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.

PBIRx's Approach To Managing Pharmacy Benefit Costs

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

In a time where the cost of prescription medications and pharmaceutical services continues to rise, there is a pressing need for them to be controlled. Did you know that records from 2014 suggest that for more than half of today's employers (77% to be exact), pharmacy benefit costs made up 16% or more of their total healthcare budgets? And although 16% might not seem like such a significant number to some right now, the reality is that the total percentage of healthcare costs dedicated to pharmacy benefits is only going to continue to grow as the cost of services continues to rise.

As one of Connecticut's top pharmacy benefit consulting firms, our goal is to provide entities with cost saving solutions that allow them to offer desired healthcare services at the lowest possible costs. To do so, we have created a proprietary tool known as our Specialty Drug Toolbox. The following is a brief look into each stage of this valuable tool that we use with each and every one of our clients:

1. Price: To determine whether or not you are paying a fair price for your pharmacy benefit plan, we consider the specific discounts and rebates that are available for generic drugs, biosimilars and limited distribution drugs. This way, we can figure out whether or not your plan offers medications and services at the right price.

2. Channel Management:  Once we are familiar with the discounts and rebates you are entitled to, the next thing we look at is the various channels that can offer them. Since rebates vary based on certain dispensing facilities, we narrow down which ones work best for your plan.

3. Clinical Review and Management: Next, we focus on your plan from a clinical perspective. That means we analyze how your plan is designed and compare it to clinical data to determine if any additional savings are available for positive healthcare outcomes.

4. Clinical and Pharmacoeconomic Outcomes: Finally, the last stage of our analysis includes studying how you are/should be managing patient disease states. This part of our approach ultimately looks at how both the patient and the disease will be cared for as the patient starts to use the services they are entitled to through your pharmacy benefit plan.

Now that you are more familiar with our approach and how we can work with you to control your pharmacy benefit costs, it's time to get started. For more information on our proprietary Specialty Drug Toolbox and how it can benefit you through our pharmacy benefit consulting and auditing services, contact us at (888) 797-2479 today.

Generic Price Increases Results in More Plan Design Tiers

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Whether you are a manufacturer of generic drugs, a pharmacy that supplies generic drugs, or a consumer that relies on certain generic drugs, you are probably aware that the cost of generic drugs is increasing at a steady rate. According to the New York Times, over the past year alone, several generic drugs have more than doubled in price, and seemingly, the rate at which they are increasing does not seem to be slowing down. But what does this mean for those that interact with these drugs on a daily basis? While for some drug channels increasing costs have brought nothing but benefits; for others, the negative effects of generic drug inflation are much more prominent. 

For generic and brand manufacturers as well as wholesalers, increased drug costs are not much of a concern. Why? For generic manufacturers, increased costs mean you are now selling the same drugs but at higher prices, therefore increasing profits. For brand-name manufacturers, shortages in generic drugs are leading consumers to their product, since lately many have shown to be less expensive than some of the more popular generic drugs. Lastly, many wholesalers are also benefiting from increased costs since increases in gross profit dollars and lifted revenue growth have come as a result of the change in price.

Unfortunately, some pharmacies, third-party payers and consumers are not as lucky when it comes to generic drug inflation. Although some pharmacies will benefit from price increases over time, those that signed at-risk payer contracts are likely to see a decrease in profits as costs continue to rise. Similarly, third party payers are also experiencing the negative effects of generic drug inflation as it increases the cost of their pharmacy benefits. That means that third party payers must now allot more of their budget to cover generic drugs for each of their clients. Finally, since some plans offer multi tiers for generics, higher cost generic drugs now fall under a higher co payment tier and thus, out of pocket costs are increasing for the consumer, which could make it financially prohibitive for them to fill the prescriptions that they need.

As the cost of generic drugs continues to rise, it becomes even more important for entities that provide pharmacy benefits to its employees or members to connect with an expert like PBIRx. PBIRx can analyze the generic drug mix for an entity and provide both optimum plan design recommendations and negotiate discounts resulting in a win-win situation. PBIRx works closely with all of their clients to create optimal health care outcomes for their members while minimizing overall health care costs. For more information on how PBIRx can help, visit us on our website or contact us at (888) 797-2479 today!

