Value Considerations in The Non-Metastatic Stage of Prostate Cancer

In 1853, the first case of prostate cancer was documented and described as “a very rare disease.”¹ Now, more than 150 years later, prostate cancer has become one of the most common diseases among men, leading to a large number of deaths worldwide.²

Innovative treatments have delayed progression of the disease but some patients experience side effects that impede their quality of life. If we are to achieve increased value in prostate cancer treatments, we must consider placing patients and their physicians at the center of development while health systems should make patient and physician experiences a central aspect of value assessments.

Health costs for prostate cancer more than double after metastasis

Metastases – the spread of cancer cells to new areas beyond the original tumor site – represent an important driver behind patient suffering and death from prostate cancer.³ Once the cancer spreads, the outlook for patients becomes worse. Research shows there is a clear link between delaying the spread of disease and improving patient outcomes.⁴ In addition, studies following men with non-metastatic castration-resistant prostate cancer (nmCRPC) throughout the continuum of care have shown that yearly healthcare resource use and costs have more than doubled once the cancer metastasized.^[5]

Putting patients at the center of development and value of innovative medicines

Men in the non-metastatic stage are slightly younger than those in the metastatic stage and the daily reality of treatment side effects can limit a man’s ability to stay fit and work. These are active men who are used to living a certain way and they want to maintain that lifestyle. Side effects such as fatigue and, specifically, cognitive impairment, hinder their vitality and physical and emotional wellbeing, which, in turn, can cause a spillover effect to family members.

It is therefore important to continually invest into our understanding of such diseases. This will allow us to search for new therapeutic approaches and introduce the much-needed treatments that can prolong and improve patients’ lives. The complexity of cancer means that patients have different treatment objectives and therefore require distinct treatment plans. Health systems should make patient experiences a central aspect of their value assessments.

Value in oncology innovation is multi-faceted

Indeed, one can think of value in oncology innovation as a prism with many viewpoints:  patients, family members, caregivers, governments, payers, and scientists each have specific perceptions of value. The value of improved  survival  is  clear  to  all  stakeholders,  but  limited  disease progression, decreased comorbidities, improved quality  of  life,  reduced  burden  on  family  members  and  health systems, and a host of other benefits are also critically important.

In many countries, the value and corresponding price of an innovative medicine is determined on the perceived benefit the medicine provides over an existing medicine, frequently based on overall survival benefits. These value assessments often do not take patient input into account which can limit access to or reimbursement for these medicines in spite of clear quality of life and other benefits that may not be observed in early trials. We again stress here the importance of a holistic and patient-centered understanding of the value of innovative medicines. This requires health systems to make patient experience part of their value assessments.

Bayer’s commitment to advancing the science of prostate cancer

At Bayer, one of our key focus areas within oncology is prostate cancer, and we remain committed to helping men not only live longer, but also to maintain and optimize the quality of that prolonged life.

Despite recent medical advancements, gaps persist, particularly in providing patients with treatments that extend survival while allowing patients to preserve their lifestyles. Given the profound burden of prostate cancer, Bayer is making significant investments in developing treatment options, with the goal of delaying progression and optimizing how to best treat patients in both advanced prostate cancer and across various stages earlier in the disease process.

The relevance of adverse events in nmCRPC:  a value-based perspective

As noted, while nmCRPC therapy has seen a rapid pace of innovation recently with the introduction of second-generation androgen receptor inhibitors, arguably the next frontier is the need for a holistic approach based on the overall risk-benefit of treating at this relatively asymptomatic stage of the disease.

Amongst the broader set of potential side effects of current nmCRPC therapy options are specific adverse events (AEs) that include: fatigue, falls, fractures, seizures, cognitive impairment, rash, and hypertension. Importantly, these AEs may occur at higher rates in a real-world setting than in a clinical trial.

A number of these AEs can be associated with significant medical cost implications; thus, more tolerable therapies may be able to positively impact (offset) such medical resource use and cost. Furthermore, a treatment which provides long-term tolerability would increase the ability for patients to remain adherent, ultimately receiving sustained benefit from therapy and delivering higher-value care.

We are serious about achieving improved patient outcomes for those men with nmCRPC. We are committed to providing more innovative treatment options that put patients and their experience at the core of the development process. We implore healthcare systems to do the same, and put patient and physician experience at the center of value assessments.

Sources:

¹ Adams J. The case of scirrhous of the prostate gland with corresponding affliction of the lymphatic glands in the lumbar region and in the pelvis. Lancet. 1853; 1:393.
² GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. Prostate Cancer. Last accessed February 2019
³ Kirby, M et al., Characterising the castration-resistant prostate cancer population: a systematic review. Int J Clin Pract, November 2011, 65, 11, 1180–1192.
⁴ Ibid
⁵ Valderrama, A., Tangirala, K., Babajanayan. et al, Healthcare Resource Utilization, Costs and Treatments in a US Population of Non-metastatic and Metastatic Castration Resistant Prostate Cancer. Poster presented at the 18^th Annual Meeting of the Society of Urologic Oncology; 2017 November 29-December 1; Washington, DC.