FDA Approves Inflectra, First Monoclonal Antibody Biosimilar

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

On April 5, 2016, the U.S Food and Drug Administration approved the second biosimilar in the United States, which is infliximab-dyyb (Inflectra), a biosimilar to inflixamab (Remicade). Inflectra is manufactured by Celltrion, Inc. for Hospira, a Pfizer company, and will be administered by intravenous injection for many of the same indications as Remicade, the originator/reference drug. 

Although the biosimilar of Remicade has just been introduced to the U.S market, Inflectra and other Remicade biosimilars have already been introduced to major European markets such as Germany, France, Italy, Greece, Spain and Austria.

According to the FDA, Inflectra can be prescribed to treat the following patients:

• Adult and pediatric patients over age 6 who have moderate to severely active Crohn's disease and have not had success with conventional therapy
• Adult patients who have moderate to severely active ulcerative colitis and have not had success with conventional therapy
• Adult patients who have chronic severe plaque psoriasis
• Patients who have moderate to severely active rheumatoid arthritis - to be used in combination with methotrexate
• Patients who have active arthritis of the spine
• Patients who have active psoriatic arthritis

As a reminder, biosimilars are biological products, meaning they are derived from living organisms such as humans, animals, yeast and microorganisms. In order to be approved, biosimilars must be extremely similar to a biological product that has already been approved, and clinically speaking, there must be no differences in safety and effectiveness when compared to the biologic or reference product.

In addition to being only the second biosimilar approved by the FDA, Inflectra is the first monoclonal antibody biosimilar to be approved. Monoclonal antibodies are made by just a single clone of cells or cell lines from a parent cell, and though they are very expensive, they are utilized widely for different disease states such as cancer, psoriasis and rheumatoid arthritis.

Regarding the dispensing of Inflectra, it is important to note that it must receive approval for dispensing by a physician since the FDA guidance states that it has “not” been approved as an interchangeable product.

With a new biosimilar hitting the market, it is important for entities that provide pharmacy benefits to be aware of how this could affect future pharmacy benefit spend. There is a good chance that pharmacy benefit managers will hold up the dispensing of biosimilars in order to maintain the hefty rebates they receive from the high cost specialty brand/originator products. As such, this is an example of the value of retaining an expert in the pharmacy benefit industry, like PBIRx, to review your PBM contract language so that you have a clear understanding of how biosimilars are being treated, i.e. excluded/included from formularies, pricing guarantees, discounts, and copay tier appropriation.  

For help understanding your PBM Agreement, call and request a courtesy review of your PBM Agreement with one of our friendly and experienced PBM Experts prior to signing a three year PBM Agreement, which could be great for the PBM profitability, but not as good for your bottom line pharmacy benefit spend. Please call (888) 797-2479 or fill out our contact form on our website.

Copay Plan Design Considerations For Specialty Generic and Biosimilar Drugs

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

With the most recent launch of both a generic and a biosimilar for two different highly utilized expensive specialty drugs (Copaxone and Neupogen respectively), it is very important that Plan Sponsors providing pharmacy benefits to their employees and members understand, not only the specific discounts that are being applied to these generic and biosimilar equivalents by your PBM, but also at which member copay tier your PBM will be adjudicating the claim.

Copaxone is available in both a 20 mg and 40 mg strength, with the 40 mg dosage less frequent per week and thus a higher adherence rate. These drugs are Brand Specialty drugs, for which pharmaceutical manufacturers provide rebates to the PBMs, which are shared at certain levels depending on your level of expertise in negotiating your PBM Agreement. Also of interest is that the manufacturer, Teva, moved two thirds of all prescriptions to the Copaxone 40 mg, which is available ONLY as a brand, to maintain market share. 

On April 16, 2015 Copaxone 20 mg Brand was released as an A Rated Generic of Copaxone 20 mg, and because Copaxone is a biologic drug, the generic drug has a different name which is Glatopa, manufactured by Sandoz. As more generics of Copaxone 20 mg come to market those drugs will also have different generic names.

The AWP for the following drugs as of September 25, 2015 is as follows:

• Copaxone 20 mg: $244.42 per unit or $7,332.60 (30 mL syringe)
• Copaxone 40 mg: $500.80 per unit or $6,009.60 (12 mL syringe)
• Glatopa 20 mg: $216.41 per unit or $6,492.41 (30 mL syringe); however, at a MAC price with certain PBMs based on how you negotiated the PBM contract and thus, the AWP would be around $6,000 or very similar to Copaxone 40 mg.

If you have a three tiered copay plan design: Generic, Preferred Brand, Non Preferred Brand, the Glatopa copay will defer to the generic copay, which is the copay you have set for typically “traditional” drugs and not high cost specialty drugs. If you have a four tiered copay plan design, which is similar except that there is an additional copay for “all” specialty drugs, Glatopa would still defer to the generic copay. If you had a five tiered copay plan with two copays for “all” “specialty drugs”: Preferred Specialty and Non Preferred Specialty, the lower cost A Rated Generic, Glatopa, would defer to the Preferred Specialty versus the "traditional drug" Generic copay and the higher cost Brand, Copaxone 20 mg, would defer to the Non Preferred Specialty copay, which is the appropriate cost share since the generic of a specialty drug is still in the thousands of dollars range.

