Presentation (CTI)

OBJECTIVES: Market Access is the process to ensure that all appropriate patients who would benefit, get rapid and maintained access to the brand, at the right price Market It is important to have right drug candidate identified & development program put in place so that asset gets due regulatory & reimbursement approvals
METHODS: Development programs & access strategies are best designed through consultative process with different stakeholders, viz. regulators, HCPs, payors & patients coupled with strong internal collaboration between research, development, commercial, manufacturing & supply chain units of the company with inputs from region & country set ups of the manufacturer. Thinking about access for drug candidate under development starts early in the process. Key points of consideration are regarding (a) Right disease strategy (b) Right drug selection (c) Right Clinical development plan (d) Right regulatory strategy & label (e) right price (f) solutions needed to navigate challenges of country health care systems for reimbursement (g) right prescription behaviors for adoption.
RESULTS: Different payers use different methods to assess new medicines against the Standard of Care They make these decisions on the basis of a number of factors, viz. (a) Disease burden (b) Budget impact (c) Relative effectiveness (d) Cost effectiveness (e) Cost utilisation (f) Comparative effectiveness (g) Pricing & funding, They encourage prescription through inclusion on the necessary formulary, clinical guidelines / protocols.
CONCLUSIONS: As time & cost of developing innovative medicine is long & costly coupled with uncertainties regarding success of Drug development program & because of limited patent time awarded to innovative drug candidate there is a limitation in realizing potential of new innovative asset. Hence it’s important to start early with right access plan / process for drug candidate.