Coverage is not the same as access

The industry often talks about being patient-centric, but cell and gene therapies are forcing a more fundamental question: what does access actually mean? If a patient is technically covered but never receives treatment, access has failed. For decades, market access success has been measured by one dominant metric: covered lives. If a therapy secured favorable formulary placement and broad reimbursement coverage, access teams could declare victory. However, the rapid growth of cell and gene therapies has exposed a hard truth that many in industry have been reluctant to acknowledge: coverage does not equal access.

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The Coverage Win Can Still Fail the Patient

On paper, many advanced therapies enjoy reimbursement pathways that would have been considered extraordinary just a decade ago. Payers recognize the transformative potential of one-time treatments and have shown a willingness to reimburse products with multimillion-dollar price tags. Despite these favorable coverage decisions, patient uptake often falls far below expectations; things fall apart quickly in the complex web of operational, clinical, financial, and patient-level barriers that traditional market access strategies were never designed to address.

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The Real Access Journey Happens After Reimbursement

Consider the journey of a patient eligible for a gene therapy. The therapy may be covered, but does the treating physician know how to identify appropriate candidates? Is the health system equipped to navigate prior authorization requirements? Can the treatment center manage the logistics of administration and follow-up monitoring? Does the patient have the financial resources, transportation, caregiver support, and confidence needed to complete treatment? Every point of friction introduces the possibility that an eligible patient never receives therapy. In this reality, payer coverage is merely the starting point.

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The Metrics Need to Change

This reality has profound implications for how pharmaceutical companies define and measure access. Covered lives remain an important indicator, but they are increasingly disconnected from the outcomes that matter most. A more meaningful set of metrics would focus on patient progression through the treatment journey:

• Identification rates
• Referral completion
• Time to treatment
• Therapy initiation
• Long-term outcomes

These measures provide a far more accurate picture of whether patients are truly benefiting from innovation than any formulary report ever could.

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Alkemi’s Perspective: Market Access Must Move Downstream

The lessons from cell and gene therapy are not confined to rare diseases or advanced therapeutics. They offer a preview of the future for specialty medicines broadly. As healthcare moves toward more outcomes-basedreimbursement, personalized medicine, and more complex treatment pathways,manufacturers will be expected to take greater responsibility for what happens after coverage is secured. Market access teams that remain focused solely on contracting and reimbursement risk finding themselves increasingly disconnectedfrom the factors that determine real-world success.

The next era of market access will belong to organizations that recognize this distinction and build capabilities accordingly. In the years ahead, the most important competitive advantage may not be who wins coverage first, but who can ensure that eligible patients successfully complete the journey from diagnosis to treatment.

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Max Klietmann is VP of Market Access Services at Alkemi, where he helps life sciences teams build payer-ready evidence and access strategies for launch and beyond.

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