Posted by Jeron Eaves and Jonny Betts, Ph.D. on December 13th, 2018.
Part Three in a Six-Part Series on Oncology Product Commercialization
In Part One of this series, we outlined five commercial challenges in oncology that biopharma decision-makers must face. Part Two dealt with the first of those challenges, the “constant state of launch” that now exists in oncology. In this installment, we introduce the complex array of stakeholders with whom biopharma companies must engage if they are to succeed in oncology markets. We’ll tackle how best to engage these stakeholders in Part Four of this series.
Each of these stakeholder groups, from oncologists to payers to patients, has its own complicated set of needs and challenges, and together they form a complex and integrated network. To engage with them effectively, biopharma companies must deeply understand the issues facing each stakeholder group, how they are related to other stakeholders in the network, and then seek to address those issues, build trust, and efficiently add value.
Below, we briefly address each of these groups. We outline why each is important and discuss the factors and trends that biopharma companies must consider when engaging with them.
Oncologists are still the most critically important stakeholder group to engage, given their continued lead role in treatment decision-making. However, the dynamics are changing for oncologists, and this has implications for commercial decision makers in pharma.
First, oncologists today are bombarded by data. The sheer speed of innovation in oncology—both clinically as well as in data generation and dissemination—is significantly increasing the amount of information that oncologists have to absorb. These data include:
- An increase in traditional clinical data generated to support regulatory approval, due to the number of assets being developed in oncology (data that is first reported at oncology congresses, then also detailed later in product package inserts)
- Emerging data sets, such as real-world evidence (RWE, generated from multiple sources such as Electronic Health Records [EHRs], claims data, patient / disease registries, and patient-generated data) and investigator-sponsored trials (ISTs)
- New guidelines and pathways, as they continue to proliferate (for example, there are now over 100 ASCO Clinical Practice Guidelines)
The large number of oncology-focused conferences and congresses is evidence of the sheer volume of information that’s becoming available to oncologists. The American Society of Clinical Oncology (ASCO) now holds no fewer than 15 major symposia and congresses per year. The European Society for Medical Oncology (ESMO) has 18, plus a range of smaller meetings.
Second, much of this data is being adjudicated through a growing number of entities who develop treatment guidelines and pathways, such as the National Comprehensive Cancer Network (NCCN), ASCO, and integrated delivery networks (IDNs).
As oncologists consolidate into group practices and corporate networks, they are increasingly being required to incorporate treatment guidelines. As a result, their clinical decision-making power is being reduced. For example, 58% of oncology practices participating in the 2016 ASCO Trends Survey reported using clinical pathways. Furthermore, 46% indicated that they were required by health plans or other outside entities to comply with more than one pathway.
With these market dynamics in play, biopharma companies must find ways to “cut through the noise” and connect with oncologists despite the significant volume of data that’s vying for their attention. In addition, companies must find strategic ways to inform those who develop guidelines and pathways about the value of their products. For products that are not on guidelines or pathways, uptake will likely be more limited and companies will need to double down on finding channels that will lead to trial use (e.g., develop champions, generate additional data).
Key Opinion Leaders (KOLs)
KOLs have always been important to biopharma companies, and not just in oncology. However, within today’s oncology market, there are several key dynamics that biopharma companies must remember.
First, KOLs often sit on the committees that develop treatment guidelines and pathways. Because their ability to influence the development of these tools is significant, it’s important for biopharma companies to cultivate solid relationships with these KOLs, and ensure that they are able to appropriately communicate the clinical and economic value of their therapies.
Second, KOLs can be very helpful in providing an objective opinion that summarizes the treatment impact of many related datasets. In multiple tumor types, top-tier KOLs from leading institutions hold significant sway in shaping treatment decision-making, an effect that is magnified by their ability to communicate broadly, not just from the podium but also through social media (e.g., Twitter, OncologyTube).
Finally, regionally-focused KOLs are also influential within their own specific health system or by their attendance at regional conferences and events. When developing their KOL strategies, biopharma companies should seek to include regional as well as national-level KOLs as each influences treatment decision-making at the community level in different ways.
Nursing staff members are an important stakeholder due to their critical role in managing the logistics associated with administering treatment regiments and helping patients deal with adverse events (AEs) and compliance challenges.
In today’s world, nurses’ jobs are getting more complicated. As a result they are becoming increasingly important to target due to the following factors:
- The expansion of combination therapies is making therapeutic regimens more complex and harder to track, manage, and administer. Today’s more complex regimens may involve a combination of infused, injected, and oral medications, all dosed on different cycles.
