Subject: Tadalafil Products 1640-A SGM P2023

Drug

Adcirca  (tadalafil tablet)

Alyq  (tadalafil tablet)

Tadliq  (tadalafil oral suspension)

tadalafil tablet

Policy:

      I.  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.

          A.  FDA-Approved Indication
               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.

          B.  Compendial Use
               Secondary Raynaud’s phenomenon

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


    II.  PRESCRIBER SPECIALTIES

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


  III.  CRITERIA FOR INITIAL APPROVAL

          A.  Pulmonary Arterial Hypertension (PAH)
               Authorization of 12 months may be granted for treatment of
               PAH when ALL of the following criteria are met:
               1.  Member has PAH defined as WHO Group 1 class of
                    pulmonary hypertension (refer to Appendix).
               2.  PAH was confirmed by either criterion (i) or criterion (ii)
                    below:
                    i.     Pretreatment right heart catheterization with all of
                           the following results:
                           a.  Mean pulmonary arterial pressure (mPAP) > 20
                                mmHg
                           b.  Pulmonary capillary wedge pressure (PCWP) ≤ 15
                                mmHg
                           c.  Pulmonary vascular resistance (PVR) ≥ 3 Wood
                               units in adult patients or pulmonary vascular
                                resistance index (PVRI) ≥ 3 Wood units x m² in
                               pediatric patients
                     ii.   For infants less than one year of age, PAH was
                           confirmed by Doppler echocardiogram if right heart
                           catheterization cannot be performed.

          B.  Secondary Raynaud’s Phenomenon
               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:
               1.  Calcium channel blockers
               2.  Angiotensin II receptor blockers
               3.  Selective serotonin reuptake inhibitors
               4.  Alpha blockers
               5.  Topical nitrates


   IV.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for members with
          an indication listed in Section III 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.


     V.  APPENDIX

          WHO Classification of Pulmonary Hypertension
          1 PAH
          1.1 Idiopathic (PAH)
          1.2 Heritable PAH
          1.3 Drug- and toxin-induced PAH
          1.4. PAH associated with:
                1.4.1 Connective tissue diseases
                1.4.2 HIV infection
                1.4.3 Portal hypertension
                1.4.4 Congenital heart diseases
                1.4.5 Schistosomiasis
          1.5 PAH long-term responders to calcium channel blockers
          1.6 PAH with overt features of venous/capillaries (PVOD/PCH)
                involvemen
          1.7 Persistent PH of the newborn syndrome

          2 PH due to left heart disease
          2.1 PH due to heart failure with preserved LVEF
          2.2 PH due to heart failure with reduced LVEF
          2.3 Valvular heart disease
          2.4 Congenital/acquired cardiovascular conditions leading to
                post-capillary PH

          3 PH due to lung diseases and/or hypoxia
          3.1 Obstructive lung disease
          3.2 Restrictive lung disease
          3.3 Other lung disease with mixed restrictive/obstructive pattern
          3.4 Hypoxia without lung disease
          3.5 Developmental lung disorders

          4 PH due to pulmonary artery obstruction
          4.1 Chronic thromboembolic PH
          4.2 Other pulmonary artery obstructions
                4.1.2 Sarcoma (high or intermediate grade) or
                         angiosarcoma
                4.2.2 Other malignant tumors
                         Renal carcinoma
                         Uterine carcinoma
                         Germ cell tumours of the testis
                         Other tumours
                4.2.3 Non-malignant tumours
                        Uterine leiomyoma
                4.2.4 Arteritis without connective tissue disease
                4.2.5 Congenital pulmonary artery stenosis
                4.2.6 Parasites
                        Hydatidosis

          5 PH with unclear and/or multifactorial mechanisms
          5.1 Hematologic disorders: Chronic hemolytic anemia,
                myeloproliferative disorders
          5.2 Systemic and metabolic disorders: Pulmonary Langerhans
               cell histiocytosis, Gaucher disease, glycogen  storage
               disease, neurofibromatosis, sarcoidosis
          5.3 Others: chronic renal failure with or without hemodialysis,
                fibrosing mediastinitis
          5.4 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. Tadalafil [package insert]. Bridgewater, NJ: Ajanta Pharma USA Inc.; July 2022.
3. Alyq [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; September 2021.
4. Tadliq [package insert]. Farmville, NC: CMP Pharma, Inc.; June 2022.
5. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://micromedexsolutions.com. Accessed April 12, 2023.
6. Chin KM, Rubin LJ. Pulmonary arterial hypertension. J Am Coll Cardiol. 2008;51(16):1527-1538.
7. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. J Am Coll Cardiol. 2009;53(17):1573-1619.
8. Badesch DB, Champion HC, Gomez-Sanchez MA, et al. Diagnosis and assessment of pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54:S55-S66.
9. Rubin LJ; American College of Chest Physicians. Diagnosis and management of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest. 2004;126(1 Suppl):7S-10S.
10. Barst RJ, Gibbs SR, Ghofrani HA, et al. Updated evidence-based treatment algorithm in pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54:S78-S84.
11. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults. CHEST guideline and expert panel report. Chest. 2014;46(2):449-475.
12. Abman SH, Hansmann G, Archer SL, et al. Pediatric pulmonary hypertension: guidelines from the American Heart Association and American Thoracic Society. Circulation. 2015;132(21):2037-99.
13. Klinger JR, Elliott CG, Levine DJ, et al. Therapy for Pulmonary Arterial Hypertension in Adults: Update of the CHEST Guidelines and Expert Panel Report. Chest. 2019:155(3): 565-586.
14. Galie N, McLaughlin VV, Rubin LJ, Simonneau G. An overview of the 6th World Symposium on Pulmonary Hypertension. Eur Respir J. 2019; 53: 1802148; DOI: 10.1183/13993003.02148-2018. Published 24 January 2019.
15. Simonneau G, Montani D, Celermajer DS, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019;53:1801913; doi:10.1183/13993003.01913-2018.
16. Hughes M, Ong VH, Anderson ME, et al. Consensus best practice pathway of the UK Scleroderma Study Group: digital vasculopathy in systemic sclerosis. Rheumatology. 2015;54:2015-2024.
17. Roustit M, Blaise S, Allanore Y, et al. Phosphodiesterase-5 inhibitors for the treatment of secondary Raynaud’s phenomenon: systematic review and meta-analysis of randomized trials. Ann Rheum Dis. 2013;72(10):1696-1699.
18. Walker KM, Pope J, et al. Treatment of systemic sclerosis complications: what to use when first-line treatment fails – a consensus of systemic sclerosis experts. Semin Arthritis Rheum. 2012;42(1):42-55.

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 14, 2023