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How to Drive Specialty and Orphan Drug Launch Success with a Patient-Centric Approach


Kelly Ratliff discusses How to Drive Specialty and Orphan Drug Launch Success with a Patient-Centric Approach
Kelly Ratliff, Vice President, Archbow Consulting

It is projected that more than 65% of new product launches will be specialty medications by 2023*, making effective launch strategies more important than ever.


But what makes one launch strategy more effective than another? And what can pharma and biotech manufacturers do prior to launching a specialty or orphan product to best target success?


We engaged Archbow Vice President, Kelly Ratliff, to help us answer questions that we often hear from our clients. Kelly brings more than 30 years of progressive experience in home infusion and specialty pharmacy to Team Archbow, including her most recent role as the President of a multi-billion-dollar specialty pharmacy. Learn more about Kelly here.


How to Drive Specialty and Orphan Drug Launch Success with a Patient-Centric Approach

A Q&A with Kelly Ratliff


Archbow Consulting (AC): Based on your previous experience leading a national specialty pharmacy, what are some considerations manufacturers should address prior to launching a specialty medication?


Kelly Ratliff (KR): From my view, there are several key considerations that, when addressed and incorporated into a commercialization strategy, support a successful launch and promote a positive stakeholder experience. These may include:

  • Anticipating patient and provider access challenges in advance. I’ve experienced situations where one, or more, major access barriers were not identified prior to launch and, therefore, created significant delays and frustration for the manufacturer, prescribers, and patients.

  • Implementing a post-launch plan for monitoring, evaluating, and adapting the launch strategy. Our industry is constantly evolving – payer coverage changes, provider consolidation, regulatory revisions, etc. It is important to have a plan to monitor and adjust based on changes in the environment.

  • Engaging a consultant with deep specialty pharmaceutical expertise as early as possible prior to approval. Since becoming a consultant, it has become apparent that we all have a tendency to leverage only what we’ve experienced. A good consulting team, however, has had the opportunity to partner in launching a wide array of products and can close any gaps in planning or knowledge clients might have. Experience in specialty distribution, patient services and network design, pricing and payer coverage, and data and analytics are all key areas to assess when choosing a partner. Having a team with deep expertise is advantageous in ensuring a successful product launch.


AC: You described the need to anticipate access challenges well in advance of a specialty product launch. Can you share more specifics?


KR: Anticipating barriers is especially critical in the rare and orphan disease space. In my experience, because these medications treat very small, disparate patient populations, the needs of the primary stakeholders (prescriber, payer, and patient) are very unique and need to be specifically addressed.


Such a small percentage of rare diseases currently have approved treatment regimens, and therefore, prescribers are often not familiar with the complex nature of the specialty pharmaceutical distribution channel. Engaging the key opinion leaders and supporting prescribers well in advance of the anticipated product launch (24-36 months) will help ensure they have the education, support, and tools needed to access and prescribe immediately upon approval. Even if the specifics are not solidified until closer to launch, an overview of the potential access channel is an extremely valuable educational tool and a way to enhance the manufacturer/prescriber relationship while setting the foundation for launch success.


Patients with rare diseases spend years navigating the healthcare system in search of a diagnosis. Following diagnosis, patients often find there are no approved treatment options available. The journey from experiencing the first symptoms to diagnosis is an emotionally and physically exhausting process for patients and their caregivers. They are strong advocates for their care, they are well informed, and they will likely be interested in any/all available clinical trials. Therefore, it is imperative that manufacturers engage with patient advocacy groups to anticipate any potential obstacles to treatment and formulate a detailed strategy to eliminate barriers. Consideration should be given to issues related to affordability, geography, educational support, translation services, storage requirements, transport, follow-up care, laboratory monitoring, site-of-care selection, etc. Market research can help identify opportunities to truly help patients when/where they need it most.


Finally, ensuring commercial and government payer coverage is addressed prior to launch is critically important. This involves a significant financial and time investment and, when done well, truly differentiates a successful launch. Understanding coverage criteria and ensuring that information is disseminated across the provider network is critical in eliminating treatment delays at launch.

Developing a strategy that promotes a coordinated, streamlined approach across all stakeholders will help minimize disruption for patients who have desperately waited for a treatment option.


AC: When clients ask what the number one thing is they can do to set their launch up for success, what do you say?


KR: As a specialty /infusion pharmacy industry veteran, I’ve observed that the most successful product launches involve scenarios where manufacturers are hyper-focused on the patient experience. They proactively take time to understand specific patient demographics and then create solutions and services designed to ensure access.


These same manufacturers are also committed to not only ensuring access upon therapy initiation but throughout treatment. Patients’ needs are unique and dynamic. Although it’s challenging to create solutions to support 100% of any population, I’ve seen successful manufacturers make significant investments identifying those nuances. These may include variables such as proximity to care, mobility and dexterity issues, translation needs, educational level, hearing and vision challenges, caregiver and family support systems, travel/transportation, site of care considerations, age, gender, comorbidities, employment gaps, etc.


True success depends on eliminating the current fragmented approach to treatment. Realizing that, by supporting the patient holistically rather than simply providing medication for a specific disease, we can collaboratively achieve the goals of all stakeholders and, most importantly, make a difference in the lives of the patients we are here to serve.


Archbow consulting helps pharma and biotech manufacturers design, build, and optimize product distribution and patient access strategies. Contact us today for assistance with your next project.



*https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023




Archbow Consulting helps pharmaceutical and biotech companies in the USA and Europe design, build, and optimize product distribution and patient access strategies. Archbow was founded by industry veterans to meet a need in the marketplace for consulting options that offer diverse real-world experience, are able to leverage deep connections across the industry, and can also provide actionable strategic guidance. We invite you to learn more about our team, services, and clients’ success, and connect with us via email, LinkedIn, Twitter or subscribing to this blog which you can do below.