EpiPen Voluntary Recall

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

On Friday, March 31, the FDA alerted consumers to the voluntary recall of 13 lots of Mylan's EpiPen and EpiPen Jr Auto-Injector products that are used for emergency treatment of severe allergic reactions.  The recalled products were distributed from December 2015 through July 2016.  These devices may contain a defective part that could result in its failure to activate. This recall impacts the 0.3mg and 0.15mg strengths.

For updates, lot numbers and additional information, go to: www.Mylan.com/EpiPenRecall. 

Consumers should keep and use their current EpiPen products, if needed, until they get a replacement.  If you have a recalled EpiPen product, contact Stericycle to provide a container to return the recalled medication.  You will also receive a voucher to redeem for a free replacement product.  Please contact Stericycle at 877-650-3494.

If you have any questions or concerns, contact Mylan Customer Relations at 800-796-9526 or at customerservice@mylan.com . 

PBIRx has notified all clients and brokers of this recall and will always be proactive to our consumers when we receive important pharmacy information that may impact their health.

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Epinephrine Devices and the Current State of the Market

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

The recent media coverage of Mylan’s EpiPen® Auto-Injector brand pricing has given rise to many changes and options in the adult and pediatric epinephrine device marketplace, including Mylan’s new lower cost generic.  In recent weeks, CVS began marketing the Impax Laboratories generic epinephrine equivalent to Amedra Pharmaceuticals’ Adrenaclick®.  Coming in February, Kaléo will be marketing the return of the Auvi-Q® Auto-Injector, a product once marketed by Sanofi Pharmaceuticals prior to a voluntary recall in October 2015.

Most of the current information that is being advertised is focusing on how the patient will save money, not how the Employer will save money.  Plans and patients need to be sure to read the fine print provided by manufacturers, pharmacies and their PBMs. For example, CVS is offering the Impax Laboratories generic equivalent to Amedra Pharmaceuticals Adrenaclick® for a cash price of $109.99, the lowest on the market.  In addition, Kaléo will be offering the Auvi-Q® Auto-Injector for patients without commercial or government insurance for the cash price of $360 and for free if patients have a household income less than $100,000. For patients with commercial or government insurance, the out-of-pocket cost will be $0.

https://www.cvs.com/content/epipen-alternative
https://kaleopharma.com/kaleo-announces-u-s-availability-and-pricing-to-patients-of-auvii-q-epinephrine-injection-usp-auto-injector-for-life-threatening-allergic-reactions/

Depending on the Pharmacy Benefit Manager, the changes to an Employer’s pharmacy drug coverage may include:

• Exclusions for brand name epinephrine devices (i.e. Cigna, United Healthcare) only allowing payment for a generic;
• A Preferred Tier with a Plan Sponsor rebate for generic and brand epinephrine devices;
• A Maximum Allowable Charge (MAC) for a generic equivalent epinephrine device and allowing the patient to select a product.

Table 1 shows the options for generic and brand name epinephrine devices that are currently available or will be available in February 2017.

Table 1.  Epinephrine Devices in 2 Pen Quantities per Box

Brand Name	Active Ingredient	Manufacturer	NDC
EpiPen® Auto-Injector EpiPen Jr.® Auto-Injector	Epinephrine Injection USP 0.3 mg and 0.15 mg	Mylan	0.3 mg - 49502-500-02 0.15 mg – 49502-501-02
Generic Equivalent to EpiPen®	Epinephrine Injection USP 0.3 mg and 0.15 mg	Mylan	0.3 mg - 49502-102-02 0.15 mg - 49502-101-02
Adrenaclick® Auto-Injector	Epinephrine Injection USP 0.3 mg and 0.15 mg	Amedra Pharmaceuticals	0.3 mg – 52054-804-02 0.15 mg – 52054-803-02
Generic Equivalent to Adrenaclick® Auto-Injector	Epinephrine Injection USP 0.3 mg and 0.15 mg	Impax Laboratories	0.3 mg - 54505-102-02 0.15 mg – 54505-101-02 *single pens also available
Auvi-Q® Auto-Injector	Epinephrine Injection USP 0.3 mg and 0.15 mg	Kaléo	0.3 mg – 60842-023-01 0.15 mg – 60842-022-01

Epinephrine is used as a life-saving treatment for patients requiring emergency treatment from allergic reactions including anaphylaxis.  Anaphylaxis results from exposure to an allergen, such as nuts or venom from a bee sting, which causes the body to release a flood of chemicals from the immune system.  Signs and symptoms of anaphylaxis include a skin rash, nausea and vomiting and a rapid, weak pulse.  This immune reaction can lead to shock from a drop in blood pressure and narrowing of the airway, blocking normal breathing.  Anaphylaxis requires an immediate trip to the emergency room and injection(s) of epinephrine.  Without immediate treatment, anaphylaxis can lead to unconsciousness or death.

