New Drug Launches: Preventing Fires Before They Start

By Liza Revelo, MBA

Founder, PharmaARMs

A new drug launch is often described as an exciting milestone.

After years of research, clinical development, regulatory review, planning, and preparation, a new therapy becomes available. There is real energy around the possibility of giving healthcare providers another option for appropriate patients.

But anyone who has supported a launch from the access and reimbursement side understands an important truth:

FDA approval is the beginning of the launch—not the end of the work.

The first days and months of launch can be some of the most rewarding, demanding, and frustrating moments for everyone involved. Sales teams, leaders, and Access & Reimbursement Managers may all be working toward the same overall purpose: helping appropriate patients access a newly available therapy. Yet each group has different responsibilities, sees different challenges, and experiences the launch differently.

A strong launch culture focuses on preventing fires rather than spending every day reacting to them.

That means frequent collaboration, early communication, and proactive planning. It means teaching ARMs to anticipate where access barriers may occur before the first denial, claim rejection, or urgent call from a provider office. It also means working together—within appropriate roles—to support provider awareness of the therapy and help facilitate access before something goes wrong.

Approval Does Not Automatically Equal Access

FDA approval means the agency has reviewed the product’s evidence and determined that its benefits outweigh the known risks for the approved use. The FDA-approved prescribing information provides the foundation for how the product can be promoted and discussed. FDA: Drug Development and Approval Process

However, approval does not mean every payer has an immediate coverage policy, every provider office knows the process, or every operational pathway is ready on day one.

Coverage can vary by payer, benefit, plan, site of care, provider type, patient eligibility, and clinical criteria.

For Medicare, coverage must fit within a benefit category and generally meet the “reasonable and necessary” standard. CMS may establish National Coverage Determinations, while Medicare Administrative Contractors may develop Local Coverage Determinations that apply within their respective jurisdictions. The National Coverage Determination process generally takes nine to twelve months after CMS formally accepts a request. CMS: Medicare Coverage Determination Process, CMS: NCD Process Timeline

For Medicare Part D products, plan sponsors develop formularies subject to CMS review, and individual plans may have different coverage requirements, utilization-management criteria, and exception processes. A coverage determination may include a decision about payment for a prescription drug, a formulary exception, or the amount a beneficiary must pay. CMS: Formulary Guidance, CMS: Coverage Determinations

In short, a product can be approved, available, and clinically meaningful while the access pathway is still taking shape.

That is where the intensity of launch begins.

One Launch, Different Accountabilities

A launch involves many teams working toward the same broad purpose, but they do not experience the launch in the same way.

Field sales teams are generally responsible for appropriately educating healthcare professionals about the product within the approved label and company policy. These are regulated promotional interactions. FDA oversight includes sales-representative presentations, and prescription-drug promotion must not be false or misleading and must appropriately present both benefit and risk information. FDA: Drug Promotion

Sales professionals may focus on provider education, account awareness, identifying questions, and helping healthcare professionals understand where a new therapy may fit for appropriate patients.

Senior leaders have a wider view. They are responsible for launch strategy, organizational readiness, resource allocation, training, cross-functional alignment, risk management, and the long-term sustainability of the launch.

Middle leaders translate strategy into day-to-day execution. They help teams prioritize, recognize field trends, identify what needs to be escalated, remove barriers where possible, and maintain focus during an intense period.

And then there are the ARMs.

ARMs often work in the space between the excitement of a launch and the reality of access. They may hear that a provider is ready to prescribe while the office is still trying to determine the benefit pathway. They may receive questions from a financial counselor before a payer has published clear criteria. They may support a specialty pharmacy, infusion center, or practice administrator that is working through a new process in real time.

None of these perspectives is wrong. They are simply different.

The Tension Is Usually About Timing

At launch, sales teams may naturally focus on provider awareness and appropriate adoption. Leadership may focus on readiness, execution, resource deployment, and the overall trajectory of the launch.

The ARM is often focused on a more immediate question:

“Can this office successfully navigate the access process for an appropriate patient today?”

That difference in timing can create friction.

A provider may be interested in prescribing immediately. The sales representative may have appropriately educated the provider on the product. But the ARM may still need to help the office understand whether the product is expected to process under the medical or pharmacy benefit, whether prior authorization is required, whether payer criteria are available, whether the site is operationally ready, or whether the dispensing pathway has been established.

From the outside, that may look like a delay.

