Jan Berger, MD, MJ

The world of specialty medications gets more complicated and more important each day. My column in the May/June 2016 issue discussed some of the issues associated with specialty medications. In this column, I want to focus specifically on the issues associated with the distribution of infusible specialty medications. 

First, let me say that I am a big fan of specialty pharmacies. Many of them bring value to both the patient and the payer. That said, I also believe they often forget how some of their decisions can affect the patient. 

This is even more evident when speaking about the specialty medications that are most often covered by the medical benefit. For a long time, specialty pharmacies had little to do with these medications. Over the past year, in working with my clients, I have seen a movement in which specialty pharmacies are managing the specialty medications, regardless of whether they are paid for through the pharmacy or the medical benefit. Additionally, I have noticed an increase in specialty pharmacies offering my clients cost savings for limiting where the patient receives their infusible medications. 

These plan designs are touted as a method of payers to decrease medication costs. Unfortunately, there is little discussion around the financial impact or care disruption that occurs for the patient. Please don’t get me wrong. I do understand the cost implications of these very expensive medications for a payer. I just don’t believe that many payers understand the overall implications of the decisions being made. 

Let’s start this conversation by looking at the potential cost implications for a patient. To best articulate this issue, I will use payer X as the payer, patient Y as the patient, and Remicade as the drug. Payer X was offered a plan design that required their members to receive the infused medication from a specialty pharmacy’s mail-order program, much like they have been doing for self-injectable specialty medications. 

At first glance, the program seemed to make a good deal of sense. The member had the convenience of receiving the medication directly at their home, and the payer saved money. Unfortunately, the discussion did not go deeper than that. The contract gave the payer the opportunity to lower the cost of Remicade by receiving a portion of the rebate that the specialty pharmacy was receiving from the manufacturer. This lowered the overall net cost of the medication. 

In many cases, this is a good thing. Unfortunately, the net cost implication was not passed on to the member. For members who have a coinsurance plan design model, receiving the medication directly from the specialty pharmacy has the potential to have a significant negative implication, as the coinsurance does not take the rebate into consideration. I have found this to be occurring more often recently. 

The second area where we are increasingly seeing a negative impact on the consumer is in the difficulty they face getting their medication infused once it is sent to their home. It is not unusual for providers to refuse to give medications, such as Remicade, to a patient if the medication was not dispensed from their office. 

The reasons that providers give vary, but most often focus on the safety and liability associated with the handling of the medication. If a patient’s physician declines to infuse the medication, it falls on the consumer to find someone who will do the infusion, such as a home health agency or an infusion center. Doing so can be equally as difficult, which leads to a disruption in care that creates the potential for wasted medication. 

The message is 2-fold: first, specialty pharmacies that are managing infused medications need to create a system that includes care coordination that integrates medication delivery and infusion. Do not leave this integration to the patient. 

Second, it is important that the payer understand the implications that the plan design has on the patient. It is not unreasonable to use a coinsurance model for infused medications, but it is unreasonable to require that a patient go to a more expensive distribution model. Additionally, it is unfair to require a patient to identify providers who will infuse a medication when their physicians refuse to do so. Plan designs need to pass a headline test: Does the design create undue burden on any affected stakeholder?

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The distribution of infusible specialty medications comes with difficulties that must be addressed by pharmacies and payers.

The Opportunities and Challenges of Specialty Distribution

The world is confused—no, this column is not about politics&mdash;rather, I asked 20 people I know what they believe a “pharmacy benefit” covered, and all but 1 of them stated that they believed “benefit” covered all the medications that they are taking. They did not say that it covered only those medications paid for by the pharmacy benefit or only those that are pills; they perceived this as a benefit that singularly addressed all of their medicines.

It is time that we listen to the consumer. I would suggest that those who make benefit decisions should start to think of the benefit the same way their employees and families think about it. Today it is often 3 different organizations that are overseeing, managing, and potentially distributing a person’s medications: one for traditional small molecule medications, a second that does similar activities for self-administered biologics, and a third that manages infused medications.

This is commonly known as the “best in class” model. A second model uses a 2-organization approach, with 1 organization to oversee, manage, and distribute the traditional pharmacy benefit medications and self-injectables (these are paid for under the pharmacy benefit), but they do not have any direct interaction with those medications that are infused and often delivered through the physician’s office or hospital (these are most often covered under the medical benefit).

