additional content cohort of individuals and how to achieve the best patient outcomes .
• Squeeze on healthcare budgets . Public and private payors are relying more on patient outcomes to make decisions that are aimed at managing scarce budgets and focusing on cost-effectiveness and comparative clinical effectiveness .
• Rise of health technologies . Advances in mobile communications and the digitization of health diagnostics , treatment , equipment , and services are changing how care is delivered and how pharmaceutical companies conduct R & D . As new technologies emerge , new regulatory policies follow , adding complexity to the approval and reimbursement processes .
• Empowered consumerism . Consumers are playing a more critical role than ever before in their own care , demanding enhanced access to information relevant to their conditions and treatment programs . The change is influencing payors , regulators , and policymakers . Pharmaceutical companies are affected in a wide range of areas : pricing , the types of drugs they develop , return on research investment , and the role they must play in patient compliance .
A disjointed system
Pharmaceutical companies around the world confront substantial regulatory constraints . Increasingly complex and strict regulatory policies in Europe and the U . S . demand multiple submissions of drug approval applications to satisfy the rules in every region , and extensive documentation to meet clinical trial and pharmacovigilance standards . At the same time , regulators are taking steps to accelerate innovation and efficiently license medicines , diagnostics , and digital applications that demonstrate positive outcomes . By communicating with regulators proactively , pharma companies now have the opportunity to grant patients early access to new medications , particularly those that target unmet diagnostic and treatment needs . At the same time , regulators — as well as providers and payors — appreciate fast-cycle analytics on patient progress to support value-based healthcare solutions .
By communicating with regulators proactively , pharma companies have the opportunity to grant patients early access to new medications .
Amid this context , patients are playing a bigger role in the healthcare dynamic than ever before . They increasingly want to be partners in determining their healthcare strategies and lifestyle choices , joining with providers in making informed decisions . Valid decisions are dependent on clear and timely demonstrations of drug outcomes and efficacy by pharmaceutical companies . ( For a survey of the external pressures that pharmaceutical companies face , see Exhibit 1 .)
To illustrate the regulatory maze that pharmaceutical companies must navigate , Strategy &, PwC ’ s strategy consulting business , analyzed payor decisions related to 19 drugs approved by the European Medicines Agency and the U . S . Food and Drug
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