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NICE Assessment outcomes (3/n) Bimzelx recommended for psoriatic arthritis | iPharmaCenter

Updated: Nov 26, 2023

November 15, 2023

NICE not recommended Pluvicto for PSMA-positive hormone-relapsed metastatic prostate cancer


Lutetium-177 vipivotide tetraxetan was not recommended by NICE for the treatment of prostate-specific membrane antigen (PSMA)-positive hormone-relapsed metastatic prostate cancer in adults.

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.

While NICE acknowledged that lutetium-177 seemed to exhibit greater clinical effectiveness than standard care, it raised concerns about the uncertainty in clinical outcomes due to high withdrawal rates from the control arm in the VISION study.

NICE emphasized the necessity for results from analyses accounting for these withdrawals to estimate lutetium-177's relative treatment effect compared to the best supportive care.


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.


NICE expressed that lutetium-177 did not represent an effective use of NHS resources when compared with standard care and cabazitaxel.

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.

Considering that the cost-effectiveness estimates for lutetium-177 exceeded the threshold deemed effective use of NHS resources, the committee concluded that it could not be considered for inclusion in the Cancer Drugs Fund.


 

October 04, 2023

NICE recommended UCB's Bimzelx for psoriatic arthritis

Bimzelx (bimekizumab), either as a standalone treatment or combined with methotrexate, is a viable option for managing active psoriatic arthritis in adults. This recommendation primarily aims at individuals whose condition has not improved significantly with disease-modifying antirheumatic drugs (DMARDs) or those who cannot tolerate these medications.

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.


In both the BE COMPLETE and BE OPTIMAL trials, Bimzelx outperformed the placebo in enhancing the signs and symptoms of Psoriatic Arthritis (PsA) across various outcome measures that evaluated different aspects of the disease.

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.


According to the submitted Network Meta-Analysis (NMA), Bimzelx demonstrates statistically superior or comparable effectiveness to ixekizumab in addressing various health aspects.

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.

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