New cellular immunotherapy and anti-cancer drug pricing

New cellular immunotherapy and anti-cancer drug pricing

October 23, 2017 Source: ihealth

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The US FDA approved Kite's CAR-T (chimeric antigen receptor T cell) immunotherapy, which is marketed by Yescarta (axicabtagene ciloleucel) for the treatment of certain types of adult large B-cell lymphoma patients.

 
It is reported that this latest anti-tumor therapy is priced at US$373,000, or about RMB 2.42 million.

 
The first CAR-T therapy approved earlier, Novartis's Kymriah is priced at $475,000, or about $3.08 million.

 
Millions, these two latest anti-cancer immunotherapy, value?

 
Before answering this question, let's look at the efficacy of other anti-cancer drugs currently on the market.

 
As more and more cancer drugs are approved, anti-tumor drug prices are also rising. New cancer drugs listed on the market are often life-saving straws for some patients and have high hopes. However, there are still questions about whether these drugs can prolong the survival or quality of life of patients.

 
Recently, researchers from the United Kingdom and Latvia published a paper in the British medical journal, BMJ, openly questioning the effects of EMA-approved cancer drugs. These researchers point directly to the new anti-cancer drugs approved by the European Medicines Agency (EMA) from 2009 to 2013.
 

Most of these latest anti-tumor therapies have entered the market. However, there is no clear evidence of patient survival or improved quality of life.

 
The researchers bluntly pointed out that although the approved new drugs have therapeutic advantages compared to existing treatments or placebos, these advantages are often weak.
 

BMJ's article is not the only one questioning the recent approval of cancer drugs. Vinay Prasad, assistant professor of medicine at the Oregon Health Sciences University, also wrote that most cancer drugs cost too much, but the benefits to patients are too small.
 

In addition, as early as June, Richard Pazdur, director of the FDA Center for Excellence in Oncology, also pointed out that the relationship between cancer treatment and patient benefit should be measured.
 

In the face of such direct doubts, officials of the EU drug review are unable to sit still. Francesco Pignatti, head of EMA oncology, hematology and diagnostics, made a public response on Thursday. He did not refute the findings in the BMJ paper. Instead, he said that the views in the BMJ article are for those familiar with cancer drug development. Not surprisingly.
 

Pignatti presented four reasons why it is not feasible to demonstrate a clear impact of the drug on survival or quality of life in many cases. The effects of the drug can be shown on the basis of other measures.
 

First, he believes that in the Random Controlled Triail, patients in the control group will enter the experimental group after the disease progresses, so the impact of the drug on overall survival may be difficult to detect.

 
Moreover, subsequent treatments "dilute" the effects of the drugs used in the early treatment. Therefore, in this case, Progress Free Survival (PFS) data will be used for drug approval. PFS is defined as the time during which treatment can induce and maintain efficacy, or at least delay the progression of cancer.
 

Second, patients with cancer treatment have a highly unmet need, as long as the tumor shrinks and the duration of the response is demonstrated in a one-arm trial, the new drug is generally approved quickly.
 
Pignatti emphasizes that this applies only to a small number of cases, and that cancer progression is highly predictable, patients have no other good treatment, and there is sufficient clinical and non-clinical data to support the risk balance of the new drug.
 
Third, Pignatti pointed out that quality of life is rarely used as the primary measure of cancer clinical trials, and that convincing improvements in quality of life are rare.
 
However, he also stated that this does not mean that the EMA does not pay attention to the study of quality of life. Although strong conclusions are usually not drawn, they are also encouraged.
 

Finally, Pignatti pointed out that the huge leap in cancer drug improvement is relatively rare. If the approval of cancer drugs is limited to an undisputed survival or improvement in quality of life, it will not really help the survival of cancer patients.
 

The purpose of cancer drugs is to save people from danger. For most families, it will also be a small expense. As a drug regulatory agency, you should still perform your duties and promote truly effective treatments to the market. Regardless of the assessment data based on the initial approval, the ultimate goal of these drugs is the same, extending the lives of patients and improving the quality of life of patients.
 

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