MHRA
- Status: likely_approved
🇬🇧 Darzalex in United Kingdom
NICE has issued 10 UK HTA decisions
Marketing authorisations
MHRA
- Status: likely_approved
MHRA
- Status: likely_approved
Health technology assessment
10 decisions from NICE for Darzalex in United Kingdom.
NICE TA959 — ✓ Recommended
- Indication assessed: treating newly diagnosed systemic amyloid light-chain amyloidosis
NICE recommended Darzalex for treating newly diagnosed systemic amyloid light-chain amyloidosis. This decision was made based on a commercial arrangement. No restriction or condition was placed on the use of Darzalex.
NICE TA841 — — Appraisal terminated
- Indication assessed: treating relapsed or refractory multiple myeloma (terminated appraisal)
NICE made a decision to terminate the appraisal of Darzalex for treating relapsed or refractory multiple myeloma. This decision means that NICE will not make a recommendation on the use of Darzalex for this indication. The decision to terminate was made without a recommendation on the cost-effectiveness of Darzalex, as no cost-effectiveness analysis was reported.
NICE TA783 — ✓ Recommended
- Indication assessed: treating relapsed and refractory multiple myeloma
NICE recommended Darzalex for treating relapsed and refractory multiple myeloma. This decision was made based on a commercial arrangement and a Patient Access Scheme, but the cost-effectiveness was not reported. There are no restrictions on the use of Darzalex for this indication.
NICE TA726 — — Appraisal terminated
- Indication assessed: treating relapsed or refractory multiple myeloma (terminated appraisal)
NICE made a decision to terminate the appraisal of Darzalex for treating relapsed or refractory multiple myeloma. This decision means that the appraisal process for this indication has been stopped. The decision was made without a recommendation on the cost-effectiveness of Darzalex, as the appraisal was terminated.
NICE TA634 — — Appraisal terminated
- Indication assessed: untreated multiple myeloma (terminated appraisal)
NICE made a decision to terminate the appraisal of Darzalex for the treatment of untreated multiple myeloma. This decision means that NICE will not be making a recommendation on the use of Darzalex for this indication. The decision was made without a recommendation on cost-effectiveness, as the appraisal was terminated.
NICE TA454 — — Appraisal terminated
- Indication assessed: treating relapsed or refractory multiple myeloma (terminated appraisal)
NICE made a decision to terminate the appraisal of Darzalex for treating relapsed or refractory multiple myeloma. This decision means that NICE will not make a recommendation on the use of Darzalex for this indication. The decision to terminate was made without a recommendation on cost-effectiveness or a restriction on its use.
NICE TA917 — ✓ Recommended
- Indication assessed: untreated multiple myeloma when a stem cell transplant is unsuitable
NICE recommended Darzalex for the treatment of untreated multiple myeloma in patients for whom a stem cell transplant is unsuitable. This decision was made based on a commercial arrangement. No restriction or condition was placed on the use of Darzalex.
NICE TA897 — ✓ Recommended
- Indication assessed: previously treated multiple myeloma
NICE recommended Darzalex for the treatment of previously treated multiple myeloma. This decision was made based on a commercial arrangement and a Patient Access Scheme. No restrictions were placed on the use of Darzalex.
NICE TA771 — — Appraisal terminated
- Indication assessed: untreated multiple myeloma (terminated appraisal)
NICE made a decision to terminate the appraisal of Darzalex for the treatment of untreated multiple myeloma. This decision means that NICE will not make a recommendation on the use of Darzalex for this indication. The decision to terminate the appraisal was made without a recommendation on the cost-effectiveness of Darzalex.
NICE TA763 — ✓ Recommended
- Indication assessed: untreated multiple myeloma when a stem cell transplant is suitable
NICE recommended Darzalex for the treatment of untreated multiple myeloma in patients for whom a stem cell transplant is suitable. This decision was made based on the drug's clinical effectiveness and cost. A Patient Access Scheme and commercial arrangement were in place to support the recommendation.
Darzalex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United Kingdom
Frequently asked questions
Is Darzalex approved in United Kingdom?
Yes. MHRA has authorised it; MHRA has authorised it; MHRA has authorised it.
Who is the marketing authorisation holder for Darzalex in United Kingdom?
Johnson & Johnson is the originator. The local marketing authorisation holder may differ — check the official source linked above.
Has Darzalex been assessed by UK health technology agencies?
Yes — 10 UK HTA decisions on record from NICE.