Stakeholders in commercialization of oncology

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Varshit Dusad

Oncology is a vibrant research area with many exciting discoveries unfolding every year, each  emerging from research labs all over the world. However, the road from innovations in the lab to successful commercial realization in the real world is long and challenging. For a new therapy and drug to be viable for patients globally, stakeholders need to be convinced beyond a reasonable level of doubt that a proposed therapy or drug enhances the overall quality of a patient’s life, more so than existing treatments. Moreover, there is tremendous pressure on oncology companies to rapidly gain market value and maintain it due to increasing competition. This has led to a proliferation in medical affairs activity in oncology companies to ensure that they win the confidence of the stakeholders early on in the product development process. In doing so they attempt to optimize commercial product release in lines of stakeholder’s expectations.

But who are these stakeholders? Let’s take a look at the ten most important stakeholders (not necessarily in order) in oncology.

1. Oncologists: Oncologists are the most important stakeholders in successful commercialization of an oncology product. As they directly interact with the patients and prescribe treatments, they play an invaluable role. Oncologists have access to the real-world treatment complications that can arise, those of which may or may not have been covered satisfactorily in clinical trials of the drug/therapy. If the latter, oncologists may resist prescribing the novel drug to the patient due to doubts on their real world efficacy.. Earning the trust of oncologists is paramount and it is fruitful to gain their opinions early on in the development process. This ensures that maximum possible complications are scientifically addressed before the commercial release of the product.

2. Key Opinion Leaders (KOLs): These are perhaps an equal or close second most important stakeholders in oncology. Key opinion leaders refer to leading experts on the drug/therapy developed by an oncology company, either in the entire world or in the local geography where the product is being launched. These KOLs often participate in development of regional, national, and international guidelines for treatment of the particular sub-therapeutic area which is targeted by the novel drug/therapy. Thus, their opinion can shape the perception of government agencies, medical bodies, practitioners, and even the public towards the science of upcoming drugs and therapy. A new distinction that has arisen in KOL categories is those that are digital influencers on social media platforms. The top KOLs may not be active on social media, however rising stars in academia often are able to emphasize and promote their research. Because of their following they are also important stakeholders for the medical affairs team of oncology companies.

3. Nursing staff: Nursing staff may seem like a support team but nonetheless  play an important role in medical services. It’s the nursing staff which keeps a regular tab on the health of the patient, manages the inventories, and does all the preparation necessary for the medical treatment. With evolving drugs (especially combinatorial drugs) and advanced therapies, nursing staff need to be up-skilled with appropriate training and tools to manage the advanced level of care. Also, they should be able to correspond easily and effectively anytime with the oncology company especially in situations concerning adverse events arising in patients.

4. Regulatory agencies: Regulatory agencies are one of the oldest and most important stakeholders in all of the healthcare sector. No drug or therapy can be launched in a geography unless the regulatory agencies there have given approval for its sale. Each regulatory agency has their own criteria and outcome measures that must be collected in clinical trials before the drug/therapy is granted approval. Fortunately, since communication between industry and regulatory agencies is old, there are systems placed on both sides to interact and coordinate. Nonetheless, the evolving landscape requires constant communication that needs to be on both sides so that these agencies  are abreast towards the latest changes. For example, companies need to watch out for accelerated programs such as “Breakthrough therapy” which allow a fast-track approval of drugs if they can offer significant advantage to an unmet demand in the market. Similarly, regulatory agencies need to understand the risks and advantages of novel therapies such as CAR-T therapy because unlike traditional treatments they are more expensive, require sophisticated infrastructure, and highly trained personnel. This makes it necessary for regulatory agencies to update their guidelines to fit the emerging landscape of oncology treatment.

5. Patients: Patients are increasingly becoming a more important stakeholder in the commercial side of oncology. One might wonder why they were not always the most important stakeholder. From a commercial aspect, the patients used to have lesser choice and information when it came to oncology treatment. However, with increasing competition in the industry, multiple products with similar clinical features are available in the market. Thus, the patients have the power of choice and also prefer to make more informed decisions in this digital age due to the easy accessibility of information. Thus, it is in the best interests of oncology companies to engage with patients directly and win them over.

6. Payers: Payers have always been an important stakeholder for oncology companies as they reimburse the treatment costs  that are the source of revenue for oncology companies. Different geographies have different payers. For example, in developing nations the payment is out of pocket from patients, which means patients and payers are the same. In Europe, government-funded healthcare pays for treatment and in the US it’s the role of insurance companies. Different payers have different mechanisms for dealing with their expenditure and how much they can spend. Moreover, with increased cost of advanced therapies, the payment model is shifting towards a value-added model. Here, treatment costs are made in stages and reimbursed in full only if outcomes adds significant value to the quality of life of the patient.

7. Patient Advocacy groups: Patient Advocacy groups are non-profits representing the community of patients and their families suffering from a disease. They can also include top KOLs in the concerning therapeutic area as a spokesperson. The goal of PAGs is to spread awareness about the disease, promote solidarity among patients, and collectively push forward better legalization and measures for overall betterment of patients. Patient Advocacy groups are very important stakeholders as they are  one of the fastest and most trustworthy ways to spread the word about your medicine to the patients.

8. Group practices: As medical services are getting complicated several independent clinics have organized themselves into group practices to handle common complexities, challenges, and confusions they face in the evolving healthcare landscape. Oncology companies often work with these stakeholders as a unit in order to  represent a larger number of patients  instead of a single, fragmented practice. Together, they develop treatment guidelines and pathways, focusing on cost-control and communicating the value of their therapies.

9. Specialty pharmacies (SP): These are other stakeholders which provide direct access to patients as they provide specialist drug formulations, education to patients and caregivers, collect medical documentation relevant for payer authorization, and coordinate with providers regarding changes in dosage and treatment. Collaborating with specialist pharmacies can help in enhancing better treatment experience for the patient.

10. Practice Managers: These are the administrative units in clinics and hospitals. They are the ones who have to deal with all the administrative workload that comes with novel therapies and chase insurance companies for reimbursement of treatment. A smoother experience for them facilitates better experience for patients, payers, and oncologists. This is the long run that helps the companies the most. 

Oncology drug development is a complex task. However, the importance of proper communication, public outreach and satisfying concerns of patients and regulatory agencies cannot be undermined. All these stakeholders need to be satisfied for successful commercialization of drugs and therapies before it can reach out to patients who often desperately need it. Mutual engagement among all stakeholders in oncology will generate more transparency between patients and oncopharma companies, better coordination among medical service providers and overall faster turnaround in updating the oncology products with real world insights.

Edited by MaryAnn Bowyer

Works cited:

https://bluematterconsulting.com/complex-oncology-audience/

Image:

https://pixabay.com/illustrations/syringe-pill-capsule-morphine-1884784/