- For use in hepatic encephalopathy (unlicensed) that is refractory despite using maximal tolerated first- and second-line therapy (e.g. lactulose, rifaximin)

Digoxin (TLS Red)

- For off-label use in medical or surgical termination, in line with trust protocols.

Ranibizumab (TLS Red)

- For proliferative diabetic retinopathy (PDR) after complete pan retinal photocoagulation, and for temporary treatment for people with PDR who have vitreous haemorrhage preventing pan-retinal photocoagulation and for temporary treatment for people with PDR who need cataract surgery, and the severity of the cataract is preventing pan-retinal photocoagulation.

Tadalafil (TLS Amber specialist initiated)

- For off-label use in secondary Raynaud’s and Digital Ulceration in systemic sclerosis, as a first-line choice of oral PDE5 inhibitors.

Shared Care Protocols

The following shared care protocol(s) have been updated or removed:

Bicalutamide for prostate cancer has been updated
Shared care protocol for Lacosamide in epilepsy to be removed
Shared care protocol for Oxcarbazepine in epilepsy to be removed
Shared care protocol for Tapentadol for severe chronic pain to be removed
Shared care protocol for Lacosamide in neuropathic pain to be removed, as well as the accompanying entry in the BNSSG Joint Formulary

Traffic Light Status Changes

Acarizax for treating allergic rhinitis and allergic asthma caused by house dust mites in line with NICE TA1045. TLS changed from Red to Amber Specialist Initiated for both adults and paediatrics.
Betula verrucosa for treating for treating moderate to severe allergic rhinitis, conjunctivitis, or both, caused by tree pollen in line with NICE TA1087. TLS changed from Red to Amber Specialist Initiated for both adults and paediatrics.
Oral semaglutide was TLS Amber and is now TLS Green for diabetes. The recommended brand to be prescribed is Rybelsus.
Lacosamide for treating epilepsy changed from TLS Amber 3 months with shared care protocol, to TLS Amber Specialist Initiated.
Oxcarbazepine for treating epilepsy changed from TLS Amber 3 months with shared care protocol, to TLS Amber Specialist Initiated.
Tapentadol for treating severe chronic pain changed from TLS Amber 3 months with shared care protocol, to TLS Amber Specialist Initiated.

NICE Technology Appraisals traffic light status discussions:

TA1075 Dapaglifozin for treating chronic kidney disease. TLS to remain TLS green, as per current position.

The following NHSE commissioning policies were noted, with red TLS:

Other discussions/decisions:

Rivaroxaban co-administered with an anti-platelet. TLS changed to Amber Specialist Recommended and SCPs retired. See supplementary information on Remedy here.
Aspirin (TLS Green) has been added to Chapter 2.7.1 under ACS. This reflects standard practice and aligns with formulary listings elsewhere. The omission in this section was an oversight.
Otomize® ear spray will soon become generic, and the generic name will be Dexamethasone/ Neomycin sulfate/ Acetic acid 0.1%w/w / 0.5%w/w / 2%w/w Ear Spray. Formulary entries (adults/paeds) and Remedy/PGDs to be updated to reflect this. (NHS list price same as Otomize £3.27/5mL). Read more here Otomize® ear spray 5ml now available as a generic – Middlesex Pharmaceutical Group
Verteporfin entry updated to include For pachychoroid-derived CNV (PCV), and pachychoroid-derived leakage (CSC) as per approved formulary application of May 2019 and subsequent audit data (indications omitted from formulary entry in error).
Methadone listing on the Chapter 4.5 Pain page has been updated. The listing (TLS Blue), which specified use recommended by Pain and Palliative Care Teams, has been changed to Amber – Specialist Recommended (as per Chapter 16.1) to better align with formulary definitions.
MagnacLac will replace MagTab as TLS Red. This will be second line, after other magnesium salts are not tolerated for patients with Gitelman syndrome or other kidney tubule disorders characterised by/ associated with magnesium losing tubulopathy.