Prescribing guide
Jascayd (nerandomilast)Dosing with pirfenidone or nintedanib, CYP3A interactions, monitoring and prior authorization criteria for idiopathic pulmonary fibrosisFor prescribers and their offices treating idiopathic pulmonary fibrosis (IPF): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS; a medication review for pirfenidone, nintedanib and CYP3A inhibitors or inducers, the Prescription and Patient Support Program Enrollment Form through CoverMyMeds or fax, and prior authorization.
Example PA threshold
FEP example: age 18 or older, %FVC or %DLCO 90% predicted or lower, FEV1/FVC 70% or higher, definite or probable UIP on HRCT, no known cause, pulmonologist, drug interaction assessment.
Monitoring
No required laboratory monitoring; diarrhea mostly in the first 3 months and most frequent with nintedanib, weight and appetite, mood, and pregnancy.
Support line
CareConnect4Me, 1-844-527-2293, enrollment fax 1-866-725-7218 (CoverMyMeds), copay as little as $0 for commercial plans, Bridge Program free 30-day supply plus 1 refill during payer delays, BI Cares Foundation free drug for eligible uninsured or underinsured.
Give your patient their plan
A one-page handout for starting Jascayd, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/jascaydBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| No REMS | The label and the FDA approval letters set no REMS. The label has no boxed warning, no contraindications and no Warnings and Precautions section. | FDA label |
| Medication reconciliation | Record background pirfenidone or nintedanib, strong CYP3A inhibitors, and strong or moderate CYP3A inducers before choosing the dose. The FEP policy also requires a documented drug interaction assessment. | FDA label |
| Enrollment form | One JASCAYD Prescription and Patient Support Program Enrollment Form prescribes and enrolls in CareConnect4Me. Submit online through the CoverMyMeds HCP portal, or fax to CoverMyMeds at 1-866-725-7218 or directly to the specialty pharmacy. The patient must check the box to enroll. | Access for Jascayd |
| Specialty pharmacy | Boehringer lists Accredo (866-344-4874), Walgreens Specialty (800-445-3674), CenterWell (855-425-3994), CVS Specialty (800-506-5276), Optum Specialty (855-312-9074) and Orsini (847-239-5646) as partners. | Access for Jascayd |
| Bridge for payer delays | The JASCAYD Bridge Program supplies a free 30-day supply and up to 1 additional 30-day refill to patients enrolled in CareConnect4Me with specialty drug coverage. The access page states a delay of at least 5 days; the CareConnect4Me footnote states 7 calendar days or more, a denial appealed within 30 days, or a coverage lapse. | Access for Jascayd |
| PA tools | Boehringer posts an IPF prior authorization checklist, letter of medical necessity, appeal and formulary exception templates, and a prior authorization guide. Reimbursement and Access Associate Directors help office staff with the fulfillment process and payer issues. | Access for Jascayd |
| Medicare patients | The Copay Program excludes government plans; CareConnect4Me points Medicare Part D patients to the Medicare Prescription Payment Plan and to the RE Assist tool for third-party foundations. | CareConnect4Me |
| Case manager | CareConnect4Me assigns a case manager as the office's point of contact for benefits verification and Bridge or Copay enrollment, and a patient navigator for the patient. | Support services |
Prior authorization criteria and what to document
One public policy as the example: Blue Cross Blue Shield Federal Employee Program, April 1, 2026. Approval 6 months for the first approval, then 12 months at a time. Renewal needs the prescriber's assessment that it is helping, by slowed lung function decline, no worse cough or shortness of breath, or a better sense of well-being, plus a drug interaction assessment. The FEP committee approved this version on March 6, 2026, and it took effect April 1, 2026. Its web address sits in fepblue.org's October 2026 policy folder. It cites the December 2025 label, so it predates the August 2026 change for moderate CYP3A inducers. The March 2026 review says it removed dual PA medications for IPF. Other plans set their own criteria and their own approval lengths for Jascayd. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age | 18 years of age or older | Date of birth on the request | FEP Blue policy |
| Idiopathic diagnosis | No identifiable cause for pulmonary fibrosis, confirmed by physical exam, PFTs and HRCT | Exam note and exclusion of known causes | FEP Blue policy |
| Lung function | %FVC ≤ 90% of predicted OR %DLCO ≤ 90% of predicted, and pre-bronchodilator FEV1/FVC ratio ≥ 70% | Pulmonary function report with date | FEP Blue policy |
| Imaging | HRCT with definite or probable findings of UIP | HRCT report | FEP Blue policy |
| Prescriber | Prescribed by or recommended by a pulmonologist | Specialty on the request, or the consult note | FEP Blue policy |
| Interactions | Drug interaction assessment has been performed by the physician | Medication list with the assessment noted | FEP Blue policy |
