Aligned with pharmacokineticist to positioned the clinical benefits of a new formulation methylphenidate (Methydur®)on dossier for NHIAprice application
Define the rationale of methylphenidate (MPH) effective concentration (6ng/ml with 50% DAT blockage) and reviewed PK-PD correlation
Identified the unmet needs of concomitantlong and short acting MPH from pharmacodynamic observation to pharmacokinetic linkage
Edited Methydur®pricing dossier for NHIA with cross functions team members
Acquired R&D support on quality by design manufacturing process of ORADUR®
formulation
Collaborated with medical affairs to transform the features of
clinical studies to payer’s, prescribers’ and patients’ benefits
Demonstrationof reimbursement price calculation methodsunder act 17-1
on different pricing scenarios included ten developed countries median
price, referenced dosage ratio price and cost calculation methods to BPE and
brand team
Forecasted years ofMethydur®market penetration based on epidemiologic
top-down data and commercial sales bottom-up models in terms of
manufacturing and developmental costand verification made by finance and
accountant
Convinced both NHIA and TFDA for acceptance
of Methydur®submitted asglobal first launch according to act 17-1 and
possession of new medical effectiveness
Accompanied with RA to review journals of unmet needs on additional IR-MPH
Collectedexternal ADHD experts’ feedback by advisory board meeting and
written statement ofMethydur® clinical benefits
Worked with external counsellors, brand teamand Business Development
unit to formulate experts’ opinions on needs and benefits as new medical
effectiveness
Coordinated experts’ attendance on NHIA DBC meeting for inquiry
Accomplishedtime limited Q&A report with finance and brand team for next
morning NHIA financial meeting
Successfully obtained Methydur® reimbursement price according to act 17-1
Methydur®reimbursed as the 2nd global first launch medication using cost
calculation method as pricing model in Taiwan
MPH launched over 60 years, via formulation innovation offered
proven clinical benefits to fulfil unmet needs and reimbursed as 2A new drug by
NHIA
Methydur®will be a milestone on biotechnology evolution among local
pharmaceutical industries