The role of the Hospital Pharmacist: Availability of medicines above price-only procurement Thijs J. Giezen, PhD, PharmD, MSc Hospital Pharmacist, Foundation Pharmacy for Hospitals in Haarlem, Haarlem, the Netherlands Situation in the Netherlands - Exploding drug budgets: 5.86 billion (2014) - Out of hospital: 4.33 billion (growth ca. 3%/ y) - In hospital: 1.53 billion (growth ca. 3-5%/ y) - Increasing pressure due to very expensive oncology drugs - Hospital pharmacist responsible for negotiation with companies 1
Price is not everything - Increasing # of drugs not available: - Levothyroxine - BCG intravesical administration - Remifentanyl - Hospital pharmacist spends a couple of hours/ week finding alternatives - A combination of price, delivery reliability and others - Biosimilars have a positive impact on both Use of biosimilars in the Netherlands (I) - Medicines Evaluation Board: - New patients can be treated with a biosimilar right away - Uncontrolled exchange between biological medicines must be avoided. In other words, a patient must receive adequate clinical monitoring and clear instructions - Traceability is important 2
Use of biosimilars in the Netherlands (II) - Federation for Medical Specialists: - New patients can be treated with biosimilars - Switching of patients from reference product to biosimilar should be avoided - Switching should preferably be done as part of a controlled study in which efficacy and safety are monitored - Cost savings should not be the major driver to switch Use of biosimilars in the Netherlands (III) - Dutch Society for Rheumatologists: - Switching is possible if there are no signals related to a negative impact on efficacy and safety - Patient has been informed - Efficacy and safety is monitored - In case of diminished efficacy or safety issues the patient must be offered to switch back - Traceability is important - Frequent switching is not recommended 3
Role of ministry/ insurance companies - Use of biosimilars is encouraged due to expected savings - Money saved with biosimilars can be spend by the hospital - At this moment: no obligations related to use of biosimilars Biosimilars in clinical practice Misunderstanding and emotions: a bad combination - Concept of biosimilarity is not very well understood - Switching induces antibodies, but patients often switch: - Due to tenders. - Between iv and sc use.. - Patients might induce antibodies after the switch - Disease might progress after the switch Education, Education, Education 4
The role of the hospital pharmacist - No personal contact with patients - Better educated to understand the technical aspects of biologicals - Bigger picture regarding the costs of medicines - Role of the hospital pharmacist: traceability - Traceability important for all biologicals - Biologicals prepared in hospital pharmacy: batch # available - Challenges remain for sc administered biologicals: - Barcode controlled administration - Availability of 2D barcodes 5
Where is the money going? - Biosimilar leads to price reduction due to competition - However, switching takes time and energy Doctors do not like to be pushed by money arguments Introduction of biosimilars: personal experience - Meeting with rheumatologists and gastroenterologists regarding implementation - Agreed that new patients are being treated with biosimilar - Rheumatologists are going to switch - Patients need to be informed - Gastro-enterologists more reluctant 6
Challenges related to use of etanercept - Biosimilar has no powder for injection - Patient need education on use of pen - Biosimilar has no indication for JIA - Traceability is challenging Where is the money going? - Nurses needed to supervise the switch - Incentive for both medical specialist and patient - Savings on biosimilar can be used to create incentive 7
Concluding remarks - Switching is safe - Continue to educate medical specialists and nurses and involve patients - Create an incentive to switch Hospital pharmacists are responsible for objective guidance of the choice of biologicals 8