Affected Medications: REMODULIN (treprostinil) (J2385) Effective Date: 09/23/2012
Last Review Date: 02/11/2015
Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Required
Medical Information:
Pulmonary arterial hypertension (PAH) WHO Group 1
Documentation of PAH confirmed by right-heart catheterization
Etiology of PAH: approve if PAH secondary to one of the following conditions: connective tissue disease, thromboembolic disease of the pulmonary arteries, human
immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to right shunts
Documentation of acute vasoreactivity testing (positive result requires trial/failure to calcium channel blocker)
NYHA/WHO Functional Class III to IV symptoms Appropriate
Treatment Regimen & Other Criteria:
For initiation of therapy patient must have mean pulmonary artery pressure at least 25 mmHg at rest or at least 30 mmHg with exertion
AND
The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition
Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out
Documentation that treprostinil is used as a single route of administration (Remodulin, Tyvaso, Orenatriam should not be used in combination)
Subsequent approval requires documentation of treatment success: exercise endurance, echocardiographic testing, hemodynamic testing, BNP, functional class
Exclusion Criteria:
PAH secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular disease, left sided valvular heart disease, etc) or disorders of the respiratory system (e.g., chronic obstructive pulmonary disease, interstitial lung disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders, etc.)
Age Restriction: 18 years of age and older Prescriber
Restrictions:
Prescribed by or in consultation with cardiologist or Pulmonologist Coverage
Duration:
Initial coverage: 3 months unless otherwise specified Subsequent coverage: 12 months unless otherwise specified
176 POLICY NAME:
REPATHA
Affected Medications: REPATHA (evolocumab) Effective Date: 01/01/2016
Last Review Date: 01/13/2016
Covered Uses: All FDA approved indications not otherwise excluded by benefit design.
Adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH who require additional lowering of LDL-C
Adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical ASCVD who require additional lowering of LDL-C
Adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C
Required Medical Information:
All indications:
Documentation of current complete lipid panel within last 3 months Documentation of baseline LDL-C (untreated)
HeFH/HoFH:
Diagnosis confirmed based on WHO criteria/Dutch Lipid Clinical Network criteria with score of greater than 8 points OR Simon Broome register diagnostic criteria with a criterion for definite FH OR genotype test confirming mutation of LDL receptor gene or familial defective apo B-100
Documentation of current rosuvastatin 20-40 mg or atorvastatin 40-80 mg and/or ezetimibe or fenofibrate use
Clinical ASCVD:
Documentation of daily high intensity statin (rosuvastatin 20-40 mg or atorvastatin 40-80 mg) and ezetimibe 10 mg use for at least 6 months - may review pharmacy profile if available
Documentation of tobacco status and cessation if applicable
Documentation of clinical ASCVD in medical history: Myocardial infarction, Unstable angina, Coronary revascularization procedure (PCI or CABG), Diagnosis of clinically significant coronary heart disease by coronary angiography, stress test using treadmill, stress echocardiography or nuclear imaging OR a coronary heart disease (CHD) risk- equivalent, defined as documented history of 1 or more of the following: Peripheral arterial disease, Ischemic stroke of atherothrombotic origin, Chronic kidney disease (CrCl 30-60 mL/min, Diabetes mellitus PLUS at least 2 additional risk factors: Hypertension; ankle-brachial index ≤0.90; micro- or macro-albuminuria; retinopathy; or family history of early coronary heart disease
Request for PCSK9 due to rhabdomyolysis:
Documentation of creatinine kinase (CK) levels greater than 10-times upper limit of normal OR
177 Chart documentation of diagnosis
Request for PCSK9 due to myalgia or myopathy:
Documentation of persistent myalgia or myopathy on 3 separate trials (each trial minimum 8 weeks duration) with pravastatin, rosuvastatin, fluvastatin separated by an adequate ‘holiday’ of 2 weeks
