Launch excellence and market access

The payer holds the money, and often the real power. In the U.S., pharmacy benefit managers (PBMs), the middlemen who negotiate drug coverage for insurers and employers, can decide whether your drug sits on a preferred tier (low patient co-pay) or a punitive tier (high co-pay, prior authorization paperwork). In countries with national systems, a government body may simply decline to fund a drug it judges too expensive for the benefit it delivers.

This is why "the payer is the customer." You can generate all the physician awareness in the world, but if the payer blocks access, prescriptions stall.

Market access, defined

Market access is the discipline of getting a drug reimbursed and available to patients at a viable price. It sits alongside traditional marketing and, at launch, often outranks it.

Market access teams answer questions like:

• Which payers cover our target patients, and what will they demand?
• What price can we defend, and what evidence supports it?
• How do we minimize friction (prior authorizations, step therapy) that discourages prescribing?

In the UK, for example, the National Institute for Health and Care Excellence (NICE) appraises whether the health service should fund a drug based on its cost relative to health gained. A "no" from NICE can effectively close a market. Access teams prepare for that appraisal years in advance.

The value dossier: your evidence, packaged for payers

Physicians respond to clinical data. Payers respond to value: does this drug justify its cost compared to what patients use today?

The value dossier is the document that makes that case. Think of it as the payer-facing argument for your drug's worth. It typically pulls together:

• Clinical evidence: how well the drug works versus the current standard of care, ideally head to head.
• Health economics: models estimating cost per unit of health gained (often measured in QALYs, or quality-adjusted life years, a metric combining how long and how well a patient lives).
• Budget impact: what happens to the payer's total spend if they cover this drug for their population.
• Unmet need: the gap in current treatment this drug fills.

A concrete example of the logic: a drug that costs more per month but keeps patients out of the hospital may be cheaper for the payer overall. That "total cost of care" story is often more persuasive to a payer than efficacy alone.

The lesson for marketers: the evidence a payer needs is not always the evidence a trial was designed to produce. Strong access planning shapes trial design early, so the data exists when the dossier is due.

Health economics and outcomes research (HEOR)

The function that builds the value evidence is HEOR: Health Economics and Outcomes Research. HEOR teams generate the studies and models that populate the value dossier and support payer negotiations.

For a non-technical audience, the key idea is this: HEOR translates clinical results into the language of money and population health, which is the language payers speak. A cardiologist cares that a drug lowers cholesterol. A payer cares how many heart attacks that prevents, and what each prevented event saves.

What a strong launch actually coordinates

"Launch excellence" is a real term of art in pharma, and it means orchestrating many functions to peak at the same moment. A strong launch aligns:

1. Regulatory timing. Marketing cannot promote a drug before approval, and promotion is tightly restricted to the approved label (the official description of what the drug is for). Legal and regulatory review gate nearly every claim.

2. Market access readiness. Value dossiers, payer negotiations, and pricing decisions must be locked before or at launch. Access delays waste the launch window.

3. Medical affairs. These teams share scientific data with physicians and specialists through non-promotional channels, building clinical understanding ahead of and during launch.

4. Sales force deployment. Reps need to reachreachThe number of unique people exposed to your message in a given period. Unlike impressions, reach counts each person once, no matter how often they see it.Voir la définition complète → the right prescribers with an approved message, and know which payers cover which patients.

5. Supply chain. The drug must physically be available. A stockout at launch is a self-inflicted wound.

6. Patient support. Co-pay assistance, adherence programs, and navigation help patients actually start and stay on therapy, especially when prior authorizations create friction.

Miss on any one of these and the others underdeliver. A brilliant campaign fails if the drug is not on formulary. Perfect access fails if the sales force is not trained. Launch excellence is fundamentally a coordination problem.

Launch archetypes: not every launch is the same

The playbook shifts with the situation:

• First-in-class launch: you are creating a new market. The challenge is educating physicians and payers on a problem they may not treat aggressively yet. Access is hard because there is no comparator price.

• Crowded-market launch: several drugs already exist. Differentiation and payer contracting dominate. You may need to offer better net pricing to win preferred formulary status.

• Specialty or rare disease launch: few patients, high price, intense payer scrutiny. Access and patient identification matter more than mass awareness. A small, expert sales effort often beats a large one.

Matching your launch model to the archetype is a core strategic judgment. Spending like a mass-market launch on a rare disease drug wastes money; treating a crowded market like a first-in-class opportunity underinvests in the contracting fight.

A note on regulation and promotion

Everything above happens inside strict rules. In the U.S., promotional claims must be consistent with the approved label and fairly balanced with risk information. The FDA's Office of Prescription Drug Promotion oversees this. Value dossiers shared with payers follow their own evidence standards. Marketers in pharma work hand in glove with legal and regulatory colleagues, not around them.

This is why pharma marketing is a specialist discipline. The creative freedom of consumer marketing does not exist here, and pretending otherwise creates real legal risk.

Key Takeaways

• Approval is not access. A drug that the FDA clears can still fail if payers refuse to reimburse it. Getting paid is a separate, equally hard job.

• The payer is frequently the real customer. Insurers, government bodies, and PBMs decide coverage and pricing, so market access often outranks traditional awareness marketing at launch.

• The value dossier translates clinical benefit into payer language: money and population health. Plan the evidence early, because trials must be designed to produce it.

• Launch excellence is coordination, not campaign. Regulatory, access, medical affairs, sales, supply, and patient support must peak together within a short, unrecoverable window.

• Match the launch model to the archetype. First-in-class, crowded-market, and rare-disease launches demand different balances of education, contracting, and targeting.