Health Plan Identifier Requirements

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

 

The Department of Health and Human Services (HHS) requires all health plans to obtain a ten-digit "unique identifier" from a government sponsored agency. Plans must use a Health Plan Identifier (HPID) to identify a health plan in standard Health Insurance Portability & Accountability Act (HIPPA) electronic transactions.

Plans that are fully insured on the medical and self-funded on their pharmacy benefit are required to apply for an HPID.

Key compliance dates to obtain the HPID are as follows:

• Health plans, with the exception of small health plans, must obtain HPIDs by November 5, 2014.
• Small health plans (annual receipts of $5 million or less) must obtain HPIDs by November 5, 2015.
• All plans that generate electronic transactions are required to use the identifier in those transactions beginning November 7, 2016.

The online application is available through the Health Plan and Other Entity Enumeration System (HPOES) housed within CMS' Health Insurance Oversight System (HIOS) and may be accessed through the CMS Enterprise Portal. Users will need to provide additional information to register in the enterprise portal and obtain a user ID and password.

The application also requests a Payer ID or National Association of Insurance Commissioners (NAIC) number. CMS has advised that self-funded employers who do not have these numbers may enter "not applicable" in this field on the application.

To learn more about the application process, you may view CMS' HPID and OEID overview presentation by clicking here. In addition, videos are available to walk through each step of the application process to obtain a HPID for a controlling health plan, a sub health plan and other entity identifier. See Quick Reference Guide to: Obtaining a Controlling Health Plan HPID.

For more information, please contact PBIRx at (888) 797-2479 today!

Specialty Drug Tool Box Spotlight: Clinical Review and Management

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

As we move forward with our proprietary Specialty Drug Tool Box, we come to the third stage known as clinical review and management. Now that you have decided which specialty drugs you will include in your pharmacy benefit plan, have agreed on competitive and auditable discounts, analyzed and chosen appropriate dispensing channel options for various high cost specialty drugs, it is time to look at your plan from a clinical perspective. You must be certain that the specialty pharmacy chosen has optimal, detailed, current and updated clinical criteria; a well established formulary; and a robust utilization management program for all high cost specialty drugs.

This stage focuses on your plan's benefit design and looks at various clinical analyses and their ability to produce higher savings than just a discount on the cost. As you search for the best solutions, keep in mind that the co-pays for preferred, non preferred and biosimilar/generic drugs should always coincide with the analyses on efficacy, drug costs and rebates. Additionally, due to the sometimes toxic side effects, complex dosing and cost of specialty drugs, it is also imperative that the disease itself is managed, in addition to managing the drug that is prescribed to effect a positive and optimal cost health care outcome.

As you work with your PBM to decide which solutions will be the most effective for your budget and the population of people you plan to provide benefits for, consider the following:

1. Has your PBM worked with you to model and report different clinical programs and interventions and the associated savings? 
2. Has your PBM shared their specialty drug prior authorization criteria to be certain that it is detailed, evidence based, robust and current?

If you feel like these topics have not been covered, we recommend asking your PBM to dig deeper into their analysis so that you can be sure you have found the best solution for your pharmacy benefit plan.

Do you need help managing the growing high costs of specialty drugs in your pharmacy benefit? Contact PBIRx today! Our mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, visit us at www.pbirx.com or give us a call at (888) 797-2479 today!

Specialty Drug Tool Box Spotlight: Dispensing Channel Management

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

 

Following along with our Specialty Drug Tool Box, the next category we focus on is that of dispensing channel management. In order to effectively manage high cost specialty drugs as part of your pharmacy benefits, you must first research and analyze all of the available dispensing channel options before making a decision on which option you will direct members to for each specialty drug. Since specialty drugs are only available for purchase at pre-determined specialty pharmacies or licensed distributors, you will have to decide which is the best for you to partner with based on not only, the array of discounts available, but also the clinical prior authorization protocol to be sure the drug is appropriate for the medical indication AND that the specialty pharmacy is managing the utilization to prevent wastage resulting in a positive healthcare outcome.

