Auditing PBM Agreements Can Save Money

PBIRx®
Intelligent Solutions in Pharmacy Benefits
12 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479

“Pharmacy” benefit costs in the US are predicted to increase from $323 Billion in 2016 to $580-$610 Billion in 2021 according to a report by QuintilesIMS Holdings, Inc.    

Pharmacy Benefit Managers love when their clients do NOT audit their pharmacy benefit agreement!   This way the creative language in their contracts is not revealed and you pay more and more each month and each year.

Auditing pharmacy claims can generate significant monetary recoveries, while at the same time providing you with the confidence that your current pharmacy benefit financial discounts and guarantees are competitive for 2017.  PBIRx can tell you what parts of your PBM contract are not competitive. PBIRx clients experience a 5%–15% recovery of total drug spend, while at the same time ensuring that the PBM contract financial terms are being adjudicated correctly.

PBIRx®, a pharmacy benefit auditing and consulting corporation with locations in Connecticut and Missouri  since 1993, has the technology, tools, years of experience and experts that can help you recover lost dollars using our AuditRx® technology.   

PBIRx has several references nationwide that will attest to not only the audit recoveries that we facilitate, but also the savings to their pharmacy benefit budget.  Pharmacy Benefit Agreements, whether direct with the PBM, through the health plan carrier (i.e. Anthem, Cigna, Aetna, etc), or through a coalition, state that auditing may be limited to a certain time period (typically the previous 12 months).  Not knowing the period of time that you can audit your pharmacy benefit claims and not reaching out to PBIRx results in a lost recovery opportunity!

Why you should have PBIRx review your Pharmacy Benefit Agreement with no fee:

• To determine if there is a potential pharmacy benefit claims  recovery
• To know if the discounts in the PBM Agreement are actually being adjudicated as stated
• To learn if the financial model (discounts, rebates, guarantees, etc.) is 2017 competitive
• To provide union negotiated pharmacy benefits at a lower cost
• To know if there are other opportunities for savings to reduce costs while maintaining current copays and plan design features in negotiated union contracts
• To be reminded of important dates that could result in lost “time value of money”, i.e. guarantee/rebate remittance, agreement renewal period, non competitive automatic renewals, etc.

PBIRx will provide a courtesy review of your PBM agreement upon request.  Please contact David Sirowich at dsirowich@pbirx.com or call 203-882-1188 to discuss your potential savings in greater detail.  You can also visit our website www.pbirx.com for more information.

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.

Telemedicine Prescription Cost Effect on the Pharmacy Benefit

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

As a company whose main priority is to stay on top of the latest news and drivers of pharmacy cost, we find it increasingly important to discuss the increase in prescription drug utilization effect that the telemedicine market is predicted to have on pharmacy benefit costs, which is one reason why so many chain pharmacies are getting actively involved in offering telemedicine services.

For those of you who are unfamiliar with the term, the American Telemedicine Association defines telemedicine as the "use of medical information exchanged from one site to another via electronic communications to improve a patient's clinical health status." Directly related to this term are "telehealth" and "teladoc," which also revolve around the idea that health professionals and services can be accessible to patients through electronic mediums rather than just face-to-face and have the ability to prescribe drugs as a solution to the described patient illness.

In recent news, there have been several pieces of legislation proposed regarding the extent to which telemedicine can be applied. For example, two United States Senators just introduced a bill that would permit health professionals working in Veterans Affairs (VA) facilities to treat their patients using the technology that is associated with telemedicine, regardless of the state. Additionally, this past summer Delaware introduced a new law that outlined how telemedicine can be practiced within its borders.

That being said, it is important to carefully analyze how prescription utilization (number of prescriptions for each person) is going to increase as many carriers begin to expand their use of telemedicine. Walgreens and MDLIVE, for example, recently began offering telehealth services in three new states, with the expectation that 25 states will have access to them by the end of 2015. Part of their offering is that remote doctor access is available for just $49.00 a visit. Additionally, CVS announced this past summer that they will be working closely with telehealth companies American Well, Doctor on Demand and Teladoc to make telemedicine programs more available to patients. 

With all of these changes taking place, one must be prepared for an increase in the number of prescriptions written since telemedicine services are much easier to access than making an appointment with patients' primary care doctors. As a result, entities providing pharmacy benefit services to their members or employees need to benchmark, not only the date that they offer telemedicine services, but also the prescription utilization to see how such utilization changes/increases as compared to when telemedicine services were not available. All PBIRx client profiles document if the telemedicine services are offered, by whom and on what effective date so that our analysts can better understand prescription utilization increases, which is a pharmacy benefit cost driver.

For more information about the telemedicine market and how your pharmacy benefits may be affected by its growth, please give us a call at (888) 797-2479. Additional information about how we can help you with your pharmacy benefits can be found at www.pbirx.com.

