Support programmes offer global healthcare ways to meet patients' needs
Published on 10th May 2021
With technological advances increasing access to patient support programmes, what legal and regulatory issues do pharmaceutical companies need to take into account when using these arrangements?
The world faces a major healthcare challenge due to an ageing population and the increased prevalence of chronic disease and multi-morbidities, while the provision of medical services undergoes profound change through digital transformation.
Patients have access to more information than they have ever had before, which can be overwhelming as well as empowering. The complexity of specialty medications and the diseases they treat, now require better management, including patient education, diagnosis, administration, follow-up, and specialty logistical support services.
That is why investment in patient support programmes (PSPs) has grown substantially in recent years. While providing patients with support programmes is not a new phenomenon, the evolution of technology has increased the access to and potential value of these programmes.
Pharmaceutical companies are now interested in creating solutions to help stakeholders, from patients to healthcare professionals to better manage disease and optimise treatment.
Evolution of PSPs
Originally, PSPs took place in call centers and were designed to enable reimbursement to prescribers and to record patient coverage. But, in recent years, PSPs have changed considerably. Nowadays, these programmes have evolved to help patients take their medication correctly, improve adherence, better manage their disease, reduce complications, and guide them through the hurdles of financial coverage.
PSPs have also become an essential tool for pharmacovigilance, since the gathering of data has become essential to improve patient safety. In terms of the use of data, PSPs are important for gathering information related to the use of medical products and to gain insight into adverse events. These programmes are a tool through which to obtain observational information and data, also known as Real World Data, which is then analysed to produce clinical evidence regarding the usage and potential benefits and risks of a medicinal product (Real World Evidence).
Today, almost all large pharmaceutical companies provide some level of patient-support services for medications that treat chronic conditions. Many small and mid-sized companies also have invested in these programmes. For those engaged in the treatment of rare diseases, in particular, PSPs are often considered the cost of entry to doing business. Companies are putting marketing efforts in to organising awareness campaigns and utilisation of these programmes.
Legal and regulatory framework
From a legal standpoint, there is no common definition of PSPs at European level that emphasises access, familiarisation and adherence of patients to their treatment. The European Medicines Agency considers PSPs only from a pharmacovigilance point of view.
However, many countries, regions, and industry groups have local regulations that directly address (and often restrict) these programmes. For example, Canada, the UK and Australia have industry codes specifically addressing PSPs and, in some cases, patient safety and data requirements or interactions with healthcare professionals (HCPs) and patients in connection with PSPs.
In the UK, the Association of the British Pharmaceutical Industry (ABPI) issued "Guidance notes for patient safety and pharmacovigilance in patient support programmes" in 2011.
According to the ABPI, a PSP is defined as a service for direct patient or patient-caregiver interaction designed to help the management of a medication or disease outcomes (for example, awareness, education and adherence) or to provide healthcare professionals with support for their patients.
Under ABPI guidance, PSPs typically include:
• Compliance/adherence programmes where consenting patients on a medication are contacted to see how they are managing with their medication.
• Call centres where patients or patient carers can contact the marketing authorisation holder (MAH) to obtain further information on medication or a particular disease area as part of a structured programme.
• Nurse-educator programmes where nurses (either employed directly by an MAH or through a third party) interact directly with patients to provide education or disease awareness, to help them properly administer medications and manage their disease.
• Homecare (home delivery, homecare programmes or homecare services), a homecare medicine delivery service that can be described as a service that delivers ongoing medicine supplies and, where necessary, associated care, initiated by the hospital prescriber, direct to the patient’s home with their consent with the purpose to improve patient care and choice of their clinical treatment.
In addition to industry-specific laws and codes, PSPs may be affected by more general regulations, such as anti-bribery and anti-corruption laws (such as the US Foreign Corrupt Practices Act, the UK Bribery Act and Brazil’s Clean Companies Act), direct-to-consumer communication and advertising prohibitions or reporting requirements that could capture transfers of value made to HCPs in connection with patient support, such as the French "Sunshine Act".
When implementing PSPs, pharmaceutical companies have to take into account a number of restrictions and considerations, including:
• PSPs always have the objective of benefitting patients (since they will be able to better manage their disease and/or treatment).
• PSPs must lack a promotional purpose (since advertising and promotion of prescription-only medicines to the general public is strictly prohibited in most countries, apart from exceptions such as the United States).
• Pharmaceutical companies must guarantee that the PSP does not contravene the standard legal prohibitions on giving incentives to HCPs or on advertising prescription drugs to the general public.
• PSPs have to comply with the requirement of proportionality.
• PSPs must be customised to the needs of the patient.
• Pharmaceutical companies have to ensure that PSPs comply with the applicable legislation, including legislation on pharmacovigilance and protection of personal data.