Pulmonary Hypertension Drugs
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Pulmonary Hypertension Drugs Policy Number: Original Effective Date: MM.04.028 10/01/2009 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST Integration 06/27/2014 Section: Prescription Drugs Place(s) of Service: Home I. Description Pulmonary hypertension (PH) is characterized by sustained elevations of pulmonary artery pressure (PAP). PH is defined as a mean PAP greater than 25 mmHg at rest. A mean PAP of 8 to 20 mmHg at rest is considered normal, while a mean PAP of 21 to 24 mmHg at rest has uncertain clinical implications. Drug therapy of PH includes vasodilators (particularly calcium channel blockers and sildenafil), anticoagulants to reduce in situ thrombosis, inotropic and diuretic agents, and oxygen therapy. Lung transplantation and combined heart-lung transplantation have been performed in patients refractory to medical management. II. Criteria/Guidelines A. Drugs that are FDA-approved for the treatment of PH are covered (subject to Limitations/Exclusions and Administrative Guidelines) for the treatment of primary or secondary PH when the following criteria are met: 1. Therapy is recommended by a pulmonologist or cardiologist 2. Right heart catheterization demonstrates a mean PAP of more than 25 mm Hg at rest. 3. Baseline assessment of all of the following is done: a. New York Heart Association Class b. Echocardiogram B. Continuation of therapy is covered (subject to Limitations/Exclusions and Administrative Guidelines) for the treatment of primary or secondary PH when the following criteria are met: 1. There is documentation of the patient's clinical response to therapy including the following: a. New York Heart Association Class and b. Echocardiogram 2. Patient is followed by a pulmonologist or cardiologist Pulmonary Hypertension Drugs 2 III. Limitations/Exclusions A. PH drugs are not covered for patients with COPD and pulmonary arterial hypertension with a FEV1<30. B. More than one drug may be appropriate for the treatment of PH. HMSA reserves the right to approve the least costly treatment. C. Only generic drugs are covered when both brand and generic drugs are available. D. Sildenafil (Revatio) will be covered at the manufacturer's recommended dose of 20 mg orally three times a day. A higher dosage of sildenafil is not known to improve health outcomes and will not be covered. E. Tadalafil (Cialis) and vardenafil (Levitra) are not covered for the treatment of PH. IV. Administrative Guidelines A. Precertification is required for the following drugs for the treatment of PH, including, but not limited to: 1. Injectable/Infused Drugs a. Epoprostenol sodium (i.e., Flolan) b. Treprostinil (i.e., Remodulin) 2. Oral/Inhaled Drugs a. For private lines of business (PPO/HMO) and QUEST, see the CVS Caremark Drug Policy for precertification requirements. B. Precertification is required for the initial three months of treatment. The following documentation from the medical record must be submitted: 1. Current clinical notes 2. Prescription drug history 3. Right heart cardiac catheterization results 4. Echocardiogram 5. New York Heart Association Class New York Heart Association Classification: Class Patient Symptoms Class I (Mild) No limitation of physical activity. Ordinary fatigue, palpitation, or dyspnea (shortness of breath) Class II (Mild) Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III Marked limitation of physical activity. Comfortable at rest, but less than (Moderate) ordinary activity causes fatigue, palpitation, or dyspnea. Class IV Unable to carry out any physical activity without discomfort. Symptoms (Severe) of cardiac insufficiency at rest. If any physical activity is undertaken, Pulmonary Hypertension Drugs 3 discomfort is increased. C. To precertify, please complete HMSA's Drug Review Request and mail or fax the form as indicated. D. Precertification is required for continuation of therapy for each additional 12 months. The following documentation must be submitted: 1. Evidence that patient is followed by a pulmonologist or cardiologist. 2. Recent clinical notes including New York Heart Association Class documenting response to treatment and echocardiogram HCPCS Codes Description J1325 Injection, epoprostenol, 0.5 mg J3285 Injection, treprostinil, 1 mg V. