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Specialty Patient Support

Patient access and adherence to specialty medications can be limited by their complexity and high cost. Learn about patient support services to address these challenges and their need for technology advancement. Read the full report or download the executive summary.


Illustration showing the challenges specialty medications can cause for patients as well as how technology can improve the process providers follow to start patients on specialty therapies.

Introduction

Each year in the U.S., nearly six billion prescriptions are dispensed to patients.Medicine Use and Spending in the U.S., A Review of 2018 and Outlook to 2023, IQIVIA Institute, 2019 When considering such a large number, it can be easy to overlook that many of these prescriptions were a burden for patients to access.

For some medications, access challenges can be so significant that prescriptions never get filled or patients are forced to discontinue therapy.

Medications exist within a hierarchy of scientific and clinical complexity that closely scales with patient challenges. Along this spectrum, specialty medications are among the most complex and difficult for patients to access, afford and adhere to. While specialty support services are sometimes available to help patients, their impact is dampened by low awareness and manual workflows.

Within this report, we examine what makes specialty therapies unique, the access and adherence challenges they present to patients and the evolution of specialty support services to help more patients get the medications they need to live healthy lives.

Features of Specialty Medications

Specialty therapies possess a few characteristics that set them apart from traditional retail medications. Knowing these differences is important for understanding why patients can struggle with access.

Scientific Complexity

Specialty therapies can go beyond managing symptoms to treating the underlying causes of disease. They often have targeted mechanisms of action and may be large macromolecules, termed biologics.The Rise of Specialty Medications: Hope for Patients, Hurdle for Healthcare, CoverMyMeds, 2019 Cell and gene therapies are also emerging as effective new treatment options for those with cancer and rare disease.The Key to Commercializing Revolutionary Gene Therapies and Other Orphan Drugs: High-Touch Services that Enhance Patient Outcomes, McKesson

Safety Considerations

Often indicated for rare/complex diseases, specialty therapies can be granted priority status by the U.S. FDA, which allows for accelerated or even abbreviated review processes.Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, U.S. Food and Drug Administration, 2018,Designating an Orphan Product: Drugs and Biological Products, U.S. Food and Drug Administration, 2018 However, clinical trial enrollment for specialty medications can be constrained by relatively small patient populations.Clinical Trial Enrollment Gets Harder as Patient Populations Shrink, BioPharmaDive, 2017

For these reasons, data on efficacy and safety may be less complete compared to the standard approval process.Real-World Evidence: Leveraging Electronic Health Records to Improve Patient Outcomes, McKesson Specialty Health, 2017 As a result, the FDA may require Risk Evaluation and Mitigation Strategy (REMS) programs to ensure that clinical benefits outweigh the risks and to limit occurrence of adverse events.Risk Evaluation and Mitigation Strategies, U.S. Food and Drug Administration, 2019

Route of Medication Administration

Consistent with their varying scientific complexity, specialty therapies are often administered in unique ways. Many are not amenable to pill form for simple oral administration. As a result, patients may take their medications via nebulization, subcutaneous injection, intramuscular injection or infusion.The Ins and Outs of Specialty Pharmacy, Pharmacy Times, 2018

The designated route of administration can influence where patients receive therapy – while some patients may be able to stay home, others may need to go to a provider's office or outpatient facility with clinical staff on standby.Medical Pharmacy Trend Report, Magellan Rx Management, 2018

Narrow Patient Populations

Specialty medications typically treat relatively small patient populations for diseases like multiple sclerosis, hepatitis C virus (HCV), human immunodeficiency virus (HIV) as well as certain types of cancers and autoimmune conditions to name a few.

Rare diseases can affect even fewer people – patient populations of less than 200,000 in the United States.FAQs from Genetic and Rare Disease Information Center, U.S. Department of Health and Human Services As certain locations may have too many or too few patients, open distribution of specialty medications is not always economical because of supply-and-demand issues and product expiration – especially biologic, cell and gene therapies which require strict temperature control and have short shelf lives.The Key to Commercializing Revolutionary Gene Therapies and Other Orphan Drugs: High-Touch Services that Enhance Patient Outcomes, McKesson,The Evolution of Specialty Pharmacy, Biotechnology Healthcare, 2008

