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.
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Northern Ireland MHRA authorised route and can be supplied as an unlicensed medicine for existing patients after it is withdrawn.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.
My Lords, the Minister will be aware that this drug is due to be withdrawn from the UK market in March, despite the results of the recent EXCLAIM-2 trial, which showed that it can be as effective as chemotherapy, with no safety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.
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.
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?
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.
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.
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.
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?
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.
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?
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.
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?
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.
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?