Regional NHS Pharmacy procurement Provide guidance in relation to product launch , availability , stability data and interim pricing arrangements . It may also assist in the managed uptake of biosimilars within the region to promote a good supply chain and healthy market for manufacturers .
What are the key requirements ? Having ensured all the key stakeholders have been involved , the key local requirements to ensure successful local implementation include :
Planning ahead and horizon scanning for the anticipated launch of a biosimilar The time line for the successful introduction of a biosimilar can be approximately six months .
Local approval process in advance of the launch of the biosimilar ( s ) This will vary from Trust to Trust ; however , the clinical unit in which the biosimilar is to the used ( this may be more than one ), should submit a proposal to the Trust ’ s Drug & Therapeutics , Committee / Medicines Prescribing Committee or similar . This will act to ensure that the introduction has the clinical unit and thus clinical leads ’ support as well as Trust approval . Ideally this should take place approximately three months prior to launch to ensure that any issues can be addressed and the introduction plan can then move forward smoothly .
Education and training Staff ( clinicians , nursing and pharmacy ) should be trained to understand the concept of biosimilars to a good level of competency to be able to address any queries from patients who might require reassurance or want to understand more about biosimilars . There are a number of educational tools available that can be tailored to a Trust ’ s individual needs , including Cancer Vanguard materials 1 ; the pharmaceutical industry can also often assist in the provision of educational sessions and materials .
Patients should also be educated regarding biosimilars , so they can be reassured regarding the product and are able to ask any questions that they might have regarding treatment . Discussions might take the form of focus groups where patients can share their concerns and ask questions , or be in the form of letters from the Trust to patients incorporating Q & As , or information leaflets , always with the opportunity for further discussions if the patient requires . Again these should be carried out a month or so before the introduction so that any concerns the patients have can be addressed well in advance . It is also often of benefit to ensure that patients are aware that the monetary savings can be further reinvested into the health economy ( which , in some cases , will provide benefits that will be visible to them ).
Availability of biosimilar at a competitive price in order to make any switch worthwhile If more than one biosimilar is being launched within the same time frame , review of which product is most suitable for use at the organisation will be required . Information driving decision-making might include : date of launch ; supply chain ; vial sizes available ; availability via a third party aseptics compounder ; extended stability data ; and price . In the NHS , regional procurement will assist and
Having ensured all the key stakeholders have been involved , the key local requirements to ensure successful local implementation must be met provide guidance regarding this and ensure good market management .
Coordination of the introduction and IT readiness There are a number of possible ways that the introduction can be carried out : – Big bang – Phased introduction .
If clinical trials using the biologic originator are ongoing , the sponsor should be contacted to see if the trial is able to use a biosimilar or must remain with the biologic . The requirement could differ from one trial to the next .
Next steps following introduction Following the introduction of the biosimilar , it is important to report on a number of key criteria . These include :
• Adverse drug reactions ( ADRs ), in order to ensure that the number of ADRs is the same after implementation as it was before implementation
• Monetary savings obtained as a result of the introduction of the biosimilar
• If patients received the biologic originator , or were switched back to it , this should be investigated and the reason obtained and reviewed to ensure appropriate monitoring .
Conclusions The aim is to ensure successful delivery and safe and timely introduction of a biosimilar . In order to do this , no change in the treatment pathway ( unless this provides further benefit ) should be observed . For example :
• Preparation should not be affected – factors that might play a part in this are extended stability
data and availability of preparations by third party providers if this is the preparation route used for the originator . The inability to provide suitable extended stability and preparation by third party providers may mean that preparation needs to be brought in-house due to third party provision not being available or short expiry dates , meaning that the risk of wastage is greater and thus third-party provision could be perceived as a risk . The outcome of this could lead to increased capacity issues on local units and possible increases in patient waiting times on day units , thereby leading to a lack of support for the introduction of the biosimilar
• Staff training and development in order to be able to answer patients ’ questions and provide assurance
regarding their treatment with biosimilars . Staff are required to be trained to a competent level to ensure that they are able to understand and relay the concept of biosimilars to patients and provide assurance that the biosimilars provide the same efficacy and outcomes and side effect profile as the originator
• Patient buy in and understanding of the biosimilar they are to receive , and also the fact that the
monetary savings will be reinvested into the health economy , which in some cases will provide benefits visible to the patients ( for example , additional staff for patient-facing services ).
Reference 1The Cancer Vanguard . Biosimilars – getting it right first time . http :// cancervanguard . nhs . uk / biosimilars-getting-it-right-first-time / ( accessed July 2019 ). hospitalpharmacyeurope . com | 2019 | 15