PBM Drug Exclusions for 2016

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Though we still have about half of the year left, now is the time when many are starting to think about their health coverage for 2016. And if you hold prescription insurance through companies like CVS/Caremark and Express Scripts, you will most certainly want to know which drugs they are excluding for the next plan year.

To help you stay up-to-date with the latest changes, we did some research and found that the following drugs will no longer be covered next year:

CVS:

• Abilify
• Amitiza
• Avonex
• Bydureon
• Carac
• Cardizem
• Clobetasol spray
• Diovan
• Invokana
• Relistor

For a complete list of drugs that CVS is excluding, check out this article from CNN Money.

Express Scripts

• Abstral
• Alvesco
• Beconase AQ
• Dipentum
• Harvoni
• Onglyza
• Qysmia
• Saizen
• Sovaldi
• Teveten HCT

For a complete list of drugs that Express Scripts will not be covering and their alternative recommendations, please click here.

As an experienced pharmacy benefit consulting firm, we at PBIRx understand just how important it is for providing entities to be aware of how certain PBMs change their drug coverage from year to year. If you have questions about how your pharmacy benefit plan will be affected by these updates or would simply like to have your plan audited to ensure you are paying fair prices for the services you do have covered, be sure to give us a call at (888) 797-2479 to start working with us today.

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.

FDA Approves Varubi for Chemotherapy Side Effects

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Earlier this month, the FDA announced that Tesaro Inc.’s Varubi, a treatment designed to prevent delayed nausea and vomiting from chemotherapy, has been approved. While it is currently only approved for adult use alongside other drugs that perform similar functions, research has shown that it is more effective during the delayed phase than placebo therapy, according to Medical News Today.

What is delayed nausea and vomiting?

Nausea and vomiting are very common side effects of chemotherapy, potentially lasting several days after undergoing treatment. By definition, “delayed nausea and vomiting” is when these effects are felt from 24 to 120 hours after chemotherapy has begun. As this can lead to serious health issues (according to the FDA), it seems only fitting that a drug to combat the effects be approved.

What is Varubi and how does it work?

The FDA also explains that Varubi is a “substance P/neurokinin-1 (NK-1) receptor antagonist.” Since the activation of NK-1 receptors are typical triggers of nausea and vomiting caused by some chemotherapy treatments, Varubi works against them to keep these side effects at bay. However, since Varubi may get in the way of enzymes known as CYP2D6 and their ability to break down particular drugs, it has been said that Varubi should not be administered to those individuals that are also taking drugs that this enzyme works with. Additionally, like all other drugs, Varubi comes with side effects of its own, including a low blood cell count, hiccups, dizziness and potential decreased appetite.

To learn more about Varubi, check out the FDA’s press announcement here.

In addition to Varubi, we would also like to point out that the FDA recently approved Merck’s Emend for pediatric patients. Similar to Varubi, Emend is a drug designed to help with nausea and vomiting that results from cancer treatment. As per the approval, it can now be taken in children 12 years old or younger, so long as they weigh at least 30 kg, to combat delayed nausea and vomiting following chemotherapy. According to the PharmaTimes, this is the “first and only NK-1 receptor antagonist cleared for this indication and patient group.” However, it is important to note that in this instance, it must be taken with other antiemetics.

As one of Connecticut’s leading pharmacy benefit consulting and auditing firms, we at PBIRx are on top of all the latest FDA drug approvals. For more information about Varubi and Emend and how their approval may impact your pharmacy benefit plan, please give us a call at (888) 797-2479.

Bristol-Myers Squibb and AbbVie Blood Cancer Drug To Potentially Receive FDA Approval

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

The latest in cancer treatment news explains that a new drug designed specifically for blood cancer may be on its way to receiving FDA approval. The drug, known as elotuzumab, comes from Bristol-Myers Squibb and AbbVie. The two have planned to market this multiple myeloma treatment as “Empliciti,” and have labeled it for those patients who have already been through one or more rounds of therapy treatment, explains FierceBiotech. As it has been given priority review by the FDA, we should know if the drug is approved within the next 6 months.

