Coledy

Problem

The problem: oral solids leave no record

Why the largest delivery route is the one with no dose-level record, what that costs, and who carries the cost.

01

No dose record

01.1

Oral Solids, 85% of All Prescriptions: Digital Blind Spot

Stock photo

Oral solids are the largest delivery route by prescription volume — and the one with no dose-level record. Inhalers and injectables can be metered; a bottle releases nothing countable.

A digital blind spot

The category is still open

Share of prescription volume
Oral solid dosage85%
Respiratory10%
Injectables5%

Shares are of prescription volume, not revenue — injectables take a far larger revenue share on under 5% of scripts. Source: IQVIA Global Use of Medicines (2024 basis); AAM US Savings Report (2025/2026); MarketsandMarkets (2024)

01.2

$528B Medication Failure: Led by Non-Adherence

Cost of medication failure in the U.S., each year
$354B$174B
  • Non-hospital services $354B
  • Avoidable hospitalisations $174B
275,000+preventable deaths every year in the U.S. alone

Recall bias and misreporting leave patient journals unreliable for clinical decisions.

Limitation of existing data — indirect estimation fails to capture the actual loss.

Legacy adherence data cannot be trusted — the deck's comparison
Self-reporting63%
Pharmacy claims53%
Manual tablet counting26%

Source: Watanabe, McInnis, and Hirsch, Annals of Pharmacotherapy (2018); CDC MMWR (2017); PQA Adherence Standards (2024/2025)

01.3

Non-Adherence Drains Over $300B in Pharma R&D

Where the $300B+ a year goes
Direct trial cash waste$180B
Opportunity cost of capital$90B
Patent exclusivity decay$30B

Wide σ hides the effect

Clinical variance: non-adherence inflates σ, masking efficacy and driving false-negative trial failures.

Delay eats the patent

Adherence-driven delays consume the 20-year patent life before approval.

Source: Tufts CSDD Study and Watanabe (2018) | Pharmaceuticals (2026).

01.4

Why the Connected-Inhaler Layer Stalled at 0.4%

The nearest precedent — a sensor clipped to a metered inhaler — counted two ways. The second number is the one that matters, and the reasons it stayed small are structural.

8.6%of inhaler drug value is 'smart' — $3.0B of $34.9B, counting the drug inside the inhaler
~0.4%device-layer revenue after 20 years — about $100M against $34.9B. This is the layer a sensor sells in.
Why it stalledWhat is different on oral solids
The drug could not carry a device price. A cheap inhaled generic has no margin for a sensor, and no adherence measure paid for one.Two funding routes exist, and the drug screen requires one of them: a manufacturer whose therapy is lost when a dose is missed, or a payer already scored on the measure.
No payer measure reached an inhaler. The party that gains from adherence was not the party the sensor was sold to.Medicare Part D's adherence measures are oral diabetes agents, RAS antagonists and statins — every one an oral solid. There is no inhaler adherence measure. This is published and structural.
An actuation is not a dose. Counting a press proved possession, never intake.A tablet verified as it leaves the bottle, one at a time, is a closer proxy — close enough to write an outcome-based contract on. It is still not proof of swallowing, and we do not claim it is.

Sources: Data Bridge (respiratory inhalers, $36.4B, 2024); smart-inhaler market $3.0B; device-layer revenue estimated from disclosed vendor accounts; CMS Part D Star Ratings measure specifications. For measurement year 2026 CMS weights the three adherence measures at 1×.

02

Cost & value

02.1

Who Is Left Holding the Cost of a Missed Dose

Every One of the 28 Has Someone Who Pays

The 28 therapies split three ways — not by disease, but by what one missed dose costs and who ends up paying it.

0.83M

A · Therapy loss

Left holding it: the manufacturer

Oncology, HIV, pulmonary arterial hypertension. A missed dose costs the therapy itself — resistance, progression, cycling toxicity.

3.2M

B · Acute event

Left holding it: the payer

CNS and psychiatry, transplant, cardiology. A missed dose becomes an event: a relapse, a rejection, an admission.

51.4M

C · Aggregate cost

Left holding it: the payer

Statins, RAS antagonists, oral diabetes agents. No single missed dose matters; the accumulation does — and all three Part D adherence measures sit here.

Figures on each card are U.S. patient treatments a year, counted per drug.

Two funding routes, never zero. A manufacturer whose therapy is lost when a dose is missed, or a payer already scored on the measure. A drug with neither is not on this list — that is what the screen tests for, and why the list is 28 and not 2,800.

