Novartis’ CAR-T gene therapy, the very first approved by FDA, to cost $475,000
Published: Aug 31, two thousand seventeen Two:14 p.m. ET
Concerns about how the therapy would be priced preceded its Wednesday approval
EmmaCourt
Novartis AG’s CAR-T cell therapy was approved by the Food and Drug Administration on Wednesday, making it the very first gene therapy to be available in the U.S.
Novartis’ NVS, -0.01% Kymriah was approved for youthfull people up to age twenty five with a form of acute lymphoblastic leukemia (ALL).
The list price is $475,000 for one-time treatment, Novartis said.
The company also said that it plans to price the therapy, Kymriah, “based on the clinical outcomes achieved,” and specifically only permit for payment when ALL patients “respond to Kymriah by the end of the very first month.” The company plans to work with the Centers for Medicare and Medicaid Services to implement the pricing strategy.
Even before Novartis’ Kymriah was approved, there was concern about pricing of the fresh therapy, given that fresh therapies are typically priced based on level of innovation and cancer is a particularly expensive area.
No, one month response is not an outcome. Eighteen (or twenty four or thirty six month) free of relapse without allo Tx, should be the reimbursable outcome https://t.co/yiKDRylRYQ
1. What you see is Swiss company using NIH funded technology and charging $475k for a treatment in United States, no due diligence on costs
CAR-T, or chimeric antigen receptor T-cell therapy, uses a patient’s immune T-cells and re-engineers them to better fight cancer.
As such, each dose of Kymriah is customized to the individual patient’s T-cells through genetic modification.
Kymriah treatment also has the possibility of serious side effects, including cytokine release syndrome (CRS), which consists of high fever and flu-like symptoms and can be life-threatening, and neurological events, which are also life-threatening.
On Wednesday, the FDA also expanded approval of Roche’s ROG, -0.16% Genentech’s rheumatoid arthritis drug Actemra to treat CAR-T cell-induced CRS; almost 70% of patients had CRS entirely resolved in two weeks using one or two doses of Actemra, the FDA said.
Kite Pharma Inc. KITE, -0.04% which is also working in the CAR-T space, has been racing to build up FDA approval; the biotech’s $11 billion acquisition by Gilead Sciences Inc. GILD, -1.42% was reported earlier this week.
Gilead shares surged 7.3% in utterly mighty Wednesday trade.
Some biotech companies working in the cellular therapy space spotted a stock boost on Wednesday, including Bluebird Bio Inc. BLUE, -4.13% with shares soaring 9.9% in strenuous trade, and Adaptimmune Therapeutics ADAP, +Three.34% with shares rising Trio.7%.
By contrast, Juno Therapeutics Inc. JUNO, +1.81% stock dropped 8.0%, Cellectis SA CLLS, -20.26% shares declined 1.6% and Bellicum Pharmaceuticals Inc. BLCM, -2.05% shares dropped Two.9%.
Novartis shares declined 1.1% in powerful trade. Novartis shares have risen Two.7% over the last three months, compared with a 1.9% rise in the S&P five hundred SPX, -0.76%
Novartis’ CAR-T gene therapy, the very first approved by FDA, to cost $475, zero
Novartis’ CAR-T gene therapy, the very first approved by FDA, to cost $475,000
Published: Aug 31, two thousand seventeen Two:14 p.m. ET
Concerns about how the therapy would be priced preceded its Wednesday approval
EmmaCourt
Novartis AG’s CAR-T cell therapy was approved by the Food and Drug Administration on Wednesday, making it the very first gene therapy to be available in the U.S.
Novartis’ NVS, -0.01% Kymriah was approved for youthful people up to age twenty five with a form of acute lymphoblastic leukemia (ALL).
The list price is $475,000 for one-time treatment, Novartis said.
The company also said that it plans to price the therapy, Kymriah, “based on the clinical outcomes achieved,” and specifically only permit for payment when ALL patients “respond to Kymriah by the end of the very first month.” The company plans to work with the Centers for Medicare and Medicaid Services to implement the pricing strategy.
Even before Novartis’ Kymriah was approved, there was concern about pricing of the fresh therapy, given that fresh therapies are typically priced based on level of innovation and cancer is a particularly expensive area.
No, one month response is not an outcome. Eighteen (or twenty four or thirty six month) free of relapse without allo Tx, should be the reimbursable outcome https://t.co/yiKDRylRYQ
1. What you see is Swiss company using NIH funded technology and charging $475k for a treatment in United States, no due diligence on costs
CAR-T, or chimeric antigen receptor T-cell therapy, uses a patient’s immune T-cells and re-engineers them to better fight cancer.
As such, each dose of Kymriah is customized to the individual patient’s T-cells through genetic modification.
