Remove Access Barriers and Maximize Product Uptake with an Integrated Hub Model Approach

Remove Access Barriers and Maximize Product Uptake with an Integrated Hub Model Approach When it comes to supporting the clinical and marketing objectives of any pharmaceutical franchise, helping to remove potential barriers for patients and providers is a primary focus for any brand team. Page 1

Improving Health Outcomes for Patients How are manufacturers using hub model programs to maximize brand access and adherence? The health and welfare of a pharmaceutical brand is directly impacted by the ability to remove obstacles that physicians and patients may encounter both at the point of care and during the ongoing administration of the drug therapy. If not properly managed, a diverse array of potential barriers to access ranging from prior authorization and step therapy requirements to reimbursement issues can delay the initiation of therapy or increase the risk of abandonment at the pharmacy. Poor adherence to prescribed drug therapies not only reduces patient health outcomes, but results in a loss of brand revenue (and potential market share), as well. Similarly, poor adherence increases overall healthcare costs, by lengthening the duration of illness or increasing the risk of potential relapse in the management of chronic conditions, and calling for additional doctor visits and hospitalizations. When it comes to both high-cost specialty drugs and those traditional drugs (referred to as specialty-lite drugs, discussed below) that also have a relatively high cost and a somewhat small patient population, complicated requirements, such as prior authorization requirements and step therapy protocols create Figure 1 REMS Risk Evaluation & Mitigation Strategies Field Reimbursement Nursing Clinical Support Home, Site of Care Call Center Reimbursement ebv / Prior Authorization HUB MODEL PROGRAMS Distribution 3PL Patient Assistance Programs Pharmacy Services Home Delivery Call Center challenges for healthcare providers and barriers to access for patients who need these medications. When reimbursement challenges are not addressed, the patient may face higher out-of-pocket costs, which can create additional barriers to access for needed therapies. Higher costs for patients can arise due to variations in insurance plan eligibility or reimbursement rates, high deductibles, co-pays and coinsurance requirements that dictate patients to shoulder more of the cost burden for the prescribed medication. SAVE $25 Co-pay Cards Vouchers Meanwhile, clinical issues, such as confusion or questions related to the medical condition or the medication itself (such as complex dosing or administration protocols or potentially debilitating side effects) can further impede therapy initiation and adherence to therapy over time. For brand teams, the ability to address all of the issues that threaten patient access to highcost drugs through a well-designed hub program can help to improve health outcomes for the patient, and support both the strategic clinical objectives of the treating physician, and the financial and business objectives of the drug franchise. Today, using a hub model program (Figure 1), brand teams can provide a single point of entry to support and streamline the patient and healthcare provider experience with the brand, and remove clinical, financial and administrative obstacles that can hinder patient access. The hub model approach relies on a digital platform that integrates all of the complex Page 2

services and tools that are needed to ensure the best patient and physician experience. A hub will connect various touchpoints, ranging from reimbursement to connecting with a pharmacy program for home delivery. Importantly, a well-designed hub integrates two approaches to support patients and healthcare providers: (1) It provides efficient, one-stop, access to relevant information and electronic forms using an automated, self-serve approach aimed at both physician and patients; and (2) It gives physicians and patients direct access to high-touch, personal support resources, in the form of direct contact with nurses (through a call center or home visit) to address clinical considerations or questions, and highly trained patient advocates to address and resolve specific issues related to reimbursement, financial assistance, prior authorization and step therapy requirements. The use of a well-designed hub model program also allows the brand team to maintain consistent messaging throughout all service offerings associated with the brand. And, because all of the hub services are provided through an online platform, the hub offers a useful framework to help manufacturers gather a range of critical data that can provide insight and shape the ongoing refinement of program offerings. Typically, pharmaceutical brand teams engage a third-party, brand-support company to design and manage the execution of an integrated hub model program to support the product in the marketplace. Traditionally, many brand teams have relied on a variety of third-party pharmaceutical service providers to provide piecemeal support in each of the different required areas. However, the use of multiple service providers can create a disconnect and further delays and confusion for patients and physicians. For the brand team, such a lack of integration can also create lost opportunities related to efficient data gathering and successful data analytics that can help support the business objectives of the franchise. More recently, a growing number of drug manufacturers have been partnering with a single, third-party service provider to collaborate in the development of a centralized hub services approach that streamlines and integrates the provision of all services related to the brand. Partnering with a single service provider to support the design and execution of the hub program can help to contain costs and ensure better integration of all of the moving parts. And the beauty of using a single, centralized hub to support a given brand is that it can be customized to meet the needs of the product and scaled over time, as needed, to benefit all stakeholders. Anticipating the Needs of Patients and Physicians While physicians make prescribing decisions based on clinical considerations related to the drug s safety, efficacy and appropriateness for the given patient, they are also influenced perhaps unwittingly by potential affordability issues that could also impact their patients. Many prescribers recognize that high out-of-pocket costs for medications may negatively impact the patient s access and adherence to therapy, and they know that inconsistent adherence to any prescribed therapy can have a negative impact on desired health The use of a well-designed hub model program also allows the brand team to maintain consistent messaging throughout all service offerings associated with the brand. outcomes. Thus, when considering drugs that are likely to incur a high out-of-pocket cost for the patients, many physicians may forego their first-choice medication, opting instead for an alternative therapeutic option that may have a lower perceived cost for the patient. This reduces both patient access to the therapy of choice (potentially negatively impacting health outcomes), and results in a loss of potential revenue and market share for the manufacturer of the preferred drug. Today, most specialty drugs (and many high-cost traditional drugs in the specialty-lite category noted above) offer coupons and vouchers (for one-time use), loyalty cards (for multiple use), and co-payprograms to help reduce the patient s out-ofpocket expenses for the drug, as well as Patient Assistance Programs (PAPs) that provide the drug free of Page 3

