Patient advocacy news // 22nd December 2021
The National Institute for Health and Care Excellence (NICE) has approved the use of daratumumab (Darzalex®) in combination with bortezomib (Velcade®), thalidomide, and dexamethasone (DVTD) as an induction and consolidation treatment for newly diagnosed myeloma patients eligible for high-dose therapy and stem cell transplantation in England and Wales. The decision comes after twice knocking back the life-extending drug combination over the past year.
According to the latest research, DVTD increases myeloma patients’ chance of longer remission times and overall survival by around 50 per cent.
Despite being approved in Scotland back in January and in Northern Ireland in April, DVTD was subsequently rejected at two separate appraisal committees by NICE for use in England and Wales.
While NICE never disputed the drug combination’s effectiveness, its appraisal committee said it needed longer-term data and further evidence to demonstrate the overall extent of the treatment benefit, particularly when taken with lenalidomide (Revlimid®) maintenance, before it could make a cost-effectiveness assessment.
Myeloma UK Chief Executive, Laura Kerby, said:
“We’re absolutely delighted the committee has finally approved this game-changing treatment, although we’re of course disappointed it’s taken a year to get to this point. The reality is that over 1,000 newly diagnosed patients in England and Wales missed out on this life-extending treatment over the past year while those lucky enough to be living in Scotland and Northern Ireland benefited from it with some very encouraging results. We’ve now set up an advisory committee to stamp out healthcare inequality, review the drugs-approval process across the UK nations and make sure patients’ needs come first. Access to vital treatment should not be a postcode lottery.”
Myeloma is a relapsing-remitting cancer, meaning that although many patients will experience periods of remission following treatment, the disease will inevitably return.
Patients’ first remission after their initial treatment, also known as first-line treatment, tends to be the longest and deepest. During their first remission, patients are less likely to experience symptoms, including bone pain and fatigue, or complications.
Around 5,800 people are diagnosed with myeloma, a blood cancer which occurs in the bone marrow, in the UK each year. Out of them, approximately 1,500 receive stem cell transplants.
This means that up to a quarter of newly diagnosed patients potentially missed out on this life-extending new treatment in England and Wales over the past year.
Head of Patient Advocacy, Shelagh McKinlay, said:
“This treatment is a step change for patients receiving a stem cell transplant. Around 1,500 myeloma patients receive stem cell transplants each year and this approval means that they can benefit from a deeper and longer first remission. This is what matters most to patients, their families and friends, so it is incredibly welcome. That said, it took too long to get here. We should not need three meetings for the NICE committee to reach a positive decision. Patients in Scotland have had access to this treatment a full year earlier than those in England and Wales, while patients in Northern Ireland have benefited from it for eight months. This is not good enough. We will continue to fight to ensure no one is left behind and that patients across the UK have equal access to the latest and most-effective treatments.”
Daratumumab is considered one of the most effective drugs in the treatment of myeloma.
Yet, until it was approved for use in combination with bortezomib, thalidomide and dexamethasone in Scotland and Northern Ireland earlier this year, it had only been available to patients much further down their treatment journey.
Rosie Dill, who served as a patient expert, championing the voice of the myeloma community throughout the appraisal process, hailed NICE’s decision as “life-changing” for newly diagnosed and future patients:
“It’s really good news for patients who are about to start treatment. It shows that there are new drugs being approved all the time and that there is a lot for patients to be hopeful for. For me personally, it’s been really nice to be able to play a part in changing the face of myeloma treatment and making a difference for others. I had the normal first-line treatment and my first remission was 18 months. What a difference this could have made to me. It’s going to make a huge difference to patients’ lives.”
Edinburgh-based patient Dave McGovern was diagnosed in April 2021 and has since received DVTD:
“I’m delighted NICE have finally approved DVTD, giving the rest of the UK access to this life-saving and targeted treatment. It reduced my cancer levels to near zero with limited side effects and prepared me well for a stem cell transplant. The results have been impressive. I definitely was expecting it to be a much tougher experience than it has been.”
David Gilliland, 54, from Crumlin near Belfast, was diagnosed with smouldering myeloma in 2017 and is yet to receive treatment. He said:
“To have another weapon in the armory is really great. Any treatment that offers longer remission to people and helps patients live as full a life as possible for as long as possible will make a big difference.”