The history of elotuzumab

Though this is recent news, the drug has been up in the air since 2008. At this time, Bristol-Myers licensed it from PDL BioPharma for the high price of $30 million. When AbbVie emerged in 2013, they and Bristol-Myers paired together and continued to work on the drug that could potentially bring relief for those who suffer from multiple myeloma.

The research

FierceBiotech reports that in Phase III results, the combination of elotuzumab, Celgene’s Revlimid and the generic dexamethasone proved its worth by beating two older drugs. However, before that, due to its success in Phase II, the FDA granted it “breakthrough-therapy designation” earlier on. This allows the creators of the drug to access high level officials throughout the entire process of being developed.

To learn more about elotuzumab and its path to FDA approval, please click here.

At PBIRx, we work hard to stay on top of all of the latest pharmaceutical news to ensure that we are prepared for any new approvals before they come. If you have questions about this blood cancer drug and how it may impact your pharmacy benefit plan if it should be approved, please contact us to learn more about how our services can help; we can be reached at (888) 797-2479 or through our contact form on our website.

Express Scripts Makes Major Staffing Changes

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

Express Scripts Holding Co., one of the largest publically traded PBMs, is continuing to make major changes to their executive level employees. Most recently, Eric Slusser, former CFO of Gentiva Health Services Inc., was appointed CFO almost immediately following the retirement announcement from Express Scripts’ CEO of 11 years George Paz - Slusser’s news broke just a day later. With a background that includes executive experience with Centene Corp. and Cardinal Health Inc., Slusser’s projected earnings are upwards of $2.75 million.

As for CEO George Paz, he will officially step down from his position in May of 2016, although he will still remain involved in the company as a non-executive chairman. His replacement is Tim Wentworth, who is currently Express Scripts’ president, according to NASDAQ. Wentworth’s resume includes experience with Mary Kay, Inc., PepsiCo, Accredo and Medco - prior to Express Scripts’ acquisition of Medco, he was with the company for 14 years and was the president of Accredo (Medco’s specialty pharmacy).

So what does all of this mean for those who use Express Scripts as their pharmacy benefit manager? As a company that manages $1 billion prescriptions for an approximate 85 million people every year (via ABC News), these changes will certainly require the PBM to place their focus on continuing to grow their profits - and at the cost of plan’s health care budgets at that. Therefore, it becomes increasingly more important for providing entities to seek the help of an expert like PBIRx, which is INDEPENDENT from the PBM and whose focus is to lower the PBM profit and increase your pharmacy benefit budget, which is at risk with the increase of high cost drug prescribing.

Here at PBIRx, we can review your pharmacy benefit contract and ultimately oversee your plan’s management to ensure that all actions provide you with the greatest benefit rather than the PBM.

For more information about our pharmacy benefit consulting and auditing services and how they can help you achieve optimal health care outcomes while minimizing overall health care costs, please visit our website or contact us at 1-888-RxPBIRx (797-2479).

The Jury Is Out: The New 340B Guidance Continues to Require Clarity

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

As PBIRx provides HRSA Compliance Audits with many 340B covered entities nationwide we must always be abreast of the newest guidelines so that we can be best in class for our clients.  A testimony to that is the recent engagement of PBIRx services for a second HRSA Compliance Audit for a major 340B hospital plan in Massachusetts. A few months after a PBIRx Audit last year, this 340B Covered Entity was audited by HRSA and passed with no issues because they had the opportunity to implement the PBIRx recommendations to be compliant with the 340B Program. 

