TA870 · CDF_review
Only if they have had 2 or 3 lines of therapy and the company provides ixazomib according to the commercial arrangement (simple discount PAS)
Source documents
Intervention
Condition
Comparators
| Name | Type | Established | Committee preferred |
|---|---|---|---|
| lenalidomide and dexamethasone | active drug | Yes | Yes |
Clinical trials
| Trial | Design | Phase | Pivotal |
|---|---|---|---|
| TMM1 | RCT | 3 | Yes |
Economic model
ICER
Methodological decisions (5)
Adjustment of overall survival to remove effect of subsequent treatments using 2-stage method with recensoring
Company: 2-stage method with recensoring appropriate; minimal difference between adjusted analysis with recensoring and unadjusted analysis on cost-effectiveness
ERG: Noted that adjustment departed from clinical plausibility; more people had survival-extending treatments in lenalidomide arm yet saw greater reduction in life years; questioned why post-progression life-year gain changed from 7.4% to 30.5% of total
Committee: Although uncertainty exists, company's approach was appropriate; bias from recensoring likely less than bias from not censoring; true cost-effectiveness could be higher than presented
ICER impact: decreases
Representativeness of TMM1 trial population versus NHS eligible population
Company: Trial population clinically appropriate for decision making
ERG: Not stated as separate position
Committee: TMM1 evidence robust and most appropriate; population differences likely contributed to differences versus SACT dataset; people in SACT dataset older and poorer prognosis; TMM1 follow-up longer and more mature
ICER impact: uncertain_direction
Choice between generalised gamma and Weibull curves for extrapolating overall survival
Company: Generalised gamma model chosen because clinicians stated it provided reasonable estimation of long-term outcomes
ERG: Weibull model was as valid on grounds of clinical plausibility and statistically better fitting than generalised gamma for both arms
Committee: Generalised gamma acceptable but Weibull should also be considered; clinical experts acknowledged both estimated similar overall-survival outcomes
ICER impact: negligible
Whether to model waning of relative treatment benefit after stopping ixazomib combination
Company: No treatment waning effect included in base case; discontinuation and waning almost completely captured within 8-year observation time
ERG: Discontinuation of treatment captured but separate from waning of treatment effect; over 90% of people only observed for around 2 years post-discontinuation, insufficient to capture waning; conducted scenarios exploring impact
Committee: Long follow-up of TMM1 largely captured treatment waning; no additional adjustments needed
ICER impact: increases
Source of health-related quality of life values for model health states
Company: Updated EQ-5D data from final analysis of TMM1
ERG: Agreed that utilities from TMM1 final analysis better aligned with literature
Committee: Utility values acceptable; better aligned with literature than prior myeloma appraisals
ICER impact: negligible
Evidence gaps
Commercial arrangement
Special considerations
Cross-references