A Generic EpiPen Might Not Be Your Best Option

Consumer Reports / Teresa Carr / August 30, 2016

Mylan is introducing a generic version of its life-saving EpiPen, 

but Consumer Reports has found another low-cost option

Mylan's plan to introduce a generic version of its life-saving EpiPen will cut the price in half, to $300 for a two-pack. But Consumer Reports has found that another low-cost option already exists.

Mylan announced the generic version of EpiPen after members of Congress as well as Consumers Union, the policy and mobilization arm of Consumer Reports, called for the manufacturer to lower the $600 price.

The generic EpiPen will be released in the next several weeks. But that's not your only—or perhaps even the best—option for getting the medicine and auto-injector.

There's already a low-cost epinephrine auto-injector available, the generic version of Adrenaclick. This product delivers the same drug, in the same dosages, but the auto-injecting mechanism works slightly differently.

It lists for about $450 for a two-pack, but we found that you could get it for as low as $140 at Walmart with a coupon from GoodRx.com. Your insurance might also cover it with a lower co-pay than brand-name EpiPens, and you might qualifty for further discounts using coupons through the manufacturer.

Mylan says that their new generic will be identical to their brand-name EpiPen. The generic device for giving yourself an injection with the drug ephinephrine will work exactly the same way to quell severe allergic reactions that interfere with breathing. And, like the brand-name version, the generic will be available in two doses—a 0.3 mg adult strength and a 0.15 mg strength for children.

Mylan told us that generic EpiPen will be available from pharmacies and directly from the company by mail.

Generic EpiPen Might Not Be Cheaper For You

With little competition and many years left on the patent for the EpiPen injector, it's "highly unusual" for Mylan to come out with a generic product to essentially compete with itself, says Stephen W. Schondelmeyer, Ph.D., Pharm.D., a professor of pharmacy economics at the University of Minnesota. "I think the company realized that they overreached on price," he says. "They can cut the price in half and still make a profit."

Even so, the generic EpiPen is overpriced, he says. "We're talking about a lifesaving product that costs a few dollars to make," says Schondelmeyer. "It's hardly a consumer win that the company has now decided to charge only $300."

Mylan told Consumer Reports that it won't offer coupons for the generic EpiPen, so even after it hits the market, some people might find it cheaper to stick with the brand-name version, says Barbara Young, Pharm.D., of the American Society of Health-System Pharmacists. "It really depends on your individual situation and insurance coverage," she says.

Young advises enlisting your pharmacists' help in pricing the various options—if possible before your healthcare provider writes the prescription. "Your doctor will need to write the prescription specifically for the device you decide on," she says.

For an EpiPen or generic EpiPen, your healthcare provider can simply prescribe the brand-name product. The generic is exactly the same, so pharmacists should be able to substitute it for the brand if you request it. To help lower the consumer's out-of-pocket costs if they are insured, Mylan announced last week it would offer larger discounted co-pay coupons, up to $300, and it expanded its patient assistance programs for brand-name EpiPens. However, those discounts are not available to people with Medicare or other government health insurance programs.

For generic Adrenaclick, your provider should prescribe "generic Adrenaclick" or simply "epinephrine auto-injector." Because those auto-injectors are slightly different than EpiPens, laws in many states prohibit phamacists from substituting one device for the other. (In some states, however, including California, Colorado, Connecticut, Florida, Vermont, and Washington, pharmacists can fill an EpiPen prescription with generic Adrenaclick, according to the drug's manufacturer, Impax Laboratories.) Just make sure that you get trained on the device before leaving the pharmacy, Young says. EpiPens and Adrenaclick pens are very easy to use and have similar instructions, but you want to make sure that you understand exactly what to do in an emergency situation.

More Competition on the Way

One reason Mylan might be coming out with a generic now is to get ahead of the competition. Earlier this year, the Food and Drug Administration turned down an application by drugmaker Teva for a generic epinephrine auto-injector due to "major deficiencies," but the company told us that it might reapply and that its product could enter the market next year.

In addition, Mark Baum, the CEO of Imprimis, a company that compounds drugs, told us that Imprimis is investigating selling epinephrine auto-injectors directly to consumers for about $100 for a two-pack of pens. Baum noted the company plans on selling them by the end of the year.

In the short term, an array of different options could make it more confusing for consumers, Young says. "But in the long run, the competition is likely to help bring down costs."


Editor's Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

What You Need to Know About Expired EpiPens

Consumer Reports / Ginger Skinner / August 26, 2016

Are they safe? And will they be effective in an emergency?

