New framework promises to improve medicines access

A new proposed framework designed by researchers including CMUS Director Professor Carl Kirkpatrick bridges the disciplines of pharmacology, epidemiology and health economics to allow meaningful dialogue between industry, regulators and payers. Ultimately this will create better outcomes for everyone.

Traditional models of drug development have not been ideal for either patients or payers. In the model employed in most of the world, drug development is considered complete when regulatory approval is attained. This arrangement has not proven ideal for payers, who have been obliged to provide reimbursement with little influence on what they were receiving or whether they chose to accept it.

An alternative arrangement, currently being employed in Europe, requires patients to wait for developers to navigate the payer landscape before the new medicine becomes available. This can take up to two years – an unacceptable delay where lifesaving medicines are concerned.

Professor Kirkpatrick’s collaborators include faculty alumnus Dr Craig Rayner from Certara, a leading drug development stewardship organisation, along with a team of international collaborators from pharmaceutical industry, consulting agencies and academic institutions. Together, they have designed a quantitative framework called Pharmacology to the Payer (“P2P”) that has the potential to address these concerns.

Drawing upon pharmacology, epidemiology, and health economics, P2P supports meaningful dialogue between industry, regulators and payers, bridging the gap between different competencies and motivations.

While the P2P framework to date has been applied to indications in infectious diseases, this approach is readily expandable to other acute and chronic diseases. The approach may inform early target product profile (TPP) requirements for investigational drugs, procurement strategies, and strategic pricing and deployment decisions, including combination with adjacent non-therapeutic interventions.

Should the framework withstand stakeholder scrutiny, it offer sponsors the possibility of earlier certainty of a path to market and business case, and earlier revenues through “provisional pricing”.

Regulators would get earlier alignment with regulatory requirements, and payers would benefit from earlier alignment with reimbursement requirements and opportunities to risk/cost share.

And finally – and most importantly – it would give patients earlier access to new medicines.