India can help solve the accessibility problem of breakthrough cancer treatment CAR -T Cell therapy, according to American physician scientist Carl June.
CAR-T therapies have been effective against certain types of blood cancer. However, the treatment remained inaccessible to most patients due to its cost.
The CAR-T therapy costs about $1 million - $1.5 million, including administration and hospitalisation costs in US.
Novartis charges Kymriah - its CAR-T therapy about $475,000 for acute lymphoblastic leukemia (ALL).
ALL is type of childhood blood cancer. Novartis guarantees refund of money if the therapy doesn’t work after one month. It charges $373,000 for adult Non-Hodgkin lymphoma (NHL) – another form of blood cancer with no refund.
Gilead has priced Yescarta at $373,000 for NHL, with no refund.
Currently CAR-T cell therapies are not available in India. The prohibitive costs makes it beyond the means of most Indians. A few who can afford, anyways have the capacity to fly to US to get the treatment.
Making the CAR-T accessible
June in a recent interview to Moneycontrol on sidelines of BioAsia-2020 in Hyderabad said, the manufacturing complexity is a major reason for the therapy cost and despite such an expensive price tag he says Novartis doesn't make much profit.
"For normal drugs only about five or 10 percent of the selling cost is manufacturing. For the CAR-T cells one third of the selling price is manufacturing. So they don't make as much profit per patient, adding to that they give it on a guarantee. If it doesn't work, you get the money back. That's called pay for performance. No other time has that ever happened," June said.
June sees the manufacturing costs can probably come down by five to tenfold.
"Right now, the way they manufacture CAR-T cells is what we did in my lab in the 1990s. So it's 20 year old technology. And there was no industry on how to make, you know, robots and so on to do it automated. The most expensive part of CAR-T cells is human labour. It's you have to have trained people. So, if you can have it done automatic, then that would drop the cost dramatically," June said.
June believes India can play a role in making CAR-T accessible and mainstream therapy.
"India is well positioned to (do) that because the country is so good with engineering. It's a natural thing to make better manufacturer," June said.
June also said India has good physicians who can do bone marrow transplants.
"…the people who start doing this will be bone marrow transplant. So they're the ones who take care of leukemia patients," June said.
But June said that the funding eco-system and government support in form of enabling rules and incentives will help the Indian companies to jump into CAR-T therapies.
"..(Kiran Mazumdar-Shaw) has started a company to do CAR-T cell therapy. There are several companies now in India who may look to solving this problem. And it needs to have a combination of some philanthropy, and then, the government has to want it to happen because it's a new industry and they can make rules and incentives," June said.
June points out that China has pumped $50 billion in CAR-T therapies and is home to around 300 clinical trials, while India has none.
June led the pioneering work at University of Pennsylvania in US to develop the treatment where patient's own T-cell is drawn from the blood, isolated and genetically modified by adding chimeric antigen receptor (CAR).
The modified T-Cell weaponised with CAR, is grown and injected back into the patient. The modified CAR-T cells targets and kills cancer cells.
T-Cell – the important component of immune system acts like police chief in our body that detects intruders like viruses and bacteria, along with cancer cells.
The outcomes of CAR -T Cell therapy were astounding. Children suffering from advanced blood cancer (acute lymphoblastic leukemia or ALL), who were almost on verge of dying, saw their cancers gone.
Around 83 percent of the children with leukemia show complete remission within three months of receiving the treatment.Swiss drug giant Novartis was quick to see the potential of the new therapy and teamed up with University of Pennsylvania in 2012. The partnership led to the development of tisagenlecleucel sold under brand name Kymriah by
Novartis, became the first CAR-T therapy approved by USFDA to treat childhood leukemia and certain types of adult lymphoma in August 2017.
Two months later, the second CAR-T therapy called Yescarta was launched by US drug maker Gilead Sciences for several types of adult Non-Hodgkin lymphoma (NHL) – another form of blood cancer.June said that CAR-T therapy is now explored as first line treatment, even before trying chemotherapy.