Patient-centric commercialisation

Justin van Gennep explains how alternative models for healthcare delivery will improve patient compliance and provide valuable, real-world outcomes data.

We're entering into an era of 'The new health', which is Quintiles perspective on the fast-morphing world of biopharma where the rules are changing on all fronts. Among the many challenges now facing biopharma companies is the issue of demonstrating the value of their products to the specific expectations of an increasingly powerful group of payers. Meeting these high expectations and demands for accountability has been exacerbated by obstacles that limit market access and reimbursement, which increases the challenge of building a business case for premium pricing on branded drugs and therapies.

In the complex and fragmented European healthcare environment, biopharmaceutical companies are struggling to obtain market access for new products. Unlike in the United Kingdom, for example, where most reimbursement decisions are made at the national level, the healthcare landscape of Europe consists of a number of local and regional decision-makers who are becoming increasingly powerful in determining which products get reimbursed and which do not. In countries such as Spain and Italy, reimbursement decisions are slightly more regionally oriented, in the sense that there is a strong push for the regional payers to be more independent from the central government. This means that these local payers have a bigger say on how their health care budget is spent, and what criteria they use to determine reimbursement. So it's not enough for a product to obtain a central EMEA registration - in countries where pharma can't get a central reimbursement decision, they have to be mindful that one region may choose to cover a product but another region may not. This requires an overall strategy designed to bring convincing data to these regional decision makers that will be meaningful to them.

The challenge for the industry, therefore, is to demonstrate the value of its products in a meaningful manner, which resonates not only with patients and providers, but with regional payers as well.

Regardless of where they are located, payers are now demanding pay-for-performance. To make an accurate determination of the viability of a drug, they will require data that provides market access information such as economic arguments, quality of life metrics and data from head-to-head trials. Payers will want to analyse traditional clinical data as well as the market access data to prove that a drug is a significant step forward in terms of therapeutic performance, and more importantly, economic value. Therefore, combining patient-centric healthcare services with real-world health outcomes data direct from the marketplace will be a critical component for success for biopharmaceutical companies looking to commercialise a new product.

To succeed in 'The new health', pharma must provide payers with as much outcomes data as possible. Although phase III trial results are a necessary and appropriate component, real-life outcomes data from patients observed in normal circumstances are the most meaningful. Furthermore, regional-level outcomes data from the population within the region reimbursement is sought would be ideal. Outcomes data out of Italy, for example, would be far more convincing to Italian payers than patient data from Scandinavia.

The question then becomes how can pharma obtain the information it desperately needs to demonstrate the value of its products? One model with considerable promise for obtaining better outcomes data is in-home healthcare delivery. In health systems such as the United Kingdom and the Netherlands, independent healthcare specialists make visits to patient's homes and help them properly administer their prescribed medications. In-home healthcare delivery not only helps to increase patient compliance, it affords the opportunity to document health outcomes from a very controlled environment. With such real-world outcomes and safety data, biopharmaceutical companies can then be better equipped to provide payers with information that will resonate with them. In a model such as this, pharma is no longer just selling a product, but providing a fully integrated service.

Some companies are already experimenting with home health care models, but most traditional biopharmaceutical companies do not have the expertise to deliver on this type of service. Direct patient care is not a core function of the industry due to its inherent conflict of interest and the fact that it can be better delivered by an independent expert. Furthermore, physicians would be very reluctant, and rightfully so, to hand over patient treatment to a pharmaceutical company. But an independent resource with the knowledge, skills and systems in place to collect and analyse patient outcomes data can be an indispensable ally in demonstrating the value of pharmaceutical products to payers.

Additionally, early in-home health care providers have been geared more toward compliance and patient ease than they have toward collecting outcomes data. Indeed, most of these providers have never even incorporated health outcomes into their business models, and as such, are ignoring an important element for the future development and distribution of medicines. Because demonstrating value to the appropriate stakeholders is of critical importance for commercial success, it is imperative that the industry leverages every possible tool it can to collect the real-world outcomes data that payers are now demanding.

Quintiles is paving the way to use in-home health care to collect real-world data via its joint venture with healthcare-at-home in Germany, and its plans to expand these industry-leading patient-centric services throughout continental Europe. A key centerpiece of this partnership is collecting regional outcomes data, applying proper analytics to it and furnishing customers with information that helps to create a strong economic argument for reimbursement. Through an understanding of the European marketplace and the complexities of the various health care systems, combined with Healthcare at Home's robust infrastructure and expertise, Quintiles will usher in a new model of pharmaceutical commercialisation in which patient-centric services and the collection and extrapolation of outcomes data will lead to better care for patients, and better returns for the industry.

Pharma is indeed in the midst of a massive paradigm shift, and a new way of bringing innovation to market must be found. A new commercialisation model is necessary, one that takes into account the needs of the new decision makers and, most importantly, the new decision requirements needed to have a successful commercial product. By leveraging real-world data from real-world patients, pharma can better prepare itself to meet these requirements and seize the opportunities of 'The New Health' successfully.

Justin van Gennep, MD, serves as Quintiles' Senior Vice President and Head of EMEA Commercial Solutions. He joined Quintiles in 1998 bringing more than 25 years of experience as a business leader in the pharmaceutical industry. Dr. van Gennep earned his medical degree from the University of Amsterdam and has participated in post-graduate programs including the INSEAD Executive Program (IEP) and a post-graduate course in Pharmaceutical Medicine UWIST.

---

'The New Health'

'The New Health' is both the movement toward an ideal state and the destination. It is defined by the challenges that biopharma executives are struggling to resolve, by the expanded stakeholder group, and by the promise of better health for humans through high-quality, accessible products and treatments that enable people to live healthier lives. It is not simply a landscape in which faster and cheaper ensures a competitive advantage. It marks a moment in which public health, multi-stakeholder collaboration and access to quality and affordable medicine must be factored into every decision - from how drugs are developed and delivered to assessing their value, and to how they are brought to market as safely and efficiently as possible. 'The New Health' presents unmistakable risks for biopharma, yet offers unmatched opportunities for those who can navigate those risks, usher in a new paradigm of drug development and put into operation a more innovative business model.