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Should Academic Medical Centers Be Able to Manufacture Their Own CAR-T Therapy?

Doctorpedia Editorial Team Doctorpedia Editorial Team December 9, 2021
Medically reviewed by Susan Kerrigan, MD and Marianne Madsen

This literally sounds like it is out of an Isaac Asimov science fiction novel: Take blood from someone with cancer. Engineer their blood cells to seek and destroy cancer. Reinfuse the cells and watch the cancer dissipate. This is truly the next frontier in cancer therapy!

 

But at an enormous price per dose, can turning medical centers into manufacturers be part of the solution?

 

What is CAR-T therapy?

 

CAR-T therapy (chimeric antigen receptor T-cell therapy) is a type of cancer therapy that attempts to combat cancer using the body’s native immune cells as opposed to surgery or abiotic cancer treatments like radiation or chemical therapy. The procedure involves removing a patient’s blood, isolating T-cells, and manipulating them to make them find and attack cancer cells instead of the infections they fight naturally. CAR-T immunotherapy is being tested for a range of cancers, and currently it is used for patients with adult B-cell non-Hodgkin’s lymphoma or childhood acute lymphoblastic leukemia who have already been through two unsuccessful standard treatments.


T-cells function by binding themselves to infected cells and releasing toxins into them. After binding, the cell’s organelles die, the cell itself begins to degrade, and the remains are disposed of by the body’s macrophages. A T-cell will naturally avoid cancerous cells; to the T-cell, they appear to be the same benign tissue as the rest of the body. In CAR-T therapy, T-cells are modified to specifically seek out and bind to cancer cells, destroying the cancer in a more natural and less harmful way than the current mainstream methods like chemotherapy allow. 

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Cancer - CAR-T Therapy

Cancer - CAR-T Therapy

Medical Centers 

 

Under the current system, a hospital extracts blood cells from a patient and sends the cells to a drug company to be genetically engineered. It takes the company two to six weeks to engineer the cells, increase their number, perform quality and safety tests, and ship them back to the hospital to be reinfused into the patient. 

 

Complications

 

Under this system, there have been various complications with the engineering process, as well as with shipping and handling.

 

CAR-T therapy is at the moment considered a commercial procedure, with pharmaceutical companies responsible for properly manipulating the T-cells to accept the new receptors needed for them to bind to and attack cancer cells. This is a lengthy process and subject to considerable regulation; it calls for specialized equipment and facilities, highly trained personnel, and the patience and experience to get it done right. Providing all of these in a commercial environment has made CAR-T one of the most expensive cancer treatments currently in use, with even a single dosage running close to $400,000 USD.

Shipping to a commercial plant also creates a longer supply chain with more potential vulnerabilities to stop patients getting the treatment they need. More costs will need to be covered and more workers paid along the way, all of which is passed back to the patient; additionally, this therapy is still considered experimental by most insurance providers, which means that health care insurance plans are less likely to cover it. 

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Cancer - Advances in Treatment

Cancer - Advances in Treatment

Solutions

 

The medical sector has hit on a possible way to reduce the formidable cost of CAR-T to the patient. By manufacturing the altered T-cells in hospitals or academic medical institutions, the commercial aspects such as royalties and facility costs are eliminated; additionally, these institutions are more often than not already equipped with the appropriate apparatus and conditions for the delicate cell manipulation involved. A cell dose could feasibly be manufactured in the same building in which the patient currently receives treatment, entirely bypassing logistical concerns; with no need to ship the cells anywhere, there is no supply chain to be disrupted and no parcels to be mishandled or improperly stored. Regulatory bodies would have less to be worried about as well, as the procedure is taking place inside a known and approved medical facility as opposed to a commercial laboratory. 

 

Reduction in costs

 

Switzerland is already implementing this system and pricing CAR-T therapy between $150,000 and $200,000. Multiply that by the 10,000 individuals in the U.S. with the types of cancer for which CAR-T therapy is currently approved and savings would be almost $2 billion a year.

 

So what is the hold up?

 

The main issue is that the FDA must redefine CAR-T from a drug to an autologous blood product, and this would mean CAR-T therapies created at hospitals and academic medical centers would not have to go through the years-long FDA regulatory process. Greater regulatory flexibility from the FDA always needs much consideration, but it would almost certainly make CAR-T therapy far more cost effective.

 

Conclusion

 

Manufacturing CAR-T therapy in medical institutions as opposed to being provided by a commercial service will significantly lower the cost to patients and drastically increase availability. This transition may be difficult to make against the current market trends, but could save millions of lives and dollars going forward. 

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