Caught in the Middle

EpiPendamonium. EpiPendemic. EpiPanic. The popular press has had a field day with the public outcry over the growing gap between the price of EpiPen (epinephrine auto-injectors, Mylan) and the ability of patients, even insured patients, to pay. The furor over EpiPen pricing is simply the best publicized of many similar price hikes that have left patients unable to pay.

Jeremy Counts, PharmD“Raising the EpiPen price to more than $600 is ridiculous,” said Jeremy Counts, PharmD, owner of Main Street Pharmacy in Blackburg, VA. “Like every other pharmacist in the country, I’m having patients come in every day asking ‘what can I do? I don’t have $600.”

Pharmacist in the Middle

“What gets missed in all the media frenzy is the pharmacists who are caught in the middle,” said Dorinda Martin, PharmD, who owns three Martins Compounding and Wellness Pharmacy locations in Austin, TX. “Parents aren’t just buying one box of EpiPens, they’re buying two or three or four boxes for each child who needs it. Depending on your health plan, you may be paying $10 or you may be paying full price. Somebody is making a good profit on EpiPens, but it isn’t the pharmacy. We just get to take patients’ totally justified anger and frustration over prices that nobody understands.”

Patients are particularly frustrated because there is no single answer for price increases. 

Options, Not Solutions

Whatever the reason for a particular drug price hike, pharmacists have few good choices. PUTT, Pharmacists United for Truth and Transparency, has published a poster that details EpiPen pricing. Pharmacies can use the poster to help patients understand who is profiting, said Arizona pharmacy owner and PUTT president Teresa Stickler, PharmD. But understanding pricing doesn’t help patients afford it. Or believe it.

Bradley Arthur, PharmD“There is no good way to explain the price increases because they often defy logic even to us,” said Bradley Arthur, PharmD, president of the National Community Pharmacy Association. “To try to explain it to a layperson just leaves them more befuddled.”

Dr. Arthur noted that about 98 percent of his claims are paid by third parties, so patients may not even be aware of price increases. The problem is the remaining two percent that may no prescription drug coverage or have high deductible coverage that exposes patients to a significant portion of the retail price. If deductibles are high enough, patients may be responsible for the entire cost.

“Any major price increase will make it harder for patients to access their drugs,” SAID Mohamed Jalloh, PharmD, Assistant Professor of Clinical Sciences at Touro University California College of Pharmacy and Ambulatory Care Pharmacist at OLE Health in Napa, CA. “A recent is the price increase for EpiPen. Due to the drastic price increase, many patients have told me they can no longer afford it.”

Just as the reason for price increases depends on the specific product, pharmacists’ ability to help patients work around drug costs depends on the specific patient, drug and drug coverage. Pharmacists may be able to help patients navigate the Byzantine labyrinth of drug prices and copays, but they cannot solve the problem.

Patients with type 1 diabetes, for example, need insulin. They may have no choice but to pay the price or go without.

Patients with type 2 diabetes may have a little more flexibility.

“If insulin injections become too expensive for managing your type 2 diabetes,” Dr. Jalloh noted, there are so many other agents that are available and affordable. Encourage patients to sit down with you and with their physician to identify alternative agents.”

Manufacturers may have patient assistance programs that can cover all or part of the retail cost. Depending on income level and other requirements, some patients without coverage may be able to get financial help. Patient assistance programs are most common for biologics and other high-cost products, but it never hurts to check.

For patients who have some sort of third party coverage, coupons or copay cards may help. Coupons generally work to keep drug prices high and inflate spending on brand name products, explained Steven Schondelmeyer, PharmD, PhD, Professor and Head of the Department of Pharmaceutical Care and Health System and Director of the PRIME Institute at the University of Minnesota College of Pharmacy. But for individual patients, coupons can be the difference between being able to afford a drug and having to go without.

Mylan, for example, has a $300 copay card that can effectively cover half of the current retail EpiPen price.

Patients can sign up for the program online. Enrollment can even be done at the point of sale and the coupon applied immediately. But it may not be enough.

“We have patients displaced at $300 for EpiPens and many more at $600,” said Amber Korn, University of North Carolina pharmacy resident at Sona Pharmacy and Clinic in Asheville, NC. PharmD. “A lot of patients are just not getting prescriptions filled because of the cost.”

Sona’s alternative is to create an epinephrine kit with drug and syringes. But a kit does not meet school requirements for an auto-injector device. Other pharmacies around the country sell similar epinephrine injector kits to patients and emergency response systems that cannot afford EpiPens.

King County (Seattle, WA) Emergency Medical Services saved more than $150,000 a year using kits instead of EpiPens. The agency sells kits, minus epinephrine, to health agencies across the region.

If generics for a high-priced product are available, it may be possible to dispense the cheaper product. Depending on the product category, therapeutic substitution may be a practical alternative.

“For dermatological products, we have had success suggesting alternatives,” Dr. Arthur said. “Unfortunately, this is not often an option with products like digoxin or those with tight therapeutic windows such as the anti-seizure meds.”

