Limited use benefit (prior approval required).

For the treatment of:

1. Osteoporosis in patients who are 60 years of age or over OR
2. Paget's Disease OR
3. Osteoporosis in patients under 60 who have documented hip, vertebral or other fractures OR
4. Osteoporosis in patients under 60 with no evidence of fracture but who have a high (>20%) 10-year fracture risk OR
5. Osteoporosis in patients under 60 with moderate 10-year fracture risk AND use of systemic glucocorticoid therapy > 3 months

Limited use benefit (prior approval required).
For the treatment of chronic Hepatitis C in treatment-naïve and treatment experienced patients who meet all the following criteria (patient must meet all criteria before consideration):

1. HCV genotype 1
2. Detectable levels of hepatitis C virus HCV RNA in the last six months
3. No co-infection with HIV
4. Fibrosis stage F2 or greater (Metavir scale or equivalent)
5. No diagnosis of cirrhosis OR compensated liver disease (cirrhosis with a Child Pugh Score = A (5-6))

Limited use benefit (prior approval required).

For the treatment of chronic Hepatitis C in treatment-naïve and treatment experienced patients who meet all the following criteria (patient must meet all criteria before consideration):

1. HCV genotype 1
2. Detectable levels of hepatitis C virus HCV RNA in the last six months
3. No co-infection with HIV
4. Fibrosis stage F2 or greater (Metavir scale or equivalent)
5. No diagnosis of cirrhosis OR compensated liver disease (cirrhosis with a Child Pugh Score = A (5-6))

Limited use benefit (prior approval required).

• Patients with World Health Organization (WHO) class III pulmonary artery hypertension (PAH), either idiopathic (i.e. primary) or
  associated with a congenital or
  systemic condition (e.g. connective tissue disease) and confirmed by right heart catheterization; AND
• who have failed to respond to sildenafil OR tadalafil; OR
• who have contraindications to sildenafil OR tadalafil.

Limited use benefit (prior approval required).

Criteria for initial one year coverage for a MAXIMUM dose dose of 400mg at weeks 0, 2, and 4, followed by 200mg every other week
or 400mg every 4 weeks.

1. Prescribed by a rheumatologist, AND
2. For the treatment of severely active RHEUMATOID ARTHRITIS:

• Patient is refractory to methotrexate weekly parenteral (SC or IM) at 20mg or greater (15mg or greater if patient is >65 years of age) for more than 8 weeks

PLUS a minimum of two of the following:

• leflunomide: 20mg daily for 10 weeks OR
• gold: weekly injections for 20 weeks OR
• cyclosporine: 2-5 mg/kg/day for 12 weeks OR
• azathioprine: 2-3 mg/kg/day for 3 months OR
• sulfasalazine at least 2g daily for 3 months

PLUS one of the following combinations:

• methotrexate with cyclosporine (minimum 4 month trial on both) OR
• methotrexate with hydroxychloroquine and sulfasalazine (minimum 4 month trial on triple therapy) OR
• methotrexate with gold (minimum 12 week trial) OR
• in patients who are intolerant or who have contraindication to methotrexate therapy, or are refractory to a combination of at least 2 DMARDS

Limited use benefit (one-year duration, prior approval required).

1. Patients with intra-coronary stent implantation following insertion.
2. Patients with acute coronary syndrome (ACS) (unstable angina or non-ST-segment elevation MI), in combination with ASA.

Limited use benefit (prior approval required).

For the management of chronic pain in patients who are unresponsive or intolerant to at least one long-acting oral sustained released product, such as morphine, hydromorphone and oxycodone, despite appropriate dose titration and adjunctive therapy including laxatives and antiemetics.

Limited use benefit (prior approval required).

1. For treatment of Benign Prostatic Hyperplasia (BPH) inpatients who do not tolerate or have not responded to an alpha-adrenergic blocker; OR
2. For use in combination therapy when monotherapy with an alpha-blocker is not sufficient.

Limited use benefit (prior approval required).

For the treatment of condylomata acuminate (genital warts) in patients who have failed:

1. self-applied podophyllotoxin (podofilox 0.5% solution); OR
2. provider-applied podophyllum resin (10%-25%)

Limited use benefit (prior approval required).

For adjunctive therapy in patients with refractory partial-onset seizures who meet all of the following criteria:

1. Are under the care of a physician experienced in the treatment of epilepsy, AND
2. Are currently receiving two or more antiepileptic medications, AND
3. Have failed or demonstrated intolerance to at least two other antiepileptic medications.

Limited use benefit (prior approval required).

