Notable drugs: Kaftrio, Mitomycin 40mg and Remdesivir 100mg vials
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The new fixed combination product Kaftrio (elexecaftor 100mg, tezacaftor 50mg and ivacaftor 75mg) was launched in the UK at the end August 2020 following approval by the European Medicines Agency to treat patients aged 12 years and above who have cystic fibrosis. It is described on dm+d as ‘generic Kaftrio’ and any products supplied previously for compassionate use have been mapped. Note that in the US the product is known as ‘Trikafta’ and any records with this description have also been mapped to Kaftrio.
NHS (England) has announced that patients in England will be some of the first people in Europe to benefit from this new “truly life-transforming” treatment for cystic fibrosis. A deal negotiated ahead of marketing authorisation means that clinicians are free to start prescribing the triple treatment immediately now that marketing approval has been granted. NICE will be working with Vertex Pharmaceuticals (Europe) Limited, the Cystic Fibrosis Trust, NHS England and NHS Improvement to update the current interim data collection agreement for Orkambi and Symkevi to include Kaftrio.
The marketing authorisation for mitomycin 40mg powder for solution for injection manufactured by Kyowa Kirin Ltd had stated that it was licensed for intravenous, intra-arterial and intravesical use. However, during 2019 this was amended so that the product was licensed only for intravesical use. This change was recognised in December 2019 when dm+d changed the VMP name to mitomycin 40mg powder for intravesical use. There was also a VMP for mitomycin 40mg powder and solvent for intravesical solution for which the manufacturer is Medac.
It became apparent that several Trusts were importing a product that was approved in the USA and Canada for intravenous use and that this product was not available on dm+d. This product, manufactured by Accord, has subsequently been granted a marketing authorisation in the UK and has been added to dm+d as mitomycin 40mg powder for solution for injection. Trust are encouraged to include a reference to the manufacturer in all new records for mitomycin 40mg so that the correct VMP and AMP can be selected. For historic records (pre 2019), due to the change of marketing authorisation and name of the Kyowa Kirin product, it is frequently not possible to identify from the description which product has been supplied.
Early access to the promising COVID-19 treatment drug remdesivir has been provided to NHS Trusts throughout the country. Usually such items are not included in the dm+d until fully licensed and approved. However, in order to monitor and report on the usage an entry was created for both the powder for solution and the solution for infusion (20ml). Feedback from Trusts indicate that they were usually unclear which formulation would be received but in order to accurately map issues of remdesivir the formulation must be specifically stated on the issue data within the pharmacy system. We would advise Trusts to review their pharmacy system descriptions and where possible create two descriptions depending on the form issued.
As remdesivir has been granted marketing authorisations for both the powder for concentrate for solution for infusion and concentrate for solution for infusion (brand name Veklury®), Trusts are encouraged to use new descriptors for each of these formulations.