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INTRODUCTION
Department:
Pharmaceutical benefits managers (PBMs) develop and manage prescription drug benefits for private insurers, cocky-insuring businesses, and other entities, such as unions and government health plans (eg, Medicare Part D). They are influential in oncology care because prescription drugs play a major role in the handling of most cancers and an increasing number of patients with cancer are treated with oral oncology agents managed by PBMs.1 As intermediaries in the prescription drug supply chain, PBMs can affect both oncology patients and practices. For patients, PBMs can influence what drugs are covered by insurance, the size of copays and possible rebates, and where drugs tin can exist purchased and administered. For providers, PBM policies tin can influence patient care delivery and do administration demands.
Although ASCO and others have raised concerns virtually the furnishings of PBM practices on care commitment, there is limited literature well-nigh the bear on of PBMs on cancer intendance.2,3 In this ASCO 2019 Country of Cancer Care in America article, nosotros review the function of PBMs in prescription drug coverage and reimbursement, discuss the touch on of PBMs on oncology care, and present data from the 2018 ASCO Practice Survey assessing the knowledge and attitude of oncology practices toward PBMs. The 2018 survey findings, discussed in more detail afterwards in this article, suggested that many oncologists accept a express understanding of the part that PBMs play in cancer care delivery. In this review, we provide an educational overview of the electric current landscape for those involved in care of patients with cancer and oncology practice administration.
Overview of PBMs
PBMs first entered the prescription drug supply concatenation during the 1980s when individual insurance companies began separating prescription drug coverage from other medical expenditures.4,5 During this period, insurance companies turned to these third parties to process chemist's shop claims and for assist with administrative strategies, such every bit implementing drug identification cards, electronic records, drug formularies, and online processing.4,v Over the next 30 years, prescription drug coverage became increasingly complex, and the role of PBMs expanded to include contract and cost negotiation with drug manufacturers, wholesalers, payers, and pharmacies.3
PBMs take consolidated significantly in the past decade. The three largest PBM companies—Express Scripts, OptumRX, and CVS Caremark—process 85% of all prescription claims and administer drug benefits for > 266 million Americans in public and private insurance plans.6,7 As PBMs' market share has grown, then has their influence on the drug delivery system.8
The sources of revenue for PBMs are unclear because their contracts are not transparent. PBMs generate revenue in role past negotiating prices and rebates with drug manufacturers, establishing formulary tiers, setting patient copays, setting clinical policies, creating pharmacy provider networks, and determining pharmacy reimbursements rates.ix,10 Most own and operate their own mail-order and specialty pharmacies.11 PBMs also receive payments from program sponsors (insurers) for processing prescriptions and managing formularies.x,12 Revenue also comes from pharmaceutical manufacturers whose drugs are listed on formularies gear up by PBMs via manufacturer rebates (frequently calculated as a percentage of drug list prices).seven,8,10,13 Boosted revenue is generated for PBMs on the margin between the amount charged to payers for a prescription drug and how much PBMs pay out to pharmacies for the same drug, also known as spread pricing.vii,10,xiv Table ane provides a glossary of select PBM-related terms and practices. The menstruum of money, products, and services in the drug supply chain is conceptualized in Figure 1 .
