127 posts categorized "Pharmacy"


Healthcare in Transition

The Trump administration began with the bold declaration to end the Affordable Care Act (ACA).  As time has passed, this has proven more difficult than the president originally planned.  The problem has become that the lack of clarity upon what will happen as health insurance is reworked.  This uncertainty has led to insurance companies losing their desire to stay in the ACA market places.  Already, the ACA has resulted in one insurance company, Humana, suffering from particularly difficult losses and quitting the market place.  With even more questions about the future of healthcare laws, it stands to reason that more health insurance agencies will follow.  For this reason, the Trump administration has decided to make interim rule changes to increase the solvency of the program until the new program has been created.  In short, these changes are three-fold:  first narrowing the enrollment window, second expanding the definition of silver-care plans and lastly giving more time for insurers to create plans for 2018.  My goal in this post will be to assess how it will affect insurers, the public and add a bit more context to the problems associated with repeal that have occurred.

Moral hazard is when one party partakes in behavior that can negatively impact another party.  For health insurers under the ACA, this is when individuals opt to join an insurance company only upon realization that they were sick.  This behavior should theoretically have trade-offs.  The fact that adverse selection for pre-existing conditions can no longer occur removes the major incentive against such actions.  Thus, it is wiser to not sign up for healthcare until it is necessary.  The problem that such waiting causes is that insurance is based on a sick-healthy ratio, and additions of sudden sickly individuals would decrease the profits that they had projected to earn.  By narrowing the time frame associated with late-term insurance enrollment, the ability of insurers to ensure profits intrinsically rises.  The fallout of this change, however, is that it may lower the amount of young people who can get insurance in the first place.  The people most likely to enroll at the last minute are the young.  These are individuals who are most needed for insurance companies to thrive.  In this way, the new regulations are a double-edged sword.  By eliminating the younger, more beneficial aspect of the ratio, Trump’s Health and Human Services department (HHS), has made it such that the potential to end up with a more sickly pool of people for insurance companies is higher.  If this were to occur, it would back-fire in its implementation yielding a more unstable market for insurance companies.

Under the ACA, the insurance market has various tiers for the health care plans.  They are summarized in descending order of value as platinum, gold, silver and bronze.  Under the current regulations, silver plans have an actuarial value (AV) of 70%.  By this it is meant that if an individual from a standard population needed healthcare, 70% of their healthcare expenses could reasonably be expected to be covered.  In implementation, a range variance exists allowing for +2 points of coverage meaning insurance companies actually pay between 68-72% of costs.  The change the Trump administration hopes to put into effect would allow a lower minimum value.  Under the new regulations, the variance range would become -4/+2.  By increasing the variance, a silver plan could now have an AV of 66% instead of the current 68%.  This would greatly increase the number of plans an insurance company could create.  However, it would also lower the value of the plans in question.  So while insurance companies would definitively benefit from this change, for the consumer, it is a mixed blessing.  By increasing the burden on individuals, a stronger argument could easily be made for a health reform bill to replace the ACA. However, it would also go counter to the desires of the constituents who voted for President Trump.  Interestingly enough, the change to AV values will have far broader implications than one might initially think.  This owes to the way that tax credit costs are currently calculated.  Since tax credit costs are based on Silver plan values, tax credits given by the government would be directly impacted by these changes.  The tax credit value, known as the “benchmark”, is based on the second lowest value silver plan in an individual’s area.  The amount of tax credit for an individual could be as low as 66% of the cost rather than present minimum of 68%.    Since the tax credit would be lower, it can then be safely assumed that some individuals may not be able to afford the more expensive plans. Thus, insurance companies may see a decrease in enrollment.