- As individual therapies launch into new indications, their dosage regimens may vary from one indication to another, which can make it even harder to stay on track.
- Nurses need to stay abreast of new developments while also ensuring that varying treatment regimens (even for the same product) are properly administered for each patient. Like the oncologists, they also face information overload.
To engage successfully with nursing staff, biopharma companies need to offer solutions that will help reduce the burden on nurses and help them do their jobs more easily. As an example, Abbvie and Genentech provide starter kits for VENCLEXTA in chronic lymphocytic leukemia (CLL) that contain color-coded blister packs to help with the dose ramp-up schedule.
In addition, pharma companies can provide clear guidance on how nursing staff can direct patients to third-party support programs for dealing with side effects or AEs. These types of offerings directly address the challenges nursing staff are facing.
Within oncology clinics, Practice Managers focus on running the office, dealing with the finances, and addressing issues related to therapy access and reimbursement. As we’ll discuss below, the access and reimbursement environment for oncology products is only going to get more complicated as time goes by, meaning an increased role for Practice Managers. For example, they are often also responsible for:
- Pointing patients to the relevant financial / reimbursement support programs.
- Effectively engaging with insurance companies on behalf of patients.
- Ensuring that the practice itself is as efficient as it can be from a business standpoint.
As clinical differentiation between competing regimens continues to become more elusive, factors such the ease of obtaining reimbursement frequently become more relevant to a clinic’s decision as to which regimen to use, all other things being equal. In such situations, biopharma companies must work with Practice Managers to help them fulfill their roles and minimize the challenges associated with administering their regimen. This means providing robust information and support regarding their challenges and questions, primarily regarding reimbursement.
Distributors, Specialty Pharmacies (SP), Hub Services Providers
Aside from stakeholders working in the oncologist’s office, specialty pharmacies, hub services providers and similar stakeholders are often the first points of contact for many patients. These entities are often engaged in providing a range of value-added services to patients:
- Facilitate patient access
- Benefits investigations
- Dispensing / triaging to co-pay assistance
- Shipping drug to patient (including starter kits, in the case of SPs)
- Call center services to address and triage patient questions on access & reimbursement
- Facilitate compliance and persistence (depending on manufacturer program design and contract with hub or SP):
- Deployment of manufacturer-designed and -sponsored programs such as custom communications, materials, starter kits through multiple communication channels (mail, email, phone, text, etc.)
- Nurse call center to address and triage patient questions on dosing and administration and AE management
They can provide a critical link from biopharma company to patient, and are key players in helping to ensure a positive patient experience—a critical factor to establish if clinical differentiation is not compelling. Biopharma companies must develop and maintain strong strategic relationships with specialty pharmacies, distributors, and hub companies.
Due to the increased number of oral oncolytics in development (representing approximately 25% of the oncology pipeline), biopharma companies will increasingly have to address the unique challenges associated with these molecules, including distribution strategy (e.g., closed vs. open network), adherence challenges, and patient financial challenges.
Integrated Delivery Networks, Group Practices, Health Systems, & Similar Entities
Corporate entities—such as group oncology practices, integrated delivery networks, health systems—are becoming more important in oncology. These entities are:
- Instrumental in establishing and/or leveraging treatment guidelines and pathways, reducing the decision-making power of oncologists (but enabling therapies included within the guidelines to be “pushed down” to clinics).
- Focused on cost-control and understanding the value of therapies.
To engage with these corporate customers effectively, pharmaceutical companies must clearly understand their needs and field highly competent key account teams. Additionally, they must appropriately leverage health economics and outcomes data and RWE to create and communicate relevant value arguments.
As we stated in Part One, the rate of innovation in oncology has been phenomenal in recent years. Indeed, 14 of the world’s largest pharmaceutical companies have at least one-third of their late-stage R&D activity focused on oncology, and around 700 organizations have at least one oncology drug in late-stage development.1 Some of the most exciting innovations are emerging in the field of immuno-oncology (IO), such as PD-1/PD-L1 checkpoint inhibitors and CAR-T therapies. Approximately 40 companies are currently developing new CAR-T therapies alone.2 As promising as these therapies could be, they represent a series of challenges for payers.
