Cigna: Ofev (nintedanib) — 1‑Year, Indication‑Specific Approval Criteria (Mar 2026)

Cigna updated Ofev (nintedanib) coverage to an indication‑specific, 1‑year approval structure for IPF, progressive pulmonary fibrosis (chronic fibrosing ILDs with a progressive phenotype), and SSc‑ILD with separate pathways for new starts and patients already on therapy. All indications now require age ≥18, documentation of baseline or current FVC percent predicted (threshold ≥40%), specialty prescribing/consultation (pulmonologist for IPF; pulmonologist or rheumatologist for non‑IPF and SSc‑ILD), and radiographic confirmation where specified (HRCT or surgical lung biopsy for IPF; HRCT for SSc‑ILD). Continuation approvals require documented clinical benefit over the prior year. Use of Ofev outside the three FDA‑labeled indications and concomitant use with Esbriet (pirfenidone) are considered not medically necessary.

CAR T‑cell Therapy: Unified Minimum Eligibility Criteria — Pulmonary Status Included

Effective March 11, 2026, UnitedHealthcare consolidated universal minimum eligibility requirements for CAR T‑cell therapy to align with ASTCT expert guidance, emphasizing a multi‑system pre‑treatment assessment rather than standalone exclusion rules. Pulmonary evaluation — specifically dyspnea assessment and pulse oximetry — is now explicitly listed among required baseline assessments alongside renal (GFR/creatinine), hepatic (AST/ALT, bilirubin), and cardiac (LVEF) evaluations. Hematologic and neurologic baselines (ANC/ALC, platelets, neurologic exam) plus comorbidity factors such as autoimmune disease, immunosuppressive therapy, and active/uncontrolled infection are included as part of the unified eligibility considerations. The update does not provide numeric cutoffs or timing windows, but frames these measures as standard components of candidate risk assessment for CAR T‑cell therapy.

Consolidated ERT Criteria for Pulmonary Lysosomal Disorders — UnitedHealthcare

UnitedHealthcare’s March 1, 2026 update consolidates medical necessity criteria for enzyme replacement therapies used in lysosomal storage disorders with pulmonary involvement (Aldurazyme, Elaprase, Lamzede, Mepsevii, Xenpozyme). Coverage requires diagnostic confirmation by enzyme assay or molecular genetic testing plus relevant clinical signs or symptoms, and dosing must follow FDA labeling. Initial and continuation authorizations are limited to a maximum of 12 months; continuations require prior receipt of the therapy and documented clinical benefit (examples include improved pulmonary function, endurance, functional capacity, or reductions in organ volumes depending on agent). The policy also clarifies certain exclusions, such as that Lamzede and Xenpozyme are not covered for CNS manifestations, and cites pivotal trial data supporting pulmonary and functional improvements for these agents.

UnitedHealthcare Pulmonary Program Updates: Nucala COPD Criteria, Jascayd Added, Ofev Reclassified

UnitedHealthcare updated several pulmonary and cystic fibrosis drug programs effective March–May 2026. Nucala (mepolizumab) COPD criteria were broadened, removing a chronic productive cough requirement and lowering the post-bronchodilator FEV1 threshold (documentation truncated), and the autoinjector and prefilled syringe formulations remain in scope (medical necessity, 3/1/2026). The Interstitial Lung Disease Agents program added Jascayd (nerandomilast) and reclassified Ofev (nintedanib) into an explicit progressive pulmonary fibrosis category with new coverage criteria (notification/medical necessity, 4/1/2026). Pulmozyme, Cayston, Trikafta and multiple CF/inhaled agents underwent annual review with no coverage changes (5/1/2026), while numerous other products had administrative reference updates or new program notifications introduced across the commercial formulary.

PA Update: CDx Tests Limited to FDA‑Cleared/Approved Assays; New NSCLC Test–Drug Pairings

UnitedHealthcare (PA-only) revised its CDx policy effective March 1, 2026 to apply explicitly only to FDA cleared/approved companion diagnostic (CDx) tests and added numerous test–drug pairings across platforms for NSCLC and other solid tumors (examples: Tepmetko, Rozlytrek, Keytruda and multiple PARP combinations). The policy enumerates platform-level coverage determinations (e.g., FoundationOne CDx/Liquid CDx, Guardant360 CDx, Oncomine Dx, xT CDx) and lists specific indication–therapeutic pairings considered proven and medically necessary. It affirms criteria for other FDA-cleared/approved CDx tests to be covered, allows repeat CDx testing at progression or recurrence, and permits concurrent tissue and plasma CDx testing for stage IV NSCLC and stage IV breast cancer. The policy cites evidence and guideline support (Hayes assessments, prospective/retrospective studies, IASLC and NCCN guidance) and provides applicable CPT/HCPCS test codes for billing.

