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A Very Cost Effective Solution to Life Saving Drug-Outrageous Epipen’s Price Gouging!

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A couple of weeks ago, I heard about the latest price gouging of a pharmaceutical drug. This time it’s the Epipen. Today I realized, there is a simple, inexpensive solution you can ask your doctor to prescribe. It’s one that several physicians have made available to their patients.

What is an EpiPen?

The EpiPen is an device that automatically injects the drug Epinephrine into the body. Epinephrine, also known as adrenaline, naturally occurs in our bodies.  It is the primary treatment for severe allergic reactions known as anaphylaxis.  The patented pen is designed to allow the patient the ability to immediately inject epinephrine when the symptoms of anaphylaxis begins.

Epinephrine has been administered for decades, to treat a variety of conditions including asthma, heart failure, and other conditions.

By in large the price of the Epipen is due to the perceived value, and patent related to the cost of the autoinjector sense of safety it affords parents and patients that were the result of a marketing campaign as noted below.

The truth of the matter is epinephrine is very inexpensive, and can be easily injected using another cost-effective method! More about that later.

EpiPen’s Profitability

In the U.S., more than 3.6 million people have been prescribed an expensive EpiPen prescription for over $200, now $300 with the recent cost increase. These increases were due to decisions made by the owner of the patent.  While the cost of epinephrine has remained extremely low.  In fact, a vial of Epinephrine is cheaper than a bottle of Aspirin, Tylenol and Advil!

In a 2007 purchase of medicines from Merck KGaA, drugmaker Mylan picked up a decades-old product, the EpiPen auto injector for food allergy and bee-sting emergencies. Management first thought to divest the aging device, which logged only $200 million in revenue. Then Heather Bresch, now Mylan’s chief executive officer, hit on the idea of using old-fashioned marketing in part to boost sales among concerned parents of children with allergies. Since the purchase,  Mylan, has continuously increased the price- from an average of about $50 in 2004 to more than $300 each today.  EpiPen, delivers about $1 worth of epinephrine, i.e., patients are  actually paying far more for the patented auto injector than the drug!

Between 1986 and 2011, he average wholesale price of 1 epinephrine autoinjector was found to have increased annually from $35.59 in 1986 to $87.92 in 2011, 147%,  in constant 2011 US dollars for single-dose equivalent products (ie, the single-unit price for instances in which only dual packs are sold).

Two international surveys support these data on the increasing cost of epinephrine autoinjectors. The first survey, conducted in 2003-2005, yielded a range of estimated international costs of an autoinjector from US$30 to US$110 (average cost was not provided).A repeat survey in 2007 yielded estimates ranging from US$54.50 to US$168.66 (median, US$97.87).

It has become a $1 billion-a-year product that outsells  its rivals and provides Mylan with about 40 percent of its operating profits.

Mylan increased its profitability from $200 million to $1 billion through an aggressive marketing and branding campaigns,  combined with a massive public awareness campaign on the dangers of child allergies. Along the way, EpiPen’s wholesale price rose roughly 400 percent from about $57 each when Mylan acquired the product. “They have done a tremendous job of taking an asset that nobody thought you could do much with and making it a blockbuster product,” says Jason Gerberry, a Leerink Partners analyst.

But while EpiPen has given countless parents a sense of security that their children can go out in the world safely, the device’s soaring price—up 32 percent in the past year alone—has forced some families to make difficult choices in order to afford the life-saving medicine. The price increases are among the biggest of any top-selling brand drug, according to DRX, a unit of Connecture that tracks drug pricing. After insurance company discounts, a package of two EpiPens costs about $415, DRX says. By comparison, in France, where Meda sells the drug, two EpiPens cost about $85. “There is a danger with that,” says George Sillup, chairman of the pharmaceutical and health-care marketing department at Saint Joseph’s University. If the company raises the price too much, “that could create some backlash.”

To put the cost of the EpiPen in perspective, a vial of 1ml of 1:1000 epinephrine costs $5.00!!! The standard dose, for adult anaphylaxis is 0.3 cc-0.5cc-meaning the dose actually costs $1.50-2.50! And it is usually less than that because hospitals make bulk purchases.

Allergists Recommend an Inexpensive Alternative

In 2011 three allergists published a study in the Journal of Allergy and Clinical Immunology, in response to the increasing cost of the EpiPen.

In their article that noted the dramatic price increase Greater access to epinephrine has the potential to decrease the number of fatal anaphylactic events. Among patients prescribed autoinjectors, only 40% of teens/adults and 60% of children less than 12 years of age had them refilled over a 6-year period in a study conducted by the Kaiser Health System in California.5 This  low number of refills,  might be a result, in part, due to the high cost to families of refilling these prescriptions.