The new administrations is realizing that creating a new healthcare law is more difficult than originally believed.  This owes to the fact that the ACA may have many problems, but has done a large amount of good for the nation as a whole.  If nothing else, the number of uninsured Americans has dropped substantially thanks to the law.  The general anger from Trump supporters about the healthcare law seems focused on its limitations and the lack of value from the law.  This makes it far more problematic to create a new healthcare law when all current plans are similar to Rand Paul’s replacement bill, see here or Tom Price’s plan see here.  The part of the ACA most often cited as problematic is the individual mandate.  Some have criticized it as “un-American”.  This stems from the fact that it is the federal government forcing individuals to buy insurance.  The problem is that removing the mandate would only serve to destabilize the insurance market.  Insurance companies would constantly raise rates in an attempt to make-up for the losses.  Eventually, insurance might become virtually unfeasible for the American population.  At this point everyone loses health insurance.  At the same time, the world is not stopping for the Republican Party to make a better law.  So by expanding the time before insurance companies must give a decision about staying in the market place, the Trump administration hopes that it will be able to alleviate the short term problems while a much better long-term alternative takes shape.

Ultimately, the ACA is a bill that has proven a transformative bill for American healthcare.  While certain specifics, like the individual mandate, are not well received, the bill has had success in getting more people health insurance.  There is a good case to be made that the Trump administration’s changes to the health law could help stabilize the market.  The problem is that the basis for that argument is also the basis of the reverse effect happening, making the situation worse.  Allowing for worse overall healthcare for some as a trade-off to stabilize the market can easily be made thanks to the steadily more plausible idea of a death spiral.  At the same time, putting the burden on the most susceptible Americans will strike a nerve with many who fight for the voices of the poor.

My opinion is that, reluctantly, the changes could yield a net good for the nation.  By this I do not mean that all the changes are for the best, just that there is enough well thought out logic to see why the Trump administration is making these particular changes.  However, the ultimate problem is that so long as questions about a new healthcare system remain in the balance, these temporary patches will only serve as the equivalence of tying a tourniquet to a man bleeding to death; a temporary fix without much value if proper treatment is not issued as soon as possible.

Kunle Adejare, PharmD '19


21st Century Cures Act – Promises or Problematic?

Late last year a new healthcare act was passed.  The 21st Century Cures Act has been lauded by many on both sides as a compromise that would help many sick individuals. The 21st Century Cures Act promised to bolster new cures and create faster regulatory processes that would help the nation get promising innovative cures to those who need them.   The basis of these claims is that the nation’s current set-up slows down innovation by asking for randomized control trials (RCTs) and spending too little on finding new cures. While these claims seem true on the surface, many criticize the new healthcare act for its incentives for pharmaceutical companies.  Personally, I have a saying that goes “A good compromise will probably leave both sides unhappy.”  So when an act passes with as much praise and speed as the new act did, I cannot help but wonder if the disadvantages would outweigh the advantages.  For this reason,  I will analyze the act’s contents to determine strengths and weaknesses of the act, then make an informed conclusion as to whether it is a net positive or negative.

The positives of the 21st Century Cures Act are numerous.  The biggest benefit for society  would have to be funding for the National Institute of Health (NIH).  The NIH is an invaluable part  of research funding in the nation.   Since the NIH does a large portion of its research through grants, organizations can more efficiently allocate money given to them in ways that benefit their research.  That established,  the new act has secured over 4 billion dollars for the NIH over the next 10 years.  The NIH is probably the single greatest driver of innovation owing to the intrinsic costs of pathophysiologic research.  The fact is that pharmaceutical companies can make no guarantee that the research to discover the pathophysiology of a disease will yield them any wealth.  It is actually a well-known fact that as much as $3 billion can be invested in new drug discovery research and no new drug may be approved by the Federal Drug Administration (FDA).  This is because the complexities of biology prevent researchers from always knowing the effect of changes they make.  In essence, intended benefits and side-effects generally do not yield actual benefits and side-effects.  So, funding the NIH to do the burden of such research frees pharmaceutical companies to aim more money on specific treatments. This will make it cheaper to find cures for disease with few or no treatments and expand the treatments already in existence.

