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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 Details

Drug Generic Name

Drug Brand Name

PA
Status

ambrisentan Letairis PA  
bosentan Tracleer BP PA  
macitentan Opsumit PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

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 phosphodiesterase-5 (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.

 

 Pulmonary Arterial Hypertension Agents – Phosphodiesterase Type 5 Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

sildenafil 20 mg tablet Revatio PA  
sildenafil oral suspension Revatio BP PA  
tadalafil-Adcirca Adcirca PA  

 Pulmonary Arterial Hypertension Agents – Prostacyclin Receptor Agonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

selexipag Uptravi PA  

 Pulmonary Arterial Hypertension Agents – Prostanoids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

epoprostenol-Flolan Flolan # test  
epoprostenol-Veletri Veletri PA  
iloprost Ventavis PA  
treprostinil inhalation solution Tyvaso PA  
treprostinil injection Remodulin BP PA  
treprostinil tablet Orenitram PA  

 Pulmonary Arterial Hypertension Agents – Soluble Guanylate Cyclase Stimulators

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

riociguat Adempas PA  
Table Footnotes
# 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.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 

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, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

   

Adempas (riociguat)

  • Documentation of the following is required for a diagnosis of 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
    • one of the following:
      • agent will not be coadministered with a PDE-5 inhibitor; or
      • clinical rationale explaining why concurrent therapy with a PDE-5 inhibitor is appropriate.

 

  • Documentation of the following is required for a diagnosis of 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 sildenafil or tadalafil; or
      • clinical rationale explaining why the member cannot use sildenafil or tadalafil; and
    • requested quantity is ≤ 90 tablets per month; and
    • one of the following:
      • agent will not be coadministered with a PDE-5 inhibitor; or
      • clinical rationale explaining why concurrent therapy with a PDE-5 inhibitor is appropriate.

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

 

ambrisentan, bosentan, and 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
    • quantity is ≤ 30 tablets/30 days for ambrisentan and Opsumit, quantity is ≤ 60 tablets/30 days for bosentan tablet, or quantity is ≤ 120 tablets/30 days for bosentan for suspension; and
    • requests for bosentan for suspension must meet the above criteria, member is < 13 years of age, and prescriber must provide member's current weight.

SmartPA: Claims for ambrisentan, bosentan tablet, and Opsumit will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for the requested agent OR if the member has a history of MassHealth medical claims for PAH, the prescriber is a pulmonologist or cardiologist, and the requested quantity is ≤ 30 tablets/30 days (ambrisentan and Opsumit) or ≤ 60 tablets/30 days (bosentan tablet).

SmartPA: Claims for bosentan for suspension will usually process at the pharmacy without a PA request if the member is < 13 years of age, has a history of MassHealth medical claims for PAH, the prescriber is a pulmonologist or cardiologist, and the requested quantity is ≤ 120 tablets/30 days (bosentan for suspension).


Orenitram (treprostinil), treprostinil injection, Tyvaso (treprostinil), and 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 Orenitram, treprostinil injection, Tyvaso, and Ventavis will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for the requested agent OR if the member has a  history of MassHealth medical claims for PAH, member has a history of paid 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
    • 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 PA request if the member has a history of MassHealth medical claims for PAH, and the prescriber is a pulmonologist or cardiologist.

  

sildenafil oral suspension

  • 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 why generic sildenafil tablets may not be appropriate.

  

tadalafil

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to sildenafil 20 mg tablets; and
    • prescriber is a cardiologist or pulmonologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis.

SmartPA: Claims for tadalafil will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for PAH, the prescriber is a pulmonologist or cardiologist, and there is a history of paid MassHealth pharmacy claims for sildenafil 20 mg tablet.

 

Uptravi (selexipag)

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

SmartPA: Claims for Uptravi will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for the requested agent.

 

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 PA request if the member has a history of paid 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: 08/2019


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Last updated 11/18/19