Companies where you see this most often are organizations such as CVS Health or Express Scripts/Accredo. Recently, some of these organizations have also begun to interject themselves in the management of the infusible “medical benefit medications.” I would suggest that this is a model that is beginning to align itself with the public’s view of what a pharmacy benefit should be. I would also suggest that this management model still has a long way to go.

Although one company may be responsible for all the management of medications regardless of payment source, none of them have a total patient-centric view of the medications. In fact, they often have little or no overlap of clinical or administrative teams and often do not have a single view of the patient in their systems or data. It is time that the pharmacy world begins to address care coordination and management the same way we are asking the medical community to do so.

Imagine a patient that had multiple sclerosis with common comorbidities of diabetes and depression. In order for this patient to have optimal outcomes and feel their best, it is important that a single person or team be responsible for the entirety of the medication management.

The following are just a few things that should be considered with a patient such as this:

Are any of these medications negatively interacting?

Do any of these medications cause side effects that could impact 1 or more of the comorbidities?

Is the patient adherent to all their medications?

If the patient cannot afford to take all the medications, which are the most important?

The pharmacy benefit has begun to attract greater attention by the public over the last few years for a number of reasons, including the increase in medications that are available and the cost of many of these medications.

It is time we push ourselves and the benefit managers to evolve the model into a single integrated management (and when possible distribution) model. I believe this would better address the needs of the patient, as well as the needs of society. What do you think?

The pharmacy benefit has begun to attract greater attention due to the increase in medications that are available and their cost. It is time we refocus on the needs of the patient and push ourselves and the benefit managers to evolve into a single integrated management and distribution model.

It Is Time We Create a Pharmacy Benefit That Is Patient Centric

The annual spring ritual of pharmacy benefit managers (PBMs) releasing their drug trend reports has begun, and one area of great interest has always been in answering the question, “What are my top drugs?”

Over the last few years, we have seen a greater number of specialty medications find their way into payers’ top 10 lists, and drugs for inflammatory or autoimmune diseases, such as Embrel and Humira, have increasingly become some of the most prevalent. Data from Prime Therapeutics show that use of this class of medications increased by over 10% from 2015 to 2016.

Further, the recently released Express Scripts 2016 Trend Report stated that, for their clients, the trend for this class rose by 26.4%.

Today, there are only 15 medications that can be classified as anti-inflammatory drugs. Drugs for anti-inflammatory diseases will find new competitors over the next few years, yet 10 years ago, there was a paucity of medications to treat these significant illnesses. As more medications become available, there will be more choices for the patient and payers to choose from.

However, it is not only new brand medications coming to market worth considering; an increasing number of biosimilars will also become available. It is unknown at this time how biosimilars affect this class of medications and its associated trend, but the 3 most common drugs—Remicade, Humira, and Enbrel&mdash;will soon have biosimilar versions available. 

When looking at drug trends, most organizations focus on the individual components of drug utilization, cost, and mix. Another study from Prime Therapeutics found that there was a 38% increase in use between 2012 and 2015 for anti-inflammatory medications.

One of the reasons commonly thought to increase the use of anti-inflammatory medications was the change in healthcare provider' decision to begin using these medications earlier in a patient’s treatment. Subsequently, this created a situation where higher-cost medications were being utilized without knowing if lower-cost medications would be effective.

 In addition to an increase in utilization and mix of the medications used, the costs of these medications also increased by 102% during the same period. The last year alone showed a 15% increase in unit cost (ESI Trend Report 2016)2; thus, the inflationary price increase caused additional financial impact. 

In particular, the anti-inflammatory class of drugs will soon see a number of biosimilars enter the market. Last fall, Inflectra, a biosimilar for Remicade, came to market; to date, the uptake of this biosimilar has been in the low single digits.

Biosimilars for 2 other drugs in the class—Enbrel and Humira&mdash;were approved by the FDA, but have not yet been launched due to patent disputes. There is a great deal of contention on whether biosimilars will make a significant difference in the utilization and cost implications in this class and across the board in the US pharmaceutical market. In the European market, where biosimilars have existed for more than 10 years, the experience has been mixed: although there has been moderate uptake, the greater effect has been on the muting of brand costs.

1. You, as the insurer or employer, need to work with your PBM to ensure that the right patients are getting the right medications at the right time. Guidelines from societies such as the American College of Rheumatology help to focus recommendations—23% of which are strong and 77% are conditional&mdash;to promote better decision making on proper courses of treatment and to take into account the needs of the patient.

 Additionally, employers and insurers should put processes in place (eg, prior authorization or step therapy) to make sure that the medications being prescribed are used at the appropriate times.

