Oct 7, 2023
Updated: Nov 26, 2023
November 15, 2023
This recommendation applies specifically to cases after taxane-based chemotherapy and an anti-androgen, or when taxanes are deemed 'medically unsuitable.'
The National Institute for Health and Care Excellence (NICE) conducted an evaluation, highlighting an existing need for effective treatment options for PSMA-positive hormone-relapsed metastatic prostate cancer that not only enhance the quality of life and survival but also entail minimal side effects.
The agency noted that the survival gain for lutetium-177 versus cabazitaxel was uncertain. Additionally, NICE deemed it appropriate to include costs for PET-CT or SPECT scans as part of PSMA testing for 62.5% of individuals receiving lutetium-177. However, the cost-effectiveness estimates for lutetium-177 were characterized by uncertainty, with none falling within the range typically considered cost-effective.
The company responsible for the drug suggested a potential exploration of a managed access route for individuals for whom taxanes are not 'medically suitable.'
However, the absence of new comparative data for relevant comparators led to uncertainties in the assessment.
October 04, 2023
To be eligible for this treatment option, patients should meet specific criteria:
They should have experienced the ineffectiveness of at least two conventional DMARDs.
Additionally, they should have undergone treatment with at least one biological DMARD.
In cases where tumour necrosis factor (TNF)-alpha inhibitors are medically contraindicated but would otherwise be considered, Bimzelx is also a suitable alternative.
Monitoring the response to Bimzelx after 16 weeks of treatment is essential. If there is insufficient improvement in psoriatic arthritis according to the Psoriatic Arthritis Response Criteria, discontinuing Bimzelx should be considered.
This recommendation for using Bimzelx in treating active psoriatic arthritis was made following a thorough assessment that included a cost comparison method.
Notably, both trials achieved their primary objective, with Bimzelx administered at 160 mg every four weeks (Q4W) demonstrating a superior response in joint improvement, as assessed by ACR50, at Week 16 compared to the placebo.
The results were as follows:
In the BE COMPLETE trial, the ACR50 response rate for bimekizumab was 43%, whereas it was only 7% for the placebo group.
In the BE OPTIMAL trial, bimekizumab showed an ACR50 response rate of 44%, significantly higher than the 10% observed in the placebo group.
These include joint manifestations (measured by ACR20, ACR50, ACR70, and PsARC criteria), extra-articular manifestations (evaluated through PASI75, PASI90, PASI100, enthesitis, and dactylitis assessments), functional capacity and quality of life (assessed by HAQ-DI, pain VAS, SF-36 PCS, and SF-36 MCS), as well as composite measures.