CASE – From obstacle to opportunity: RMP implementation as a Go-to-Market strategy

Client Need

Regulatory Agencies require Product initiation and use is subject to safety measures (i.e. RMP) to minimize risks to patients due to the drug's AEs. The implementation of the RMP requires structures, resources and activities normally not conducted by neurologists.

For this reason, the RMP might cause significant delays in the drug's uptake as well as risks to the benefit/risk profile of Product, if not properly implemented.

Client wanted to:

  1. Identify roadblocks to RMP implementation, 
  2. Devise and implement solutions to minimize such hurdles and ensure optimal adoption of Product.

Approach

Hospitals were assessed through field visits aimed at understanding: availability, location and capacity of resources, knowledge of the product and RMP procedures, required training and education, administrative, local payment and logistics hurdles.

All assessments were collected and analysed to determine the ability to implement the RMP on a centre-by-centre basis, in order to design local solutions. Solutions designed were divided between local "Quick Wins" (e.g. identify resources and explain RMP requirements, write hospital RMP protocols, efficiently divide RMP activities amongst HCPs) and more global "Long Term" actions (e.g. RMP Outsourcing Network).

Quick Wins were directly implemented by LSC in Hospitals, while a long-term RMP development map was recommended, country by country or region by region. Authorization and Market Access implications were also taken into account in order to ensure a consistent and synergistic approach within each Region.

Results

  • Project was considered a company-wide best practice for launch excellence and the assessment framework used consistently across markets by MSLs to assess hospitals' ability to run the RMP
  • More than 300 Hospitals assessed through field visits: activity very well received by customers
  • Over 50 Hospitals directly prepared for RMP: prepared centres saw faster Product uptake
  • Implementation of the RMP was transformed from a hurdle into a go-to-launch program enabling pre-launch interactions with customers and institutions (e.g. guidelines, budget impact)
  • The program had additional benefits in Emerging Markets, in terms of developing specialty medicines use (e.g. local registries for access, controlled distribution to reduce misuse, parallel trade and fakes).

Designed and developed by: Brand039