2. Initial fill strategies should also be implemented. It is not unusual when a new medication is started that it is found to be either ineffective or to cause adverse effects that create a situation where the medication needs to be discontinued. In that situation, costs are incurred unnecessarily and medication is wasted. 

3. By putting in place an initial fill program, you create a check in between the patient and their physician at end of the second week of the new medication to assure that the medication is working and that there are no side effects that would require changing the medications.Have a biosimilar strategy in place. Although there are only a few biosimilars on the market, it is not too early to work with your PBM to determine how biosimilars will be handled in your plan design. You will want to think about several things, including:

a. Whether biosimilars will have their own tier or be on a preferred tier.

b. Whether biosimilars will be utilized as part of a step therapy.

c. Whether patients will be required to switch to a biosimilar.

d. Whether patients already on a name brand specialty drug be grandfathered on their drug. 

Please be clear, I am not suggesting that anti-inflammatory medications are not valuable; rather, I believe that these medications have been found to be quite valuable clinically, and in some cases, they have changed the outcomes of patients with significant health conditions.

Instead, I am stating that these medications can have significant cost implications to all stakeholders, and we need to make sure that we are utilizing them in the right way.  

1. Prime Therapeutics research finds nearly half of members discontinue costly rheumatoid arthritis drug after one year [press release]. St. Paul, MN: Prime Therapeutics; September 27, 2016. https://www.primetherapeutics.com/en/news/pressreleases/2016/xeljanzamcp-release.html. Accessed February 2017.

2. 2016 drug trend report. Express Scripts website. https://lab.express-scripts

.com/lab/drug-trend-report. Published February 2017. Accessed February 2017.

3. Prime Therapeutics finds autoimmune specialty drug spend has doubled, account for 10 percent of drug expenses [press release]. St. Paul, MN: Prime Therapeutics; September 30, 2016. https://www.primetherapeutics.com/en/news/pressreleases/2016/autoimmuneamcp-release.html. Accessed February 2017.

4. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2016;68(1):1-25. doi: 10.1002/acr.22783.

In addition to having a major impact on patient health outcomes, medications can have significant cost implications for all stakeholders; insurers and employers need to work with their pharmacy benefit managers to ensure that the right patients are getting the right medications at the right time.


Follow the Numbers: A Focus on Anti-Inflammatory Medications

I was born in the 1950s, at a time when polio was rampant in our country. Fortunately, a vaccine was discovered during that time, but nevertheless, I still had a relative who contracted the disease, and he lived his life significantly impacted by its effects. Later, in the 1970s, as I was training to be a pediatrician, I spent a great deal of time treating infants and children who had a number of infectious diseases, including meningitis and epiglottitis. Many survived after being afflicted, but many other children did not. Thankfully, the scientific community once again did what they had done a number of times prior and identified and produced vaccines that could prevent these horrible diseases, subsequently saving many lives. These vaccines changed the practice of medicine and pediatrics not just in the United States, but worldwide. 

In the present day, with the naming of new officials in President Trump’s administration, our country may be on a course that could have widespread negative effects on population health. On January 10, Robert Kennedy Jr—a leader in the antivaccine movement in the United States&mdash;was named the chair of the Vaccination Safety Committee, which has been tasked with looking at “vaccine safety and scientific integrity.” Although I believe we have a responsibility to understand the impact of vaccines and medications, we should be cautious about using information that has no tie to good scientific evidence. 

Over a number of years past, research has repeatedly shown that there is no link between vaccines and any developmental conditions, and studies that claimed there was a link between vaccines and autism have been disavowed. I would suggest that continuous research on questions that have been answered is not a good use of our country’s time, money, or other resources. In addition, we do a disservice to continue to place many infants, children, and some adults at risk by confusing the public about the importance of vaccines in the fight against preventable diseases. 

The naming of this new committee comes at a time when we are looking at value in healthcare. We seek to identify those areas and activities that show the greatest positive impact in care and outcomes, and on this topic specifically, few would disagree that vaccines bring great value. It could be said that vaccines are the poster child for high-value care, so we must aim to not let good science and scientific evidence get away from us. In fact, I am looking to the scientific community to continue their good work in identifying vaccines for many other deadly infections.

In our quest to identify the areas and activities that show the greatest positive impact and value in care and outcomes, we must aim to not let good science and evidence get away from us, particularly when considering vaccination.

