Katya Svoboda: Market access is very broad. There are so many different areas, but it's important to have them all come together into a seamless market access strategy and execution. Perspectives from the payer, provider, and patient need to be considered when thinking through market access challenges and developing strategies.

At EVERSANA, we create all components of market access strategies, with a strong value message setting the foundation. The value message describes the product's benefits in a way that resonates with key stakeholders, including payers who decide if and how to reimburse it. Several functional areas work closely together to develop the messages. It often starts with a literature review to understand the disease and unmet needs, as well as the treatment paradigm. Our value and evidence group uses that to identify evidence gaps and opportunities to generate evidence to strengthen the value story for payers. 

Developing evidence to support the product value is critical and often makes a huge difference in the quality of market access and pricing potential. Our agency develops marketing strategies and tools to communicate value messages to stakeholders. In the US, a field-based team delivers the messages to payers and negotiates contracts when needed to secure market access. Our revenue group executes on government pricing requirements. 

Brett Olson: Market access also equates to patient access. It's key to identify all relevant market access components early, which will enable you to have a successful commercial launch. The reimbursement process is crucial, falling into two primary buckets: pharmacy benefit-based products, or oral therapeutics, versus medical benefit products, those that are injected or infused by a healthcare provider. 

One common theme from a patient services perspective that we see is payers implementing utilisation management controls, i.e. step edits or prior authorisations to ensure patients have tried or failed another therapy before they receive the therapy that's prescribed. That, in turn, creates roadblocks for patients to gain access to prescribed therapy, that the prescriber has deemed most beneficial for that particular patient.

The patient services arm steps in to help that individual navigate ways in which they can obtain the medication not only through the coordination of benefits process, but also from a financial perspective to help the patient find ways to afford the medication. 

Svoboda: The public doesn't always think through the flow of funding. There's not an unrestricted amount of resources to pay for all healthcare for everybody, so choices on which products and services to reimburse need to be made based on the resources available. There will always be implications. With the IRA in the US, for example, there's a new limit on patient out-of-pocket costs for the drug benefit under Medicare. Everyone thinks, "Oh, that's great for patients," but the funding is going to come from somewhere. So now, more comes from the manufacturers and the health plans. Higher costs for health plans will likely result in higher premiums, and then the patients will pay more upfront. 

It's important to think through the bigger picture and understand the implications. 

Olson: Health literacy is unfortunately very poor amongst a large percentage of patients. We often find and hear from customers that, "Our patients just aren't well-versed in knowing and understanding what resources are available". We've seen that manifest itself more recently through the rollout of the Medicare Prescription Payment Plan, with patients often confused about what the programme is or how it works, leading to difficulty navigating medication access in the pharmacy. 

Among the manufacturer partners that we work with, I think there are a lot of areas of market access that are even misunderstood. Often times we find individuals that tend to work in their own silo of patient services or perhaps they're in value and evidence or government affairs or a different area, which lends expertise in those verticals, but often not across broader market access functions.

Svoboda: Market access is very different across regions globally. Some countries make decisions on which therapies to reimburse centrally at the national level, and others have regional decision-making. Some are more clinically oriented, and others put more weight on economics and budget. Some countries set prices and some have free pricing. Some countries look to other countries to reference the pricing, and others don't reference other countries. 

In the US, there are a lot of payers that operate independently. Commercial payers, Medicare, and Medicaid have different nuances, and coverage decisions could lead to differences in access for patients based on their insurance type, product type, and geography.  

Consolidation has led to the formation of large PBMs and payers that control the majority of lives. Their size gives those organisations leverage to demand rebates from manufacturers in exchange for coverage and quality of access.

An account and regional segmentation can be very helpful in understanding how to prioritise and engage with payers.

Svoboda: It starts with the product's value in terms of the clinical data of the product compared to the standard of care, how much of an unmet need it can fill, and the potential cost savings of taking the product vs. alternatives. We layer in other attributes such as the mechanism of action, cost of goods sold, and current and pipeline competition. Looking at the analogues can also be very helpful. How are analogue products priced, and how has that been accepted by payers, providers, and patients? Ultimately, we conduct research, analysis, and modelling to understand the downstream effects of pricing on payer reimbursement and provider and patient uptake.

In the US, you also have to take into account what we call gross to net, which is basically discounts and contracting that affect the bottom line. Payer mix is an important consideration. Are there a lot of Medicaid patients? If so, a certain discount for the Medicaid population needs to be anticipated. Will rebates need to be given to a PBM for inclusion or better placement on their formulary?  Will discounts need to be provided to hospitals or other sites of care? These are just some examples.

All of this comes together when making pricing decisions.

Olson: To Katya's point, it's all those discounts that factor into your gross to net, whether it's rebates you're providing to payers, your patient assistance programme 340B, wholesaler/distributor fees, or copay card discounts that you're providing to patients. It's imperative that manufacturers develop a sound strategy as they commercialise that takes into account the dynamics of gross to net. That could be through GTN or budget impact models, developing strong value and evidence to support how they set their price.