Although the increasing cost of epinephrine autoinjectors might restrict access for some patients, lower-cost alternatives exist. Prefilled epinephrine syringes made in a clinic can be safely provided to patients who cannot afford prescription autoinjectors. They are routinely given to patients in countries in which autoinjectors are not available or unaffordable. Research suggests that prefilled syringes are stable and sterile for 2 months in arid climates and 3 months in humid climates.

EpiPen Alternatives-Prefilled Epinephrine Syringes

If you need the lower cost alternative, please share the excerpt of their report in the Journal  of Allergy and Clinical Immunology information below with your physician:

Materials needed to prepare a prefilled syringe are simple and include the following:

  • 1. ampules containing 1 mg/mL epinephrine plus a preservative;
  • 2. disposable plastic 1-mL syringe; and
  • 3. a 23-gauge, 2.5-cm needle.

Other alternatives described in the literature include providing an epinephrine ampule with a 1-mL syringe and an appropriate needle without prefilling the syringe. The main drawback to not having the syringe prefilled is the time required to draw up the epinephrine into a syringe. On average, parents take 142 ± 13 seconds to withdraw epinephrine from an ampule into a syringe.

If performed at the first signs or symptoms of a systemic reaction, this time lag should not be clinically significant. Because epinephrine is light sensitive, the ampule and prefilled syringes should be protected from light by wrapping them in aluminum foil or protecting them in a light-free container, such as an eyeglasses case. Syringes should be appropriately labeled to avoid confusion with other medications.

Beyond simply cost, the ability to customize the epinephrine dose for patients might make alternatives to autoinjectors desirable. The epinephrine autoinjector is available in 2 standard doses: 0.15 and 0.3 mg. Neither of these doses is appropriate for children weighing less than 10 kg. Physicians can create prefilled syringes with doses personalized to a patient’s weight. Obesity also renders epinephrine autoinjectors less effective. These patients could benefit from personalized dosages.

Anaphylaxis Incidence

  • Anaphylaxis occurs at a rate of 50 to 2,000 episodes per 100,000 people in the U.S.
  • Anaphylaxis causes approximately 1500 deaths in the U.S. annually.
  • The cause of anaphylaxis is unidentified in one-third to two-thirds of patients.
  • There were 1.03 million allergy-related emergency department visits each year from 1993 to 2004.

Importance of Carrying and Using Epinephrine

  • Studies of fatal anaphylactic reactions to food have fund that most of the episodes occurred away from home, and most of the victims did not have epinephrine with them.
  • In a study of fatal and nonfatal anaphylaxis, none of those who died received epinephrine before the onset of severe respiratory symptoms, whereas all of the survivors received epinephrine before or within five minutes of developing severe symptoms.

 

Speed of Potentially-Fatal Anaphylaxis

  • It takes only one to two minutes for a mild allergic reaction to escalate to anaphylaxis.
  • The faster the onset of an anaphylactic reaction, the greater the likelihood that it will be severe.

 

Risk and Incidence of Anaphylactic Reactions

The number of people in the U.S. with allergic sensitivities that put them at risk for anaphylaxis may be as high as 45 million. Actual incidence is unknown, because anaphylaxis is underreported due to lack of a standardized, internationally accepted definition and inconsistencies in diagnosis.

At-Risk for Anaphylaxis

  • Up to 5% of the U.S. population (15 million Americans, based on the present population of 300 million) may be allergic to insect stings.
  • 48 to 67 percent of people who have had a reaction to an insect sting could have a repeat reaction. In general, second reactions are more severe than the first. 54
  • 40 to 100 anaphylactic deaths from insect stings occur each year.
  • Approximately 12 million Americans have food allergies.
  • The incidence of food allergy is increasing.
  • At least 1.1 percent (3.3 million) Americans are allergic to peanuts or tree nuts.
  • The prevalence of peanut allergy in American children under five years of age doubled between 1999 and 2004.
  • Each year, 30,000 Americans require emergency room treatment for food allergies, and 100-200 Americans die from allergic reactions to food.
  • An estimated 3 to 18 million people are allergic to latex.
  • 0.7 to 10 percent (as many as 30 million people, based on the present U.S. population of 300 million) are allergic to penicillin.51
  • Penicillin is responsible for an estimated 75 percent of anaphylaxis deaths in the U.S.
  • Most deaths from penicillin have occurred among individuals with no history of allergy.

 

Anaphylaxis Rarely Causes Death!

The really good news, is that despite these increases, a recent article published in The Journal of Allergy & Clinical Immunology (JACI), researchers examined the death rate among hospitalization or emergency department (ED) presentations for anaphylaxis and the mortality rate associated with anaphylaxis for the general population.

The authors found that case death (fatality) rates were between 0.25% and 0.33% among hospitalizations or ED presentations with anaphylaxis as the principal diagnosis. These rates represent a total of between 63 and 99 deaths per year in the US, ~77% of which occurred in hospitalized patients. While the rate of anaphylaxis hospitalizations rose from 21.0 to 25.1 per million population between 1999 and 2009, but, overall death (mortality) rates remained  stable in the last decade and ranged from 186 to 225 deaths per year.