From the ARM’s perspective, it is responsible launch support.

The ARM is not trying to slow momentum. The ARM is helping make sure that momentum is realistic, compliant, and sustainable.

Preventing Fires Is Better Than Putting Them Out

Many difficult launch issues are predictable.

Provider offices will have coverage questions. A therapy may have different medical- and pharmacy-benefit pathways. A payer may require prior authorization, supporting documentation, or an exception request. Offices may need to understand specialty-pharmacy requirements, site-of-care expectations, coding and billing processes, or patient-support resources.

The question is not whether these challenges can happen.

The question is whether the team identifies them early enough to prepare.

A proactive ARM does not wait for the first rejection to ask how a payer processes a product. They do not wait for an office to become frustrated before confirming whether the team has the appropriate resource. They do not wait until a patient is ready to start before determining whether the site understands the expected pathway.

Instead, they collaborate early.

They ask thoughtful questions. They listen for operational concerns. They identify accounts that may need support first. They recognize patterns across their territory. They share field insights with leadership and cross-functional partners before a small issue becomes a recurring barrier.

This is not about trying to control every outcome. Payer decisions, provider decisions, and patient-specific circumstances are often outside an ARM’s control.

It is about reducing avoidable surprises.

A proactive approach may include:

• Understanding the expected medical- and pharmacy-benefit pathways.

• Monitoring published payer policies and identifying gaps that require clarification.

• Helping offices understand the appropriate process before an initial submission.

• Identifying operational questions early, including dispensing, site of care, administration, billing, and documentation needs.

• Making sure the team knows when and how to use approved resources.

• Escalating recurring barriers early so leadership can assess trends and support broader solutions.

• Collaborating appropriately with sales and internal partners while respecting each role and compliance boundaries.

When this happens well, the field is not simply reacting to access issues. It is preparing for them.

The Value of Discovery Questions

A proactive launch approach is not just about identifying the issue that was presented. It is about asking enough thoughtful, open-ended questions to understand the full access and operational picture.

Often, a provider office may describe a concern as a single problem:

“We are waiting on coverage.”

But when an ARM uses appropriate discovery questions, the underlying issue may be more complex. The office may be unclear about the expected benefit pathway. The prior authorization may be incomplete. The correct payer contact may not have been identified. The site may have questions about specialty-pharmacy coordination, product acquisition, coding, billing, administration, or documentation requirements.

The stated issue may be real—but it may not be the only issue.

This is where strong ARM support becomes especially valuable. Rather than immediately responding to the surface-level question, an ARM can use a needs-assessment mindset to explore the process more fully.

Examples of appropriate discovery questions may include:

• “Can you walk me through the steps the office has completed so far?”

• “Has the team confirmed whether this is expected to process under the medical or pharmacy benefit?”

• “What feedback, if any, has the payer, specialty pharmacy, or dispensing channel provided?”

• “Is there a specific point in the process where the office is becoming stuck?”

• “Has the site previously obtained, administered, or billed for a therapy through a similar pathway?”

• “What information or process would be most helpful for the team to clarify next?”

These questions are not intended to interrogate the office or delay action. They are designed to help identify the root cause of a barrier before it becomes a larger problem.

Sometimes, that conversation uncovers an unmet operational need that may not have appeared in the original request. Other times, it creates a timely education opportunity—for example, clarifying how the benefit pathway works, explaining what documentation may be required, or helping the office understand the appropriate resource or escalation process.

This is one reason proactive collaboration matters so much during launch. An ARM who asks thoughtful discovery questions may identify future barriers before they affect the next patient, the next referral, or the next prior-authorization submission.

In access and reimbursement, the first question is often only the starting point.

The real value comes from respectfully digging deeper, understanding the workflow, and helping the office prepare for what may come next—while staying within appropriate role, policy, and compliance boundaries.

The ARM’s Launch Experience

For ARMs, launches can be both energizing and frustrating.

The work is meaningful because an ARM may help provider offices move from uncertainty to clarity. But the role can also be difficult because the ARM is often close enough to see an access barrier without being the person who controls the decision.

ARMs do not write payer policies. They do not make coverage determinations. They do not make treatment decisions. They cannot promise approval or guarantee a timeline.

What they can do is help offices navigate the appropriate process.

That may include helping an office consider questions such as:

• Is this expected to process under the medical or pharmacy benefit?

