Asked by
of Drefelin
To ask Her Majesty’s Government what steps they are taking to
align the timelines between cancer drugs being licensed and being
approved by the National Institute for Health and Care
Excellence.
of Drefelin (CB)
My Lords, I beg leave to ask the Question standing in my name on
the Order Paper and declare an interest as chief executive of the
charity Breast Cancer Now.
The Parliamentary Under-Secretary of State, Department of Health
and Social Care () (Con)
NICE is committed to publishing draft guidance on cancer drugs
around the time of licensing, with final guidance published
within three months of licensing wherever possible. The MHRA and
NICE work closely together to ensure that licensing procedures
and health technology assessments are as streamlined as possible.
For cancer drugs, the NHS in England provides funding from the
point of draft positive NICE guidance, delivering faster access
to promising new cancer treatments.
of Drefelin (CB)
My Lords, the delay between licensing and NICE technology
appraisal has been dealt with in the case of two out of the three
drugs approved under Project Orbis, through agreements between
NHS England and the drug company concerned. Unfortunately for
women with secondary incurable breast cancer, for which there are
very few treatment options, no agreement has been made with the
drug company Gilead, and this creates a new treatment lottery.
Are interim access agreements meant to be the permanent solution,
and if not, what can be done to address this lottery and close
the gap between Orbis licensing and NICE appraisal?
(Con)
I thank the noble Baroness for her Question. Clearly, there is
distress and concern at the delay between MHRA approval and NICE
licensing. The drug Trodelvy was licensed by the MHRA for both
unresectable locally advanced and metastatic triple-negative
breast cancer through Project Orbis. On NICE’s appraisal of
Trodelvy to determine its clinical and cost-effectiveness for use
in the NHS, NICE hopes to have guidance next year but, in the
meantime, NHS England, NHS Improvement and NICE continue to work
with the manufacturer to explore options for interim access to
Trodelvy.
(Lab)
My Lords, despite what the Minister says, the fact is that
innovative new drugs such as the cancer drugs the noble Baroness
mentioned are reaching patients in this country far too slowly.
We lag behind many other countries. How can we expect to be a
centre of science and research if the NHS is so slow to develop
the medicines that are produced?
(Con)
I think noble Lords will agree with that frustration at the speed
of approval and licensing, but in most cases it does happen
speedily. One of the central issues is making sure that there is
confidence in the ability to purchase. We are looking at a number
of different ways to accelerate the process, including through
ILAP—the accelerated partnership—while also making sure that MHRA
and NICE can speak where they are allowed to, given some of the
legal restrictions on their discussions. For example, I went a
couple of weeks ago to a board-to-board meeting between MHRA and
NICE at which they discussed issues of common concern.
(LD) [V]
My Lords, picking up on the point of the noble Lord, Lord Hunt,
there is a particular problem in the United Kingdom with NICE and
MHRA appearing not to talk together as much as they should to
help streamline the process, where that is appropriate. An
academic paper in March demonstrated that the CDC in America has
a much stronger, streamlined system that works, with far fewer
drugs being delayed. How can NICE and MHRA learn from what is
happening abroad?
(Con)
It is important that we learn the best lessons from abroad on
incredibly important issues such as this. Where NICE and MHRA are
allowed to talk to each other and co-operate—there are some
restrictions, as I am sure many noble Lords are aware—both
clearly recognise that there are great concerns and distress on
the part of the many patients who want access to these drugs, and
they are trying to work out how they can speed up the process as
much as possible.
(CB) [V]
My Lords, how can we speed up the process once new, innovative
medicines have been approved by NICE so that patients get their
benefit? Is the Minister aware that other countries, especially
Germany and France, are leading the way with cancer drugs while
England is near the bottom of the list? That is not good enough,
is it?
