• Michael Misialek, MD

The Eye Popping Cost of Immunotherapy

Immunotherapy has taken the medical community by storm. With advances coming almost daily, new studies are giving researchers, doctors and patients new hope for conquering cancer. Immunotherapy has already shown successes in lung cancer, melanoma and brain cancer with more uses on the horizon. However, it comes at a cost, and that is a very steep price…in one instance, costing over $1,000,000 a year!

What is cancer immunotherapy?

Immunotherapy tackles cancer by harnessing the power of the immune system. Immunotherapy can be broken into 3 major categories: monoclonal antibodies, vaccines and nonspecific immunotherapies. Antibodies are the body’s ammunition against cancer. Antibodies can be produced specific to a patient’s tumor and then injected into the patient.

Vaccines can be used to both prevent and treat cancer. Already we have effective vaccines against some cancers. There are vaccines for HPV, which protects against cervical cancer, and hepatitis B, which protects against liver cancer. Recently an effective vaccine against metastatic prostate cancer was approved (Provenge).

Nonspecific immunotherapies are one of the hottest areas in cancer research currently. These can be divided into:

Cytokines – These are molecules which stimulate the immune system.

Checkpoint inhibitors – These release the brakes on the immune system, i.e. PD-1/PD-L1.

Immunomodulating drugs – Cause a boost to the immune system, i.e. Thalidomide

Nivolumab (Opdivo) and pembrolizumab (Keytruda) target PD-1, a protein on T cells that is important in recognizing other cells. When PD-1 is blocked, the immune system “brakes” are released and the T cell response against cancer is boosted. These drugs have been shown to shrink some tumors or slow their growth. Both drugs have been approved for patients with non-small cell lung cancer as a second line treatment after tumor begins to grow after standard chemotherapy.

Cost of immunotherapy

The success of immunotherapy in melanoma has also received a lot of attention grabbing headlines. The recent CheckMate 067 trial of nivolumab (Opdivo) plus ipilimumab (Yervoy) in advanced melanoma, presented earlier this year at the annual ASCO meeting, showed a median survival rate of 11.4 months, far superior to that of nivolumab or ipilimumab alone (6.9 months and 2.9 months, respectively). This is truly remarkable. However, the cost of combination therapy is almost $300,000 a year. Given the average insurance co-pay of 20%, this would leave patients with a $60,000 bill.

Further compounding the problem is the trend towards using high doses of these costly medications. Many abstracts at ASCO used pembrolizumab at doses 5 times the FDA indication. This equates to over $1,000,000 a year for a patient. This is unsustainable. We will have to confront the rising costs and as such, some deep questions. How much is too much? When does society say enough? What is the value of life?

A team effort

A team effort is needed to confront this cost of care crisis. Pathologists, as critical members of the care team, play an important role in the care of patients being considered for immunotherapy. It is the testing performed by pathologists that helps determine eligibility of patients for treatment.

Pathologists are also experts in helping monitor test utilization. Education provided by pathologists helps serve to increase cost awareness. It is only though a multi-disciplinary team approach that will best establish how and when to utilize this novel treatment regimen.

#immunotherapy #costofcare #precisionmedicine #pathology

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