Table 3. . Restrictions on recommended populations.

Generic name	Category (rare/control)	Appraisal ID	Population in final scope	Recommended population in FAD	Ref.
Sapropterin	Rare	TA729	People with PKU whose HPA has been shown to be responsive to sapropterin dihydrochloride therapy	Option for treating hyperphenylalaninaemia that responds to sapropterin (response as defined in the summary of product characteristics) in people with PKU, only if they are under 18 and a dose of 10 mg/kg is used, only using a higher dose if target blood phenylalanine levels cannot be achieved at 10 mg/kg, or aged 18 to 21 inclusive, continuing the dose they were having before turning 18 or at a maximum dose of 10 mg/kg, or are pregnant (from a positive pregnancy test until birth). Sapropterin is recommended only if the company provides it according to the commercial arrangement	[14]
Secukinumab	Control	TA719	People with non-radiographic axial spondyloarthritis with objective signs of inflammation, whose disease has responded inadequately to, or who are intolerant to, NSAIDs	Option for treating active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by elevated C-reactive protein or MRI) that is not controlled well enough with NSAIDs in adults. It is recommended only if TNF-alpha inhibitors are not suitable or do not control the condition well enough and the company provides secukinumab according to the commercial arrangement	[15]
Empagliflozin	Control	TA773	Adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction	Option for treating symptomatic chronic heart failure with reduced ejection fraction in adults, only if it is used as an add-on to optimised standard care with an ACE inhibitor or ARB, with a beta blocker and, if tolerated, an MRA, or sacubitril valsartan with a beta blocker and, if tolerated, an MRA	[19]
Incisiran	Control	TA733	Primary prevention population - Adults who are primary prevention with elevated risk with serum LDL-C ≥2.6 mmol/L despite maximally tolerated statins or adults with a history of HeFH without ASCVD and serum LDL-C ≥2.6 mmol/L despite maximally tolerated statins. Secondary prevention population - Adults with ASCVD (including HeFH) and serum LDL-C ≥2.6 mmol/L despite maximally tolerated statins	Option for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet in adults. It is recommended only if there is a history of certain cardiovascular events and LDL-C concentrations are persistently 2.6 mmol/l or more, despite maximum tolerated lipid-lowering therapy, that is maximum tolerated statins with or without other lipid-lowering therapies other lipid-lowering therapies when statins are not tolerated or are contraindicated, and the company provides inclisiran according to the commercial arrangement	[21]
Dapagliflozin	Control	TA775	Adults with CKD who are receiving individually optimised standard care	Option for treating CKD in adults. It is recommended only if it is an add-on to optimised standard care including the highest tolerated licensed dose of ACE inhibitors or ARBs, unless these are contraindicated, and people have an eGFR of 25 ml/min/1.73 m2 to 75 ml/min/1.73 m2 at the start of treatment and have type 2 diabetes or have a uACR of 22.6 mg/mmol or more	[23]

ACE: Angiotensin-converting enzyme; ARB: Angiotensin-receptor blocker; ASCVD: Atherosclerotic cardiovascular disease; CKD: Chronic kidney disease; eGFR: Estimated glomerular filtration rate; HeFH: Heterozygous familial hypercholesterolaemia; HPA: Hyperphenylalaninaemia; LDL-C: Low-density lipoprotein cholesterol; MRA: Mineralocorticoid receptor antagonist; MRI: Magnetic resonance imaging; NSAIDs: Non-steroidal anti-inflammatory drugs; PKU: Phenylketonuria; TNF: Tumour necrosis factor; uACR: Urine albumin-to-creatinine ratio.