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Table 43: Pulmonary Hypertension Agents


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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

Drug
Notes

ambrisentan Letairis PA   A90
bosentan Tracleer PA   BP, A90
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.

 

Therapy for Pulmonary Arterial Hypertension in Adults: Update of the CHEST Guideline and Expert Panel Report (2019)1

  • For treatment naïve patients with WHO FC II and III, initial combination therapy with ambrisentan and tadalafil is suggested to improve 6-minute walk distance (6MWD). For patients unwilling or unable to tolerate combination therapy, monotherapy with an endothelin receptor antagonist (ERA), phosphodiesterase-5 (PDE-5) inhibitor, or riociguat is recommended.
  • For treatment naïve patients in WHO FC IV, initiation of a parenteral prostanoid agent is recommended. For patients who are unwilling or unable to manage parenteral therapy, a combination of an inhaled prostanoid with an oral PDE-5 inhibitor and an ERA is recommended.
  • For WHO FC III or IV patients who have an inadequate response to established PAH-specific monotherapy, the addition of a second class of PAH therapy is recommended to improve exercise capacity.

World Health Organization Functional Classification (WHO-FC) of Patients With PH2

  • 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 Klinger JR, Elliott CG, Levine DJ, Bossone E, Duvall L, et al. Therapy for Pulmonary Arterial Hypertension in Adults: Update of the CHEST Guideline and Expert Panel Report. Chest. 2019 Mar;155(3):565-586. doi: 10.1016/j.chest.2018.11.030. Epub 2019 Jan 17. Erratum in: Chest. 2021 Jan;159(1):457. PMID: 30660783.

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

Drug
Notes

sildenafil 20 mg tablet Revatio PA   A90
sildenafil oral suspension-Liqrev Liqrev PA  
sildenafil oral suspension-Revatio Revatio PA   BP, A90
tadalafil suspension Tadliq PA  
tadalafil tablet-Adcirca Adcirca PA   A90

 Pulmonary Arterial Hypertension Agents – Prostacyclin Receptor Agonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

selexipag Uptravi PA  

 Pulmonary Arterial Hypertension Agents – Prostanoids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

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

 Pulmonary Arterial Hypertension Agents – Soluble Guanylate Cyclase Stimulators

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

riociguat Adempas PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA 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.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)
  • Treatment of WHO Group 1 pulmonary arterial hypertension (PAH)
  • Pulmonary hypertension associated with interstitial lung disease (PH, ILD)

Non-FDA-approved, for example:

  • Raynaud phenomenon

Note: The above lists may not include all FDA-approved and non-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.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

   

Adempas (riociguat)

  • Documentation of the following is required for a diagnosis of CTEPH:
    • appropriate diagnosis; and
    • member ≥ 18 years of age; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • persistent or recurrent CTEPH after surgical treatment, or CTEPH is inoperable; and
    • requested quantity is ≤ three tablets/day; and
    • one of the following:
      • no recent paid pharmacy claims for tadalafil or sildenafil; or
      • agent will not be coadministered with a PDE-5 inhibitor.
  • Documentation of the following is required for a diagnosis of PAH:
    • appropriate diagnosis; and
    • member ≥ 18 years of age; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • inadequate response or adverse reaction to one or contraindication to both of the following: sildenafil, tadalafil; and
    • requested quantity is ≤ three tablets/day; and
    • one of the following:
      • no recent paid pharmacy claims for tadalafil or sildenafil; or
      • agent will not be coadministered with a PDE-5 inhibitor.

