Real World Evidence & Market Access Summit USA

Dec 3, 2015 - Dec 4, 2015, Philadelphia

Leverage Real Life Data & Analytics for Value-based Market Access

RWD – Will the Promise be Fulfilled?

What are the challenges around access to & the collection of RWD from a UK and European perspective?

Simon Brander is one of the Founders of CSL, who specialize in data management and analytics for Life Sciences.



RWD and data-driven healthcare has been heralded as the next big thing in healthcare1 however, there are some real barriers emerging and pharma needs to be aware of these and take the necessary action.

Open data

The open data initiatives across Europe are encouraging public bodies to open data on an FOC (free of cost), or at worst, cost basis for all. The UK has embraced this in a big way and has been pioneering the release of health data. Until recently (Q1 2014), this open agenda was also extended to patient data (suitably anonymized and with guidelines on use) but a backlash by the press and the public has put pay to this2. It is now unlikely that the commercial companies (e.g. Pharma) will get access to primary care patient data, and access to secondary care data, which is still possible but much more restrictive, could cease altogether.

Patient driven data

With access to public health data drying up, the alternatives are data collected by patients using devices and apps. Just about every device and app is being designed to capture data; data has value and this is where the device and app providers see their long term commercial return. The data value to pharma is large – if you can really understand how patients are behaving with your product, you can (a) help them adhere to the regimen and therefore, get the benefit they should be receiving and (b) collect information on their wellbeing so that you can demonstrate value to payers. VBP (Value Based Pricing) is coming and pharma needs to be in a position to provide, or challenge, the value measures that will underpin this. In addition, the understandings gleaned also have much wider uses such as helping shape drug development and enhancing patient engagement.

So what are the barriers to this virtuous development?

1. Distrust and “what’s in it for me, the patient?”:

  • Using apps or devices is going to involve commitment and effort by the patient, the more limited the better but there needs to be an incentive. In the US, this is simple because there is a direct or indirect commercial link between pharma and the patient, and financial incentives (the most powerful kind) can be brought to bear. In Europe, the cost of medicines and indeed healthcare is hidden so different rewards/motivators are required.

2. Personal benefit:

  • Patients want their data to be used for their personal healthcare benefit, it needs to be shared with their medical team. An altruistic benefit – helping the wider community – is less powerful.

3. Legal restrictions:

  • Patients (and emerging data protection laws) require that data shared is only used for the purpose for which it was given, secondary use is not automatic. Note most Big Data insights have arisen from the secondary use of data. These new laws could effectively block these initiatives.

4. Security:

  • Patients will expect their data to be stored securely and that the storage and use of the data will be managed to ensure that their rights and wishes are always observed.

 

The challenges for pharma (and device companies) are as follows:

- Legal issues

  • Does everyone in the organization understand the legal landscape of data use and data protection? With data becoming so much more available, there are potential PR minefields ahead if companies inadvertently stumble into misusing personal data. The law is incomplete but rapidly developing in this area.

- Capability and infrastructure

  • Is it realistic for the pharma company to collect and manage RWD itself? Do they have the necessary (secure) infrastructure and is the data physically in the right jurisdiction? The NHS in England is likely to expect all data intermediaries to be ISO 27001 compliant.

- Public perception

  • Could pharma themselves be a barrier (big, bad, commercial entities) to the release of data by patients? Would a 3rd party not be a better option?

- Guardianship

  • Who is going to be the custodian of the data to ensure that the rights and wishes of the patients are always respected? Patients will expect this to be an independent party. Trusted websites and charitable bodies are positioning themselves in this space but even they may not be the right parties to store and manage the data.

Conclusion

So will the RWD promise be fulfilled?

In the long term it has to be, it is the future of healthcare, but right now the jury is out. Just because the tools to capture and store data are rapidly developing, it is not a given that patients will share their data or that companies can do what they hoped with it. A range of options will need to be followed through and a recognition that there will be setbacks has to be accepted as the price of getting this right. All companies, regardless of their sector, need to understand and get closer to their customers. For Pharma and Life Sciences in general, the patient is the ultimate customer.


References

1. There is a growing expectation within the media, public and even healthcare professionals that technology will transform healthcare. Respected IT figures such as Bill Gates have publicly stated that they see healthcare becoming more data driven and there is a huge investment in technology and apps. Apple’s latest iWatch is also a health monitor linked into its iHealth platform. This is arguably where Apple sees its future large-scale revenue opportunities.

Bill Gates: My Plan to Fix The World's Biggest Problems 
Apple Makes a Strong Wearables Play With Health Kit; What About iWatch?

2. This public attitude change can probably be traced back to the Edward Snowden revelations around the wholesale collection of data by the NSA in the US. Suddenly the press and the public started waking up to just how much data is being collected and what can be done with it. At a low level, we are all irritated by the constant bombardment with unsolicited emails and phone calls. The perennial question is “how did they get my email address/phone number?” and “why are companies being so cavalier with my personal data?” There is now a general distrust of business and individuals will need a lot of persuading to part with personal data, particularly health data.


About the Author:

Simon Brander is one of the Founders of CSL, a company started in 1993 specializing in data management and analytics for Life Sciences. 

CSL are part of a UK industry-wide group (BHBIA) reviewing the existing and emerging legislation on data protection with the aim of providing guidelines to the healthcare industry. CSL and the BHBIA are both points of contact for information and guidance. For more information see www.csl-uk.com or email me at simonb@csl-uk.com



Real World Evidence & Market Access Summit USA

Dec 3, 2015 - Dec 4, 2015, Philadelphia

Leverage Real Life Data & Analytics for Value-based Market Access