Evolution of US Payer Management of Oncology, a Study of Non-Small Cell Lung Cancer (NSCLC) and Chronic Lymphocytic Leukemia (CLL)
Through Two LabsAnne Runyan, Daniele Severi-Bruni, Joe Honcz and Mason Daniels. Two Labs is a leading pharmaceutical company based in Columbus, Ohio.
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Background and Introduction:
It is well known that the cost of oncology drugs in the US is high and rising. Between 2015 and 2018 alone, U.S. spending on oncology drugs grew 64% from $23.7 billion to $56.7 billion.[i]. Despite the large increase in costs, US payers have historically not actively managed oncology drugs. Research conducted in 2017 confirmed that payers primarily managed oncology drugs with traditional clinical management tools, such as pre-authorizations, incremental adjustments, and amount limits, which were mostly ineffective in controlling costs.[ii].
To better understand how US oncology payer management has evolved over the past three years, we conducted an online survey of 25 pharmacy directors and medical directors of US insurance companies. The study also looked at whether there were differences in management when looking at different indications within oncology. The people surveyed represented a total of 112.5 million lives covered. We have also developed a formula tracker that analyzes Pharmacy Benefit Manager (PBM) exclusion lists for 2021 to better understand whether payers are beginning to actively manage categories within oncology. Finally, we had an in-depth conversation with a former P&T decision maker with experience at multiple managed care organizations nationwide.
While payers do not actively increase management in oncology as a whole, each oncology indication seems to be considered individually. We are starting to see a growing variability in the level of management across different therapeutic areas of oncology. There are several characteristics to consider when determining whether an indication in oncology can be managed by payers: size of the patient population, disease severity/severity, availability of clinical trial data that can be used to direct funds to compare, and the level of competition.
Payers are less concerned about managing indications with smaller patient populations because the overall budget impact of these indications still remains manageable and there is usually not enough competition to allow for differential management of therapeutically similar agents. For indications with a higher mortality rate, payers are hesitant to limit physician choice in any way. It is more challenging for payers to manage indications when there is a lack of comparable evidence for different products. The emerging opportunity for tighter management is in disease states that are increasingly crowded with competitors, with very similar clinical evidence, and with a disease state that is less aggressive. It is in these areas that some payers demonstrate willingness and ability to manage.
Findings by disease area:
Chronic Lymphocytic Leukemia (CLL)
It is estimated that 21,040 individuals in the US will be diagnosed with CLL by 2021. Patients are diagnosed at age 70 on average. Despite an oncological indication, this disease has a favorable prognosis with a five-year survival rate of 85%.[iii]
In recent years, Bruton Tyrosine Kinase (BTK) inhibitors have shifted the standard of care in CLL[iv]. There are currently three BTK inhibitors on the market: Brukinsa, Calquence and Imbruvica. A fourth product, Venclexta, is also indicated for the treatment of CLL and has comparable data to the BTK inhibitors. These drugs come with a high price tag, with a WAC/year ranging from $157,497 to $181,669 and a three-year cost of up to $545,007.
Due to the high cost and potential for long treatment duration, payers in our sample rated the overall budget impact of BTK inhibitors as high (Figure 1)
The way clinical trials are designed allows for indirect comparisons of the safety and efficacy of each CLL agent. The resulting analysis shows that there is minimal differentiation between products (Figures 2).
When payers were asked to rate the therapeutic value of each BTK inhibitor on a scale of 1 to 5 where 1 is no therapeutic value and 5 is a breakthrough therapeutic innovation, they gave similar scores for each agent (Figure 3)
None of the payers in our sample were currently administering a BTK inhibitor outside of NCCN guidelines in 2020. In three to five years, four payers expected to administer at least one BTK inhibitor more restrictively than product label and placement in NCCN guidelines.
However, when the PPE exclusion tracker was analyzed, we found that Express Scripts (ESI), a PPE impacting more than 60 million lives, listed Imbruvica and Venclexta as preferred options and excluded Calquence from the formulary.[v].
Talks with a former payer indicate that if ESI has taken this action, other PPE and Managed Care organizations are likely to follow. He notes, “No one wants to be the first to take action, but once someone else does, others will be quick followers.” He compares this with other disease categories that have traditionally been ‘no touch’, such as HIV. As HIV treatment shifted from multi-tablet regimens (MTR) to single-tablet regimens (STR), payer began to introduce slow use management (UM) tools, such as pre-authorization and step therapy. The frequency of UM tool increased in direct relation to the increasing number of STR approved. Today, most payers have followed suit and the category is now better managed than it has been in the past 20 years. He notes that there have also been similar tipping points in anti-infectives and that it is a trend we are now seeing with an increasing number of biosimilars.
Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common form of lung cancer and accounts for 84% of all lung cancer diagnoses. The prognosis for NSCLC patients is poor, with NSCLC accounting for 25% of all cancer deaths and a low five-year survival rate of 25%[vi].
Immune checkpoint inhibitors, such as PD-1 and PD-L1 inhibitors Keytruda, Opdivo and Tecentriq, have significantly improved the standard of care in NSCLC[vii].
Compared to CLL, payers in our sample rate the budget impact of PD-1 and PD-L1 inhibitors as moderate and lower than CLL, but expect this to increase in the future (Figure 4).
As with CLL, payers see minimal differentiation between products and rate all PD-1/PD-L1 inhibitors as moderate to high clinical value (Figure 5). However, we understand from a literature review that in NSCLC it is difficult to directly compare products, due to the way clinical trials are set up[viii].
Today, all but one of the payers in our sample report that they are administering PD-1/PD-L1 inhibitors according to NCCN guidelines. While five payers expect to run these agents more restrictively in three to five years, this can be difficult in practice.
Assessment of the PPE exclusion tracker and MCO formulations confirm that PD-1/PD-L1 inhibitors are not limited to outside the label or NCCN guidelines. Talks with a former payer show that the only constraint payers currently use in NSCLC is to limit the place of care for expensive agents like Keytruda.
There are several reasons why BTK inhibitors are a good category for payers to exercise control. The relatively high budget impact makes management a priority. The availability of data across products makes it possible to indirectly compare these agents and choose preferred and non-preferred options, while providing physicians with effective treatment options. Payers have a degree of comfort in managing CLL because of the level of sharpness. The disease has a lower death rate than other cancers and there is more time to treat patients, and therefore more time to try different drugs.
Payers in our study rate the budget impact of NSCLC treatments as lower than that of CLL agents. The way clinical trials are set up makes it difficult to compare products, causing management hesitation among payers. The high morbidity rate leaves little room for error and, as a result, payers are hesitant to limit the choice of doctors. However, payers in our sample expect the budget impact of PD-1 and PD-L1 inhibitors to increase in the future. As the budget impact grows, the data matures, the category gets busier and payers feel more comfortable managing indications within oncology, NSCLC will be an important indication to monitor.
Overall, when considering the future of payer management of oncology drugs in the US, it will be helpful not to think of oncology as a whole, but as a series of disease states, each with unique characteristics and considerations.
[i] IQVIA, Global Oncology Trends 2019, Therapeutics, Clinical Development and Health System Implications, Institute Report, May 2019
[ii] Runyan A, Banks J, Bruni DS. Current and Future Oncology Management in the United States. J Manag Care Spec Pharm. 2019;25(2):272-281. doi:10.18553/jmcp.2019.25.2.27
[iii] Leukemia – Chronic Lymphocytes – CLL – Statistics. lobster.net. Published June 25, 2012. Updated January 2021. Accessed April 21, 2021. https://www.cancer.net/cancer-types/leukemia-chronic-lymphocytic-cll/statistics
[iv] Cote B. Research efforts abound as the role of BTK inhibitors continues to evolve in CLL. onclive.com. Accessed on April 21, 2021. https://www.onclive.com/view/research-efforts-abound-as-the-role-of-btk-inhibitors-continues-to-evolve-in-cll
[v] Internal Two Labs Formulary Tracker Database
[vi] Lung Cancer – Non-Small Cell – Statistics. lobster.net. Published June 25, 2012. Updated January 2021. Accessed April 21, 2021. https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics
[vii] Yoneda K, Imanishi N, Ichiki Y, Tanaka F. Immune checkpoint inhibitors (ICIs) in non-small cell lung cancer (NSCLC). J UOH. 2018;40(2):173-189.
[viii] Fessas P, Lee H, Ikemizu S, Janowitz T. A molecular and preclinical comparison of the PD-1 targeted T cell checkpoint inhibitors nivolumab and pembrolizumab. Semin Oncol. 2017;44(2):136-140. doi:10.1053/j.seminoncol.2017.06.002
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