Guest Column | June 6, 2016

Cancer Care's Evolving Recovery And Remission Phase Demands Evolved Medical Devices

By Harshal Shah, Cambridge Consultants

In the last few decades, cancer research has received one of the highest shares in global R&D spending. This has driven the fast-paced introduction of new cancer medicine, including a new generation of kinase inhibitors, new targeted immune-therapies, and newly formulated chemotherapy agents, all of which are helping manage side effects and improve overall prognoses in cancer care. One striking effect of such innovative medicines is the improvement in progression-free survival and overall cure rates. With today’s gold standards of cancer care, treatment and progression-free survival average four years — a drastic improvement from a few decades ago, when the average was six months.

As a result of prolonged treatment, remission, and recovery phases, much of the care can now be delivered in an outpatient setup. Patients can visit oncology or infusion centers to get their routine drugs administered while still maintaining an engaged and normal life, as far as possible. Such transformation in the cancer patient journey resembles more closely long-term treatment of chronic conditions, as opposed to short-term treatment in an acute care setup.

However, one element of cancer care that is not aligned with the non-clinical, long-term care model is the availability of drugs on self-administration device platforms. For instance, drugs used to treat chronic conditions are often developed as combination products to enable routine administration by patients or caregivers at home, using injector pens or large-volume pumps. I believe cancer treatment will evolve to align with this type of long-term care, and will create solutions to administer at home with advanced delivery devices. Certainly, use of such self-administration platforms may differ depending on a variety of factors, including the patient’s health, pace of recovery, and treatment phase.

This article is the second in a four-part series exploring the role of innovation as it pertains to the distinct stages of cancer: diagnosis, treatment, remission and recovery, and palliative care. (You can view part one here.) 

Let’s start by examining what is driving the development of self-administration drug delivery platforms:

Patients’ Expectations — With more patients enjoying a better quality of life through the use of new self-administered therapies for other conditions, it is only natural to expect more from cancer treatment options. Educated patients would naturally ask why they cannot self-administer certain medications at home. And, having survived the toughest phase of their treatment, patients will also expect the lives of their caregivers and family members to return to normal, with fewer visits to hospitals and clinics.

Health Economics — As cancer care costs balloon, there are increased efforts to reduce those costs. That said, stakeholders understand that putting pressure on the cost of new, cutting-edge drugs is not ideal, as it undermines the motivation to spend toward future generations of cancer drugs. Additionally, from the health policy perspective, every visit to clinic by a cancer patient in stable condition, and every drug administered via IV, with the patient spending hours in infusion chair, has a cost in terms of time or money for everyone involved — patients, family members, nursing staff, and physicians. This scenario, in particular, has the highest potential to build a health economics case supporting greater investment in delivery devices and cancer drugs formulated for administration in a home setup.

Advanced Technologies — With the evolution of the modern care model for chronic conditions, we have seen rapid innovation in drug delivery devices and formulation technologies. Advanced formulation technologies offer the possibility of synthesizing drugs with a wide variety of physiological properties for subcutaneous administration; such technologies also create opportunities to develop cancer drugs and delivery devices suitable for self-administration.

In summary, the opportunity drivers strongly support innovation in cancer treatment and a push for self-administered care. To take steps in this direction, it now is more a matter of strategic focus from leading stakeholders in oncology care. Companies like Roche and Amgen have already demonstrated their inclination toward this idea, offering their blockbuster drugs Herceptin and Neulesta on pump devices.

Despite feasibility from a formulation and device technology point of view, several challenges remain before complex drugs can be offered on self-administration platforms. Several device characteristics could help resolve those challenges:

Form Factor — It’s important to have a small form factor for devices designed to deliver daily medication for chronic conditions (such as diabetes), but this factor takes on a reduced importance when designing such platforms for cancer medications.

Since most drugs for cancer care are not administered on daily basis, devices with bigger form factor or larger footprint are more widely acceptable. They must, however, eliminate the need to visit a clinic, and they must not require the patient or caregiver to go through the lengthy and often difficult re-constitution phases.

The focus is not solely on making the device miniature, discreet, or accommodating of an individual’s rugged lifestyle. The focus is instead on avoiding clinic visits and creating easy, error-free administration.

Durable And Versatile — While disposable device design might be the norm for chronic condition drugs, it may not be well aligned with complex cancer drugs and their wide array of physiological properties, which often require expensive engineering. Instead of focusing design on a single use for a specific type of drug, it might be more appropriate to consider a device platform that enables administration of a variety of drugs through different stages of cancer treatment. Versatile and durable systems that could auto-reconstitute and administer drugs in combination, or in sequence with other drugs, may be the most suitable element of a device designed for oncology care.

Closed-Loop Connectivity — A number of oncology drugs are administered contingent on a patient meeting certain level of “healthy” vital signs and demonstrating certain criteria on specific blood tests. A web of devices already exists to monitor vital signs and perform blood tests in a home care setup, but the key is to design these devices in conjunction with drug delivery devices for complex oncology drugs, and to create a platform that evolves the home diagnostics ecosystem and health monitoring devices.  The future of oncology care in prolonged recovery and remission is a concept by which physicians can remotely authorize administration of necessary drugs, based upon an examination of blood and vitals reports received from patients’ connected devices.

Device Cost — While delivery platforms and drugs for most chronic conditions have become commoditized, this is less so the case for cancer treatments. Most breakthrough cancer drugs command significantly higher prices in mature healthcare markets. Due to fierce competition in the cases of drugs for chronic conditions, such as rheumatoid arthritis (RA) and diabetes, their margins are not as high as cancer drugs.

However, this price gap allows for room to absorb the cost of advanced engineering in devices designed for cancer care, as opposed to other diseases with “commoditized” treatment options. In other words, payers would be willing to consider advanced and high-value devices that could save significant resources while reducing the overall cost of care and the disease burden.  

Thus, drug delivery platforms should be a primary focus of innovation for cancer’s recovery and remission phase, as they have a significant impact on improving patient’s quality of life, and there should be a significant market for them moving forward.

About The Author

Harshal joined Cambridge Consultants in 2015 as Head of Oncology Drug Delivery, focused on growing the company’s drug delivery business in the U.S. — in particular, expanding its offerings in the oncology space. With more than eight years of strategy and management consulting experience in pharmaceuticals, biotech, and drug-device combination products, Harshal has a deep knowledge and understanding of drug delivery device design, development, and commercialization. His past experience includes working with Bristol-Myers Squibb, Johnson & Johnson, PRTM Management Consultants, and managing his own practice as principal of Labyrintheus Consulting.