HPE Biosimilars: Where are we and what is next? - Page 14

IMPLEMENTATION

Successfully introducing biosimilars : key considerations

To enable the successful implementation of a biosimilar at organisation level , a number of key elements must be in place . Here a personal UK perspective on how a Trust has introduced biosimilars into its formulary is presented
Tim McCarthy BPharm MSc Deputy Chief Pharmacist ( acting ) & Drug Resource Manager , The Royal Marsden NHS Foundation Trust , UK
To carry out the successful introduction of a biosimilar at Trust level , the key local stakeholders ( patients , clinicians , pharmacists and prescribers ) should not see any difference in a patient ’ s treatment pathway and overall experience , from administration of the drug to adverse events and clinical outcome , unless , of course , this is of benefit to the pathway ( for example , reduced patient waiting times ).
Who are the key stakeholders ? Internal ( within the Trust ) Clinical leads The clinical leads need to understand and buy into the concept of biosimilars from the outset . Without the support of the clinical leads , the introduction of the biosimilar will not be possible .
Nursing staff Nursing staff need to understand the concept behind biosimilars in order to discuss patients ’ questions and provide assurance to them if required .
Patients Without the patients ’ buy in and acceptance of the concept of biosimilars and the assurance from health care professionals in relation to this , successful introduction will hit major obstacles from the start .
Pharmacy team The pharmacy team is key in coordinating and managing the readiness requirements for the local introduction of the biosimilar . This may include education and training for clinicians , nurses , other health care professionals and patients , assisting in the readiness of prescribing systems , procurement of product , management of the withdrawal of the originator and introduction of the biosimilar , and post-implementation monitoring and reporting .
IT department With the number of different electronic prescribing systems available and the different levels of complexity required to add a new drug to the system , the requirement to involve IT should not be overlooked , in order to remove an avoidable obstacle early on in the introduction process .
External ( in the wider healthcare environment ) Charities and support organisations Having the support of such organisations is important and assists in providing patients with the assurance that the biosimilar introduction and switch ( for some patients ) is safe and will not be detrimental to their care . Charities can also assist in the development of patient information leaflets to assist the introduction of the biosimilar .
Pharmaceutical industry / manufacturers The manufacturer of the biosimilar is able to provide important information ( often prior to launch of the product ) that will help ensure that the required pathway with the anticipated biosimilar is manageable , while at the same time providing information ( other than regarding cost ) that will assist in the Trust ’ s decision regarding which product is most suitable when more than one biosimilar might be coming on the market . This might include launch date , vial sizes available , ability to meet supply chain demands , storage requirements , availability through a third party aseptic compounding unit , and extended stability data .
Third party provider ( if product requires aseptic preparation ) The ability to have this as an option if the biosimilar is aseptically prepared and the originator was previously provided via this route is useful . The extended stability data available from the third party provider should also be suitable ; again , this might affect the decision made with regard to the most suitable product for use at the Trust should the stability offered vary because this might affect possible wastage .
Commissioners ( National Health Service / Clinical Commissioning Groups ( CCGs )) They are able to provide incentives for the timely introduction of a biosimilar . This can be done in a number of ways ; in the past this has been seen through local agreements between Trusts and CCGs to provide funding to resource the implementation of the biosimilar , for example , funding of staff posts in patient-facing clinics . More recently NHS England has incorporated the introduction of biosimilars into the Medicines Optimisation Commissioning for Quality Innovation ( CQUIN ) programme , for which Trusts receive payment should they meet the targets set within the CQUIN . These funds can then be invested into the resources required to introduce the biosimilar , or the service into which the biosimilar is to be introduced ( noting , however , that how the money is reinvested is at the individual Trust ’ s discretion ). It has been shown from national uptake data in the UK and experiences across Europe that incentivisation is a significant driver in successful uptake of biosimilars because without incentives , uptake is minimal .
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