Specialty Drugs: Promising Future. Complex Reality.

IntroductionSpecialty Drugs Image Final

During the past ten years, pharmaceutical & biotech companies have made significant progress discovering new specialty medications for both rare and prevalent conditions; these advanced medicines are rapidly becoming available to serve niche patient populations. Unfortunately, gaining access to such specialized drugs can be difficult due to HCP awareness, insurance issues, and complex dosing procedures. How would you know if one of these medicines were right for you? Most likely you wouldn’t – an issue which is poised to become an increasing healthcare dilemma within the next decade. Though estimates vary, specialty drugs are expected to account for 45 to 50 percent of total US drug spending by 2020. Yet from every stakeholder angle, our healthcare system is currently ill equipped to manage such explosive growth. Consequently, what can we expect from this shifting landscape, and who will patients depend on to help them access these life-saving treatments?


The age of general medicines for diseases like depression, hypertension, and cholesterol is coming to a close as traditional chronic medications such as Cymbalta, Diovan, and Lipitor, for example, lose patent protection. Generic medications treat these conditions well, to the extent that large pharmaceutical companies are now transitioning into the specialty drug space, a new frontier with the opportunity to drive revenue.

However, specialty drugs are much more complicated than traditional drugs because they require extensive support structures and services. Highly expensive and needing lengthy approvals, specialty drugs create a substantial amount of paperwork well before distribution. Consider that patients often need pretesting for drug suitability, along with all manner of aid from financial assistance to training in self-administration, such as injections. Furthermore, the products themselves may be fragile and frequently involve specific handling and storing conditions before shipment. Additionally, initial administration of the drug generally requires clinician involvement, while ongoing hurdles are found in the form of dosing complexity, patient monitoring and long term adherence plans. A further complicating factor is that drug coverage may fall under a health plan’s medical benefit instead of its pharmacy benefit, contributing to the perplexity of the approval procedure – a daunting process which many patients cite as the most wearisome obstacle among the various steps.

Potential Solution

The uncertainty surrounding patient support within this uncharted territory is evident; no single group (be it health care providers, payers, specialty pharmacy or pharmaceutical manufacturers) has come forward to assume the role of treatment coordinator around these specialty products. Who, then, will assemble the disparate pieces to create a centralized patient care capability? Although physicians and nurses are perhaps best placed to aid in this regard, they are already required by government and other entities to address numerous administrative issues related to specialty drug use, and they certainly cannot be expected to build the solution alone. Specialty pharmacies are in a position to assist in this role since they commonly communicate directly with patients, though they were never equipped to serve this function and lack the capability for extensive patient care coordination. Similarly, manufacturers are uniquely situated to offer support for the drugs they produce, and are now presented with the opportunity to integrate solutions across various pharmacy, payer, and HCP partners. Considering that manufacturers are the most intimately aware of issues concerning their products, such as patient burden and adherence, as well as distribution chain and coverage matters, the potential role fits.

Moving forward, these companies must embrace patient support as a core competency rather than a disjointed set of brand tactics. Subsequently, marketing modification will be a key driver in this shift; manufacturers should replace traditional marketing strategies geared toward mass market drugs with an emphasis on patient focused services. As we further envision this centralized capability, patient experience officers become indispensable, as well as the development of a holistic management platform for patient support. Undeniably, this integrated level of infrastructure will be expensive and complicated to implement – an undertaking further challenged by the varied nature of disease characteristics, product attributes, and supporting partner dynamics within each particular case. Nevertheless, this model embodies Nuvera’s vision of building a world where healthcare organizations put the patient experience first and foremost in their efforts to enhance treatment outcomes.

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