Global Outlook on Market Access

Increase in the number of drugs in large pharma product pipeline and requirement for orphan drugs to target the unmet medical needs of patients are the key factors increasing the demand to study the market for potential and effective pricing of the product

  • Entry of disruptive technologies, like big data analytics and m-health, are expected to increase in the future, as more HTA organizations around the world require real-world evidence
  • In case of accelerated approval, the necessity of pharma to prove post-market end-points , by predicting rather than demonstrating clinical benefits is also fuelling the market growth

Regional Overview

Europe has a better established medical/ healthcare system and a strict regulations across the continent. Hence RWE adoption is focused a bit more in EU than in the US

  • Close to 1000 clinical trial authorization applications have been filed in UK in 2017, contributing to 30% of the overall applications across EU. Of this 8% is from phase IV studies
  • NIHR (The National Institute for Health Research) supports the industry through its Clinical Research Network
  • Pricing regulations remains the same across the 4 regions , where as the reimbursement routes varies country to country
  • APAC’s pharma market is growing at a faster pace compared to the USA and is mainly driven by the aging population and greater market access
  • Development of biosimilar in emerging market is shifting pharma focus into these regions
  • China is expected to be the front-runner in this biosimilar drug and pushing for more innovation

Recent Market Trends

Identifying new ways to reach global market along with the aim to retain premium pricing of the drugs (in major geographies) is the main focus of pharma in HEOR sector. Innovative pricing and advertising are being adopted to retain market share

  • Market exclusivity is applicable to the subset of conditions for an orphan drug for which the authorization is obtained and in case the same sponsor is applying for a second subset of condition, the drug will not get an extended exclusivity period, instead will be covered in the initial grant

Impact: The exclusivity period for a drug is reduced and hence it directly affects the revenue generated by the sponsor. Drug efficiency and safety has to be gathered from RWE and post market surveillance, to prove the same in order to retain the market

Geography Impacted: Europe

  • Co-pay programs and other such initiatives including “Captive Pharmacies” have emerged, who have long term relationship with the manufacturers, usually promote only branded manufacturer’s product instead of alternatives or generics that are low in cost
  • Examples of such relationship includes Valeant Pharmaceuticals International -Philidor Rx Service, Horizon Pharma PLC - Linden Care Pharmacy

Impact: Co-pay programs help reach targeted patients and hence increase the probability to obtain better outcomes, to prove drug efficiency and to price the drug higher. In case of a hit, this also helps payers to participate actively in these programs

  • CFDA - Reforms on drug-registration policies are being published and are designed to improve the registration process

Impact: This will bring in more innovation in China and also will encourage pharma to address rare diseases mainly through fast-track approval process.

Geography Impacted: China

  • Promotion of Big Data: Chinese Ministry of Industry and Information Technology is taking an effort to utilize the available resources, considering the fact that health care big data is an important and strategic resource of the country
  • Achieving advanced personalized care and precision medicine by tapping data and provide a one-stop service is the major aim of this promotion. E.g. Medical Big Data Center has been set up in Tsinghua University's Center for Statistical Science to support the increasing demand for medical big data research

Impact: Scattered availability of data is always an issue when it comes to RWE. Promotions like these will help obtain complied data easily and also reduce cost on data licensing for the buyers

Frontrunner Markets: US, EU5, China, Australia, Japan

  • Series of price reforms in Japan is seen including
  • Change from a biennial pricing to annual revision being on effect from 2021
  • Narrowing down the price-maintenance premium (PMP) criteria for patented products – Truly innovative drugs to get that premium

Impact: It affects both in-market and new drug pricing including patented, off-patent and generics

Geography Impacted: Japan

  • Pharma companies including BMS rolling out first outcomes-based insurance for hep-C and AZ has launched pay-by-installment program for lung-cancer patients treated with Tagrisso

Impact: Experimenting new models will improve patient access to medicines