SmartPA: Claims for Adempas will usually process at the pharmacy without a PA request if there is a history of paid claims of the requested agent, or if the member is ≥ 18 years of age, 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 20 mg tablets, there is no history of paid MassHealth pharmacy claims for sildenafil 20 mg tablet and tadalafil 20 mg tablet within the last 30 days, and there is no history of paid MassHealth pharmacy claims for sildenafil 20 mg tablet and tadalafil 20 mg tablet for ≥ 15 days of therapy within the last 30 days, and the requested quantity is ≤ three tablets/day.†

     

ambrisentan, bosentan, and Opsumit (macitentan)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • one of the following:
      • for ambrisentan and Opsumit, requested quantity is ≤ one tablet/day; or
      • for bosentan tablet, requested quantity is ≤ two tablets/day; or
      • for bosentan for suspension, all of the following:
        • member is < 13 years of age; and
        • prescriber must provide member's current weight; and
        • requested quantity is ≤ four tablets/day.

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 of 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 ≤ one tablet/day (ambrisentan and Opsumit) or ≤ two tablets/day (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 ≤ four tablets/day.

  

Brand-name Flolan

  • Documentation of the following is required:
    • medical records documenting an allergic response or adverse reaction to the generic product or history of allergic reaction to the inactive ingredients used in the manufacturing process of a certain product; or
    • medical records documenting an inadequate response to a generic equivalent of the requested product.

SmartPA: Claims for brand-name Flolan will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for brand-name Flolan.

   

epoprostenol (generic Veletri)

  • Documentation of the following is required for a diagnosis of PAH:
    • appropriate diagnosis; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • inadequate response, adverse reaction, or contraindication to an epoprostenol product available without prior authorization.

SmartPA: Claims for epoprostenol (generic Veletri) 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.

   

Liqrev, and sildenafil oral suspension (generic Revatio)

  • Documentation of the following is required for a diagnosis of PAH:
    • appropriate diagnosis; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • one of the following:
      • no recent paid pharmacy claims for Adempas; or
      • requested agent will not be administered with Adempas; and
    • one of the following:
      • member has severe dysphagia and is currently utilizing only formulations that can easily be swallowed (e.g., solutions, suspensions, films, or dispersible tablets); or
      • member utilizes tube feeding; or 
      • member is <13 years of age; or 
      • medical necessity for the requested formulation instead of sildenafil tablets; and
    • for Liqrev, medical necessity for use instead of sildenafil oral suspension (generic Revatio).
    • For recertification for a diagnosis of PAH, documentation of continuation to meet the criteria for use of the suspension instead of the tablet formulation as noted by one of the following:
      • member has severe dysphagia and is currently utilizing only formulations that can easily be swallowed; or 
      • member utilizes tube feeding; or 
      • member is <13 years of age; or 
      • medical necessity for the requested formulation instead of tablets.

 

  • Documentation of the following is required for a diagnosis of Raynaud phenomenon:
    • appropriate diagnosis; and
    • one of the following:
      • member has severe dysphagia and is currently utilizing only formulations that can easily be swallowed (e.g., solutions, suspensions, films, or dispersible tablets); or
      • member utilizes tube feeding; or 
      • member is <13 years of age; or 
      • medical necessity for the requested formulation instead of sildenafil tablets; and
    • for Liqrev, medical necessity for use instead of sildenafil oral suspension (generic Revatio); and 
    • one of the following:
      • inadequate response or adverse reaction to one, or contraindication to all of the following: amlodipine, nifedipine, topical nitroglycerin; or
      • PDE5 inhibitor is being used for the healing of digital ulcers. 

 

Orenitram (treprostinil), treprostinil injection, and Ventavis (iloprost)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • inadequate response, adverse reaction, or contraindication to epoprostenol; and
    • for Ventavis, requested quantity is ≤ nine ampules/day.

SmartPA: Claims for Orenitram, treprostinil injection, 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, the prescriber is a pulmonologist or cardiologist, and, if the request is for Ventavis, the requested quantity is ≤ nine ampules/day.

  

sildenafil 20 mg tablet

  • Documentation of the following is required for a diagnosis of PAH:
    • appropriate diagnosis; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • one of the following:
      • no recent paid pharmacy claims for Adempas; or
      • requested agent will not be administered with Adempas.