| Renewal | Prescriber assessment that the drug is helping by at least one of slowed decline of lung function, improved or no decline in cough or shortness of breath, or improved well-being, plus a repeat interaction assessment; initial approval 6 months, renewal 12 months | Serial FVC or DLCO and symptom notes | FEP Blue policy |
Jascayd dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 onward | 18mg twice daily, approximately 12 hours apart, with or without food; no titration. Maximum 18mg twice daily. A 60-tablet bottle is a 30-day supply. | FDA label |
| Intolerance | Reduce to 9mg twice daily if 18mg twice daily is not tolerated, except with concomitant moderate CYP3A inducers or pirfenidone. | FDA label |
| With pirfenidone | 18mg twice daily; do not reduce to 9mg. Pirfenidone decreased nerandomilast Ctrough,ss by about 50%, and efficacy was not observed with 9mg twice daily plus pirfenidone in FIBRONEER-IPF. No clinically significant change in pirfenidone PK was seen. | FDA label |
| With nintedanib | No dose change; no clinically significant change in nerandomilast Ctrough,ss or in nintedanib PK. The 18mg result was consistent with the overall population in the nintedanib subgroup. | FDA label |
| Strong CYP3A inhibitors | 9mg twice daily. No change for moderate or weak inhibitors. | FDA label |
| Before August 2026 | The February 2026 label said to avoid moderate and strong CYP3A inducers and listed pirfenidone as the only exception to the 9mg reduction. | Earlier FDA label |
| Missed dose | Take the next dose at the next scheduled time; do not make up a missed dose. | FDA label |
| Dysphagia | Disperse an uncrushed tablet in about 100mL of non-carbonated room temperature water, stir 15 to 20 minutes, drink within 2 hours, then rinse with about 100mL and drink. | FDA label |
Monitoring the Jascayd label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| First 3 months | Diarrhea | 42%, 31% and 17% on 18mg, 9mg and placebo overall; with nintedanib 62%, 50% and 28%; with pirfenidone 24% (18mg) and 8%; with neither 26%, 17% and 8%. Mostly mild to moderate, generally within the first 3 months. | FDA label |
| Discontinuation | Adverse reactions | 15% on 18mg, 12% on 9mg, 11% on placebo; diarrhea was the leading cause at 6% and 2%, and 13% on 18mg with nintedanib. No diarrhea discontinuations with pirfenidone. | FDA label |
| Ongoing | Weight and appetite | Weight decreased 11% against 8%, and 16% against 12% with nintedanib; decreased appetite 9% against 5% | FDA label |
| Ongoing | Mood | Depression, including suicidal ideation, 12% against 10%; FIBRONEER-IPF excluded severe depression or suicidal behavior or ideation | FDA label |
| Less common | Asthenia, amylase increased, vasculitis | 5% against 2%, 1% against 0%, 1% against 0% on 18mg | FDA label |
| Any time | Pregnancy | Rat embryo-fetal loss at about 5 times the MRHD; advise of the potential risk of fetal loss and to report pregnancy | FDA label |
Jascayd drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Pirfenidone | Ctrough,ss down about 50%. Keep 18mg twice daily; 9mg showed no efficacy with pirfenidone in FIBRONEER-IPF. | FDA label |
| Nintedanib | No clinically significant PK interaction either way; diarrhea more frequent (62% against 28% on placebo at 18mg). | FDA label |
| Strong CYP3A inhibitors | Itraconazole raised Cmax 1.3-fold and AUC 2.2-fold. Reduce to 9mg twice daily. | FDA label |
| Strong CYP3A inducers | Carbamazepine cut Cmax 31% and AUC 51%, with Ctrough,ss predicted down about 70%. Avoid. | FDA label |
| Moderate CYP3A inducers | Bosentan cut Cmax 15% and AUC 41%, with Ctrough,ss predicted down about 58%. Keep 18mg twice daily; do not reduce to 9mg. | FDA label |
| Renal and hepatic impairment | No change for eGFR 15 or higher or Child-Pugh A or B; not recommended with eGFR below 15 or Child-Pugh C. | FDA label |
| Open FDA commitment | The October 2025 approval letter lists a dedicated pirfenidone DDI trial (PMC 4912-1), with trial completion scheduled for March 2027. | FDA letter |
| Inducer commitment | The August 14, 2026 S-002 letter approved the moderate inducer dosing from 2 DDI trials (1305-0113 and 1305-0119) and records PMC 4912-2 as fulfilled. | FDA letter |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedThe FEP policy asks for age 18 or older, a pulmonologist, lung function tests and a CT scan showing definite or probable usual interstitial pneumonia. It also asks for no known cause of the fibrosis and a documented drug interaction check. The office sends the lung function and CT reports along with the request.
- The lung function numbers do not match the policyThe FEP policy asks for an FVC or DLCO of 90% of predicted or lower, with a pre-bronchodilator FEV1/FVC ratio of 70% or more. The pulmonologist's office can check which result the plan read and resend the full report.
- Insurance is slow to decideThe JASCAYD Bridge Program gives a free 30-day supply and up to 1 more 30-day refill during a coverage delay. Boehringer's prescriber pages give the delay as at least 5 days on one page and 7 calendar days on another. People without insurance for specialty drugs, or paying cash, do not qualify.
