Acing Market Access: Six Steps to Take Before Launch
Our first post in this series discussed how early market access research, conducted in the 12-18 months before launch, helps pharma companies identify differentiators and establish accurate expectations.
As your organization moves closer to launch, your market access team will need to establish a commercially focused definition for your patient population. You’ll need to identify treating physicians, define the current standard of care, and establish how your brand will fit into the existing landscape. Critically, your team will also need to develop a pricing and contracting strategy to encourage early coverage determinations.
In this post, we’ll discuss the crucial steps pharma companies should take in the 6-12 months before launch to ensure a successful market debut.
- Map the Patient Journey
While your HEOR team has already analyzed the patient journey in preparation for your clinical trials, understanding it from a commercial lens is quite different. To define your market and determine target HCPs, your market access team will need to identify the geographic areas with a high concentration of your potential patients. You’ll also need to map the flow of a typical patient journey, and track how care progression from initial disease presentation through testing to treatment. Where are the majority of treating physicians, and what’s the referral process? Knowing which HCPs are prescribing for your patients will help you stratify those physicians and determine your HCP target priorities before launch.
Delve into lab and EMR data
Lab data is probably the most important real-world data source at this stage, because it can help your team identify potential patients and understand which HCPs are ordering relevant tests in this therapeutic area. EMR data, specifically the unstructured chart notes and dictations taken during patient visits, indicates how physicians are approaching the diagnosis and prescription process. EMR data also shows you how many prescribers are influenced by payer policies: Are physicians prescribing less restrictive drugs that are easier to access?
EMR data can also be used to reveal unexpected detours in the patient journey, such as misdiagnoses. For example, one client recently found that patients were receiving the same treatment paradigm despite being diagnosed with different diseases. By examining the ICD-10 codes used in conjunction with EMR data, the client was able to find twice as many potential patients and engage in targeted physician education to ensure the correct diagnosis.
Gain full visibility with claims
From a single medical claim, manufacturers can see everything from the referring physician to the rendering physician to the IDN, clinic, outpatient or ambulatory facility where a patient was treated. Claims also provide the ICD-10 codes used as well as patients’ insurance plan and reimbursement details, which in turn show what physicians went through to get the treatment prescribed. Looking at the longitudinal claim history for a particular patient can help your team better understand the typical patient journey.
When your team brings lab data and EMR data into that mix, you can also see what lab tests were ordered and for what reasons, which provides insights into how physicians are developing a treatment paradigm. Harnessing this interconnected real-world data at a patient level allows your team to identify patterns and trends that will help you remove barriers along the patient access journey.
- Anticipate Payer Response to Your Brand
In the year before launch, pharma companies should research the current payer landscape to understand what factors are most important to payers in a disease state. Do payers tend to prioritize efficacy, price, or mechanism of action? How are they managing existing treatments, and how are they likely to react to a new therapy? Even though it’s early on, your market access team will need to analyze formulary, policy and restriction data to evaluate access patterns across channel types.
Historic analog analyses are crucial for helping your team predict payer responses to your brand. By studying how similar drugs performed in the market—and analyzing their pricing strategies, market penetration, competition, and patient demographics—you can learn how to best position your own brand. The drugs you select as analogs should be similar to yours in multiple ways. While you don’t necessarily need an analog from the same therapeutic area, you should select analogs that are similar in terms of market dynamics. For example, if you’re launching into a protected class, your analogs should be protected class drugs.
If your drug is going to be the first in its class for a new indication or diagnosis, you should ensure that your analogs were similarly novel in their time. Payers pay more attention to first-to-launch drugs, and they require more clinical evidence to combat their initial skepticism about treating a new patient population. Market share also has a huge influence on launch uptake, and should be considered in analog selection. If your brand is launching as an alternate to a drug for which payers are already contracting, access will be more challenging.
- Conduct Just-in-Time Payer Analysis
As you move closer to launch, your team should conduct a third or fourth round of payer analysis to reveal any weak spots in your go-to-market strategy. Think about every element payers will consider whenever your product profile comes across their desk, from potential restrictions to new-to-market blocks, including the factors that tend to preoccupy payers in your indication.