The Value of Vaccination: Myth vs Evidence in the New Administration

The term “partial fill” is not new to the pharmacy industry. Historically, partial fills were used by pharmacies when there was a supply deficit: a partial fill of a prescription was given to a patient while they were waiting for the remainder of the prescription to be available. This partial-fill model most frequently occurred with traditional small-molecule medications. More recently, partial fill has taken on a very different meaning.

Whereas traditional oral small-molecule medications are often distributed on a 90-day cycle, this has not been the case for specialty medications. Very few payers allow a 90-day fill of specialty medications. More often, payors have been utilizing a 30-day fill cycle. Over the last couple of years, however, the dispensing has further decreased, in some cases to 14 to 16 days. This is the world of partial fills.

Although 90-day fills of medications have become common in the traditional pharmacy benefit management setting, there are some payers that have been reluctant to make that available to patients. Those that have not made 90-day fills available through plan design voiced their concern about the “stockpiling” and potential wastage of medications.

As specialty medications are fast replacing small-molecule medications in payor top 10 lists, the cost-control focus has turned. I am now hearing many similar concerns regarding medication wastage that we heard in the past. The difference comes in the price tag of the medication, as specialty drugs can frequently cost more than $100,000.

Payers with whom I work understand the opportunity that specialty medications afford patients who are utilizing them. Many of these medications address medical problems with unmet needs. Payors also understand the need to cover these medications; however, they do not want to fund medication waste. One way they are addressing this concern is through the use of a specialty-focused partial-fill plan design.

Although partial fills for specialty drugs began just a few years ago, in the last couple of years, this plan design has gained traction. A recent study funded by EMD Serono found that 43% of plans were implementing designs that included partial fills. I have seen 2 major areas of variation within the plan design:

The specifics around a partial fill vary according to the benefit design attached to it, and whether the requirement is focused on first fill only or subsequent fills, as well. The large majority of organizations that utilize a partial-fill program focus on oral oncology medications. In addition to oncology, other organizations have taken a broader vision, and include anti-inflammatory, multiple sclerosis, and hepatitis C drugs, as well. In addition to variation in focus on certain medication classes, there is also variability on when the partial-fill plan design is in effect.

Almost half of the payors that utilize such a plan focus on the first fill. These organizations believe that this plan design has the greatest impact at the onset of treatment. There are other organizations, however, that believe a partial fill goes beyond efficacy and safety, utilizing it for subsequent fills, with a relatively small group utilizing a partial fill for all fills.

As I stated above, partial-refill plan designs vary. One of the reasons for this variation lies in the desired goal of the payer. In speaking with my clients I have found that reasons vary from financial focus and impact to clinical focus and a number of areas in between.

What Are the Opportunities of a Partial Fill?

Some say that a partial fill is really a reduction-of-waste program, while others have pointed out the potential for impact on quality of care. A third group sees a partial fill as a medication-support and education tool.

The reality is that depending on the services that surround the partial-fill plan design, it can be any or all 3. The best of the partial-fill programs have aspects that include:

Clinical evaluation of potential side effects and efficacy prior to completing the secondary-portion fill of the medication.

Ensuring that a patient still needs the medication. This may include issues such as admission to an inpatient facility in the interim or a change in circumstances, such as diagnostics, clinical goals, or death.

Addressing medication adherence issues associated with the medication.

Reviewing additional clinical information regarding a patient’s condition or the medication.

A complete medication reconciliation to identify potential complications or issues associated with drug-drug interactions.

Communicating with the prescribing physician if he or she is not the evaluating clinician.

Helping to identify alternative treatments if there are clinical (side effect or efficacy) issues with the initial medication.

What Are the Downsides of a Partial Fill?

There are 2 areas of concern associated with partial fill that have been identified. The first is a patient’s out-of-pocket costs. During the early evolution of partial fill, patients were required to pay a full month’s co-pay or coinsurance, while only receiving the partial-fill portion of the prescription.

This created a great deal of dissatisfaction and noise by patients. This payment model is rarely used today, and is no longer an issue. The second area of concern that has been identified is when there is little or no clinical interaction between the partial fill and the completion of the fill.

This partial-fill model can reduce unnecessary fill completion and, therefore, reduce costs; however, this misses an opportunity to potentially improve clinical outcomes, and support patients regarding medical conditions that often need significant clinical support.

I am a believer in a partial-fill plan design for specialty medications. I believe that this program supports plan members in getting the best potential outcome associated with their medication, while ensuring cost savings when a full fill of a medication is not necessary.