As always, cost will be the driver for epinephrine device selection by both patients and insurers.  PBIRx can discuss with clients how to manage these epinephrine device options by analyzing current utilization and implementing cost savings programs.   Our dedicated pharmacists are developing strategies to offer our clients and their members the best savings available in the marketplace.

PBIRx, an independent pharmacy-focused company, provides analytical, consulting and auditing services utilizing a strong Clinical Department with state of the art technology to advocate for the Plan Sponsor and their employees.  Our clinical recommendations benefit both the Plan Sponsor and the employees versus the profitability for the pharmacy benefits manager.  

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.

Skin Patch Proves Effective for Peanut Allergies, EpiPen Rival Is On Its Way

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Did you know that as many as 8 million Americans, roughly 2.5% of the U.S. population, has food allergies? Focusing on children, peanut allergies are known to be the main cause of anaphylaxis, and EpiPens have long been used to aid such individuals when a severe and potentially life-threatening reaction occurs. However, with recent price hikes on the EpiPen, this type of treatment has become unaffordable for many.   An alternate form of treatment is necessary and, fortunately, there may be an answer to this (or two).

According to a recent article from the National Institutes of Health, “a wearable patch that delivers small amounts of peanut protein through the skin shows promise for treating children and young adults with peanut allergy, with greater benefits for younger children.” These findings come from a clinical trial that has been ongoing, and the treatment’s official name is epicutaneous immunotherapy (or EPIT). 

In the article, Daniel Rotrosen, M.D., director of NIAID’s Division of Allergy, Immunology and Transplantation (DAIT), explains how this treatment is designed to work. Ultimately, the goal of epicutaneous immunotherapy is to “engage the immune system in the skin to train the body to tolerate small amounts of allergen”.   Compared to other oral treatments that proved to be hard for about 10-15% of children and adults to tolerate, the patch appeared to be more effective and was found to be a safe and well-tolerated treatment.

Alongside this announcement comes the announcement of a rival to the EpiPen – Kaléo, Inc.’s Auvi-Q auto-injector. With the EpiPen’s recent increase in cost, Kaleo explains that they understand the challenges patients are currently facing, and it is their goal to provide affordable access to their auto-injector. The Auvi-Q device contains the same epinephrine drug that is found in Mylan’s EpiPens, comes with a voice-prompt system that helps patients as they use it, and is equipped with a needle that will automatically retract after administration is complete. Currently, no list price has been announced by Kaléo, Inc.

PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts.

EpiPen Costs Skyrocket, Cause Outrage

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

We are sure you have heard some talk about the EpiPen lately, but in case you missed it, earlier this year Mylan raised the cost of a pack to be more than $600 - a significant hike from what it originally cost when the company first purchased the rights to the drug/device in 2007 (at that time, EpiPens cost about $57 each). Since 2007, NBC News reports that the following actions have been taken:

• In 2008 and 2009, Mylan raised the price of EpiPens by 5%.
• At the end of 2009, Mylan tried a 19% price hike.
• From 2010-2013, there was a succession of 10% price hikes.
• From Q4 of 2013 to Q2 of 2016, Mylan raised EpiPen prices by 15% every other quarter.

It is no surprise that consumers are outraged over the EpiPen's new cost, as these are used for life threatening allergic reactions. With the new school year approaching many have a need to purchase an EpiPen and provide it to the school nurse, but the cost has made this increasingly difficult.

So why is the price of EpiPens so inflated?

Although it only costs about a few dollars to make (CNBC reports that only about $1 worth of epinephrine is used in these devices), there is currently NO EpiPen generic available in the United States. However, after the uproar began and Mylan faced more scrutiny from both consumers and Congress, they just announced that they will be launching a generic version of EpiPens for about half of the current price ($300). Teva Pharmaceuticals is also working on its own generic version of the EpiPen, and expects to receive approval sometime next year.

Mylan has also taken other actions to try and make EpiPens more affordable to consumers and members, such as by increasing the consumer/member out of pocket cost reduction from "up to" $100 to "up to" $300 - more details available here.

All that said, it is important for payors to understand that increased costs will be experienced, not only because of the increase in prescription costs for EpiPens, but also because of increased and conceivably unnecessary utilization or stockpiling of the brand drug. Additionally, offering a coupon for EpiPens will result in higher costs because eliminating the member copay results in brand loyalty, even though a lower cost generic will be available soon.

This is where we at PBIRx come in. We fight for our clients to get the most value for their health care dollars, and are well aware of the tactics used by Big Pharma to take advantage of consumers. If you have questions about the recent EpiPen news or would like to learn more about how we can help you during this time, please call (888) 797-2479 today.