REGULATORY, PRICING AND REIMBURSEMENT LANDSCAPE OF BIOSIMILARS IN AUSTRALIA
Author(s)
Patel P, Tripathi S, Chauhan E, Jain A
PAREXEL International, Chandigarh, India
OBJECTIVES: To understand the dynamics of regulatory approval, pricing, and reimbursement of biosimilars in Australia METHODS: Publically available documentation of biosimilar appraisals by the Therapeutic Goods administration (TGA) and Pharmaceutical Benefits Advisory Committee (PBAC) were reviewed to obtain data on the following variables: indication extrapolation, time taken for reimbursement after TGA approval, economic analysis in PBAC submission, and interchangeability at physician/pharmacy level of biosimilars. RESULTS: The literature search identified 13 biosimilars approved by TGA. Of which, three biosimilars were not considered relevant for the review due to non-availability of data. Out of 10 biosimilars, 8 got approval for multiple indications corresponding to the reference biologics based on their comparable clinical results in a subset of the approved indications. However, etanercept received approval only in four of six indications. Additionally, one remaining biosimilar (insulin glargine) got approval in line with its reference biologic (there was no need for indication extrapolation). 7 of 10 biosimilars were appraised and recommended by PBAC within 6 months of TGA approval except one (somatropin: 20 months). Of these seven, five submitted cost‑minimization analysis in PBAC and demonstrated potential net savings at 5th year and/or over 5 years (Australian Dollar: 10-60 million and 100-150 million, respectively). With respect to the adoption of biosimilars at the provider level, only three biosimilars received interchangeable status (2–Prescriber and 1–Pharmacist). Differences in route of administration and dosage strength to the reference biologics were cited as key reasons for non-interchangeability. CONCLUSIONS: Biosimilars in Australia go through standard regulatory, pricing and reimbursement appraisal process. Further, the majority of biosimilars have been recommended on the basis of cost-minimization by PBAC, thereby highlighting their role in the reduction of overall health care costs. Additionally, more initiatives would be needed to drive adoption of biosimilars at patient and provider level.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PHP165
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Approval & Labeling, Decision & Deliberative Processes, Prescribing Behavior, Reimbursement & Access Policy
Disease
Multiple Diseases