The Case for Market Access...Early and Often

The market access function is an important one, but based on my experience, it is often misunderstood and the timing of when it should be added to the corporate leadership team and organization can vary greatly.

Market access may include the roles of developing and implementing commercial and CMS (Medicare & Medicaid) payer strategy, payer account management, developing copay card/patient assistance programs/HUBs/cash pricing, setting product pricing, building/managing account teams, access marketing piece development, etc. At some organizations, it also includes managing the trade function and/or key accounts with warehousing (3PL), wholesalers, distributors, retail chains, networks, hospitals/integrated delivery networks (IDNs), group purchasing organizations (GPOs), etc.

My market access background has mostly been with small or start-up organizations. Often, the head of market access will initially manage all functions and then appoint team members as the coverage improves, sales grow, increased budgets become available, etc.

Ken Abreu

This article is written mainly for the benefit of the smaller organization, but all should be able to take something away from it.

The Market Access Dilemma

Many smaller organizations have limited resources, especially when initially launching a first or new product in the market. Often, they will start with medical and regulatory to get the clinical studies going with the hospital or provider sites. Once the clinicals start to look promising in phase III trials, senior management will then hire a vice president of marketing and/or sales to begin the commercial plan. Usually, 3-6 months from the FDA Prescription Drug User Fee Act (PADUFA) date or commercial launch date, they will hire and train sales representatives. Then, they launch the product with much fanfare.

Things start to pick up and grow for a few months, until they end up hitting the payer “no coverage” wall. Often, it will take a payer one or two quarters to review and decide to cover/not cover and reimburse a new drug. Sometimes, a few claims will slip through and get approved, but once the drug is reviewed, they will stop if it is not covered. Then, eventually and unfortunately, the VPs of marketing and/or sales get the boot, since product sales are not growing.

This can often be avoided or minimized if the market access team can engage with Pharmacy Benefit Managers (PBMs) and payers around six to twelve months prior to commercial launch. In order to decide which payers to focus on, the organization should invest in some research to determine the payer mix, which is the percentage of business that is expected to flow through commercial, Medicare & Medicaid (including Managed Medicare/Medicaid) payers. It is also important to determine if the product will fall under the pharmacy benefit (e.g., a true drug) or the medical benefit side (e.g., for devices, diagnostics, drug/device combinations, etc.).

A reimbursement landscape assessment should also be done early in order to determine the payer mix and market basket in the space and what value your product offers over the competition. You need to also determine the strength and depth of your clinical and cost effectiveness/savings/offset data and if guideline inclusion is necessary to secure coverage. Once you have this, you can determine your positioning strength which will help in determining the potential leverage that you have and the rebating ranges (if you even need to rebate at all – if a unique offering) that you might need to offer. If the drug is a brand, you would at least want to obtain a Tier 3 position to be able to compete with other brands. If the market is heavily genericized, then you might need to try for a Tier 2 preferred position (which will require a much higher rebate). If your product is first-in-class or a rare/orphan drug, you most likely will not need to rebate since the product is unique and fills an unmet need.

If the product is a device or if the pharmaceutical is a diagnostic, it may need to be covered by payers on the medical benefit side. While general pharmaceuticals are mainly managed on the pharmaceutical benefit end, where manufacturers typically engage with pharmacy directors at the PBMs or payers, medical benefit products generally involve dealing with medical directors. Instead of trying to secure a Tier 3 or 2 position, you are shooting to secure both a medical coverage policy and separate reimbursement for the product. So, engaging early with the payers early will help you determine the type of benefit coverage you need and how soon you might be able to obtain coverage/reimbursement and be added to their formulary or coverage list. In some cases, payers add products 1-2 times/year and in others, it might be more like quarterly.

You will need to work cross-functionally with senior management, marketing, medical, legal, finance and others to propose your pricing and net gross-to-net (GTN) cost to bring this product to market while obtaining sufficient coverage.

Three times in my career, I have been hired around 6-12 months after launch, because all the above were not done and sales were low. Twice, I came on board around 6-12 months prior to launch and the outcome was much different and coverage was better from the start.

So, while it may seem premature to hire the market access lead early on, it should pay off at commercial launch if he/she did all of the right things and had enough time to execute effectively.

By starting the access approach prior to launch, you should have a good gauge of coverage expectations for the first year of launch and what is required, based on payer account engagement intelligence. This not only assists in developing the market access plan, but it can also assist the corporate launch plan and help determine when and how to roll out the sales team, payer account team, etc., which optimizes the corporate budget and deploys resources more strategically.

In addition to pre-launch payer engagement, starting ideally within a year of launch, can help with the building of the following that will be needed for providers and payers at launch:

• Developing the comprehensive market access plan.
• Determining the distribution model and partners (e.g., if trade is part of market access).
• Determining the scope, size, and rollout of the sales team with sales operations, sales management, etc. based on anticipated coverage.
• Preparing the value proposition with medical and marketing.
• Developing cost-effectiveness and budget impact models, if necessary.
• Assisting in correct wholesale acquisition cost (WAC) price setting (e.g., vs. competitors, if payer rebates are needed, etc.).
• Building a reimbursement hub, copay card, patient assistance program (PAP), etc.
• Hosting a payer advisory board to gain payer insight on the value of the product/positioning.
• Preparing an academy of managed care pharmacy (AMCP) dossier/formulary kit; provider/payer sales aids and website materials.

All the above and most activities of market access are done on a cross-functional basis, working closely senior management and most departments.

Are all these suggestions necessary prior to launch? No, but it is needed early on, and if not done ideally prior to launch, you will be playing catch up. Again, there is only so much budget, but you can launch without a lot of this and capture some sales or do it the “right way”. In some cases, I worked with companies who agreed to delay commercial launch for 3-6 months to allow me to put some of this in place. The results in the end, were positive, but again, not all organizations have this luxury.

You should at least consider hiring a market access head 8-12 months prior to launch to start the process and payer engagement meetings to start the coverage/reimbursement discussions with the most important payers so that some coverage is obtained close to or at launch or shortly after launch vs. starting after launch. The team can be expanded, step-by-step, after launch, as it will usually take 1-3 years to secure excellent payer coverage - as payers gain claims experience and your organization's value proposition with clinical support further improves over time.

Ken Abreu is a pharma/biotech industry veteran with 23 years of pharma and 20 years of managed markets experience. He was recently a market access leader with GE Healthcare.