 | Tabular array 1. Glossary of PBM-Related Terms and Practices |
Fig one. Conceptual diagram of the period of products, services, and money in the drug supply concatenation. Rx, prescription. Adapted from Sood et al.thirteen
Potential Value of PBMs
As intermediaries between payers, drug manufacturers, and pharmacies, PBMs potentially take the ability to lower prescription drug prices and promote value.seven PBMs can leverage their marketplace ability to negotiate lower prices and rebates from drug manufacturers, resulting in savings that can be passed on to payers and patients.13,15 For instance, PBM advancement organizations claim that PBM formularies lower medical costs while providing patients with admission to more affordable drugs.xvi,17
PBMs claim to increment value past implementing formulary and utilization management strategies that promote evidence-based medicine and by encouraging the use of cost-effective medications and generic substitutions.16-21 PBM-preferred specialty chemist's networks are framed as an optimal model for managing cost and access.22,23 Some PBM specialty pharmacies as well provide clinical services designed to amend the quality of patient care, such as educational programs aimed at improving drug adherence or mitigating adverse effects.23
Although PBMs exercise not disclose information almost the size of drug discounts and rebates,13 some studies accept found that PBM negotiations with manufacturers practice issue in lower drug prices for payers and insurers. For example, wellness plans that use PBM-preferred pharmacy networks have demonstrated lower pharmacy costs,24,25 and formulary restrictions have been found to reduce the utilize of drugs and associated drug costs.26 The Centers for Medicare and Medicaid Services (CMS) reports that PBM-negotiated rebates from manufacturers have lowered internet prices and contributed to slowing drug-spending growth in public programs like Medicare and Medicaid in recent years, although the share of prescription drug costs lowered past rebates is projected to decrease.27,28
Challenges With PBMs
As prescription drug prices continue to rise, in that location is increasing concern among regime agencies, policy makers, and medical groups that PBMs may not be delivering lower drug prices or improving value in drug spending.27 For example, tying rebates to drug prices may incentivize PBMs to list higher-price drugs on formularies and discourage the employ of lower-cost or generic drugs,xiii with unintended and potentially negative consequences on patient outcomes.26,29
Critics of PBMs are concerned that consolidation in the industry, particularly PBM ownership of mail-order and specialty pharmacies, represents a conflict of interest that may lead to pharmacies switching patients to college-cost, improve-reimbursed medications.10,xiii Vertical consolidation is demonstrated past the fact that PBMs have affiliated insurers and specialty pharmacies. Horizontal consolidation is shown through the market share dominated past the three largest PBMs.thirty Both types of consolidation have farther increased market place share and the leverage that PBMs take in contract negotiations with payers, manufacturers, and pharmacies,13 which the White House Council of Economic Advisors linked to rise drug prices in a 2018 report.13,31
The lack of transparency in PBM practices may have a negative impact on the cost of care. Many PBM transactions are contractually defined and opaque, making it difficult to track the true beneficiaries of price savings. At that place are concerns about whether the discounts PBMs receive from drug manufacturers and pharmacies are passed on to patients.xiii,32 Moreover, the electric current framework of formulary tiers, preauthorization requirements, and copayments may be creating cost and admission issues for patients, as well as financial hazard and administrative burden for practices.eight,33-37
At that place are examples of legislative activity to address these issues, including a contempo federal law that prohibits PBMs and insurers from using gag clauses, a do through which pharmacies are blocked from providing drug cost information to patients and employers (Table 1).38,39 Prior to the protransparency gag clause legislation, PBMs could contractually foreclose pharmacies from informing patients if the out-of-pocket greenbacks price of a medication would be less than their copay (ie, going through their wellness insurance drug benefit).
PBMS IN ONCOLOGY
Section:
The price of prescription drugs is a major concern in oncology. Prices are increasing in both inpatient and outpatient prescription settings,40,41 and the costs of oncology drugs are growing at a faster charge per unit than those of other prescription drug classes.41,42 This rise in price is affecting older (generic) and newer cancer drugs, with the annual cost of new medications routinely exceeding $100,000.43-45 At the same fourth dimension, cancer drugs are increasingly targeted to specific molecules, making manufacturing more complex and non necessarily interchangeable or available in generic grade.34 Cancer drugs may besides crave special procedures for handling and administration.11
PBMs accept implemented policies that may shift costs to patients (eg, specialty formulary tiers) and make it more than difficult for patients to access prescribed treatments (eg, utilization direction practices like prior authorization and step therapy; see Table ane for a glossary of select PBM-related terms and practices).