charge for patients meeting specified income (and other) criteria. Thus, brand teams must leverage the hub program to address potential barriers to access that could arise from the healthcare professional choosing a drug with a lower perceived cost to the patient. Specifically, the hub program should be designed to ensure that the prescribing physicians have quick, straightforward access to all of the financial resources that are available to help patients offset out-of-pocket costs for high-cost medications. The goal is to ensure that physicians are fully aware of the many programs that may be available to make highcost branded therapies more affordable for patients, and to provide easy, online access to information, enrollment forms and activation steps. To further support physicians, the hub program can also provide a single point of access to find product literature and order samples. And the hub program can even be linked to the brand sales representative s customer relationship management (CRM) system, to provide another level of seamless integration between physicians and pharmaceutical sales representatives. Ease of Access For any patient, the main focus should be on their most important objective fighting his or her illness, managing symptoms and seeking remission not struggling to figure out how to access and pay for the drugs that their physicians have prescribed. Toward that end, it is in the brand team s best interest to design a hub that provides seamless access to all resources in a way that removes rather than creates potential obstacles to drug prescribing and patient uptake. Improving Data Gathering and Analytics As noted, the use of a centralized hub program to support a specialty or specialty-lite drug allows the brand team to consistently capture and aggregate important behavioral and clinical data. Relevant data can be collected at various patient opt-in stages (for instance, when the patient registers on the site, or activates a coupon or co-pay card). Depending on the needs of the brand team, the following types of data can be efficiently tracked through a hub: Information related to the patient s speed to therapy Refill and drug abandonment rates Duration on therapy Reported side effects Most-sought-after educational tools or material related to the drug or disease state Enrollment and activation rates for available coupon, co-pay and Patient Assistance Programs (PAPs) Number and types of calls to the call center, and much more Access to such useful information can give brand teams unprecedented insight, which can be used to better support patients and physicians, and to shape ongoing program improvements. Such data can also be used to send refill reminders and targeted educational materials (such as tips for managing side effects), to help patients stay on therapy over time. Hubs: Not Just for Specialty Drugs Any More Page 4