(Con)
I thank the noble Baroness. It is important that NICE, MHRA and
others hear some of the concerns, and the fact that we are being
held to account today shows how important this is. Unfortunately,
some existing legislation restricts MHRA’s ability to share
information with partners, including NICE, which would help them
to plan their processes more efficiently. NICE, MHRA, NHS England
and NHS Improvement are talking about the concerns raised by
noble Lords and generally about delays in the process. They are
talking about how they can improve access, including through
initiatives such as the Innovative Licensing and Access Pathway
launched in January 2021, and sharing as much information as they
can upfront. Both MHRA and NICE are aware of the concerns and
made that clear when I met them recently after their
board-to-board meeting.
(Lab)
My Lords, I will follow up on questions that noble Lords have
already asked. The ongoing NICE methods and processes review
missed the opportunity to propose a new process to mirror
accelerated regulatory processes. There are concerns that
capacity constraints will limit NICE’s ability to publish
decisions as close to marketing authorisation as possible,
including for oncology drugs, through the new Project Orbis
route, as has been the case with the secondary breast cancer
drug, Trodelvy. Have the Government assessed whether the system
is fit for purpose in achieving the objective which the noble
Lord has articulated: to deliver quick patient access to new,
clinically effective treatments? What concrete steps have been
taken so far to address any concerns?
(Con)
Both NICE and MHRA are aware of the concerns, particularly
regarding the delay between approval and licensing. That is why
they are having conversations with NHS England and NHS
Improvement to make sure, as far as possible, that they can
discuss co-operation to ensure the speedy approval of drugs.
(Con)
My Lords, regarding the efficacy of cancer treatment, so far this
year, six friends of mine have died from cancer; all were under
80 and three were younger than me. I know of many more who have
terminal cancer, regrettably. I also knew one person who died
from coronavirus aged 55. She had leukaemia, or blood cancer,
which destroyed her immune system, and she caught the virus while
she was being treated in hospital. To put cancer in perspective,
how many people under the age of 80 have died this year from
cancer and how many people under the age of 80 have died in this
terrible pandemic, which has shut down society, damaged our
children’s education and mortgaged their future for decades to
come?
(Con)
I thank my noble friend for his question. The focus was on
fighting Covid and making sure that people were vaccinated as
quickly as possible. As noble Lords know, economics is about the
allocation of scarce resources and there are always trade-offs.
Sometimes there are unintended consequences of focusing on one
condition rather than another. I will write to my noble friend
with an answer to his specific question.
(CB)
My Lords, so far, we have spoken about England. The drugs are
licensed for the whole of the United Kingdom and NICE regulates
what happens in England. Wales is aligned to some extent and
Northern Ireland much more closely; Scotland applies a different
system. Will the Minister undertake to look at whether other
parts of the United Kingdom are dealing with this more
efficiently? As he does so, will he also take care that NICE is
not being used as a back-door way of rationing?
(Con)
The noble Baroness raises an important point, especially given
that health is devolved to the devolved Administrations. As much
as possible, we work England-wide, but we also ensure that we
co-ordinate UK-wide and that Ministers and officials regularly
meet with those from the devolved Administrations.
(Con)
My Lords, some of the territories in the world which have the
cheapest, safest and widest choice of medicines do not have their
own regulators. Instead, they automatically recognise the
decision made by globally acknowledged licensers. Does my noble
friend agree that one way of addressing the question of
expedition that the noble Lord, , and others raised
would be for global Britain to work for the consumer as well as
the drugs companies and to recognise automatically drugs licensed
by the FDA, the European Medicines Agency and other equivalent
bodies?
(Con)
I thank my noble friend, who has been an advocate for free trade,
for his question. Sometimes in the conversation about
recognition, there is a debate between harmonisation and mutual
recognition but also unilateral recognition. One of the concerns
often raised when looking at unilateral recognition is that
negotiators feel that, sadly, they are losing a bargaining chip.
The other thing to recognise is that one country’s standard is
often another country’s non-tariff barrier. MHRA is the UK
regulator and I have been told that it thinks it important that
we have our own arrangements in place for the regulation of
medicines.
