“There are no regulatory or accreditation requirements that enforce the staffing guidelines,” Meier said. Although the Joint Commission recommends a staffing standard, hospitals aren’t currently required to have palliative care teams in order to be accredited, Meier said.
“The hope is to shine a light on the gap in what everyone agrees is the [staffing] standard. If we’re invested in improving the quality of care, this is what it will take.”
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KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.