Download Pulmonary Arterial Hypertension (“PAH”)

PHARMACY PRE-AUTHORIZATION CRITERIA
DRUG (S)
Pulmonary Arterial Hypertension (“PAH”) Medications
Adcirca (tadalafil)
Adempas (riociguat)
Flolan (epoprostenol)
Letairis (ambrisentan)
Opsumit (macitentan)
Orenitram (treprostinil)
Remodulin (treprostinil)
Revatio (sildenafil)
Tracleer (bosentan)
Tyvaso (treprostinil)
Uptravi (selexipag)
Ventavis (iloprost)
POLICY #
24118
Flolan J-1325
Remodulin J-3285
Tyvaso J-7686
Ventavis Q-4074
INDICATIONS
Letairis, Tracleer, Revatio: For improvement in exercise ability and delay in clinical worsening in
patients with WHO Group I pulmonary hypertension (PAH)
Opsumit: For the treatment of pulmonary hypertension (WHO Group 1) to delay disease
progression
Ventavis: For the treatment of pulmonary hypertension (WHO Group 1) to improve a composite
endpoint consisting of exercise tolerance, symptoms and lack of deterioration
Orenitram, Remodulin, Tyvaso: For the treatment of pulmonary arterial hypertension (WHO
Group 1) to diminish symptoms associated with exercise
Uptravi: For the treatment of pulmonary hypertension (WHO Group I) to delay disease
progression and reduce the risk of hospitalization
Adcirca: For improvement in exercise ability in patients with WHO Group I pulmonary
hypertension
Flolan: for long-term intravenous treatment of adult patients with NYHA Class III or IV primary
pulmonary hypertension or adults with pulmonary hypertension due to scleroderma (systemic
sclerosis)
PHARMACY PRE-AUTHORIZATION CRITERIA
Adempas: For the treatment of pulmonary hypertension in patients with persistent/recurrent
chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical
treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class or
pulmonary arterial hypertension (WHO Group 1), to improve exercise capacity, WHO functional
class and to delay clinical worsening
New York Heart Association functional classification:
Class 1: No symptoms with ordinary physical activity.
Class 2: Symptoms with ordinary activity. Slight limitation of activity.
Class 3: Symptoms with less than ordinary activity. Marked limitation activity.
Class 4: Symptoms with any activity or event at rest
CRITERIA
Criteria for Adcirca, Orenitram, and Revatio:
• Patient has clinically documented Pulmonary arterial hypertension (defined as a mean
pulmonary arterial pressure >25mm Hg at rest or >30mm Hg during exercise, with a
normal pulmonary capillary wedge pressure)
• Patient must be followed by and drug therapy prescribed by a cardiologist or
pulmonologist
Criteria for Letairis:
• Patient has clinically diagnosed primary or secondary pulmonary arterial hypertension
(defined as a mean pulmonary arterial pressure >25mm Hg at rest or >30mm Hg during
exercise, with a normal pulmonary capillary wedge pressure)
• Patient exhibits Class II or III symptoms
• Patient has had an intolerance to, or treatment failure of a calcium channel blocker
OR
• Patient failed to have a pulmonary vasodilatory response to an acute short acting
vasodilator
Criteria for Tracleer:
• Patient has clinically diagnosed primary or secondary pulmonary arterial hypertension
(defined as a mean pulmonary arterial pressure >25mm Hg at rest or >30mm Hg during
exercise, with a normal pulmonary capillary wedge pressure)
• Patient exhibits Class III and IV symptoms
• Patient has had an intolerance to, or treatment failure of a calcium channel blocker
OR
• Patient failed to have a pulmonary vasodilatory response to an acute short acting
vasodilator
• Patient has had an intolerance to, or treatment failure of Letairis
• Patient is not concurrently on glyburide or cyclosporine
Criteria for Opsumit:
• Patient has clinically documented Pulmonary arterial hypertension (PAH) (WHO Group 1)
PHARMACY PRE-AUTHORIZATION CRITERIA
with WHO/NYHA Functional Class II or III.