Valeant Pharmaceuticals' Drug Costs Continue To Concern

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

In late June, PBIRx first identified the over 500% cost increase of Glumetza, which continued to quadruple overnight. For those of you who are not familiar with Glumetza, it is a drug used for the treatment of diabetes, with Glumetza being manufactured by Salix Pharmaceuticals (Salix was acquired by Valeant for $15.8B earlier this year). Upon learning about this cost increase, PBIRx developed an algorithm and identified any Glumetza utilizing member from our vast database of clients. Then, the PBIRx Clinical Staff researched evidence based alternative efficacious lower cost medication options, notified each client for approval to have their specific PBM facilitate communication with the Glumetza utilizer(s)’ prescribing doctor to provide information on the significant cost increase for Glumetza, along with the  lower cost alternatives. This very time sensitive action resulted in thousands of dollars in savings for PBIRx clients.

However, it is important to note that the increase in Glumetza’s cost is not the only piece of news raising concerns about Valeant Pharmaceuticals International. Another drug, Cuprimine, which is used to treat several health conditions such as Wilson’s disease and rheumatoid arthritis, also saw a cost increase, making it much more difficult for patients to comfortably pay health care bills. But the patients are certainly not the only group of people raising an eyebrow at the recent spikes - lawmakers are too.

Just last month, the New York Times reported that “Valeant’s habit of buying up existing drugs and raising prices aggressively, rather than trying to develop new drugs, has also drawn the ire of lawmakers and helped stoke public outrage against the growing trend of higher and higher drug prices imposed by big drug companies.” In fact, this year alone, Valeant has raised their prices on brand-name drugs approximately 66%, making this one of the greatest increases seen when compared to other drug companies.

So what is being done about Valeant’s latest actions? More recent news from the New York Times explains that Valeant has been issued two federal summonses (one from Manhattan and one from Massachusetts) as a result of their pricing, distribution and patient support practices. Although this does not necessarily mean a charge or settlement will occur, it is worth it to note that action is being taken to try and investigate the situation further.

Philidor’s Connection

Along with the recent news about Valeant, we also feel it is important to briefly touch on Philidor Rx Services and their connection to this pharmaceutical company. Some sources suggest that Philidor was not acting honestly (for example, they changed prescriptions to get insurers to pay for drugs) and as a result, many large PBMs such as Express Scripts, CVS Caremark and OptumRx have removed Philidor Pharmacy from their network. Not to mention, Valeant has announced that they are terminating their relationship with Philidor as well. As a providing entity, if you have members that use Philidor, they must receive a new prescription from their doctor or work with Philidor to have their prescription transferred.

For all of the latest on this topic and other industry news, be sure to connect with us on all of our social media profiles. Then, for more information about how PBIRx can help you with your pharmacy benefits, please visit www.pbirx.com or call (888) 797-2479 today.

340B Orphan Drug Exclusion Ruling By Federal Court

PBIRx®

Intelligent Solutions in Pharmacy Benefits

612 Wheelers Farms Road, Milford, CT 06461

(888) 797-2479

As of October 14, 2015, 340B Covered Entities such as rural referral centers (RRC) and free standing cancer hospitals (CAN) that had “Opted In” to purchase Orphan Drugs will no longer be able to utilize 340B pricing for “any” drug for which there is at least one Orphan Drug designation per ruling by Rudolph Contreras, United States District Judge.

Though entities that “Opted In” agreed to track the use of each drug by indication and to maintain audible records, the ruling is in favor of The Pharmaceutical Research and Manufacturers of America (PhRMA), which claims that HRSA incorrectly interpreted the Orphan Drug exclusion to be used for indications other than the Orphan Drug indication as a 340B eligible drug.

Another option for 340B Covered Entities was to “Opt Out” of submitting any drugs that are considered Orphan Drugs because “they are unable or unwilling to track by indication."

What is interesting is the large number of existing drugs for which there IS at least one Orphan Drug designation that would be surprising to some such as Crestor, Humira, Enbrel, Prozac, Betaseron, Copaxone and others. One thought is that by seeking at least one Orphan Drug designation for an existing drug, manufacturers therefore would not have to provide a 340B pricing discount and at the same time increase the cost of the drug.

A recent PBIRx 340B Compliance Audit for a covered entity that had “Opted Out” of submitting for drugs that are considered Orphan Drugs uncovered a significant issue. The 340B Covered Entity was using two different Contract Pharmacies that were each using two different Contract Pharmacy Service Providers (CPSPs). CPSPs establish automated operating procedures for the contract pharmacy program.

PBIRx’s  340B Compliance Audit identified that one contract pharmacy had submitted for 92 prescriptions for Crestor, which has one Orphan Drug designation, while the second contract pharmacy was compliant and had no submissions for Crestor or any other drug for which there is an Orphan Drug designation. Therefore, one of the covered entities contract pharmacy was non compliant and as such, posed a big loss of 340B status risk for the covered entity as HRSA could view this as diversion. PBIRx is working diligently with the client on an immediate resolution to protect their very valuable 340B status.

To protect your 340B status, contact our experienced and knowledgeable team for your 340B HRSA Compliance Audit at (888) 797-2479. Through the use of our cutting edge technology, we can provide you with the most comprehensive evaluation report and provide the necessary solutions where needed.

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.

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.