Kymriah treatment also has the possibility of serious side effects, including cytokine release syndrome (CRS), which consists of high fever and flu-like symptoms and can be life-threatening, and neurological events, which are also life-threatening.
On Wednesday, the FDA also expanded approval of Roche’s ROG, -0.16% Genentech’s rheumatoid arthritis drug Actemra to treat CAR-T cell-induced CRS; almost 70% of patients had CRS fully resolved in two weeks using one or two doses of Actemra, the FDA said.
Kite Pharma Inc. KITE, -0.04% which is also working in the CAR-T space, has been racing to build up FDA approval; the biotech’s $11 billion acquisition by Gilead Sciences Inc. GILD, -1.42% was reported earlier this week.
Gilead shares surged 7.3% in utterly powerful Wednesday trade.
Some biotech companies working in the cellular therapy space eyed a stock boost on Wednesday, including Bluebird Bio Inc. BLUE, -4.13% with shares soaring 9.9% in intense trade, and Adaptimmune Therapeutics ADAP, +Trio.34% with shares rising Three.7%.
By contrast, Juno Therapeutics Inc. JUNO, +1.81% stock dropped 8.0%, Cellectis SA CLLS, -20.26% shares declined 1.6% and Bellicum Pharmaceuticals Inc. BLCM, -2.05% shares dropped Two.9%.
Novartis shares declined 1.1% in strong trade. Novartis shares have risen Two.7% over the last three months, compared with a 1.9% rise in the S&P five hundred SPX, -0.76%
Novartis’ CAR-T gene therapy, the very first approved by FDA, to cost $475, zero
Novartis’ CAR-T gene therapy, the very first approved by FDA, to cost $475,000
Published: Aug 31, two thousand seventeen Two:14 p.m. ET
Concerns about how the therapy would be priced preceded its Wednesday approval
EmmaCourt
Novartis AG’s CAR-T cell therapy was approved by the Food and Drug Administration on Wednesday, making it the very first gene therapy to be available in the U.S.
Novartis’ NVS, -0.01% Kymriah was approved for youthfull people up to age twenty five with a form of acute lymphoblastic leukemia (ALL).
The list price is $475,000 for one-time treatment, Novartis said.
The company also said that it plans to price the therapy, Kymriah, “based on the clinical outcomes achieved,” and specifically only permit for payment when ALL patients “respond to Kymriah by the end of the very first month.” The company plans to work with the Centers for Medicare and Medicaid Services to implement the pricing strategy.
Even before Novartis’ Kymriah was approved, there was concern about pricing of the fresh therapy, given that fresh therapies are typically priced based on level of innovation and cancer is a particularly expensive area.
No, one month response is not an outcome. Eighteen (or twenty four or thirty six month) free of relapse without allo Tx, should be the reimbursable outcome https://t.co/yiKDRylRYQ
1. What you see is Swiss company using NIH funded technology and charging $475k for a treatment in United States, no due diligence on costs
CAR-T, or chimeric antigen receptor T-cell therapy, uses a patient’s immune T-cells and re-engineers them to better fight cancer.
As such, each dose of Kymriah is customized to the individual patient’s T-cells through genetic modification.
Kymriah treatment also has the possibility of serious side effects, including cytokine release syndrome (CRS), which consists of high fever and flu-like symptoms and can be life-threatening, and neurological events, which are also life-threatening.
On Wednesday, the FDA also expanded approval of Roche’s ROG, -0.16% Genentech’s rheumatoid arthritis drug Actemra to treat CAR-T cell-induced CRS; almost 70% of patients had CRS totally resolved in two weeks using one or two doses of Actemra, the FDA said.
Kite Pharma Inc. KITE, -0.04% which is also working in the CAR-T space, has been racing to build up FDA approval; the biotech’s $11 billion acquisition by Gilead Sciences Inc. GILD, -1.42% was reported earlier this week.
Gilead shares surged 7.3% in utterly strong Wednesday trade.
Some biotech companies working in the cellular therapy space witnessed a stock boost on Wednesday, including Bluebird Bio Inc. BLUE, -4.13% with shares soaring 9.9% in strong trade, and Adaptimmune Therapeutics ADAP, +Trio.34% with shares rising Trio.7%.
By contrast, Juno Therapeutics Inc. JUNO, +1.81% stock dropped 8.0%, Cellectis SA CLLS, -20.26% shares declined 1.6% and Bellicum Pharmaceuticals Inc. BLCM, -2.05% shares dropped Two.9%.
Novartis shares declined 1.1% in powerful trade. Novartis shares have risen Two.7% over the last three months, compared with a 1.9% rise in the S&P five hundred SPX, -0.76%