To avoid these logistical challenges, manufacturers often dispense specialty medications through exclusive or limited distribution networks (LDNs) of select pharmacies – but this can create barriers to patient access.The Ins and Outs of Specialty Pharmacy, Pharmacy Times, 2018,Managing the Costs of Specialty Drugs, Elsevier, 2017

Cost

While representing only 2.2 percent of U.S. prescription volume, specialty medications accounted for 45.4 percent of pharmacy revenue in 2018, which equates to $218.6 billion.Medicine Use and Spending in the U.S., A Review of 2018 and Outlook to 2023, IQIVIA Institute, 2019,Specialty Drug Spend Soars. Can Formulary Management Bring It Down to Earth?, Managed Care Magazine, 2019 Such statistics underline the significant cost of specialty medications, which often face little to no brand name or generic (biosimilar in the case of biologics) competition.What’s Special About Specialty, CVS Health

According to the Centers for Medicare and Medicaid Services (CMS), any Part D drug with a wholesale acquisition cost over $670 per month (over $8,040 per year) is eligible for specialty tier placement.Announcement of Calendar Year (CY) 2018 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter and Request for Information, Center for Medicare and Medicaid Services, 2017 However, this CMS recommendation may represent the low-end of cost for specialty medications.

A recent study calculated the average annual cost of 61 prevalent specialty medications for chronic conditions at $78,871.Trends in Retail Prices of Specialty Prescription Drugs Widely Used by Older Americans: 2017 Year-End Update, AARP Public Policy Institute, 2019 This number is about 10-fold higher than the annual CMS threshold and about three-fold higher than the average annual cost for the same specialty medications in 2006.Trends in Retail Prices of Specialty Prescription Drugs Widely Used by Older Americans: 2017 Year-End Update, AARP Public Policy Institute, 2019 As a general observation, cost typically scales with complexity for specialty medications.

Reimbursement

Given their range of complexity and expense, reimbursement processes can vary significantly among specialty medications. For example, about half of specialty medications are covered under the pharmacy benefit of patients’ health plans while the rest are covered under the medical benefit.Managing Specialty Drug Spend Under the Medical Benefit, Innovations and Automation for More Effective Management, CVS Health Payor Solutions, 2017

This coverage decision is often based on where the medication is dispensed. If medications are administered at a hospital, provider office or outpatient facility, the medical benefit is typically used, whereas the pharmacy benefit is used for medications administered at home.Pharmacy benefit vs. medical benefit, Inside Edge Consulting, 2015

This variability can impact how easily patients are able to access their medications. In fact, absence of real-time claims adjudication and traditional formulary process on the medical benefit influences how payers manage new specialty medications, with 100 percent of payers installing medical PA requirements within three months of drug launch.Medical Pharmacy Trend Report, Magellan Rx Management, 2018

While technology like electronic prior authorization (ePA) is often available for pharmacy benefit claims, it is less common for medical benefit claims, which can lead to care delays for patients.

The unique features of specialty medications can strain the healthcare ecosystem and keep patients from receiving needed care. In response, new strategies and industry participants have emerged within healthcare to overcome challenges created by these complex therapies.

Expanding Healthcare Ecosystem for Specialty Medications

The complexity and challenges of specialty medications has created opportunities for growth and change within healthcare. Over the past three decades, the healthcare ecosystem has expanded to help fulfill niche roles and requirements for these complex therapies.

Graphic depicts each healthcare stakeholder that hub services support: pharmaceutical manufacturers, payers, specialty pharmacies, patients and providers.

Specialty medications are complex, requiring collaboration among the entire healthcare ecosytem to start patients on therapy.

Channel Strategy

In contrast to many traditional retail medications, specialty medications may require strict temperature control from production to dispense. Product can spoil if temperature is not properly maintained, becoming ineffective or even unsafe for patient use.

As a result, manufacturers can require cold-chain distribution to ensure that medications are properly handled and reach patients immediately before administration.The Key to Commercializing Revolutionary Gene Therapies and Other Orphan Drugs: High-Touch Services that Enhance Patient Outcomes, McKesson Manufacturers use LDNs to maintain this level of control over product logistics – limiting waste, guaranteeing quality and confirming safety.The Ins and Outs of Specialty Pharmacy, Pharmacy Times, 2018

For those specialty therapies requiring provider administration, distribution and reimbursement can be unique. In many cases, provider offices purchase medications, take responsibility for their storage, later administer them to patients and seek reimbursement in a process termed buy-and-bill.The 2019-20 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, Drug Channels Institute, 2019

Alternatively, provider offices can receive specialty medications from a pharmacy for short-term storage and on-demand administration to patients in a process termed white bagging. A third option, termed brown bagging, involves dispense of specialty therapies directly to patients who then bring the medications to a designated site-of-care for administration.