One of the major concessions of the act, from a safety stand point, is that the 21st Century Cures Act has eroded the FDA’s strength to determine the value of new cures.  The problem with the act comes in the degradation of the data that is being given to the FDA.  It is no secret that RCTs are regarded as incredibly valuable data.  This owes to the fact that personal experience is subject to many external factors including one’s own biology.  The bigger issue with the new law and the FDA is “real-world experience.”  From a scientific standpoint, RCTs are “ideal-world experience”.  RCT’s do not give perfect data of all the flaws of a drug, they set a relatively high bar that allows the FDA to make reasonable assumptions about the safety of a drug.  By moving over to “real world experiences”, more side-effects could be missed.  This is important because many drugs carry risks that are not discovered until years after they have been in the market.  Considering that it takes 12 years to get a black box warning on a medication and 5 to get it removed, the negative implications of rapid approval start to become more worrying.   Without expediting the process of getting black box warnings added or getting drugs removed from the market, it becomes worrying that many new drugs are being added to the market. 

The 21st Century Cures Act’s most worrying aspect is that it could lead to many dangerous drugs coming to market, without novel drugs that may help ever seeing the light of day.  The FDA was created at a time when dangerous substances with little or no medical value were being peddled as cures.  The act could end up creating more overall problems caused by an expansion of medications known as me-too drugs.  To be fair, me-too drugs do come with benefits.  In the statin class, many me-too drugs currently exist for the sole purpose of competing with other drugs in that class.  Because the market, dyslipidemia, is so large even a small percentage can be worth billions over a decade.  If one can make an improvement in this class then the benefits are net positive.  Me-too drugs can also increase economic output via creating a need for advertising, production and other media.  Another noteworthy advantage is that it could lead to drugs that are not as potent as a competitor getting priced more cheaply to undercut the competition.  The problem is that, it could also jeopardize patient safety by adding many new drugs with too little information on them.  The lack of information could lead to inappropriate use creating harm or death.  For example, 81 mg aspirin is no longer sold under the therapeutic label of “baby aspirin”.  This is because it was noted that 81 mg aspirin could cause Reye’s syndrome in children with viral infections.   Adults are not subject to this same deadly adverse effect, and with the existence of other drugs such as ibuprofen or acetaminophen, it was decided that aspirin would no longer be used in children.  Since even well-known drugs can have interactions that are not well known for years, adding more medications with less data could have effects that will not bode well in time for society.  While adding new classes of drugs can hold many of the same negatives, it also gives a unique form of treatment.  In the long run, new drug classes could potentially be used in conjunction with existing therapy.  In this way, the funding for new drugs comes off as dubious.

In summation, while the 21st Century Cures Act was a well-intentioned idea, its overall likelihood for net negative healthcare is high.  The positives are noteworthy.  We will see more drugs enter the market.  This will almost assuredly increase the number of jobs and boost the economy in general.  New cures will help patients and lead to instances of better outcomes.  At the same time a rational person can look at the situation and say that the possibility for negatives does exist.  Adding 1 or two more high intensity statins could help the healthcare industry, but if a patient is statin intolerant then 20 new cure does not help.  Also, those who are already doing well on a statin but might need an additional medication will not benefit from this new act.  Adding more problems is the lack of data that is compounding this problem.  In the healthcare industry, mistakes can be life altering or threatening.  Adding more potential cures without sufficient data to assess them is not a good idea.  In this respect, the 21st Century Cures Act is problematic legislation that will not help patient healthcare as much as it was promised to do.

Adekunle O. Adejare, PharmD Candidate – ‘19


More Faculty, Staff, Student and Alumni Achievements

Karin Richards, chair of the department of kinesiology, presented at the Regional Conference on Aging on the topic Calm Minds, Active Bodies.

She will also be presenting at on “Applying Behavior Change Techniques” at a workshop in Richmond Virginia.

Richards was also selected as a master trainer by the American Council on Exercise for applying behavior change techniques

 Paula Kramer PhD, OTR/L, FAOTA, director of the post-professional doctor of occupational therapy program, has been invited to give the keynote address for the New York State Occupational Therapy Association conference on November 5.

 Dorela Priftanji PharmD’17 was awarded the Pennsylvania Society of Health System Pharmacists Student of the Year Award at the annual assembly.