 And just because a therapeutic alternative is available doesn’t mean it is practical. It may be possible to substitute Adrenaclick (epinephrine injection, Amedra) for EpiPen, suggested Norman Tomaka, PharmD, a hospital pharmacy consultant in Melbourne, FL. That could bring the price down to around $400, but availability and insurance coverage are spotty.

“Worst case, you can dispense an injection kit,” said Dawn Butterfield, RPh, owner of West Cocoa Pharmacy and Compounding in Cocoa, FL. “A kit isn’t as convenient as an EpiPen, but it is just as effective once injected.”

            Jeremy Counts took the kit concept a step farther. He dispensed prefilled epinephrine syringes. Prefilled syringes have been standard in wilderness medicine and other price or space and weight sensitive applications for years. But shelf life is limited. And the state Board of Pharmacy soon put a stop to prefilled syringe sales.

“I cautioned my patients the FDA does not recommend prefilled syringes for more than 30 hours,” he said. “I also told them the literature says prefilled epinephrine syringes are good for three months when protected from heat and light. I absolutely encourage everyone to get an EpiPen if they can. It has better shelf life, it’s reliable, it’s easy, it’s the best solution you can get on the market today. But if you can’t afford EpiPen, a prefilled syringe or a syringe and an ampule of epinephrine can still save your life.”

Mylan has raised the price of EpiPens from about $60 before it acquired the product in 2007 to just over $600 in 2016, just in time for the back to school rush.

“EpiPen is a very seasonal product,” said industry analyst Ronny Gal, PhD, Sanford C. Bernstein & Co. “More than half of sales are in the two months ahead of the school year as parents refresh their kids’ backpacks. The recipe for this outcry is a seasonal product, purchased largely by young families that have moved to high deductible health plans and aggressive price increases by the manufacturer.”

Mylan’s aggressive pricing is hardly unique in the industry. Turing Pharmaceutical made headlines in 2015 by boosting the price of Daraprim (pyrimethamine), a single-source generic used primarily to treat parasitic infections, by 5,000 percent.

An article published in the Journal of the American Medical Association in August noted that noted that the price of insulin jumped 300 percent between 2002 and 2013. Isoproterenol prices jumped 2,500 percent  and digoxin 637 percent. Despite the widespread assumption that generic drug prices generally fall, the price of some 400 generics increased more than 1,000 percent between 2008 and 2015.

The problem

According to industry insiders, there is no single cause for price increases. Some price skyrocket just because the manufacturer can do it.

Manufacturers with patent protection for a product have free rein to set pricing. As long as the company has market exclusivity, it can set any price as long as it is willing to bear the blowback from public, providers and payers. Highly effective hepatitis C medications such as Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg, Chiron) were introduced at more than $1,000 a tablet simply because the manufacturer could.

Market exclusivity give manufacturers a legal monopoly. In some cases, drug makers with products that have lost patent protection can still enjoy a functional monopoly.

“This is exclusivity that comes from being the only manufacturer of a product in the marketplace,” explained Dr. Schondelmeyer. “For a new generic to enter the market takes two, four, maybe five years to develop and get FDA marketing approval. That sole manufacturer has a functional monopoly. Some raise prices extremely aggressively, some are a little less aggressive and raise the price by ‘only’ 50 to 100 percent.”

Turing Pharmaceuticals became the poster child for aggressive price hikes after purchasing the rights to Daraprim from Impax Laboratories in 2015. Although the patent on pyrimethamine expired decades ago, Turing was the sole manufacturer. Turing chief Martin Shkreli drew fire from Wall Street to Main Street and Capitol Hill when he hiked the price of Daraprim from $13.50 to $750 per tablet.

EpiPen has a similar functional monopoly. The biggest difference is that Mylan has spread its price increases over several years, although most of the increase has come in the past three years.

EpiPen was originally approved by the Food and Drug Administration in 1988 and was eventually acquired by Merck KGaA. In early 2007, the list price for EpiPens was $68. Rising generic maker Mylan acquired the product as part of a larger purchase.

Since 2007, Mylan has had little competition. Marketing and lobbying campaigns have boosted awareness of anaphylactic shock, the utility of epinephrine and the safety of its auto-injector.  EpiPens are available at Disney parks, on airliners and schools nationwide. Other companies have tried, and largely failed, to enter the epinephrine auto-injector market.

By July, 2013, the price was up to $265, then jumped to $461 in 2015. This year the price jumped to $608. Mylan has announced a generic version of EpiPen that could be available later this year for $300.

Products that are about to lose patent protection often see steep price increases toward the end of market exclusivity. Manufacturers want to extract the maximum profit possible before generic competition and new entrants force prices lower. Analysts speculate that the potential for generic competition and competing formulations could be one reason behind the rising rate of EpiPen price increases over the last three years.

Impending competition has been responsible for much of the pricing increase in insulin products. Lantus (insulin glargine injection, Sanofi-Aventis) has seen significant price increases as its biosimilar Basaglar ((insulin glargine injection, Lilly, Boehringer Ingelheim) moved toward approval.

 And sometimes price increases are the result of genuine shortages. The FDA tightened quality requirements after 81 patients in the U.S. died from contaminated heparin traced to counterfeit raw materials in China. The price of heparin skyrocketed as supplies of approved product dwindled.