Svoboda: Payers review new products and make decisions about how to cover them. For pharmacy benefit drugs, they use a tiered formulary to drive use to their preferred drugs and ultimately control their cost. Each tier is linked to different patient copay or cost share amounts. Patients are incentivised to use a preferred product for a lower cost responsibility, and physicians are incentivised to prescribe the product that is more affordable for their patients.

There are also management restrictions that payers can put in place. It could be that the patient has to try something else and fail it before a payer will reimburse a product, or the payer may limit coverage to the type of patient that was included in the clinical trial. Some management restrictions can greatly reduce utilisation. 

Because of payer management and their ability to drive utilisation towards or away from a particular product, it is critical that they understand the value each product brings. 

Manufacturers need to develop a strong, evidence-backed value story to educate payers on the importance of their product. If the value story alone does not support the manufacturer's access goal, they can often improve tier placement or reduce restrictions through contracting or by generating and presenting additional evidence to support the product's value proposition. 

In addition to this, it is important to secure proper coding for products and procedures. If the proper codes are not assigned, providers may not be reimbursed for their efforts and expenses. The amount of reimbursement a provider gets can either incentivise them to use the product more, or disincentivise use if reimbursement is low.

Olson: As we think about medical benefit products, where physicians are buying the product and essentially billing the payer later, they're effectively taking on the financial risk of the product up front. To Katya's point, especially when you're a new product, and you're launching from a coding perspective, you're launching with a miscellaneous J code until you actually have a J code that's established and in place after launch.

There's a tremendous amount of trepidation from providers when there are uncertainties around reimbursement. As manufacturers navigate these challenges and lean on partners to ensure that they have the right pieces in place from a coverage, coding, and payment perspective, physicians want to know that they have that security, that they're going to get reimbursed appropriately for the product, and obviously not have situations where they're underwater from a reimbursement perspective.

Olson: From a patient services perspective, data and analytics are critical to evaluating and measuring the effectiveness of programme offerings. Manufacturers want to understand how their programmes are being utilised, identify and track key metrics, but also leverage the data to help shape and shift patient services strategy and services offered to patients and providers.  As part of the overall market access story, data and analytics inform manufacturers of how quickly their therapy is getting into the hands of patients and ultimately enabling that patient to live a healthier life.

With payer-implemented utilisation management controls, any delay in processing a step edit or prior authorisation means therapy delays for the patient. Unfortunately, too many times that leads to the patient and/or provider having a negative experience with a particular product. Understanding and monitoring the nuances of the data can lead to efficiency gains with your HUB vendor, translating into speed to therapy and less frustration for the patient and provider.  

From a trade and channel perspective, monitoring the performance of specialty pharmacy partners can also produce efficiencies across your patient support programme. There is often a data black hole for manufacturers, for their products, and for competitors' products as it relates to both network and non-network specialty pharmacies. Our manufacturer partners want to be able to close that gap and measure time to fill, prior authorisation turnaround times, payer information, and brand substitution, for example. Gaining access to the right data and analytics then helps inform the appropriate strategy for your SP partners and course correct if needed.

I think manufacturers are also very keen to understand how to ensure that therapy is being received by patients as quickly as possible.

Svoboda: To build on that, it's important to incorporate market access thinking very early in the lifecycle – phase one, phase two – to really understand how you could design your trial. What are you developing? Make sure that it will be something that payers want to see in the way that they want to see it. We've seen products come to market without the data payers need to see to support their reimbursement decisions. As a result, payers may decide not to reimburse the product or they may place onerous market access restrictions on the product, ultimately impacting uptake at launch. Eventually, manufacturers would need to develop more data to support better access. 

Early market access planning is getting much more focus and attention than it used to as payers clamp down to control their costs, and manufacturers understand the importance, but still, there's a lot of opportunity to do more and do it earlier.

Olson: Working with manufacturers, you often hear that a lot of drug launches fail, I think as many as two-thirds fall short of pre-launch expectations. Typically, what we've seen when things go wrong is they may not have engaged partners early enough, or that strategy wasn't set to account for shifts in market dynamics. Perhaps they didn't contract appropriately with payers, or there were gaps in their trade and channel strategy that led to delays in product availability in the channel. A variety of dynamics are at play; developing a sound market access strategy can fend some of those off, but those that delay in engaging partners often have negative outcomes. Engaging the right partners early and often can help mitigate some of the churn and potential negative consequences.

Olson: Having experienced partners and teams is critical. Finding organisations that share similar values, and having a team who has the experience of serving in various market access roles, whether on the manufacturer side or the vendor side, that really know and understand market access very deeply makes a huge difference. 

With experience comes a diverse set of knowledge working across multiple clients, translating in a tonne of anecdotal real-world situations that can apply to a variety of clients and situations. I believe manufacturers value that perspective.