Rethink: Channel Strategy for Oral Oncolytics. How manufacturers can benefit from provider-led care coordination to improve patient outcomes.

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Rethink: Channel Strategy for Oral Oncolytics How manufacturers can benefit from provider-led care coordination to improve patient outcomes.

When facing a cancer diagnosis, patients must have access to the most clinically appropriate therapy, including oral oncolytics, when and where they need it. Enabling access and supporting adherence at the most appropriate site of care improves more than patient satisfaction it improves outcomes. For cancer patients, initiating therapy quickly and managing side effects are critical to receiving the full benefit of therapy. Equally important is an array of factors that influence whether a patient remains on therapy, including how well the patient understands the treatment regimen, affordability and other potential barriers that providers are deeply embedded in as they coordinate and support care. A channel strategy that places distance between the prescriber and the patient negatively impacts the provider s ability to help patients navigate these hurdles and, by extension, the commercial success of your oral oncolytic. Your distribution strategy must ensure your product is conveniently available where oncology patients are already receiving care, when they need it, with the level of clinical and administrative support they require. A forward-thinking approach to channel strategy means including all sites of care where patients are being treated. Oral Oncolytic Product Challenges Patient Cost: Oral oncolytics are often costly and fall under the pharmacy benefit Adherence: Self-administration poses adherence challenges 1 Side Effects: Side effects, a primary driver of non-adherence, 2 are often harder to identify and manage when patient administers therapy at home Prior authorization: Pre-authorization requirements may delay access Mail order: Can delay time to treatment and result in product waste Is it time to rethink your channel strategy? 2

Rethink: Health System Specialty Pharmacy and In-Office Dispensing Health systems are establishing their own specialty pharmacies in record numbers. With the most complete view of each patient through the electronic health record, health systems can provide more integrated, comprehensive care for cancer patients on complex treatment regimens. For health systems taking on financial risk for patient outcomes, developing specialty dispensing and related patient services allows them to retain greater clinical oversight and more effectively manage patients across the continuum of care. In fact, by 2021, 50 percent of health systems are expected to have formal adherence programs in place with community pharmacies, and approximately 25 percent will have formal agreements with payers for cost-effective use. 4 We really are focusing on the total continuum of care and all transition points. Our pharmacists and pharmacy technicians are taking care of patients when they re at home. And we re looking at a pipeline of drugs that are administered on the outpatient side or in the patient s home, so we are measuring outcomes in these hightouch, very acute care patients. Despina Kotis, Director of Pharmacy, Northwestern Memorial Hospital Growth of Health System Specialty Pharmacy and In-Office Dispensing 3 47.1% of hospitals with more than 600 beds operate a specialty pharmacy 1 in 11 hospitals had a specialty pharmacy operation in 2016 Oncology practices dispensing oral oncology medicines: 24% in 2013 58% in 2016 More than 56% of dispensing community oncology practices are part of ION Solutions Specialty Oncology Network (SON) pharmacy and dispensing program Manufacturers must also examine community oncology practices, which are a key distribution source for oral oncology agents and a trusted site of care. A growing number of practices often rely on in-office dispensing to gain more control over treatment and create an additional revenue source. In addition to delivering greater convenience, integrating dispensing into the patient-provider relationship allows for face-to-face counseling that can improve adherence as patients better understand why and how to continue therapy. Some community oncology practices partner with their GPO or specialty distributor to provide in-office dispensing services. In fact, in-office dispensing has been met with a great deal of support from manufacturers as they leverage insights from the data generated by these relationships. As you consider your channel strategy, think about how care delivery is evolving and how limiting distribution channels makes ongoing treatment and close monitoring of the patient s progress more complicated for providers, ultimately limiting access for patients. What s at Stake When the Prescriber is Disconnected from the Specialty Pharmacy? The risk of reduced compliance and adherence increases when patients use multiple pharmacies to support their regimen 5 Fill metrics from outside pharmacies provide an inacurrate picture of adherence. 6 In fact: Treatment delays, dosing changes, and a lack of personalized support for medication therapy management create complexity that negatively impacts adherence The patients preferred, trusted provider loses the opportunity to provide education and medication reconciliation when a product is dispensed a critical moment in the patient journey Providers limited view of the patient s medical record can result in fragmented care and a more confusing treatment journey for the patient 3