One of the best ways to determine how payers will respond is to conduct a simulated P&T committee review, which clarifies how payers will approach your brand’s efficacy data, safety profile, pricing, and value props. Perhaps most importantly, simulated reviews give you a valuable opportunity to hear feedback early on, which can be especially beneficial when that feedback is negative or underwhelming.
In P&T committee meetings, payers will also invite key physicians in to argue their case for or against a brand. Simulated P&T meetings can reveal pain points of existing therapies that can lead your team to recognize a new differentiator. Do physicians hear many patient complaints about particular side effects that your product minimizes? Does your product’s dosing regimen mean fewer patient visits? Even clinically insignificant physician preferences can factor into payer decisions on how to manage your brand. If physicians prefer your drug to the alternatives, payers are less likely to require costly prior authorizations.
- Recognize Payer Pricing Expectations
Your team’s pricing, contracting, rebating and distribution strategies can make or break a product launch. A year before launch, most pharma companies have already conducted independent pricing research to set a brand’s price. However, it’s important that your team understands how payers are likely to respond to that price before you send account managers to payer discussions. If your brand is entering the market at a higher price than the standard of care, payers may expect rebates.
No matter how you’re planning on pricing your product, knowing how that price will be perceived in the P&T decision-making process is crucial. Conducting a simulated pricing study can yield a band of acceptable price points with high and low thresholds. Learn what payers think is a high price—albeit one which will likely result in formulary placement, probably with restrictions—versus a prohibitively expensive price, which may result in no formulary placement at all.
- Complete Payer Segmentation
Once your team understands how payers are managing access within your space, your team can complete a payer segmentation analysis. By segmenting payers by market share, line of business, and geographic reach—not to mention their hierarchical relationships with PBMs, IDNs, and other entities—you can see which relationships are most important to cultivate in advance.
Knowing which payers are early and late restrictors—and early and late adopters—is crucial, as it will help you prioritize your engagement and decide on a strategy for those conversations. For example, if your account managers are able to quickly provide product education (and potentially contracting offers) to early restrictors, you may be able to circumvent a restrictive policy altogether. Your secondary targets should be payers that are known to be late restrictors.
On the opposite end of the spectrum, early adopters can be safely de-prioritized until a later date. These payers can be depended upon to place your drug on formulary, and to write the policy (and required testing) to label. The goal of your payer segmentation process should be to determine the payers and PBMs to target first for the largest return on investment.
- Refine Your Payer and Provider Messaging
Lastly, your team will need to refine your payer and physician education strategy. Your brand’s preapproval information exchange (PIE) deck will already contain key information from your real-world data analysis of the patient journey, including how your brand will help both patients and payers avoid suboptimal outcomes and costs. Before your drug is approved, your MSLs can begin to educate payers on the benefits of your brand.
Your team should also recruit prominent physicians in your indication to serve as key opinion leaders. These individuals can provide disease state education to their peers, both in discussion forums for specialists and in published materials. Physicians will need to be educated on topics like how to identify the right subset of the total disease population, and how to determine a patient is an ideal candidate for your drug. This kind of evidence-based physician education has been proven to increase treatment adoption by 150% in the first six months after launch.
As you develop your engagement strategy, make sure to identify all of the HCPs you need to reach, from advocacy groups to health systems and centers of excellence. Right before launch, consider conducting on-the-fly market research or even one-on-one interviews with physicians to test how your messaging is landing. Another mock P&T session can also give you unvarnished physician opinions, which can help you fine-tune your language and ensure your value props are both memorable and effective.
Make sure to create a target product profile that articulates your brand’s value for providers, and be prepared to use both personal and non-personal promotion methods to spread the word about your brand’s benefits and coverage once you’ve launched. You’ll probably need to create an HCP-facing brand website, ideally with a self-service coverage details look-up tool to help providers more easily prescribe your product. No matter how you deliver your messaging, your team should aim to provide prescribers with all the resources they need to navigate access hurdles and get patients on your therapy.
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