 Several faculty members and former colleagues were published in the American Journal of Pharmaceutical Education, Vol. 80, Issue 7. “Variables Affecting Pharmacy Students’ Patient Care Interventions during Advanced Pharmacy Practice Experiences” was a collaborative effort of Laura Bio PharmD, Brandon Patterson PharmD, PhD, Shanta Sen PharmD, Angela Bingham PharmD, Jane Bowen PharmD, Ben Ereshefsky PharmD, and Laura Siemianowski PharmD.

Jim Holaska PhD, associate professor of pharmaceutical sciences, recently published two articles listed below. One of the articles was a comprehensive review of diseases associated with mutations in nuclear envelope proteins and the proposed disease mechanisms. The second review focused on the cellular function of one of these proteins named emerin and how mutations in this protein cause muscle disease.

  1. Holaska, J. M. 2016. Diseases of the Nucleoskeleton. Comprehensive Physiology. 6:1655–1674.
  2. Collins, C. M., Nee, K. A. and Holaska, J. M. 2016. The Nuclear Envelope Protein Emerin and Its Interacting Proteins. eLS. 1–9.

Jessica Adams PharmD, assistant professor of clinical pharmacy, attended the 6th Clinical Pharmacy Summit in Manila, Philippines Sept 16-18th as faculty for ACCP. She presented on HIV, tuberculosis, sexually transmitted infections, opportunistic and fungal infections, and intra-abdominal infections to a group of pharmacists from the Philippine Pharmacists Association who are preparing to take the BCPS exam.

Amy Jessop PhD, MPH, associate professor of health policy and public health, and a recent grad, Muhamed Gashat MPH ’16 penned a paper entitled "Barriers to HCV Treatment in Methadone Users" was highlighted on the National Aids Treatment Advocacy Project (NATAP.ORG).

 Evana Patel PhB'16 won best paper in her session at the Academy of Business Research Fall 2016 Conference in Atlantic City


The European Biosimilars Market

In previous blogs, I have written about what biosimilars are and have speculated about the development of the US biosimilars industry. While the US biosimilars market may not fully mature for another decade, the European biosimilars market has been expanding for years. In this blog, I will analyze what the European biosimilars market looks like and whether it is a preview of the US biosimilars market.

The biosimilars market in Europe has existed now for over a decade. The first approved biosimilar was a somatotropin in 2006. Since then, Europe has seen 22 biosimilars emerge in several different drug classes (more information available here). With all the potential savings that biosimilars offer, 22 products may seem like a small number to be developed over a decade. Similar to the US, a barrier for biosimilars in Europe is the development pathway. The European Medicines Agency (EMA)which operates similarly to the FDA, provides the legal pathway for biosimilars. Unlike the FDA however, the EMA has made many different product specific guidelines which may be hindering the adoption of biosimilars. Additionally, the EMA does not provide pricing or reimbursement guidelines. This responsibility instead falls to each individual member state. Some member states like Germany and the UK have made pricing policies favorable to biosimilars. Germany has prescribing quotas and the UK has reimbursements for physicians. Others, like Italy and France, have policies that are less favorable in the form of universal price regulation. This regulation does not offer any incentive for the adoption of biosimilars. This mesh of product specific legal guidelines and member state specific pricing policies has slowed the biosimilars market in Europe.

Despite these challenges, biosimilars still offer great savings in Europe. Biosimilars can be as low as 30% less expensive than the European reference products. Even with the slow adoption, some reports show that biosimilars could save Europe as much as $33 billion by the year 2020. At first glance, it seems as though these savings would create an environment where all European member states would mimic the UK and Germany and embrace biosimilars. One might expect that over the next decade, biosimilar policy and use across Europe will look almost identical. History, however reveals that this may not be the case. It is no secret that biosimilars can bring savings to the health care, so countries that have not already adopted them are not guaranteed to adopt them in the future. What is likely is that biosimilars will continue to bring savings, but only to the handful of member states adopting favorable policies.

