The case for market access…early and often

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The market access function is important, but in my experience it is often misunderstood and when it should be added to the leadership team and organization can vary widely.

Market Access may include the roles of developing and implementing a CMS (Medicare & Medicaid) business and payer strategy, managing payer accounts, developing copay/patient assistance card programs patients/HUB/cash pricing, setting product pricing, building/managing account teams, access marketing coin development, etc. In some organizations this also includes managing the sales function and/or key accounts with warehouses (3PL), wholesalers, distributors, distribution chains, networks, hospitals/integrated delivery networks (IDNs) , Group Purchasing Organizations (GPOs). ), etc.

I have primarily worked in the area of ​​market access with small organizations or start-ups. Often the Market Access Manager initially manages all functions, then appoints team members as coverage improves, sales increase, larger budgets become available, etc. .

This article is written primarily for the benefit of the small organization, but everyone should be able to get something out of it.

The market access dilemma

Many small organizations have limited resources, especially during the initial launch of a first product or a new product in the market. Often, they will start with medical and regulatory studies to launch clinical studies with hospital sites or suppliers. Once clinical trials begin to show promise in Phase III trials, senior management will then hire a VP of Marketing and/or Sales to begin the business plan. Usually 3-6 months after 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 great fanfare.

Things start to improve and grow for a few months, until they finally hit the payor’s “no coverage” wall. Often it will take one or two quarters for the payer to review and decide whether to cover/not cover and reimburse a new drug. Sometimes a few claims will pass and be approved, but once the drug is reviewed they will stop if it is not covered. Then, ultimately and unfortunately, the VPs of Marketing and/or Sales have the upper hand as product sales do not grow.

This can often be avoided or minimized if the market access team can engage with Pharmacy Benefit Managers (PBMs) and payers approximately six to twelve months before commercial launch. In order to decide which payers to focus on, the organization must invest in research to determine the payer mix, i.e. the percentage of activity that should go through commercial, Medicare, and Medicaid payers (including Managed Medicare/Medicaid). It is also important to determine whether the product will fall under the pharmaceutical benefit side (eg, a real drug) or the medical benefit side (eg, for devices, diagnostics, drug/device combinations, etc.).

An assessment of the reimbursement landscape should also be done early to determine the payer mix and market basket in the space and the value your product offers relative to the competition. You should also determine the strength and depth of your clinical and cost-effectiveness/savings/compensation data and whether inclusion of guidelines is necessary to ensure coverage. Once you have that, you can determine your positioning strength, which will help you determine the potential leverage you have and rebate ranges (if you even need rebate at all – if it’s is a one-time offer) that you may need to offer. If the drug is a brand, you would want at least a level 3 position to be able to compete with other brands. If the market is heavily generic, you may need to try a Tier 2 Preferred Position (which will require a much higher discount). If your product is first-in-class or a rare/orphan drug, you probably won’t need reimbursement since the product is unique and fills an unmet need.

If the product is a device or if the pharmaceutical product is a diagnostic, it may need to be covered by payers on the medical benefit side. While general pharmaceuticals are primarily managed on the pharmacy benefit side, where manufacturers typically engage with pharmacy directors at the PBM or payer level, medical benefit products typically involve dealing with medical directors. Instead of trying to get a level 3 or 2 position, you aim to get both a medical coverage policy and separate reimbursement for the product. So, talking to payers early will help you determine what kind of coverage you need and how soon you might be able to get coverage/reimbursement and be added to their form or list of benefits. cover. In some cases payers add products 1-2 times per year and in others it may be more quarterly.

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

Three times in my career I was hired about 6-12 months after launch, because all of the above was not done and sales were low. Twice I came on board about 6-12 months before launch and the result was very different and the coverage was better from the start.

So, although he may seem premature to hire the Market Access Manager early on, it should pay off in commercial launch if he did all the right things and had enough time to execute effectively.

By starting the pre-launch access approach, you should have a good idea of ​​coverage expectations for the first year of launch and what is required, based on the payer’s account commitment information. This not only helps develop the market access plan, but it can also help the business launch plan and help determine when and how to deploy the sales team, account payer team, etc. , which optimizes the company’s budget and deploys resources more strategically. .

In addition to pre-launch payer engagement, ideally beginning within a year of launch, can help build the following elements that will be needed by vendors and payers at launch:

  • Development of the global market access plan.
  • Determine distribution model and partners (eg if trade is part of market access).
  • Determination of the scope, size and deployment of the sales team with sales operations, sales management, etc. depending on the coverage provided.
  • Development of the value proposition with medical and marketing.
  • Develop profitability and budget impact models, if necessary.
  • Assist in correct wholesale acquisition cost (WAC) pricing (e.g. versus competitors, whether payer discounts are needed, etc.).
  • Build a reimbursement hub, co-pay card, patient assistance program (PAP), etc.
  • Organize a payer advisory council to gain insight from the payer on product value/positioning.
  • Preparation of an Academy of Managed Care Pharmacy (MCPA) dossier/form kit; vendor/payor sales aids and website materials.

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

Are all these suggestions necessary before launch? No, but that is needed early on, and if not done ideally before launch, you’ll be playing catch-up. Again, the budget is limited, but you can launch without much of that and capture some sales or doing it the “right way”. In some cases, I’ve worked with companies that have agreed to delay commercial launch for 3-6 months to allow me to set up some of this. In the end, the results were positive, but again, not all organizations have this luxury.

You should at least consider hiring a Market Access Manager 8-12 months prior to launch to initiate the process and Payer Engagement Meetings to initiate coverage/reimbursement discussions with larger payors to whether some coverage is obtained near or at launch or shortly after launch compared to the start after launch. The team can be expanded on a step-by-step basis after launch, as it typically takes 1-3 years to ensure excellent payor coverage – as payors gain experience with claims and the proposal for your organization’s value with clinical support further improves over time.

Ken Abreu is a pharmaceutical/biotechnology industry veteran with 23 years of experience in the pharmaceutical sector and 20 years of experience in managed markets. He was most recently Head of Market Access at GE Healthcare.

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