The Biosimilars Implementation Roadmap is an innovative learning tool that can help multidisciplinary cancer care teams obtain the knowledge they need to implement, expand, and sustain biosimilars as a treatment option for patients with cancer. The Roadmap will give users information about how to lay the groundwork for biosimilars, train and prepare their care team to offer biosimilars, implement biosimilars, and evaluate ongoing progress. “Expert Insights” from the Advisory Committee that informed the Roadmap give teams a deeper understanding of how biosimilars fit into their cancer program. Accompanying resources provide more information and are available in the Resource Library.
Many types of biological products are used therapeutically and for supportive care for patients with cancer. Biologics are large, complex molecules that are produced by biotechnology in a living system (for example, a microorganism, plant, or animal cell). The U.S. Food and Drug Administration (FDA) regulates and approves biological products, which include therapeutic proteins, monoclonal antibodies, and vaccines.
Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an already-approved FDA biological product (called the “reference product”). For more information, access the FDA Biological Product Definitions.
In Europe, biosimilars have been in use for more than a decade and have been shown to reduce costs and increase patient access to these products.
In the U.S., Congress enacted legislation to create an abbreviated regulatory process for biosimilars, The Biologics Price Competition and Innovation Act of 2009. With the introduction of biosimilars to the U.S. market, the hope is to produce long-term savings that can be passed on to the healthcare system and patients.
In 2015, the first biosimilar approved in the U.S. was filgrastim-sndz (Zarxio), a biosimilar to filgrastim (Neupogen), a supportive care drug used to prevent infection during chemotherapy.
In July 2019, the first two therapeutic anticancer biosimilars launched in the U.S. market. As of March 2021, the FDA has approved 29 biosimilars (not all in oncology). Biosimilars are regularly being approved by the FDA. For a current list of all approved biosimilars, consult the FDA’s Purple Book.
Although biosimilars offer potential cost savings to the U.S. healthcare system, there have been challenges integrating biosimilars into practice due to a variety of factors including complex workflows, payer requirements, provider acceptance, and market expectations. However, there are strategies the multidisciplinary cancer care team can employ—from working with payers to developing policies and procedures to incorporate biosimilars into the oncology workflow.
Rheumatology (Oxford)
"Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process… As most prescribers are not familiar with this drug development paradigm, educational programmes will be needed so that prescribers see biosimilars as fully equivalent, efficacious and safe medicines when compared with originator products."
Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN)
This publication highlights some of the potential challenges regarding adopting biosimilars into clinical practice and summarizes several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.
Biosimilars Council: A Division of AAM
"This paper addresses several misconceptions often present in a comparison of the U.S. and European markets and identifies both cautionary lessons for the U.S. biosimilars industry and lessons the United States would do well to follow."
European Medicines Agency and the European Commission
"As healthcare professionals are at the forefront of patients’ care, it is vital that they have access to reliable information on these medicines: what they are and what scientific principles support their clinical development, approval and safety monitoring. This guide has therefore been prepared with the important objective of providing healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars."
Pharmaceutics
"The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US’s latest ‘Biosimilar Action Plan’."
U.S. Food & Drug Administration (FDA)
"The searchable database contains information about all FDA-licensed biological products regulated by CDER, including licensed biosimilar and interchangeable products, and their reference products, and FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by CBER."
Practices should partner with payers to determine biosimilar preferred agents or contract to secure a favorable reimbursement rate based on the percentage of biosimilar used.
It is important to educate patients on why biosimilars may be a good option for them, how they compare to other drugs, and if there are any changes in their out-of-pocket cost.
Typically, we think of the insured patient, but we know in the real world we have underinsured patients, uninsured patients, and, in my practice, we have international patients who are self-pay.
Biosimilars mean something very different for all of these groups in terms of their specific financial responsibilities regarding these treatments. However, in my experience, patients have responded positively to the biosimilar option, given the cost savings associated with it.
Providers should place greater focus on net cost recovery rather than actual invoice price when considering which biosimilar makes the most economic sense. Each manufacturer selects a different approach when building contracts with providers and group purchasing organizations (GPOs).
Some manufacturers provide upfront discounts in the form of an off-invoice discount, and others use back-end rebates. Some are a flat rebate and others are tied to individual performance tiers or GPO aggregates. Focus on net cost recovery factors in invoice price, all rebates, and expected payer reimbursement.
Providers must also pay close attention to average sales price (ASP) trends for each biosimilar, as some manufacturers do a better job at protecting ASP, which leads to better reimbursement trends over a longer period.
All practices are going to have a managed care component. It varies by practice, but every practice needs to have an optimal managed care contract. It is important for each service line leader to understand the stipulations of the payer contracts to maximize value-added care and payer restrictions.
It is important for practices to understand what their expected contractual is for each payer and how that is impacted. Many payers are following Medicare’s pricing structure, so there is more benefit to using biosimilars and then adding the rebate on the back line. However, underpayments can happen if you do not have someone tracking and following up on rebates. There are new analytics and tools available to practices to help track rebates and ensure net cost recovery.
Authorization is the same as it would be for an originator product. It is important to know that every biosimilar has a different HCPCS code, which is then linked to a medical policy most of the time.
It is important for your support staff to know they need to get a prior authorization for this particular code, which aligns with the product the patient will ultimately receive, so they match on all fronts.
It is critical to communicate with support staff. For example, if there are six biosimilars for an originator product, each biosimilar has its own authorization code.
Our EMR creates a super bill. We can look at the bill as we are working on a prior authorization. This helps make it easy for us.
If a practice chooses to switch a preferred product and convert a patient from one to another, a new prior authorization has to be obtained. It is important to make sure your team is aware of this. While it may take a little more work, you are ensuring the patient is first.
Biosimilars are considered innovator products in the eyes of the Centers for Medicare and Medicaid Services (CMS). CMS reimburses biosimilars at a different percentage than their originator competitors.
In a situation in which a singular active ingredient has multiple biosimilars (e.g., rituximab/trastuzumab), your “preferred” agent may be very much driven by pass-through status designation.
It is important to understand the reimbursement rate of each biosimilar product compared to their reference products. Biosimilars have different billable units from their reference products, making their rates sometimes difficult to understand. It is important to keep track of the billing code, the billable unit, and the reimbursement per unit.
The important thing to keep in mind is each biosimilar has a specific code. But when a new biosimilar is introduced, the reimbursement rate for that product is going to fluctuate a lot in the beginning or until an established ASP and Q code is available for the product.
Many practices offer biosimilars when the payer requires it, which may be different from a practice that endorses and prefers a biosimilar. There is still a lot of addressable opportunity when it comes to uptake of biosimilars.
My previous practice saw the value in biosimilars early on and chose to pursue the initiative on our own time, rather than waiting for the payers to force us to change. We were proactive and began working with payers by agreeing to managed care contracts, which showcased our value proposition to patients. By approaching it this way, we were able to change market share to more than 75 percent biosimilars within a couple quarters.
Practices need to be clear on what they are trying to pursue. We dispense biosimilars because we believe the patient deserves access to lower-cost alternatives, since we have a lot of new high-cost drugs coming to the market.
From our institution’s perspective, it was important for leaders to see the potential cost avoidance with biosimilars and get a firm understanding of what a biosimilar is.
Once we had the initial buy-in, we then proceeded to strategize on who needed to be involved to help make the rollout as smooth as possible.
For us, it was a pharmacy-led initiative, but the bullhorn was a physician-champion. We internally discussed who would be the best champion. We decided it was important for the champion to be a person the practice trusts and who knows how to communicate with other providers who may be hesitant to use biosimilars.
Ours was co-led by our practice president and medical director, and they worked in tandem with the pharmacy.
We identified five physicians who were previously reluctant to adopt therapeutic interchanges, updates to doses, or laboratory monitoring.
We visited with those five physicians early on and determined what would be needed for biosimilars to be successful and create buy-in. This gave us plenty of time to engineer a program, which was well-suited for the entire practice.
Sometimes we do not always realize all the people who need to be involved when it comes to implementing a new initiative like this. People you will need to engage with may include nursing staff, electronic medical record managers, finance staff in terms of insurance compliance, and people from the external companies you may want to partner with. It is important to first identify all key stakeholders and then list them to make sure you have all the right people in place.
Biosimilar implementation is creating change for everyone. So it is important to engage all your stakeholders to be able to successfully introduce biosimilars to your practice.
Suggested list of stakeholders to implement biosimilars:
"The FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. This website provides information, resources, and educational opportunities for providers and patients."
Each person is influenced by different factors. It is important to determine what drives each of your stakeholders. What makes them spend five more minutes in their day doing a task or going that extra mile? What will give them satisfaction to participate?
The U.S. is moving to value-based care, which calls for us to become low-cost providers within our managed care plans. Our contracts and governmental payers are aligning their incentives with our ability to provide lower-cost care.
So, do we want to be about the future? Do we want to begin to develop the muscle to provide value-based care and know we are positioning ourselves for success in the future?
Biosimilars are another tool in your toolbox for patients, and they are not going away. Payers will start requiring them. So let’s take the opportunity to prepare and do it on our own time, which will lead to greater success.
We can either drive the train, or it is going to be driven for us. We can get these changes in place over the next few months, or we can be in a scenario in which we need to do something by next week.
Most important, patient safety is critical in administering these drugs. If they are not loaded into the system or are not appropriately attached to certain regimens and protocols, you run the risk of giving a patient the wrong biosimilar.
Finally, decisions are being made with the hope of staying with a regimen for a few quarters or a year—we will not be requesting changes every single quarter.
Depending on the size of your practice, it is helpful to have a dedicated task force to consistently look at reimbursement, patient satisfaction, provider satisfaction, nursing complaints, drug waste, errors, and upcoming changes to provider or payer contracts.
Once you embark on the initiative, it does not stop. It is helpful to have a standing group in place so your initiative is sustained after launch.
One up-front expense is refrigerator space. You must have dedicated, physical locations in which to store biologics. The overwhelming majority of biosimilars require refrigerated storage (e.g., three shelves of trastuzumab or three shelves of pegfilgrastim, which take up space).
Refrigerated storage space was the one thing we could have done a better job of planning for on the front-end.
Proper inventory management including separate storage or labeling to prevent an inadvertent mix-up when pulling a product for preparation is critical.
Assessing your EMR customization capabilities at the start is very important for maximizing efficiency. Having your preferred drugs auto-substituted can make your provider and clinician workflows more efficient by saving time, emails, and phone calls for approvals.
This publication highlights some of the potential challenges regarding adopting biosimilars into clinical practice and summarizes several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.
Before implementing a new initiative, it can be helpful to conduct an organizational readiness assessment. There are frameworks, tools, and resources available that you can adapt to your organization’s assessment needs.
"This white paper is a guide for all leaders interested in understanding the underlying psychology of change and leveraging its power to impact quality improvement efforts: to achieve breakthrough results, sustainably, at scale."
"Sustainability in healthcare or clinical settings is affected by many organizational, financial, regulatory, and political factors. Understanding these factors can help stakeholders build capacity to sustain a clinical practice and position their efforts for long term success."
"A comprehensive, practical guide for health care practitioners and researchers to plan and deploy methods to support uptake of effective practices in routine care settings."
"Use these worksheets as a starting point for thinking through your PSE change strategy or as a brainstorming tool with your team members."
Prescribers are key to patients’ usage of biosimilars. Prescribers educate patients about biosimilars and help build trust about their use.
Prescribers also advance the use of biosimilars in their practice—there must be buy-in for biosimilars to be successful. Prescribers determine the course of therapy and whether a biosimilar is appropriate for a patient.
U.S. Food & Drug Administration (FDA)
"The FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. This website provides information, resources, and educational opportunities for providers and patients."
Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN)
This publication highlights some of the potential challenges regarding adopting biosimilars into clinical practice and summarizes several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.
U.S. Food & Drug Administration (FDA)
"Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. This website provides helpful information for patients about biosimilars."
The role of Advanced Practice Providers (APPs) will differ from practice to practice. However, APPs need to be aware if their practice has a preferred agent within a class and be involved in the discussion about processes and procedures, particularly if they are going to prescribe biosimilars.
The other important piece is patient education. Make sure upfront that APPs are discussing biosimilars with patients. That is the key to success.
U.S. Food & Drug Administration (FDA)
"The FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. This website provides information, resources, and educational opportunities for providers and patients."
Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN)
This publication highlights some of the potential challenges regarding adopting biosimilars into clinical practice and summarizes several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.
U.S. Food & Drug Administration (FDA)
"Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. This website provides helpful information for patients about biosimilars."
Pharmacy plays a key role in operations and safety—from storage to how to order, to patient education, to billing.
At our practice, we have an agreement in place in which pharmacists can make changes for our providers if a provider has expressed their preferences upfront. So when the payers come with the mandated switches, the pharmacists can make the changes in the EMR, update the treatment plan, and send it to our operations team.
Pharmacy needs to take a front seat in creating the therapeutic interchange policy and procedure so it aligns and fits into the workflow. Each practice can take a different approach, but it is important to understand these products are AB Rated. You do not have state laws in place like you do for brand generics. You need exact wording within a policy, which gives pharmacy the ability to adjust products based on practice preferences.
At my institution, the pharmacist also serves as an educator for our patients, particularly when patients have questions about why their insurance now requires them to use a biosimilar.
We are the ones who generally get a phone call from the nurse saying a patient has concerns. We have the background information after working with our prior authorization team to explain why there is a switch in case a patient was not aware of the change on the front end.
U.S. Food & Drug Administration (FDA)
"The FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. This website provides information, resources, and educational opportunities for providers and patients."
Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN)
This publication highlights some of the potential challenges regarding adopting biosimilars into clinical practice and summarizes several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.
U.S. Food & Drug Administration (FDA)
"Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. This website provides helpful information for patients about biosimilars."
Pharmacy admixture technicians need a firm understanding of the fact that even though these agents have similar active ingredients, they are not interchangeable and need to be treated as unique agents.
Pharmacy admixture technicians should help ensure proper inventory management, including separate storage or labeling to prevent an inadvertent mix-up when pulling a product for preparation.
U.S. Food & Drug Administration (FDA)
"The FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. This website provides information, resources, and educational opportunities for providers and patients."
U.S. Food & Drug Administration (FDA)
"Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. This website provides helpful information for patients about biosimilars."
Nurses should be educated about the purpose of biosimilars. Subsequently, nurses should be able to educate their patients about the importance of biosimilars and build trust with patients regarding biosimilar use.
U.S. Food & Drug Administration (FDA)
"Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. This website provides helpful information for patients about biosimilars."
U.S. Food & Drug Administration (FDA)
"The FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. This website provides information, resources, and educational opportunities for providers and patients."
Practice administrators often oversee patient financial counselors, so they need to understand prior authorizations and the workflows necessary to properly gain approval if or when an interchange occurs.
U.S. Food & Drug Administration (FDA)
"The FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. This website provides information, resources, and educational opportunities for providers and patients."
Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN)
This publication highlights some of the potential challenges regarding adopting biosimilars into clinical practice and summarizes several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.
U.S. Food & Drug Administration (FDA)
"Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. This website provides helpful information for patients about biosimilars."
Insurance/billing staff should:
The Controller usually presents to the Board of Directors and the Finance Committee; therefore, controllers need to understand the broad initiative, the expected rebates, how ASP applies, and what trends are being seen with payers and step therapies.
The role of financial navigators can vary, but they may:
As a financial navigator, if I see something during prior authorization that may be less expensive for the patient, I alert the care team. But ultimately, it is up to the physician to do what they think is best for the patient.
U.S. Food & Drug Administration (FDA)
"Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. This website provides helpful information for patients about biosimilars."
U.S. Food & Drug Administration (FDA)
"The FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. This website provides information, resources, and educational opportunities for providers and patients."
Our process was a six-month lead-in with education and regular small group planning meetings. While our initiative was pharmacy-driven, our physician champion was the face of the initiative. We assessed and planned for how and what patients were going to be told about biosimilars and potential costs.
Six months may seem a little bit long, but we knew biosimilars were here to stay, and we wanted the initiative to be as successful as possible.
From an organizational standpoint, when we started out, biosimilars were a pharmacy-led effort. However, we partnered with the chief medical officer who met with a variety of groups across the hospital and asked about any concerns and anticipated barriers that could prevent us from being successful. We used that information to inform our planning and implementation efforts.
It is crucial to engage and educate individuals working in prior authorization and financial counseling. Individuals working in prior authorization need to understand biosimilars are not generic medications. Each biosimilar has a unique J or Q code. The prior authorization team must know there cannot be a same-day change. Biosimilars are not interchangeable.
Our physicians were getting inundated with messages saying, “This patient is only eligible for this version of the biosimilar.” Every single time their answer was, “Okay, just make it happen.”
To help streamline the process, our Pharmacy and Therapeutics (P&T) Committee and medical executive approved an auto-substitution policy. This eases the burden on physicians and allows the prior authorization team to interface directly with pharmacists.
Our pharmacists essentially act as scribes, getting everything changed and making sure the orders are accurate and safe on behalf of the prescriber. The pharmacist then tees it up for the prescriber to sign the orders.
It is important to note that our auto-substitution policy is worded very strategically so the prescriber does not need to be involved if it is a biosimilar product for a reference product, and the patient’s insurance will cover it.
You must have individuals in operations and executive leadership involved. You need people who are working with the insurance providers, staying on the pulse of Medicare, Medicaid, and the top three commercial payers so the practice knows what the requirements are ahead of time and can be responsive instead of reactive.
It is important to stay up to date on payer fee schedules, manufacturer contracts, rebate tiers, out-of-pocket costs for patients, and ASP changes so these things can be part of the discussion.
From an operation’s perspective, there are several key components, which must be in place:
We have four individuals on the authorization team right now for a 14-prescriber practice. At this point, we do need to recruit for a medical coder who is devoted to our service line to follow up on reimbursement claim denials. As the chief of pharmacy, I have three other pharmacists who report to me. So those are just some ballpark numbers as far as what has worked for a practice of our size.
My pharmacy team looked at maximizing drug rebates from manufacturers through our GPO, reducing errors, and making things more efficient at the clinic level. We took the sole lead, so nurses could be nurses and providers could be providers.
Then, we were able to use it as leverage to get more pharmacists and technicians, and we just started to watch the net cost recovery climb.
Ongoing internal communication and education are key. It is important to establish good patient/provider communication regarding biosimilars. This has been by far the biggest factor in our success or lack thereof, in some cases.
When a patient hears the term biosimilar, they equate it with a generic, which equals inferior. It is important to make sure there are processes in place to ensure conversations are taking place, and providers are prepared for sometimes difficult conversations.
In our experience, the best person to relay the message about biosimilars to the patient is the provider, because of the established relationship they have.
Based on hiccups that I have run into, it is important to have the physician champion or executive director for your practice sit down with a leader in finance.
The finance leader needs to communicate to finance staff that it is very important to involve pharmacy when a denial that you cannot easily figure out comes in. Let pharmacy look at it and see if something needs to change in the workflow.
In our practice, decisions are led a lot of times by the payer (e.g., when they tell us there are agents they prefer over the reference product). We then reach out to the provider and our specialty practice pharmacist.
We have an agreement in our practice in which specialty practice pharmacists can inform physicians of the options, and then the pharmacists will go in and make the appropriate changes in the system. From there, the provider communicates with the patient about the use of a biosimilar.
When we have mandated switches or know of upcoming switches, we use our EMR to identify patients on the reference product who need to be switched to the biosimilar. Then we make sure the education happens.
We try and take a very proactive approach to the prior authorization process.. The prior authorization team will also identify patients who are eligible for conversion to a biosimilar if they were missed in the initial conversion effort.
For infusion centers or practices that are part of a healthcare system, determine if the healthcare system has preferred drugs. There are instances in which different parts of the same healthcare system go against one another in terms of what their preferred drugs are, even when they share the same EMR.
So if your center or practice is part of a larger institution or healthcare system, it is important to involve leaders early in discussions about biosimilars, especially regarding preferred drugs.
"Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. This website provides helpful information for patients about biosimilars."
"The FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. This website provides information, resources, and educational opportunities for providers and patients."
It really starts with your payer landscape and involving your practice’s dedicated representative who is responsible for contract negotiations. Reach out to the payer and say, “If we use this, we can save you X amount. So please make that drug tier one.”
We have been successful in engaging the manufacturers of a particular biosimilar—which we see as the most cost efficient for our team—to work with the insurers in our region to become a tier one agent. This approach has been more successful than going to the insurer as the negotiating party.
We have had success working with manufacturers’ access and reimbursement side. They can provide support to your billing teams. So if you do encounter issues (e.g., step therapies or denials) sometimes it is quick and easy to reach out to the manufacturer for help.
Manufacturers can also help with copay cards or providing access to indigent patient populations to take some of the burden from the authorization/finance team to get their product covered.
There are a variety of methods you can use to evaluate your initiative, but it is important to have a written plan to guide your evaluation.
"This framework is a practical, nonprescriptive tool, designed to summarize and organize essential elements of program evaluation."
This worksheet can help you develop and guide your PDSA cycle.
This websites provides key elements of an evaluation plan, which can help guide your evaluation efforts.
As you develop your project plan, make sure you have accounted for the following:
I would take a stepwise approach to determine what biosimilars to offer. I would review:
The first piece is to develop a policy that allows you from a medical and legal perspective to have your team covered and protected when they interchange on behalf of the prescriber. Then, get your policy (e.g., therapeutic interchange or auto-substitution policy) approved through your medical executive committee.
