Baricitinib for treating severe alopecia areata

Company: Not explicitly stated; used placebo comparison in trials

ERG: Would have preferred analyses including comparisons with NHS treatments such as immunosuppressants

Committee: Comparisons with placebo in base case is acceptable given wide variation in NHS practice; acknowledged unmet need for comparison with actual NHS treatments

ICER impact: uncertain_direction

Company: not explicitly stated in this section

ERG: not explicitly stated in this section

Committee: no active treatment as comparator

ICER impact: negligible

Company: Basket of active treatments (ciclosporin, methotrexate, azathioprine, intralesional corticosteroids, contact immunotherapy, prednisolone, topical corticosteroids, topical minoxidil, oral minoxidil, mycophenolate mofetil, anthralin, wigs) costed from secondary care perspective in revised base case; restricted to 10-year time horizon

ERG: No alopecia areata medicines used after non-response; only pharmacological mental health treatments, wigs and orthotics; provided scenarios with 1 or 2-year restrictions based on clinical expert feedback

Committee: Committee considered both company's and EAG's compositions and applied maximum best supportive care use in both arms with 10-year limit for medicine use for alopecia areata

ICER impact: uncertain_direction

Company: People with baricitinib non-response are less likely to have best supportive care compared with no active treatment group; decreased this differential in revised base case

ERG: Same proportion of people should have best supportive care after non-response in both arms; no evidence supports differential use; provided scenarios with 0%, 25%, 50%, 75% adjustments

Committee: Both arms should have the same proportion of best supportive care after non-response, but agree to consider range of proportions

ICER impact: decreases

Company: 4-state Markov model (induction, maintenance, best supportive care, death) with treatment response defined as SALT score ≤20 at 36 weeks; no one can transition from non-response to response after induction period

ERG: EAG considered the model structure appropriate and similar to models for other dermatological conditions

Committee: company's model structure for revised base case is appropriate for decision making

ICER impact: negligible

Company: Adverse events were mild, had little detriment to HRQoL, and did not increase healthcare costs; did not include in economic model

ERG: Adverse events should be included in economic modelling

Committee: Adverse events should be included in economic modelling

ICER impact: increases

Company: BRAVE trial populations are broadly representative of NHS patients

ERG: Trial populations had more severe alopecia areata and lower depression/anxiety than NHS population; treatment effects may underestimate effect in newly diagnosed or treatment-naive population

Committee: BRAVE populations broadly generalisable except for depression, anxiety, and QoL impact levels; acknowledges treatment effects may be underestimated in newly diagnosed population

ICER impact: increases

Company: not explicitly stated

ERG: BRAVE populations had more severe, difficult-to-treat alopecia areata; findings may underestimate treatment effect in newly diagnosed patients

Committee: BRAVE populations broadly generalisable except for depression, anxiety and quality-of-life impact; treatment effects may be underestimated in newly diagnosed or treatment-naive population

ICER impact: uncertain_direction

Company: SALT score of 20 or less used as definition of treatment response

ERG: Used SALT score ≤20 for treatment response definition

Committee: SALT score of 20 or less as treatment response

ICER impact: negligible

Company: EQ-5D appropriate for measuring health-related quality of life

ERG: Not explicitly stated

Committee: Acknowledged that almost half of people had scores of full health at baseline and no improvement in EQ-5D-5L scores after treatment; identified as a key uncertainty

ICER impact: increases

Company: Company's assumed proportion

ERG: EAG's assumed proportion

Committee: Apply the same proportion of people having best supportive care in both baricitinib and no active treatment arms; consider a range of proportions

ICER impact: increases

Company: EQ-5D-5L, HADS, SF-36 and Skindex-16 Alopecia Areata measures are appropriate for assessing quality of life

ERG: These measures may not be appropriate because many domains (e.g. mobility) are not relevant to alopecia areata; the measures may not capture important psychological aspects of the condition

Committee: The measures used may not adequately capture the profound impact of severe alopecia areata on quality of life; EQ-5D-5L may not be picking up important aspects of the condition

ICER impact: increases

Company: EQ-5D-5L data from Adelphi study, using difference between severe and mild subgroups to represent change from baseline after treatment

ERG: EQ-5D-5L data from BRAVE trials, used to estimate within-person changes after treatment response

Committee: true utility values likely lie between BRAVE and Adelphi studies; consider a range for decision making

ICER impact: increases

Company: Company's utility values

ERG: EAG's utility values

Committee: Consider both company's and EAG's utility values

ICER impact: uncertain_direction