Rethink: Timely and Appropriate Product Access Manufacturers may consider limiting a product s specialty pharmacy network for a variety of reasons: garnering greater control over the patient experience surrounding their product, including how/when patients access it and the support associated with that experience; easier aggregation of specialty pharmacy data; or reducing the volume of product that has to be available in the supply chain. However, the unintended consequence of a limited network is that patients being treated in both community practices and health system sites of care may be restricted in their ability to access the therapy quickly. Limited networks may force patients to deal with multiple specialty pharmacies, complicating their treatment experience. And perhaps even more importantly, the patients full care team is not able to provide the same degree of clinical oversight when they are not connected to the specialty pharmacy dispensing the product and providing the pre- and post-dispense patient services. When manufacturers restrict access to provider-led specialty pharmacies, they ignore the role that health system SPs and community oncology practices play in coordinating and supporting patient care a level of care coordination that can shorten time to treatment and improve outcomes. Health systems and community oncology practices have developed the resources to help patients quickly navigate access and affordability challenges. Increasingly, these sites of care are finding efficient ways to handle benefits investigation, prior authorization and financial assistance to help speed time to therapy. Technology is also playing a role by creating visibility into the patient s treatment cost so physician and pharmacy staff can lead productive conversations with the patient before treatment begins. Many community oncology practices leverage tools from their GPO partners that help them streamline these administrative services, including robust in-house dispensing solutions that help them fill prescriptions and adjudicate claims within one interface. Patients appreciate the simplicity of accessing their full treatment regimen from the physician practice or hospital they know and trust. For this reason, provider-led specialty pharmacies are ideally suited to help patients start therapy quickly and offer the ongoing, high-touch clinical guidance to support their adherence to therapy. The last thing any cancer patient needs is more complexity. Willis Chandler, President, Health Systems & Services AmerisourceBergen With on-site dispensing, a patient leaves with their treatment in hand; unlike the PBM-led mail order model, which can delay treatment by weeks. 7 Health systems and community oncology practices are also better equipped to provide comprehensive clinical support, including patient education, medication management, adherence interventions and real-time monitoring of side effects. Partial fill dispensing programs and toxicity checks allow for early side effect management and related dose adjustments, minimizing product waste and cost, while optimizing treatment. 4

Distributors are critical partners that help health systems and community oncology practices access oral oncology medicines. Health systems may be surprised to learn that their distributor can help them expand their influence in specialty pharmacy in ways that go beyond product access. A distributor s specialty pharmacy consultants can guide the health system toward technology and create a skilled staffing model to ensure the specialty pharmacy operates efficiently, creating a positive patient experience throughout the treatment journey. Yet there are times when a provider-led specialty pharmacy cannot access a product they need to support a patient s treatment. This could be the result of a manufacturer s limited distribution network, restrictions within the provider s payer contracts, limitations with the specialty pharmacy s accreditations or even readiness to support the unique requirements that come with specific treatments like those in rare disease. In any of these cases, providers need a partner, a trusted specialty pharmacy that can function as an extension of their treatment and clinical relationship with the patient. Clinically Coordinated Care Within the provider-led model, the specialty pharmacy partners work with health systems and physician practices to provide dispensing services when limited distribution networks or other constraints create a barrier that limits their ability to serve the patient. Not only does the specialty pharmacy dispense the medication, the team works with each referring practice or health system to develop an approach for clinically coordinated care. From patient education at the start of therapy to care coordination and ongoing data-sharing, a trusted specialty pharmacy partner supports all sites of care by filling gaps in access so providers can continue to manage treatment and patients can realize the best possible outcomes. Physician and Health System Specialty Pharmacy access the EHR Pre-dispense Review electronic health record (EHR) and prescription with physician as appropriate Obtain benefits verification and patient assistance Post-dispense Decrease time to fill specialty prescription Follow up with patient for adherence and side-effect management Coordinated care between physician and pharmacist The Results Improved Patient Outcomes Health system specialty pharmacies provide meaningful results in patient care. 8 95% 24-72 hours Expedite prescription dispense Patient satisfaction so patients start therapy sooner The Future is Health System Specialty Pharmacy By 2021, 50% of HS will have formal adherence programs with community pharmacies. 9 By 2021, about 25% of HS will have formal agreements with payers for cost-effective use. 9 5

Rethink: Real-Time Analytics for Better Decision-Making Manufacturers are increasingly looking toward dispensing and clinical outcomes data to better characterize product performance. Historically, harvesting meaningful specialty pharmacy and patient-level data that shows the effectiveness of a product has meant entering into data agreements with individual specialty pharmacies and niche data aggregators and pulling it all together in-house for a full-market view. These additional contracting activities present an additional burden on the manufacturer from a time, cost and expense perspective and represent a key limiting factor in providing product access to the desired patient community. What if a solution existed that aggregates, integrates, analyzes and provides a view of your product s data across the patient journey? A comprehensive solution that allows data and product access to over 100 pharmacies through one single contract, significantly streamlining the current effort required to access these pharmacies today? Additionally, what if this solution provided an actionable unified data and analytics view providing key metrics and KPIs (i.e., time to fill, time on therapy, market share, patient journey, cost of care) that removed the hurdle of including small and independent specialty pharmacies, health system specialty pharmacies and in-office dispensing oncology practices in your channel strategy? It s a solution that s quickly becoming a reality. Visualizing Product Value and the Patient Journey with Data Aggregated data across multiple SPs Supply chain analytics, PLUS: Deidentified patient data Treatment decisions Dispensing data Targeted patient interventions Heath outcomes Produces Unified view of product performance Actionable insights into the patient journey Real-world outcomes data to demonstrate a product s clinical & economic value Reduces Excessive contracting Access barriers Burden of managing multiple SPs The result is a holistic end-to-end view of the product s journey, from supply chain analytics to pharmacy effectiveness to patient-level information. This real-time, actionable intelligence will help manufacturers facilitate optimal targeting, segmenting and forecasting for improved product performance. In addition to our end-to-end supply chain analytics platform, CERTIO TM,we have developed a specialty pharmacy data aggregation solution that provides manufacturers with a unified, actionable market view of the product s journey to the patient and eliminates the burden of excessive contracting. Leveraging this data provides actionable insights related to dispensing in a wide range of specialty pharmacy settings. Kevin Hallinan Managing Director, Data Services and Strategy, Strategic Global Sourcing AmerisourceBergen 6