• Has the payer published a coverage policy or utilization-management requirement?

• Is prior authorization, an exception request, or supporting documentation needed?

• Does the site have the operational capability to obtain, administer, store, bill for, or monitor the product?

• Is there an appropriate specialty-pharmacy, distributor, hub, or site-of-care process to confirm?

• What should be clarified with the payer, pharmacy, provider, or internal support channel?

For Medicare Part D, CMS notes that formulary-exception requests require a supporting statement from the prescriber showing that the request is medically necessary. CMS: Exceptions

This is why a good ARM does not simply say, “It should be covered.”

A good ARM says:

“Let’s identify the benefit pathway, review what the payer or dispensing channel requires, and make sure the office has the appropriate information for the next step.”

That is not a promise. It is practical, compliant, professional support.

The Leadership Responsibility: Prepare Teams for Reality

Leadership has a responsibility to create a launch environment where teams are prepared for reality—not just prepared to deliver a launch plan.

That means giving the team accurate training, approved resources, clear communication pathways, and a practical understanding of what may still be unknown.

It also means giving people permission to say:

“I do not know that answer yet, but I will help identify the right next step.”

That is not a weakness. It is responsible support.

A strong leadership culture helps teams distinguish among what is known, what may vary by payer or site of care, what is still evolving, and what should be escalated.

It also makes it safe for ARMs to surface barriers early. An access issue should not be viewed as negativity or resistance. It may be important launch intelligence.

If multiple offices are asking the same question, if a payer requirement is creating confusion, or if a site-of-care process is not working as expected, the team needs to know. Those insights can lead to stronger training, better resources, clearer communication, and more thoughtful cross-functional planning.

Compliance Does Not Pause During a Launch

Launch urgency can create pressure to solve every problem quickly. That is exactly when professional judgment matters most.

For example, financial-support discussions involving federal healthcare-program beneficiaries must be handled carefully and in accordance with company policy and applicable law. The federal Anti-Kickback Statute prohibits knowingly and willfully offering or receiving remuneration to induce or reward referrals or business reimbursable by federal healthcare programs. HHS OIG: General Fraud and Abuse FAQs

Some therapies may also have an FDA-required Risk Evaluation and Mitigation Strategy, or REMS. These are safety programs that can include requirements beyond the prescribing information to help ensure the benefits of a drug outweigh its risks. FDA: REMS FAQs

Compliance requirements are not obstacles to launch success. They are part of responsible launch execution.

The most valuable support is not the fastest answer. It is the accurate, compliant, appropriately scoped answer.

What Strong Launch Teams Do Differently

The best launch teams do not ask, “Whose goal matters most?”

They ask, “What does each team need to do well so the launch can progress responsibly?”

Sales teams need clear, compliant product education and a strong understanding of when to involve access support.

ARMs need timely information, realistic expectations, approved resources, clear escalation pathways, and leadership support when access processes have not yet caught up with clinical interest.

Middle leaders need visibility into recurring field barriers so they can prioritize training, communication, and cross-functional solutions.

Senior leaders need to recognize that early launch friction is not always a performance issue. Sometimes it is a critical signal about payer readiness, operational complexity, field training needs, or gaps in the support model.

The strongest launches are not necessarily the ones where every question has an immediate answer.

They are the launches where teams communicate early, respect one another’s roles, stay within appropriate boundaries, escalate responsibly, and keep the provider-office experience at the center of the work.

Final Thought

A new drug launch is intense because people care deeply about getting it right.

Sales teams want providers to understand a new treatment option. Leaders want the organization to execute well. ARMs want provider offices to have a clear, compliant, workable path to access.

Those goals are not in conflict when an organization recognizes the value each team brings.

The leadership challenge is to create an environment where urgency does not become pressure to overpromise, and where access barriers are treated as information to solve—not obstacles to ignore.

When ARMs are encouraged to collaborate frequently, think ahead, communicate early, ask the right discovery questions, and look for potential barriers before they become urgent problems, the team does more than reduce launch-day stress.

It helps prevent fires before they start.

This article is for educational purposes only and is not legal, regulatory, reimbursement, clinical, or patient-specific advice. Requirements, policies, and processes vary by product, payer, setting, and jurisdiction.

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Liza Revelo, MBA, is the founder of PharmaARMs.com, a community and resource hub dedicated to supporting pharmaceutical reimbursement professionals with practical insights, tools, and peer connection.