1. Are we prepared for the transition from clinical to commercial?
As a new product is readied for commercialization, biopharma companies must consider the level of clinical services and adherence support needed. When building a channel strategy, look at the appropriate support mechanisms to unlock a therapy’s potential. What strategies are in place to reach payers, patients, and providers?
The right commercialization partner will have the experience and digital tools to streamline this process and to assist with the sometimes challenging transition from the clinical phase, with the benefit of dedicated staff, to the commercialization phase. A partner should also support rare disease education for providers and payers, helping biopharma companies bring their product to new patient populations through these critical stakeholders
Biopharma companies must also consider targeted customer classes of trade that will have access to these products. The uniqueness of the class of trade and access strategy for downstream customers requires partnering with a specialty distribution partner who brings expertise and a high level of customer account management. Additionally, a specialty distribution partner should have the ability to provide access to customers using very specific identifiers and customer classification to reach targeted patient populations.
2. What are the pricing considerations and how will you define the value proposition?
Every life-changing therapy should be celebrated and supported, regardless of the number of lives it impacts.
Yet, with novel rare disease therapies, the limited size of the patient population is one element that must be considered in pricing decisions. The difficulty defining the exact patient population, along with is limited scope, can be a challenge for payers. What is the availability and cost of raw materials, cost of the end-product, and shipping and storage requirements? What do the demand forecasting models say about this new product? Site of care selection, which is based on product attributes and patients’ diagnosis, also plays a role in product cost.
How will you demonstrate the value of your product to key stakeholders? Consider a partner who can help develop an evidence-driven value proposition that communicates that value. Conducting thorough pricing research that takes into account payers, providers, and patient perspectives can inform your decisions around pricing structure. Biopharma companies must take into account the competitive and clinical landscape. How a product is priced can impact sites of care and what patient services are needed.
3. What is the optimal distribution model?
For success, biopharma companies need access, data, and connections to downstream customers. It’s important to consider that these customers will not stock expensive rare and orphan products for extended periods of time, as it’s not financially feasible to keep inventory in many downstream locations. Biopharma companies, then, should find a specialty distributor who can deliver products the following day, just-in-time.
Products for rare diseases should be stocked strategically at specialty distribution centers that can hold an optimized amount of inventory based on historical demand, forecasted demand, and proven history of successful business continuity plans and resources.
Since many specialty pharmaceuticals, including therapies for rare diseases, require precise temperature controls, considering the storage and temperature requirements for the new product is crucial. Is your distribution partner equipped with the ability to handle the product in the correct environment, end-to-end?
Biopharma companies benefit from a commercialization partner with a distribution network and provider reach that ensures product is available wherever patients choose to receive care and is consistent in delivering on time to support dosing schedules.
A distribution partner that maintains a detailed classification of individual customer classes of trade will ensure that product is delivered to the appropriate sites of care. Biopharma companies should consider the size and range of the partner's distribution network and ask about their alignment with GPOs. With products for rare diseases, additional indications are often approved post launch, so work with a partner that shows the ability grow with the product as it's approved for other indications, including additional sites of care.
4. What role will data play?
Just because biopharma companies don't handle orders directly doesn't mean they shouldn't have insight into them. Look for a distribution partner who offers reliable reports to stay informed on changes in inventory, distribution, and finances.
The right partner will offer analysis of uptake data and patient engagement metrics, measuring against key performance indicators and recommending real-time adjustments to improve the patient support and reimbursement strategies. Additionally, specialty distribution can easily achieve requirements for data capture, including HUB or patient IDs, for end-to-end tracking throughout the patient journey.
5. What is an often-forgotten key step to getting the right product to the right patient?
For a channel strategy to be effective, it is critical to help patients overcome access barriers and require services beyond distribution. Patients who need rare disease products, like many other specialty pharmaceuticals, may need additional ongoing support through financial assistance, care coordination, and support during insurance coverage changes.
Collaborate with a partner who has the knowledge of patient assistance programs. Working with a consultative partner who has a history of building collaborative relationships with advocacy groups can improve the access, data, and connections needed to bring your product to market.
Are there flexible patient management programs, that combine high-tech and high-touch medication adherence solutions? Electronic patient assistance programs speed up eligibility checks and help patients get on therapies faster. A patient services provider that uses various options to supply copay assistance through funds delivered directly to the patient lifts a barrier to access.