- A copay you cannot payWith commercial insurance, the JASCAYD Copay Program can lower the cost to as little as $0 a month. Medicare, Medicaid, TRICARE, VA and other government plans are excluded. For uninsured or underinsured people, the Boehringer Ingelheim Cares Foundation runs a free-drug program with income rules, and our help paying page lists charity funds.
- The prescription went to the wrong pharmacyBoehringer's prescriber site has offices send Jascayd prescriptions through CoverMyMeds or to a specialty pharmacy. It lists Accredo, Walgreens Specialty, CenterWell, CVS Specialty, Optum Specialty and Orsini as partner pharmacies. A prescription sent elsewhere is a routing problem, and the office resends it.
CareConnect4Me (Boehringer Ingelheim)
- CareConnect4Me Copay Program for commercially insured patients, who may pay as little as $0 per fill
- Copay Program exclusions, any government-funded plan such as Medicare, Medicaid, TRICARE or VA, and people paying cash Access for Jascayd
- JASCAYD Bridge Program, a free 30-day supply and up to 1 more 30-day refill during an insurance delay of at least 5 days, for people whose insurance covers specialty drugs Access for Jascayd
- Bridge terms on Boehringer's CareConnect4Me page, a documented delay of 7 calendar days or more, a denial with an appeal within 30 days, or a lapse from changing plans, for people 12 or older in the US or Puerto Rico
- BI Cares Patient Assistance Program, free Jascayd for eligible uninsured or underinsured people who meet income and coverage rules, run by the Boehringer Ingelheim Cares Foundation Access for Jascayd
- A patient navigator with 24/7 availability, plus Patient and Community Clinical Educators who meet at home, by phone or on Zoom Support services
- Information on the Medicare Prescription Payment Plan and the RE Assist tool for independent foundations
Questions prescribers' offices ask about Jascayd
What is the Jascayd dose when the patient also takes pirfenidone?
18mg twice daily, with no reduction to 9mg, per the August 2026 label (sections 2.1 and 7.1). Pirfenidone lowered nerandomilast Ctrough,ss by about 50%, and in FIBRONEER-IPF efficacy was not observed with 9mg twice daily on background pirfenidone. The same no-reduction rule applies with moderate CYP3A inducers.
How common is diarrhea when Jascayd is added to nintedanib?
62% on 18mg, 50% on 9mg and 28% on placebo in patients on background nintedanib in FIBRONEER-IPF, per the August 2026 label (section 6.1). Discontinuation for diarrhea in that subgroup was 13%, 2% and 1%. Nintedanib did not change nerandomilast exposure to a clinically significant degree.
What monitoring does the Jascayd label require?
None by routine laboratory test; the August 2026 label has no boxed warning, no contraindications and no Warnings and Precautions section. Section 6.1 reports diarrhea, weight decrease and decreased appetite above placebo, and depression including suicidal ideation at 12% against 10%; the trials excluded severe depression or suicidal behavior or ideation.
Which drug interactions change the Jascayd dose?
Three, per section 7.1 of the August 2026 label: strong CYP3A inhibitors reduce the dose to 9mg twice daily (itraconazole raised AUC 2.2-fold), strong CYP3A inducers are avoided (carbamazepine cut AUC 51%), and moderate inducers or pirfenidone keep 18mg with no reduction. Moderate and weak CYP3A inhibitors need no change.
What do insurers ask for to approve Jascayd for IPF?
The FEP policy 5.45.019 shown here, effective April 1, 2026, asks for age 18 or older, %FVC or %DLCO of 90% predicted or lower, pre-bronchodilator FEV1/FVC of 70% or higher, definite or probable UIP on HRCT, no known cause, a pulmonologist and a documented drug interaction assessment. It approves 6 months, then 12 months at renewal, and cites the December 2025 label.
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Sources
- JASCAYD- nerandomilast tablet, film coated: prescribing information, revised 8/2026, and Patient Information, revised 12/2025, Boehringer Ingelheim Pharmaceuticals, Inc., via DailyMed, 2026-08-14.
- JASCAYD (nerandomilast tablets) prescribing information, revised 02/2026, FDA, accessdata.fda.gov, 2026-02-26.
- JASCAYD® (nerandomilast) tablets | CareConnect4Me, Boehringer Ingelheim Pharmaceuticals, Inc., 2026-11-09.
- How to Access | JASCAYD® (nerandomilast) tablets, Boehringer Ingelheim Pharmaceuticals, Inc., 2026-11-09.
- Support Services | JASCAYD® (nerandomilast) tablets, Boehringer Ingelheim Pharmaceuticals, Inc., 2026-11-09.
- Pharmacy Policy 5.45.019, Jascayd, Blue Cross Blue Shield Federal Employee Program, 2026-04-01.
- NDA 218764/S-002 supplement approval letter, CYP3A inducer dosing, FDA, 2026-08-14.
- NDA 218764/S-001 supplement approval letter, labeling harmonized with NDA 220449, FDA, 2026-02-26.
- NDA 220449 approval letter, progressive pulmonary fibrosis, FDA, 2025-12-19.
- NDA 218764 approval letter, idiopathic pulmonary fibrosis, FDA, 2025-10-07.
A reference drawn from the August 14, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 9, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.