LLY

What regulatory or reimbursement hurdles could delay the full rollout of the digital platform and impact sales timelines?

Created August 08, 2025 at 12:41 PM

Regulatory and reimbursement obstacles that could slow the launch of SenderraCare+ (and therefore dampen the sales trajectory of EBGLYSS™)

Below is a systematic rundown of the most common “road‑blocks” that specialty‑pharmacy digital platforms encounter in the United States (and, where relevant, in other major markets). While the press release does not call out any specific barrier, any of the items listed can postpone a full‑scale rollout, push back the date when patients can actually start using the platform, and ultimately compress the revenue window for Lilly’s new atopic‑dermatitis biologic.

1. U.S. Federal Regulatory Hurdles

Area	Why it matters for SenderraCare+	Typical timeline / risk
FDA oversight of software‑as‑a‑medical‑device (SaMD)	If the platform includes clinical decision‑support (e.g., dosing calculators, alerts for missed injections, safety monitoring, or AI‑driven adherence scoring), the FDA may classify it as a medical device (Class II). A 510(k) or de‑novo submission would be required before the software can be marketed to patients.	Review cycles range from 90 days (traditional 510(k)) to 6‑12 months for more novel algorithms. A request for additional data can add further delay.
Cyber‑security & patient‑data protection	The platform must meet HIPAA security and privacy rules. Any breach‑risk assessment, penetration testing, or third‑party vendor audit that uncovers deficiencies must be remediated before the product can be launched.	Remediation can take weeks‑to‑months, especially if a major redesign of data‑handling pipelines is needed.
State pharmacy‑practice regulations	Some states require that any “remote” counseling or medication‑management service be delivered by a pharmacist licensed in that state. The platform’s ability to provide real‑time adherence coaching across all 50 states may need individual board approvals or a “multistate license” arrangement.	Staggered state approvals can stretch rollout over 6‑12 months, with the most restrictive states (e.g., California, New York) often being the last.
Telehealth parity & reimbursement rules	Although the platform is primarily a pharmacy‑centric tool, many states treat it as a telehealth service. If the platform’s video‑consult or messaging components are not covered under state parity laws, patients may have to pay out‑of‑pocket, reducing adoption.	Parity statutes are updated annually; a change in law could require a quick redesign or re‑branding of the service.
Electronic Prior Authorization (ePA) standards	Integration with payer ePA engines (e.g., CoverMyMeds, Surescripts) often requires adherence to HL7 FHIR or other proprietary APIs. Failure to achieve full integration before go‑live means manual prior‑auth work, which erodes the “streamlined” promise and can delay treatment initiation.	Integration testing can take 3‑6 months per major payer, and any change in payer API (common) forces a re‑test.

2. Reimbursement & Payer‑Related Barriers

Barrier	How it impacts the platform rollout & EBGLYSS sales	Mitigation timeline
Formulary placement & tiering	Even if EBGLYSS is FDA‑approved, payers may initially place it on a high‑cost specialty tier or require step‑therapy. Without favorable formulary status, patients (or their insurers) may delay or abandon therapy, nullifying the platform’s “accelerated initiation” promise.	Negotiations with PBMs can take 3‑9 months; a delay in securing “preferred” status compresses the sales window.
Coverage determination for digital adherence services	CMS and commercial payers are still defining CPT/HCPCS codes for “digital health adherence monitoring” (e.g., 98966‑98968 for remote physiologic monitoring). Until a specific billing code is accepted, the platform’s value‑added services may be unreimbursed, leading providers to reject the platform or patients to opt out.	Code adoption typically requires a formal NCCI or CMS rulemaking – a 12‑month cycle.
Medicare Part D “coverage gap” (donut hole) & specialty tier copays	Many AD patients are covered under Medicare Part D. If the specialty drug’s out‑of‑pocket cost remains high, patients may defer starting therapy despite digital support, reducing early‑adoption velocity.	No regulatory fix; requires pricing negotiations or patient‑assistance programs, which themselves need to be cleared with the Office of Inspector General (OIG).
Prior‑Authorization (PA) complexity	Even with a streamlined digital intake, payers may require extensive clinical documentation (e.g., EASI scores, prior treatment failures). If the platform cannot auto‑populate or transmit this data in the exact format the payer demands, manual PA processing will re‑introduce delay.	Mapping to each payer’s PA form can take 4‑8 weeks per payer; changes in payer policy require re‑submission.
Value‑Based Contracting (VBC) negotiations	Payers increasingly demand outcomes‑based contracts for high‑cost biologics. If a VBC agreement is not in place at launch, the payer may limit the number of patients who can be placed on EBGLYSS, slowing overall uptake.	VBC contracts typically require 6‑12 months of data collection and negotiation.
State Medicaid coverage variability	Medicaid programs are state‑run and often have separate prior‑auth pathways and separate reimbursement rates for digital health services. Some states may not reimburse a digital specialty‑pharmacy platform at all, limiting access for low‑income patients.	Requires individual state negotiations; could take 6‑12 months per state.