The preferred method varies by network stakeholder, with each option delivering distinct economics and value. For example, payers may prefer brown bagging as they can directly negotiate medication prices with the manufacturer, guide patients to cheaper sites-of-care for administration and process more claims through the pharmacy benefit where utilization management is simpler. As a result, use of the buy-and-bill model for distribution and reimbursement has decreased while white and brown bagging has increased by 11 percent from 2010 to 2016.The 2019-20 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, Drug Channels Institute, 2019

Specialty Pharmacies

Many retail pharmacies do not keep specialty medications in stock and/or are unable to help patients through associated reimbursement paperwork. Some may even require payment upfront, which is not feasible for many patients.The Evolution of Specialty Pharmacy, Biotechnology Healthcare, 2008

Specialty pharmacies evolved as a solution for complex medications that require high-touch services for distribution, reimbursement and patient management. As specialty medications have grown in number and utilization, so have specialty pharmacies. In fact, the number of accredited specialty pharmacies reached 911 in 2018 – a 139 percent increase from 2015.Specialty Pharmacies on the Rise, Drug Topics – Voice of the Pharmacist, 2019

Specialty pharmacies often seek accreditation from independent organizations to showcase their capabilities and ability to deliver value-based care, which can be important for gaining inclusion into manufacturer LDNs and payer networks to secure reimbursement.Accreditation Explosion Among Top Specialty Pharmacy Trends, Journal of Clinical Pathways, 2018

There are three primary types of specialty pharmacies, including independent, PBM-owned and provider-owned. PBM-owned specialty pharmacies are largest by market share, accounting for over 70 percent of prescription revenues from specialty medications.The Top 15 Specialty Pharmacies of 2018: PBMs Keep Winning, Drug Channels Institute, 2019 By controlling dispense of specialty medications, PBMs can direct members to preferred specialty pharmacies, implement utilization management strategies more effectively and share in government-sponsored 340B discounts by acting as contract pharmacies to providers, hospitals and other covered entities.Here’s How PBMs and Specialty Pharmacies Snag Super-Size Profits from the 340B Program, Drug Channels Institute, 2019,As Hospitals Pursue Specialty Pharmacy (and Walgreens Bets More on 340B), PBMs Become Their Best Frenemies, Drug Channels Institute, 2019

Independent specialty pharmacies have lost market share in recent years as a result of these PBM-owned specialty pharmacies narrowing payer networks.The Top 15 Specialty Pharmacies of 2018: PBMs Keep Winning, Drug Channels Institute, 2019,The State of Specialty Pharmacy 2019: Industry Trends and Photos from #Asembia19, Drug Channels Institute, 2019 To gain network access and remain competitive, independent specialty pharmacies must offer superior business capabilities and services to all stakeholders.The State of Specialty Pharmacy 2019: Industry Trends and Photos from #Asembia19, Drug Channels Institute, 2019

Provider-owned specialty pharmacies have grown significantly over the last few years to deliver higher-quality care to patients prescribed complex medications as well as to benefit from 340B drug-pricing discounts. From 2016 to 2018, the number of large hospitals (600 beds or more) with a specialty pharmacy increased by 29 percent (from 47 percent to 76 percent).Here’s How PBMs and Specialty Pharmacies Snag Super-Size Profits from the 340B Program, Drug Channels Institute, 2019 For patient-administered specialty medications covered under the pharmacy benefit, provider-owned specialty pharmacies must also gain inclusion into payer networks for patients to fill prescriptions at these locations.Here’s How PBMs and Specialty Pharmacies Snag Super-Size Profits from the 340B Program, Drug Channels Institute, 2019

Hub programs for patient support

Clinical and reimbursement complexity of specialty medications create healthcare challenges that can be difficult for individual network participants to overcome on their own. For patients, this can mean delay in time to therapy and medication non-adherence. Hub programs sit at the center of the healthcare ecosystem and coordinate with key network stakeholders to help patients access, afford and adhere to specialty medications.Finding the ‘HUB’ in Specialty Pharma Services, Pharmaceutical Commerce, 2013,Delivering an Enhanced Patient and Prescriber Experience for Personalized Therapies, Drug Channels Institute, 2019,Continuing evolution of hub services, Pharmacy Today, 2017,(Hub services: Simplifying Specialty Pharmacy, Pharmacy Times, 2018

Graphic depicting the hub and spoke model for patient support services (PSP). PSPs are the hub and connect the spokes, which include patients, providers, pharmacies and pharma manufacturers.

