What can be gained from increased early-stage interaction between regulators, payers and the pharmaceutical industry?

Abstract

New medicines are the lifeblood of the global innovative pharmaceutical industry. Developments in genomics, proteomics, immunology and cellular biology are set to promise a plethora of novel targets for the industry to create and develop innovative new medicines. For a new medicine to fulfill its therapeutic and commercial potential (i.e., successful market access), it is now simply no longer a matter of its creator/developer generating evidence to demonstrate its quality, safety and efficacy to a standard expected by those responsible for making a decision on its marketing authorization (‘regulators’). Nowadays, the successful market access of a new medicine not only requires market authorisation with an acceptable (i.e., competitive) label, but also that those responsible for making a decision on whether or not it is worth paying for (i.e., independent appraisal committees who advise payers as well as payers themselves; the term ‘payers’ has been used as an umbrella term to capture both groups) have the necessary clinical and other evidence they need to make a timely and favorable reimbursement determination at the proposed price. Typically this means that the clinical evidence for a development compound’s that is available at the end of its Phase III clinical trial program to demonstrate its therapeutic value is both strong and relevant to the decisions payers are called upon to make. This poses strategic and operational challenges for the global pharmaceutical industry because the clinical evidence needs of the payers differ both qualitatively and quantitatively from those of the regulators.

Keywords::

• medicines
• payers
• pharmaceutical industry
• regulators
• scientific advice

Financial & competing interests disclosure

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.