Will COVID-19 quarantine checkpoint inhibitors?

With respiratory function being a primary concern for COVID-19 patients, Kantar considers the top implications of COVID-19 on checkpoint inhibitor utilization among non-small cell lung cancer (NSCLC) patients.
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Kelly
Blinzler

Vice President, Health Division

Michael
DeStefano

Client Services Director, Health Division

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Approximately 1.7 million Americans1 are diagnosed with cancer each year. Nearly everyone who needs chemotherapy spends time in physician offices (>50%) or a hospital site of care (~40%) to receive their infusion therapy. Although there are home health care infusion services, this represents only 3% of overall cancer infusion therapy.2

The COVID-19 pandemic has led to extensive changes in healthcare delivery, accessibility of personal protective equipment (PPE), transportation, and the need for social distancing.

The potential impact of COVID-19 on cancer patient care and treatment may vary based on specific patient circumstances. The calculus of weighing the risk/benefit of treating by infusion during the pandemic varies between cancer types (e.g. indolent vs. aggressive). Lung cancer poses specific challenges because patients are often diagnosed with advanced/metastatic (stage IV) disease creating a general urgency to treat with infusion therapy. Half of all stage IV NSCLC patients have a regimen including checkpoint inhibitors (CPIs).3 Current checkpoint inhibitors include: Keytruda (Merck & Co), Opdivo (BMS/Ono), Tecentriq (Roche/GNE), and Imfinzi (AZ).

Recognising that lung cancer is second in incidence behind breast cancer, that checkpoint inhibitors are standard of care for a large segment of stage IV NSCLC patients, and that respiratory function is a key concern among COVID-19 patients, Kantar considered the top implications of COVID-19 on checkpoint inhibitor utilization among NSCLC patients.

Method

Kantar conducted a Delphi study with a diverse group of eight Kantar experts including those with subject matter expertise in oncology therapeutics, epidemiology, forecasting, market access, marketing strategy and sales. The study incorporated two rounds of pre-surveys followed by a virtual discussion to achieve a consensus of the factors most likely to impact checkpoint inhibitor usage in NSCLC. Factors discussed include patient characteristics, physician perceptions, NSCLC regimens, sales representative disruption, site of care for administration, patient affordability, and epidemiology.

Results

To assess the top factors of COVID-19 that may impact checkpoint inhibitor utilization in NSCLC during the short term (March through July), it is important to consider each patient journey and the specific segments most likely to be impacted. For example, metastatic NSCLC patients with tumors harboring ALK rearrangements or EGFR mutations are likely using oral agents which alleviates the need to travel for regularly scheduled infusion treatments; thus, these segments are less likely to experience deferral of therapy due to COVID-19. For this reason, Kantar focused mainly on metastatic NSCLC patients without ALK rearrangements or EGFR mutations in which infusion therapy is standard of care.

Checkpoint inhibitors are administered through infusions and depending on the product, every two to four weeks. In the current environment both infusion providers and patients must weigh the risk and benefits of a disruption in therapy versus risk of exposure to COVID-19 by coming in for regularly scheduled infusions. Additionally, there may be some delay in patient diagnosis based on reduction in numbers of patients seen per day.

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Human Factors

Kantar experts identified several human factors (physician and patient perception) that may play into the decision surrounding deferral in therapy based on patient characteristics especially if patients present with fever or express fear to come to the infusion clinic. Patients at higher risk of a deferral are likely to be older, particularly 75 and older, have comorbid conditions, and have stable disease with their current lung cancer treatments.

Fifty-eight percent of stage IV NCSLC patients are 70 or older,3 and these elderly patients are among those at high risk for COVID-19. Immunocompromised patients and those with underlying respiratory conditions were considered most ‘at risk’ for deferring treatment, among NSCLC patients with comorbid conditions. There was also discussion of potential deferral among younger stable patients; however, this segment was deemed of lower likelihood for deferral compared to other listed groups. In addition, patient attitudes toward COVID-19 and continuity of their therapy will be balanced with physician recommendation.

Kantar considered whether the mechanism of action (MOA) of checkpoint inhibitors versus other infusion therapies might affect the oncologist view of which patients to defer. Fifty-six percent of stage IV NSCLC checkpoint inhibitor use is monotherapy and there could be potential for a different view of patient risk versus those on immunocompromising regimens, such as a platinum doublet.3 Although there is expectation that avoiding immunocompromising therapy is positive when feasible, Kantar experts do not believe oncologists will segment patients specifically due to the mechanisms involved in their regimens but will rather focus on the individual patient risk factors for contracting COVID-19. If data emerges suggesting that patients on immunotherapy (i.e. checkpoint inhibitors) are less likely to get COVID-19 than those on immunosuppressive therapy, there will be an opportunity for education on this dynamic.

Operational Factors

Manufacturers’ sales organizations have been unable to physically promote their products due to social distancing, including shelter-in-place orders by some state governments. Additionally, many professional conferences have been cancelled or moved to virtual platforms. A Kantar study among physicians4 identified 46 information sources that physicians use to learn about products beyond their personal experience. Social distancing requirements will impact frequency and methods in which brand messages are received, but Kantar does not anticipate the lack of in-person sales calls to negatively affect checkpoint inhibitor use. Checkpoint inhibitors are well-entrenched among metastatic NSCLC patients who do not have an abnormal “EGFR” or “ALK” gene. In addition, all products will face the same limitations. In this time of uncertainty, the market leader is likely to continue to be advantaged as the go-to brand and other brands may suffer for the loss of opportunity to grow share, but the checkpoint inhibitor class is unlikely to suffer from a lack of face-to-face promotion.

