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Contributors: Kent Groves, PhD, Chief Global Strategy Officer, dentsu health; Croom Lawrence, Commercial Lead, Ampel BioSolutions; Aarohi Achwal, Senior Associate, Content Management, dentsu health; Rupali Bajaj, Senior Research Associate, dentsu; Minal Jain, Research Analyst, dentsu

Precision Medicine - Headwinds and Tailwinds to Personalized Care

Nothing has been easy in the shift from ‘one-size-fits-all’ medicine to personalized care.  Now, precision medicine needs an overhaul. 

Traditionally, precision medicine was defined as a targeted approach using DNA, molecular signatures, epigenetics, lifestyle, comorbidities, and other factors. 

During the period from 2008 through 2020, the number of precision medicines in the US increased from 5 to 285. Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers.

This explosion of drug investment was indicative of the excitement and momentum around a global push to eradicate disease with an expanded armamentarium to allow “treat to target” to flourish.  What happened?

Bringing the Era of Trial and Error to a Close

Targeted therapies (advanced biologics) have outpaced the mainstreaming of molecular diagnostics.  Over time, as professional judgement led to experimentation to achieve the desired patient reported outcome (PRO) the need to close the loop with targeted treatment and diagnostics became more acute.  Unlike the “un”targeted approaches that are often associated on the trial-and-error method, an expanded definition of precision medicine, with a smarter and more integrated tool set, will enable healthcare professionals (HCPs) to try the optimal therapeutic approach… the first time.

As cost constraints and care rationing under the transition to corporatist “value-based” care, any reduction in cost, misdiagnosis, non-targeted treatment, and unnecessary side effects must shift focus of care from reaction to prediction, and from Rx cycling to prevention. That’s how money is saved and quality of life (QOL) is improved.

Now arguably today, precision medicine and healthcare personalization must integrate even more factors, from “explainable” AI, data-driven digital experiences, wearable devices, mobile apps, and myriad AI powered innovations.  Today these sectors are siloed, but they must converge, pooling their data into ever more intelligent AI-led experiences.  Convergence will redefine the world of diagnosis, treatment, and the personal communications from living brands that are essential to sustained behavior change.

How can a newly expanded definition of precision medicine help?

All diseases are now “rare diseases”. 

When once a small population needed a special status called “rare”, now all diseases will be defined by endotypes and phenotypes - smaller segments of like patients with common molecular characteristics.

Let’s take cancer for example.  Cancer detection involves measurement of biomarkers, which leads to the application of targeted therapy (which targets specific cancer cells). Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules. Today, they have implemented the precision medicine approach across 90% of their portfolio.

 For rare diseases, the DISCOVER program of Columbia University uses genomic sequencing. By sequencing the genomes of over 1,000 patients, they have identified 20 new ultra-rare genetic conditions.

Many international groups also have high hopes from precision medicine for diabetes care. As of 2021, 537 million adults were living with diabetes worldwide. It is worrying, but the recently released consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) offers some reprieve. As per the report, precision medicine could be applied as a standard of care for better identification of molecular signatures and defined endotypes, and more predictive diagnosis and treatment of monogenic diabetes, and eventually can be used to subcategorize entirely new forms of diabetes.

What’s holding this back?

High cost of development, squeezed profit margins, and US/Global government approvals play a decisive role in both approvals and reimbursement for new targeted approaches. Short term cost savings is crowding out predictive, longitudinal care solutions. 

The good news is several countries where medicine accessibility leans towards the positive end of the spectrum are facing these constraints head on. Australia, Belgium, Canada, France, Japan, and the US have made extensive efforts to implement national programs for precision medicine. In Belgium and France, the access to a single biomarker test is characterized by policy support and referral pathways. In Germany, medicine approval by the European Medicines Agency (EMA) leads to reimbursement of the medicine by statutory health insurance, with free pricing in the first year.

That said, it’s not all sunshine and roses everywhere. For instance, in France, although 34 out of 37 EMA-approved precision medicines are available, the delay in the addition to the reimbursement list and treatment guidelines impede medicine uptake.

Furthermore, as precision medicine and diagnostics are expensive to produce for smaller population sizes, they need to be priced higher, which can be impacted by existing national legacy pricing models such as the Canadian Patented Medicine Prices Review Board (PMPRB).  While some patients and insurers might be willing to pay more if the prospect of these medicines working is higher, the manufacturers might be less inclined to pursue registration if strict pricing models are in place.

Bright Spots.

Powerful patient opinion leader groups and advocacy organizations and their physician expert champions are a key starting point.  HCPs especially in private practice or in concierge groups compete extensively on offering cutting edge technology to woo a patient cash payer.  Longevity, wellness, and specialty concierges specialized in precision medicine are a bright spot that can offer new options, and indeed hope for patients and caregivers.  

As the value of “general meds” continues to lose traction, governments, health NGOs and pharmaceutical manufacturers across the globe are working to put precision medicine on the healthcare industry map. In 2016, the US launched the Precision Medicine Initiative with a $215 million investment to expedite biomedical research, equip HCPs with new tools, and encourage people to share their health data. The UK government also founded and expanded the UK Biobank, establishing Genomics England, to run the 100,000 Genomes Project. It has embedded whole genome sequencing into routine clinical care in the National Health Service (NHS).

In Canada, the government, and Juvenile Diabetes Research Foundation Canada, jointly invested a sum of $33 million for diabetes prevention, management, and treatment. The EMA and the FDA also joined hands to advance precision medicine for rare disease patients. Their efforts aimed at expanding access to clinical trials, improving patient engagement, and to bring precision therapies to market. Together, they also support a parallel advice program that enables companies to engage with regulatory agencies for product development. Through this program, companies can offer their medical products in multiple markets.

At the same time, pharmaceutical companies are also playing their part and are already a step ahead. Roche expanded its collaboration with Janssen Biotech Inc., to create diagnostics technologies, such as immunohistochemistry (IHC) for targeted therapies. Bayer, another pharma giant, plans to develop biomarkers and therapies for cardiovascular research projects. Several biopharma companies from Australia and New Zealand have also made strides in the precision medicine research.

Precision Medicine Redefined

Keeping pace with the times, many health and pharma companies have even embraced novel technologies and partnered with technology giants to drive innovation. For instance, M2Gen, a bioinformatics company focused on oncology research, teamed up with Microsoft to improve data analytics. Tempus, a leader in AI and precision medicine, collaborated with Pfizer to boost AI-and-ML-driven efforts in therapeutic development. This is just the beginning; in the next five years 51% of companies globally plan to increase investment in AI tools.

When we talk about the future of precision medicine, we envision a harmonious union of healthcare and technology. From HCPs and patients to policymakers and researchers, everyone involved in the various sectors of the precision medicine pipeline, from drug makers and diagnostics to AI-powered digital health, must come together for improving patient care.

Precision medicine may not offer a cure, but it can offer hope, and at times, willingness to live is the best precision medicine one could ask for.

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