HPE Viatris Handbook | Page 22

short of their goal to meaningfully assess value ”. 9

Many healthcare organisations have wrestled with questions of value and value for money and the NPC has developed detailed guidance on patient-centred value assessment . 10 In brief , value assessments should focus broadly on all aspects of the healthcare system , recognising that many aspects of healthcare are interconnected . Focusing only on medications and excluding the rest of the healthcare system ( e . g ., procedures , diagnostic tests , hospitalisations , clinic / office visits ), will result in an incomplete assessment .

The pharmacist as the biosimilar expert The pharmacist has an important role to play in relation to the selection , purchasing and use of biosimilars . In order to play their full part , they need to have a good understanding of the drugs themselves – formulation , storage requirements , handling requirements and also of the way in which they are used – authorised indications , presentations , disease outcomes and numerous practical aspects such as the budget impact of different biosimilars . In addition , pharmacists can expect to contribute to the education of other staff and patients about these complex drugs , to the development of hospital / organisation policies for their use and to post-marketing pharmacovigilance schemes .

Purchasing and selection Purchasing decisions should be guided by BIAs and value assessments . They should also be informed by knowledge of the formulation of the drug that is actually used , e . g ., subcutaneous or intravenous dosage forms . As illustrated by the Danish example above , a simple cost-minimisation analysis may fail to capture the reality of the situation . If a saving in the acquisition cost of the drug leads to longer ‘ chair times ’ and greater demand on clinic resources the net result could be that fewer patients are treated . Additional considerations will include the manufacturer ’ s experience with biologics , supply chain , patient assistance programmes and support materials , homecare services and reimbursement schemes .

Introduction , switching and substitution The successful introduction of a biosimilar in a hospital requires the support and ‘ buy in ’ of all the clinicians , prescribers and patients . This may require education , training and a clear understanding and transparency at all levels of the drug logistics in the hospital so that the concept of biosimilarity is understood and common myths are tackled . 11

The pharmacy team will be involved in preparing prescribing systems for the biosimilar products and coordinating the withdrawal of the reference product . Inevitably this will involve discussions about the interchangeability ( the practice of substituting one drug for another with the same clinical effects by the prescriber ) and switching ( substituting one drug for another with the same therapeutic intent ) and automatic substitution ( the practice of substituting one drug for another interchangeable drug at the pharmacy level without consulting the prescriber ). The impact of having a clear programme for control of switching is essential for general acceptance of biosimilars in the local hospital .

Switching and substitution can be a cause of anxiety for patients and there is a risk of the ‘ nocebo ’ effect ( a negative reaction to a treatment that cannot be explained based on the known pharmacology of the drug ). Pharmacists need to be ready to provide information and answer patients ’ questions . One resource that may be helpful is a detailed Question and Answer guide published by The European Commission . 12

Prescribing and pharmacovigilance All biologics , including biosimilars , must be identified by a unique name . This is important for product traceability and pharmacovigilance . At a practical level , it is important for pharmacists to be able to identify the treatment that a patient has been receiving , which includes a batch-oriented follow-up for each biosimilar , so that they are able to advise appropriately on continuing treatment . The reference product , biosimilars and bio-identicals will contain the same active substance with the same international non-proprietary name . Thus , the sole unique identifier is the trade name . Pharmacists need to ensure that electronic prescribing systems are designed to use the trade names of biosimilars and manual records also provide facilities for prescribing by trade name for these products .

When biosimilars are introduced , there should also be a pharmacovigilance ( risk management ) plan in place . In practice , this could mean that records are kept of adverse reactions to biosimilars are recorded together with full details of what the patient was receiving ( including name , manufacturer and batch number ). However , this risk management plan is not different from what is being done for reference products . In some specialities , registries ( e . g ., BADBIR – the British Association of Dermatologists Biologic and Immunomodulators Register 13 ) have been established to monitor patients receiving biologics . These can provide valuable information about the ongoing safety and effectiveness about biosimilar treatment and also help to identify opportunities for the introduction of biosimilars .

Conclusion There are numerous points at which the expert pharmacist can and should contribute to the safe , effective and economic use of biosimilars . Given the complex nature of the drugs themselves , the costs of the drugs and the systems required for safe prescribing and traceability , there are many opportunities for the expert pharmacist to add significant value .