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii's Patients' Bill of Rights and Responsibilities Act (Hawaii Revised Statutes §432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA's determination as to medical necessity in a given case, the physician may request that HMSA reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. VI. References 1. A clinical trial of ambrisentan and tadalafil in pulmonary arterial hypertension associated with systemic schlerosis (ATPAHSS) (NCT01042158). Sponsored by United Therapeutics. Last updated January 4, 2010. Available online at Clinicaltrials.gov. Last accessed March 2010. 2. Badesch DB, Abman SH, Simonneau G et al. Medical therapy for pulmonary arterial hypertension: updated ACCP evidence-based clinical practice guidelines. Chest 2007; 131(6):1917-28. Pulmonary Hypertension Drugs 4 3. Badesch DB, Tapson VF, McGoon MD et al. Continuous intravenous epoprostenol for pulmonary hypertension due to the scleroderma spectrum of disease. A randomized, controlled trial. Ann Intern Med 2000; 132(6):425-34. 4. Barst RJ, Galie N, Naeije R et al. Long-term outcome in pulmonary arterial hypertension patients treated with subcutaneous treprostinil. Eur Respir J 2006; 28(6):1195-203. 5. Barst RJ, McGoon M, McLaughlin V et al. Beraprost therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2003; 41(12):2119-25. 6. Barst RJ, Rubin LJ, Long WA et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. The Primary Pulmonary Hypertension Study Group. N Engl J Med 1996; 334(5):296-302. 7. Channick RN, Olschewski H, Seeger W et al. Safety and efficacy of inhaled treprostinil as add-on therapy to bosentan in pulmonary arterial hypertension. J Am Coll Cardiol 2006; 48(7):1433-7. 8. Chen YF, Jowett S, Barton P et al. Clinical and cost-effectiveness of epoprostenol, iloprost, bosentan, sitaxentan and sildenafil for pulmonary arterial hypertension within their licensed indications: a systematic review and economic evaluation. Health Technol Assess 2009;13(49):1-320. 9. Effects of the combination of bosentan and sildenafil versus sildenafil monotherapy on pulmonary arterial hypertension (PAH) (Compass 2) (NCT00303459). Sponsored by Atelion. Last updated March 9, 2010. Available online at Clinicaltrials.gov. Last accessed March 2010. 10. Galie N, Brundage BH, Ghofrani HA et al. Tadalafil therapy for pulmonary arterial hypertension. Circulation 2009; 119(22):2894-903. 11. Galie N, Ghofrani HA, Torbicki A et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med 2005; 353(20):2148-57. 12. Galie N, Humbert M, Vacheiry JL et al. Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind placebo-controlled trial. J Am Coll Cardiol 2002; 39(9):1496-502. 13. Galiè N, Manes A, Negro L et al. A meta-analysis of randomized controlled trials in pulmonary arterial hypertension. Eur Heart J 2009; 30(4):394-403. 14. Hoeper MM, Leuchte H, Halank M et al. Combining inhaled iloprost with bosentan in patients with idiopathic pulmonary arterial hypertension. Eur Respir J. 2006 Oct; 28(4):683-6. 15. Hoeper MM, Markevych I, Spiekerkoetter E et al. Goal-oriented treatment and combination therapy for pulmonary arterial hypertension. Eur Respir J 2005; 26(5):858-63. 16. Humbert M, Sanchez O, Fartoukh M et al. Short-term and long-term epoprostenol (prostacyclin) therapy in pulmonary hypertension secondary to connective tissue diseases: results of a pilot study. Eur Respir J 1999; 13(6):1351-6. 17. Jain M, Varga J. Bosentan for the treatment of systemic sclerosis-associated pulmonary arterial hypertension, pulmonary fibrosis and digital ulcers. Expert Opin Pharmacother 2006; 7(11):1487-501. 18. Jing ZC, Jiang X, Wu BX et al. Vardenafil treatment for patients with pulmonary arterial hypertension: a multicenter, open-label study. Heart 2009; 95(18):1531-6. 19. Langleben D, Christman BW, Barst RJ et al. Effects of the thromboxane synthetase inhibitor and receptor antagonist terbogrel in patients with primary pulmonary hypertension. Am Heart J 2002; 143(5):E4. Pulmonary Hypertension Drugs 5 20. Macchia A, Marchioli R, Tognoni G et al. Systematic review of trials using vasodilators in