[Ip-health] UACT Statement on UK NICE Rejection of Yescarta

Manon Ress manon.ress at cancerunion.org
Tue Sep 4 08:16:20 PDT 2018


http://cancerunion.org/2018/09/04/uact-statement-on-uk-nice-rejection-of-yescarta/

UACT STATEMENT ON UK NICE REJECTION OF YESCARTA

UACT is disappointed by the preliminary rejection of Yescarta by the UK’s
National Institute for Health and Care Excellence (NICE) over its high
price, for two reasons:

1) Gilead is asking too much for the treatment which is largely based upon
the US National Institutes of Health (NIH owned inventions, and

2) the UK government has not given any public indication it is considering
alternatives to withholding coverage to address the problem of an excessive
price.

Yescarta is the Gilead trade name for axicabtagene ciloleucel, a
CD19-directed chimeric antigen receptor T-cell (CAR T) technology invented
by the NIH, licensed to Kite/Gilead and approved by the European Commission
for use throughout the European Union on August 27th, to treat two
aggressive forms of non-Hodgkin lymphoma. Gilead has priced the treatment
in the US at $ 373,000. The list price in the UK is not public.

In the United States, axicabtagene ciloleucel is indicated for the
treatment of adult patients with relapsed or refractory large B-cell
lymphoma after two or more lines of systemic therapy, including diffuse
large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal
large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from
follicular lymphoma. The European Medicines Agency (EMA) approved Yescarta
for the treatment of diffuse large cell lymphoma (DLBCL) and primary
mediastinal B-cell lymphoma (PMBCL). [
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004480/smops/Positive/human_smop_001318.jsp&mid=WC0b01ac058001d127
]

Axicabtagene ciloleucel/Yescarta which targets untreatable forms of blood
cancer is the first CAR T therapy assessed by NICE which will also evaluate
another CAR T therapy by Novartis, Kymriah, and later, other gene and cell
based therapies.

The preliminary rejection by NICE does not bode well for the future access
to these therapies and requires government action not complacency.. To be
blunt, the failure of multiple government policies will lead to the
premature death for UK patients.

Governments, especially in this case the NIH and the UK, have serious
responsibilities. They should be held accountable for not using the
statutes they have to ensure that live saving therapies are in fact
accessible and affordable.

The NIH requires companies that license its inventions to bring them to
practical application, but it also defines this as an obligation that “the
invention is being utilized and that its benefits are to the extent
permitted by law or Government regulations available to the public on
reasonable terms.” [35 USC 201(f)]. The NIH has done nothing to ensure that
prices are reasonable, sending the signal to companies like Gilead,
Novartis and Astellas that the NIH won’t ever interfere with their pricing
decisions.

The UK government uses the grant of patents as an incentive to invest in
the invention and development of new technologies. In the case of
axicabtagene ciloleucel, the key inventions were funded by the U.S.
government and licensed on concessionary terms to Kite/Gilead. This is not
a drug. The key axicabtagene ciloleucel inventions are medical procedures
involving the use of a public domain virus to modify the patient’s own
T-cells to fight cancer.

The UK government, and its agencies, have two powerful tools to end the
Gilead monopoly on axicabtagene ciloleucel.

One tool is to use the Crown Use provisions set out in Sections 55-59 of
the UK Patent Act of 1977 to grant compulsory licenses on any patents
related to axicabtagene ciloleucel, on the grounds that the price is
excessive, a fact consistent with the NICE finding that the price is too
high to justify reimbursement.

The second tool is a finding that patents on axicabtagene ciloleucel are
invalid. Article 4A of the UK Patent Act declares that “A patent shall not
be granted for the invention of . . . a method of treatment of the human or
animal body by surgery or therapy.” This appears to be exactly the
description of axicabtagene ciloleucel.

UACT calls upon the UK government to issue a finding that the patents on
axicabtagene ciloleucel are invalid, as regards the procedures to treat
patients, and if necessary, to involve Section 55 of the UK Patent Act for
“Use of Patented Inventions for Services of the Crown.”

For UACT and its members, recognizing the plain language and obvious
relevance of the UK patent exception as well as using the crown use
provision is clearly better than letting UK patients die.



ANNEX

UK Patents Act 1977

https://www.legislation.gov.uk/ukpga/1977/37/section/4A

Article 4A

Methods of treatment or diagnosis

(1)A patent shall not be granted for the invention of—

(a)a method of treatment of the human or animal body by surgery or therapy,
or

(b)a method of diagnosis practised on the human or animal body.

(2)Subsection (1) above does not apply to an invention consisting of a
substance or composition for use in any such method.

(3)In the case of an invention consisting of a substance or composition for
use in any such method, the fact that the substance or composition forms
part of the state of the art shall not prevent the invention from being
taken to be new if the use of the substance or composition in any such
method does not form part of the state of the art.

(4)In the case of an invention consisting of a substance or composition for
a specific use in any such method, the fact that the substance or
composition forms part of the state of the art shall not prevent the
invention from being taken to be new if that specific use does not form
part of the state of the art.]

For further reading:
NICE Decision:
https://www.nice.org.uk/guidance/GID-TA10214/documents/appraisal-consultation-document

UK rejects Gilead’s CAR-T cancer cell therapy as too expensive by Ben
Hirschler on August 28, 2018
https://in.reuters.com/article/us-gilead-sciences-britain/uk-rejects-gileads-car-t-cancer-cell-therapy-as-too-expensive-idINKCN1LD16V


-- 
Manon Ress, Ph.D.
Union for Affordable Cancer Treatment (UACT)
Cell Phone +1 571 331 6879
www.cancerunion.org
Email: info at uact.org
Twitter: @Cancer_Union
Telephone: 202.332.2670

Mailing Address:
1621 Connecticut Avenue NW
Suite 550
Washington, DC 20009


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