There are several options to consider in regards to the dispensing of specialty drugs. The following is a list of a few channels that are available to provide you with the service you need:

• Retail pharmacy
• PBM owned specialty pharmacy
• Doctor's office
• In house hospital pharmacy
• Infusion center
• Limited distribution approved pharmacy
• Niche specialty pharmacy that offers high touch patient services at similar discounts to the PBM owned specialty pharmacy

At PBIRx, we suggest looking into each of these options in great detail since drug discounts, member management services and rebates vary based on the specific dispensing facility. Additionally, be aware that your PBM may only promote their own specialty pharmacy even when there are pros and cons to other dispensing options. That is why PBIRx suggests asking your PBM about the opportunities listed above, since they might satisfy your needs better than the pharmacy your PBM promotes.

In order to find the right solutions for our clients, using proprietary algorithms, PBIRx diligently analyzes and audits all of the available dispensing options for high cost specialty drugs as part of our efforts to help you manage your pharmacy benefits. For more information on how we can help, visit us at www.pbirx.com or contact us at (888) 797-2479 today!

340B Audits At PBIRx

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

 

Established in 1992 by the U.S Federal Government, the 340B Drug Discount Program requires drug manufacturers to provide discounts on outpatient drugs to eligible health care organizations or covered entities. According to the Health Resources & Services Agreement, HRSA, the 340B program enables such covered entities to stretch Federal resources as far as possible, given their ability to reach more eligible patients and provide more in depth services.

In 2012, however, congressional scrutiny of the 340B program oversight inspired the HRSA to conduct audits of 340B eligible entities. To remain in line with the program's purpose, it became their goal to prevent the diversion of covered drugs to non-qualified patients and they hope to prevent drugs from being subject to duplicate discounts under both the 340B program and the Medicaid rebate program.

To carry out their audits, HRSA targets certain entities based on their DSH status, 340B purchasing volume and the use of contract pharmacy arrangements. To date there have been over 200 HRSA audits initiated, and there is a current audit rate of approximately 6-8 entities per month.

Since obtaining a 340B status is critical to obtain certain drugs at such discounted prices, we at PBIRx want to make sure that our clients retain their status and not lose it. That is why we perform on site independent third party 340B compliance audits!

Our audits are a replica of the HRSA audits and are performed by a PBIRx audit team including pharmacists, analysts and experts in HRSA pharmacy policy. At the conclusion of their audit, we provide clients with a detailed evaluation report to help them prepare for their actual HRSA audit. Within our reports, we inform clients of which areas may compromise their participation in the 340B program and will help devise a solution to prevent it from happening. PBIRx has also provided additional support resulting in increased revenue from missed 340B opportunities.

Take action today and maintain your 340B status. For more information about our audits, visit us at www.pbirx.com or contact us at (888) 797-2479.

The Truth Behind Limited Distribution Speciality Drugs

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

In the pharmaceutical world, Specialty Drugs are a high cost commodity that are often overlooked. By definition, Specialty Drugs are prescription medications that require special handling, administration or monitoring. They are typically used to treat complex or chronic conditions and though they are necessary for the well-being of many, they are undoubtedly some of the most expensive medications currently available - well over $600 per Rx to $35,000 per Rx for a 30 day supply.

Drugs of this kind can be taken orally, injected or inhaled, and since they are prescribed in different doses, they require extensive management in more areas than just price. To assist in the management of specialty drugs, there is an 11 digit code included within their packaging that provides insight into its strength, name, and even its manufacturer.

Many high cost specialty drugs fall under the category of Limited Distribution Drugs (LDD). Limited distribution refers to the idea that only certain Specialty Pharmacies are approved to handle and distribute these drugs to patients. Manufacturers of LDD Specialty Drugs select one or more Specialty Pharmacy allowed to dispense the LDD. If a Pharmacy Benefit Manager's (PBM) Specialty Pharmacy was not selected to dispense such a drug, the PBM must facilitate the delivery of the drug through one of the drug manufacturer's selected LDD pharmacy(ies). The selected one or more Specialty Pharmacy provides many manufacturer required services including special provider/patient training on the dispensing, dosing, and side effects of the LDD drug. The pharmacy is also responsible for working with providers to be sure that they are aware of the Risk Evaluation Mitigation Strategy (REMS) documents that must be discussed with the patient and completed by both the provider and the patient. REMS documents can be up to 100 or more pages of information.

LDD Specialty Drugs are NOT assigned to the same discounts that are assigned to other Specialty Drugs. The pricing provides increased profits to all PBMs and must be evaluated and negotiated prior to signing a contract.