The European biosimilar experience is unlikely to be repeated in the US. The FDA may end up with a less cumbersome development pathway than Europe which could then lead to more rapid adoption. Individual states will also not have the same policy and reimbursement variability as European member states. In other words, policies in Pennsylvania will look similar to those in New York, while policies in the UK will continue vary greatly from policies in Italy. With that being said, the US biosimilars market will still be unpredictable. All Europe teaches us is that despite unique road blocks, biosimilars can still bring large saving to health care systems who accommodate them.

Robert Bond, PharmD '18


What is Big Data and how will it revolutionize the health industry? Part II

Big Data is poised to revolutionize the healthcare industry. The revolution goes beyond just analyzing text based notes. It is being used in predictive analytics, prescriptive analytics, genomics, and in many other ways.

You may have heard the term “Internet of Things.” This refers to the fact that many devices are now connected to the Internet, from your phone to your car to wearables like the Apple Watch and FitBit. It is estimated that by 2020, there will be 25 billion connected devices.  These devices capture real time data, and allow for real-time alerts. They produce tons of data on the individual. In combination, they can provide us even more information on entire populations.

Big Data can fill in the blanks for predictive analytics, “the use of data, statistical algorithms and machine-learning techniques to identify the likelihood of future outcomes based on historical data.” Electronic Medical Records can be reviewed and analyzed. An individual patient generates much data which can be analyzed to make predictions on whether or not they will comply with their doctor’s recommendations. For example, one hospital found that patients who live in certain neighborhoods are likely to miss appointments. They concluded that it was actually cheaper to send them a taxi to bring them to the appointment than it was to deal with a missed appointment. This was determined by utilizing multiple data sources: patient data, neighborhood data, and administrative data.

Remember, these data are not all being collected by the researcher. They are being collected independently, and the researcher is able to query the different sources to make a prediction.

Prescriptive analytics are a goal of Big Data in healthcare–to be able to identify and predict the path of a patient, then intervene to set them on the right path. For example, if a patient is supposed to walk a certain number of minutes a day, their phone or wearable would be able to see, in real time, if they choose to do so. If the patient allows these data to be shared with their physician, the physician can connect with the patient and determine why they are not complying. This would allow for immediate interventions that were not possible before.

When a person uses their cell phone late at night, it may indicate they are having trouble sleeping, which their physician can then address. These are very simple examples, but they demonstrate how real-time data can be captured and used to nudge patients in the proper direction.

Genomics research is a third area of opportunity in Big Data. The cost of mapping out an individual’s genome has plummeted since the completion of the human genome project. The individual’s genome itself is a massive dataset. When you can compare the genomes of millions of people, you can gain insight into the effectiveness of medicines. We are already seeing a move towards personalized medicine, which will only be strengthened by the Big Data revolution.

Traditionally, an oncologist might find that patients of European descent respond differently from non-Europeans to a particular treatment, which can then be used to determine the first-line or second-line treatment for those subpopulations. Now, with genomic testing, oncologists can see that those with a particular genetic marker respond very well or not at all to a particular treatment. With rapid genomic testing, the oncologist can then use a patient’s genomic information to recommend the treatment most likely to be effective. We are now able to identify patient sub-populations based on genetic markers, which allows for targeted gene therapy, Think of the advances this will bring us in treating cancer or other devastating diseases.

As more genomic data are captured and compared, we will be able to make insights that were nearly impossible to make before. We can begin to see what was once invisible. The more data there are, the more insights we can glean.

When enough Big Data are available, the insights we will be able to make are beyond comprehension.   It is already transforming how we think of health and public health and it will continue to revolutionize healthcare for years to come.


Magdi Stino, Health Policy PhD Candidate


The Reference Product Strikes Back

A lot of consideration has gone into biosimilars and what they mean for the biologics drug market. The idea behind biosimilars is that they will reduce costs by providing cheaper alternatives to existing biologic drugs. As mentioned in previous blogs however, biosimilars are by no means a cheap and simple cure to high drug costs. There are several road blocks like high production costs and long periods of development biosimilars must face on the way to the market place. These road blocks cut into the discounts biosimilars could offer. This leaves a unique opening for reference products. Reference products could lower their prices slightly and make the discounts offered by biosimilars not worth the risks of adoption.