Over time, hubs have expanded to offer a vareity of services required for starting patients on specialty medications.

At a minimum, hub programs act as a primary liaison to patients prescribed a complex therapy. Over time, services offered through hub programs have expanded to include connecting commercially and government insured patients to financial assistance, completing reimbursement activities {prior authorization (PA), PA appeals, benefits investigation (BI), benefits verification (BV)} supplying patients with bridge therapy while coverage is being determined, collecting patient data for FDA-mandated regulatory compliance, guiding patients through any pre-therapy requirements, optimizing distribution of complex therapies to narrow patient populations, reporting outcomes data and managing adherence programs.Finding the ‘HUB’ in Specialty Pharma Services, Pharmaceutical Commerce, 2013,Delivering an Enhanced Patient and Prescriber Experience for Personalized Therapies, Drug Channels Institute, 2019,Continuing evolution of hub services, Pharmacy Today, 2017,(Hub services: Simplifying Specialty Pharmacy, Pharmacy Times, 2018

Completing the PA process remains one of the most important functions of hub programs as this step significantly influences time to therapy for patients.2017 Hub Services Report, Pharmaceutical Commerce, 2017 A survey to patient support providers revealed that improving PA-related services is a major area of focus. Such services are also useful for specialty medications on the lower-end of complexity and expense (i.e., “specialty-lite”), but still present access barriers to patients.2017 Hub Services Report, Pharmaceutical Commerce, 2017

While specialty pharmacies can provide similar services as hub programs, an LDN for a given specialty product may include multiple specialty pharmacies that likely coordinate patient care in slightly different ways with varying quality.Finding the ‘HUB’ in Specialty Pharma Services, Pharmaceutical Commerce, 2013,2017 Hub Services Report, Pharmaceutical Commerce, 2017 Providers also can lack insight into where a specialty prescription should be sent, and sending to the wrong specialty pharmacy can lead to care delays as work like BI/BV must be restarted.

Hub programs can provide a consistent patient journey through completion of administrative requirements before triaging prescriptions to appropriate specialty pharmacies for dispense. Such uniformity and avoidance of duplicated effort may be advantageous for manufacturers.

While manufacturer-based hub programs also exist, they can be a privacy and regulatory risk without proper firewalls in place to remain separate from internal business and marketing efforts.Finding the ‘HUB’ in Specialty Pharma Services, Pharmaceutical Commerce, 2013,Continuing evolution of hub services, Pharmacy Today, 2017,Hub services: Simplifying Specialty Pharmacy, Pharmacy Times, 2018 Third-party hub program vendors can create a uniform patient experience, relieve manufacturers of risk and focus on improving processes to help more patients access and remain on specialty therapies.

Chart defining the similarities and differences between major healthcare stakeholders offering patient support services.

Patient Advocacy Groups

With many specialty medications indicated for rare or chronic diseases, advocacy groups can be key for educating patients on treatment options and connecting patients with financial aid, healthcare resources and support services.Patient Financial Assistance Programs for Specialty Healthcare: A List of Resources, Therigy Across the U.S., an estimated 1,215 non-profit patient advocacy groups are helping meet the needs of patients while also lobbying patient interests to state and federal legislatures.Patient Advocacy Groups Take in Millions From Drugmakers. Is There Payback?, Kaiser Health News, 2018

Given the complexity and expense of specialty medications, patient advocacy groups are essential for empowering vulnerable patients with information and improving treatment access. These organizations can also create awareness for patient support programs that can help to improve access, affordability and adherence to specialty medications.

Healthcare Impact of Specialty Medications

Specialty medications can have a major positive impact on patient health by modifying the course of a disease instead of only treating symptoms. Like never before, patients with rare and complex diseases have effective treatment options as new specialty medications come to market.

