With approximately 4,000 cell and gene therapy products in the pipeline, and considering that these are relatively new clinical modalities, biopharma leaders are challenged with finding experienced hands to guide commercial and market access success for these products, especially as so many are launching into rare and subspecialty disease markets.
A question I get asked frequently is: "What should be my planning calendar for key market access and launch success activities, especially if I'm at a small, resource-constrained company launching its first product into oncology?"
With that in mind, I've put together the following calendar to help plan your activities, with some guidance on what's "mission critical" vs. "nice to have" for those who may be headcount, time, or budget constrained.
Nine Months Prior to Launch
- Ramp up your relationship-building with key opinion leaders in your disease area. If you haven't done a KOL/Thought Leader/Expert map, or if it isn't recent, get one. If you're resource constrained, you can get 90% of the way there by asking a few of the more easily identified thought leaders to tell you (1) who else they talk to about this topic, (2) who they call when they have a tough case, and (3) what early-career researchers or clinicians have caught their eye due to interest in this topic.
- Identify your patient advocates (groups and individuals) and get their input in a structured way. Especially in oncology and rare disease, patient groups can help catalyze conversations around your product and provide valuable insights into patient needs and preferences. Also, if you end up with an access or pricing fight down the line, they are good to have on your side. If you're resource constrained, this outreach can be a well-crafted email, simple direct mail piece to advocacy groups, or a one-page patient website that can grow over time.
- Start early work to develop your payer value proposition, pricing strategy, and reimbursement strategy. You don't need to land on a price yet, but you should develop a plan for when you'll kick off that workstream in earnest, and start getting proposals for pricing analyses, payer and HCP primary market research, and similar. Start sketching out your Target Product Profile (TPP) that will be a cornerstone of primary market research discussions. Talk to your forecasting team early about expectations around discounts and reserves, such as Medicaid and 340B, and gather information from your HEOR/RWE colleagues that can start to inform value proposition.
- Develop a payer engagement plan. Understand your expected payer mix based on the disease area, decide who will be calling on payers to deliver your messaging, and what resources you may need, internal and external, and on what timeline to be able to address payer marketing through launch and beyond.
- Begin having unbranded conversations with payers about unmet need and disease burden. Don't assume that payers will have any knowledge about the disease area you're focused on, especially if it's a later line or relapsed/refractory cancer, or a rare disease. Proactively characterize the disease burden and the level of unmet need with a short and sweet unbranded presentation deck that a payer field team, or a market access executive in a smaller company, can use in payer discussions.
Six Months Prior to Launch
- Begin crafting your value proposition and messaging for payers, using insights from key opinion leaders and patient advocacy groups to guide your approach. This messaging should emphasize the clinical and economic benefits of your product, how it can improve patient outcomes, and any value messaging you can use to back up your expected pricing. This is one mission-critical area where engaging an external expert or two is helpful, unless you're very experienced in development of payer value props.
- Develop strategies for Guidelines, Pathways, and Formularies, including development of an action plan for submitting data and request letters to organizations such as National Comprehensive Cancer Network (NCCN) for an oncology product, keeping in mind that the organizations that accept submissions typically need to receive those six to eight weeks prior to your PDUFA date. If you don't have an internal team experienced with NCCN submissions, this is another area where outside help can have an outsized ROI, optimizing positioning and reach while preventing common missteps that payers may use to limit access later on.
- Kick off payer market research workstreams, generating discussion guides, TPPs, and pricing ranges to test with representatives from key payers. Make sure that any external group you're engaging with to conduct these interviews can reach real decision-makers (not payers who have been retired since cell therapies emerged on the market) and has enough experience to be able to probe for deeper insights. Use this work to understand what utilization management payers may deploy. Complete this work by 3 to 4 months prior to expected launch. Talking to four or five payers that represent at least a few of the largest groups (United, Cigna, larger Blues plans, an IDN such as Kaiser) should be sufficient as a baseline if you don't have the resources for a larger study.
