Download MM.04.028 Pulmonary Hypertension Drugs

Pulmonary Hypertension Drugs
Policy Number:
MM.04.028
Line(s) of Business:
HMO; PPO; QUEST Integration
Section:
Prescription Drugs
Place(s) of Service:
Home
Original Effective Date:
10/01/2009
Current Effective Date:
05/22/2015
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 and
Administrative Guidelines) for the treatment of primary or secondary PH when all of 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 and Administrative Guidelines) for
the treatment of primary or secondary PH when all of 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.
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III. Limitations
A. PH drugs are not covered for patients with chronic obstructive pulmonary disease (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 name and generic drugs are available.
D. Sildenafil (Revatio) will be covered at the manufacturer's recommended dose of 20 mg taken
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 (Flolan; Veletri)
b. Treprostinil (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.
2.
3.
4.
5.
Current clinical notes;
Prescription drug history;
Right heart cardiac catheterization results;
Echocardiogram; and
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
(Moderate)
Marked limitation of physical activity. Comfortable at rest, but less than
ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV
(Severe)
Unable to carry out any physical activity without discomfort. Symptoms
of cardiac insufficiency at rest. If any physical activity is undertaken,
discomfort is increased.
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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; and
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. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial
hypertension in adults: CHEST guideline and expert panel report. CHEST August 2014; 146(2):
449-475.
2. 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.
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3. 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.
4. 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.
5. Galiè N, Brundage BH, Ghofrani HA et al. Tadalafil therapy for pulmonary arterial hypertension.
Circulation 2009; 119(22):2894-903.
6. Galiè N, Ghofrani HA, Torbicki A et al. Sildenafil citrate therapy for pulmonary arterial
hypertension. N Engl J Med 2005; 353(20):2148-57.
7. 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.
8. 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.
9. 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.
10. Macchia A, Marchioli R, Tognoni G et al. Systematic review of trials using vasodilators in
pulmonary arterial hypertension: why a new approach is needed. Am Heart J 2010; 159(2):24557.
11. 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. Circulation 2009;
119(16):2250-94.
12. McLaughlin VV, Genthner DE, Panella MM et al. Reduction in pulmonary vascular resistance
with long-term epoprostenol (prostacyclin) therapy in primary pulmonary hypertension. N Engl
J Med 1998; 338(5):273-7.
13. McLaughlin VV, Shillington A, Rich S. Survival in primary pulmonary hypertension: the impact of
epoprostenol therapy. Circulation 2002; 106(12):1477-82.
14. Oudiz RJ, Schilz RJ, Barst RJ et al. Treprostinil, a prostacyclin analogue, in pulmonary arterial
hypertension associated with connective tissue disease. Chest 2004; 126(2):420-7.
15. Ryerson CJ, Nayer S, Swiston JR et al. Pharmacotherapy in pulmonary arterial hypertension: a
systematic review and meta-analysis. Respiratory Res 2010; 11:12.
16. Simonneau G, Robbins IM, Beghetti M et al. Updated classification of pulmonary hypertension.
J Am Coll Cardiol 2009; 54(1 suppl):S43-54.
17. Simonneau G, Rubin LJ, Galie N et al. Addition of sildenafil to long-term intravenous
epoprostenol therapy in patients with pulmonary arterial hypertension: a randomized trial. Ann
Intern Med 2008; 149(8):521-30.
18. The Canadian Agency for Drugs and Technologies in Health (CADTH). Therapeutic Review
Report. Drugs for pulmonary arterial hypertension: comparative efficacy, safety, and costeffectiveness—recommendations report. March 2015. Available online at:
https://www.cadth.ca/sites/default/files/pdf/TR0006_PAH_Recs_Report.pdf.
19. The Canadian Agency for Drugs and Technologies in Health (CADTH). Rapid Response Report:
Summary with Critical Appraisal. Drug therapy for chronic thromboembolic pulmonary
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hypertension: a review of the comparative clinical effectiveness. September 9, 2014. Available
online at: https://www.cadth.ca/sites/default/files/pdf/htis/dec2014/RC0580%20Drug%20for%20CTEPH%20Final.pdf.
20. Flolan (epoprostenol sodium) [prescribing information]. Research Triangle Park, NC:
GlaxoSmithKline; April 2015. Available online at:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Inform
ation/Flolan/pdf/FLOLAN.PDF.
21. Veletri (epoprostenol) [prescribing information]. South San Francisco, CA: Actelion
Pharmaceuticals US, Inc; June 2012. Available online at:
https://www.veletri.com/pdf/veletri_full_prescribing_information_2nd_gen.pdf.
22. Remodulin (treprostinil) [prescribing information]. Research Triangle Park, CA: United
Therapeutics Corp; December 2014. Available online at:
https://www.remodulin.com/downloads/remodulin-prescribinginformation.pdf.
23. Wilkins MR, Paul GA, Strange JW et al. Sildenafil versus endothelin receptor antagonists for
pulmonary hypertension (SERAPH) study. Am J Respir Crit Care Med 2005; 171(11):1292-7.