Personalized Medicine Brings Value Globally

Jeff Elton highlights the differing market access strategies for personalized medicine around the globe.

Personalized medicine that is well delivered is precision medicine - producing the diagnostic and therapeutic approach most likely to yield a positive outcome for patients and health systems. Because of its potential to cut costs, personalized medicine is important for rapidly developing health systems in emerging economies and for those economies that are developed but highly cost-constrained.  Personalized medicine is  transforming global health care, as nations grapple with capping high health care costs and seek therapeutics that offer value to patients and health systems.

How personalized medicine evolves into clinical practice differs across regions and countries, as some countries evaluate therapeutics differently. Reimbursement systems also differ.

Over the past decade, innovations in personalized medicine, such as companion diagnostics and therapeutics, usually have been available in the US first. This has been a function of where the diagnostics or therapeutics originated, the regulatory pathways involved, and the reimbursement environment. 

In Western Europe for example, regulators often evaluate a new medicine and then determine what value it will bring to patients and health care systems before giving it approval. Regulatory, coverage and reimbursement decisions may be made independent of life sciences company influence. I find that frequently regulators want to understand the impact of new therapeutics and verify that new therapeutics offer value over current drugs.

The Value Bundle

In some Northern European countries, such as Norway, regulators often take a bundle approach to approving therapeutics by assuring the availability of a validated companion diagnostic and funding it in combination with the new therapeutic. 

Companion diagnostics can help identify patients who may benefit or likely not benefit from a targeted therapy. These diagnostics can optimize the clinical utility of the therapeutic and lead to verifying that the elements needed to practice medicine efficiently are in the system. This can facilitate a better understanding of the costs and economics involved in utilizing a therapeutic, and may eliminate therapeutics that do not meet a new standard of care.

In the US however, FDA approval may not be granted for a therapeutic simultaneously with a companion diagnostic.  If a diagnostic does not match up to a companion drug, the utility of the therapeutic action may be limited, because those patients in whom a therapeutic works best may not be identified.

In China, life sciences companies can often shape the nature of a solution collaboratively with physicians, government entities and patients.

In another instance, we find that in China the regional authorities require evidence of value before they will allow sale of a new therapeutic or diagnostic - setting the pricing at a level they believe appropriate, whether they or the consumer will be paying. Through this system, some of the more advanced molecular diagnostic tests are becoming available, but often only because life sciences companies require the availability of these diagnostics so that doctors can determine those patients potentially benefitting from targeted therapeutics.

In China, life sciences companies can often shape the nature of a solution collaboratively with physicians, government entities and patients. Accenture finds that the system in China allows life sciences companies to work with leading health systems, key clinical leaders, and regional governments to assure the availability of all component elements of a new therapeutic solution.

By contrast in the US - while there may be an accelerated regulatory approval process – we find that life sciences companies need to provide data to large number of private and public reimbursement authorities to assure some level of coverage and accessibility. This can be viewed by some as a complicated system for securing reimbursement and does not necessarily involve approval of a companion diagnostic.

Localized Ecosystems

The ecosystems for personalized medicine differ in all geographies and countries.  In the US, leading academic centers, the National Institutes of Health, and clinical standards bodies and associations have played critical roles in creating access often before there is broad private and government reimbursement or availability of the therapeutic in community care centers.  In Europe, key partners include government-funded research entities and academic centers, such as the UK's National Institute for Health Research and Norway's Ministry of Health and Care Services.

For instance, I understand that the French government is providing funding for research and practical clinical application of next-generation sequencing of tumors, and is working to ensure the availability of this diagnostic platform for all citizens. In this system, fewer decision makers are involved than, for example, in the US. While early innovations are not always accessible first, they are usually broadly accessible rapidly after value has been established.

I also understand that the system in Canada is less national and more regional or provincial because of restraints on clinical infrastructure and the funding of the health system. While accessibility depends on the country's national guidelines, it is most influenced by the capacity of regional systems.

Value Partnerships

When fully and practically implemented, I believe that personalized medicine can improve the performance of health systems and change clinical outcomes by facilitating the use of therapeutics that add value to the system. But to do so, across all geographies, a therapeutic's value should be established during its clinical development and use.   

Increasingly my company finds that smaller numbers of government or government-funded entities are becoming key influencers and decision makers, guided by increasingly sophisticated data and value analytics.  I believe there is a role for the life sciences company in this process. It is one where the company is a data-driven value advocate. Companies should view the government and quasi-government entities as customers and partners in the delivery of value to their health systems and patients.  We see new revenue or reimbursement models complementing a value partnership in which value is tied to the performance of a personalized medicine system that entails the therapeutic and the diagnostic. 

While regulators in different countries may differ in their approaches to regulating and approving new diagnostics and therapeutics, the regulators should limit health care system costs. The appropriate way to do so is by approving new therapeutics that offer value over those already in the market: those therapeutics that improve clinical outcomes and return patients as closely as possible to their normal lifestyles.

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