- Create a key account management plan for market access: Develop a plan to manage relationships with key market access accounts, including payers, health systems, and integrated delivery networks. If you're planning a more limited distribution network with designated centers of excellence delivering your product, headcount here can be lighter. Collaborate with cross-functional colleagues to make sure that guidelines/pathways groups and patient advocacy groups also have a relationship manager or single point of contact, which could be one person in an advocacy/professional society liaison role.
- Engage with Pharmacy Directors and institutional Cell & Gene Therapy leaders. Many institutions (IDNs, Cancer Centers, and Academic Medical Centers) are creating new departments or leadership teams specifically to help handle the prescribing, logistics, delivery, and reimbursement of these complex therapies. Make sure that you have engaged with these individuals, whether through market research, advisory boards, or other conversations to ensure that their concerns are heard and that your market access and commercial teams are prepared with solutions to facilitate logistic complexities at launch. Listen carefully to their needs and make sure that these are incorporated into your tactical planning in terms of educational resources, HUB services, and similar. This group in particular may save you time and resources because they are business-savvy and deal with payer and distributor issues on a daily basis.
Four Months Prior to Launch
- Develop a comprehensive market access tactic plan that includes ways to engage payers, providers, and patients, and lists all of the resources and tactics you will need to enable access and reimbursement information, from reimbursement and coding guides to patient assistance programs. Other common resources to plan for development are templated letters to help HCPs and revenue cycle managers navigate prior authorizations, medical necessity questions, and appeals of denials from payers. Understand the types of tactics that you can use under FDAMA 114 to disseminate health care economic information (HCEI) to formulary decision-makers, including leaders such as Pharmacy Directors, Revenue Cycle Managers, Practice Managers, and Administrators at IDNs and Academic Medical Centers, and include that in your planning.
- Scope your expectations for HUB services and Patient Assistance Programs so that you can begin evaluating proposals from vendors. If you haven't contracted for these before, ask colleagues at other companies, as well as the Pharmacy Directors and Cell & Gene Therapy program managers at key institutions, whether there are any programs they had great success or great challenges with, and deploy that guidance in your decision-making. Many providers of HUB services do a very solid job, so let them compete on service quality and price to deliver what you need.
- Solidify your distribution strategy and plan contracting with your distribution and logistics network, including specialty pharmacies and other partners who will help get your product to patients, keeping in mind that most cell and gene therapies have specific, and sometimes complex, logistics concerns, particularly for autologous cell therapies. Make sure that the costs of these services are well understood in your organization and have been baked into forecasts. Logistics are not an area to cut costs for this type of therapy, and speeding up delivery or turnaround times could become a product differentiator.
- Understand the billing and coding requirements for your product and a process for securing appropriate codes if any challenges or unique situations are expected. This is another area where engaging external experts who do this all day, every day, is very worthwhile.
Four Months Prior to Launch
- Execute on your market access tactical plan, ensuring that tactics and resources are in development and will be ready in time.
- Get ready to contract with the appropriate service providers for patient assistance programs, HUB services, distributors, and similar to make sure that all of your logistics and support programs are covered.
Two Months Prior to Launch
- Ensure your field reimbursement, key account manager, and payer field teams are getting trained with the right materials, messaging, and tactics.
- Ensure that any time-sensitive submissions that impact market access and payer decision-making, such as NCCN letters and dossiers for an oncology launch, or various Health Technology Assessment dossiers for a European launch, are in flight.
- Coordinate with marketing team to ensure that key value messages are built into marketing tactics for HCPs, patients, and other audiences beyond payers.
- Establishing your key performance indicators (KPIs) and tracking metrics so you can keep a close eye on access and reimbursement success.
- Make sure all remaining tactics and resources are on the schedule for Medical, Legal, and Regulatory Review (MLR) in time for hitting the launch date.
I hope that this helps you and your team plan ahead for bringing these exciting therapies to market! And our team is here to support you on navigating any of the items on this list, so feel free to get in touch with us.
