Biopharma Insights: Top Trends to Watch in 2018

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Biopharma Insights – February 2018


Top Trends to Watch in 2018


By Brian BambergerLife Sciences Practice Lead


InteroperabilityBy all accounts, 2017 was a busy year for health care organizations, health information technology vendors and others. We expect that hard work will continue — if not accelerate — in 2018 to address the myriad business and legislative requirements facing the health care system. With that in mind, here are the top trends to watch in 2018.

  1. Biosimilars. The federal government and states will continue their efforts to establish the needed infrastructure for approval and adoption of biologics and biosimilars. The Food and Drug Administration (FDA) issued guidance on new naming conventions. The new changeover in names applies to both newly licensed biologics and biosimilars, and will also be applied retrospectively to biologics already on the market. Understandably, stakeholders are concerned about associated costs and burden of implementation and are raising their concerns to the FDA, which might tweak its guidance in response. There also is a need to capture patient information and outcomes in electronic health records (EHRs) for pharmacovigilance purposes as biologics come onboard.
  2. Blockchain. Blockchain is health care’s latest bright, shiny object, meaning it will continue to attract attention in 2018. A data structure that can be time stamped and signed using a private key to prevent tampering, some people may know blockchain as the technology underlying the online currency Bitcoin. Despite the apparent — and possibly premature — enthusiasm by payers, many questions surround the use of blockchain in health care.
  3. EPCS. Electronic prescribing of controlled substances (EPCS) will experience an accelerated uptick in adoption, which will also increase controlled substance prescription volume. Providers are finally beginning to invest in and use EPCS infrastructure because 1) use of EPCS relates to required quality reporting targets for Medicare and other payers and 2) a growing number of states are requiring EPCS to fight the opioid epidemic. That said, vendors will have to be nimble to adapt to rapidly changing state EPCS requirements, which vary across states. These include controlled substance prescribing limits and adding new data elements, such as diagnosis, onto prescriptions.
  4. Electronic prior authorization (ePA). An increasing number of drugs — especially specialty medications needed for the rising number of chronic illnesses — require prior authorization (PA). ePA is poised to take off in 2018, in part because of implementations involving the ability of many EHRs and pharmacy benefit managers to accept and exchange basic information for PAs. As pharmacy moves to become instrumental in the care process in 2018, new use cases will arise. For example, pharmacists will become more involved in ePA for long-term care patients.
  5. Fast Healthcare Interoperability Resources (FHIR). FHIR is one of the latest in the Health Level 7 (HL7) family of standards. It underpins the accelerating movement toward open, standardized application programming interfaces (APIs). Providers and pharmaceutical companies are considering how to use innovative APIs to communicate with patients and partners. Increased adoption of FHIR-based APIs is expected in 2018. FHIR also is becoming key to Internet-based information exchange networks. FHIR is also being considered for the transport of data for specialty pharmacy enrollment, which is part of efforts to automate specialty pharmacy (see below). FHIR is in the background of Apple’s new initiative to include clinical and other patient data on its iPhone.
  6. Medication adherence. Poor medication adherence is partially responsible for avoidable hospital admissions, and 33% to 69% of all medication-related hospital admissions at a cost of about $100 billion per year. To be sure, medication noncompliance is a long-standing issue. Now we have reached an inflection point where technology, value-based care and concerns about the costs of chronic illness are converging to meaningfully address the problem. This will require the ability to mine EHR data to identify noncompliant patients and provide information about costs, gaps in care and outcomes.
  7. Prescription drug monitoring programs (PDMPs). In response to the ongoing opioid epidemic, states will continue to enact legislation mandating that prescribers and pharmacists consult PDMPs before controlled substance prescriptions are written and the drugs dispensed. PDMPs are independent, state-run databases of controlled substance prescriptions that now exist in all states and the District of Columbia. Efforts will accelerate to integrate PDMP data into prescriber workflows in EHRs, which also is a growing legislative requirement by states.
  8. Real-time benefit check (RTBC)Intense interest will continue in 2018 around the RTBC. In contrast to current formulary and benefit information provided to electronic prescribers, the RTBC provides real-time information at the patient level, which is pulled directly from the payer. It allows the prescriber to see patient-specific condition management programs (such as prior authorization and step therapy), true out-of-pocket costs for a medication (specific copay/coinsurance amount) and specific deductible information. (Read more about it in this issue of BioPharma Insights).
  9. Specialty pharmacy automation. The industry will continue working on automating specialty prescribing in 2018, with focus on the specialty enrollment process. These efforts build on standards and implementations for electronic prescribing as well as complement the work under way to automate other aspects of specialty pharmacy. Stakeholders are coming together to identify additional or enhanced standards to support enrollment and other aspects of specialty pharmacy automation. HL7’s FHIR is likely to become the standard of choice to extract relevant patient administrative and clinical data from EHRs. The National Council for Prescription Drug Programs’ Specialty Electronic Prescribing Task Group is looking at how new data elements that are useful for the enrollment process can be incorporated into the SCRIPT standard. These include, for example, additional patient contact and demographic information, diagnosis, lab values, height and weight.
  10. Virtual visits. Stakeholders will continue to jump on the virtual visit (aka telehealth) bandwagon in 2018. Myriad efforts are under way to implement and pay for such services by the Department of Veterans Affairs, Medicare, Medicaid and private payers. Pharmacies will ramp up use of virtual visits as part of a strategic move to offer more direct patient care. However, critics wonder if potential cost savings and consumer acceptance and satisfaction will actually materialize at expected levels. [Read more about virtual visits in this issue of BioPharma Insights.]

Interested in what else is in store for 2018? I’d be happy to share my thoughts. Reach out to me at