Tuesday, June 18, 2024

Multiple Myeloma Treatment: G-BA Amends Directive for Talquetamab Benefit Assessment

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The Federal Joint Committee (G-BA) recently resolved to amend the Pharmaceuticals Directive to include the benefit assessment of Talquetamab (marketed as Talvey) for multiple myeloma patients who have undergone at least three prior therapies. This assessment, effective from March 7, 2024, aligns with Section 35a SGB V, focusing on orphan drugs.

Under Section 35a SGB V, the G-BA assesses the benefit of new medicinal products. For orphan drugs, the additional benefit is considered proven upon marketing authorization, per Section 35a, paragraph 1, sentence 11, SGB V. This ensures orphan drugs are acknowledged for their benefit without requiring evidence of medical benefit relative to appropriate comparator therapies unless their turnover exceeds €30 million annually.

If the turnover threshold is surpassed, the pharmaceutical company must provide evidence within three months, demonstrating the additional medical benefit relative to appropriate comparator therapies, as defined by the G-BA. The G-BA decides whether to conduct the benefit assessment itself or commission the Institute for Quality and Efficiency in Health Care (IQWiG). The procedure for orphan drugs was modified in March 2012 to assess the extent of the additional benefit based solely on approval studies, given the legal assumption of their proven benefit upon authorization.

Talquetamab Shows Potential in Treating Relapsed Multiple Myeloma

Talquetamab indicated for relapsed and refractory multiple myeloma in adults after at least three prior therapies, has demonstrated a non-quantifiable additional benefit. This conclusion is based on data from the phase I/II MonumenTAL-1 study, involving 339 participants across 47 sites globally. The study evaluates Talquetamab’s efficacy and safety, with primary endpoints including overall response rate (ORR) and progression-free survival (PFS).

At the data cut-off, 28.1% of non-TCRDT pretreated patients and 45.2% of TCRDT pretreated patients had died. Median survival time was not reached. Median PFS was 9.56 months (non-TCRDT) and 5.03 months (TCRDT). Data from EQ-5D-VAS and EORTC-QLQ-C30 indicated improvements, though the single-arm design precludes comparative assessment. Severe adverse events were common, particularly blood and lymphatic system disorders.

Due to the single-arm design, a comparative assessment is not feasible. The reliability of data is classified as a “hint,” signifying the evidence’s limited inclusiveness. The assessment estimates 1,210 to 1,310 patients in the statutory health insurance (SHI) target population. Treatment should be initiated and monitored by specialists experienced in managing multiple myeloma. Additional risk minimization measures include providing training materials and a patient card to highlight risks like cytokine release syndrome and neurological toxicities.

Multiple Myeloma

Cost Analysis and Dosage Regimen for Talquetamab in Multiple Myeloma Treatment

The cost analysis, based on product information and the LAUER-TAXE®, considers the dosages recommended. For Talquetamab, premedication with corticosteroids, antihistamines, and antipyretics is required during the step-up phase. The average body weight for dosage calculations is 77.7 kg, and treatment costs are approximated after deducting statutory rebates.

Weekly dosage regimen:

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  • Step-up phase costs for Paracetamol, Dexamethasone, and Dimetindene
  • Treatment phase costs for Talquetamab at 0.4 mg/kg weekly

Biweekly dosage regimen:

  • Similar premedication costs as the weekly regimen
  • Talquetamab treatment at 0.8 mg/kg biweekly

According to Section 35a, paragraph 3, sentence 4 SGB V, the G-BA designates new active ingredients that can be used in combination with the assessed product. This designation is necessary for implementing combination discounts under Section 130e SGB V. However, Talquetamab, authorized for monotherapy, does not involve such combinations. The resolution does not introduce new information obligations or bureaucratic costs. The process sequence includes dossier submission, publication of the benefit assessment, written statements, oral hearings, and final resolution adoption.

 

Resource: Gemeinsamer Bundesausschuss, May 13, 2024

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