First, all IO therapies are generally expensive, befitting their high level of innovation. Second, in the case of personalized therapies such as CAR-Ts the fact that each patient’s therapy has to be created based on that individual’s specific tumor means that they are priced extremely highly (often several hundred thousand dollars). In the near term, IO therapies will likely continue to be reimbursed. However, as competition grows and more cost-effectiveness data becomes available, payers will refine their management approaches. As a result, IO therapies will face greater scrutiny, as well as likely downward pressure on reimbursement.
This new, more challenging reimbursement environment could include restricted access, preferred coverage guidelines, and other cost-control measures. Biopharma decision makers must be prepared for this, and they must also be ready to get creative, perhaps by executing risk-sharing or “pay for performance” agreements with payers.
In addition, the increasing use of combination regimens across many tumor types will spur greater payer scrutiny. This will likely be greatest in diseases such as multiple myeloma, which are characterized by multi-year treatment approaches and the use of combination regimens containing multiple targeted therapies.
No discussion of stakeholders would be complete without addressing patients. There is a continuum of ways in which biopharma companies can connect with patients. At a high level, the key points on that continuum can be described as:
- No Outreach – This has been the traditional approach in most places, and generally considered the lowest risk, particularly in oncology.
- Direct-to-Patient (DTP) – DTP outreach can range from brochures placed with primary care physicians, to online ads targeting people who search using terms related to certain malignancies, to other forms of direct patient engagement.
- Direct-to-Consumer (DTC) – Long a staple in the US in many therapeutic areas, DTC is newer in oncology, not widely deployed, and not without controversy. For example, Bristol-Myers Squibb encountered a backlash after then ran DTC ads for OPDIVO in NSCLC, as related in the New York Times in August of 2016 (Cancer Drug Ads vs. Cancer Drug Reality).
DTP and DTC outreach can be effective in getting patients to ask about a specific therapy when in their oncologist’s office, which can be a critical determinant in treatment decision-making, especially in tumor types with limited clinical differentiation between competing therapies. As patients seek to play an increasingly large role in their health management and treatment decision-making—driven in part by the use of wearables and mobile devices—companies should consider them an increasingly important stakeholder group with whom to interact.
Given the range of options, biopharma companies must consider their own business situations and determine how best to engage with patients. As time progresses, rising competition in oncology might demand that companies increasingly deploy DTC marketing in specific instances. In addition, DTP / DTC might help newer therapies get usage, thereby working around pathways that might not include them. While oncologists often must follow one guideline or another, they are usually given the flexibility to deviate from those guidelines for a certain percentage of patients. For newer therapies, DTP / DTC outreach may be one mechanism for helping encourage trial.
Exploring the Implications for Biopharma Companies
To engage with the stakeholder groups mentioned above—and drive commercial success—biopharma companies must understand the needs and determine the priority of each stakeholder for their specific therapy, and then develop strategies, messages, and programs specific to those needs. For those stakeholders most focused on understanding product value and controlling costs, biopharma companies must move beyond messages and collateral, and focus on new ways to leverage emerging data sets data to make compelling value arguments.
In most cases, those strategies will ultimately be implemented by companies’ field forces, which can encompass a range of commercial functions (Sales, Marketing, Payer Marketing, Account Management, etc.), as well as Medical Affairs. Now more than ever, it is critical to ensure that those field forces are properly organized, sized, equipped, trained, and integrated.
Doing this well requires solid analysis, articulation of business goals, and understanding of trade-off decisions. To succeed, decision makers must answer a range of questions, such as
- What is the optimum organizational approach for our customer-facing teams? Is it a structure that uses numerous highly specialized roles, with each focused on a specific area of expertise? Or, is it better to use an approach that emphasizes cross-training, so that fewer roles can handle more tasks, leaving only a subset of the most challenging cases to a small cadre of specialists?
- What’s the best way to foster effective cross-functional coordination across these teams?
- How can we maintain compliance in an era of increased coordination between commercial and medical teams?
The questions above are front and center as biopharma companies look to optimize their business models and the organizations that must implement them. In the next article, we’ll tackle some of these questions.
- IQVIA Institute for Human Data Science, Global Oncology Trends 2018, Innovation, Expansion, and Disruption, May 2018, p. 3, accessed 19 September 2018 at https://www.iqvia.com/institute/reports/global-oncology-trends-2018
- Jill Condello, Andrea Favaro, Martin Lachs, Rebecca Walker, “Access and Reimbursement for Adoptive T-Cell Transfer Drugs”, Pharmaceutical Executive, vol. 37, issue 12, 11 Dec. 2017, accessed 13 December 2018 at http://www.pharmexec.com/access-and-reimbursement-adoptive-t-cell-transfer-drugs