3. International (EU/UK) Considerations (if SenderraCare+ will be offered outside the U.S.)

Issue	Potential impact
EU Medical Device Regulation (MDR) classification	The MDR treats many health‑IT solutions as Class IIa medical devices. A “conformité européenne (CE)” certificate is mandatory before marketing. The MDR process can take 12‑18 months, especially if a Notified Body requests additional clinical evidence.
UK’s MHRA & NHS Digital Health Technology Assessment (HTA)	The NHS may require the platform to be listed on the Digital Technology Assessment Criteria (DTAC) framework. Absence of a NHS‑approved “digital health product” could preclude reimbursement for the digital component.
Data‑localization & GDPR compliance	The platform must store EU personal data within EU borders (or have appropriate Standard Contractual Clauses). Any breach or non‑compliance can trigger heavy fines and a forced service shutdown.
Reimbursement codes (e.g., German DiGAs, French “Tiers payant”)	To get the digital service reimbursed, a separate health‑app evaluation (e.g., DiGA fast‑track) is needed. This adds 6‑12 months before the platform can be billed to the statutory insurer.

4. Operational & Integration Risks that Translate into Regulatory/Reimbursement Delays

Risk	Why it matters for rollout	Typical mitigation period
Interoperability with EMR/EHR systems	If the platform cannot pull in patients’ diagnostic codes (e.g., L40.81 for moderate‑to‑severe AD) or medication histories, clinicians may be unwilling to trust the enrollment workflow, leading to manual work‑arounds that defeat the “single‑pane” promise.	Integration testing with major EHR vendors (Epic, Cerner, Allscripts) often requires 3‑6 months of sandbox work and a formal “go‑live” certification.
Pharmacy Benefit Manager (PBM) data‑exchange	Real‑time claim adjudication and benefit verification are essential for the “accelerated initiation” claim. If the platform cannot connect to a PBM’s API, enrollment may be delayed until manual verification is completed.	PBM onboarding typically runs 4‑8 weeks per PBM; multiple PBMs increase the timeline.
Patient‑access program (PAP) eligibility verification	Many specialty biologics rely on manufacturer‑sponsored copay assistance. The digital platform must capture eligibility data, upload to Lilly’s PAP portal, and receive a decision in real time. Any mis‑alignment can cause a “gap” between prescription and first dose.	PAP integration often requires a separate contract and data‑mapping exercise (2‑3 months).
Cyber‑risk & third‑party vendor certification	If a cloud‑hosting partner (e.g., AWS, Azure) experiences a breach or fails a SOC 2 audit, the platform must be taken offline for remediation. This can stall a phased launch.	Remediation timelines vary; typical remediation after a failed audit is 30‑90 days.

5. Potential Timeline Scenarios

Scenario	Key bottleneck(s)	Approx. delay to “full‑scale commercial launch”
Best‑case	All SaMD classifications cleared via a streamlined 510(k) (≤90 days), CMS approves a new HCPCS code for digital adherence monitoring, and major commercial payers place EBGLYSS on a preferred formulary tier.	0–2 months after press‑release (i.e., Q4 2025).
Mid‑range	FDA requires additional clinical data for SaMD; CMS takes 12 months to adopt a new code; a few large PBMs delay API integration.	4–8 months (launch pushed into early 2026).
Worst‑case	Platform is deemed a Class II medical device requiring a full pre‑market approval (PMA) plus a post‑market study, while several state pharmacy boards object to out‑of‑state pharmacist counseling; CMS denies reimbursement for digital services.	12–18 months (launch not until late 2026 or beyond).

6. Strategic Recommendations to Reduce Delay Risk

Pre‑emptive FDA SaMD strategy – Submit a “de‑novo” request with a robust usability/clinical‑validation package before public launch. Use the FDA’s “Pre‑Submission” program to get early feedback.
Secure provisional HCPCS/CPT codes – Engage CMS through the “New Technology Add‑On Payment” (NTAP) or “Remote Physiologic Monitoring” pathways to obtain interim billing mechanisms while the permanent code is processed.
Payer coalition – Form a joint “value‑based partnership” with the top 3–4 commercial PBMs and Medicare Advantage plans to lock in formulary placement and digital‑service reimbursement before the platform goes live.
State‑by‑state licensing hub – Partner with a national pharmacy‑licensing service (e.g., the National Association of Boards of Pharmacy) to streamline multistate pharmacist credentialing.
Modular rollout – Deploy the enrollment & benefit‑verification modules first (which are largely regulatory‑free) and add the advanced adherence‑monitoring module later, after SaMD clearance.
Robust data‑privacy framework – Implement a privacy‑by‑design architecture (encryption‑at‑rest, tokenization, audit trails) to satisfy HIPAA, GDPR, and emerging state privacy laws (e.g., California CPRA) in a single effort.
Parallel EU/UK pathway – If the platform is planned for global use, start the CE‑mark and NHS‑DTAC processes now, as they are long‑lead and can be completed while U.S. activities progress.

Bottom Line

While the clinical value proposition of a single‑pane, real‑time digital specialty‑pharmacy experience is strong, regulatory clearance (especially FDA SaMD review), payer reimbursement code adoption, and state pharmacy‑practice licensing are the three highest‑impact obstacles that could postpone a full rollout of SenderraCare+. Each of these categories typically adds 3–12 months of lead time, and any one of them slipping can compress the early‑sales window for Lilly’s EBGLYSS™ launch. Proactive, parallel engagement with the FDA, CMS, major PBMs, and state boards will be essential to keep the platform’s go‑live timeline aligned with the drug’s commercial launch plan.