Medical innovation is giving patients more options for how their conditions are treated. Recent FDA approvals span cardiovascular disease, Alzheimer’s disease and thyroid eye disease, with advances that include a first-of-its-kind oral therapy and a new way to receive an existing treatment. These developments are encouraging, but a new treatment can benefit patients only if they can access it. As medicine advances, insurance coverage and utilization management policies must be prepared to keep pace.
More Choices for Patients
For patients with high cholesterol, the FDA recently approved the first oral PCSK9 inhibitor. These therapies have traditionally been administered by injection, but the new once-daily pill gives appropriate patients another way to receive treatment while targeting the same pathway as injectable PCSK9 medications. This new method of administration provides more ease for patients who need it.
Treatment delivery is also evolving in Alzheimer’s disease. The FDA approved lecanemab-irmb, a subcutaneous formulation of lecanemab for initiation treatment in early Alzheimer’s disease. The option allows treatment to be administered through a weekly injection rather than relying solely on intravenous infusions.
Patients with thyroid eye disease, who have historically only had one treatment available, now have another treatment option that can be used regardless of disease activity or duration. The treatment is administered through five intravenous infusions over 12 weeks.
These approvals are different in important ways, but each expands the choices clinicians and patients can consider when determining an appropriate course of treatment.
Progress Requires Access
More treatment choices can give clinicians greater flexibility to account for a patient’s condition, medical history and individual needs. Different routes of administration may also matter for patients who have difficulty traveling to infusion centers, using injectable medications or incorporating treatment into their daily lives.
But FDA approval does not automatically translate into patient access. Formulary exclusions, prior authorization, step therapy and other coverage requirements can determine whether patients are able to benefit from a new therapy. New methods of administering medication can also improve adherence in many patients.
Coverage decisions should recognize that innovation is not limited to entirely new mechanisms of action. A new formulation, route of administration or treatment schedule can also meaningfully change the patient experience.
The recent wave of approvals offers a glimpse of what continued medical innovation can bring. Policymakers and insurers now have an important role to play in ensuring coverage policies evolve so that scientific progress can become meaningful progress for patients.
