Subject: Tadalafil Products SGM 1640-A P2025

Drug

ADCIRCA  (tadalafil )

ALYQ  (tadalafil )

TADLIQ  (tadalafil )

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications^1-4

Indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with New York Heart Association (NYHA) Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.

Compendial Uses⁵

Secondary Raynaud’s phenomenon

All other indications are considered experimental/investigational and not medically necessary.

Prescriber Specialties

This medication must be prescribed by or in consultation with a pulmonologist or cardiologist for the diagnosis of pulmonary arterial hypertension (PAH).

Coverage Criteria

Pulmonary Arterial Hypertension (PAH)^1-4,6-9

Authorization of 12 months may be granted for treatment of PAH when ALL of the following criteria are met:

• Member has PAH defined as WHO Group 1 class of pulmonary hypertension (refer to Appendix).
• PAH was confirmed by either of the following criteria:
  • Pretreatment right heart catheterization with all of the following results:
    • Mean pulmonary arterial pressure (mPAP) > 20 mmHg
    • Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
    • Pulmonary vascular resistance (PVR) > 2 Wood units. For pediatric members, pulmonary vascular resistance index (PVRI) > 3 Wood units x m² is also acceptable.
  • For infants less than one year of age, PAH was confirmed by Doppler echocardiogram if right heart catheterization cannot be performed.

Secondary Raynaud’s Phenomenon^5,10-12

Authorization of 12 months may be granted for treatment of secondary Raynaud’s phenomenon when the member has had an inadequate response to one of the following medications:

• Calcium channel blockers
• Angiotensin II receptor blockers
• Selective serotonin reuptake inhibitors
• Alpha blockers
• Angiotensin-converting enzyme inhibitors
• Topical nitrates

Continuation of Therapy

Authorization of 12 months may be granted for members with an indication listed in the coverage criteria section who are currently receiving a tadalafil product through a paid pharmacy or medical benefit, and who are experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Appendix

WHO Classification of Pulmonary Hypertension (PH)⁷

Note: Patients with heritable PAH or PAH associated with drugs and toxins might be long-term responders to calcium channel blockers.

Group 1: Pulmonary Arterial Hypertension (PAH)

• Idiopathic
  • Long-term responders to calcium channel blockers
• Heritable
• Associated with drugs and toxins
• Associated with:
  • Connective tissue disease
  • Human immunodeficiency virus (HIV) infection
  • Portal hypertension
  • Congenital heart disease
  • Schistosomiasis
• PAH with features of venous/capillary (pulmonary veno-occlusive disease [PVOD]/pulmonary capillary hemangiomatosis [PCH]) involvement
• Persistent PH of the newborn

Group 2: PH associated with Left Heart Disease

• Heart failure:
  • With preserved ejection fraction
  • With reduced or mildly reduced ejection fraction
  • Cardiomyopathies with specific etiologies (i.e., hypertrophic, amyloid, Fabry disease, and Chagas disease)
• Valvular heart disease:
  • Aortic valve disease
  • Mitral valve disease
  • Mixed valvular disease
• Congenital/acquired cardiovascular conditions leading to post-capillary PH

Group 3: PH associated with Lung Diseases and/or Hypoxia

• Chronic obstructive pulmonary disease (COPD) and/or emphysema
• Interstitial lung disease
• Combined pulmonary fibrosis and emphysema
• Other parenchymal lung diseases (i.e., parenchymal lung diseases not included in Group 5)
• Nonparenchymal restrictive diseases:
  • Hypoventilation syndromes
  • Pneumonectomy
• Hypoxia without lung disease (e.g., high altitude)
• Developmental lung diseases

Group 4: PH associated with Pulmonary Artery Obstructions

• Chronic thromboembolic PH
• Other pulmonary artery obstructions:
  • Sarcomas (high- or intermediate-grade or angiosarcoma)
  • Other malignant tumors (e.g., renal carcinoma, uterine carcinoma, germ-cell tumors of the testis)
  • Non-malignant tumors (e.g., uterine leiomyoma)
  • Arteritis without connective tissue disease
  • Congenital pulmonary artery stenoses
  • Hydatidosis

Group 5: PH with Unclear and/or Multifactorial Mechanisms

• Hematological disorders, including inherited and acquired chronic hemolytic anemia and chronic myeloproliferative disorders
• Systemic disorders: Sarcoidosis, pulmonary Langerhans cell histiocytosis, and neurofibromatosis type 1
• Metabolic disorders, including glycogen storage diseases and Gaucher disease
• Chronic renal failure with or without hemodialysis
• Pulmonary tumor thrombotic microangiopathy
• Fibrosing mediastinitis
• Complex congenital heart disease

Place of Service:

Outpatient

The above policy is based on the following references:

1. Adcirca [package insert]. Indianapolis, IN: Eli Lilly and Company; September 2020.
2. Alyq [package insert]. Parsippany, NJ: Teva Pharmaceuticals; April 2023.
3. Tadliq [package insert]. Farmville, NC: CMP Pharma, Inc.; October 2023.
4. Tadalafil [package insert]. Bridgewater, NJ: Ajanta Pharma USA Inc.; May 2023.
5. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed April 1, 2025.
6. Simonneau G, Montani D, Celermajer DS, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019;53(1):1801913. doi:10.1183/13993003.01913-2018
7. Kovacs G, Bartolome S, Denton CP, et al. Definition, classification and diagnosis of pulmonary hypertension. Eur Respir J. 2024;64(4):2401324. doi: 10.1183/13993003.01324-2024
8. Chin KM, Gaine SP, Gerges C, et al. Treatment algorithm for pulmonary arterial hypertension. Eur Respir J. 2024;64(4):2401325. doi: 10.1183/13993003.01325-2024
9. Ivy D, Rosenzweig EB, Abman SH, et al. Embracing the challenges of neonatal and paediatric pulmonary hypertension. Eur Respir J. 2024;64(4):2401345. doi: 10.1183/13993003.01345-2024
10. Curtiss P, Svigos K, Schwager Z, Lo Sicco K, Franks AG Jr. Part II: The treatment of primary and secondary Raynaud's phenomenon. J Am Acad Dermatol. 2024 Feb;90(2):237-248. doi: 10.1016/j.jaad.2022.05.067
11. Maltez N, Maxwell LJ, Rirash F, et al. Phosphodiesterase 5 inhibitors (PDE5i) for the treatment of Raynaud's phenomenon. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD014089. doi: 10.1002/14651858
12. Del Galdo F, Lescoat A, Conaghan PG, et al. EULAR recommendations for the treatment of systemic sclerosis: 2023 update. Annals of the Rheumatic Diseases Published Online First: 11 October 2024. doi: 10.1136/ard-2024-226430

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 12, 2025