These results suggest that the overwhelming majority of hospitalizations or ED presentations for anaphylaxis did not result in death, with an average case fatality rate of 0.3%. Nationwide, despite the increase of anaphylaxis incidence, it is also reassuring that mortality rates associated with anaphylaxis have remained stable in the last decade and were well under 1 per million person-years. Both these observations likely reflect the quality of care that can be provided in the urgent care setting.

While another study estimated, based on the present population of 300 million and the epidemiology of food allergies, an estimated 32,400 food-induced anaphylactic episodes can occur in the U.S. each year, resulting in about 2000 hospitalizations and 150-200 deaths.

Although anaphylactic reactions are potentially life threatening, the probability of dying is very low, especially for those cases that involve Emergency Department or hospital attention.

So the good news is, that if you have an allergy, your risk of dying from an anaphylactic reaction is quite slim.  If cost is an issue, please explore the previously mentioned options with your physician. An inexpensive, prefilled syringe is just as effective as an autocorrector, because they both deliver the same drug!

Sources:

http://money.cnn.com/2016/08/30/investing/epipen-alternative-100-dollars/

http://allergynotes.blogspot.com/2012/09/epinephrine-autoinjectors-are-expensive.html

http://www.jacionline.org/article/S0091-6749(12)01010-X/fulltext

http://www-thomsonhc-com.ezproxy.hsc.usf.edu

 

Lack of worldwide availability of epinephrine autoinjectors for outpatients at risk of anaphylaxis: http://www.annallergy.org/article/S1081-1206(10)61129-5/abstract

 

NIH expert panel makes recommendations for food allergy research. June 5, 2007:

www.niaid.nih.gov/news/newsreleases/2007/foodAllergyExpertPanel.htm

 

 

World Allergy Organization survey on global availability of essentials for the assessment and management of anaphylaxis by allergy-immunology specialists in health care settings:

http://www.annallergy.org/article/S1081-1206(10)00227-9/abstract

 

Increasing Cost of Epinephrine Auto-Injectors

http://www.jacionline.org/article/S0091-6749(12)01010-X/fulltext#back-bib3

 

How Marketing Turned the EpiPen Into a Billion Dollar Business

http://www.bloomberg.com/news/articles/2015-09-23/how-marketing-turned-the-epipen-into-a-billion-dollar-business

Price of 1 EpinephrineAmpule: http://www.buyemp.com/product/epinephrine-ampule

Price of Pre-filled Epinephrine Syringe: http://www.bemedsupply.com/product-p/1-823388.htm

Anaphylaxis Information-The American Academy of Family Physicians:

http://www.aafp.org/afp/2003/1001/p1325.html

American Academy of Family Physicians Patient Guide to Anaphylaxis: http://www.aafp.org/afp/2003/1001/p1325.html

World Allergy-Anaphylaxis Synopsis:

http://www.worldallergy.org/professional/allergic_diseases_center/anaphylaxis/anaphylaxissynopsis.php

Death From Anaphylaxis Surprisingly Uncommon:

https://www.aaaai.org/global/latest-research-summaries/Current-JACI-Research/death-anaphylaxis

 Neugut AI et al. Anaphylaxis in the United States. Arch Int Med. 2001;161:15-21.

American Academy of Allergy Asthma & Immunology. Allergy statistics:

www.aaaai.org/media/resources/media_kit/allergy_statistics.stm

Golden DB. Insect sting anaphylaxis. Immunol Allergy Clin North Am. 2007;27(1):261-72.

Reisman RE. Natural history of insect sting allergy: relationship of severity of symptomatic

initial sting anaphylaxis to re-sting reactions. J Allergy Clin Immunol. 1992;30:335-39.

Tang AW. A practical guide to anaphylaxis. Am Fam Physician. 2003;68(7):1325-32.

National Institute of Allergy and Infectious Diseases (NIAID). NIH News Release.

Sicherer SH, Munoz-Furlong A, Burke AW, et al. Prevalence of peanut and tree nut allergy in

the US. determined by a random digit dial telephone survey. J Allergy Clin Immunol.

1999;103:559-62.

Sampson HA. Update on food allergy. J Allergy Clin Immunol. 2004;113(5):805-18.

Sampson HA. Anaphylaxis and emergency treatment. Pediatrics 2004;111(6):1601-08.

Ownby DR, Ownby HE, McCullough J, et al. The prevalence of anti-latex IgE antibodies in 1000 volunteer blood donors. J Allergy Clin Immunol 1996;971188-92. 60

Bayrou O. Latex allergy. Rev Prat. 2006;56(3):289-95.

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