Inclisiran (Leqvio®) added to a new section of the Drug Tariff (Part VIIIC)

From September 2021, the Drug Tariff includes a new section, Part VIIIC, which sets out arrangements of payment 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 prices as authored in the NHS Dictionary of Medicines and Devices (dm+d). Part VIIIC outlines the reimbursement price of one product, Inclisiran, under such a commercial arrangement.

What types of products will be listed in Part VIIIC?

Part VIIIC will include products that the Secretary of State is on notice are available from a manufacturer or supplier at a nominal price that is significantly below the NHS list price for the product because of a commercial arrangement between NHSE&I and the manufacturer or supplier of the product.

What products are listed in Part VIIIC?

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)

What is Inclisiran used for?

Inclisiran is a new low-density lipoprotein cholesterol (LDL-C)-lowering treatment indicated for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia. Novartis is working collaboratively with NHSE&I to develop and/or improve patient pathways to support improved lipid management, which is one of the priorities set out in the NHS Long Term Plan. Inclisiran has been identified by NHSE&I as a treatment what it wishes to adopt 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.

When is Inclisiran going to be available in the market?

The launch of Inclisiran into the lipid management pathway in England under a population health management framework is expected to start in September 2021.

Where can I obtain stock of Inclisiran from?

AAH UK has been awarded the tender for supply of Inclisiran to primary care in England under a Solus distribution arrangement. AAH UK are expected to start selling Inclisiran into primary care from September 2021. Inclisiran will be available to order from AAH at a nominal charge of £45 per pack, as agreed within the commercial agreement between Novartis and NHSE&I for supply against NHS prescriptions. Stock for private prescriptions (list price) can be obtained by contacting Novartis Customer Care directly on 08457 419 442 or via e-mail commercial.team@novartis.com

How is the reimbursement price for Inclisiran determined?

The Secretary of State has determined the basic price for Inclisiran based on the nominal price of the listed pack size and takes into account the commercial arrangement between NHSE&I and the manufacturer or supplier, although the Secretary of State will not have been privy to the details of the commercial arrangement.

Why can Inclisiran not be reimbursed at the NHS list price?

Ordinarily, pharmacy contractors would have been reimbursed the NHS list price for Inclisiran if it was listed in Part VIIIA of the Drug Tariff, as a Category C product. As it would not represent value for money for the NHS and the taxpayer to reimburse contractors the NHS list price for Inclisiran and in order to implement this treatment at an affordable price and limit the financial impact on primary care, an alternative reimbursement process had to be sought.

The Secretary of State determined a basic price for Inclisiran based on the commercial arrangement between Novartis UK and NHSE&I which ensures that this drug is available to purchase at the nominal price via the designated wholesaler (AAH UK). The commercial agreement, executed by the Commercial Medicines Directorate (CMD), ensures the affordability (and reduces the drugs budget impact) of the treatment to enable adequate access for high-risk atherosclerotic cardiovascular disease (ASCVD) patients across England.

Do the Part VIIIC arrangements for Inclisiran apply to England and Wales?

No. The Part VIIIC arrangements for Inclisiran apply to England only.

What can I do if Inclisiran cannot be obtained at the Part VIIIC list price?

Contractors should not expect to incur any additional charges or fees when ordering Inclisiran from AAH UK. The product will be available to order at the nominal charge of £45 per pack, as agreed within the commercial agreement between Novartis and NHSE&I. However, contractors who are unable to source products listed in Part VIIIC at or below the basic price, or who are the subjected to additional charges when purchasing the products listed in this Part, may request a review of the basic price and repayment of any additional costs incurred. The review requires the following steps to be taken:

• 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 5 working days from receipt.
• Should no resolution be identified by the suppliers within 5 working days of receipt, then contractors should escalate the issue to PSNC who will work in collaboration with NHSE&I and Novartis to seek a resolution to issues raised.
• To support the handling of the review, contractors are required to submit evidence of any difficulties experienced including issues with pricing or supply. Any claims and supporting evidence will then be referred by PSNC to Department of Health and Social Care.

Following a successful review, where pricing issues are identified, any adjustments will be applied by the NHS Business Service Authority (NHSBSA) to the contractors account at the earliest possible payment date.

Will the arrangements for Inclisian extend to other drugs that may be listed in Part VIIIC in future?

No, it was agreed with DHSC that arrangements for Inclisiran would not set a precedent for any future considerations to Part VIIIC of the Drug Tariff.

For further information or to escalate a pricing or supply issue with Inclisiran please contact info@cpe.org.uk