Guest Column | March 8, 2016

How Medtech Can (Profitably) Improve Palliative Care Patients' Quality Of Life

By Harshal Shah, Cambridge Consultants

Cancer care is one of the biggest segments of healthcare spending.  An increasing patient population, advanced therapies, and improving, progression-free survival have all contributed to the segment’s overall cost burden. Treatment costs for patients have grown rapidly over the last decade, fueling debates with conflicting opinions from industry, healthcare providers, policy makers, insurers and patient advocacy groups.

While cost savings and quality of care are typically thought of as contrasting elements, medical technology and innovation have the power to improve both quality of care and the overall patient journey, while simultaneously supporting cost savings and reducing overall disease burden on the healthcare system.

In this four-part series, I will explore the role of innovation as it pertains to the distinct stages of cancer: diagnosis, treatment, remission and recovery, and palliative care.  The opportunities to improve quality of life through different phases of the patient journey are vast, and they start with developing and improving products with out-of-the-box thinking, integrating the latest technologies, and growing our understanding of patient needs — aligned with the economics of cancer care.

The Most Difficult Stage (And The Most Ignored)

Let’s focus first on the final stage of the patient journey, as it typically is the most ignored stage in terms of improving patient quality of life: Palliative care, specialized medical care for patients living with a terminal illness.

The focus in this stage of care is not on curing the disease, but rather treating and managing symptoms, side effects, and conditions that impact quality of life. In cancer care, a large number of patients continue to receive second- or third-line therapies to minimize the growth and spread of the cancer, and (hopefully) to slow deterioration of the patient’s condition.

This stage gets the least attention from both industry policy makers and thought leaders. Several factors contribute to this lack of attention and lack of motivation to invest in improved palliative care.  For example, until 2010, in the United States, most private insurers had lifetime maximum caps on reimbursements, and a large number of cancer patients under palliative care would have exceeded or come very close to exceeding those maximums.  Reimbursement scenarios and ROI usually govern the interest and investment from private sector innovation.  

On the other hand, universal coverage programs like Medicare and Medicaid have a chronic issue of budget constraints, and naturally put emphasis on bare minimum coverage, without consideration for patient experience and quality of life through the palliative phase of treatment.  Moreover, the standard of care established by such government-funded programs stopped evolving due to a budget crunch that leaves no room to address holistic views of the disease burden.

Another challenge of bettering palliative care arises from the difficulty of building a health economics case — an essential element to getting reimbursement for any new innovation or technology. Reasons contributing to the difficulty of establishing a health economics case include the questionable reliability of qualitative feedback from patients about the different aspects of quality of life, psychological factors that drive patients to decline participation in trials, and patient focus on using their remaining time on things that matter to them.  

Resolving this challenge will require industry policymakers to differentiate their methodologies for capturing data for regulatory submission and building a case for reimbursement:  Trials intended to gain regulatory approval don’t need to follow the same guidelines as studies intended to build a health economic case. Instead of taking the traditional and scripted approach to clinical trials, a greater emphasis should be put on patient behavior, human factors, and user-centric studies. By playing a more engaged role, device developers will more effectively motivate the right sets of patients to enroll in user studies, which will ultimately yield quality outcomes and effective health economic cases.

Simple Innovations, High Impact

Patients with different types of cancers and at different stages of disease progression have different needs in terms of managing symptoms and side effects. They also differ in criteria for the priority and perception of comfort and quality of life. However, some of the central themes of palliative care remain consistent across different types of oncology patients, and at almost every stage of palliative care.  Those themes are managing pain, maintaining mobility, improving breathing, managing insomnia, and managing physiological and emotional aspects. When you observe conventional equipment for health monitoring and drug delivery, those technologies really do not align with management of these critical elements.

The key to preserving a patient’s physical, mental, and psychological health is to maintain their mobility for as long as possible through the disease’s progression. However,  most drug delivery equipment and monitoring devices tie the patient to a bed or otherwise restrict mobility. The most prominent symptom that patients need to manage is acute and chronic pain, and the most commonly used continuous administration equipment — IV pumps that deliver pain medications — requires patients to live with cables, pipes, and a desktop-sized machine going with them all the time.

