Patient support programmes have a lot to offer pharma, but companies face big challenges in ensuring that they provide accurate, relevant and consistent data that fulfills all regulatory obligations.
The last few years have seen a global proliferation of Patient Support Programmes (PSPs), led by an acceleration in drug approvals which reached a 21-year high in the US in 2017 – more than double the previous year – as well as a greater demand for patient-centric outcomes.
PSPs are designed by pharma to help patients take their medication correctly, improve adherence, manage their disease better, reduce complications and provide financial assistance – while also providing an opportunity for companies to connect more directly with their consumers. A secondary benefit of PSPs is the huge amount of patient safety data that can be gathered relating to the real-world use of medical products – including adverse events – making them a valuable tool for pharmacovigilance.
With the growth of PSPs globally, pharma is recognising the challenges of managing increasingly complex programmes across traditional and emerging markets where consistency of data capture and adherence to regulatory compliance are essential. A 2017 survey of marketing authorisation holders in Europe found that a large portion of pharmaceutical companies are struggling to provide appropriate oversight and management of their PSPs. Pharmaceutical companies, that run hundreds of PSPs simultaneously, often have no standardised mechanisms for recording, reconciling and managing the huge volumes of data PSPs generate, affecting their ability not only to use the data effectively, but also to adhere to strict pharmacovigilance standards. This is a lost opportunity for pharma companies, with poor data quality creating burdens for operational teams and destroying the value of downstream signal management. Understandably, finding a solution to these critical issues is becoming an industry priority, and pharma is looking to technology to provide the answer.
The scale of the problem
There are a number of barriers that stand in the way of optimum patient safety data collection for PSPs, including the increasing complexity of medicinal products, the growing focus on medical support, diversity of languages and data protection coupled with a more stringent regulatory backdrop. Pharmaceutical companies often implement sets of PSPs for recently launched products resulting in hundreds if not thousands running concurrently across the world. To approach the logistics of managing the variety and diversity of such a large number of programmes, the running of many PSPs is outsourced to third parties. While this relieves resource pressure on pharma, it transfers the obligations for managing adverse event collection to the contract research organisation (CRO), which in turn must demonstrate diligence in managing the safety processes.
Additionally, PSPs are usually driven by pharma brand teams with variable levels of medical affairs input; dealing with product risks and adverse events often takes a back seat. This can result in the belated engagement of safety teams, which have to play catch-up and meet unrealistic deadlines. The consequences of such inefficient processes span high global training and management costs, low data quality and, at times, issues with regulatory commitments. Consequently, pharmaceutical companies, concerned that they may be missing vital feedback on their medicines, view improving data capture and regulatory compliance along with training as key priorities for their PSPs.
The lack of a proactive and standardised approach to PSPs presents an additional challenge for pharma as this has a big impact on the quality, and therefore usefulness, of the data collected. PSPs are rolled out globally across many different countries and in a range of languages to meet local requirements. However, all data has to be translated back into English and provided to central teams for processing and analysis. This creates a significant administrative burden given the management of large volumes of unstructured data alongside the associated risks of misinterpretation during the translation process. Furthermore, the way in which PSP operators collect patient data varies depending on the programme and the country; for example, information on one product could be collected via face-to-face meetings, telephone, email or by automated voice mail, which all contributes to a lack of data consistency. PSPs must also be tailored to the different healthcare systems they are operating in, reflecting the different funding methods, such as insurance-based, taxation-funded or self-pay as well as the idiosyncrasies of each market, adding an additional layer of complexity for data collection.
All these factors compromise the quality and consistency of the data received from patients and therefore also the ability of pharma teams to structure, understand and analyse the data centrally, ultimately undermining patient safety.
What is at stake?
Regulatory authority inspectors such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) are responsible for ensuring that PSP sponsors are meeting their pharmacovigilance obligations. They have the power to investigate whether this is happening and can request evidence that pharma and any contracted third parties have well documented processes in place and evidence of pharmacovigilance training.
PSP sponsors who are found to come up short face significant penalties with action from regulatory authorities. One EMA investigation of a major pharma company spanned almost five years and resulted in significant remedial actions including re-analyses of the complete data sets.
To support compliance, the Association of the British Pharmaceutical Industry (ABPI) recently issued a guidance document, emphasising the importance of managing patient safety for PSPs, and setting out a clear framework for how the marketing authorisation holder can meet ethical, legal and regulatory pharmacovigilance requirements. The message from regulators is clear; adhering to pharmacovigilance standards is not a nice to have for PSPs – it is a necessity.
With the system as it stands, pharma undoubtedly faces big challenges in ensuring its PSPs are providing accurate, relevant and consistent data that it is meeting all regulatory obligations. There is industry-wide acknowledgement that the fragmented landscape of PSPs needs to be replaced by a new, smarter approach that is scalable across countries, and incorporates all languages, brands and diseases.
Fortunately, rapid advances in technology are providing digital solutions. New research from Deloitte reveals we are already witnessing an increasing use of partnerships between technology vendors and big pharma in order to improve patient-centric outcomes. Accordingly, the use of cloud-based, encrypted, user- friendly digital platforms are starting to transform the management and processing of PSPs and enabling the capture of high-quality data on adverse experiences at source as well as enabling patients to manage co-morbidities through a single portal. Secure cloud-based platforms are highly scalable and enable deployment of consistent solutions globally that ensure data is collected, stored and transferred in line with pharmacovigilance and privacy legislation. Processes are also highly traceable and with audit trails available for regulatory inspectors.
In order to tackle the challenges of PSPs it is vital that big pharma adopts intelligent and intuitive solutions that can streamline processes, cutting time and costs whilst improving efficiency and patient safety.
Dr Andrew Rut is chief executive and co-founder of MyMeds&Me, the developer and provider of SAAS solution for digital capture of adverse event and product quality reports for the life sciences industry.