Summary
Biologic prior authorizations are uniquely complex because they sit at the intersection of payers, PBMs, manufacturers, and providers. Unlike traditional drugs, biologics often require weight-based dosing, lab values, step-therapy proof, and site-of-care details. With split coverage between pharmacy and medical benefits, providers juggle multiple portals and rework high denial rates. Simplifying this process demands one unified workflow that assembles, validates, and routes requests — reducing denials and speeding patient access to therapy.
The Rising Burden of Biologic Prior Authorizations
Biologics represent some of the most effective and expensive treatments in healthcare today. But getting patients access to them is rarely straightforward.Unlike a typical prescription, a biologic order can trigger dozens of requirements: proof of failed therapies, recent labs, dosing calculations, and payer-specific documentation. For clinics, that translates into 15–20 hours of staff time each week navigating portals, faxes, and follow-ups. For patients, it means waiting weeks or even months before starting therapy.
The Two Paths of Biologic Coverage
One of the biggest sources of complexity is the split between pharmacy benefit and medical benefit:
Pharmacy benefit: Self-injectable biologics, usually managed by PBMs and ePA rails. While digital platforms like ePA exist, denials are still common due to the strict requirements.
Medical benefit: Infused biologics, billed under the medical benefit. These require more detailed documentation (e.g. infusion site, weight-based dosing, clinical notes) and must be submitted to a separate portal for each payer.
Many biologics fall into both categories depending on the payer and site of care. This forces providers to constantly pivot between systems.
We take a deeper dive into the pharmacy vs. medical benefit split, and why it creates so much rework, in our article “Pharmacy vs. Medical Benefit: Why Biologic Coverage Splits Create Delays”.
Why Denials Are So Common
Even with ePA, 20–40% of biologic prior authorizations are denied on first submission. The most commons reasons for denial are missing documentation or mismatched payer rules.
Common triggers include:
Outdated or missing lab results
Incomplete step-therapy history
Incorrect dosing or J-code documentation
Wrong benefit lane (pharmacy vs medical)
Site-of-care restrictions
Every denial means more paperwork, more staff time, and more patient frustration.
"80% of physicians reported that prior authorization can lead to patients completely abandoning a prescribed or ordered course of care. Most alarming, one-third of physicians reported that prior authorization has led to a serious adverse event for a patient in their care. And a serious adverse event is something like hospitalization, permanent impairment or even death.”
- Heather McComas, Director at American Medical Association
The Stakeholder Puzzle in Biologic Access
Biologic access isn’t a straight line between the doctor and the payer. It’s a crowded ecosystem where every stakeholder has its own incentives, portals, and rules.
PBMs build formularies around rebate economics, not just clinical value. A biologic may be “preferred” one year, only to be replaced by a biosimilar the next, forcing providers to restart the PA process and justify therapy switches.
Payers add further complexity through site-of-care restrictions, mandatory renewals every 6–12 months, and step-therapy edits that require patients to fail cheaper drugs before accessing a biologic.
Specialty pharmacies are often mandated, removing provider choice and adding duplicate paperwork to prove eligibility.
Manufacturer hubs provide benefit verification and copay assistance, but every program comes with its own forms, patient consents, and back-and-forth before support can start.
Providers carry financial risk under buy-and-bill models. A single missed or denied PA can translate into thousands of dollars lost in unreimbursed drug costs.
Each stakeholder is optimizing for its own margin or compliance requirement. For clinics, the result is the same: multiple logins, shifting rules, and rework that consumes hours every week.
What “Good” Could Look Like
The industry doesn’t need more portals. It needs a biologics-first workflow that brings everything into one place:
Verify coverage across both medical and pharmacy benefits.
Auto-assemble packets directly from the EHR with labs, therapy history, and clinical notes.
Pre-validate against payer rules before a submission is sent.
Route smartly through ePA rails or medical benefit portals, depending on the drug and plan.
Connect patients to affordability programs without extra forms or calls.
That’s the workflow RUMA is building. For providers, it means less rework and fewer denials. For patients, it means faster access to therapies that can change their lives.
The Bottom Line
Biologic prior authorizations are more complex than any other drug class, with stricter rules, split benefits, and multiple stakeholders. Traditional ePA platforms weren’t designed for this reality.
A biologics-first approach can cut denials, reduce staff burden, and get patients on therapy faster, helping clinics and payers manage cost and access without the friction that defines today’s system.
RUMA is building this future.
Ready to simplify biologic access? Contact us today