Anne McMaster, a retired nurse in Seattle with a serious allergy to bees, used to buy a new EpiPen every year when her current one expired. That stopped about three years ago when her out-of-pocket costs for the potentially life-saving medication spiked and she couldn't afford the higher price. Instead, she just kept her old injector, figuring an expired EpiPen is better than no EpiPen at all.

"I would never tell anyone else to do it because of the risks of it not working," McMaster says. "But for me, it was a risk I had to take."

Although there are some lower-cost alternative injectors on the market, and Mylan, the maker of EpiPen, says it is introducing programs to make the device more affordable for consumers, many Americans are wondering whether it is indeed okay to use expired EpiPens.

It's important to replace your epinephrine injector before the expiration date stamped on the pen. That’s because epinephrine deteriorates over time and relying on an outdated one (past the standard 12- to 18-month expiration date) can leave you with an auto-injector that's less effective, or not effective at all, when you most need it.

But what should you do if you are having an allergic emergency and the only injector you have is an expired one? It's probably better to use it than not, some experts say.

"If a patient were to experience an allergic emergency that required use of epinephrine and the only injector available was an outdated one, I would use it," says Andrew Murphy, M.D., a board-certified allergist at the Asthma, Allergy and Sinus Center in West Chester, Pa. "The risk would be that the epinephrine would have degraded and you may not get an optimal dose."

An April 2015 study in the Annals of Allergy, Asthma & Immunology looked at 35 expired EpiPens and found that injectors that were up to two years past their expiration date could retain 90 percent or more of the initial dose listed on labeling.

Murphy stresses that you shouldn't use any injector, even if it's technically not expired, if the medicine is pink or brown (instead of colorless), cloudy, or contains solid particles. In that case, "the medicine clearly has decayed and the injector should not be used at all," Murphy says.

Murphy also says that anytime you use an auto-injector—expired or not—you should call 911 or go to the emergency room, even if the shot seems to be working. That's because severe allergic reactions can require more than just a shot of epinephrine.

Storing and Disposing EpiPens
Be sure to store epinephrine auto-injector properly. And that doesn't mean in the refrigerator: Extremes of heat or cold can degrade the medicine, as can exposure to light and humidity. So while you might need to carry one around with you, when you are at home or work store it at room temperature in a dry, dark place. And while it might be tempting to keep a spare in the glove compartment of your car, that's probably not a good idea because it can get too hot or cold, in there. If your child needs one while at school, ask the nurse to keep it. Many schools have special lockers for such medicines.

It's also important to properly dispose of expired EpiPens or used injectors, says Barbara Young, Pharm.D., of the American Society of Health-System Pharmacists.

Auto-injectors thrown into in your household trash could prick or injure people or pets in your home. Instead, if you've used the injector, give the device to the healthcare professional you saw afterward. Take expired EpiPens to a doctor’s office, hospital, or pharmacy for disposal, Young says.

You can find a drop-off location near you at SafeNeedleDisposal.org.

A final tip: When filling an EpiPen prescription, ask the pharmacist to give you auto-injectors with the latest expiration date.


Editor's Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

The Cost Of A Life-Saving EpiPen Has Increased 400% Since 2007

From Consumerist / August 19, 2016 / By Laura Northrup

If you or someone in your family has severe allergies, the EpiPen is a familiar and essential product. Yet if you have good health insurance, what you may not know is that the cost of the pens has increased significantly since pharmaceutical giant Mylan acquired the drug in 2007.

Different sources list different prices, but the cash price for an EpiPen has increased somewhere between 400% and 600% in the last decade since Mylan acquired the product. A pack of two pens can cost hundreds of dollars at retail.

According to reporting in Bloomberg BusinessWeek from last year (warning: auto-play video at that link), Merck got rid of the EpiPen, which wasn’t a big money-maker at the time, by selling it to Mylan. The auto-injector pen contains about a $1 dose of the drug epinepherine, yet somehow costs 400% more on the wholesale market, and the cost to insurance companies and patients forced to pay retail has probably increased even more.

While the EpiPen is a 25-year-old device, there is no direct generic equivalent. One important money-making strategy for Mylan has been to hand out free pens to familiarize people with the product. The company has also been working to make sure that the pens end up purchased in bulk for schools and in other public places for allergic emergencies…just like the automated defibrillators that are now easy to find. Mylan has even worked with the same consultants as defibrillator-maker Medtronic.

Well, okay, but what can patients actually do about those high prices? For lower-income patients whose insurance doesn’t cover the devices, there’s a patient assistance program, and the company also offers coupons that bring the co-pay down if your insurance does cover the device.

