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Drug Category: Cardiovascular Agents

Medication Class/Individual Agents: Peripheral Vasodilators and Pulmonary Hypertension Agents

I. Prior-Authorization Requirements

 Pulmonary Arterial Hypertension Agents-Endothelin Receptor Antagonists

Clinical Notes

Drug Generic Name

Drug Brand Name

PA
Status

Average cost per claim ($)

ambrisentan Letairis PA   $6,772.59  
bosentan Tracleer PA   $7,183.18  
macitentan Opsumit PA   $7,182.00  

Please note: In the case where the prior authorization (PA) status column indicates PA for an FDA “A”-rated generic equivalent of a brand name drug, both brand and generic require PA.  Prior authorization requests submitted for a brand name drug must meet the criteria for the drug itself and the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective generic equivalent.

 

2009 America College of Cardiology Foundation/American Heart Association: ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension1

  • Goals of treatment include improvement in the patient’s symptoms, quality of life and survival.
  • Supportive therapy may include warfarin anticoagulation, diuretics and oxygen.
  • Continuous intravenous epoprostenol improves exercise capacity, hemodynamics, and survival in pulmonary hypertension and is the preferred treatment option for the most critically ill patients.
  • Patients with poor prognostic indexes should be initiated on parenteral therapy, while patients with class II or early III symptoms commonly initiate therapy with endothelin receptor antagonists or PDE-5 inhibitors.

WHO/NYHA Classification Functional Status of Pulmonary Arterial Hypertension

  • Class I: Patients with no symptoms, and for whom ordinary physical activity does not cause fatigue, palpitation, dyspnea, or anginal pain
  • Class II: Patients who are comfortable at rest but who have symptoms with less-than-ordinary physical activity resulting in slight limitations of physical activity
  • Class III: Patients who are comfortable at rest but have symptoms with less-than-ordinary effort resulting in marked limitations of physical activity
  • Class IV: Patients who have symptoms at rest. These patients manifest signs of heart failure.

Key symptoms of PAH include fatigue, dizziness and fainting (near syncope).

1 America College of Cardiology Foundation and American Heart Association: 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 Apr 28;53(17):1573-619.

2 Barst RJ, McGoon M, Torbicki A, et al. Diagnosis and differential assessment of pulmonary arterial hypertension. J Am Coll Cardiol 2004; 43:40S-47S.

$ This value represents the average cost per claim of the most commonly prescribed quantities as of 12/2013. Where applicable, cost represents that of an A-rated generic equivalent (#).

 

 Pulmonary Arterial Hypertension Agents-Phosphodiesterase Type 5 Inhibitors

Drug Generic Name

Drug Brand Name

PA
Status

Average cost per claim ($)

sildenafil 20 mg tablet Revatio PA   $125.35 (#)  
sildenafil, intravenous Revatio H   N/A  
tadalafil Adcirca PA   $1,788.84  

 Pulmonary Arterial Hypertension Agents-Prostanoids

Drug Generic Name

Drug Brand Name

PA
Status

Average cost per claim ($)

epoprostenol-flolan Flolan #   $5,687.64  
epoprostenol-veletri Veletri PA   $6,098.10  
iloprost Ventavis PA   $14,554.17  
treprostinil inhalation solution Tyvaso PA   $13,031.67  
treprostinil injection Remodulin PA   $18,571.03  

 Pulmonary Arterial Hypertension Agents-Soluble Guanylate Cyclase Stimulators

Drug Generic Name

Drug Brand Name

PA
Status

Average cost per claim ($)

riociguat Adempas PA   $7,874.68  
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
H This drug is available only in an inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy or physician's office.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Treatment of WHO Group 1 pulmonary arterial hypertension (PAH)
  • Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA for an FDA “A”-rated generic equivalent of a brand name drug, both brand and generic require PA.  Prior authorization requests submitted for a brand name drug must meet the criteria for the drug itself and the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective generic equivalent.

  • All prior-authorization requests must include clinical diagnosis, drug name, dose, and frequency.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

  

Adcirca (tadalafil)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to sildenafil; and
    • prescriber is a cardiologist, or pulmonologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis.

SmartPA: Claims for Adcirca will usually process at the pharmacy without a prior authorization request if the member has a  history of MassHealth medical claims for Pulmonary Arterial Hypertension (PAH), the prescriber is a pulmonologist or cardiologist, and there is a history of MassHealth pharmacy claims for sildenafil 20 mg tablet.