Imagine a biologic called Reference Product 1 which costs patients and insurers $10,000 a year. Now imagine a biosimilar called Biosimilar 1 comes along and costs patients only $8,500 a year. This is a 15% reduction in cost which is a fair estimate of the discount offered by biosimilars. Depending on the patient or insurer, this reduction in cost may be enough for Biosimilar 1 to be preferred over Reference Product 1. Now imagine that in response to Biosimilar 1, the manufacturer of Reference Product 1 lowers the price by $1000, resulting in a sales price of $9,000This means that patients and insurers are only saving slightly about 5% over what they would spend with the Reference Product 1 if they use Biosimilar 1. In this situation, a comparison must be made between saving 5% or sticking with an original product that has been both studied and used more. Sure some patients will elect to use the cheapest possible alternative but others will pay the higher price for the tried and true product. This could create a situation where the manufacturers of the biosimilar is forced to raise prices or take their product off the market.

Manufacturers of biosimilars must rely on an economic principle known as Economies of Scale in order to compete with the manufacturers of the reference product. The idea of Economies of Scale is that increasing the quantity of the product will decrease the per unit cost of making it. Biosimilar 1 has fixed costs for producing it like the costs of factory and equipment. These fixed costs are spread out more by producing a larger quantity of Biosimilar 1. Once enough patients use Biosimilar 1, the costs of production lowers enough to make the biosimilar profitable for the manufacturer. If the manufacturer of the reference product lowers the price and keeps patients from using the Biosimilar 1, then the sale of the Biosimilar 1 will not be profitable. This is particularly true for biosimilars targeted at small patient populations. In this environment, a smaller number of patients would make up a larger percentage of the   population. Therefore, the manufacturers of the reference product would not need to keep as many patients in order to hurt the profitability of the biosimilar.

This does not mean that there is no room for biosimilars in the biologics market however. Some biosimilars will be priced at a greater discount than the 15% mentioned earlier. These biosimilars may bring prices down low enough that reference products could not compete. Also, biosimilars do not have to be made by competing manufacturers. It may be that manufacturers of reference products will also make biosimilars to their own reference product. These manufacturers already have the equipment and expertise necessary which means production costs would not be as great. In this scenario the biosimilar would not have to deal with competition from a reference product since it is being made from the same manufacturer. In conclusion, biosimilars are not necessarily going to wipe out reference products once they hit the market. In some instances, the reference product may still have a competitive advantage over the biosimilar despite higher costs. Biosimilars will almost guarantee that prices for reference products will come down if only just a little.


Robert Bond, PharmD '18


Biosimilars and P&T Committees

Imagine that you are on an APPE rotation at a local managed care organization (MCOs) and your preceptor asks you to research a medication that is being considered on the Pharmacy and Therapeutics Committee (P&T Committee). Because P&T Committees are inter-professional committees designed to consider whether to add a new medication to a formulary, you as a student pharmacist are expected to find information to help make that decision. Since pharmacists are expected to speak the language of business and science, your research must cover a broad area. As you begin to research the medication, you notice that it is a biosimilar to a reference drug the hospital already carries. With biosimilars still new to the United States and only a one or two examples to learn from, your research becomes more challenging than you had expected. This scenario will be a reality for many student pharmacists as the number of biosimilar continue to increase. This blog will address some of the new considerations health care providers need in order to appropriately integrate biosimilars to their practice.

The first of these considerations is the savings that a biosimilars will bring to the MCO. The way to go about understanding this is to see where it will stack up in the Medicare Part D Formulary Tiers. This system is used by Medicare to represent how much the beneficiary will pay for a drug. Drugs in the lowest tier are preferred generics which are the least costly. Drugs in the highest tier are typically specialty drugs which are the most expensive. Since biosimilars cannot go through the more direct pathway that generics use to get to the market, they will most likely be placed in a higher tier than generics. With that being said, biosimilars are not starting completely from scratch like reference drugs meaning that they will be on or below the reference drug’s tier. It is therefore reasonable to assume that the lowest tier a biosimilar will reach is the second tier. This is preferred brand tier which is in the middle of the pack in terms of cost. Since reference products could be placed in tiers two through five, the saving a biosimilar could offer will vary.

