Life Sciences Policy

The intensity of the debate on the price and value of innovative medicines and their affordability has only grown in the US over the last five years. This has led to a range of policy proposals at the Federal and State level targeting drug pricing and marketing of innovative medicines. There has been specific attention on price controls particularly in Medicare, the role of value assessment, international price referencing, rebates, the evolution of the employer sponsored insurance model, and the breadth of public coverage.

Drug pricing is likely to address the millions of uninsured due to COVID unemployment, high patient cost sharing, and growing federal costs of Medicare. CRA’s policy team helps clients to anticipate how these policy debates will evolve, the impact this would have on patient access to innovative medicines, investment in future innovation and the commercialization of medicines.

Over the last ten years, scientific advances have supported the development of many new and innovative technologies. The decades-long focus on higher impact targeted therapies has paved the way for the recent and anticipated advances in new treatments including gene and cell therapies. Many orphan medicines have been developed for previously untreatable rare diseases. In oncology, the trends towards multi-indication medicines and combination therapies, as well as medicine/device combinations, are pushing the boundaries of available treatment options with growing treatment costs.

The introduction of these novel therapies has also radically changed how healthcare providers and systems deliver patient care. In many cases, these therapies must be supported by a specialized healthcare infrastructure and use of advanced diagnostic testing.

Given the novelty of medicines in development, it is unsurprising that this has introduced a number of novel policy challenges for payers to exert greater control over pricing and reimbursement.

CRA’s policy team helps clients to anticipate trends and compile the evidence needed to respond to policy challenges affecting market access. We develop analyses and economic assessments that influence policy debates around the world, from shaping the patent regime in Europe to understanding barriers in access to medicines in developing countries.

CRA helps clients to understand and respond to global policy and healthcare financing issues and their links with political objectives around healthcare sustainability, access to medicines and health outcomes.

There is great disparity between the policies and challenges of developed countries, with well-established healthcare systems, and those of emerging middle-income countries that are increasing healthcare spending to support more universal health coverage, and the lowest income countries.

CRA works with clients to examine how different countries finance healthcare and the impact this has for access to medicines.

There is increasing convergence across the life sciences sector bringing together pharmaceuticals, diagnostics, medical devices, and increasingly, digital health.  The new paradigm of “personalized healthcare” has enabled new approaches to treat diseases by considering variability in genes, environment and lifestyle for each individual.

Genomics insights are driving this transformation leading to new opportunities for early detection, screening and prevention of disease which needs to be incorporated into healthcare systems, with significant impact on patients and care pathways.

Similarly, digital health (including eHealth and mHealth) is an emerging and rapidly developing field which has the potential to increase the quality and efficiency of healthcare systems.  The COVID-19 pandemic has rapidly accelerated the use of telehealth and digital technology with an uncertain future for funding or regulation.

While there is general recognition of the benefits these health technologies can offer, there is a danger that innovation in diagnostics, medical devices and digital health solutions are not recognized, rewarded, or adequately funded and the result is that these technologies are not delivering to patients.