  

Adempas (riociguat)

  • Documentation of the following is required for a diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH):
    • an appropriate diagnosis; and
    • member ≥ 18 years of age; and
    • prescriber is a cardiologist, or pulmonologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis; and
    • persistent or recurrent CTEPH after surgical treatment, or CTEPH is inoperable; and
    • requested quantity is ≤ 90 tablets per month; and
    • agent will not be coadministered with a phosphodiesterase-5 inhibitor.
  • Documentation of the following is required for a diagnosis of pulmonary arterial hypertension (PAH):
    • an appropriate diagnosis; and
    • member ≥ 18 years of age; and
    • prescriber is a cardiologist, or pulmonologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis; and
    • one of the following:
      • an inadequate response, adverse reaction, or contraindication to Adcirca or sildenafil; or
      • clinical rationale explaining why the member cannot use Adcirca or sildenafil; and
    • requested quantity is ≤ 90 tablets per month; and
    • agent will not be coadministered with a phosphodiesterase-5 inhibitor.

SmartPA: Claims for Adempas will usually process at the pharmacy without a prior authorization request if the member has a history of MassHealth pharmacy claims for the requested agent OR if the member has a history of MassHealth medical claims for Pulmonary Arterial Hypertension (PAH), the prescriber is a pulmonologist or cardiologist, there is a history of MassHealth pharmacy claims for sildenafil 20 mg tablets or Adcirca, there is no history of MassHealth pharmacy claims for sildenafil 20 mg tablets or Adcirca within the last 60 days, and the requested quantity is ≤ 90 tablets/30 days.

 

Letairis (ambrisentan), Tracleer (bosentan)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • prescriber is a cardiologist, or pulmonologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis; and
    • one of the following:
      • an inadequate response, adverse reaction, or contraindication to Adcirca or sildenafil; or
      • clinical rationale explaining why the member cannot use Adcirca or sildenafil; and
    • quantity is ≤ 30 tablets/30 days  for Letairis or quantity is ≤ 60 tablets/30 days for Tracleer.

SmartPA: Claims for Letairis and Tracleer will usually process at the pharmacy without a prior authorization request if the member has a  history of MassHealth pharmacy claims for the requested agent OR if the member has a history of MassHealth medical claims for Pulmonary Arterial Hypertension (PAH), the prescriber is a pulmonologist or cardiologist, there is a history of MassHealth pharmacy claims for sildenafil 20 mg tablet or Adcirca, and the requested quantity is ≤ 30 tablets/30 days (Letairis) or ≤ 60 tablets/30 days (Tracleer).

 

Opsumit (macitentan)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • prescriber is a cardiologist, or pulmonologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to Tracleer (bosentan); and
    • one of the following:
      • an inadequate response, adverse reaction, or contraindication to Adcirca or sildenafil; or
      • clinical rationale explaining why the member cannot use Adcirca or sildenafil; and
    • quantity is ≤ 30 tablets/30 days.

SmartPA: Claims for Opsumit will usually process at the pharmacy without a prior authorization request if the member has a  history of MassHealth pharmacy claims for the requested agent OR if the member has a history of MassHealth medical claims for Pulmonary Arterial Hypertension (PAH), the prescriber is a pulmonologist or cardiologist, there is a history of MassHealth pharmacy claims for sildenafil 20 mg tablet or Adcirca and bosentan, and the requested quantity is ≤ 30 tablets/30 days.

 

Remodulin (treprostinil), Tyvaso (treprostinil), Ventavis (iloprost)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • prescriber is a cardiologist, or pulmonologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to epoprostenol; and
    • quantity is ≤ 9 ampules/day (≤ 270 ampules/30 days) for Ventavis.

SmartPA: Claims for Remodulin, Tyvaso, and Ventavis will usually process at the pharmacy without a prior authorization request if the member has a  history of MassHealth pharmacy claims for the requested agent OR if the member has a  history of MassHealth medical claims for Pulmonary Arterial Hypertension (PAH), member has a  history of MassHealth pharmacy claims for epoprostenol or Flolan, the prescriber is a pulmonologist or cardiologist, and if the request is for Ventavis, the requested quantity is ≤ 270 ampules/30 days.

  

sildenafil 20 mg tablet

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • member ≥ 18 years of age; and
    • prescriber is a cardiologist, or pulmonologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis.

SmartPA: Claims for sildenafil 20 mg tablets will usually process at the pharmacy without a prior authorization request if the member has a  history of MassHealth medical claims for Pulmonary Arterial Hypertension (PAH), the prescriber is a pulmonologist or cardiologist, and the member must be ≥ 18 years of age.

  

Veletri (epoprostenol)

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • prescriber is a cardiologist, or pulmonologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis; and
    • clinical rationale explaining why the member cannot use generic epoprostenol.

SmartPA: Claims for Veletri will usually process at the pharmacy without a prior authorization request if the member has a  history of MassHealth pharmacy claims for Veletri.

 Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 05/2010

Last Revised Date: 04/2014


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Last updated 04/22/14