Epipen: An public health policy issue for the ages

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Anaphylaxis is the severe and sudden onset of an allergic reaction triggered by allergies to a specific food, medication, insect bite/sting and/or latex. According to a press release by The Asthmas and Allergy foundation of America (AAFA), anaphylaxis is estimated to occur 1 in 50 Americans although it may be higher at 1 in 20. AAFA found many of these at risk individuals were not prepared to react to a reaction episode, due to the lack of ownership of an epinephrine auto-injector pen. Reasons for lack of ownership were not cited however in the past year attention has been drawn to its cost. Mylan, the #1 producer of the over the past 10 years, with their patented epinephrine auto-injector delivery system, the Epipen.epipen-price-under-mylan

The Business Insider performed a cost analysis of the Epipen, citing a market price increase from $100 in 2007 to $600 in 2016. Mylan’s has had few competitors. Their main competitor was Auvi-Q by Kaleo until its recall in 2015. One competitor still exists on the market today, Adrenaclick by amedra pharmaceuticals with a price tag of approximately $200 with a good prescription coupon.

The FDA has made it easier for Mylan to hike up their prices by limiting manufacturer competition through the recall or blockage of other epinephrine auto-injector devices as well as the back log for generic drugs that has been occurring producing a delay of competitors entering the market. Such politics granted Mylan the ability to increase their prices astronomically however in this past summer they received extreme backlash from two major stakeholders. Congress asked Mylan CEO to justify Epipen price hikes and the dropping of the Epipen coverage by Cigna, a major insurance company. This pushback motivated Mylan to create a generic version of this drug delivery system as well as patient coupons (up to $300) in coverage of Epipen costs to address concerns about its price. These are steps in the right direction however there needs to be more action to keep advocate for whose healthcare coverage still does not grant them the ability to pay $300 or less in out-of-pocket expenses.

I challenge the FDA to uphold their mission to protect the public’s health by ensuring safety, efficacy and security of human drugs and medical devices while accelerating innovation to make medical products more effective, safer and more affordable. The FDA must amend their current policies and procedures to promote the presence of competitors for safe and effective epinephrine auto-injector pens to eradicate the monopoly. This can be done through the overhaul of the generic drug backlog to funnel competitors into the market as well as looking for additional ways for those without adequate health insurance coverage to more affordable epinephrine auto-injector pens and discounts. I challenge competitors to propose refillable epinephrine auto-injector pens, like Dr. Cathleen London in Maine, to provide patients with an feasible alternative. A refillable pen will drastically cut down on the burden of cost for those American citizens whose lives depend on the ownership and access to epinephrine auto-injector pens in case of an anaphylactic shock episode.

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4 Responses to “Epipen: An public health policy issue for the ages”

  1. samodennis Says:

    I very much enjoyed this blog post and I agree that reducing the cost of drugs and particularly such a vital drug like an EpiPen is a public health priority. I do wonder, however, of the impact that President Trump’s Executive Orders may have on changing policy at the FDA or for providing resources that may be able to reduce the generic backlog.

    Admittedly I do not have a very broad knowledge of Trump’s Executive orders (does anyone?) especially ones that limit federal government hiring and that try to curtail added regulations. Would the changes advocated in this post be possible in the current political climate?

    I found this interesting article published on STAT about how other programs within the FDA might face hardships under the new administration.
    https://www.statnews.com/2017/01/30/fda-regulations-executive-order-trump/

  2. asraparekh Says:

    Interesting post!

    Agreed the FDA needs to allow other manufacturers to make it but they also need to ensure that the other manufacturers meed the regulations and requirements since this is a matter of life and death.

    Research shows that 4 out of 5 people that own the epipen do not use it correctly (http://www.annallergy.org/article/S1081-1206%2814%2900752-2/pdf). Proper training is required for correct use of epipen.

    In this situation, there has been a 400% price hike for this device which is a scam and this should be curtailed by the government (http://www.annallergy.org/article/S1081-1206%2814%2900752-2/pdf). In August 2016, Hilary Clinton and the American Medical Society (AMA) did urge the pharmaceutical industry to exercise it’s power in restraining the costs (https://www.statnews.com/2016/08/24/ama-urges-epipen-manufacturer-rein-exorbitant-costs/).

    I think the FDA is justified in their regulations but action needs to be taken by the government and pharmaceutical industry to ensure the epipen costs are brought down to a reasonable amount.

  3. xiyuwangblog Says:

    Thank you for this interesting post! The price surge of Epipen or the overall US prescription drug pricing is such a hot topic that I’ve been followed recently. I agree with your proposed idea of 1) let the FDA encourages competition and thereby enhance market efficiency; and 2) encourages competitors to develop a refillable pen which might drastically reduce costs.

    Meanwhile, I would like to make a comment about Mylan Pharmaceutical’s so-called “patient assistance program” that reimburses the patients up to $300 for the Epipen costs. Such patient assistance programs have been used by many pharma companies for their brand-name drugs, in which patients can print coupons at the product’s website, obtain at the physician’s office, or obtain at the pharmacy counter. At the first glance it does seem that through this assistance program, patients can get the same products at a much lower price. However, Dr. Joseph Ross, a professor at Yale School of Medicine, published at NEJM (http://www.nejm.org/doi/full/10.1056/NEJMp1301993#t=article) and stated that patient assistance programs help patients to reduce short-term drug costs but do not off-set the higher long-term costs. In fact, Dr. Ross’ own research showed that 62% of coupons are used for brand-name drugs (high price) who have lower-cost and equally-efficacious generic alternatives. Furthermore, very few of such patient assistance programs offer savings for more than a year. It is more like a one-time benefit to induce patients’ loyalty to the brand, and then incur much higher costs in the long run.

    Therefore, in my opinion, it is also very important to educate both patients and physicians about the cost implications about patient assistance programs and increase their awareness of alternative prescription options.

  4. reddaysblog Says:

    I have read about this recently, and it seems like allowing Eipipen distributors to double-down on a monopoly by developing a cheaper alternative is only creating more instability in an already problematic market. Of course, we wouldn’t dream of government officials being so naive to reinforce such market dynamics, but do we also assume that they wouldn’t be so dangerously responsible and even arrogant to reward the instability? This is wild, if not brilliant, and leaves me wondering where the money is going….

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