Within the next four years, it is estimated that 65 percent of launching pharmaceutical products will be specialty medications.The Global Use of Medicine in 2019 and Outlook to 2023, IQIVIA Institute, 2019 For providers, this could mean a total of ~35 new, cutting-edge treatment options for difficult diseases; and for patients, this can mean a chance at wellness for the first time, in some cases.

Ring graphic with 65% colored magenta to illustrate that 65% of pharmaceutical launches will be for specialty medications in the next 4 years

The majority of launching pharmaceutical products in the next four years will likely be specialty medications.The Global Use of Medicine in 2019 and Outlook to 2023, IQIVIA Institute, 2019

Research and development to achieve such innovation can take many years and cost billions of dollars.Innovation in the pharmaceutical industry: New estimates of R&D costs, Journal of Health Economics, 2016 As a result, specialty medications are often significantly more expensive than traditional retail medications. Ensuring that utilization of specialty medications is properly managed is a major concern for payers/PBMs.CoverMyMeds Patient and Provider Surveys, 2020

The reimbursement landscape for specialty medications is often complicated by strict PA and step-therapy criteria that must be met before patients can begin treatment.

While such processes are relatively straightforward for traditional retail medications, unique distribution models, narrow networks, additional network participants and lack of clarity surrounding specialty claims covered by the pharmacy or medical benefit can create confusing workflows for specialty medications.

In addition, processes like BI, BV, PA, lab scheduling, dose titration and REMS create even more complexity for stakeholders and patients. Even after a first dose of specialty medication is administered, these complications can recur as payer/PBM formularies change or patients switch insurance plans.

Shifting to value-based care and reimbursement models for expensive specialty therapies can help to mitigate risk for payers but can create patient-outcomes reporting challenges for other healthcare stakeholders.

Without support, patients and providers are left to navigate and complete the steps required to begin specialty therapies on their own.

Provider and Patient Burden

A recent survey to 400 providers reveals that many are burdened by the process to start patients on specialty therapies.CoverMyMeds Patient and Provider Surveys, 2020 In fact, four out of five surveyed providers expressed that starting patients on specialty medications comes with at least some level of difficulty.CoverMyMeds Patient and Provider Surveys, 2020

Graphic showing a number of stethoscopes with 57% of them colored magenta to represent the percent of surveyed providers that do not have, or unsure about, the insurance information needed to start patients on therapy.

Based on a survey to 400 providers.CoverMyMeds Patient and Provider Surveys, 2020

The reason for such difficulty may stem from a lack of access to necessary information for completing reimbursement activities. In fact, 57 percent of providers reported that they do not have, or are unsure about, the insurance/benefits information needed to start patients on complex therapies.CoverMyMeds Patient and Provider Surveys, 2020

Despite serving an integral role in coordinating patient care, one out of four providers do not feel that they are adequately supported while starting patients on specialty medications and over a third of surveyed providers were not even aware of patient support services.

When healthcare complexity causes setbacks for industry stakeholders, it is often patients that experience the consequences. In a recent survey, 60 percent of over 500 patients prescribed specialty medications had some difficulty in receiving their first dose of therapy – nearly a third described their experience as difficult or very difficult.CoverMyMeds Patient and Provider Surveys, 2020

Without support, patients have reported coordinating their own care to begin specialty therapies. In fact, ~three out of four surveyed patients claimed they were involved or very involved throughout the specialty process.CoverMyMeds Patient and Provider Surveys, 2020 Consistent with previous research,The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study, Journal of Medical Internet Research, 2018,Make MS Medications Accessible: Recommendations, National Multiple Sclerosis Society over a third of surveyed patients also reported making multiple phone calls to various industry stakeholders while tracking down needed information to begin specialty therapies.CoverMyMeds Patient and Provider Surveys, 2020

For 82 percent of patients, such efforts accounted for at least one hour or more of work or personal time – over a third of patients claimed to have spent more than three hours.CoverMyMeds Patient and Provider Surveys, 2020 Such time and effort have led some patients to describe beginning a specialty therapy as a full-time job.The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study, Journal of Medical Internet Research, 2018,Make MS Medications Accessible: Recommendations, National Multiple Sclerosis Society Inefficiencies of the specialty workflow can delay start of treatment out to eight weeks in some cases. During the interim period, patients have reported deteriorating health and worsening of symptoms.The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study, Journal of Medical Internet Research, 2018