Cost Challenges
ASCO and other oncology groups have documented how PBM and payer policies may increase costs of oral cancer drugs to patients.8,12,46,47 As plan administrators, PBMs use a variety of cost-containment and cost-sharing strategies.5 Cancer drugs are routinely on the highest formulary tier and a subset of plans place all cancer medications on a specialty tier.34,48 Drugs on the highest or specialty tiers typically require cost sharing past patients of 30%-fifty% of drug costs.34,47 For example, Medicare Office D beneficiaries are liable for 25%-33% coinsurance for cancer drugs on the highest specialty tier, and these out-of-pocket expenses drive Medicare beneficiaries quickly into the donut hole, a coverage gap where they are responsible for paying a high proportion of drug costs until their out-of-pocket spending qualifies them for catastrophic coverage.49,l Since the passage of the Affordable Care Deed in 2010, the portion of the drug toll for which most Part D beneficiaries are responsible while they are in the donut pigsty has shrunk from 100% to 25%.51 Even so, out-of-pocket spending for cancer drugs, peculiarly targeted oral anticancer medications, is financially burdensome.52 One contempo assay estimated the boilerplate out-of-pocket spending for a patient with Medicare Part D who requires a 12-calendar month prescription for their anticancer drug was $10,470 in 2019 (ranging from $seven,220/y for lapatinib to $15,472/y for lenalidomide).53
College copays and large out-of-pocket costs have been shown to lead to drug noncompliance and drug abandonment and associated negative health outcomes.26,35,49 Therapy noncompliance is cost sensitive and patients enrolled in high-deductible plans are more affected than those with low deductibles.5 In an assay of a nationally representative pharmacy claims database, patients with cost sharing > $500 were four times every bit likely to carelessness oral oncolytics compared with those with cost sharing of $100 or less.54 The high costs of care, including prescription drug expenditures, are also a major cause of personal defalcation and fiscal and psychological distress in patients with cancer.5,46
Access Challenges
PBM practices tin impede patients' access to cancer drugs. PBM utilization direction approaches, for case, can include administrative rules that limit or restrict patient access to certain cancer treatments.47 A 2019 survey of cancer patients by the American Cancer Society Cancer Action Network reported that 34% of patients had to expect for insurance approval of a handling, and that utilization direction policies result in treatment delays and increased stress for patients.55 Handling delays caused by utilization management policies tin lead to patients discontinuing prescribed treatments and to poorer outcomes.47,55,56 Delays in cancer care have previously been associated with worse outcomes,57-59 and the adverse impact of cancer care delay caused directly by utilization management strategies (eg, prior authorisation and stride therapy) on outcomes deserves more than investigation. Prior authorization is of item concern to oncologists47 and to the broader physician customs: in a 2017 survey by the American Medical Association, 92% of physicians reported prior authorization tin have a negative impact on clinical outcomes.56
Access may exist affected past restrictive formularies that limit the number of drugs included in a grade of drugs and past pace therapy (sometimes called "fail first") policies that require use of the payer'due south preferred drug before coverage of the initial drug selected by the prescribing oncologist.47 Restrictive formularies and step-therapy approaches are specially problematic in cancer where drugs within a grade may non be interchangeable and the exclusion of certain drugs from coverage could negatively bear upon outcomes.47 In the era of precision therapy, it is plausible that a targeted agent's effectiveness could exist compromised by first starting with step therapy–dictated, less-preferred medication. "Nonmedical switching," whereby a patient is required to modify from a previously prescribed therapy to a dissimilar, less expensive therapy for no medically advantageous reason, is another utilization direction exercise that could impede patient access to optimal cancer intendance.60,61 Currently, there are limited oncology- or PBM-specific data nigh the prevalence or impact of nonmedical switching.
PBM pharmacy requirements that shift drug dispensing away from oncologists can too introduce patient intendance and toll issues. Practices with in-office dispensing are sometimes excluded from eligible pharmacy networks when they do not meet standards assigned by the PBM. Furthermore, PBMs may incentivize or require that patients fill prescriptions at PBM-owned or -affiliated pharmacies.8 These practices diminish potential patient benefits of in-office dispensing, such as quicker access to medications and direct medico-patient communication virtually dosing and agin furnishings, both of which tin can improve adherence.62 Expensive waste material of unused medication attributed to post-order pharmacies, which are often incentivized or required by PBMs, is also a concern.62
ASCO Practise SURVEY Information
Section:
Measuring how oncologists view the role of PBMs in cancer care and how PBM policies influence patient care and exercise management accept been a major focus of ASCO. ASCO has used informal polling to document its members' impressions of the office of PBMs in care delivery and has been surveying oncology practices about overarching practice trends and pressures for nearly a decade through its annual practise survey. Practice survey methods were detailed previously in this Journal of Oncology Practise commodity serial.37 In 2017, oncology practices identified payers as their top pressure source, with prior authorization and coverage denials cited as specific payer strains.46 In 2018, the ASCO exercise survey included a serial of PBM-related questions. The resulting information, described in detail in the following paragraphs, suggest many oncology practices perceive high levels of administrative burden resulting from PBM requirements, yet they take limited understanding of PBM activities and how PBM policies are affecting their patients.
