HPE Biosimilars: Where are we and what is next? - Page 17

including cost-effectiveness data , should be consulted to establish the likely place of the new medicine for both new and existing patients . The capacity of the different clinical hospital departments to implement changes to the current prescription pathways , or to define new pathways , needs to be assessed , together with the number of patients using each therapy and their cost compared with the cost of the new medicines to include in the formularies . This assessment must take into consideration the doses administered and the dosage forms made available by the manufacturer ; once all this information is collected , a detailed timeline can be developed . 7
Ideally , the established formulary review processes should be used to evaluate each biosimilar drug , with clinical judgment always taking priority over the value proposition of the medicines . Health systems are likely to use incentives to drive the use of biosimilars , but patients must be monitored to determine if there is a proper response to the medicine and to safeguard against any unexpected or known adverse events . 7
The selection of biosimilars requires the review of elements such as the experience of the manufacturers with biologics , as well as their supply chain , pricing information , patient assistance programs and support materials , homecare services , the biosimilar administration devices and reimbursement initiatives . Nomenclature , methodologies for preparation and administration , and storage conditions must also be considered , together with processes for adequate transitions of care , particularly for those patients who self administer their biologic in their own home . Finally , implementation of medication system changes
The established formulary review processes should be used to evaluate each biosimilar , with clinical judgment taking priority over the value proposition of the medicines at the institutional level , and also educational requirements for both providers and patients in order to avoid confusion and errors during the switch need to be factored for . 6 , 8
When the National Institute for Health and Care Excellence ( NICE ) recommends the use of a reference product , there is no need for an additional Health Technology Assessment ( HTA ) for the biosimilar , 7 but a cost-minimisation model may have to be submitted in some cases . 9 If the reference product is not eligible for reimbursement , then the introduction of the biosimilar in a formulary will require a full cost-effectiveness analysis , although there are regional differences . In Wales , the entity responsible for issuing the HTAs does not normally appraise biosimilars , and the existing guidance for the originators automatically applies to the biosimilar approved for the same indication and patient population ; however , when no recommendations exist for the originator , the biosimilar is not endorsed . 10 In Scotland , full submissions for biosimilars are not frequently assessed , being only required for indications or populations for which the reference medicine is not recommended . 11
The role of pharmacists in the adoption of biosimilars Pharmacists responsible for developing formularies need to examine and evaluate the clinical and scientific data regarding bioequivalence of the biosimilar and originator as well as other relevant evidence from clinical trials , while being aware of the differences in the regulatory approval process for the two types of products . 1 , 12 Pharmacists can have a higher level of familiarity with biosimilars
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