Patients also struggle to afford their prescribed specialty medications. In fact, specialty therapies are abandoned more frequently than any other medication during the deductible period of patients’ health plans.Medicine Use and Spending in the U.S., A Review of 2016 and Outlook to 2021, IQIVIA Institute, 2017

Consistent with this trend, 43 percent of surveyed patients cited financial factors as their top reason for missing doses and 83 percent reported financial assistance to help afford their specialty medication as important or very important.CoverMyMeds Patient and Provider Surveys, 2020 In addition, as cost-sharing for specialty medications increases, so does medication non-adherence and therapy discontinuation which have been linked to increased mortality and hospitalization.41. Impact of Cost Sharing on Specialty Drug Utilization and Outcomes: A Review of the Evidence and Future Directions, American Journal of Managed Care, 2016,The Role of Specialty Pharmacy in Medication Adherence, Pharmacy Times, 2016

Graphic depicting 100 patient icons with 82% colored magenta to represent the percent of surveyed patients that reported spending an hour or more of their personal time making phone calls to coordinate their own care. Some even spend 3 or more hours.

Based on a survey to over 500 patients taking specialty medications.CoverMyMeds Patient and Provider Surveys, 2020

Taken together, such data underline the need for effective patient support services to help improve the specialty medication workflow for patients and stakeholders.

Evolving Patient Support Services

Support programs serve as an important resource for patients beginning a specialty therapy by providing services to help with medication access, affordability and adherence.

Enrolled patients are connected with financial assistance programs, receive education on their therapies and obtain the help needed to coordinate care.Finding the ‘HUB’ in Specialty Pharma Services, Pharmaceutical Commerce, 2013 Providers are supported with expert assistance for healthcare processes like BI, BV, PA and PA appeals. Some programs can even assist providers with scheduling prerequisite lab tests and dose titration for patients, which is critical as these steps can significantly delay time to therapy if not efficiently coordinated.End-To-End Electronic Support Improves Patient Access for Specialty Medications, CoverMyMeds, 2019

Once these processes are completed and approved, prescriptions are considered “clean” and ready for dispense to patients. However, limitations of the traditional hub model restrict program potential.Revolutionizing Patient Access and Support for Specialty Therapies: Multiple Sclerosis, CoverMyMeds, 2019 Development of electronic patient support services can fill the gaps – helping more patients to experience end-to-end support for specialty medications.

Traditional Hub Model

The traditional hub model for patient support services involves a team of patient care coordinators that manually work to fulfill each task within the specialty workflow.Finding the ‘HUB’ in Specialty Pharma Services, Pharmaceutical Commerce, 2013 By collecting needed information via phone calls to patients and network participants, these coordinators are able to complete all necessary forms which are then faxed to an appropriate stakeholder for next-steps.Finding the ‘HUB’ in Specialty Pharma Services, Pharmaceutical Commerce, 2013

After starting patients on therapy, these coordinators also supervise patient adherence through reminders and collect information on patient outcomes.

While these support services lend a much needed helping hand, a survey to 10,000 patients across several therapeutic areas found that only one in five were even aware of such programs.Patient Services – Pharma’s Best Kept Secret, Accenture Life Sciences, 2016 Even if patient awareness was higher, it is unclear if traditional hubs could effectively scale their support. As more patients are enrolled into traditional hubs, more full-time employees (FTEs) are needed to cover the extra work which can increase program costs significantly.A Change of Pace for Accessing Specialty Medications, CoverMyMeds, 2019 As a result of these inefficiencies, 83 percent of manufacturers of specialty medications expressed that there is room for improvement in the current hub model.2019 State of Specialty Pharmacy Report: Tracking the Future of Specialty Pharmacy, CSI Specialty Group, 2019

Outdated communication via phone calls and faxes can also contribute to slow completion progress and delay in time to therapy for patients. As hub programs are most impactful within two to three years of specialty product launches, incentive to automate manual processes and standardize workflows within the traditional hub model has been limited.A Change of Pace for Accessing Specialty Medications, CoverMyMeds, 2019

Electronic Patient Support Services

Through advances in healthcare IT, many steps in the specialty workflow have the potential for automation. By making manual steps the exceptions within a primarily electronic workflow, more patients can experience support and accelerated time to therapy.

