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Patient-Centered Drug Development for Oncology Products

Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes burdensome treatment regimens with uncertain outcomes. One patient struggles to take the correct dosage at the prescribed times through the “brain fog” caused by his cancer. Another’s livelihood is at risk as a three-week-long absence for chemotherapy treatments disrupts her ability to do her job. Another finds himself frustrated as he works to understand the complicated insurance coverage and reimbursement available for his treatment.

As a former senior executive of a well-established oncology specialty pharmacy, I saw first-hand how oncology patients often struggle not only against their devastating diseases but also with the clinical, financial, and emotional barriers that complex treatment regimens bring. Both patients and their caregivers can find themselves grappling with confusing, painful, or disruptive treatments which make compliance a significant challenge.

So how can we in drug development address these strains on the patient experience? There is a growing belief in the pharmaceutical industry that more patient-centric attitudes from the very beginning of drug development could ease unintended patient burdens. This belief has given rise to the patient-centered drug development (PCDD) model in recent years to address the apparent disconnect between manufacturers and patients. Whereas historically drug developers have been primarily focused on the novel science and concerned with satisfying regulatory requirements, PCDD revolves around the patients and incorporates their voice in each phase of development.

Definition of Patient-Centered Drug Development

In their conference titled “Assessing meaningful patient engagement in drug development: a definition, framework, and rubric,” Dr. Eleanor Perfetto and Elisabeth Oehrlein defined PCDD this way:

Patient-focused drug development is a formal process by which drug developers and regulators form a partnership with the patient to enhance drug development, research, regulatory, and reimbursement processes with the patient voice. This partnership engages patients to obtain as critical input their views, experiences, and preferences throughout a product’s lifecycle.

The PCDD approach stems from both the 2012 Food and Drug Administration Safety and Innovation Act and the 2017 Prescription Drug User Fee Act reauthorization. With these initiatives, the FDA has thrown its support behind the concept of PCDD and drug developers who incorporate the patient perspective to contextualize regulatory decision‐making.

The authors of the paper “Patient‐centered drug development and the Learning Health System” identify five key characteristics of PCDD:

  1. Patients are valued co‐researchers, informing decisions about unmet needs, trial endpoints, device design, trial design and execution, and evidence translation and dissemination.
  2. Developers systematically seek, well understand, and incorporate patients’ views of value, benefit, and risk into all phases of development.
  3. The research process is more transparent and well-understood by patients.
  4. Clinical research participation is more convenient for patients and is seen as a care option.
  5. Development includes caregivers’ perspectives.

Questions to Ask During PCDD

When patients are engaged from the beginning of a product’s development, the long-term advantages for all parties cannot be understated. PCDD can improve the patient experience and lead to increased adherence by enabling positive changes in many areas:

Patient Experience

  • Capacity of the patient: What is the average age of your patient population? At what stage of therapy will your treatment be administered? How will such demographics affect the patient’s ability to comply with a product’s regimen?
  • Dosage timing: Many oncology patients experience “brain fog” and therefore struggle to keep track of dosage amounts and timing. Can regimens be simplified to improve adherence and reduce the chances of medication errors?
  • Delivery method: Both IV and oral delivery have benefits and drawbacks, so which is right for your product? Is there a way to make combination pill and IV therapies less confusing for the patient? Is a too-large pill getting in the way of patient compliance?
  • Day-to-day disruption: When a patient must spend three weeks travelling to a treatment center each day and then sitting in a chair for eight hours, it naturally disrupts that patient’s life and livelihood. How can such onerous interruptions be mitigated?
  • Side effects: Side effects from oncology treatments are notoriously grim. Can these be mitigated or better managed by getting early-development patient input?

Third-Party Integration

  • Caregivers: Many patients rely heavily on caregivers at home to assist with their treatments, so how can understanding their concerns and difficulties assist in your development program?
  • Providers: What factors will make providers more likely to prescribe your drug over other treatments?
  • Payment schedules: Oftentimes, a disconnect occurs between dosage timings and the schedules by which payers fund treatments (for example, when a 30-day limit is placed on payment for a 60-day regimen). How can this logistical difficulty for the patient be eased?
  • Payer reimbursement: Occasionally when a combination therapy is prescribed, it requires drug products from two different manufacturers — this leads to separate copays, cycle times, payment structures, nursing support, and copay programs for the patient. Can the two disparate systems be unified to create a cohesive experience?

Implementation of PCDD

Developers need to start considering the holistic patient journey at the earliest stages of strategy development. At Camargo, we treat the patient as our “North Star” by beginning with the end in mind and integrating patient engagement along the way.

By understanding the clinical, financial, and emotional needs of the patient over time, we can map an integrated, longitudinal patient journey, rather than a snapshot at a point in time. To that end, we often engage key opinion leaders from both the clinical and the payer communities to gain their front-line therapeutic expertise, which is critical to gain an accurate, holistic patient viewpoint.

Camargo’s inter-disciplinary expertise is carried out through a Regulatory, Scientific, Medical, and Commercial approach to drug development. Of these four disciplines, both Medical and Commercial focus on the patient and provider experience as operational benchmarks. By using this method, Camargo can isolate a product’s therapeutic advantage point that elevates both patient outcomes and the provider experience.

Contact Camargo today to find out how we can help you map the patient journey for your product and adopt a patient-centered approach in your development program.


Author:
Dan Duffy
Chief Executive Officer