You can also opt out of using Mylan’s product altogether. Dosing your own epinepherine in a syringe isn’t recommended, but there’s another auto-injector on the market that costs less than an EpiPen. Since it isn’t a generic, you can’t just receive one at the pharmacy when your doctor has prescribed EpiPens.

When our colleagues down the hall at Consumer Reports checked prices for the device, they found that the Adrenaclick cost less than half as much as the EpiPen. Another alternative product, Auvi-Q, was recalled and taken off the market earlier this year.

Check with your insurance company, but all of these products should be covered: it’s just that the ubiquity of the EpiPen makes it the first product that doctors and patients both think of. It’s the Kleenex or Band-Aid of lifesaving injector devices.

What’s important is to make sure that everyone knows how to use the alternative device, if your doctor agrees that one of : the allergic person and other household members should know how to administer the drug.

For children, make sure that parents and other caregivers, as well as staff and nurses at the school know that the device is an Adrenaclick and not the more familiar brand.

Though that may not help much either: one parent who spoke to MarketWatch said that her high-deductible health plan means that a two-pack of EpiPens costs $500 with a discount coupon from Mylan, while a two-pack of the Adrenaclick cost $400.

https://consumerist.com/2016/08/19/the-cost-of-a-life-saving-epipen-has-increased-400-since-2007/

A Surprising Way Big Pharma Keeps Drug Prices High

Delaying the release of generics drugs can cost consumers millions, and should be illegal, say consumer groups and the FTC

By Steve Mitchell
Last updated: October 13, 2015

Ten years ago, consumers were on the verge of getting a lower-priced, generic version of the brand nameantibiotic Doryx (doxycycline). But the drug's manufacturer, Warner Chilcott, stopped making the drug in its original capsule form and instead began producing it as a tablet. This seemingly minor change meant that generic manufacturer, Mylan, was blocked from being able to market the matching generic tablet it had been developing.

Warner Chilcott is now embroiled in a lawsuit that charges it used those and similar tactics—such as adding score lines to the tablets and ceasing production of the unscored tablets—to manipulate the patent and generic laws to stay one step ahead of generic manufacturers.

That tactic, called “product hopping,” is a strategy drug makers have begun using in recent years to stall the development of generic versions of a medication so they can keep brand-name drug prices high. But it is coming under fire from the Federal Trade Commission and several consumer groups, which charge in a federal court case that it’s a violation of antitrust law that bilks consumers of millions of dollars in high drug prices.

In the case, the generic-drug company Mylan accuses Warner Chilcott of using product hopping to prolong its patent on Doryx. A district court in Pennsylvania sided with Warner in April, ruling that its product hopping tactics did not violate antitrust law.

But Mylan has appealed the decision. And last week it got a boost from several consumer groups, includingConsumers Union, the policy and advocacy arm of Consumer Reports, AARP, Consumer Action, Consumer Federation of America, Families USA, U.S. PIRG, and others, which jointly filed an amicus brief in support of the appeal.

The FTC also flexed its muscles, filing a separate amicus brief in support. The consumer groups and the FTC fear that if the initial decision is left to stand, it will open the door for other drug companies to use product hopping to stifle generic competition and keep drug prices high. And that would mean consumers would be stuck with a hefty bill.

The delay of getting even one generic drug on the market could easily cost consumers hundreds of millions of dollars, says George Slover, a senior policy counsel for Consumers Union. “If product hopping is allowed to become standard practice, the cost to consumers could be staggering."

Slover says there’s hope the courts will declare product hopping illegal. In May, a different federal appeals court, the Second Circuit, upheld a ruling that Actavis’ product hopping with its Alzheimer’s medication Namenda was illegal. In that case, New York state accused Actavis (now Allergan) of switching Namenda from an immediate-release to an extended-release formulation to delay generic immediate-release alternatives from being launched.

When we contacted Allergan, which now owns both Doryx and Namenda, for this story, it declined to comment on either case.

It could take a prolonged battle in the courts to finally settle the law against product hopping. But Slover notes that it took more than a decade for consumer advocates to stop another generic-blocking scheme called “pay for delay.”

Under that tactic, the brand-name drug maker pays off a generic manufacturer to delay the launch of its generic formulation of the drug, so the brand name can continue to sell at a high price. For years, courts ruled that drug companies were shielded from the antitrust laws because of their patent. The FTC ultimately took the fight against pay for delay to the Supreme Court, which ruled in 2013 that the antitrust laws apply to the scheme.


Editor's Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).