Adalimumab for Sarcoidosis: 3‑Month Start, 1‑Year Renewal Criteria (Cigna IP0652)

Cigna revised its IP0652 pulmonology policy to define time-limited approval windows and prescriber/consultation requirements for adalimumab use in sarcoidosis. Initial therapy approvals are limited to 3 months for adults after documented trials of corticosteroids and at least one immunosuppressive agent, with prescribing or consultation by a pulmonologist, ophthalmologist, or dermatologist. Continuing therapy approvals require at least 3 months on therapy, documented objective improvement versus baseline plus symptomatic benefit, and are granted for up to 1 year. The policy aligns coverage with guideline recommendations supporting TNF inhibitors after failure of steroids and immunosuppressants and standardizes objective measures for ongoing benefit assessment.

IP0420 Update: Baseline BMI Clarified; 3‑Month Behavioral Trial Required

The March 2026 amendment to IP0420 clarifies that BMI and comorbidity assessments must be measured at baseline (prior to initiating the requested weight-loss medication) and explicitly lists asthma and COPD among acceptable weight-related comorbidities for the BMI ≥27 pathway. The policy removes the prior “failed to achieve desired weight loss” language and instead requires documented engagement in behavioral modification and dietary restriction for at least 3 months, with all weight-loss medications to be used concomitantly with behavioral modification and a reduced-calorie diet. Product-specific initial approval durations and age limits are specified (e.g., phentermine 3 months, Contrave 4 months, Qsymia 6 months; pediatric criteria for Qsymia and orlistat included), and continuing therapy generally requires meeting baseline criteria and often ≥5% weight loss from baseline (baseline defined as pre-treatment) for renewals. Preferred product/formulary checks are embedded for certain agents and continuing approvals are typically granted for one year when criteria are met.

Cigna 6/15/2026: 25(OH)D Testing Guidance — CF, High‑Risk Groups & Coding

Cigna updated its vitamin D testing policy effective 6/15/2026 to clarify when total serum 25(OH)D (CPT 82306/0038U) and active 1,25(OH)2D (CPT 82652) testing are medically necessary. 25(OH)D testing is explicitly covered for cystic fibrosis as a malabsorption risk, for other high-risk diagnoses (eg, osteoporotic disease, CKD, hepatic failure, exocrine pancreatic insufficiency, granulomatous disease) and for medication-related risk factors; age ≤18 and >64 years, prior documented deficiency, and suspected toxicity are independent indications. The policy aligns specific ICD codes (including E84.0–E84.9 for cystic fibrosis) with coverage rationale and cites CF Foundation and AAP guidance recommending annual 25‑hydroxyvitamin D testing in people with CF and against using 1,25(OH)2D for routine vitamin D status assessment. Providers should order 25(OH)D testing per these criteria and note that 1,25(OH)2D is reserved for distinct, specified indications.

Respiratory Interleukins (Cinqair®, Fasenra®, Nucala®) — Updated Apr 1, 2026

UnitedHealthcare (UMR) updated its Respiratory Interleukins policy covering Cinqair®, Fasenra®, and Nucala®, effective April 1, 2026. The March 2026 bulletin lists the entry as “Status = Updated,” but the excerpt provides no details on changes to clinical criteria, prior authorization, coding, dosing, age limits, or indications. This entry is part of a broader set of medical benefit drug policy updates effective April 1, 2026, so providers should expect substantive policy language to be available in the payer’s policy library. Consult UnitedHealthcare/UMR’s full respiratory interleukins policy for the specific coverage and utilization management updates.

Infliximab Criteria Clarified for Sarcoidosis and Immunotherapy Toxicities

Cigna updated IP0660 to clarify infliximab coverage criteria for sarcoidosis and immunotherapy-related toxicities, separating initial-therapy from continuation requirements and formalizing approval durations. For sarcoidosis, initial approval (age ≥18) requires prior corticosteroid and at least one immunosuppressant trial and may be approved for 3 months; continued therapy requires ≥3 months on infliximab, objective organ-dependent benefit and symptomatic improvement for 1-year approval. For certain dermatologic immunotherapy toxicities, continuation requires ≥4 months on therapy, objective lesion improvement and symptom relief for 1-year approval. Dosing limits are specified: induction up to 5 mg/kg with maintenance every ≥8 weeks for initiation, and up to 10 mg/kg every ≥4 weeks permitted for established therapy.