The next step in determining whether or not to add a biosimilar to a formulary is to anticipate what challenges the biosimilar could face. Suppose the biosimilar you are researching has fewer indications than the reference product. This means that while some of your patients may be placed on the lower cost biosimilar, other will still require the reference product. If that is the case, then the formulary will still require both the biosimilar and reference product be available in the pharmacies which will increase costs. The costs of still carrying the reference drug in the inventory may offset any savings. Another consideration is whether or not the biosimilar will face shortages. Biosimilars are not equivalent to one another in the same sense as generics. This means that if there are two biosimilars to the same reference product and one of them becomes available, a pharmacy cannot automatically switch to the other. P&T committees must account for this when they select a biosimilar and understand that shortages may create costs which again offset savings. These are just two examples of unique issues that must be thought about with biosimilars.

Of course, biosimilars will still have many similarities to other drugs in the context of a P&T committee. Considerations like available dosage forms, medication safety, pharmacokinetic profile will be examined like with any drug. As medication experts who are knowledgeable about the science and business of drugs, responsibility is likely to fall to the pharmacist to bring these new considerations to the table.

Robert Bond, PharmD '18


PCP Student Receives Travel Grant for National Conference

Christina Ly- Professional PictureChristina Ly PharmD’17 was one of only four students selected nationwide to receive a travel grant worth up to $2,500 from the American College of Apothecaries (ACA), International Academy of Compounding Pharmacists (IACP) and American College of Veterinary Pharmacists (ACVP) Foundations. Ly received the award at the 2016 ACA/IACP/ACVP Educational Conference held from February 24-27, 2016, in Coronado, CA.

The Educational Conference is a joint endeavor by the three hosting organizations, ACA, IACP, and ACVP. The conference provides continuing education sessions to pharmacists and pharmacy technicians that are focused on topics related to independent pharmacy, pharmaceutical compounding, pharmacy law, and veterinary pharmacy. In addition to attending educational sessions, travel grant winners have the opportunity to attend an association board meeting and network with working professionals from across the country. Information on the Educational Conference can be found at www.educationalconference.org.


Introduction to Biosimilars

As clinical guidelines are published and the pharmaceutical industry innovates, the practice of pharmacy changes. At the fore front of innovation is the biologic. These medications are capable of achieving clinical outcomes that traditional small chemical medications cannot. Biologics are not without disadvantages. In addition to being more challenging to create, these medications are also orders of magnitude more expensive. This cost has kept biologics as an alternative or not even an option to patients who would greatly benefit from their use. In order to solve this issue, the pharmaceutical industry is developing biosimilars, or medications that are similar to existing biologics and are offered at a lower cost.

Most medications that are found in a pharmacy are small molecule products. These drugs are synthesized chemically and have been relatively cheap to produce. When a small molecule drug is first offered on the market by a single proprietary manufacturer, they are known as brands drugs. The costs of these products are typically high for a regulated period of time, that proprietor is the only entity legally allowed to produce that drug. This creates a temporary monopoly, allowing the proprietor to sell at a price with no competition. After that period of time is up, other manufacturers are allowed to create what is known as generics. This system of proprietor creation and then generic competition is regulated by the Hatch-Waxman Act. This legislation has two goals. The first is to create an incentive for new drug creation by allowing innovator manufacturers enough of a monopoly to make a profit despite high research and design cost. The second is to lay down a framework where generics can come in and make prices reasonable for patients. When both goals are met, a balance is struck between continuing innovation and low drug costs. Hatch-Waxman has created a model that works well for the brand-generic model which for the time being describes the inventory of most pharmacies.