Evaluation of other causes of muscle symptoms (hypothyroidism, vitamin D deficiency, rheumatologic or musculoskeletal disease, exercise, steroid myopathy, antipsychotics, immunosuppressants, bisphosphonates, alcohol or drug abuse, drug or food interactions) Appropriate
Treatment Regimen & Other Criteria:
Repatha for clinical ASCVD and HeFH : 140 mg every 2 weeks or 420 mg once monthly; for HoFH: 420 mg once monthly
HeFH/HoFH:
Must take along with maximally tolerated doses of statin and ezetimibe if no contraindication
Clinical ASCVD:
Approve only if documentation of cardiovascular event (myocardial infarction, ischemic stroke, coronary revascularization procedure, etc.) while on optimized doses of and optimized adherence (80% or greater) to statin and/or ezetimibe
Must take along with maximally tolerated doses of statin and/or ezetimibe if no contraindication
Exclusion Criteria:
Fasting serum triglycerides greater than 400 mg/dL
History of documented ASCVD and LDL-C less than 70 mg/dL No history of documented ASCVD and LDL-C less than 100 mg/dL Age Restriction:
Prescriber Restrictions:
Prescribed by or in consultation with Cardiologist, Endocrinologist, or Lipid Specialist
Coverage Duration:
178 POLICY NAME:
REVATIO
Affected Medications: REVATIO (sildenafil) Effective Date: 01/01/2014
Last Review Date: 12/09/2015
Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Required Medical
Information:
NYHA/WHO Functional Class II or III symptoms
PAH WHO Group 1 confirmed by right heart catheterization OR by Doppler echocardiography
Etiology of PAH (idiopathic or associated with connective tissue disease)
For Revatio injection: patient was previously receiving Revatio tablets but is now temporarily unable to take oral medications
Subsequent approvals require documentation of treatment success such as improved walking distance or improvements in functional class
Appropriate Treatment
Regimen & Other Criteria:
Exclusion Criteria: Concomitant nitrate therapy on a regular or intermittent basis Age Restriction:
Prescriber Restrictions:
Coverage Duration: Revatio tablets = 12 months , unless otherwise specified Revatio injection = 3 months, unless otherwise specified
179 POLICY NAME:
REVLIMID
Affected Medications: REVLIMID (lenalidomide) Effective Date: 04/01/2014
Last Review Date: 09/10/2015
Covered Uses: All FDA-approved indications not otherwise excluded by plan design. NCCN indications with evidence level of 2A or higher
Required Medical Information:
Reauthorization: documentation of disease responsiveness to therapy Appropriate
Treatment
Regimen & Other Criteria:
Documentation of dose adjustment based on appropriate lab values Revlimid is warranted in any of the following settings:
Active/symptomatic/smoldering myeloma or progressive solitary plasmacytoma Revlimid is used as a single agent for steroid-intolerance, or in combination with
dexamethasone with or without bortezomib or carflizomib or cyclophosphamide or bendamustine
Revlimid is used as maintenance monotherapy for patients responding to primary induction therapy or for patients with stable or responsive disease following stem cell transplant,
Appropriate thromboprophylaxis for Revlimid used in combination with other agents Low or intermediate-1 risk MDS
In those with a 5q deletion, patients have transfusion-dependent anemia (i.e., greater than 2 units of red blood cells in the previous 8 weeks) or symptomatic anemia
In those without a 5q deletion and symptomatic anemia when patients are ineligible for or have failed a trial of erythropoietin.
NHL
Revlimid is used in relapsed or refractory disease in patients with CLL/SLL Revlimid is used as monotherapy or in combination with rituximab for relapsed,
refractory, or progressive disease in almost all subtypes of NHL (excluding cutaneous T- cell Lymphoma)
Systemic light chain amyloidosis
Revlimid is used in combination with dexamethasone as primary therapy. Classical Hodgkin Lymphoma
Revlimid is used in relapsed or refractory disease
180 Exclusion Criteria: Consider holding therapy if Karnofsky Performance Status 50% or less or ECOG
performance score 3 or greater Age Restriction:
Prescriber Restrictions: Coverage Duration:
Initial approval: 6 months unless otherwise specified Reauthorization: 12 months unless otherwise specified
181 POLICY NAME: