 benefit managers (PBMs) and community oncologists has not been an easy one. With the increasing prevalence of oral oncolytics, PBMs and community oncologists have seen a concurrent increase in their mutual interaction. Each can rail against the other, claiming better, faster, and more cost-effective care, or community oncologists can find a way to co-exist with and manage PBMs in a manner that would benefit patients and their practice.

In many areas of medicine, the role of PBMs is established. PBMs can be a beneficial part of the patient care team, especially for chronic conditions such as hyperlipidemia, hyperglycemia, and hypertension. However, the role of PBMs in cancer care is less clear. For acute, severe, and often life-threatening conditions like cancer, the community oncologist is better able to provide the intense, rapid-response, personalized, and familiar care that is necessary.

Adverse reactions and dosing refinements are common in oncology care and require prompt attention by someone familiar with patient history. PBMs do not have access to patient medical records and are, therefore, hampered in their ability to understand and resolve problems. In contrast, community oncology pharma- cists and pharmacy technicians, working under the supervision

of their community oncologists, have access to patient medical records and are familiar with the 50-plus oral anticancer agents, the most frequent and expected reactions, and the most prompt and effective response.

Community oncology-based pharmacists, pharmacy technicians, and oncologists know their patients and the drugs in ways PBMs do not. PBMs are very much on board with dispensing many drugs, but they may have less experience with the more varied and critical care cancer drugs. PBMs are well-suited to manage the orals process, to adjudicate claims, and to manage the process of obtaining drugs, but they are not experts in determining drug access options.

During traditional chemotherapy, patients are very closely monitored by clinic staff —from the lab technicians, pharmacists, pharmacy technicians, nurses, nurse practitioners, and chemotherapy nurses to the physicians. This changes with oral drugs, placing a much greater responsibility on the pharmacist and pharmacy technicians.

In most practices, it is the responsibility of the dispensing pharmacist, lab technician, and oncologist to manage the patients receiving oral chemotherapy. These chemotherapy agents often carry the same risks and reactions as an intravenous chemotherapy agent. In the absence of a linear connection between dispensing and patient management, there is a disconnect that affects treatment, compliance, outcomes, and the cost of care for patients.

It is not only the standard of care, but also required by law in most states, that the dispensing pharmacist, pharmacy technicians, and oncologists are responsible for patient education and management. For oral cancer drugs, this includes dosing plan explanation (eg, should the drug be taken with or without food, drug storage and handling, possible adverse reactions, how to mitigate those reactions, monitoring compliance, and when to provide medical intervention). Based on their knowledge of the agents, community oncology pharmacists and pharmacy technicians are prepared make recommendations to the oncologist for OTC medications or supportive care medications that can ameliorate common reactions, such as diarrhea or skin toxicities, rather than discontinuing treatment. They are familiar with options such as dosing changes and/or drug holidays, and they recognize signs of toxicity and know when lab testing, in-office hydration, or other supportive care may be warranted. Recognition of these signs can avoid disruptive occurrences, such as trips to the emergency department.

Community oncology-based pharmacists, pharmacy technicians, and oncologists have access to patient records and can more closely monitor patients which empowers them to provide the most coordinated care. These tools are not available to anyone outside the practice, including PBMs.

Patients receiving their oral drugs from a community oncology practice have access to those drugs within 24 hours of prescribing, and they begin treatment immediately. Patients receiving their oral cancer drugs through a PBM, on the other hand, often have a much longer wait, sometimes 14 days or more. Common causes of delays include:

		More complicated or cumbersome internal PBM protocols that require more time to process a prescription

		Multiple back-and-forth conversations between the PBM and the practice

		Time needed to confirm and re-confirm patient information, including addresses and insurance coverage, as well as additional information requests

		Transferring prescriptions for processing between facilities for actual dispensing

Some PBMs force patients currently receiving their oral drugs from the community oncologist to switch to pharmacies that the PBM owns. However, PBMs are often disconnected from the patients and may invoke internal systems that make presumptions about the preferred method of care and attempt to dispense drugs without evaluating what might be the best care, from the patient’s perspective.

For drug prior authorization, PBMs document all of the information necessary for subsequent prescriptions, including the physician and patient names, payer information, drug name, dosage, and authorization. Some PBMs will automatically create a prescription and fax it to the physician. Without scrutiny from the oncologist or staff, patients may be directed away from the practice’s pharmacy.

Physician dispensing has become increasingly popular in the United States and has expanded to include a variety of medications in both the retail and specialty spaces. This growth in popularity has largely bene ted overall patient care. William Shell, MD, in 

, reports that patient compliance with drug therapy is 60% to 70% higher from a dispensing physician than a pharmacy.

Patients cannot be compelled to fill their prescription from a specific dispenser; however, many report receiving correspondence from their PBM that implies they must use a pharmacy owned by the PBM. These letters often explain that the insurance company has its own pharmacy, from which the patient may already be receiving other prescribed drugs, and offer for the patient to also get their oral cancer drug from this same source. Many patients find this confusing and do not understand the repercussions that jeopardize the monitoring, care control, and care management that they receive at their community oncology pharmacy, and they mistakenly, or unintentionally, switch their drug dispenser.

A community oncology pharmacist will recognize drugs that may be di cult to tolerate or patients whose conditions may require multiple dosing refinements. In these cases, in anticipation of modifications, practices will often dispense a 15-day supply rather than a 30- or 90-day supply. PBMs can lack the expertise for such forethought or do not have the experience with care management to know when a smaller supply might be the wiser, more economical choice. In-house pharmacies are often able to lower medication waste in cases when a patient’s drug dose is expected to be reduced or when drug tolerance is a consideration.

Although PBM problems are not guaranteed, patient care is enhanced when a practice is aware of what may happen and is prepared to handle problems as soon as they arise. Practices that have coping systems in place and have developed ways of dealing with the PBM problems can enhance patient care and avoid treatment delays.

PBMs may delay shipping a drug because they require address confirmation; they often send a letter requesting address confirmation to the very address they wish to con rm. Other times patients wait, often too patiently, for overdue drugs. Paper work problems, red tape, and conflicting or missing information are often easily resolved with a short conversation. Relatively simple problems that can cause unnecessary delays can usually be resolved just by picking up the phone.

Community Oncology Pharmacy Association Support

The Community Oncology Pharmacy Association (COPA), within the Community Oncology Alliance (COA), was formed in response to the increasing number of community cancer clinics dispensing oral cancer drugs and ancillary therapies. COPA is a nonprofit entity that has established standards; provides information, education, and resources; enhances information exchange; and advocates for the patient-centric model of integrated, high-quality cancer care. Due to the increasing costs of cancer drugs, there are commercial interests, such as PBMs and specialty pharmacies, attempting to separate oral cancer therapy from the point-of-care and oncologist control, thus interfering with the physician-patient relationship. As a nonprofit focused on enhancing patient care, COPA is in the unique position of serving as a noncommercial organization dedicated to addressing a variety of pharmacy-related issues, all in the sole interest of patient care.

COPA provides tools that can assist practices in resolving issues with PBMs and benefit patients, including:

		Letter templates when challenging, usually in cases of steering, PBM violation of the Health Insurance Portability and Accountability Act and other laws

		Access to State Boards of Pharmacy consumer complaint forms to report incidents of interference in the physician-patient relationship over drug dispensing

		Access to HHS’ Office for Civil Rights (OCR) forms to file a Health Information Privacy Complaint

Many larger practices are developing internal protocols to deal with some of the most common problems. Rapid referral systems establish procedures for follow-up—daily, when necessary&mdash;if a delay of the onset of treatment due to drug delays could be detrimental to the patient’s prognosis. Follow-up systems enable practices to track prescriptions as they move through a PBM system, avoiding potential delays and preventing intentional or unintentional poaching, trolling, or steering.

COPA has also developed a system to document incidents of PBM abuses by collecting data on PBM and specialty pharmacy-related incidents to identify trends, patient care issues, and pricing issues and to provide tools that can ensure maximum patient benefit. These data are also available to support proposed regulatory or legislative action. COPA also maintains a chronology of actual patient stories of PBM abuses. Go to 

to review the complete listing in Real Life Impact of Pharmacy Bene t Managers: April 2017, May 2017, September 2017.

Community oncologists expect their pharmacists to make sure patients have their prescribed drugs— whether from the practice or a PBM&mdash;and are fully educated and compliant and properly monitored and managed. PBMs can be both part of the problem and the solution to meeting those expectations. When they are part of the problem, community oncology pharmacists and pharmacy technicians are not alone and have tools to help them help patients. 

Ray Bailey, RPh, is pharmacy director for Florida Cancer Specialistsâ€¨and Research Institute’s clinical sites and a member of the Board of the Community Oncology Pharmacy Association.

Ricky Newton, CPA, is treasurer and director of nancial services and operations for the Community Oncology Alliance and an advisor to the Community Oncology Pharmacy Association. 

Director of Financial Services and Operations

1634 I Street NW, Suite 1200 Washington, DC 20006 

1. Shell W. The history of physician dispensing website. Complete Claims Processing Inc website. ccpicentral.com/history-of-physician-dispensing.php. Accessed August 23, 2017. 

Articles

Evidence-Based Oncology

PBMs: Their Role, the Problems, and How Practices Can Work With Them

 setting is extremely diverse and complex. Management of the many distinct oral oncolytic regimens through pharmacy dispensing platforms in clinical practice can leave gaps within the healthcare system that should be addressed. These gaps are not caused by knowledge gaps; they result from a lack of contact with consistent and updated education material that succinctly describes and explains the primary details of treatment with specific medications, including but not limited to compliance obstacles and solutions, instructions on managing side effects and major adverse effects, and expectations of therapeutic onset and duration.

To this effect, the National Community Oncology Dispensing Association, Inc (NCODA), has developed education material dedicated to the promotion of better patient care in the oncology setting. Called Positive Quality Intervention (PQI), the material is developed by NCODA members across oncology practices throughout the United States who share their best practices. With numerous therapies to cover, a healthcare team must efficiently manage and allocate resources, a task that can potentially lead to competing priorities. A patient’s attention must also be directed toward other facets of dispensing, such as financial assistance and healthcare navigation. Sharing information across the organization can help clinicians stay current and help drive positive patient care interactions. An eye on the overall health of a patient and the ability to provide affordable healthcare and patient satisfaction can push the practice of oncology pharmacy forward.

In the 2000s, approximately 20% of the cancer medications in use were oral therapies. That number has nearly doubled, with oral medications making up 40% of treatments now used in oncology, in tandem with diagnostic and surgical procedures as well as various pharmacy-driven regimens that continue to expand every day.

 Barriers to effective use of oral anticancer agents include low adherence and patient literacy. Patients are often confused with the vast amount of information they receive, right from diagnosis and initiation of treatment, and some may also be intimidated by the regimen itself. Miscommunication of therapy regimens can lead to lower adherence and reduced treatment efficacy, increased hospitalization, disease progression, and increased health costs for both the patient and the provider network.

Trying to stay up-to-date on targeted oral medications that are indicated for only certain types of rare cancer can be challenging. Each new oral agent has its own specific barriers that could lead to patients’ not being able to successfully stay on therapy long enough or not being able to benefit fully.

NCODA’s PQI is designed with both the pharmacist and patient in mind. The treatment and management of oncology patients on oral drug therapy is constantly evolving. The professionals at in-office dispensing practices are uniquely positioned to ensure appropriate treatment, increase compliance, and maximize patient health outcomes. As NCODA quality standards, PQIs are designed to operationalize and standardize those practices to achieve these positive clinical outcomes. NCODA’s quality standards, publicly available on the organization’s website,

 are built into 4 domains that work cohesively with one another to create a more standardized and effective form of oncology practice

The 4 quality standards of NCODA help drive the basis of PQI while simultaneously being influenced by the PQIs themselves. The primary components of these standards can yield improved management of oral oncolytics in patient care:

With the objective of providing exceptional patient care, in-office dispensing practices should focus on maximizing patient convenience, providing timely access to treatment, ensuring financial support, and delivering individualized patient education. Developing a strong relationship with the patient is extremely important for sustaining and growing a practice toward better patient care. This involves, but is not limited to, direct access to patients and reviewing patient therapy regimens through direct patient interaction, developing standards of practice for dispensing the medication to the patient, and monitoring overall patient safety. Consistent patient vigilance with ever-changing regimens and therapy transitions is necessary to avoid medication waste and extraneous expenses. Cost avoidance is key to any clinical practice, and by adequate resource management, practices can obtain more effective value from treatment regimens. A strong patient-centered focus can increase patient compliance and adherence to medication and result in a more persistent regimen that can have a stronger overall therapeutic response.

PQIs were developed to ensure that a patient-centric model exists at all times within the in-office dispensing setting and to improve the overall management of patients who receive oral cancer medications. Interventions made by NCODA members and professionals were created, reviewed, and implemented to increase the speed to therapy, reduce costs and hospitalizations, improve persistence and compliance, and provide a higher level of patient care.

By identifying and recommending appropriate therapy, practices face inherent challenges in keeping current with new drug approvals, new indications, and compendia/guideline updates:

		Helping to minimize and manage the toxicities associated with treatment, with the goal of keeping patients on consistent therapy as long as efficaciously possible

		Providing an efficient operation of a demanding dispensing process

		Designing medication management tools that focus on specific issues associated with managing oral drug therapies for cancer

Using the practice of evidence-based medicine, the PQIs are developed for specific medications and/or diseases and continuously guide in-office dispensing professionals in managing a patient’s drug therapy. Through PQIs, practices are able to mitigate toxicities and assist providers by highlighting appropriate drug therapy and dose based on individual patient characteristics.

PQIs involve clinical reference tools to establish an up-to-date library of education for all practices involved in oral medications for oncology. The education materials themselves, which are reviewed by NCODA professionals and archived, can be accessed and used by practices for patients at an acceptable literacy level for effective communication during the counseling phase of dispensing. These materials will be made available online as well as through monthly meetings for healthcare professionals through NCODA, providing both literary and audio support. The material also includes standards of practice for inventory maintenance for timely initiation as well as assistance in pharmacist verification and validation.

Foundational elements are established to facilitate the ongoing nature of pharmacy operational elements, which include:

		Work flow and process ow diagrams, including both single- and multisite practices and dispensing areas

		Central business office alignment, which refers to the integration of billing services and billing reconciliation

		Group purchasing organization affiliations 

		Claims accounting, which involves editing, adjudication, and reconciliation 

		Financial counseling and patient advocacy 

This quality standard interfaces with creating a proper dispensing space; a thorough communication plan involving healthcare providers, patients, and auxiliary staff; continuous quality improvement; and corrective/preventive action assessments for standards of procedure to fulfill an all-encompassing healthcare process.

Having data integrated into oncology dispensing pharmacy platforms is critical to closing the gaps in educational material and improving on the patient-centered model. The ability to closely link to prescriber-level data provides a distinct advantage in helping to manage patients and track multiple data points such as adverse drug reactions, dose changes, cost avoidance, medication waste, and therapy discontinuation. Being able to provide additional care beyond the first medication fill is crucial to creating a stronger connection to the patient and data points such as financial support and adherence rate. One of the most underused aspects of community oncology care is the vast amount of contact time with the patient involving both subjective and objective data. Tapping consistent data provides the ability to predict future trends in therapy education and management, for which NCODA can create proactive education to manage an ever-changing oncology landscape. Broadening those trends over the large network of NCODA member practices across the country can exponentially increase the speed and brevity at which best practices can be developed to suit the needs of the healthcare provider community.

NCODA is collaborating with promising health IT initiatives that will better interface with pharmacy dispensing systems to help evaluate the impact of the PQIs. Areas of interest include evaluating how long patients stayed on therapy and whether emergency department visits and hospitalizations were reduced when information written in a PQI was followed. This type of analysis will be vital in the new quality-driven positive-outcomes world. The data would be gathered across large and small NCODA practices as well as those that have or have not participated in the Oncology Care Model (OCM). Documenting a positive impact with PQIs will confirm the quality care that patients receive at oncology centers and also lend support to the in-office dispensing model.

The prospective outlook on the oral oncology space will be evaluated with future PQIs. Quantitative measurement of these early initiatives, however, may require a different outlook. We can possibly evaluate NCODA members, in both OCM and non- OCM practices, who perform best practice surveys before implementation of PQIs at a predetermined time range—for example 6 months prior to and then 2 months after PQI implementation. A comparison of practice changes can provide preliminary evidence about the impact of PQIs as well as the depth of oncology practice overall.

The PQI pipeline developed by NCODA is dictated by the reported needs of NCODA members and includes broad topics such as medication-related adverse event management. With the addition of practices in various degrees of size and scope, the network of information developed will help create standardized resources for a growing range of healthcare systems. The sharing of best practices facilitates the evolution and improvement of oncology care across the healthcare setting.

NCODA’s constantly growing list of PQIs has been addressing the following topics:

		Epidermal growth factor receptor medications

		Specific drug-based follow-up call schedule

Advancing the value of dispensing practices for oncology physicians constitutes a significant part of the NCODA mission. The need for best dispensing practices in the oncology setting is increasingly becoming apparent, and PQIs play an integral role in helping achieve this. With the PQI initiative, NCODA members across cancer centers can use their collaborative power to develop best practices that can lead to the best possible patient care.

Pharmacists, nurses, pharmacy technicians, and physicians make up the diverse group of NCODA’s membership. Each professional contributes and helps make the organization and its mission possible and successful. By creating a new type of progressive practice network focused on standardizing the oncology field, NCODA is able to prepare for the incoming wave of oral oncology medications that cover more tailored therapy regimens across a wide pool of varying patient demographics. Positive quality interventions are designed to fulfill the triple aim of improving patient satisfaction and care quality, improving the health of the overall population, and reducing the per capita cost of healthcare.

 With future data-collection methods and a pipeline of PQI creation in place, these standardized practices will help extend patient therapy and prevent loss of efficacy which will lead to better care throughout the comprehensive oncology space. 

Joshua Nubla, PharmD, is assistant manager of stakeholder engagement, National Community Oncology Dispensing Association, Inc.

Neal Dave, PharmD, is area pharmacy manager, Texas Oncology.

Michael Reff, MBA, is executive director and founder, National Community Oncology Dispensing Association, Inc; and pharmacy manager, The Patient Rx Center

Hematology and Oncology Associates of Central New York. 

An in-depth look into a nationwide collaborative initiative to standardize and improve oncology dispensing practices for the benefit of patient/provider education, adherence, and overall care.



Positive Quality Interventions: An Innovative Platform for Oncology Practice Collaboration

, when health system formularies were created, they were simply a current list of medications stocked in the pharmacy, along with some related information about each drug.

 In the 1980s, the clinical and economic value of well-controlled and managed formularies were highlighted.

 Today, Pharmacy and Therapeutic (P&T) committees are considered a critical tool for healthcare organizations to ensure safe, appropriate, and cost-effective use of pharmaceuticals for patient care. A guideline on P&T committees and formulary systems, developed by the American Society of Health-System Pharmacists, summarizes the best practices and techniques that should be implemented for optimal formulary system management.

 Policies and procedures for procuring, dispensing, administering, and appropriate utilization of medications are also included in the formulary management process.

To promote evidence-based medicine, there must be a systematic approach to the evaluation of biomedical literature and its application to clinical practice, which should be applied to formulary decision making.

 This often goes beyond the FDA approval process. The most important decision at hand for a P&T committee is the definition of a formulary drug. Typically, formulary agents are deemed urgent or used with sufficient frequency that they are stocked in the pharmacy in appropriate quantities to ensure patients have sufficient access to safe, efficacious, and cost-efficient drugs.

A formulary agent may be restricted or unrestricted, with restrictions defined by indication, service, or specialty group (eg, infectious disease); medical staff hierarchy (eg, attending only), or patient population (eg, cystic fibrosis, pediatric). Off-criteria uses of formulary agents constitute a nonformulary use. Ideally, medication utilization evaluations should be conducted on a regular basis to assess compliance with formulary restrictions. When multiple agents within a therapeutic category are available on the market (such as low-molecular weight heparins or histamine-2 receptor antagonists), drug class reviews are often conducted in an attempt to declare therapeutic equivalence and maintain only 1 preferred agent on the formulary. An increasing number of medications within a therapeutic category can lead to greater price variation among the medications, which creates potential for significant cost savings through declaring agents therapeutically equivalent and allowing them to be interchanged. 

In addition to cost savings, patient safety is enhanced by minimizing look-alike sound-alike medications through streamlined inventory and the medication reconciliation process. Minimizing the number of agents available on a formulary also improves staff competency and knowledge about specific medications. 

Selecting an agent for inclusion in a formulary requires numerous operational considerations: 

		With respect to purchasing, it is important to determine if a drug is supplied by the organization’s pharmaceutical distributors or if it is a specialty/limited-distribution drug requiring direct shipment. Not all pharmaceutical wholesalers are able to supply the drug product, particularly high-cost specialty medications. Since most pharmacy departments purchase products from wholesalers at a cost minus discount, the pharmacy will be charged a higher price if the drug being reviewed comes from another source, potentially resulting in a significant increase in drug expenditures due to the loss of the cost-minus discount. Manufacturers can switch between different distribution strategies to best fit the needs of patients and providers as the marketplace changes. 

		Drugs with a limited distribution are not shipped as frequently as deliveries from wholesalers. Under these circumstances, additional storage space may be needed, such as a refrigerator or a freezer, to ensure timely patient care. Packaging of the pharmaceuticals is also important to take into consideration, especially with increased usage of barcode medication administration (BCMA). BCMA can improve medication safety by verifying that the right drug is being administered to the right patient. BCMA technology has been proven to reduce medication administration errors.

 To ensure BCMA is being used effectively, compliance rates should be evaluated regularly and any potential barriers to compliance should be investigated. 

Often, the barrier identified is the lack of a barcode. The FDA currently requires barcodes on containers, but does not require that unit dose containers be available for all medications. Since not all manufacturers provide barcoded unit-of-use dosage forms, pharmacies are often required to prepare dosage forms through automated repackaging equipment. The barcodes are also used to ensure the correct drug is loaded into the automated dispensing cabinet (ADC) and in compounded sterile products (CSP)—all in an effort to improve patient safety. Technology-assisted CSP preparation uses computerized workflow processes that require barcode scanning of containers and ingredients. 

The stability of the CSP also plays a role in formulary management. For medications that require refrigeration, the refrigerator must be connected to an ADC on the patient care unit where the patient room is located. Ensuring there is space to appropriately store the medication is crucial; size and product classification determine storage conditions and how medications can be dispensed. ADCs ensure secure storage of drugs, but require careful inventory management so that all of the needed drugs in adequate quantities are available for patient use. Compliance with USP <800> is vital to determining what drugs can be stored in an ADC or compounded at the organization. USP <800> describes hazardous drug handling related to the receipt, storage, compounding, dispensing, administration, and disposal of both sterile and nonsterile products and preparations.

When selecting a preferred formulary agent, the cost of the drug and the reimbursement amount should also be considered. However, the cost of a drug should only be considered after its clinical efficacy and safety are established. For health systems that are 340B-eligible, providing a competitive 340B price is critical to the formulary decision. Created by Congress through the Veterans Health Care Act of 1992, 340B is a drug discount program that allows safety-net providers with large shares of low-income patients to access discounted drug pricing.

Reimbursement should also be an important consideration in the formulary evaluation. For hospitalized patients (in-patients), drugs are reimbursed as part of a Diagnosis-Related Group (DRG), so the best-priced product is the preferred product. However, on the outpatient side, the price of the product is as important as the reimbursement. With rising medication costs, pharmacy benefit managers are increasing the number of tiers in a formulary, changing co-payment structures, and dictating the brand, where, and how patients can receive their medications. These decisions often conflict with the final hospital formulary decision and require a routine audit process to compare the actual reimbursement with what was projected. Insurance companies often change their preferred formulary agent to match changes within pricing structures or rebates. 

Protocol to Incorporate Formulary Changes 

When planning for formulary additions and changes, the medication’s integration into technology should be carefully coordinated: 

		Dosage forms, concentrations, and ordering options should be limited and standardized. 

		Required monitoring for efficacy and toxicity should be built into computerized prescriber order entry (CPOE) panels or sets whenever possible. 

		If a drug is infused through a smart pump, it should be programmed with a standardized concentration and volume and the appropriate limits. 

		All formulary drugs should be available for ordering in the CPOE system, minimizing the need for verbal orders. 

In addition to the clinical and operational considerations necessary for formulary evaluation, the focus of health systems has changed. Healthcare organizations now focus on value-based reimbursement models and participating in accountable care organizations. These changes are simultaneously forcing P&T committees to change. There has been a transition to ensuring compliance with regulations and meeting publicly reported quality metrics.

 P&T committees have also expanded their focus to include the oversight of CPOE and the associated medication orders and order sets and building the necessary clinical decision support. However, the most significant change in healthcare that has impacted P&T committees and formulary management is the focus on cost containment and reimbursement while being able to provide high-quality patient care. As the healthcare payment structures continues to change, the structure and oversight of P&T committees will continue to transform, too. 

One of the most notable drivers of this change is the high cost and complicated treatment regimens of oncology drugs. It is now essential for health systems to, in addition to input from the medical staff, consider the patient mix and chief insurance provider when making a formulary decision. To make this transition, P&T committees will need to transform how they have historically conducted business. 

Traditional drug monograph reviews are solely based on safety, efficacy, and acquisition cost. After a request for formulary addition is received, the monograph is created by a clinical pharmacist and reviewed by physician stakeholders. The recommendations are often based on a published consensus statement or guideline, which may not consider the overall cost within the recommendation. In the future, health systems will be looking at P&T committees to take different factors into consideration to determine how best to utilize drugs to provide the most value to their patients, weighing efficacy, safety, cost, and outcomes. 

Cancer care accounts for 5% of total US healthcare costs, and these costs continue to rise. Estimates suggest that the annual rate of spending will rise to $158 billion in 2020 from $120 billion in 2010, and the expenditures for oncology drugs are rising more rapidly than any other facet of healthcare.

 There continues to be an increasing financial burden associated with chemotherapeutic agents. The rising cost of cancer treatment is a significant contributor resulting in personal bankruptcy.

To start the discussion around value and to determine the best way to include pharmacoeconomic analyses into formulary management, several initiatives have been undertaken in an attempt to define the value of drugs used for cancer care, including the American Society of Clinical Oncology’s Value Framework, the European Society of Medical Oncology’s Magnitude of Clinical Benefit Scale, the National Comprehensive Cancer Network’s Evidence Blocks, Memorial Sloan Kettering Cancer Center’s Drug Abacus, and the Institute for Clinical & Economic Review’s Value Assessment Framework. These frameworks display similarities, but differ in their purpose, focus, and means of assessment. The final objective of all of these initiatives is to assist with the assessment of value in cancer care; however, most of these frameworks are relatively new and a significant amount of work remains to be done to determine how best to integrate these assessments into the ultimate formulary decision.

Although the costs of drugs continue to rise, the question of the relative value of the drug itself is left unanswered by our current healthcare system. We cannot continue to review drugs in silos based only on safety, efficacy, acquisition costs, and outcomes. Healthcare systems also need to be aware of all the current regulations and intricacies of their CPOE system to ensure safe delivery of drugs that are added to the formulary. 

Molly Billstein Leber, PharmD, BCPS, FASHP, is manager, Medication Policy and Formulary Management, Yale New Haven System, New Haven, Connecticut. 

Molly Billstein Leber, PharmD, BCPS, FASHP 

200 Orchard St. Scranton (SRC)-Department of Pharmacy 

1. Tyler LS, Cole SW, et al; ASHP Expert Panel on Formulary Management. ASHP guidelines on the pharmacy and therapeutics committee and the formulary system. 

2. Poon EG, Keohane CA, Yoon CS, et al. Effect of bar-code technology on the safety of medication administration. 

. 2010;362(18):1698-1707. doi: 10.1056/NEJMsa0907115. 

3. Seibert HH, Maddox RR, Flynn EA, Williams CK. Effect of barcode technology with electronic medication administration record on medication accuracy rates. 

. 2014; 71:209-218. doi: 10.2146/ajhp130332. 

4. <800> Hazardous drugs—handling in healthcare settings. United States Pharmacopoeia website. usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. Published February 1, 2016. Accessed August 23, 2017. 

5. § 602; PHS Act § 340B; 42 U.S.C. § 256b. Government publishing office website. gpo.gov/fdsys/pkg/USCODE-2010-title42/pdf/USCODE-2010-title42-chap6A-subchapII-partD-subpartvii-sec256b.pdf. Accessed August 23, 2017. 

6. Boucher B. Formulary decisions: then and now. 

. 2010;30(6 Pt 2):35S-41S. doi: 10.1592/phco.30.pt2.35S. 

7. Meropol NJ, Schrag D, Smith TJ, et al; American Society of Clinical Oncology. American Society of Clinical Oncology guidance statement: the cost of cancer care. 

. 2009;27(23):3868-3874. doi: 10.1200/JCO.2009.23.1183. 

8. Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American Society of Clinical Oncology Value Framework: revisions and reflections in response to comments received. 

. 2016;34(24):2925-2934. doi: 10.1200/JCO.2016.68.2518. 

9. Cherny NI, Sullivan R, Dafni U, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). 

. 2015;26(8):1547- 1573. doi: 10.1093/annonc/mdv249. 

10. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) with NCCN Evidence Blocks. National Comprehensive Cancer Network website. nccn.org/evidenceblocks/. Published 2016. Accessed August 23, 2017. 

11. Drug Abacus. Memorial Sloan Kettering Cancer Center website. https:// drugpricinglab.org/tools/drug-abacus/. Accessed August 31, 2017. 

12. Ollendorf D, Pearson SD. ICER evidence rating matrix: a user’s guide. Institute for Clinical and Economic Review website. icer-review.org/wp-content/ uploads/2016/01/Rating-Matrix-User-Guide-FINAL-v10-22-13.pdf. Published 2016. Accessed August 23, 2017. 

The hospital formulary system is an ongoing process that evaluates and selects the safest, most effective, and most economical care for hospitalized patients. As healthcare continues to change, so will the formulary management process.  



Formulary Considerations: The Past, Present, and Future

today’s evolving healthcare landscape shoulder the responsibility of delivering high-quality care while reducing costs throughout the entire revenue cycle. This cycle encompasses several key steps to appropriately bill patients and third party providers and capture revenue. The major components of the revenue cycle include patient access, clinical documentation, coding, billing processes, denial management, and reimbursement.

 To optimize the revenue cycle, key stakeholders, including clinicians, financial staff, and institutional leadership, need to be engaged in the process to maximize reimbursement for the health system and minimize patient costs and burden. Pharmacists and pharmacy staff play a pivotal role in cost containment through optimization of medication regimens and engagement in the revenue cycle, particularly for high-cost medications (

 The high-cost medications referred to in this article are those commonly used in the treatment of patients with cancer, such as oral antineoplastics, immunosuppressants, antifungals, and select anticoagulants.

To facilitate the billing process, the medications must be appropriately coded. Every hospital has a charge description master, which includes the general ledger number, product description, billing units, Healthcare Common Procedure Coding Systems (HCPCS) codes, revenue codes, and pricing information.

 With constant updates to CMS’ billing requirements and rapid changes in the drug market of new brand and generic medications, there is a high possibility that HCPCS codes can easily become out- dated or incorrectly associated with a medication. For example, blinatumomab (Blincyto), approved in 2014 for the treatment of Philadelphia chromosome—negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, had different HCPCS codes for 2015 (J7799) and 2016 (J9039)

 It is essential for hospital and pharmacy leadership to understand the financial implications of such changes. These leaders should include individuals well-versed in charge coding and actively engaged in the ever-changing drug market and insurance industry.

In addition to the complexities associated with billing, the problem of sky-rocketing drug prices has garnered much attention in recent years and made budget management more complex. In its annual report on national trends in prescription projections and spending, the American Society of Health-System Pharmacists (ASHP) showed a 6% increase in US prescription sales between 2015 and 2016, totaling $448.2 billion in 2016.

 Overall, adalimumab was associated with the highest overall spend in 2016 with $13.6 billion in expenditures; in clinics and nonfederal facilities, in iximab had the highest expenditure with $5.3 billion in spending.

Nonfederal facilities are de ned as licensed hospitals that are not owned by the government, including inpatient treatment and rehabilitation facilities. Nonfederal facilities also include general and specialty acute care institutions. Federal facilities refer to US ships or hospitals that belong to the Public Health Service, the Veterans Health Administration, and other federal branches. Higher drug prices and more prescribing were primarily responsible for the growth in expenditure in nonfederal hospitals and clinics.

 Drug expenditures in 2017 are projected to increase 6% to 8% overall and by 3% to 5% in hospitals.

 Therefore, health-system pharmacy leaders and clinicians should be actively engaged in the revenue cycle process and develop strategies that emphasize cost containment and ensure optimal medication reimbursement.

Top 5 Opportunities for Pharmacy Team Engagement in Containing Drug Costs and Maximizing Reimbursement in Patients Undergoing Cancer Treatment 

Pharmacists caring for patients undergoing cancer treatment are in a unique position to help other providers and patients navigate the convoluted reimbursement structure. Strategies include finding suitable therapeutic alternatives to meet the needs of formulary restrictions or obtaining approval for off-label use of agents. Starting upon admission and continuing post discharge, transitions-of-care pharmacy team members provide continuity of care and enhance medication adherence. Transitions-of-care pharmacy team efforts, starting upon admission and continuing through discharge, can ensure coverage and enhance medication adherence.

Many antineoplastic and supportive care medications are expensive and/or challenging to obtain. Timely acquisition is essential in order to initiate cancer treatment expeditiously. This article reviews key strategies that pharmacy team members can utilize to optimize medication-related revenue cycle compliance, including prior authorizations (PAs), hospital formulary management, patient assistance programs, accessibility of medications, and risk evaluation and mitigation strategies (REMS) programs.

1. Managing inpatients who are taking medications outside of the hospital formulary as outpatients.

Hospital formularies ensure safe, efficacious, and cost-effective medication use in the inpatient setting, especially for high-cost medications.

 Medications included on a hospital formulary vary based on an institution’s patient population and contracting options, among other factors. Strategies to appropriately manage admitted patients who continue to take medications as outpatients that are not included on the inpatient hospital formulary include therapeutic interchanges, nonformulary review processes, and using the patients’ own medication(s) during their hospital stay.

A therapeutic interchange is a tool that provides a roadmap to transition patients from an outpatient medication that is not on the hospital formulary to a medication that is included, and this often presents healthcare providers with a medication that has an equivalent dosage as the formulary medication.

 For example, if a patient was taking candesartan 8 mg by mouth once daily as an outpatient and losartan was the hospital formulary angiotensin receptor blocker, a therapeutic interchange would direct prescribers to order losartan 50 mg orally once daily. These interchanges are most effective when the electronic health record (EHR) automatically directs prescribers to this alternate choice when the nonformulary drug is ordered. This strategy alerts prescribers that they are attempting to order a non-formulary medication and presents them instantly with alternatives. Some institutions utilize automatic therapeutic interchanges whereby the pharmacist, upon order verification, would automatically make the switch to the appropriate formulary medication. Developing therapeutic interchanges requires appropriate research and evidence supporting the specific interchange so that the healthcare team has information readily available.

For a medication that is not a part of an institution-approved therapeutic interchange, most institutions have a process in place whereby pharmacists are responsible for reviewing non- formulary medications and providing formulary alternatives, when appropriate.

 Depending on the specific institutional practice, this may be built into the role of the pharmacist who is verifying orders or a pharmacist with specialized training in the particular therapeutic area may be consulted for reviewing and approving nonformulary medication use, if needed. By having a review process in place, prescribers can become accustomed to discussions with the pharmacist when ordering nonformulary medications to assist with providing formulary alternatives.

When it may not be appropriate to transition a patient to a hospital formulary medication, the hospital may elect to order the medication and dispense it from their inventory. In certain circumstances, if a patient brought the medication with them to the hospital, that may be used during the hospital stay. This may occur if waiting for the hospital to acquire the nonformulary medication poses a safety risk to the patient or if the medication requires a patient-specific distribution channel, such as a REMs program or clinical trial. Ensuring safe use of a medication brought in by a patient requires appropriate practices for ordering and verifying these medications. Many EHRs have an option to allow the prescriber to indicate that a patient’s own medication may be used. This acts as a trigger for the verifying pharmacist to check the product by confirming identity and appropriate dating. When applicable, appropriate barcoding of the patient’s own medication also needs to be accounted for using institution-specific practices.

An example of this in oncology practice is the tyrosine kinase inhibitor, dasatinib. If a hospital did not have this medication on formulary, it would not be clinically appropriate to substitute another agent during the hospital stay. If the patient brought his or her own supply to the hospital, it would be important to not interrupt therapy, to continue the medication using the patient’s supply. Many hospital formularies do not include all oral antineoplastic agents; this becomes an important education point when prescribing oral chemotherapy in the outpatient setting by informing patients that they should be prepared to bring their own supply in the event of hospitalization.

Using a combination of the above strategies will prepare institutions to appropriately manage patients that are taking medications outside of the hospital formulary as they transition to being inpatient.

2. Setting patients up for success by facilitating coverage via outpatient prescription insurance.

Outpatient prescription insurance plans also have a formulary to optimize medication use for their members. Often, medications and criteria for their use differ between the hospital formulary and the outpatient insurance formulary. Additionally, preferred drugs may differ from institutional pharmacies based on contracting or rebates received from a pharmacy bene t manager (PBM). In order to best assist patients in navigating the outpatient prescription formulary, it is first necessary to access and interpret the outpatient formulary and then meet any requirements necessary to access the formulary medication.

One method to determine outpatient prescription coverage is to process a test claim through an outpatient pharmacy. This practice will adjudicate the prescription to make a coverage determination but then immediately cancel the claim to prevent the prescription from processing completely. To use this method, it is important to clarify the intention of the test claim to the outpatient pharmacy—safety and insurance issues can arise if prescribers are attempting to ll the same prescription multiple times. If one does not have access to a test claim process, some outpatient insurance plans will post their formulary information online. It is important to note that updates to these documents are determined by the individual insurance plans and may not correlate in real-time with decision changes.

For the most accurate information, it is best to contact the company via phone. Also, what is listed on the online formulary will not be specific to the patient in terms of any deductible or other patient-specific plan information, so contacting the insurance company directly or having the patient use their online portal to obtain the most accurate patient-specific information about coverage may be necessary. Several test claims of different drugs in a therapeutic class may be needed to help determine the preferred drug with the most affordable cost. It is important to remember that the test claim result is only an estimate specific to that pharmacy as the co-pay may differ at another pharmacy due to various insurance and pharmacy acquisition cost factors.

Once outpatient insurance coverage has been determined, it may be necessary to facilitate PA of the medication. The PA process typically requires the prescriber to review the patient’s medical history and ensure that they meet certain criteria for medication use. PA approval can take place over the phone, even online in some instances, and an immediate determination could be made. Other cases require forms to be submitted via fax or online, and coverage determination may take 24 to 72 hours. Once issued, it is important to note that the standard timeframe for the PA is 1 year, but that it may be a shorter period in other instances and re-authorization must be obtained to ensure continuity of care.

An area of growing complexity, especially when navigating from the inpatient to the outpatient setting, is the realm of biosimilar medications. Although a hospital formulary may include one brand of a biologic, the outpatient PBM formulary may prefer another. An example of this is filgrastim, where a hospital formulary may include filgrastimsndz (Zarxio), while the outpatient plan prefers filgrastim (Neupogen). This is also common with the new follow-on biologic for insulin glargine, Basaglar, which is becoming more common for outpatient formularies even though many hospitals still have Lantus or another basal insulin as their preferred product. Being aware of these different formulary preferences can help patients safely transition from inpatient to outpatient, avoiding interruptions in treatment or duplications in these high-risk medications.

3. Assisting patients to obtain drugs with no coverage or high co-pays.

Patient assistance programs, private grants, and medication replacement programs are a few mechanisms that support patient access to medications.

 Pharmaceutical manufacturers can provide assistance to obtain insurance approval and help patients get coverage for their medications. The provision of this assistance is often outsourced to a third-party company that oversees the disbursement of funds and/or free medications.

Most insurance plans have strict guidelines outlining which medications are covered within their plan. There are specific clinical scenarios with limited treatment options where a medication may need to be used off label or its FDA approval may be pending. In these situations, obtaining reimbursement from the insurance company can be challenging. Free distribution programs offered by pharmaceutical manufacturers provide an alternative to procuring expensive medications. However, the approval process can take several days to weeks, so starting early can prevent delays in treatment initiation. Submission of specific income documentation and copies of insurance denial is often required, which can be time-consuming to collect.

On an institutional level, many pharmacy departments have hired reimbursement coordinators/specialists, who may be pharmacy technicians or nonhealthcare individuals with a background in finance or health insurance. These individuals focus on PAs, drug replacement, co-pay assistance, and denial management and they work closely with the PBM and insurance companies to find alternatives and investigate co-pays for high-cost medications. They serve as a liaison to the financial offices at the hospital and coordinate with replacement drug programs to recover medications. Upon obtaining the power of attorney from patients, reimbursement coordinators can request co-pay assistance from manufacturers on the patients’ behalf and provide valuable assistance, especially for patients who may be too ill or overwhelmed by the reimbursement process. The addition of pharmacy reimbursement coordinators/specialists has significantly reduced the amount of time pharmacists and other health- care providers spend on getting drugs reimbursed for patients.

 These programs often lead to increased outpatient prescription capture rates for institutional pharmacies. One institution increased its outpatient pharmacy’s capture rate from 57% to 73% for the general pediatric service.

There are exclusions for some programs, such as federal or state Medicare and Medicaid programs, where patients may not be allowed to receive co-pay assistance. This can be particularly di cult for patients who cannot afford high co-pays or for those who must first meet their deductible. Additionally, several private programs offer grants to cover out-of-pocket costs for patients undergoing cancer treatment. Being on funding cycles and considering their high demand, these grant programs are at risk of quickly exhausting their capital. It is important to have a backup plan in place and understand the extent of assistance that a patient may require so an entire treatment is covered.

4. Navigating patient registration for drugs requiring REMS programs.

The FDA Amendments Act of 2007 gave the regulatory body authority to require a REMS from manufacturers to ensure that the benefits of a medication outweigh its risks (

The drugs selected for REMS programs have been found to have safety risks, such as teratogenic effects; special initiation requirements; or communication mandates to the patient beyond a black box warning.

 These programs often require the physician to undergo additional training to gain the privileges to pre- scribe these drugs. Patients also have to complete a survey, undergo education, and sometimes obtain the medication through a designated pharmacy. Medications such as thalidomide, lenalidomide, and pomalidomide, which can cause severe birth defects, require female patients to undergo pregnancy testing and all patients to agree to contraceptive use. While these added steps improve safety, the process significantly slows down drug procurement and complicates their use in the inpatient setting.

In scenarios where the medication is distributed directly to the patient, patients must use their own supply during hospitalization. Outpatient pharmacies are required to adapt to the increasingly complex monitoring requirements of specialty medications that have limited distribution and high costs, require close monitoring or specialty handling, need patient or provider education, and are used in a unique patient population. This has resulted in a shift to higher utilization of specialty pharmacies, which are equipped to distribute specialty medications as they maintain adequate training and necessary procedures. PBMs often have preferred pharmacies, and it is time consuming to determine what the preferred pharmacy is for each patient.

In certain circumstances, it may be urgent to start cancer treatment. However, we often experience delays with obtaining high-cost novel targeted medications. PAs delay drug procurement in addition to identifying the patient’s preferred pharmacy, which is more often a mail order pharmacy (

) so that these medications need to be directly shipped to the patient. Providers and support staff spend a large amount of time on the phone with insurance representatives to obtain PA and ensure timely drug delivery, and specialty pharmacies work to ensure prompt delivery of medications as soon as approval is obtained. It is important to communicate with the pharmacy when urgent delivery is needed so the drug can be overnighted to the patient, if necessary. 

Due to drug shortages or restricted use, some medications undergo limited supply distribution. For example, procarbazine, a drug used in combination treatment for lymphoma in the brain, is not carried by all pharmacies. There also have been instances where a patient’s insurance required a specific specialty pharmacy, but that pharmacy was unable to obtain a supply of the drug. These circumstances take a significant amount of time to manage and ensure patient access to the medication.

