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Kymriah

Top Ten most popular articles on Pharmafile.com this week!

Novartis’ faulty data scandal dominated the headlines this week, as the Swiss firm faced fierce backlash over covering up the use of bad data in getting its $2.1 million gene therapy Zolgensma approved by the FDA. While executives at Novartis subsidiary AveXis were kicked out, the US Senate demanded answers.

Medicare will cover CAR-T therapies in United States

Medicare will cover the cost of Novartis’ and Gilead’s CAR-T therapies Kymriah and Yescarta, the US Centers for Medicare and Medicaid services (CMS) said.

Medicare, the federal government’s health plan for over-65s has said it will cover the FDA approved CAR-T therapies Kymriah and Yescarta when provided in healthcare facilities that have programmes in place to track patient outcomes, known as REMS.

Novartis' Kymriah to be covered by Japan's national insurance system

Japan’s national medical insurance system will pay for Novartis’ CAR-T therapy Kymriah following approval from the Central Social Insurance Medical Council.

Kymriah, which costs 33.49 million yen ($305,455), will be covered by Japan’s national health insurance from the 22 May. Kymriah will thus become the most expensive treatment covered by Japan’s system.

Coverage will however be limited to leukaemia patients under the age of 25 who have failed to respond to other therapies.

Scottish Medicines Consortium rejects Novartis' CAR T therapy Kymriah

Scotland’s cost effectiveness body has refused to fund Novartis’ CAR T therapy Kymriah for adult patients with lymphoma.

The Scottish Medicines Consortium (SMC) said that it could not accept Kymriah as a treatment for adult patients with diffuse B cell lymphoma who have relapsed or not responded after two previous lines of treatment.

The decision follows a similar one from England and Wales cost regulator, NICE, last year. The government body rejected Kymriah as a treatment for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Novartis' CAR-T therapy Kymriah gets NICE green light in diffuse large B-cell lymphoma

NICE has announced another momentous decision for lymphoma patients in England and Wales:, recommending Novartis’ chimeric antigen receptor T cell (CAR-T) therapy Kymriah (tisagenlecleucel) for the treatment of adults with relapsed or refractory diffuse large B-cell forms of the condition (DLBCL) who have not responded or have relapsed after two courses of chemotherapy.

It is estimated that 200 patients will be eligible to access the treatment each year in England and Wales.

Canada Health approves Novartis' CAR-T therapy Kymriah

Health Canada has approved Novartis’ CAR-T therapy Kymriah for use in paediatric and young adult patients aged between three and twenty-five years old with B-cell acute lymphoblastic leukaemia (ALL) and for adults with relapsed or refractory (r/r) large B-cell lymphoma.

However the one time treatment, which harnesses the patient’s immune system in the fight against cancer, is expected to cost the Canadian healthcare system more than $400 million over three years.

Novartis unveils strong longer-term Kymriah data at ASH 2018

Novartis has lifted the curtain on longer-term analysis data for its CAR-T therapy Kymriah (tisagenlecleucel) at the American Society of Hematology (ASH) Annual Meeting 2018, showing that the treatment demonstrated “strong efficacy with durable responses” in children and adolescent patients with relapsed or refractory (r/r) acute lymphoblastic leukaemia (ALL), and in adult patients with r/r diffuse large B-cell lymphoma (DLBCL).

Top Ten most popular articles on Pharmafile.com this week!

The appointment of GSK veteran Arnaud Breabout to the position of Senior Vice President and CFO of Mundipharma took the top spot this week. Meanwhile MHRA chief Dr Ian Hudson announced he was stepping down.

Equally as Brexit inched ever closer it was revealed that use of antidepressant had gone up in the month following the referendum. At the same time, the ABPI responded to Theresa May’s new deal.

Kymriah to be made available in UK for paediatric leukaemia patients via Cancer Drugs Fund

NICE has announced its recommendation that Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) be made available in the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL) for patients under the age of 25 via the Cancer Drugs Fund.

Eligible patients within this age range will have proven unresponsive to current treatment – blinatumomab or chemotherapy – or relapsed following stem cell transplant, so it has been estimated that around 25 to 30 people will benefit from the decision in England each year.

20 year old man died after leukaemia cell was accidently mixed into CAR T therapy

Image Credit: Jimjamjak

A 20 year old man died after a single leukaemia cell accidentally ended up in a batch of cells that were being manufactured into a CAR-T cell therapy, according to researchers at the University of Pennsylvania.

The mistake, which brought about a fatal relapse in the 20 year old man, was reported in the journal Nature Medicine.

The patient was entered into an early stage trial of CTL019, which was eventually licensed to Novartis and sold under the brand name Kymriah.  

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