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Coverage criteria policies

Advanced drug therapy for pulmonary hypertension: epoprostenol (generic, Flolan® and Veletri®), treprostinil (Remodulin® & Tyvaso®), iloprost (Ventavis®) and sildenafil injection (Revatio®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan will be used to determine your coverage.

Administrative Process

Advanced drug therapies for pulmonary hypertension will not be covered without prior authorization from HealthPartners Pharmacy Administration.

Coverage

Advanced drug therapy is generally covered for patients when the following criteria are met:

Prescribed by a pulmonologist or cardiologist, and

  1. A diagnosis of either vasoreactive pulmonary arterial hypertension after trial and failure of calcium channel blocker therapy or in non-vasoreactive pulmonary arterial hypertension, and
  2. A diagnosis of PAH defined as WHO group 1 class of pulmonary hypertension as confirmed by right heart catherization with all of the following pretreatment results:
    1. mPAP ≥ 25 mmHg
    2. PCWP ≤ 15 mmHg
    3. PVR > 3 Wood units

Utilization for all other indications will be reviewed for medical necessity.

Sequential combination use requires documentation of medical necessity (including response to single-drug therapy, and rationale for adding a medication).

Use of sildenafil injection requires verification of medical necessity for the parenteral formulation.

Medications

Epoprostenol (Flolan, Veletri and generic): is indicated to improve exercise capacity in the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.

Treprostinil (Remodulin): is FDA-approved for

  1. Pulmonary Arterial Hypertension in Patients with NYHA Class II-IV Symptoms, to diminish symptoms associated with exercise. It may be administered as a continuous subcutaneous infusion or continuous intravenous infusion; however, because of the risks associated with chronic indwelling central venous catheters, including serious blood stream infections, continuous intravenous infusion should be reserved for patients who are intolerant of the subcutaneous route, or in whom these risks are considered warranted.
  2. Pulmonary Arterial Hypertension in Patients Requiring Transition from Flolan, to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

Treprostinil inhaled (Tyvaso): is FDA-approved to improve exercise ability in patients with WHO Group I pulmonary arterial hypertension and NYHA Class III symptoms. The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities. While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan or sildenafil. The controlled clinical experience was limited to 12 weeks in duration.

Iloprost inhaled (Ventavis): is FDA-approved for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms. In controlled trials, it improved a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration.

Sildenafil injection (Revatio): is a phosphodiesterase 5 (PDE5) inhibitor FDA-approved for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominately patients with NYHA Functional Class II-III symptoms and etiologies of primary pulmonary hypertension or pulmonary hypertension associated with connective tissue disease. Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity.

Definitions

Pulmonary hypertension (PH) is characterized by elevated pulmonary arterial pressure and subsequent right ventricular failure. It is diagnosed by right heart catheterization measurements and defined by a mean pulmonary artery pressure of ≥25mmHg at rest.

Pulmonary hypertension may occur as a result of idiopathic processes, genetic predisposition or other disease processes such as heart failure and COPD.

Treatment of pulmonary hypertension is directed at correcting underlying causes such as in the case where PH occurs as a result of another disease process. Prostaglandin therapy is considered advanced therapy in that it is not used to correct underlying causes but rather it is used to control pulmonary blood pressure itself.

The World Health Organization (WHO) classifies pulmonary hypertension into five groups based on the etiology of disease (partial listing):

  1. Pulmonary arterial hypertension (PAH)
  2. Idiopathic PAH
  3. Heritable
  4. Pulmonary hypertension owing to left heart disease
  5. Pulmonary hypertension owing to lung diseases
  6. Chronic obstructive pulmonary disease
  7. Interstitial lung disease
  8. Chronic thromboembolic pulmonary hypertension
  9. Pulmonary hypertension with unclear multifactorial mechanisms

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS Codes

Codes

Description

J1325

Injection, epoprostenol, 0.5mg

S0155

Sterile diluents for epoprostenol, 50 mL (Not used with Veletri)

J3490

Revatio 10 mg/12.5mL solution – Unclassified drugs

J3285

Injection, treprostinil, 1 mg

J7686

Treprostinil, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, 1.74 mg

Q4074

Iloprost, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, up to 20 mcg (Please note: AWP/WAC pricing is the same for the 10 mcg and 20 mcg unit dose vials. Therefore bill/reimburse 1 unit of the code regardless of strength used)

J8499

Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified

S9347

Home infusion therapy, uninterrupted, long term, controlled rate intravenous or subcutaneous infusion therapy (e.g., epoprostenol); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

NDC Codes

Codes

Description

00703198501

epoprostenol sodium 0.5 mg solution

00703199501

epoprostenol sodium 1.5 mg solution

00173051700

Flolan 0.5 mg solution

00173051900

Flolan 1.5 mg solution

66215040301

Veletri 0.5mg solution

66215040201

Veletri 1.5mg solution

55150016613

sildenafil citrate 10mg/12.5ml vial

00173051801

Sterile Diluent for Flolan solution

66302010101

Remodulin 1 mg/mL 20 mL solution

66302011001

Remodulin 10 mg/mL 20 mL solution

66302010201

Remodulin 2.5 mg/mL 20 mL solution

66302010501

Remodulin 5 mg/mL 20 mL solution

66302020603

Tyvaso 0.6 mg/mL single use solution x 4

66302020602

Tyvaso refill 0.6 mg/mL single use solution x 28

66302020601

Tyvaso starter 0.6 mg/mL single use solution x 28

66302020604

Tyvaso starter 0.6 mg/mL single use solution x 4

66215030200

Ventavis 10 mcg/mL solution

66215030230

Ventavis 10 mcg/mL solution x 30

66215030300

Ventavis 20 mcg/mL solution

66215030330

Ventavis 20 mcg/mL solution x 30

00069033801

Revatio 10 mg/12.5 mL solution

00069033621

Revatio, 10mg/ml oral suspension

00069419068

Revation, 20mg oral tablet

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. Flolan Prescribing Information. GlaxoSmithKline. June, 2016
  2. Veletri Prescribing Information. Actelion Pharmaceuticals July, 2016.
  3. Remodulin Prescribing Information. United Therapeutics Corporation. December, 2014.
  4. Tyvaso Prescribing Information. United Therapeutics Corporation. June, 2016
  5. Ventavis Prescribing Information. Actelion Pharmaceuticals November, 2013
  6. Revatio Prescribing Information. Pfizer Pharmaceuticals, Inc. May, 2015
  7. 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. McLaughlin VV, et al; American College of Cardiology Foundation Task Force on Expert Consensus Documents; American Heart Association; American College of Chest Physicians; American Thoracic Society, Inc; Pulmonary Hypertension Association. J Am Coll Cardiol. 2009 Apr 28;53(17):1573-619.
  8. Guidelines for the diagnosis and treatment of pulmonary hypertension. Task Force for Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC); European Respiratory Society (ERS); International Society of Heart and Lung Transplantation (ISHLT), Galiè N, et al. Eur Respir J. 2009 Dec;34(6):1219-63.

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Policy activity

  • 07/29/2010 - Date of origin
  • 07/12/2017 - Effective date
Review date
  • 04/2017

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