While implantable pain medication pumps are a viable option for patients in the recovery or remission stages, they are not an option for patients in palliative care, due to increased risk of infection and surgical complications. But pain levels for most patients progress too rapidly to be managed by oral nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids. A similar situation arises when patients are prescribed continuous administration of psychoactive drugs, which are used to improve or maintain mobility, and to stabilize body movements. The drugs are supposed to maintain and improve mobility, but continuous administration effectively tethers the patient to a cumbersome delivery system or a bed.

One potential solution to keep patients free from hospital beds is patch pump technology —not a new concept, but one that could benefit from further development. A pump that stores multiple drugs and is wirelessly controlled by the patient or a caregiver could be a great innovation, helping to keep patients free from the clutter of tubes and heavy equipment. It also could greatly improve the patient experience by keeping them mobile, freeing them from the 24/7 monotony of being stuck in a hospital bed, at least until that measure becomes absolutely necessary. The benefits of introducing such a wearable pump device can easily justify its commercial potential, especially with the growing number of patients in palliative care. The more time they spend in the palliative care stage, the higher the cost-saving potential in indirect nursing spending.

Another area where palliative care could benefit from a more dedicated industry effort is management of problems related to breathing. While these issues are more prominent in esophageal cancer patients, most patients at some stage of disease progression need some help managing their breathing, drinking, and eating due to a contracting esophagus. The current standard of care is stenting, which keeps the esophagus expanded and aids all three functions.

However, single-diameter stents are designed to accommodate expansion enough for eating and drinking, and are not comfortable for patients who just need help with breathing. The idea of stents that can be expanded or contracted with a remote control are discussed frequently, but never pursued, for the same reason that traditional applications of cardio/endo stents do not require this feature: The volume of use in a palliative care setup may not justify the research and development cost.

However, we will likely see this situation turn around once there is a mechanism in place for reimbursing innovators in drug development for rare diseases. When medical device developers can charge a profitable price for such products, there will be greater commercial motivation for addressing such low-volume conditions, especially when devices can improve patients’ survival conditions for months or even years.

Innovations Must Address More Than The Patient’s Physical State

Palliative care has an impact on the patient’s mental and psychological health. A big factor in managing stress and depression is to help the patient maintain interactions with loved ones. The harsh reality of palliative care is that, for the most part, the patient’s loved ones are not involved in their care on a daily basis. There are a variety of factors that influence this situation, including family members’ need to continue working in order to maintain financial stability, other family commitments, and the location of patient’s care center versus their home.  

It’s difficult to imagine that, in this age of Skype and FaceTime, most patients in hospice and palliative care are unable to easily communicate with their loved ones. But with disease progression, patients can lose the ability to handle smart phones or tablets. Some patients forget how, or are not familiar with using smart devices. Furthermore, navigation through the apps and menus can be difficult, particularly for patients who have developed dexterity issues.

What would be most useful in this situation is a simple device — with just three or four buttons — that could establish a video call with the push of a button, contacting a person associated with that button.  The concept is similar to Firefly, a simple, five-button cell phone designed for children. These simple devices would enable patients to connect with their loved ones, and could improve their mental health to great extent.   

Communication devices that could be easily integrated with a hospital bed or monitor system are easy enough to develop, but the concept hasn’t received much attention so far. Such add-ons may not qualify for reimbursement; however, there would be a sizeable market of customers who would consider spending small amounts to stay close to an ill family member.

A Unique Goal Requires A Unique Approach

While understanding and qualifying patient needs in palliative care is a challenging task, developers who emphasize direct engagement with their designers, engineers, and innovators, building around the day-to-day lives of patients, have the best chance of staying ahead of the curve. This stage in the patient journey has single greatest dependency on patient preference and needs, as opposed to the needs of physicians, surgical oncologists, radiologists, or caregivers, who play critical and larger roles in the diagnosis, treatment, and recovery/remission phases.  Therefore, improved, cost-effective palliative care will require a different approach in identifying opportunities, developing products, building economic cases and, ultimately, commercializing the products.

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.