Typically, LDD Specialty Drugs are assigned significantly lower discounts, if any, costing the client more and increasing PBM profits. Also, the discounts vary depending on which LDD pharmacies are used by the PBM. Thus, a $10,000 drug like Tyvaso at an estimated AWP of $10,000 with NO discount could be Post AWP less 17% with another PBM. Medical brokers do not have clinical algorithms and do not lease MediSpan to quickly determine which PBIRx clients' LDD drug pricing is optimized because of proprietary algorithms used during the RFP process or renegotiation of financial terms after an audit. PBM contracts often address the pricing of LDD drugs in words versus numbers, i.e LDD drugs vary in pricing OR provide Specialty Drug pricing without the inclusion of LDD drugs and their discounts. PBM profitability is ensured through vague information on LDD pricing to prospective clients.

Sutent and Bosulif, oral cancer drugs ranging in price from $4,000 to $14,000 depending on the strength and dosing, will be moved to LDD as of November 1, 2014. For one PBIRx client, the current discount for Sutent is Pre AWP -17.7%. As an LDD drug, Sutent will price at Pre AWP -12% after November 1, 2014 or approximately $10,000 more annually for the $14,000 strength. The client will be subject to a higher cost, while both the client's PBM AND the LDD Specialty Pharmacy will benefit from increased profits. It is also very important to understand the meaning of "Pre" versus "Post" AWP in comparing discounts, especially with high cost Specialty Drugs.

With a robust Specialty Drug Pipeline it is predicted that many new very high cost drugs will be dispensed as LDD drugs, and with Specialty Drug spend climbing upwards to 40% of total pharmacy spend, it is an area where an expert, such as PBIRx, can make a huge difference to a client's bottom line. Currently there are over 600 LDD drugs with various National Drug Codes (NDC).

Watch for more blogs addressing the PBIRx Specialty Tool box, which addresses many other components of managing Specialty Drug costs beyond LDD drugs.

At PBIRx, we use advanced technology to create algorithms that allow us to manage and utilize information about high cost Specialty Drugs so that we can further educate our clients. It is our goal to provide customized solutions to our clients in the management of pharmacy benefit costs resulting in optimal heath care outcomes while minimizing overall health care costs.

For more information on how we can help, visit us online at www.pbirx.com or contact us at (888) 797-2479 today!

Getting to Know PBIRx®!

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

As an entity that provides benefits to its employees or members, it's important to make sure that your plan covers several medical categories to ensure optimal health care coverage. In today's medical field, the demand for high cost specialty drugs and prescription medications specifically is continuing to rise. Managed Care Plans, Hospitals, Employer Groups, Unions and Third Party Administrators are eager to work with companies that can help them to reduce and optimize their growing pharmacy spend. In fact, today, pharmacy costs represent approximately 40% of total health care costs!

Since pharmacy costs make up a significant portion of health care costs, many entities recognize the importance of offering pharmacy benefits to their employees or members. However, as the costs of specialty drugs continue to rise, so do the costs of the pharmacy benefits that may be included in your plan.

This is where we come in! At PBIRx, our experienced, diverse and educated team of consultants will work with you to reduce your pharmacy benefit costs without sacrificing any health care outcomes or opportunities. To assist you with your pharmacy benefit plans, we offer the following services here at PBIRx:

• Pharmacy Benefit Consulting
• Pharmacy Benefit Auditing (AuditRx®)
• Pharmacy Benefit Actuarial Services, including Clinical Technology Intelligence and Dynamic Clinical Integration
• Third Party 340B HRSA Compliance Audits
• First Fill Optimization

In each of these services, we work closely with our clients to provide customized solutions that help reduce and control pharmacy costs in their health plans. Using robust technology, along with a staff that includes actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and other experts in the pharmacy benefit management industry, we evaluate your current pharmacy benefit plan and devise a strategic plan that reduces overall costs while maintaining the benefits your employees/members currently receive, resulting in positive and lower costing healthcare outcomes.

For more information on how we can help, visit us at www.pbirx.com or give us a call at (888) 797-2479. Also, be sure to LIKE us on Facebook and FOLLOW us on Twitter to stay up to date with the latest news in the pharmaceutical industry and pharmacy benefit cost savings opportunities.