The National Institute for Health and Care Excellence (NICE) has issued a second draft “no” on ixazomib (Ninlaro®) for the treatment of patients with relapsed or refractory myeloma.
This means that a final decision on the treatment has not been made but that, as it stands, NICE is not minded to recommend ixazomib be made routinely available on the NHS in England and Wales.
The NICE decision was for the treatment combination of ixazomib, lenalidomide (Revlimid®) and dexamethasone. This decision will not affect patients already being treated with ixazomib, either through the Named Patient Programme (NPP) or on a clinical trial.
Myeloma UK Acting Policy and Public Affairs Manager, Shelagh McKinlay said: “This second draft “no” is disappointing, but while the consultation is ongoing there is still the potential for a positive decision to be reached. We are glad that NICE have decided to seek further views before reaching a final decision.
“Triple combination treatments such as this one are becoming the international standard in myeloma treatment and patients in the UK deserve to have access to them. Ixazomib is not only an effective treatment option, it is the first oral treatment of its kind, offering patients much needed flexibility in how they live their lives.”
“The company have requested that the treatment be considered for funding through the new Cancer Drugs Fund (CDF). The CDF is still relatively new and it is important that it reaches its full potential to deliver faster access to the most promising new treatments. We will continue to work with the company and NICE to try to deliver a positive outcome for patients.”
Ixazomib is a new proteasome inhibitor, similar to bortezomib (Velcade®), and is the first oral drug of its kind. You can read more about ixazomib in our Horizons Infosheet.
NICE have issued this second draft guidance in an Appraisal Consultation Document (ACD) and will now ask more questions to gain any information that could help turn the draft “no” into a final approval. Myeloma UK will continue to work with the company and with NICE and will respond to the negative draft ACD, making a strong positive case for the approval of ixazomib.
The deadline for gathering views is 26 September. The NICE consultation is an open process. Once NICE has gathered views from all stakeholders, NICE will meet again to consider its decision.
NICE agreed that ixazomib is well-tolerated by patients who would welcome the drug as it is an oral form of treatment.
However, NICE wants more information on the clinical benefits of ixazomib compared to treatments already available on the NHS before making a final decision. It was also stated that with the current level of evidence, NICE could not consider ixazomib cost-effective at this time.
These are all factors that Takeda (the pharmaceutical company which makes ixazomib) and other stakeholders will have the chance to comment on in their response
Gaining NICE approval for ixazomib is likely to be challenging.
One of the main issues is that it is being appraised in combination with two other drugs, including another “novel” drug, lenalidomide, which impacts negatively on its cost-effectiveness.
However as this is draft guidance, there is the opportunity for more discussion. Myeloma UK has obtained feedback from clinicians and patients who say ixazomib works well in clinical practice and we will submit further evidence to demonstrate the positive impact it can have on patients’ quality of life. We will keep working with Takeda and others to make a case for ixazomib’s approval.
The decision affects myeloma patients living in England and Wales.
The Scottish Medicines Consortium (SMC) has not yet assessed ixazomib. In Northern Ireland, the Department of Health, Social Services and Public Safety usually make a decision on whether to fund a new treatment following publication of the final NICE decision.
This decision does not affect patients who are receiving ixazomib through the Named Patient Programme (NPP) which provides free access to ixazomib where patients are relapsed and meet a certain set of criteria.
We are aware of NHS England preventing access to the NPP in some areas. If you have experience of this, please email firstname.lastname@example.org.
Takeda have agreed that the NPP will be in place until one year after being approved by the European Medicines Agency or until NICE approve ixazomib.
If you have any questions or comments please email email@example.com or call the Myeloma Infoline on 0800 980 3332.