The 340B Drug Pricing Program Omnibus Guidance, 90 pages published in the August 28^th Register (80 Fed. Reg. 52300) does provide more specificity relative to the definition of a 340B patient and what is considered a 340B eligible drug under the program:

• The prescription must be written by an “employee” or “independent contractor” of the facility or clinic and authorized to bill for services provided by such employee or independent contractor at such facility or clinic.
• A prescription written by a provider that is NOT an employee or independent contract, but has privileges or credentials at the 340B hospital is NOT an allowable 340B prescription.
•  A prescription written by a provider, who was referred by the employee or independent contractor, and who resides at a non covered (not in the 340B database) healthcare organization is NOT an allowable 340B prescription.
• Federal and state laws govern whether the employee or independent contractor of the facility can issue a prescription via telemedicine and/or telepharmacy.
• Services provided to a patient MUST be provided at the facility or location that has registered for the 340B program and is listed on the public 340B database. This covered entity must be able to not only access the patient’s health records, but also access documentation to prove that the covered entity has established a relationship with the patient.

     Another major change or clarification in the guidance is that 340B covered entities cannot prescribe 340B eligible drugs to inpatients upon discharge. The inpatient must make another “outpatient” appointment before their prescription is 340B eligible.

As the complexity increases in HRSA guidelines for 340B entities, look to PBIRx, which provides a team of experts with longevity in several HRSA guideline areas to ensure that your PBIRx HRSA Compliance Audit Report and follow up takes away any concern of your 340B status, as a result of a HRSA audit failure. 

An Introduction to Addyi™

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

If you have been keeping up with the latest drug news, then you have probably noticed much discussion over the FDA's approval of "Viagra" for women. To help you stay up-to-date with all of the latest developments on this drug, today we are answering a few questions you may be curious about; see below:

What is Addyi™?

Addyi™ has been called “The Female Viagra.” It is used to treat a condition called “generalized hypoactive sexual desire disorder” in premenopausal women. Its generic name is fibanserin. It was initially studied as an antidepressant but has shown to help about 1 in 10 women increase sexual desire. It works on serotonin, a neurotransmitter, in the brain.

What is special about this drug?

It is the first drug FDA approved to treat this condition.

How much will it cost?

Currently unknown, but according to hints from the manufacturer, Sprout Pharmaceuticals, the cost is expected to be a minimum of $400 per month.

Is Addyi™ currently available?

The drug launch is expected to be in October of 2015.

How many people will use Addyi™?

Unknown, but one survey in women aged 18-59 found up to 30% of women lacked sexual desire within a one year period.

Will Addyi™ be heavily marketed?

We expect this to be true. The manufacturer, Sprout Pharmaceuticals, was purchased one day after FDA approval for $1 billion dollars by another drug company, Valeant. The CEO of Sprout, Cynthia Whitehead, who will continue to work under Valeant, has said that it planned to hire 200 sales representatives. In addition she has said that Sprout/Valeant plans to run a patient co-payment assistance program. Read more of what Cynthia had to say in an interview with the International Business Times here.

Is Addyi™ safe?

Addyi™ is associated with nausea, dizziness, fainting and drowsiness. Use with alcohol can lead to severe hypotension and fainting. Alcohol is contraindicated with its use.

What is the FDA doing to ensure drug safety?

Addyi™ will only be available under a program called the Addyi™ REMS program. REMS (Risk Evaluation and Mitigation Strategy) is a FDA mandated program to ensure that the benefits of a drug outweigh its risks. Doctors and pharmacists must pass a comprehension test before prescribing or dispensing this drug.

Is Addyi™ really like Viagra™?

Only in that it treats a sexual dysfunction condition. Viagra™ only works on improving blood flow to the penis, is taken as needed, and is effective nearly all the time. Addyi™ works in the brain, needs to be taken every day, and needs to be taken for up to 8 weeks to see if it is effective. It is only effective 10% of the time.

For more information about Addyi™ and how its approval could impact your current pharmacy benefit plan, or, to simply learn more about your pharmacy benefit plan in general and how it can be affected by any drug approval, please give PBIRx a call at (888) 797-2479 today.