By Dana Edwards, Navigant
After making it through the rigorous processes of product development and regulatory approval, a commercial stage company ideally should know precisely customers’ needs related to access and a strategy to meet those needs. Unfortunately, companies often apply a one-size-fits-all program template because, maybe, for example, it worked in the past or “that’s what our competitors are offering.”
Just as new products require unique journeys from concept through development to gain approval, they also need customized strategies to gain traction once on the market. A successful product commercialization program takes a multifunctional, multichannel approach that adroitly positions the product with stakeholders – patients, providers, and payers – across the care continuum.
As a critical component to this continuum, support services must be designed to attract and benefit the ideal patient and provider targets. Thoughtful consideration and planning must drive patient access and uptake, and mechanisms need to be implemented to evaluate effectiveness. As such, manufacturers should view each new product launch as a unique event, and create a program specific to the drug or device, especially with respect to the patient and provider journeys, as well as relevant regulations.
This article examines how to determine the level of support services required for your new product launch, as well as considerations for setting up those support services compliantly.
Setting the Right Strategy
To begin, make sure your team is creating a commercialization strategy based on current reality, and not assumptions made early in the product development stages. Much can change from early concept to product launch – including the defined market, market development needs, ideal patient pool, competitive landscape, regulations, and more.
For example, an up-and-coming biotech company experienced a massive turnover in product team staff a few months prior to launch. Given the timeline to launch, the new team relied on the assumptions of its predecessors, which completely underestimated the market’s pent-up demand for the technology. This resulted in higher demand for product and services than the company could initially accommodate.
With much at stake, the team quickly regrouped to reset the commercialization strategy and expand support services. While the product went on to become a best-in-class service offering, the initial launch would have gone much more smoothly if the original assumptions had been reviewed, tested, and validated prior to market launch.
In addition, as you begin investing in developing your pre-launch strategy, assess the market using a mix of qualitative research and real-world evidence from comprehensive claims datasets. This will allow you to translate qualitative insights into the realities of real-world application of the current standard of care, as well as uncover potential barriers to adoption and surmise a defensible estimate of your product's realizable market value. The results also will inform your market development and commercialization strategies, including appropriate patient services to address potential access barriers.
As you form and populate an appropriate commercialization strategy, focus on three high-level areas:
- Product type
From manufactured biologics to medical devices with companion diagnostics, the variety of life sciences products entering the market is increasingly complex and may require new services to support patient access. These new products often come to market via intricate routes of administration, alternative use cases, site of care differences, highly specific patient candidate pools, and heightened regulatory requirements that sometimes include a Risk Evaluation and Mitigation Strategies (REMS) program.
Each of these factors will dictate service components that need to be incorporated into the service model and special considerations for service execution. For example, does your product require a physician to administer the product, or is it self-administered? Are there any special monitoring requirements, or does the product require special handling, like cold chain distribution? Does the product have shelf life considerations?
- Patient journey
The patient journey depends on a variety of factors, including the disease area, standard-of-care treatment modality, and how the product fits into current standard of care. The goal of support services is to help ensure the smoothest, most streamlined patient experience possible — fully considering issues of access, affordability, and adherence during and after the decision is made to prescribe the product:
- Access – Is the patient required to exhaust other treatment options before gaining consideration? Will the patient have to go to a pharmacy to pick up a prescription, visit an academic center of excellence to receive an infusion, undergo a minimally invasive surgical procedure, or something else?
- Affordability – Will insurance cover the cost, or must the patient pay out of pocket? Are there special considerations with your target patient population?
- Adherence – Are there socio-economic, health-system, disease state, or other factors that could impair a patient’s willingness or ability to comply with treatment requirements or follow-up care?
The answers to these questions will help to inform the types of services you consider including in your commercialization strategy.
- Provider stakeholders
The more conveniently clinicians can get up to speed on the clinical and economic benefits a new product offers, the more likely they are to adopt it. Knowing this — and that most payers, integrated delivery networks, and hospital systems now rely on cross-functional committees to determine which therapy options to adopt — it is critical to incorporate support services that help foster “big picture” understanding of how a product will benefit the healthcare system, while also catering to the prescribing specialty area and expertise level to trigger diagnosis and, if necessary, referral.
For example, if most of your patient population will require treatment from a specialist, but first must present to a primary care physician, then support services should be created to help educate PCPs about the product indications, and, if necessary, referral pathways for patients. Likewise, consider educational services for specialists to understand when to choose your new product over the standard of care, as well as ways to streamline processes, such as through EMR integration and digital prescribing.
After assessing the product type, patient journey, and provider stakeholder needs, your product commercialization strategy can begin to take shape. At this point, begin outlining the tactics to implement as part of your product support service programs, taking into consideration any budgetary needs and/or regulatory requirements or restrictions.
