Back in August, Illinois became the first state to require companies offering health insurance policies in the state to pay for epinephrine injectors, or EpiPens for individuals 18 and younger. The law, House Bill 3435, takes effect January 1, 2020, and was signed into law by Illinois governor JB Pritzker.

What Are EpiPens?

EpiPens are used during an anaphylactic attack, or severe allergic reaction, delivering an emergency dose of epinephrine, or adrenaline. This helps to minimize swelling and opens airways. Failure to administer the drug as soon as possible can result in patient disability or death, according to Health Canada.

The law specifically states that Illinois insurance policies must pay for “medically necessary epinephrine injectors for persons 18 years of age or under.”

It defines an “epinephrine injector” as “an auto-injector approved by the United States Food and Drug Administration.”

But what you should know is that the new law does not mandate coverage of the “EpiPen” at all. Rather, it requires coverage of EpiPens or one of the five alternative epinephrine injector products, including a generic version from its manufactuer, Mylan and one from Teva Pharmaceuticals that was approved last August.

EpiPens Are Pissing People Off

According to Tonya Winders, the head of the Allergy and Asthma Network, Illinois is the first state to mandate EpiPen insurance coverage.

Unfortunately, EpiPen hasn’t been in the public’s good graces in recent years, as concerns about its price have thwarted its effectiveness and efficacy.

#1—Pricing Spike

The law comes after a decade of rising EpiPen prices, which many cannot afford. After Mylan bought the right to produce EpiPen from a German drug maker back in 2009, the company, along with another branded competitor, progressively raised the price from approximately $124 to around $700 for a two-pack.

Many attribute the severe spike to the change in health insurance plans, especially those with high deductibles on their individual insurance plans.

As we already mentioned, the price of EpiPens have skyrocketed over the years, going from around $100 per pen in 2009, to around $700 for a two-pack as of today. Last year, the FDA approved a generic form of the drug produced and manufactured by Mylan, which costs half as much.

With steady increases in food allergies and other serious allergic conditions, families are relying on EpiPens more than ever before,” Illinois State Senator Julie Morrison, who sponsored the bill, said in a statement.

We should be doing everything we can to expand access to affordable lifesaving drugs and medicines. No child with a serious allergy should be without an epinephrine injector because they cannot afford one.”

#2Aren’t Prescriptions Already Covered?

But, if we are talking about generic forms of the injectors, how much of a difference will this law actually make? That remains to be seen for a number of reasons—first, many insurance companies already cover prescribed EpiPens.

For physicians, this law was a bit strange. Why? Most insurance companies were already covering prescribed EpiPens, which is a standard-of-care medication. Wouldn’t the company be subject to extreme scrutiny and liability if a consumer/patient died as a result of this? Maybe that’s why it took almost 30 years for a state to mandate EpiPen coverage.

#3—Out of Pocket Expenses Remain

In its current form, the bill does not address out-of-pocket costs for patients. This is concerning for two reasons, because coverage doesn’t necessarily guarantee reasonable costs for consumers, as there is a likely potential they are still paying hundreds of dollars out-of-pocket for failing to meet their annual deductible, and also each insurance plan may have varying co-pay

In other words, the insurance company may not be violating the law, but could be violating the spirit of it, according to Garth Reynolds, executive director of the Illinois Pharmacists Association.

#4—Defective Packaging

Just this week, Health Canada and the drug manufacturer, Pfizer are warning consumers that a “very small number” of EpiPens might have defective packaging, making them difficult to remove from their cases in an emergency.

Specifically, the problem is with the tube that holds the auto-injector device, not the device itself. In an estimated two out of every one million devices, the rim of the outer plastic tube may be deformed, making it harder to slide the device out of the tube, Pfizer said.

The problem affects the EpiPen (0.3 milligrams) and EpiPen Jr. (0.15 milligrams) devices with an expiry date of September 2020 or earlier.

What You Can Do

SOURCE Mylan N.V.

Health Canada is urging people who carry EpiPens to check their device to make sure it slides easily out of its tube.

Here’s how to check your EpiPen:

  1. Flip open the carrier tube cap
  2. Gently turn the tube upside down
  3. Let the device slide into your hand, without shaking it or dropping it
  4. Check the tube to make sure that the rim is not deformed
  5. Do not remove the blue safety release from the auto-injector. It should be left on until the device is going to be used.
  6. If everything seems fine, put the device back in the tube and close the tube.

Health Canada recommends that you check every new EpiPen you get to make sure it slides out easily.

If you find a defective EpiPen or the device won’t slide out of its tube, you should return it to your pharmacist for a replacement, according to Health Canada.

This lends the question of whether Mylan could be subject to a product liability action. Currently, Mylan was ordered to pay $30 million to settle financial nondisclosure to investors after a Department of Justice investigation, where it was found that the EpiPen makers were overcharging for the allergy treatment.