From Bench to Community Oncology Clinic: The Promise of Immunotherapy

Immunotherapy as a treatment modality for cancer has been studied for over 5 decades. However, with the recent surge in new treatment options, immunotherapy seems to have come of age. An increasing number of immunotherapy agents have been approved for multiple tumor types over the past few years, bringing the promise of a more effective and less toxic form of cancer treatment. However, as these agents are increasingly making their way from the bench to the clinic, we as community oncologists will have to learn how costly new immunotherapy agents will be incorporated into the changing reimbursement landscape.

The cost of cancer care in the United States is growing rapidly and currently represents 5% of total healthcare spending.¹ Costs are estimated to grow from $158 billion to $173 billion by 2020, reflecting an increase of 27% to 39%. Drug costs are a key driver of oncology spending, including immunotherapy and targeted agents—the per patient per year spending on chemotherapy has increased from 15% to 20%. The response to rising costs by both Medicare and commercial payers has been to explore various payment models including clinical pathways, the oncology medical home model, bundled payments, and the Oncology Care Model. The overhanging question is how will these new and potentially beneficial therapies be incorporated into payment models that are designed to contain the cost of cancer care?

Is QALY the Answer?

There is no question that those of us in community practice have seen some remarkable responses to immunotherapy. Pembrolizumab was first approved in 2015 for the treatment of metastatic melanoma based on improved overall survival (OS) and progression-free survival.² Subsequently, nivolumab received approval for non—small cell lung cancer (NSCLC), and more recently, atezolizumab received approval for platinum-resistant metastatic bladder cancer, also based on significant survival benefit. The cost of pembrolizumab before discount is $12,500 per patient per month or approximately $150,000 per year. Similarly, both nivolumab and atezolizumab cost approximately $150,000 per year.³

The Institute for Clinical and Economic Review (ICER) recently evaluated the cost effectiveness of all 3 approved immunotherapies targeting programmed death-1 (PD-1; nivolumab) or programmed death-ligand 1 (PD-L1; pembrolizumab and atezolizumab).⁴ The report, which analyzed the clinical benefit of each drug against cost and health-system affordability, found that that a “substantial minority” of patients had gained clinical benefit, but for those patients who did respond, there was a substantial improvement in OS. In terms of cost effectiveness, ICER estimated that atezolizumab cost $219,179 per quality-adjusted life year (QALY) gained, pembrolizumab cost $240,049, and nivolumab $415,950. The report placed a benchmark of $100,000 to $150,000 per QALY. To reach this benchmark, ICER estimated that atezolizumab would require a reduction in its wholesale acquisition price (WAC) of 31% to 53%. For pembrolizumab, the WAC would require a reduction of 39% to 61%, and nivolumab would require a reduction of 57% to 68%.

How do we as community oncologists manage the financial burden of these costly medications in our current buy-and-bill model? The current unit cost for pembrolizumab is $4650, and for nivolumab it is $3000. As community practitioners, we need to be very diligent about obtaining preauthorization and documentation to ensure timely payment. As the indications for immunotherapies expand, the financial burden on practices is expected to substantially increase. The out-of-pocket costs associated with these treatments can also be prohibitive for many patients. Practices will need a robust financial assistance program to help with patient copayments, either through foundation programs or through the pharmaceutical companies themselves.

Bristol-Myers Squibb started a direct-to-consumer marketing campaign for nivolumab, in 2015, that has cost approximately $125 million.⁵ The drug maker has stated that this aggressive direct-to-consumer approach is a way to facilitate discussions regarding immunotherapies between healthcare providers and patients.⁵ This approach by the company has received a fair amount of criticism from academic and community oncologists, as well as patient advocates. We have definitely noticed the effects of this marketing campaign in our practice. In our experience many patients have a misconception that these therapies represent a “miracle cure.” Marketing campaigns have certainly influenced patient opinions about immunotherapy. As a community oncologist, the onus is on us to temper patient expectations about these treatments and also to bring up cost-benefit discussions with patients.

Looking Ahead

So where are we in this age of immunotherapy? I think we would all agree that this new treatment modality has the potential to revolutionize the practice of oncology. We are now seeing immunotherapies gaining wider use in the frontline setting in both metastatic melanoma and NSCLC. However, using these new therapies in the clinic has shown that they are far from a “miracle cure.” Many patients fail to respond to immunotherapy.

Oncology as a whole must shift away from the one-size-fits-all treatment model. As newer therapies emerge, resources must be directed to identify those patients who would actually benefit from newer treatment modalities, allowing both patients and practitioners to make more informed treatment decisions. With the expansion of big data, we in the community should anticipate a shift in focus towards patient outcomes, because in the coming years, both payers and patients will demand treatments based on value. We in the community will be on the frontline of this changing landscape. In our current structuring of oncology care, immunotherapies will not remain an affordable treatment modality in the future.

There are several important questions that we must ask ourselves going forward, a key one being ‘How will community oncologists be able to incorporate emerging therapies and maintain financial viability?’ As I have previously mentioned, mitigating patient expectations regarding immunotherapy and honest discussions regarding the cost of these agents compared with potential benefits are a must. We also need to advocate for more research into identifying markers that would predict benefit, allowing practitioners and patients to have an informed discussion about the treatment plan.

Sumeet Chandra, MD, is a medical oncologist at Medical Associates of Brevard in Melbourne, Florida.

ADDRESS FOR CORRESPONDENCE

Sumeet Chandra, MD

Medical Associates of Brevard

2290 West Eau Gallie Boulevard, Suite 202

Melbourne, FL 32935

E-mail: sumeetchandra@gmail.com

Community oncologists will be at the forefront in this emerging age of immunotherapies and will need to be strong advocates for greater information and affordability of these new and potentially groundbreaking therapies. REFERENCES

1. Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011;103(2):117-128. doi: 10.1093/jnci/djq495.
2. Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372(26):2521-2532. doi: 10.1056/NEJMoa1503093.
3. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non—small-cell lung cancer. N Engl J Med. 2015;373(17):1627-1639. doi: 10.1056/NEJMoa1507643.
4. Institute for Clinical and Economic Review. Treatment options for advanced non-small cell lung cancer: effectiveness, value and value-based price benchmarks. Institute for Clinical and Economic Review website. https://icer-review.org/wp-content/uploads/2016/08/MWCEPAC_NSCLC_Evidence_Report_Plus_Supplement_101716.pdf. Updated October 7, 2016. Supplement October 17, 2016. Accessed December 29, 2016.
5. McCaffrey K. DTC ads for Opdivo face further backlash. MM&M website. http://www.mmm-online.com/campaigns/dtc-ads-for-opdivo-face-further-backlash/article/516023/. Published August 15, 2016. Accessed January 9, 2017.

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