For biologics, this model cannot be applied. The reason for this difference is due to the method of how biologics are synthesized. Biologics are made from genetically engineered cells. These cells then create proteins which are then isolated. As you can imagine, this process is much more complex and difficult. The process for engineering these cells may be trade secrets which means non-proprietary manufacturers must come up with a different way to arrive at a similar protein. The fact that the active pharmaceutical ingredient is a protein makes replication more challenging for non-proprietary manufacturers. A protein’s function is in part derived from its tertiary structure, the way in which the protein is folded. Slight alterations in the amino acid chains which make up the protein could alter tertiary structure and therefore alter is function. In other words, the creation of generics for biologic proprietary medications are nearly impossible.

This is where biosimilars come into the picture. Biosimilars are highly similar medications to a reference product. A reference product is like the brand product of the original model. The sponsors of the biosimilar must go through a new legal route before they can market the product. Thus far, that legal pathway has been through the Biologics Price Competition and Innovation (BCPI) Act. This act is designed to work similarly to the Hatch-Waxman Act. The BCPI is not the complete story however, leaving the path biosimilars must go through unclear. The amount of research needed for a biosimilar and the time that it will take to develop a biosimilar for example are still unknown.

In conclusion, biosimilars are medications that are clinically similar to proprietary biologics and can be produced and sold at a lower cost. Due to the complex nature of biologics themselves, biosimilars will not be the new generics but could lower health care costs and bring innovative pharmacotherapy to more patients.

Robert Bond, PharmD '18


Lowering Drug Costs and the 340b Drug Pricing Program

In order to protect patients from high drug costs, the Centers for Medicare and Medicaid Services (CMS) offers several plans qualifying patients can sign up for (more information available here). There are patients however, who are in need of federal assistance on drug costs but do not qualify for one of these plans. In order to reach some of these patients, the congress created a policy under section 340B of the Public Health Services Act. This policy is managed by the Health Resources and Services Administration (HRSA) and is known today simply as the 340b drug pricing program.

This program is aimed at the hospitals and medical centers who likely treat these underserved patients populations. These organizations are known as , covered entities.   Examples of covered entities include, but are not limited to Federally Qualified Health Centers, Ryan White HIV/AIDS program grantees, children’s hospitals and sexually transmitted disease clinics (full list found here). Patients at these facilities who qualify benefit from access to 340b covered drugs because their drug costs will be significantly less than patients not eligible for 340b drugs. These facilities will benefit because the manufacturer and wholesaler are obligated to sell these drugs at the low 340b price. These savings are typically 23.1% for brand products and 13% for generic products. Covered entities also have the ability to negotiate lower prices from those discounts which would result in further savings. These entities are then reimbursed by Medicaid at slightly higher prices which fall somewhere above the actual acquisition cost or AAC. AAC is what the pharmacy pays for drugs. It therefore factors in all sales and discounts the pharmacy may receive from a wholesaler. Medicaid may pay pharmacies at slightly higher than AAC in order to incentivize pharmacies to participate in the 340b drug pricing program.

The 340b pricing program is still a work in progress. One of the principle issues has been compliance with the program. It can be difficult for covered entities to follow the rules HRSA has established for the 340b program. Imagine that there is a pharmacy with 10 stock bottles of a maintenance drug. One of those bottle was purchased for a 340b patient at a 340b price. The challenge is ensuring that only the 340b patient receives medication from the 340b stock bottle. This becomes incredibly difficult when you factor in many 340b patients on multiple medications. If patients who are covered by Medicare or Medicaid received 340b drugs at typical prices (AWP minus a negotiated percentage) then federal resources would be spread too thin to help the underprivileged.

Fortunately, more changes are expected to occur. One change is in regard to better defining qualifying patients. With new changes, patients must have in-person medical visits with a 340b covered entity to qualify. Another example of a potential change is with manufacturers. Before any changes, the HRSA did not have the power to audit manufacturers and ensure they were proving drugs to covered entities at a discounted price. With the changes, the HRSA would be given the power to both audit manufacturers as well as impose penalties on those who do not comply with 340b regulations. These changes, when implemented, will improve 340b but more is needed for 340b to achieve its original goal of spreading federal resources to the underprivileged.

Robert Bond, PharmD '18

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