Cancer Drugs: Licensing and Approval

Baroness Morgan of Drefelin Excerpts

Monday 8th November 2021 Lords Chamber

Asked by

[Baroness Morgan 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.

[Baroness Morgan 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 (Lord Kamall) (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NICE is committed to publishing draft guidance on cancer drugs around the time of licensing, with final guidance published within three months of licensing wherever possible.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.

[Baroness Morgan 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?

[Lord Kamall (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.