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25May
How to Improve Transparency with Real World Data to Support Market Access?
The USFDA defines real-world data (RWD) as ‘the data relating to patient health status and/or the healthcare delivery that is routinely collected from a variety of sources’, and real-world evidence […]
18Jan
How Innovative Alternate Payment Models Are Bringing Change In Healthcare?
Drug prices in the US are the highest in the world, which necessitate new or alternate payment approaches. For instance, the new treatments for hepatitis C virus (HCV) infection are […]
28May
Tapping Payers’ Data to Document the Effect of a New Therapy in the Real World
Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability to the regulatory agencies, used to be simple; which ended with the drug being marketed to the targeted physicians and dispensed by pharmacies post approval. Thus, this whole process involved a limited set of stakeholders, viz. physicians, regulatory agencies, and pharmacies.
03Apr
Importance of Tapping Payer’s Data to Document the Effect of a New Therapy
Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability […]
29Mar
Generating Scientific Evidence (Efficacy/Safety/Cost Data) from India
Every country exercises strict control on medicines’ market access. Typically, this requires successful completion and adequate presentation of results from phase I through phase III clinical trials, bringing forward the […]
27Nov
How Are Biobetters Different From Biosimilars?
The biologics market is rapidly growing, at almost twice the rate of pharma industry. Estimates are such that 7 of the top 10 global medicines by spending will be a […]
15May
Adaptive Licensing and Real World Evidence (RWE)
We all want safe and effective medicines to reach patients as soon as possible, but as we know, drug development, market authorization and payer assessment are all slow sections of […]