As mentioned above, some PBMs have already applied a MAC to Glatopa dropping the cost by approximately $1,100 to $1,300 less expensive than the Copaxone 20 mg brand. HOWEVER, IF THE COPAY LEVEL FOR THIS NEW CATEGORY OF HIGH COST SPECIALTY GENERIC IS NOT IN YOUR PLAN DESIGN, YOUR PLAN COULD BE LOSING NOT ONLY THE COST SAVINGS, BUT ALSO THE INCENTIVE FOR THE MEMBER TO TALK TO THE DOCTOR ABOUT THE LOWER COST ALTERNATIVE.

The same logic exists for biosimilars of high cost specialty brand drugs, which are not interchangeable and are subject to the doctor’s prescribing along with state and federal laws. On September 3, 2015, Zarxio, the biosimilar of Neupogen was launched. Though conceivably having a lower AWP as compared to the brand Neupogen, PBMs receive rebates for the brand and are likely not to lower the member copay for biosimilars so quickly. In a recent PBM survey by PBIRx, PBMs vary as to the discounts they are applying to these new specialty generic and biosimilar drugs, as well as to which member copayment tier will apply.

PBIRx has been providing pharmacy benefit consulting and auditing for 25 years and is constantly on the cutting edge of monitoring new drugs and existing drugs to work with our clients to lower costs on a continuum. For more information related to generic and biosimilar discounts and copays, please contact us at (888) 797-2479.

Biologics: An Overview

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

By definition, biologics are medical products that are made from natural sources such as a microorganism, a human or an animal. Unlike other drugs that are made through a chemical process, biologics are manufactured in a living system and are usually very large molecules or mixtures of molecules that can not easily be identified. 

Just like other pharmaceutical drugs, biologics are used for the purpose of treating a medical condition or disease. Since biologics have proven to be an adequate solution for the treatment and prevention of some medical conditions, it is expected that over the next decade, the global biologics market will grow tremendously. In fact, at this rate, it is anticipated that by 2018, about 45 of the top 100 drugs will be biologics, pulling in about 50% of sales for that group of drugs.

When discussing biologics, it is also important to touch on their relationship with biosimilars and analyze how the growth of biologics will impact the production and growth of biosimilars as well. First and foremost, a biosimilar is any biological product that is very similar in nature and composition to an already licensed biological product. However, since biologics are extremely complex, it appears that it will be much more difficult for manufacturers to make a biosimilar version of originator biologics. Furthermore, in order to truly understand the safety and effectiveness of such biosimilars, manufacturers will need to carry out clinical trials where these drugs are tested. As a result, one can expect that biosimilar sales may not grow at the same rate as biologics since the process of integrating them into the market will be a much slower one.

At PBIRx, we are always following the latest pharmacy trends to better understand how the industry is changing. In turn, we are able to better analyze our clients' pharmacy benefit plans and develop solutions that are more in tune with the latest industry breakthroughs. For more information on biologics or to find out how we can help you with your pharmacy benefit plan, please visit us on our website or contact us at (888) 797-2479 today.

Specialty Drug Tool Box Spotlight: Pricing

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

 

Here at PBIRx, we believe that it is crucial for our clients to fully understand the nature of pharmacy benefits and how to approach their cost and other associated health care outcomes. In our previous blog, we highlighted our proprietary Specialty Drug Tool Box and provided an overview of each of the four components that lie inside in order to educate our readers on the process of managing this growing segment of the pharmacy benefit. Today, we'd like to place our focus on the first component, pricing, to provide a more in depth look at the first stage of managing pharmacy benefits. See below:

Before figuring out which specialty pharmacies you will work with to dispense specialty drugs to patients, it's important to ask your PBM about any current discounts or rebates that apply to certain specialty drugs and also agree on a timeline, i.e quarterly for the PBM to provide new specialty drug updates and associated discounts. Since specialty drugs can be extremely expensive, you also want to discuss which drugs are similar, i.e treat similar disease states, and therefore should be preferred with a rebate.

In order to find cost-effective solutions, it is also important to take a look at biosimilar or generic drugs that can be used in place of specialty drugs and consider at least identifying them in your 2015 plan design program so that they can be added when approved. Currently there are several generic versions of specialty drugs and it is important that your PBM Agreement applies the lowest MAC pricing to these generics. Many PBMs do not provide MAC pricing to specialty drug generics. When it comes to pricing, there are many other questions that you should ask your PBM. Some are as follows:

• Does your PBM contract state different discounts for different limited distribution drugs?
• Does your PBM provide a per prescription rebate, a per brand prescription rebate or 100% of the actual manufacturer rebate for specialty drugs?
• Can your PBM provide an updated specialty drug list with current discounts of the new drugs launched?
• Do you audit high cost specialty drugs for adjudication accuracy?

Be sure to check back for our next blog, which will focus on the second component of our specialty drug tool box, channel management!

At PBIRx, our mission is to create optimal health care outcomes while minimizing overall health care costs. For more information on how we can help, visit us at www.pbirx.com or contact us at (888) 797-2479 today!