These programs typically provide a range of services that support patient access to therapy, including:
- Reimbursement support to help patients navigate their insurance coverage. Reimbursement support includes services like benefit investigations to research a patient’s policy for coverage, prior authorization support to help obtain appropriate authorization for coverage, or appeals support. For this, you need to factor in the reimbursement environment and payer landscape – coding, coverage, and payment considerations for patients to gain access. Also, reimbursement support might range from automated benefit verification or prior authorization for pharmacy benefit to high-touch appeals support for medical benefits. So, what level of support does your program need?
- Fast Start or Bridge programs to help patients initiate therapy quickly while working through access challenges.
- Patient assistance in the form of free product for uninsured patients, financial assistance or co-pay assistance for underinsured patients, or referrals to charitable organizations for government-funded insured patients.
- Adherence support to help patients initiate and stay on therapy. For this, consider clinical vs. customer service staff vs. automated outreach. For example, will you send patients automated refill reminders, or hire customer service representatives to make personalized follow-ups based on AI generated triggers?
- REMS support to meet FDA directed requirements to prevent, monitor, and/or manage a specific serious risk by informing, educating, and/or reinforcing actions to reduce the frequency and/or severity of such an event. These can range from offering educational packets to full registry tracking, and more.
Also, consider the level of support to provide from low-touch — such as automated technology-based support — to high-touch, full-case management support. For example, for low touch, you might provide general information on whether the product is covered through government-sponsored and/or commercial and private insurance programs. For high touch, you might go a step farther and enable your customer service representatives to call an insurance provider directly on behalf of a patient to determine coverage based on that patient’s specific policy.
As you begin to build out your commercialization plan, consider these common areas of support need:
How will customers initiate and access services? Do you need to set up a provider portal or website? Will a designated phone or fax number be needed? Have you established clear standard operating procedures (SOPs) that must be followed? Does a CRM or database need to be set upto support execution of services and as well as meet reporting requirements?
Internally, you will need to provide operational training on how to administer these services, and clinical training so your customer service representatives understand the product they are supporting. Consider, for example, what your customer service representatives need to know to educate providers and/or help patients. Are there any restrictions on what they can or cannot say or do? Do you need to create any support materials, such as telephone scripts, email templates, FAQs, etc.?
Communication and Marketing Planning
How will you drive patient and provider awareness of your program? What tools does your sales team need? For example, they may need talking points to help them explain the program, or “do’s and don’ts” guidance. Maybe they need promotional materials, such as brochures, an overview video, or product samples?
Too often, this area becomes a classic case of the left hand not knowing what the right hand is doing. Often, these programs are set up to provide a certain type or level of service. Make sure your sales team fully understands the program nuances and what support services it entails.
For example, in one recent case, a field team member erroneously promised a clinician help writing an appeal letter for reimbursement. However, the program SOPs dictated that the program could only provide a template with demographic information filled in – the clinician must write his or her own clinical rationale for why coverage should be allowed. Upon learning this, the field team member was forced to backtrack and reset expectations, which angered and frustrated the physicians, who were then less enthusiastic about the prescribing the new product.
The better your entire team understands what the program offers — and how to access resources if any questions arise — the more successful your product commercialization strategy can be.
Are you familiar with recent regulations in the patient services space? What hurdles to access are you anticipating and what assistance can be provided to address these compliantly?
Support service programs are under vigilant compliance scrutiny; field force monitoring, transparency reporting, and risk-assessment activities are critical when launching a medical device or pharmaceutical product, as is having a plan for the ongoing administration and monitoring of your service offering. It also is important to ensure your patient services programs are administered in a compliant manner, including compliant systems, written standards, adequate training of personnel, and with appropriate monitoring.
Successful product commercialization strategies find a strong balance among meeting regulatory expectations and patient and provider needs. There is no one-size-fits-all approach for an industry or therapeutic area. As such, adequate resources – including time, staff, and budget – should be allocated and based on the product, patient journey, and potential realizable market. Manufacturers that invest these necessary resources go to market confident their commercialization strategies and support service plans will be best equipped to succeed.
About The Author
Dana Edwards is a director in Life Sciences at Navigant. With more than 20 years of experience in the pharmaceutical and life science industry, she helps pharmaceutical and biotech manufacturers identify solutions to support patient access to therapy. She has led the design, development, and implementation of programs servicing both patients and providers to support patient access to and coverage for high-cost therapies. Her focus on quality assurance and process improvement has led to innovative work processes and system solutions to facilitate a portfolio of services addressing complex reimbursement issues across payer types.