Rybelsus® tablets re-classified as a special container
Following representations from Community Pharmacy England, with the support of Novo Nordisk Ltd, the Department of Health of Social Care (DHSC) has re-determined the special container status of Rybelsus® (semaglutide) tablets.
From 1 April 2024, all three strengths of Rybelsus® tablets (3mg, 7mg and 14mg) will be re-classified as special containers to be supplied as complete packs as they meet the relevant criteria as set out in Part II Clause 10B of the Drug Tariff.
Special container status for Rybelsus® will allow pharmacy teams to supply the complete pack size or combination of complete packs nearest to the quantity ordered. Where the quantity ordered falls exactly between two containers, pharmacy teams should round down, and supply the nearest complete container.
All three strengths of Semaglutide tablets (3mg, 7mg and 14mg) will enter Category C, Part VIIIA of the April 2024 Drug Tariff with the reference product Rybelsus® annotated as a special container.
FAQs
Q. What quantity of Rybelsus® will I be reimbursed for on a prescription requesting 28 Rybelsus® tablets (any strength)?
A. Pharmacy owners will be reimbursed the nearest complete pack size which is 30 tablets.
Q. What quantity of Rybelsus® will I be reimbursed for on a prescription requesting 56 Rybelsus® tablets (any strength)?
A. Pharmacy owners will be reimbursed based on a combination of containers nearest to the quantity ordered which is 60 tablets (2 packs of 30 tablets).
Q. What quantity of Rybelsus® will I be reimbursed for on a prescription requesting 45 Rybelsus® tablets (any strength)?
A. Pharmacy owners will be reimbursed for only one pack of 30 tablets. This is because where the quantity ordered falls exactly between two containers, pharmacy teams should round down, and supply the nearest complete container.
Q. Can I dispense the exact prescribed quantity if this is different to the special container pack size?
A. Where the quantity ordered does not coincide with that of the special container pack size you are required to supply the nearest complete pack size nearest to the quantity ordered. However, in a small number of cases, where there is an over-riding clinical requirement to dispense the exact quantity ordered rather than the nearest complete pack or sub-pack size, pharmacists would need to assess the clinical appropriateness of splitting the pack to dispense the exact quantity bearing in mind the impact on the stability of the drug once removed from its original packaging. There may be patient safety issues to consider if a pharmacist decides to dispense the exact quantity ordered. For example, if a hygroscopic drug is stored and used incorrectly, exposure to moisture could affect the integrity of the drug and potentially decrease its stability and/or efficacy.
Q. Will my payment be based on endorsement if I dispense the exact quantity ordered of a drug (which is not a multiple of a special container pack size)?
A. For products classed as a special container, pharmacy owners are reimbursed according to special container rules. The payment rules for special containers may mean that in some cases pharmacy owners are reimbursed more than the prescribed quantity and, in other cases, it may be less. Any endorsement of a quantity that does not correspond to the special container pack size (or multiple of) will be disregarded by the NHSBSA.
Q. Can Rybelsus® tablets be dispensed into a Monitored Dosage System (MDS)?
A. Pharmacists will need to assess the clinical appropriateness of dispensing the exact quantity of Rybelsus® into weekly trays by considering the stability of the drug once it is removed from its original packaging.
For further guidance on stability of drugs in Monitored Dosage Systems (MDS) please refer to the Specialist Pharmacy Service guidance on Usage of Medicines in Compliance Aids.
Since August 2019, Community Pharmacy England’s Dispensing & Supply team has reviewed over 4,000 products against Drug Tariff special container criteria. The three main criteria under which Community Pharmacy England has focused its attention are drugs that are considered hygroscopic, viscous external preparations and those packaged into containers from which it is not practical to dispense the exact quantity. Of those checked, Community Pharmacy England has identified and submitted applications for nearly 900 products that appear to meet one or more of the special container criteria but are not annotated as such in the Drug Tariff and/or the NHS Dictionary of Medicines and Devices (dm+d).
Where a product meets the special container criteria as set out in the Drug Tariff, a special container indicator for the relevant pack size (complete pack or sub-pack) is applied to the respective product entries in the dm+d and in the Drug Tariff, where listed.
For a list of all the monthly changes to the special container status of products please see the following page Notice of changes to special container status of products.
If you identify any particular product(s) which are not currently classed as special containers but you believe satisfy the criteria (as set out in Part II CLAUSE 10 B of the Drug Tariff), please notify Community Pharmacy England’s Dispensing and Supply Team (0203 1220 810 or ds.team@cpe.org.uk) who will investigate and assess if it meets the relevant criteria. Where appropriate, Community Pharmacy England will make application to the NHSBSA and DHSC seeking for the special container status of the product(s) to be re-determined.
