Saturday, June 15, 2024

Strategic Use of Selinexor in Multiple Myeloma: NICE’s Conditional Approval

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A recently published report by the National Institute for Health and Care Excellence (NICE) provides detailed guidance on the use of the combination therapy of Selinexor with bortezomib and dexamethasone for the treatment of multiple myeloma in adults. This therapy is conditionally recommended for specific patient categories, adhering to strict eligibility criteria designed to ensure both effective and cost-efficient treatment management within the NHS framework.

The intention behind these stringent criteria is to optimize therapeutic outcomes by targeting the use of this combination multiple myeloma therapy to those patient groups most likely to benefit from it, while also managing the financial resources of the healthcare system responsibly. This approach allows for a more precise and judicious use of advanced treatments, ensuring that the investments made in expensive medical therapies yield substantial health benefits in terms of patient recovery and quality of life improvements.

The report specifies that the combination multiple myeloma therapy is recommended only for adult patients with multiple myeloma who:

  • Have undergone only one previous line of treatment and whose condition is refractory to both daratumumab and lenalidomide, or
  • Have undergone two previous lines of treatment and whose condition is refractory to lenalidomide. Moreover, it is stipulated that Selinexor should be provided according to a commercial arrangement, indicating a cost-effectiveness consideration in its application.

Continuity and Restriction: Navigating Selinexor Use in Multiple Myeloma Treatment Lines

Importantly, the recommendation does not intend to discontinue or alter the ongoing treatment regimens that were initiated before the publication of this guidance. Patients currently under multiple myeloma treatment outside these recommendations are to continue with their existing funding arrangements until a consensus is reached by them and their healthcare provider on the appropriate time to discontinue the multiple myeloma treatment.

The decision to restrict the use of the Selinexor combination to specific lines of treatment arises from the evaluation of its clinical efficacy and cost-effectiveness in comparison with other available therapies. Initially, the combination is considered only after the failure of first-line treatments such as daratumumab and lenalidomide, and not beyond the third line of treatment. The relevant comparators for Selinexor at second-line treatment include Carfilzomib plus dexamethasone, while at the third-line, the comparison extends to Ixazomib plus lenalidomide and dexamethasone, and Panobinostat plus bortezomib and dexamethasone, depending on the sensitivity to lenalidomide.

Direct clinical trial comparisons have shown that the Selinexor combination can prolong the duration before worsening of the condition compared to bortezomib plus dexamethasone in second-line treatment but not significantly in the third line. Additionally, these trials did not demonstrate an increase in overall survival with the Selinexor combination compared to the comparators at either line of treatment. Indirect comparisons have also been conducted with other treatment combinations like Carfilzomib and Ixazomib, showing no significant differences in survival or disease progression rates, though these findings are marked by considerable uncertainty.

Multiple Myeloma

Evaluating Selinexor’s Cost-Effectiveness: NICE’s Appraisal in Multiple Myeloma Therapy

The cost-effectiveness of the Selinexor combination is deemed acceptable by NICE when compared to Carfilzomib plus dexamethasone in the second line and with the Panobinostat combination in the third line, fitting within the range considered acceptable for NHS resources. However, when compared to the Ixazomib combination in the third line, it exceeds the threshold for what NICE normally considers acceptable, limiting its recommendation to specific conditions and lines of treatment only.

NICE’s technology appraisal guidance can include various healthcare technologies such as medicines, medical devices, diagnostic techniques, surgical procedures, and health promotion activities. These appraisals are crucial as they address variability in access and clarity regarding the clinical and cost-effectiveness of treatments across the NHS, ensuring standardized healthcare access.

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The Impact of NICE’s Legally Binding Recommendations on NHS Treatment Accessibility

The process of developing this guidance involves several stages and can take forms such as single technology appraisals, cost comparisons, or multiple technology appraisals, depending on the breadth and complexity of the technology assessed.

Following NICE’s recommendations is not merely procedural; it is legally binding for the NHS. The NHS Constitution mandates that treatments recommended by NICE must be available to patients if deemed clinically appropriate by their healthcare providers, typically within three months from the date of the publication of the guidance.

This framework not only ends uncertainty surrounding the use of various treatments but also standardizes therapeutic access, ensuring all patients have equitable access to the recommended care. This policy framework reflects a comprehensive approach to integrating clinical efficacy with economic considerations, aiming to optimize patient outcomes while ensuring sustainable healthcare spending.


Resource: National Institute for Health and Care Excellence, May 15, 2024

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