Author: Meghna Misra, VP of Product at Claritas Rx
We’ve written a lot about why patient consent breaks down in specialty pharmacy: the state-by-state rules, the hub-to-specialty-pharmacy handoffs, the forms that arrive illegible. This post asks a different question. When consent is captured early and made available across the ecosystem, do patients actually do better?
To find out, the Claritas Rx data science team ran a retrospective analysis across roughly 64,000 patient-brand records from 15 specialty brands in six therapeutic areas. The short answer: consented patients were more likely to get their first fill and more likely to still be on therapy six months later. The longer answer, including where the effect was strongest and where we couldn’t draw conclusions, is below.
How We Set Up the Comparison
The hardest part of measuring consent’s impact is separating it from everything else. Patients who consent may differ from those who don’t in age, coverage, or when they started therapy. So rather than compare broad populations, we built matched pairs.
Each consented (“test”) patient was matched one-to-one with a comparable non-consented (“control”) patient on demographics, payer, and timing. We then compared two outcomes that matter most to brand and access teams:
- Conversion (fill rate): did an enrolled patient actually receive a first fill? We looked at enrollments from about 2013 through June 2024, most of them between 2018 and 2024.
- Persistence: was the patient still on therapy at six months? Because this requires six months of follow-up, it effectively reflects patients who started on or before about December 2023.
The data was de-identified client data spanning multiple therapy areas and manufacturer and hub partnerships. Alongside fill and persistence, the study also tracked consent capture rates and the downstream workflows consent unlocks, such as benefits verification, prior authorization, and financial assistance.
What We Found
Consented patients came out ahead, and the gaps were not small.
| Outcome | Improvement for consented patients | Statistical significance |
|---|---|---|
| First fill rate | +3 to +48 percentage points | All significant (p<0.05), across matched cohorts of 5,556 patients per group |
| 6-month persistence | +8 to +33 percentage points | Large majority significant (p<0.05) |
In total, more than 10 brand and indication combinations showed statistically significant gains in fill rate, persistence, or both.
The range is wide on purpose. It reflects real differences between brands, therapy areas, and patient services models, not a single averaged number. For a brand on the high end, consent may be one of the biggest levers available for getting patients to a first fill. For a brand on the low end, it is still a measurable gain on outcomes that are notoriously hard to move.
Where It Mattered Most, and What We Can’t Say Yet
The strongest effects showed up in immunology and hematology brands. Improvements appeared across multiple therapeutic areas, though, so this is not a single-category story.
We also want to be clear about the limits. Several smaller brands were inconclusive, either because the sample was too small or because there was no valid comparison group. In rare disease especially, small populations make clean matched comparisons hard. An inconclusive result there is not evidence that consent doesn’t matter; it means the data can’t yet answer the question.
This was a retrospective, matched-cohort study, so it shows a strong association between consent and better outcomes, not proof that consent alone caused them. Matching on demographics, payer, and timing removes many obvious differences between groups.
What This Means for Your Program
Consent is usually budgeted as a compliance cost. These results suggest it belongs in the same conversation as first fill and persistence, the metrics brand teams already track.
A few practical questions follow for manufacturers, hubs, and specialty pharmacies:
- Do you know your consent capture rate by brand and by partner? If not, you can’t tell whether a fill-rate gap is an access problem or a consent problem.
- When does consent get captured? Consent collected late, or on paper that never leaves one partner’s system, can’t trigger benefits verification, prior authorization, or financial assistance when they’re needed.
- Can you measure the impact for your own brand? The spread in our results means an industry average won’t tell you much. A matched comparison on your own data will.
Consent Clearinghouse does more than adjudicate consent and expose misalignment between partners. It gives them the means to act on it quickly, so a consent gap gets closed before it becomes a fill-rate gap. That’s the infrastructure behind the patients in this analysis.
Want to see what consent is worth for your brand? Talk to our team, or learn more about Consent Clearinghouse™.