It can be logistically challenging, especially for patients from out of town, to have their drugs delivered to a hotel or temporary residence. They often need someone to sign for the package, which requires the caregiver to leave the patient’s bedside to obtain medications. Some medications require special handling, such as refrigeration, which adds complexity. Mail order prescriptions may have lower co-pays for chronic medications. If caregivers know medications will be delayed, they can defer the start of cancer treatment until the entire regimen can start at the same time—unless the patient’s clinical situation prevents this. It is often difficult to predict what other medication needs may arise during a course of chemotherapy; therefore, a local community pharmacy is often necessary for obtaining medications to manage symptoms in a timely fashion. In addition, patients often have to rely on caregivers, friends, and relatives to ensure timely delivery of their medications, which may include personally carrying or mailing the medications to the patient’s temporary location.

With the clinical and financial implications of high-cost medications, and their impact on health system revenue, it is of utmost importance for all key stakeholders to be engaged in the complex revenue cycle. Tackling PBMs’ insurance formularies and the reimbursement process can be dynamic and complex. It is crucial for the pharmacy team to collaborate with other providers, hospital financial team members, PBMs, and hospital leadership and leverage their skill sets to manage costs and optimize reimbursement for the health system. Overall, this collaboration will maximize benefits for both institutions and patients, ultimately ensuring the most optimal use of medications. 

Brandon R. Shank, PharmD, MPH, BCOP, is a clinical pharmacy specialist, Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX.â€¨

Phuoc Anh (Anne) Nguyen, PharmD, MS, BCPS, is a clinical pharmacy specialist, Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX.

Emily C. Pherson, PharmD, BCPS, is a clinical pharmacy specialist, Department of Pharmacy, Johns Hopkins Hospital, Baltimore, MD. 

Brandon R. Shank, PharmD, MPH, BCOPâ€¨

Clinical Pharmacy Specialist, Division of Pharmacy,

The University of Texas MD Anderson Cancer Center

1515 Holcombe Blvd - Unit 377, Houston, TX 77030. 

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2. Loyd LM. Optimizing pharmaceutical reimbursement: one institution’s approach. American journal of health-system pharmacy. 

3. Jarrett AT, Patel KR, Babbitt R. Understanding pharmacy department billing and the charge master. American journal of health-system pharmacy. 

. 2008;65(23):2213-2214. doi: 10.2146/ajhp070675.

4. Blincyto - Coverage and correct coding — revised. CGS website. cgsmedi- care.com/jc/pubs/news/2015/0215/cope28409.html. Updated January 7, 2016. Accessed August 4, 2017.

With the clinical and financial implications of high-cost medications, and their impact on health system revenue, it is of utmost importance for all key stakeholders to be engaged in the complex revenue cycle.

Pharmacy Team Engagement in Navigating the Revenue Cycle for High-Cost Medications in Patients With Cancer

Amanda Forys on How Medicare Will Refine Its Biosimilar Policy

Amanda Forys, MSPH, director of Xcenda’s Reimbursement Policy Insights consulting team, discusses how Medicare will address and possibly change its biosimilar policies as the FDA offers more guidance and as biosimilars become more prevalent in the market.

How do you think Medicare may refine its biosimilars policy as the FDA releases more guidance and more biosimilars reach the market?

FDA guidance could affect a little bit of what Medicare is doing. The FDA and CMS are going to have some lessons learned moving forward. There are a lot of other really big issues coming up around the Medicare program in general, that could affect biosimilars and could affect all products. A couple of those things, I believe, are going to be hot-button issues, but I’ll start with just biosimilars in general.

Right now, with a biosimilar, the originator product has its own billing code and all biosimilars to that originator product are grouped together into a billing code. In the industry, a lot of members of different biosimilar forums and other councils for biosimilars have not been interested in keeping it that way and have been working very hard to ask that they each get their own code. They’re saying that these are products that are each unique, they are not biosimilar to one another, so grouping them together is quite confusing for providers and was not necessarily the intent of the BPCIA [Biologics Price Competition and Innovation Act] when that legislation was passed. There is a lot of tension there with CMS and people asking for them to split the codes up.

Then you have MedPAC coming in and they are saying we want to simplify the whole system and what we’d like to do is we’d like to see the originator product and the biosimilar grouped together and share a code. When that happens, you are going to see the price of that originator product drop substantially and that will really save the Medicare program money. While, in theory, yes that probably could save money, the intent of the BPCIA isn’t necessarily clear, and that may not be possible, it might not be something you can do legally, by grouping those products together with the way the biosimilar is defined. That’s going to be something that has to be ironed out and you may see some guidance as interchangeables come to the market and the FDA irons out interchangeables you might see them say, how are we going to treat that? Are we going to give that its own code, its own separate billing code? Are they going to be grouped with all of the other biosimilars? Will they even share a code with the originator product because they are an interchangeable? We just don’t know yet. That is something that could be a concern or an issue for biosimilar manufacturers. It’s just really ironing out payment.

Also, to see some of the other pressures to control drug prices, that’s a huge hot topic right now on [Capitol] Hill. Are you going to see CMS suing significant things to change the average sales price base payment methodology that they have for Medicare Part B drugs? Could that happen and, if so, how will that affect the market? I think you’ve got what’s happening in general and then how will that affect biosimilars, just as much as how is the biosimilars market going to change. On the Part D side, we are definitely going to need to see more clarification on [whether] a biosimilar can be considered a brand, that is something that manufacturers are looking for and asking for that clarification, so that they can offer that 50% rebate in the coverage gap for patients. So, that is something that will be defined more and more. MedPAC has recommended that be put in place, so we will see if that actually happens in the future. 

Dr Brandon Shank on Biosimilar Naming and Suffixes

AJMC®TV interviews let you catch up on what’s new and important about changes in healthcare, with insights from key decision makers-from the clinician, to the health plan leader, to the regulator. When every minute in your day matters, AJMC®TV interviews keep you informed. Access the video clips at ajmc.com/interviews.

October 2017

PBMs: Their Role, the Problems, and How Practices Can Work With Them

Positive Quality Interventions: An Innovative Platform for Oncology Practice Collaboration

Formulary Considerations: The Past, Present, and Future

Pharmacy Team Engagement in Navigating the Revenue Cycle for High-Cost Medications in Patients With Cancer

AJMC®tv Interviews, October 2017

Medical World News®, October 2017

In Conversation With a Pharmacist: Management of CAR T-Cell Treatment

Pharmacy's Changing Role as Cancer Care Transitions From Infused to Oral Therapies