Technology enables a scalable model for patient support services that addresses complexity across the full spectrum of specialty medications while allowing for customization to fit the individual needs of specific products. Such changes have already contributed to a 27 percent reduction in time to therapy during a preliminary study.Revolutionizing Patient Access and Support for Specialty Therapies: Multiple Sclerosis, CoverMyMeds, 2019

Enrollment

While it is estimated that less than 10 percent of patient enrollment into support services is completed electronically,Automating Specialty Pharmacy: Identifying Gaps, NCPDP, 2015 new technology can automate patient enrollment at the point of prescribing so that potentially all patients have the opportunity for support.

This method uses the ePrescription itself to trigger enrollment into support services when the provider prescribes to a program-operated non-dispensing pharmacy. By capturing the prescription earlier during the patient journey, care coordination activities can be completed sooner to help improve time to therapy.

Reimbursement Activities

Other steps within the specialty workflow also lend themselves to automation, including, BI, BV, PA and scheduling any needed lab work for patients. Platforms for completing BI/BV and PA electronically already exist and have been integrated into electronic patient support services for specialty medications.

Such technology will allow for automatic determinations based on preset payer-defined criteria. The opportunity for real-time responses can accelerate stakeholder decision-making to limit unnecessary treatment delays for patients. While industry standards are still under development,Three Reasons to Join the Industry-Wide Effort to Speed Time-to-Therapy for Specialty Pharmacy, Drug Channels Institute, 2018 flexible and customizable technology is important for accommodating diverse stakeholder workflows.

Visibility

A centralized platform, accessible to all relevant healthcare stakeholders within the specialty workflow, creates visibility for completing outstanding tasks and driving efficient care coordination. Such a complete, longitudinal view of patient cases can limit unnecessary phone calls among stakeholders and patients as progress is tracked virtually in real time.End-To-End Electronic Support Improves Patient Access for Specialty Medications, CoverMyMeds, 2019

Giving patients insight into the status of their specialty prescriptions through online or mobile resources can also help to promote efficient care while reducing uncertainty and avoidable phone calls to healthcare stakeholders. Empowering patients with visibility and transparency may be valuable for reducing prescription abandonment and medication non-adherence.

Network Connectivity

Adoption of new, unfamiliar technology has traditionally been a difficult, time-consuming process within healthcare. However, by expanding on familiar technology with an existing user base, the barrier to viral stakeholder adoption of electronic patient support services is lowered.End-To-End Electronic Support Improves Patient Access for Specialty Medications, CoverMyMeds, 2019 Awareness for the new technology is broadcast through an active healthcare network with established rapport and confidence in vendor capabilities.

Adherence Journey

Tech-enabled tools can help remind patients to take their medications or refill prescriptions. By leveraging text and email, care coordinators can remain in contact with patients through preferred communication channels and provide assistance when needed. Such technology facilitates open dialogue with patients that can be important for improving adherence to medications.Finding the ‘HUB’ in Specialty Pharma Services, Pharmaceutical Commerce, 2013

Standardization for Specialty Medications

Since 2018, the National Council for Prescription Drug Programs (NCPDP) has been working to establish and refine industry standards for specialty medications.Automating Specialty Pharmacy: Identifying Gaps, NCPDP, 2015

NCPDP's Specialty Pharmacy Work Group 18 is comprised of healthcare experts across the industry and meets quarterly to align on major topics within the specialty drug space. By creating a standard framework through which prescriptions for specialty medications can be processed, the NCPDP aims to reduce stakeholder burden while helping patients to start therapy faster. So far, a general workflow has been drafted that outlines major steps of the specialty process while pointing out opportunities for technological advancement.

In the traditional retail pharmacy space, standardization of industry transactions has contributed to efficient processing of over five billion prescriptions per year (~14 million per day).Medicine Use and Spending in the U.S., A Review of 2018 and Outlook to 2023, IQIVIA Institute, 2019,Three Reasons to Join the Industry-Wide Effort to Speed Time-to-Therapy for Specialty Pharmacy, Drug Channels Institute, 2018 To see a similar boost in productivity for specialty medications, installation of similar standards may streamline stakeholder workflows, reduce administrative costs and help patients get the medications they need to live healthy lives. As standards are developed and revised, we will update this report to reflect current progress.

The Report on Specialty Patient Support is written and published by CoverMyMeds with guidance from industry experts on the Advisory Board for the overarching Medication Access Report.