TABLE 2.

Relapsing/Remitting MS Case Study: COA Type, Time Point, and Application

COA	COA type	Number of decisions featuring COAs	COA in initial coverage text, n (%)	COA in reauthorization coverage text, n (%)	COA application in initial coverage
					Limiting access, n (%)	Documenting baseline, n (%)	Supporting diagnosis, n (%)
Expanded Disability Status Score	ClinRO	49	22 (44.9)	27 (55.1)	2 (9.1)	20 (90.9)	0 (0)
Some functional arm/hand use consistent with performing activities of daily living	COA, unspecified	20	20 (100)	0 (0)	20 (100)	0 (0)	0 (0)
Objective measure of walking ability/walking speed	COA, unspecified	18	18 (100)	0 (0)	18 (100)	0 (0)	0 (0)
Multiple Sclerosis Walking Scale	PRO	5	0 (0)	5 (100)	0 (0)	0 (0)	0 (0)
Multiple Sclerosis Functional Composite Score	PerfO	5	0 (0)	5 (100)	0 (0)	0 (0)	0 (0)
6-Minute Walk Test	PerfO	5	0 (0)	5 (100)	0 (0)	0 (0)	0 (0)
Fatigue Symptom and Impact Questionnaire Relapsing Multiple Sclerosis Scale	PRO	5	0 (0)	5 (100)	0 (0)	0 (0)	0 (0)
Stabilization, slowed progression, or improvement in ≥1 symptom, such as motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling sensation	COA, unspecified	4	0 (0)	4 (100)	0 (0)	0 (0)	0 (0)
New York Heart Association Functional Class	ClinRO	4	4 (100)	0 (0)	4 (100)	0 (0)	0 (0)
Ambulate without aid or rest for ≥5 meters/ambulate without aid or rest for ≥100 meters	PerfO	3	3 (100)	0 (0)	3 (100)	0 (0)	0 (0)
9-Hole Peg Test	PerfO	2	1 (50)	1 (50)	0 (0)	1 (100)	0 (0)
Timed 25-foot Walk Test	PerfO	2	1 (50)	1 (50)	0 (0)	1 (100)	0 (0)
Overall	NA	122	69 (56.6)	53 (43.4)	47 (68.1)	22 (31.9)	0 (0)

We collected 13 individual COAs for MS, but excluded 1 COA from our case study to focus exclusively on drugs indicated for relapsing/remitting MS.

ClinRO = clinician-reported outcome; COA = clinical outcome assessment; MS = multiple sclerosis; NA = not available; ObsRO = observer-reported outcome; PerfO = performance outcome; PRO = patient-reported outcome.