The Manufacturer-Distributor Partnership Improving Access and Outcomes for Patients Oncology therapies have become more complex and more expensive, while also increasingly turning cancer into a chronic disease. Developing an optimal commercialization strategy for an oral oncology medication requires frank discussions with all stakeholders. Those conversations must consider the ramifications of access decisions. How will a product s access strategy impact health systems and community oncology practices ability to optimize treatment regimens and outcomes? Given their proximity to prescribers and access to the patient s EHR, provider-led specialty pharmacies are ideally suited to quickly navigate the many clinical and financial challenges cancer patients may face during treatment. Manufacturers should begin working with a trusted distribution partner at least 18 months before launch to design a product- and patient-specific channel strategy. In the best situations, manufacturers and distribution partners act as one team working toward shared success. Above all, it s about getting the right cancer therapies to the right patients at the right time to achieve the best possible outcomes. The Value of the Distributor The right distribution partner will: Maximize product availability for your customers Help you recognize revenue as quickly as possible Minimize your financial risk Share product performance insight Provide patient and prescriber uptake data Guarantee the integrity of your products Specialty Pharmacy Criteria for Optimal Access While clinical expertise, accreditation and data capabilities are essential, not all specialty pharmacies are equal. Manufacturer-aligned specialty pharmacies partner with providers to execute a clinically coordinated care model that prioritizes the patient experience, resulting in better outcomes. Consider the benefits: Knowledge that comes from national dispensing and nursing support, fieldbased provider sales teams and managed care sales teams to support patients and prescribers, as well as contracts with a broad range of payers and PBMs. Reach that comes from partnership with providers across all sites of care. Integrated data that is timely, actionable and transparent. A wide breadth of services, including benefits investigation, co-pay and foundation assistance, timely dispensing and robust clinical support. A provider-led model that returns the script to the practice. 1 Lindsey, Heather. Improving Adherence to Oral Oncolytics. Oncology Times. 25 October, 2011. Accessed 16 April 2018. Available online at https://journals.lww.com/oncology-times/fulltext/2011/10251/ Improving_Adherence_to_Oral_Oncolytics.3.aspx 2 Ibid. 3 Fein, Adam J., The 2018 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers, Drug Channels Institute, 2018. 4 Zellmer WA, ed. Pharmacy forecast 2017: strategic planning advice for pharmacy departments in hospitals and health systems. Am J Health-Syst Pharm. 2016; 73:e617-43 5 Marcum, Zachary et al. Effect of Multiple Pharmacy Use on Medication Adherence and Drug Drug Interactions in Older Adults with Medicare Part D. Journal of the American Geriatrics Society. 21 Jan 2014. Accessed 16 April 2018. Available online at https://onlinelibrary.wiley.com/doi/abs/10.1111/jgs.12645. 6 Blank, Christine. Mandatory Mail Order Can Hinder Medication Adherence. Drug Topics. 15 September 2012. Accessed 16 April 2018. Available onine at http://drugtopics.modernmedicine.com/drug-topics/ news/modernmedicine/modern-medicine-feature-articles/mandatory-mail-order-can-hinder-med 7 Egerton, Nancy J. In-Office Dispensing of Oral Oncolytics: A Continuity of Care and Cost Mitigation Model for Cancer Patients. American Journal of Managed Care. 18 March 2016. Accessed 23 April 2018. Available online at http://www.ajmc.com/journals/supplement/2016/improving-patient-access-to-critical-therapies-in-the-age-of-cost-sharing/in-office-dispensing-of-oral-oncolytics-a-continuity-of-care-and-costmitigation-model-for-cancer-patients. 8 Proprietary data. 9 Ibid 4. 7

With a leading market position in specialty pharmaceuticals, AmerisourceBergen is a conscious connector, bringing manufacturers, payers and providers together to uncover new ways stakeholders can realize the full value of specialty pharmaceutical therapies and reduce the total cost of care. We create a marketplace where manufacturers can ensure providers and their patients have access to critical therapies. As a distribution partner, we bring a deep understanding of customers and insights about the opportunities and risks of different channel strategies and network decisions. AmerisourceBergen offers consulting expertise to guide customers through the myriad decisions related to designing a specialty pharmacy strategy, gaining accreditation and optimizing business performance. Our leadership in speciality pharmaceuticals positions us to act as a purposeful partner to health systems and practices, advocating on their behalf for the benefits of a provider-led specialty pharmacy model. Learn more about why AmerisourceBergen is an essential commercialization partner at AmerisourceBergen.com