Asked by
To ask His Majesty’s Government, following the announcement that
Takeda Pharmaceuticals plans to withdraw Mobocertinib from
market, what steps they are taking to ensure that lung cancer
patients have access to the medicines they need.
(Con)
My Lords, the Medicines and Healthcare products Regulatory Agency
is engaging with Takeda Pharmaceuticals to ensure that, where
appropriate, patients receiving Mobocertinib have access,
following the company’s decision to withdraw it from the market
globally. Mobocertinib is not licensed in Northern Ireland but
has been available through the Northern Ireland MHRA authorised
route and can be supplied as an unlicensed medicine for existing
patients after it is withdrawn. Alternative treatments for new
NHS patients may include NICE-recommended immuno- therapies, such
as Nivolumab, or chemotherapy.
(UUP)
My Lords, the Minister will be aware that this drug is due to be
withdrawn from the UK market in March, despite the results of the
recent EXCLAIM-2 trial, which showed that it can be as effective
as chemotherapy, with no safety concerns. It is currently the
only drug in the UK that is licensed for use in exon 20 patients
who have the rare subtype EGFR-positive lung cancer. Removing it
from the market means that these patients will have no treatment
options open to them beyond chemotherapy, which will certainly
reduce lifespan and increase mortality rates. On behalf of those
patients, I plead with the Minister to work with Takeda to
deliver a compassionate use policy for all exon 20 patients,
including, crucially, those who cannot yet take the drug, to
serve as a pathway for them to access it while waiting for an
alternative treatment.
(Con)
My Lords, I share the noble Lord’s disappointment that the
company has taken the decision to withdraw Mobocertinib from the
market globally. I understand that this decision was taken after
the treatment failed to meet its primary end-points in the phase
3 EXCLAIM-2 trial. I assure the noble Lord that, for existing
patients, and through a compassionate use scheme for new
patients, although this drug was the only NICE-recommended
treatment targeted for exon 20 patients, alternative
NICE-recommended immunotherapies may be appropriate treatments
for patients at the same stage in the disease pathway.
(Con)
My Lords, frequently in the House questions have been raised
about the shortage and accessibility of some drugs to NHS
patients. With this drug, there are concerns around its efficacy
and effectiveness. How is the issue being communicated to
patients who are using this drug, because they are vulnerable
consumers and patients? How will the Government ensure the
efficacy of other drugs and treatments in its place?
(Con)
My noble friend raises a very important point about
communication. When patients are in receipt of drugs and surgery,
it is a very vulnerable time, and it is important they are
communicated to in an appropriate manner. Takeda has worked
closely with the MHRA, the NHS, and the clinical and patient
communities to ensure that details of the withdrawal have been
appropriately communicated to the lung cancer community. There is
also a direct communication to healthcare professionals, to be
distributed together with details of compassionate use
programmes. This drug will still be available currently and in
the future. Regarding efficacy, it is important that, when drugs
are brought to the market, they are successful and do what they
were brought on the market to do. If that is not the case, they
need to come to an end, unfortunately.
(CB)
The Minister is correct when he says the drug is being withdrawn
because it did not meet the end-point. We should remember that
the drug was marketed with advanced approval because the phase 2
trials were so effective. Because this drug is being withdrawn
worldwide and there are alternatives available, it is important
that NICE revises its guidance to include other drugs, including
other immunotherapies that are effective for non-small cell
carcinoma, which this drug was approved for.
(Con)
I am most grateful to the noble Lord for his lifelong service to
the community and to this House. He raises a very good point. On
the one hand, NICE is clear that there are alternatives to this
drug, but it will still be available to current patients. I take
on board what the noble Lord says, and I will report it back to
the department.
(LD)
My Lords, following on from the previous question, and given the
importance of speed of access to treatment for cancer sufferers,
can the Minister explain what the Government are doing to speed
up the process for NICE approvals for new cancer drugs and how
that process is being tied into the MHRA licensing process, so
that they can run in parallel, rather than one having to wait for
the other?
(Con)
The noble Lord raises a good point, and I agree with it. Since
2016, the cancer drugs fund, worth £340 million per year, has
delivered faster access for tens of thousands of NHS patients to
some of the most promising new cancer medicines—in some cases, up
to eight months faster, including for Pembrolizumab and
Selpercatinib. These are two very important drugs, and the hope
is that they will be successful moving forward. Only time will
tell, but the Government are committed to introducing life-saving
drugs.
(Lab)
The Pharmaceutical Journal found last year that inequity of
access through the compassionate use programme has become a
significant issue, with some trusts not using the programme at
all. What steps are the Government taking to ensure that new and
existing patients across the country will be able to access
Mobocertinib and other treatments for lung cancer?
(Con)
I thank the noble Baroness for that question. As I have outlined
in my previous answers, to the best of my knowledge, the existing
drug will be allowed but some of the newer ones will be
introduced and available. If the noble Baroness knows of specific
trusts that do not make this available, I ask her to please let
me know and I will look into it.
(Con)
I declare my interest as chair of Genomics England and a board
member at BioNTech. Access to therapeutics is critical, but the
earliest possible diagnosis is crucial for survivability.
Although the new lung cancer screening programme is welcome, I
draw the Minister’s attention to a paper published in the Lancet
this month which said that, although it does have favourable
participation and will improve lung cancer outcomes overall, it
is still showing inequalities by smoking, deprivation and
ethnicity. What steps are the Government are taking to address
this?
(Con)
I am grateful to my noble friend, but am not familiar with the
paper to which she refers. On her specific question, the
Government are focusing on areas of social deprivation. She
mentions that this is preventable; the Prime Minister has made it
one of his key tasks to stop the next generation of smokers even
becoming smokers. We can all do more with our personal health:
giving up smoking is an obvious one, but we could also be eating
better and staying fitter. There is more to be done, particularly
in areas of social deprivation.
(Con)
My Lords, as pharmaceutical industries in Northern Ireland make a
vital contribution to the supply of drugs and medicines in our
country, should these drugs not be allowed to circulate freely
through Britain’s internal market?
(Con)
My noble friend raises an important point. The drug supply is
available, albeit through different areas—for example, the
Northern Ireland MHRA. As I indicated in my previous answer, if a
drug is available in England, it is also available in Northern
Ireland. There is no reason why anybody in Northern Ireland
should not be in receipt of life-saving drugs.
