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Novartis’ CAR-T Kymriah gets green light in England

Speedy decision contrasts with NICE's 'no' to rival Yescarta in larger adult DLBCL population

Kymriah

Novartis has set a “fair and affordable” price for its CAR-T therapy Kymriah that should make it available for up to 30 children every year with acute lymphoblastic leukaemia (ALL), according to NHS England.

The first NHS hospitals could start administering the cell-based treatment within the next few weeks, and centres in London, Manchester and Newcastle have already applied for approval to deliver the new immunotherapy. The money for Kymriah (tisagenlecleucel) will come from the Cancer Drugs Fund (CDF).

A deal between Novartis and NHS England just 10 days after the therapy’s EMA approval means UK-based ALL patients could be the first in Europe to get access to Kymriah, a one-time therapy that is custom-made for each individual patient using their own immune cells.

Adult patients with another cancer approved for treatment using Kymriah – diffuse large B cell lymphoma (DLBCL) – will have to wait to hear guidance from NICE, on this larger and more costly patient population.

Novartis’ oncology manager for the UK and Ireland, Mari Scheiffele, said “flexibility [was] shown by all parties to ensure young patients can access this life-saving treatment as quickly as possible.”

Kymriah costs £282,000 per patient at full list price, but the level of discount offered to the NHS has not been disclosed.

Simon Stevens

NHS England's Simon Stevens

NHS England chief executive Simon Stevens acknowledged that CAR-T therapy is “a true game changer” in cancer, adding that “this constructive fast-track negotiation also shows how responsible and flexible life sciences companies can succeed – in partnership with the NHS – to make revolutionary treatments available to patients.”

The rapid agreement on Kymriah is in stark contrast to NICE’s speedy rejection in draft guidance of Gilead/Kite Pharma’s rival CAR-T Yescarta (axicabtagene ciloleucel), which was approved at the same time as Kymriah in Europe for adults with DLBCL and primary mediastinal large B-cell lymphoma (PMLBL). That might suggest Novartis will have a tougher time when it comes to the adult DLBCL indication for Kymriah.

Novartis said in a statement that it hoped the NHS will “continue this collaboration and flexibility” on DLBCL, “where there is also a high unmet need for patients who have relapsed and have no other treatment options.”

For now, the NHS’ position on DLBCL is somewhat academic, as Novartis said at the time of Kymriah’s approval that it would only be supplying the CAR-T for children with ALL in the first instance because of manufacturing capacity constraints.

The company been struggling with production issue for the CAR-T since its US launch last year, specifically variability in product specifications that in some cases have led to manufacturing failures.

Article by
Phil Taylor

5th September 2018

From: Healthcare

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