ABSTRACT

Patient centricity is a hot topic and is a large part of “pharma talk.” While the patient treatment outcomes are deemed critically important, that does not mean that the patient “voice” is always directly considered. Patient-reported outcomes are obtained through carefully designed and validated patient questionnaires are increasingly used by regulatory and payer agencies worldwide to validate patient outcomes claims for use in label and access discussions with payers. Communications on patient-reported outcomes are highly regulated by the Food and Drug Administration/European Medicines Agency and other regulatory agencies. Many physicians discuss drug options with patients and listen to specific requests for a drug. The introduction of co-pay offset coupons have helped patients with private insurance to address their increasing cost contribution. Patient centricity is an important concept in medical care and prescription drug development. Evidence of treatment outcomes of new drug treatments requires a close assessment of the patient’s response to treatment.