 

  • Documentation of the following is required for a diagnosis of Raynaud phenomenon:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response or adverse reaction to one, or contraindication to all of the following: amlodipine, nifedipine, topical nitroglycerin; or
      • PDE5 inhibitor is being used for the healing of digital ulcers.

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, there is no history of paid claims for Adempas within the last 30 days, and there is no history of paid MassHealth pharmacy claims for Adempas for ≥ 15 days of therapy within the last 30 days.†

   

tadalafil

  • Documentation of the following is required for a diagnosis of PAH:
    • appropriate diagnosis; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • one of the following:
      • no recent paid pharmacy claims for Adempas; or 
      • agent will not be co-administered with Adempas; and 
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to sildenafil 20 mg tablets; or
      • member is treatment naïve and the requested agent will be used in combination with ambrisentan.

 

  • Documentation of the following is required for a diagnosis of Raynaud phenomenon:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response or adverse reaction to one, or contraindication to all of the following: amlodipine, nifedipine, topical nitroglycerin; or
      • PDE5 inhibitor is being used for the healing of digital ulcers; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to sildenafil (generic Revatio); or
      • medical necessity for use of the requested agent instead of sildenafil (generic Revatio).

SmartPA: Claims for tadalafil 20 mg tablet 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, there is a history of paid MassHealth pharmacy claims for sildenafil 20 mg tablet, there is no history of paid MassHealth pharmacy claims for Adempas within the last 30 days, and there is no history of paid MassHealth pharmacy claims for Adempas for ≥ 15 days of therapy within the last 30 days.†

   

Tadliq

  • Documentation of the following is required for a diagnosis of PAH:
    • appropriate diagnosis; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • one of the following:
      • no recent paid pharmacy claims for Adempas; or 
      • agent will not be co-administered with Adempas; and 
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to sildenafil 20 mg tablets; or
      • member is treatment naïve and the requested agent will be used in combination with ambrisentan; and
    • one of the following:
      • member has severe dysphagia and is currently utilizing only formulations that can easily be swallowed (e.g., solutions, suspensions, films, or dispersible tablets); or
      • member utilizes tube feeding; or 
      • member is <13 years of age; or 
      • medical necessity for the requested formulation instead of tadalafil tablets.
    • For recertification for a diagnosis of PAH, documentation of continuation to meet the criteria for use of the suspension instead of the tablet formulation as noted by one of the following:
      • member has severe dysphagia and is currently utilizing only formulations that can easily be swallowed; or 
      • member utilizes tube feeding; or 
      • member is <13 years of age; or 
      • medical necessity for the requested formulation instead of tablets.

    

Tyvaso (treprostinil inhalation solution), Tyvaso DPI (treprostinil inhalation powder)

  • Documentation of the following is required for a diagnosis of PAH:
    • appropriate diagnosis; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • inadequate response, adverse reaction, or contraindication to epoprostenol; and
    • for Tyvaso DPI, medical records documenting an inadequate response, adverse reaction, or contraindication to Tyvaso inhalation solution.
  • Documentation of the following is required for a diagnosis of PH-ILD:
    • appropriate diagnosis; and
    • prescriber is a pulmonologist or cardiologist, or prescriber provides consultation notes from a pulmonologist or cardiologist regarding the diagnosis; and
    • for Tyvaso DPI, medical records documenting an inadequate response, adverse reaction, or contraindication to Tyvaso inhalation solution.

SmartPA: Claims for Tyvaso 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, and the prescriber is a pulmonologist or cardiologist. 

 

Uptravi (selexipag)

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • appropriate dosing; and
    • prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided; and
    • requested quantity is ≤ two tablets/day; and
    • for Uptravi vial, the member is stabilized on Uptravi tablets and is temporarily unable to take oral medications.

SmartPA: Claims for Uptravi tablets 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.

    

 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: 03/2024


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Last updated 05/16/24

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