That being said, I advise my clients to work with their specialty pharmacy to ensure there are solid clinical programs included with this plan design.

What has been your experience with partial fills? Are they barriers to care or an improvement on care? I look forward to hearing from you.

Specialty-focused partial-fill plan designs are gaining traction, with conflicting opinions on whether they reduce waste or impact the quality of care.

Partial-Fill Programs: Good Practice or Barrier to Care

If we were to look back 10 years in the pharmacy- and medication-focused world, we would find the following:

Small molecule medications were the focus of members, providers, and payers.

The issues surrounding medication costs focused on point of distribution and choice of generics or “preferred” medications.

All of the medications in a payer “top 20” list were small molecule medications.

Most of the support systems surrounding medications also focused on these small molecule medications.

There was burgeoning knowledge about biologic medications with limited focus on cost and support issues.

Boy, how the world has changed. Today, more than 80% of small molecule medications that are used are generic medications. The main area of focus and concern among payers and providers on these medications is supporting medication adherence for these cost-effective medications.

The energy today has pivoted to specialty medications. The reasons for this focus, at least in part, depend on which stakeholder you may be. The issues include:

For the most part, specialty medications have found themselves on most payer “top 10” lists.

The cost of these medications continues to increase and has affected both payers and patients. (Only recently, as payment models have changed, has cost had a significant impact on providers.)

There are a growing number of specialty medications that appear on most payer “top 20” lists.

Although some of the support activities for patients associated with specialty medications are similar to those of small molecule medications, there are many activities that were not considered or needed in the past.

In order to understand the support that needs to surround specialty medications, one only needs to look at the lifecycle of these medications in a patient’s world. The first issue that is identified is drug choice.

Historically, medication choices were made by the physician, either based on medications that they were comfortable with or on those medications that had lower-tier status on the patient’s formulary. The increased availability and use of specialty medications coincided with the increased availability of companion testing and genomic alignment.

Only recently have there been multiple specialty medications in a class that can allow for cost compression. The earliest classes in which we found examples of this include medications such as growth hormones, rheumatoid arthritis medications, and medications for hepatitis C. It is likely that decisions associated with appropriate medication choice will continue to be more complicated as precision medicine matures.

The second area of support associated with specialty medications is drug distribution. With small molecule medications, the distribution model was based on either a retail or mail distribution for the patient. Initially, specialty medications were also predominately distributed through retail pharmacies or, in the case of injectable or infusible medications, were distributed through the physician’s office.

Over the last 10 years, specialty medications have increasingly been distributed through specialty pharmacies. As the world of specialty medications has continued to grow, the role of specialty pharmacies has grown. Many of these organizations have limited specialty medications through their specific distribution channels. This has brought both greater support and greater challenges to those utilizing these medications.

The activities associated with the distribution of specialty medications have been found to be of value to many patients, and the support associated with that distribution has included pharmacist and nurse education by those with focused knowledge of the condition, as well as the medication. This support level is often not available at the retail pharmacy, as many of these conditions are rare and therefore not seen by most retail pharmacists on a regular basis.

Many patients find this specialized support quite helpful when it comes to the complicated regimens often required. The challenge of the specialty pharmacy distribution model is that many patients find themselves in a situation where they are unable to find a physician who will infuse the medication because they, themselves, do not distribute the medication.

Physicians often state that they are uncomfortable infusing medications when they do not know where they came from or how they have been handled. This can place the patient in a very difficult situation. Most recently, a number of specialty pharmacies have begun to offer home infusion services that address this problem.

The third area of support necessary for many patients taking specialty medications is financial issues. This is not to say that patients taking small molecule medications do not, in some cases, have financial issues. However, cost is often a reason why people are noncompliant with their medications. The difference with specialty medications is that there tends to be greater financial barriers associated with them due to the significantly higher costs.

An increasing number of patients are stating that they have to forgo paying for other necessities in order to afford their medications. This has created an entire industry focused on medication payment assistance. In some cases, it is the pharmaceutical company that aids the patient with payment assistance. In other cases, it is the specialty pharmacy or an independent company that supports the patient with payment issues.

We are entering a period in healthcare where new specialty medications are treating otherwise untreatable conditions. What we have to make sure of is that we also address the challenges associated with specialty medications.

Are there other challenges that your organization is addressing? I look forward to hearing from you.

New high cost specialty medications are increasingly treating otherwise untreatable conditions, creating a series of challenges for stakeholders across the healthcare landscape.