How do you ensure that your product will be included on payers’ “golden list” -aka formulary- and will be broadly accessible? The obvious answer is to rely on the historical triumvirate of efficacy, safety, and affordability, but as innovation slows, “me too” assets reach markets, and the cost of healthcare keep rising, the pharmaceutical industry has increasingly relied on patient support programmes (PSPs) to elevate their offering, often flirting with illegality.
PSPs are by no means mandatory, but most are now part of an expected offering by patients, physicians, and payers alike, and come in many shapes and sizes: diversified educational resources to empower patients and physicians, support to navigate complicated reimbursement landscapes for specialty drugs, and financial assistance for broader access, specifically in the US market, as well as disease management and lifestyle mobile apps to provide day-to-day support to patients. Aside from providing all parties with welcome resources, PSPs arguably create win-win situations by also enabling soft marketing opportunities for manufacturers, as exemplified by the comprehensive PSP linked to Aduhelm prescriptions.
Unfortunately for pharmaceutical companies, these services cannot typically be leveraged to obtain preferential payer considerations, but their absence would be frowned upon. “Out-of-the-box” thinking thus becomes necessary to provide additional value to, and been seen in a better light by, patients and payers. While pharmaceutical companies have noticed the distress of patients regarding life-altering diagnosis and have developed mental health support services enabling the creation of tight-knit patient communities in rare diseases -such as Akcea’s TEGSEDI Mentorship programme connecting “veterans” with newly diagnosed patients, or Biomarin’s all-out musical casting and production Hemophilia: The Zoomsical (yes, you read this right)- the fastest emerging and most promising patient services are leveraging digital health technologies to promote adherence, wellbeing, and accurate care.
Digital health technologies already have a proven track record of improving patient adherence and overall health, making them cost-effective tools for payers and opening avenues for their integration into PSPs.
The healthcare industry is gearing up to digital health as patient services, leveraging mobile apps to provide care management tools such as medication and appointment reminders, electronic notebooks for side effects, as well as lifestyle and wellbeing tools for typically chronically ill patients. In this domain, Pfizer’s LivingWith® app appears to be the most comprehensive “in-house” product, including health records, wearable technology to gather sleep patterns, integrated organizers, community networking, and also lets oncology patients request help from their family. Others, such as Seagen, have relied on third-party apps to offer similar services or offered remote temperature monitoring post-infusion to their cell therapy patients (BMS).
One step further (or rather one step earlier in the treatment algorithm), companies such as Pfizer and Novartis have been leveraging artificial intelligence (AI) and machine learning (ML) to respectively identify heart failure patients at-risk of ATTR-CM prior to physical diagnosis, and improve treatment decisions and patients outcomes in metastatic breast cancer. The use of AI/ML in health systems has the potential to revolutionise patient care and pro-actively manage patient health and co-morbidities, with manufacturers showing willingness to invest and unlock tools on their own budgets.
Payers are also in on the game, with UnitedHealth launching the Level2® digital health therapy combining wearable real-time glucose monitoring technology and customized support resulting in remission of type 2 diabetes patients, and early diagnosis of COVID-19 infection in an at-risk population, providing “a high-touch, therapeutic benefit to help participants take charge of their type 2 diabetes and achieve better health” (Amy Meister, D.O., CEO of Level2). Remote patient monitoring (RPM) has the potential to significantly cut costs in chronic diseases such as diabetes -which cost the US healthcare system $327 billion in 2017 alone– and prevent hospital admission for cardiac events -which are projected to cost more than $1,000 million globally by 2030. So, why are they not broadly implemented? Why are pharmaceutical manufacturer not offering them as patient services?
The interest in RPM has been catalysed by the pandemic and the chase after value-based healthcare, yet significant limitations remain in infrastructures, reimbursement, and privacy laws.
RPM and telehealth programmes are increasingly implemented by health systems, but with reimbursement policies slated to expire after the pandemic for such offerings, the industry is still unsure about the connection between RPM and telehealth programmes to payment reforms and reimbursement. In addition to reimbursement uncertainties, RPM is confronted with interoperability hurdles, with major health systems such as Mayo Clinic integrating third-party EHRs, countries building their own centralised patient registries such as the AIFA and Valtermed registries in Italy and Spain respectively, leveraged to democratise outcome-based reimbursement for gene therapies.
One could argue that as big pharma goes through its digital transformation -with the likes of Novartis claiming to be “powered by data science and digital technologies”– RPM EHR-integrated patient services could and should become a reality in the coming years, but could be hindered by data privacy guidance and compliance reservations (GDPR, HIPAA). Indeed, numerous pharmaceutical companies have elected to migrate their patient services call centres to third party providers to get handling of confidential patient data out of their hand.
Hence, while RPM may appear as a perfect tool to register outcomes, pro-actively manage care, and ensure premium pricing and efficient monitoring of outcome-based contracts for payers, it seems unlikely that pharmaceutical manufacturers will be willing and able to invest in their own digital RPM patient services soon.
Based on their prospects to considerably cut healthcare costs and influence payer negotiations, how can pharma players implement RPM and other digital PSPs? Third-party partnerships. The future of digital PSPs likely relies on established healthcare technology players such as Philips, Epic, Cerner -or “budding” competitors such as Amazon Care.