ASCO received responses from 291 US clinical oncology practices to its 2018 survey, with 270 (92.8%) providing data on their experiences with PBMs. The survey respondents came from diverse geographies and settings and together represented > 8,400 oncologists (45%) who care for adult patients with cancer in the United States.63 Half of the responding practices reported interacting with ane (north = xi) or more (n = 123) PBMs, and another third (n = 86) were unsure of the number. Notably, the remaining l respondents (19%) were screened out of subsequent questioning considering they reported interacting with no PBMs—an improbable finding given PBMs' loftier penetration of the prescription drug market. This section provides an overview of oncology practices' reported understanding of PBM practices, as well every bit the impact of PBM policies on drug accessibility, the provision of care, and practise administration.
Understanding of PBM Practices
Respondents to the 2018 do survey were asked to assess their understanding of "PBM operations and negotiating tactics, including formulary development and management, unlike rebates and discounts PBMs receive, coupons, clawback amounts/Direct Indirect Remuneration (DIR) fees" (Table 1). A bulk of respondents (55%; northward = 109) had no to very little understanding of PBM operations and negotiating tactics. Agreement was peculiarly express amid hospital-endemic practices (68.nine% hospital-owned v 39.eight% physician-owned practices reported no or very little understanding) and among practices without in-office dispensing of cancer treatments (66.3% without dispensing 5 45.0% with dispensing), the latter of whom may stand up to benefit from some PBM services. Survey respondents with patient care roles were more than likely to written report express understanding than those with authoritative roles (61.5% of clinical respondents v 51.1% of administrative respondents).
Despite limited understanding of PBM operations, responding oncology practices were largely familiar with PBM impacts on their authoritative and patient care duties. Ten percent of practices (north = xx) reported benefits to working with PBMs, with written comments noting improvements to patient admission (north = 8), reduced patient costs (n = 2), and reduced financial burden (n = 2), among other benefits. Overall, a depression acknowledgment of benefits corresponded with loftier levels of perceived interruptions to exercise administration and patient intendance activities .
PBM Policies and Drug Accessibility
In the 2018 do survey, three-quarters of practices reported that PBMs interfered with patient care and/or made it difficult to get their work done (Fig 2 ). In addition, 186 of 200 respondents (93%) encountered PBM utilization direction policies, with prior authorization delays, step therapy/fail-outset requirements, noncoverage of drugs recommended/required for treatment, and placement of cancer drugs on highest formulary tiers cited equally common experiences (Fig iii ). Doctor-owned practices reported that these policies had a greater negative touch on than health system–endemic practices. It is articulate that for any policies aimed at addressing the PBM-related problems described in this review, the differential impact on physician-owned practices versus health system–endemic practices should be considered.
Fig two. Impacts of chemist's shop do good manager policies on oncology practices.8
Fig iii. Consequences of chemist's shop benefit manager utilization management and formulary policies.8
PBMs and Problems With Providing Care
PBMs may directly contact some patients to initiate and manage their prescriptions. ASCO's information reveal that this has introduced disruptions, waste, and errors into the drug prescription process for oncologic treatments (Fig 4 ). More 60% of responding practices reported that PBMs had contacted their patients without notifying their providers (62%; n = 123). Mail service-order shipments were a major business concern for these oncology practices, with nearly half reporting drug waste resulting from unwanted drug refills (42%) and 24% noting the shipment of premixed medications to patients without appropriate safeguards. Errors in the form of incorrect medications or dosages and unprompted mid-regimen changes were also reported.
Fig iv. Results of chemist's shop benefit director interactions with patients with cancer.eight
PBMs and Exercise Administration
In add-on to influencing patient care, PBM policies can result in uncompensated costs and administrative piece of work for practices. A majority of practices responding to ASCO's survey reported that PBMs interfered with their do administration (n = 114; 56%; Fig 2 ). To handle PBM-related piece of work, practices reported hiring staff (n = fifty; 25%), shifting responsibilities amidst existing staff (north = 47; 24%), or both (n = 15; 8%). A majority of practices allocated staff time to handle PBM paperwork (n = 108; 54%), with time spent on activities including prior authorizations (n = 96; 89%), seeking copay help on behalf of patients (n = 86; 80%), and addressing PBM-related medication errors and patient complaints (n = 40; 38%).