02.2

What Non-Adherence Costs Across the 28 Therapies

Claims call 30% of insured U.S. hypertension patients non-adherent. Blood and urine assay put it at 40–60%. The 10–30 point gap is people who FILLED the prescription and did not take it, counted as adherent by every figure above. The comparison group is contaminated, so each number is pushed toward zero. At the low end of the gap Group C alone is $45.9B, not $30.6B.

Hypertension non-adherence, by how it is measured
Insurance claims30%
Blood and urine assay40–60%

CNS drugs only — 2.19M of the 3.2M. Annual cost, adherent versus not, from a 13,007-patient Medicaid cohort where just 25.7% were adherent.

Days never dispensed. The maker is paid for the days that are — the loss is the gap, not the whole year.

Sources: Roebuck et al., Health Affairs 30(1) 2011 (C). Medicaid oral-atypical-antipsychotic cohort, 13,007 patients (B). A is priced off days not covered, from the portfolio pages’ per-drug counts and costs and a pooled oral-oncology adherence of 84%. The claims-versus-assay gap comes from LC-MS/MS studies in uncontrolled-hypertension clinics, so the low end is used.

02.3

Key Value Drivers: Pathways to Payer Cost Reduction

Verified adherence pays back through five mechanisms — each a claim the payer stops paying.

MechanismWhat non-adherence causesClaim avoidedDrugs in the portfolio
Resistance & therapy failureGaps let the virus or tumour escape the drug, burning an expensive line of therapy.Salvage therapy and next-line switchingBiktarvy · Venclexta · Tagrisso · Vemlidy
Relapse, flare and crisisInterrupted control brings the disease back as an acute episode.ER / ICU admissions, transfusionsRexulti · Latuda · Opsumit · Xeljanz · Keppra
Return on a high-cost therapyThe payer has already bought the drug — only adherence makes it work.Paying for a therapy that failsBiktarvy · Dovato · Lynparza · Venclexta · Gleevec
Irreversible organ damageSilent progression turns into lifelong, high-cost care.Transplant, dialysis, disability claimsEnvarsus XR · Januvia · Crestor · Vemlidy
Aggregate claims at mass scaleCheap drugs, very large populations — small adherence gains move total spend.Aggregate CV and stroke claimsLipitor · Eliquis · Plavix · Crestor · Brilinta · Januvia

Every drug in Groups A, B and C maps to one of these five. The per-drug tables that follow carry the same driver in their last column, so a payer can trace any line item back to the claim it removes.

02.4

The Value Engine: Aligning Pharma, Payer, and Patient Incentives

Stock photo

One Record, Four Stakeholders, Four Reasons to Want It

Three buyers pay, and the regulator gains without paying — only three of the four are customers.

Payer

Pays

U.S. insurers, government, PBMs

  • Star Ratings — up to a quarter of the rating
  • Targets members near the 80% cliff
  • Explains hospital days claims cannot

Pharma

Pays

Drug manufacturers

  • Persistence — more refills per patient
  • Non-adherers excluded from rebates
  • RWE from trial through to launch

Patient

Pays, where a plan passes savings on

Care recipient

  • Real-time support, not memory
  • Copay could fall when a verified score clears a bar — but it needs a value-based design clause, and none exists yet

Regulator

Gains without paying

Policy and review

  • Tamper-evident dispense records
  • Prevention of drug diversion
  • National-scale data infrastructure

02.5

Target Payers & Value Propositions

Three buyers, different economics — and in all three pharma buys persistence, plans buy avoided admissions, and the record is what makes either provable.

Pharma-funded

Pharma

Groups A & B · branded specialty

Persistence — holding a patient on a branded therapy for longer is revenue the maker keeps. Under outcomes contracts, verified adherence also excludes non-adherent patients from the rebate.

Plan-funded

Health plans

Group C · mass chronic

Avoided admissions are the bigger prize; Star Ratings are the bankable entry — three Part D measures and a 5% quality bonus at four stars, bought for members near the 80% cut point.

Upside

Regulators & consumers

Diversion, REMS, D2C

Tamper-evident dispense records for controlled drugs, funded from REMS and regulator budgets; direct-to-consumer for supplements and oral GLP-1.

The payer's value loop Verified dose event › real-time miss detection › intervention › avoided cost Coledy's product is the loop itself, not the measurement that feeds it.

Inquiries

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