Join the DDA or

New Part VIIIC added to English Drug Tariff

Special payment arrangements for inclisiran (Leqvio)

September 2nd 2021

Tagged: DM Zone news Clinical Zone news England

By Ailsa Colquhoun

From September 2021, the Drug Tariff includes a new section, Part VIIIC, which sets out the reimbursement arrangements for products with a nominal price (i.e where the purchase price of the product is significantly lower than its NHS list price).

Products listed in Part VIIIC are available at nominal prices because of commercial deals in place between the manufacturer or supplier and the NHS England and NHS Improvement (NHSE&I) which allows manufacturers to supply a drug to the NHS at a reduced cost compared to its published NHS list price in the NHS Dictionary of Medicines and Devices (dm+d).

At present the only product listed in Part VIIIC is inclisiran (Leqvio) 284mg/1.5ml solution for injection pre-filled syringes (Novartis Pharmaceuticals UK Ltd), a new low-density lipoprotein cholesterol (LDL-C)-lowering treatment indicated for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.

NHSE & I wishes to adopt Inclisiran systematically and at scale to help tackle cardiovascular disease (CVD) in a large high-risk patient population who are unable to reach their LDL-C goals on maximum tolerated lipid lowering therapies. To achieve the scale and volumes required to positively impact a nation’s cardiovascular health outcomes, the initiation and management of this treatment will be predominantly carried out within a primary care setting.

Inclisiran will be expected to be introduced into the lipid management pathway in England under a population health management framework from this month (September 2021).

A solus distribution arrangement with AAH UK has been reached, with packs priced at an agreed £45 per pack.

The Part VIIIC arrangements for Inclisiran apply to England only, and it has been agreed with DHSC that arrangements for Inclisiran would not set a precedent for any future considerations to Part VIIIC of the Drug Tariff.

No endorsement is required for the reimbursement of this product.

 If there are any issues with the supply, ordering and pricing of the product, contractors must contact AAH UK in the first instance.

  • This can be escalated to Novartis via the wholesaler if appropriate, and a resolution to all issues raised will be sought within five working days from receipt.
  • Should no resolution be identified by the suppliers within five working days of receipt, then dispensing teams should contact the DDA with evidence of any difficulties experienced including issues with pricing or supply.