To conclude, as the part of PBMs in the assistants of prescription drug benefits has expanded, their opaque business concern practices and impact on drug prices take come up under increasing scrutiny. PBMs are thoroughly integrated into the drug supply chain, and it is difficult to isolate PBM actions from those of insurers, programme sponsors, and manufacturers. However, evidence suggests that PBM practices likely touch the price of and admission to intendance for patients. The ASCO 2018 do survey begins to quantify the perceived bear upon of PBMs on cancer care commitment amid oncology practitioners. A large proportion of survey respondents were not confident in their understanding of the circuitous function and impact of PBMs, only most respondents reported experiencing disruptions to patient care and uncompensated authoritative brunt resulting from interactions with PBMs. General familiarity with and negative impressions of PBM activities were both more prevalent among medico-owned than infirmary-endemic oncology practices, suggesting that practices that have closer interactions with PBMs are more than likely to perceive a negative affect on oncology care. The survey findings underscore the need for greater organization transparency and increased provider education so the deportment and influences of PBMs are more widely understood.
ASCO is committed to protecting oncologists' ability to provide the best treatment at the correct time and so patients have admission to the most effective cancer treatments, and ASCO strongly supports efforts to control the costs of prescription drugs.8,46,47 Some of the price and access challenges associated with PBMs outcome from a lack of communication or coordination between PBMs and oncology practices. The high proportion of practices in the 2018 survey that reported errors and waste material as a result of directly PBM contact with patients could be reduced, for example, by improving communication betwixt the PBM and dr.. At a minimum, the prescribing medico should ever be consulted earlier whatsoever medication, regimen, or dosing changes. Addressing many of the challenges described in this article will require policy-based solutions. In comments responding to various CMS proposals, ASCO expressed its concerns regarding patient admission and timely intendance and urged CMS to more carefully examine the impact of PBM practices on patient intendance and outcomes. ASCO is actively advocating on Capitol Hill and in states legislatures for reforms to many of the PBM practices described herein, such as utilization management, every bit well as for improvement in transparency. Moving frontward, ASCO volition continue to monitor the bear on of PBMs on patients and practices and advocate for policies that ensure fair and transparent drug pricing, directly advice betwixt patients and their oncology care providers, and oncology specialist representation in formulary design and other processes related to the delivery of cancer drugs.
© 2020 by American Society of Clinical Oncology
See accompanying editorials on pages 270 and 273 and accompanying oncographic on page 275
Conception and design: All authors
Authoritative support: Caroline Schenkel, Kelsey Kirkwood
Drove and assembly of data: Trevor J. Royce, Kelsey Kirkwood, Sheetal Kircher
Data analysis and interpretation: All authors
Manuscript writing: All authors
Concluding approval of manuscript: All authors
Accountable for all aspects of the piece of work : All authors
AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
Touch on of Pharmacy Do good Managers on Oncology Practices and Patients
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are cocky-held unless noted. I = Immediate Family Fellow member, Inst = My Establishment. Relationships may not relate to the subject area matter of this manuscript. For more data about ASCO's conflict of interest policy, delight refer to www.asco.org/rwc or ascopubs.org/op/authors/writer-centre.
Open up Payments is a public database containing information reported by companies virtually payments fabricated to US-licensed physicians (Open Payments).
Sheetal Kircher
Stock and Other Ownership Interests: Penrose Therapeutics, Abbott/AbbVie
No other potential conflicts of interest were reported.
Acquittance
We thank the members of the ASCO State of Cancer Care in America editorial board, including Morganna Freeman, Blase Polite, Jerome Seid, and Robin Zon, who provided guidance on the focus and goals of this commodity. We likewise give thanks the following ASCO staff for their contributions to the project: Suanna S. Bruinooge, Allyn Moushey, Deborah Kamin, Michael Francisco, Sybil Greenish, Richard L. Schilsky, and Shimere Sherwood. Finally, we give thanks the practices who completed the 2018 ASCO Exercise survey.
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Source: https://ascopubs.org/doi/full/10.1200/JOP.19.00606
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