Quote 1

Operationally, infusion suites typically have several chairs within the same physical space. Guidelines for COVID-19 have been developed for kidney dialysis clinics which includes the 6-foot distancing in both waiting rooms and during dialysis.5 Additionally, if a patient has respiratory symptoms, they are ideally placed in a separate room from otherwise well patients. Kantar expects that infusion clinics may also adopt these strategies, although we did not find specific government directed guidelines for oncology infusions.

In addition, personal protective equipment will be needed for staff at a time when this is in short supply.

Quote 2

Not only will this potentially impact volume of infusions, but it will negatively impact the practice economics of the infusion suite due to staff cost for fewer infusions without an increase in reimbursement rates. Historically, the suites were all about volume with careful scheduling to maximize capacity. To meet capacity needs it is possible to expand days or hours of operation; however, this may not be feasible based on staffing requirements and need for PPE for additional personnel. A key question is if this will lead to longer term changes in infusion suite design, including practice economics, or further site-of-care shifts.

Kantar expects some deferrals in infusion administration due to infusion capacity constraints during the lockdown since there is not capacity of in-home health infusion services to make up this difference. Once the lock down is over, there will likely be an influx of patients, including new patients, that have had delayed diagnosis or treatment beginning with the bravest and followed by the more cautious.

Economic Factors

From an economic perspective, about three-fourths of NSCLC patients are 65 and older meaning the majority will have Medicare6 and many have supplementary health insurance for Medical benefits. For this reason, Kantar does not anticipate economic reasons to be a primary driver for a deferral in treatment among those older, comorbid patients. However, depending on the severity of the economic downturn, unemployment, loss of insurance and discretionary money there may be increased financial strain on the remaining 25% of patients and those without MEDIGAP. It will be important for manufacturers to pay attention and be prepared with co-pay and other support for patients. Affordability has always been an important factor in product utilization and the number of patients seeking support will likely increase.

Epidemiology

As discussed above, there are valid reasons to believe NSCLC patients may defer treatment to some extent based on analysis of human, operational and economic factors inherent with the therapeutic area and checkpoint inhibitor treatment. Deferred treatment will impact disease progression, and deferred visits to health care providers in general may impact diagnosis and detection of progression. As such, Kantar also considered whether these factors will impact NSCLC epidemiology and whether the impact will be short term or longer term in nature.

Overall Kantar believes there will be no underlying changes to NSCLC epidemiology when viewed from a long- term perspective (i.e., year over year over a 5 to 10-year period). However, Kantar anticipates shorter-term perturbations to the pattern of new diagnoses and progression, due to social distancing and the deferral of screening and the regular patterns of care.

Due to the COVID-19 pandemic, CMS expanded provider reimbursement to include tele-medicine which will allow practices to assess a patients’ status remotely and devise specific policies for patients that have suspicious respiratory symptoms. However, diagnosis of NSCLC and analysis of disease progression requires physician examination, biopsy, and laboratory tests thereby requiring in-person visits. Tele-medicine will not aid in continuation of new diagnoses nor the detection of disease progression in the short term for late stage NSCLC, suggesting there may be a temporary drop in the number of newly diagnosed cases during the pandemic. Unfortunately, there may also be a slight temporary increase in mortality from disease progression due to treatment deferral.

This temporary dip in newly diagnosed patients may result in a dip in treated patient starts over the next few months, but patient starts should resume post lockdown and include a bolus of patients who deferred therapy. Note, this assumes we end the lockdown over the next two to three months and there is no recurrence. If the lockdown continues or needs to be resumed the timeframe pushes out but the implications are still the same – slowdown in diagnosis and catching progression during the lock down followed by a bolus of patients for up to 12 months afterwards.

Quote 3

On a more practical level for forecasters, Kantar notes that this short-term impact is more likely to be reflected in specific product sales trend breaks than decreased patient numbers in the underlying epidemiology due to lag times of epidemiologic data. According to Kantar epidemiologists, we would not see an impact on NSCLC incidence using cancer registries, such as SEER (Surveillance, Epidemiology, and End Results), and other primary sources for another three plus years because of reporting lag times. Additionally, in order to see an impact in the overall population there would need to be large and prolonged changes in diagnosis rates. As discussed above, given our current assumption that the lockdown will continue for two to three months with no major resurgence of COVID-19, Kantar currently does not expect this to be the case.

Conclusions and Discussion

Kantar concluded that among the seven evaluated factors that most negatively impact checkpoint inhibitor utilization trends through July 2020, it is a combination of factors that will contribute to short term reduction in treatment. Those expected to have the highest impact include patient fears, physician view of patient risk / benefit based on individual circumstances, and some reduction in infusion capacity during the lock down.

Quote 4

The expectation is for a bolus of diagnoses during a ‘return to normal’ period which may increase the competitive opportunity between the checkpoint inhibitor brands. Although lack of personal sales promotion is not expected to shift overall checkpoint inhibitor trends, there is an opportunity to cause a shift in brand dynamics as the bolus of new patients cycle through the system.

A key question is whether there may be longer term adjustments to how practices and institutions evaluate and manage their oncology patients and infusion services. This could include tele-medicine and the expansion of the physical infusion space and growth of home infusion capabilities including expansion of these services by current providers. If these adjustments are incorporated into the provider practices, the health system will be better prepared to maintain patient treatments if a future outbreak occurs.

Reference

  1. National Cancer Institute
  2. Kantar 2018 Oncology Market Access Study
  3. CancerMPact® Patient Metrics 2019
  4. Kantar Medical/Surgical Physician Sources & Interactions Reports, 2018 and 2019 studies. Kantar Media Medical/Surgical Digital Insights Report, 2019 study.
  5. https://www.cdc.gov/coronavirus/2019-ncov/hcp/dialysis.html
  6. Kantar 2019 NSCLC Payer Mix
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