AND
• Patient has had prior therapy, intolerance, or contraindication to ONE Phosphodiesterase
type 5 (PDE-5) inhibitor approved for use in PAH (sildenafil, vardenafil, avanafil or
tadalafil)
AND
• Patient has had prior therapy, intolerance, or contraindication to ONE endothelin receptor
antagonist Letairis (ambrisentan) or Tracleer (bosentan).
Criteria for Flolan, Remodulin, Tyvaso, Uptravi, and Ventavis:
• Patient has clinically diagnosed primary or secondary pulmonary arterial hypertension
(defined as a mean pulmonary arterial pressure >25mm Hg at rest or >30mm Hg during
exercise, with a normal pulmonary capillary wedge pressure)
• Patient exhibits Class III or IV symptoms ( Flolan, Tyvaso, and Ventavis only)
• Patient exhibits Class II to IV symptoms (Remodulin only)
AND
• Patient has had an intolerance to, or treatment failure of a calcium channel blocker after
favorable response to acute vasoreactivity testing
OR
• Failure to have a pulmonary vasodilator response to an acute challenge of a short acting
vasodilator
AND
• Intolerance to, contraindication*, or treatment failure to Tracleer (bosentan)
* Contraindications to bosentan include: pregnancy, LFT abnormalities, co-administration with
either cyclosporine or glyburide
Criteria for Adempas:
Pulmonary Hypertension associated with chronic thrombotic and/or embolic disease:
• Patient must have persistent/recurrent chronic thromboembolic pulmonary hypertension
(CTEPH), WHO Group 4
• Patient must have recurrent or persistent disease after surgical intervention
OR
• Patient must have inoperable disease determined by V/Q scan and/or pulmonary
angiography in consultation with an experienced pulmonary thromboendarterectomy
center
Pulmonary Arterial hypertension:
• Patient has a diagnosis of WHO Group 1 PAH
AND
• Sildenafil has been ineffective, not tolerated, or contraindicated
PHARMACY PRE-AUTHORIZATION CRITERIA
DRUG (S)
Pulmonary Arterial Hypertension (“PAH”) Medications
#24118
LIMITATIONS
If the above criteria are met initial authorizations is 3 months.
Subsequent approval (up to 1 year) will be based on current progress notes from the physician
documenting disease stability/status.
Revatio 20mg quantity limit- 90 tablets per month.
Tracleer quantity limit - 60 tablets per month.
Tyvaso limitation of one starter kit per year.
REFERENCES
1. Adcirca full prescribing information. Indianapolis, IN. Eli Lilly and Company.
2. Adempas full prescribing information. Whippany, NJ, Bayer HealthCare Pharmaceuticals
3. Flolan full prescribing information GlaxoSmithKline.
4. Letairis full prescribing information. Gilead Sciences Inc. Foster City, CA
5. Opsumit full prescribing information. San Francisco, CA, Actelion Pharmaceuticals
6. Orenitram full prescribing information. Research Triangle Park, NC, United Therapeutics
Corporation.
7. Remodulin full prescribing information United Therapeutics.
8. Revatio tablets [package insert]. New York, NY: Pfizer Labs
9. Tracleer (bosentan) full prescribing information. Actelion Pharmaceuticals, Inc
10. Tyvaso full prescribing information. Research Triangle Park, NC. United Therapeutics Corp.
11. Facts & Comparisons online
12. Ventavis full prescribing information. Cotherix, Inc. South SanFrancisco, CA
P&T REVIEW
HISTORY
3/05, 9/05, 6/07, 9/07, 3/08, 6/08, 9/09, 9/10, 12/11, 10/12, 10/13, 6/14, 10/14, 11/15, 5/16,
11/16
REVISION
RECORD
3/08, 6/10, 5/16, 11/12, 11/16