In recent years, the hub service model has arisen to streamline and automate many of the complex needs and requirements associated with classic specialty drugs. But more recently, hub programs have increasingly been used to benefit another group of drugs high cost, traditional drugs that occupy the middle ground between premium-priced specialty drugs and relatively low-cost drugs that are dispensed through retail pharmacies and have few if any special requirements associated with reimbursement, education and distribution. In general, these two groups of prescription drugs tend to have the following characteristics: Specialty Drugs Have very high cost (averaging $1,000 or more per month) Are typically reimbursed via the patient s medical benefit (using J-code reimbursement), rather than the pharmacy benefit Tend to be infused or injected Are often distributed through a limited specialty pharmacy Often require extensive monitoring and some level of nursing support and/or in-home training to ensure adherence Traditional Drugs with Relatively High Costs (often called specialty-lite medications) Have also relatively high cost (typically averaging $400 $1,000/ month) Are typically reimbursed via the patient s pharmacy benefit Tend to be oral medications or self-administered via sub-cutaneous injection Are typically dispensed through a mix of retail specialty pharmacies or through a home delivery program Often require some initial education prior to initiating therapy and limited external support needed (varies per product) after initial administration As is the case for specialty drugs, many of these high-cost traditional medications also benefit from the use of a less-intensive hub program. Because any drug-specific hub program is, in fact, designed to be a customized solution, this approach provides a flexible way for brand teams to aggregate all special services or requirements that may be required by the brand, and provide a single, automated point of access for both patients and physicians. Important Spokes on the Hub The ability to integrate all key hub services through a single digital platform helps brand teams to engage patients and physicians directly, and build better relationships with both sets of stakeholders. The types of services that can be integrated and managed through the development of a dedicated hub program are shown in Figure 1 on page 2. Each element is described briefly below. Reimbursement ebv/ Prior Authorization Support With the increasing incidence of closed or restricted formularies, many providers are unsure of the coverage restrictions or requirements imposed on the medications they might prescribe at the point of care. In many cases, this uncertainty limits the willingness of prescribers to write prescriptions for newer medications for which their patients may not be covered. One critically important service provided by a hub model is real-time electronic benefits verification (ebv). Historically, benefits verification has been obtained by someone in the physician s office calling the health plan to obtain coverage information for the patient in question. This time-consuming process which can take hours or even days can delay the patient s initiation on therapy. By contrast, hub providers are able to leverage technology to verify the patient s benefits in real time. The ebv approach uses the claims process to both instantly verify the The ability to integrate all key hub services through a single digital platform helps brand teams to engage patients and physicians directly. patient s current coverage, and identify any other benefit restrictions that must be addressed, such as PA or step therapy requirements. PA requirements create a timeconsuming administrative process, requiring physicians to justify their prescribing choices in an effort to override formulary constraints that may otherwise limit a patient s access to the drug. To eliminate PA-related barriers to access, it is in the brand team s best interest to provide the tools and resources necessary to help healthcare providers to move efficiently through the cumbersome PA requirements. If not properly managed, the PA process can create delays for the patient to start therapy, and if the hassle factor is high enough it may provide a deterrent for the physician, who may opt for a competing therapeutic option. This not only reduces patient access to the initial treatment option, but negatively Page 5

impacts market share for the brand, as well. When the digital suite of solutions offered by the hub platform provides real time ebv service and helps to streamline and manage the PA process, physicians are able to quickly address and resolve these administrative issues and start the patient on the prescribed course of therapy right away. Similarly, the hub provides easy access to many high-touch support services and other resources offered by the brand. For instance, via a dedicated call center, both patients and physicians can reach highly trained patient advocates who can help to investigate and verify insurance benefits, research payer requirements and restrictions, clarify and manage PA requirements and tracking, and help manage coverage denials and appeals. Patient Assistance Programs (PAP) PAPs operated by branded drug manufacturers and charitable foundations to provide free or reduced-cost medications to patients who cannot afford them, usually based primarily on the patient s income relative to the federal poverty limit, the number of family members and several other factors. A properly designed hub model program gives patients (and their physicians) access to both automated, self-serve capabilities and, if necessary, high-touch, patient-advocate support, to guide the efforts needed to investigate and enroll in any drug-specific PAP programs that may be available for the patient. Coupons, Co-pay Cards and Vouchers Coupons, vouchers and co-pay programs are an important offering from pharmaceutical brands. They help to ensure access to medications by providing financial assistance to help offset out-of-pocket costs for patients. Such programs have grown in popularity in recent years to provide some level of financial support to patients and help subsidize the rising cost of pharmaceuticals (higher outof-pocket expenses lead to higher levels of therapy abandonment). And importantly, they can help to provide a temporary financial bridge to make the drug more affordable (and support rapid initiation of therapy) while PA requirements are being worked out to allow for reimbursement under the patient s insurance plan. Today, there are more than 500 active co-pay assistance programs available, so providing patients with the tools and resources needed to investigate the options is an essential support service that can be provided through the hub. Pharmacy Services For patients taking multiple drugs to treat chronic conditions, home delivery is often preferable to reliance on a neighborhood retail pharmacy, and home delivery can help to automate refills, as needed. For high-cost, high-touch specialty and traditional medications, the integrated hub program provides an ideal mechanism to coordinate all pharmacy-related services related to fulfillment and home delivery of the prescribed medication. Additionally, a home delivery pharmacy can manage the distribution of customized patient care kits, including special overviews and materials that a retail pharmacy could not otherwise provide. Through the centralized hub, patients can access the forms they need to arrange for home delivery of their medications. This is especially Page 6

