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.

Understanding the Fine Print in PBM Proposals and Agreements

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

By now it is common knowledge that drug prices are rising in nearly every category. In 2015, branded drug costs increased by 14.77%, specialty drug costs increased by 9.21%, and generic drug costs increased by 2.93% when compared to the previous year (as reported by Employee Benefit News). With that said, many have looked to try and control these costs, and earlier this month, Express Scripts, a PBM, announced that they are working to develop more strategies that result in employers being able to offer drug benefits in a more affordable way.

Specialty drugs, drugs that are used to treat more complex disease states such as cancer, are said to have an extremely high inflation rate - about 10% - 20% each year. With this in mind, Express Scripts developed what they refer to as their Inflation Protection Program. As of January 1, 2016, Express Scripts is now offering a program, which sounds too good to be true, to “shield participating plans from the full cost impact of year-over-year price increases on brand drugs.” This program only addresses high cost “brand” drugs for which PBMs negotiate significant rebates and for which there are often lower cost “generic” drugs and “over the counter” alternatives. However, it is in the fine print where the unveiling of the ambiguity lies.

Too good to be true?

To employers who offer pharmacy benefits to their employees or members, knowing that Express Scripts is willing to cover the cost of services when inflation goes above an agreed upon threshold can result in a heavy sigh of relief. However, it is “understanding” the fine print, not only in the proposal, but more importantly in its entirely in the actual PBM Agreement. For example, how is your plan’s inflation cap determined and what must YOU do in order to ensure that Express Scripts will continue to uphold their side of the deal?

If something sounds too good to be true, listen to your gut. This is why you need to work with PBIRx, which is independent of the PBM. That means we always put our clients’ best interests first and not the PBM’s profitability. As a pharmacy benefit auditing and consulting firm for over 25 years, PBIRx is a master and expert at understanding, interpreting and negotiating PBM Agreements and adjunct agreed upon calculation methodology language so that our clients come out the winner. Together we challenge PBM Agreement language that sounds too good to be true!

For more information about our pharmacy benefit consulting and auditing services, please visit www.pbirx.com or call (888) 797-2479 today.