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El NICE inglés y Yescarta. Actualización

Dice Fiercepharma que Gilead ha conseguido que el NICE acepte la financiación de Yescarta para linfoma en adultos, vía el Cancer Drugs Fund, después de ofrecer un descuento confidencial sobre el precio de 300k libras.

Hace muy pocos días, el NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE (NICE) inglés ha publicado un documento para pública consulta sobre la  efectiviad de Kymriah  YESCARTA en su indicación solicitada: tratamiento de adultos con linfoma difuso de células B grandes o mediástinico primario con fracaso tras al menos dos líneas de tratamientos.

Este documento concluye, de modo provisional:
 1 Recommendations 
1.1 Axicabtagene ciloleucel is not recommended, within its anticipated marketing authorisation, for treating relapsed or refractory diffuse large Bcell lymphoma or primary mediastinal large B-cell lymphoma in adults after 2 or more systemic therapies.
 1.2 This recommendation is not intended to affect treatment with axicabtagene ciloleucel that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. Why the committee made these recommendations
Why the committee made these recommendations
 There is no standard treatment for relapsed or refractory diffuse large Bcell lymphoma or primary mediastinal large B-cell lymphoma after 2 or more systemic therapies. Best supportive care is used and usually includes salvage chemotherapy. Evidence from a small, single-arm study suggests that people having axicabtagene ciloleucel have good response rates, overall survival and progression-free survival. But, there are no direct data comparing axicabtagene ciloleucel with salvage chemotherapy (referred to as best supportive care by the company). This means that the exact size of the benefit of axicabtagene ciloleucel compared with salvage chemotherapy is unknown. Axicabtagene ciloleucel meets NICE’s criteria to be considered a lifeextending treatment at the end of life. However, all the cost-effectiveness estimates are above the range normally considered to be a cost-effective use of NHS resources. Axicabtagene ciloleucel does not meet the criteria for inclusion in the Cancer Drugs Fund. Because of this, axicabtagene ciloleucel is not recommended.

Cost-effectiveness results 
The range of the cost-effectiveness estimates is wide and all are above £50,000 per QALY gained 

3.23 The company’s deterministic base case showed that the incremental costeffectiveness ratio (ICER) for axicabtagene ciloleucel compared with salvage chemotherapy was over £50,000 per QALY gained. The exact ICER is commercial in confidence and cannot be reported here. The ERG made some changes to the company’s model to reflect its preferred basecase analysis, specifically: 

  •  excluding patients with unknown ECOG performance statuses from the SCHOLAR-1 cohort (see section 3.20) 
  •  using a hybrid approach to extrapolate overall survival with axicabtagene ciloleucel (see section 3.17) 
  •  using alternative structural cure assumptions 
  •  assuming that CRS is managed for 4 days in intensive care
  •  applying discounted long-term costs for stem cell transplants
  •  using a different cost of stem cell transplant (see section 3.21). 

These changes resulted in an ERG exploratory base-case ICER that was over £100,000 per QALY gained. The committee noted the wide range between the company’s and ERG’s base-case ICERs. It agreed that there was a high degree of uncertainty associated with both the company’s and ERG’s estimates because of the limitations in the data for the comparator and the immature survival data for axicabtagene ciloleucel. The committee concluded that based on the data and analyses presented to it, the cost-effectiveness estimates were all above £50,000 per QALY gained.

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