important for medications that have strict cold-chain storage and delivery requirements or any other specialized handling needs. In addition, the hub gives patients access to a dedicated pharmacy call center, so they can connect with pharmacy technicians who are trained to educate patients about the product, answer questions and help manage the home-delivery services. Distribution and Third-Party Logistics (3PL) When it comes to the sales channel for various specialty drugs and a growing number of high-cost traditional drugs, different manufacturers choose different approaches, based on the needs of the brand. For such drugs, a dedicated specialty pharmacy is often used. This approach is especially important for drugs that have cold-chain storage and distribution requirements or limited shelf life, as it gives the brand team maximum control over distribution logistics and costs, and provides strong opportunities for data gathering and analytics. However, in other cases, the drug may not require a dedicated specialty pharmacy for distribution. In these cases, a hybrid approach may be used. Such a hybrid approach may involve the use of a limited network of retail pharmacies (selected, for instance, to provide desired geographic coverage) that can still provide a strong measure of control and data visiblity for the drug maker. When the brand s distribution and 3PL requirements are managed seamlessly through a centralized service hub, the patient enjoys a single point of access to arrange for home delivery of the drug or locate a nearby retail pharmacy that is sure to have the drug in stock, but is not hindered by any logistical complexity that is being managed behind the scenes. Hub models will include complete Patient Assistance Programs (PAPs) in assisting underinsured or non-insured patients with affordability options and then coordinate the product delivery to physician offices. Distribution centers will also handle physician sampling programs or delivery to pharmaceutical sales representatives. Nursing Clinical Support For most patients, proper management of side effects is essential for maximizing adherence to therapy. Through a brand-specific hub, patients can access specially trained nurses through call centers or in-home visits who can provide the personalized, clinical support they need to educate, coach and motivate patients, help them understand complex dosing and administration protocols and manage side effects that could hinder adherence, and even demonstrate proper injection techniques. The level of personal, high-touch service offered by the brand team will vary, based on needs of the drug itself. Risk Evaluation and Mitigation Strategies (REMS) Compliance Drugs that have a Risk Evaluation and Mitigation Strategies (REMS) designation on the label must comply with complex safety-related requirements put in place by the U.S. Food and Drug Administration. REMS are required to safeguard the medication in the marketplace and promote safe use. REMS requirements typically call for special training (for instance, requiring pharmacists receive training and certification related to specific parameters, such as required lab values or other patient-eligibility criteria), management of patient registries for REMS products, Such requirements also specify a rigorous safety-education component, and specific safety and recordkeeping protocols for the manufacturer, any distributors who handle the drug, and all clinical and Page 7

retail pharmacies that dispense the drug. A hub services program can aggregate access to, and management of, the many requirements associated with REMS-designated medications, at both the physician and patient level, in terms of enrollment in registries, training, reporting, recordkeeping and more. Field Reimbursement For some brands, the use of a network of field reimbursement specialists either located near high-volume prescribing sites such as physician offices or hospitals, or centrally located and regionally assigned can be arranged and managed through the hub. Such specialists visit the practice, as needed, to provide staff training and support as it relates to complex reimbursement requirements for specialty drugs and high-cost traditional drugs. The goal of such hands-on support at the practice is to help prescribers overcome any financial or administrative barriers that could impede patient access to the target therapy. Customize the Offerings to Optimize the Solution Different drug franchises have various needs, in terms of the level of service and specific program requirements that ensure maximum, informed support from prescribers and optimal uptake and adherence from patients. Given the complexities associated with today s specialty drugs and high-cost traditional drugs, brand teams should leverage the full value of the centralized hub model program design one that integrates automated self-service offerings with high-touch personal support. Hub model programs should address and resolve any obstacles that could create access barriers to the brand as swiftly and efficiently as possible. Flexible, strategic program design is especially important for drugs in disease categories for which numerous competing therapeutic options may be available. Triplefin collaborates with brand teams to build successful hub model programs that help enhance the patient experience, decrease prescription abandonment and drive your brand s success through every phase of the patient journey. For 32 years, Triplefin has continually helped pharmaceutical brand managers remove barriers to brand access and adherence. Today, more than 45 pharmaceutical manufacturing companies (including 15 of the top 20), representing more than 150 brands across multiple therapeutic categories, have connected with Triplefin and experienced success with Triplefin s solutions. For more information, please visit Triplefin.com. Page 8