Pinnacle Health Hospitals
It is good to have a ratified policy that outlines the approach to reviewing biosimilar medications for formulary consideration. This policy is an example from a hospital based practice.
After your policy is in place, the next step is to create a standard operating procedure (SOP). A suggested SOP would be:
You will also want to create an internal pharmacy department SOP, which details all the steps pharmacy will need to take. Having these SOPs in place really keeps things smooth, the workflow moving, and everyone happy.
When you start the conversation with the patient, do not use a biosimilar’s brand name. Instead, set the stage broadly. Make sure any paperwork that must be signed by a patient is as overarching as possible. So when you get to the prior authorization step, and if the biosimilar has been switched, you do not have to start the process over, which can lead to delays.
Determine if your EMR has a function that can determine which insurance plan has preferred biosimilar agents (not all insurance payers have the same preferred biosimilar).
Enter into your EMR any order sets or order forms with your institution’s preferred agent(s). It helps take the guesswork out of it for providers and saves time.
For our order sets, our default is the preferred biosimilar product when possible. Also, wherever there is a guideline, we put the biosimilar into the order set.
This is a very tricky conversation to have with patients. We developed a document/communication tool that encompasses the most important information we felt needed to be relayed to patients. Patients receive this information prior to their next appointment, at which time they would receive said biosimilar. We send this document through the patient portal.
Penn Medicine
A document/communication tool developed by Penn Medicine that encompasses the most important information they felt needed to be relayed to patients prior to their next appointment at which time they would be receiving a biosimilar. This document is also sent through the patient portal.
We start patient education in the waiting room. We post signs, essentially in every examination room. We have leaflets in the waiting area. We use resources that are readily available and patient-friendly (for example, using the language the FDA uses). This helps make the conversation much easier for providers when they bring the topic up for the first time. It also helps nurses and the pharmacists who are doing the education side of it.
We have a biotherapy/chemotherapy class every patient must graduate from before they begin treatment. So when a patient is scheduled to take a biosimilar, we let them know in class.
U.S. Food & Drug Administration (FDA)
"Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. This website provides helpful information for patients about biosimilars."
Cancer Support Community (CSC)
This quick video explains what biosimilars are and how they are being used to treat certain types of cancer.
American Cancer Society (ACS)
This website provides information to patients about biosimilars and the FDA approval process.
There can be a variety of challenges when it comes to biosimilar implementation, but I think a solution is being very proactive with your managed care committee and working with the payers and the PBMs to talk about the value proposition (i.e., how the practice is decreasing cost of care) and working with the payer to have a choice. However, if that approach does not work, leverage your billing and revenue cycle team to help implement process changes quickly.
It is important for practices to be heavily engaged with their managed care team. They need to understand why the practice is not agreeable to white bagging, why the practice wants to keep patients in the practice for treatment, and what various payer issues are and can then negotiate with the payer. Be clear on why this is important: safety of the patient, integrity of the practice, and the integrity of the licensure for both providers and pharmacists.
This publication highlights some of the potential challenges regarding adopting biosimilars into clinical practice and summarizes several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.
We are fortunate to have a P&T subcommittee devoted solely to oncology issues. We have a standing biosimilars agenda item during our monthly subcommittee meeting. So we have hardwired dedicated time each month to make sure we are having this conversation and addressing related issues.
It is helpful to evaluate your initiative so you can not only track progress, but also identify areas where you need to improve. Ideally, you should start planning for evaluation when you start developing your initiative. It is important to identify baseline data (if any are available), establish your aim(s), develop metrics to measure your success, and identify the types of data you will collect.
Below are suggested metrics and outcomes to measure as you implement and evaluate your initiative:
Mountain-Pacific Quality Health
This worksheet can help you develop and guide your PDSA cycle.
Agency for Healthcare Research and Quality (AHRQ)
This websites provides key elements of an evaluation plan, which can help guide your evaluation efforts.
Once you have specified the objective of your initiative and identified outcome metrics that will help you know if you have met your objective, an evaluation plan will help you strategically capture, review, and share your progress. Your evaluation plan should include:
Quality improvement is iterative, and evaluation should be as well.
Be sure that your evaluation plan is feasible. Ask yourself if:
Transparency in quality improvement builds trust and confidence among patients and members of the care team. Consider:
This websites provides key elements of an evaluation plan, which can help guide your evaluation efforts.
Funding & support provided by Pfizer, Amgen, and Coherus.