For the use in combination with other anti-epilepticmedication(s) in the treatment of partial seizures in patients who are refractory to adequate trials of two anti-epileptic medications used either as monotherapy or in combination.

Limited use benefit (prior approval required).

Coverage will be limited to a maximum of 14 days.

Limited use benefit (prior approval required).

For treatment of:

1. asthma when used in patients on concurrent steroid therapy.
2. asthma patients not well controlled with or intolerant to inhaled corticosteroids.

Limited use benefit (prior approval required).

For transplant therapy.

Limited use benefit (prior approval required).

For treatment of type 2 diabetic patients who are not adequately controlled by or are intolerant to metforminand sulfonylureas or for whom these products are contraindicated.

Limited use benefit (prior approval required).

For:

1. secondary prevention of osteoporosis in women who experience failure on bisphosphonates.
2. secondary prevention of osteoporosis in women who have a personal history or a first degree relative with a history of breast cancer

Limited use benefit (prior approval required).

For the treatment of:

1. Paget's Disease or
2. Osteoporosis in patients who are 60 years of age or over OR
3. Osteoporosis in patients under 60 who have documented hip, vertebral or other fractures OR
4. Osteoporosis in patients under 60 with no evidence of fracture but who have a high (>20%) 10-year fracture risk  who have a high  (>20%) 10-year fracture risk or
5. Osteoporosis or risk of osteoporosis in patients under 60 who have been, or who will be on systemic corticosteroid therapy equivalent to a dose of prednisone ≥7.5mg per day for ≥3 months.  Approval period of one year.

Limited use benefit (prior approval required).

For the prevention of stroke and systemic embolism in at-risk patients who have non-valvular atrial fibrillation (AF) AND in whom: 

1. anticoagulation is inadequate following a reasonable trial on warfarin, OR
2. anticoagulation with warfarin is contraindicated or not possible due to inability to regularly monitor via International Normalized Ratio (INR) testing (i.e., no access to INR testing service at a laboratory, clinic, pharmacy, and at home)

Exclusion criteria:

• Patients with impaired renal function (CrCl or estimated GFR < 30 mL/min); OR
• Patients ≥ 75 years of age AND without documented stable renal function; OR
• Patients with hemodynamically significant  rheumatic valvular heart disease especially mitral stenosis; OR
• Patients with prosthetic heart valves

Notes:

1. Documented stable renal function is defined as creatinine clearance or estimated glomerular filtration rate that is maintained for at least 3 months (i.e., 30-49mL/min for 15mg once daily dosing or ≥ 50mL/min for 20mg once daily dosing for at least 3 months).
2. At-risk patients with atrial fibrillation are defined as those with a CHADS2 score of ≥ 1. Although the ROCKET-AF trial included patients with higher CHADS2 score (≥ 2), other landmark studies with the other newer oral anticoagulants demonstrated a therapeutic benefit in patients with a CHADS2 score of 1. Prescribers may consider an antiplatelet regimen or oral anticoagulation for patients with a CHADS2 score of 1.
3. Inadequate anticoagulation" is defined as INR testing results that are outside of the desired INR range for at least 35% of the tests during the monitoring period (i.e., adequate anticoagulation is defined as INR test results that are within the desired INR range for at least 65% of the tests during the monitoring period).
4. A reasonable trial on warfarin is defined as at least 2 months of therapy
5. Since renal impairment can increase bleeding risk, renal function should be regularly monitored. Other factors that increase bleeding risk should also be assessed and monitored (see Xarelto product monograph).
6. Patients starting rivaroxaban should have ready access to appropriate medical services to manage a major bleeding event.
7. There is currently no data to support that rivaroxaban provides adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves, so rivaroxaban is not recommended in these populations.

Limited use benefit (prior approval required).

1. For the adjunctive treatment of seizures associated with Lennox-Gastaux syndrome in adults and children 4 years and older, when prescribed by a neurologist or experienced specialist
2. Patient has failed, is intolerant to, or has contraindications to at least two adjunctive antiepileptic drugs

Limited use benefit (prior approval required).

For the treatment of patients with type 2 diabetes mellitus who: 

• did not achieve glycemic control or who demonstrated intolerance to an adequate trial of metformin AND a sulfonylurea.

Limited use benefit (prior approval required).

For the treatment of chronic Hepatitis C in treatment-naïve and treatment experienced patients who meet all the following criteria (patient must meet all criteria before consideration):

1. HCV genotype 1
2. Detectable levels of hepatitis C virus HCV RNA in the last six months
3. No co-infection with HIV
4. Fibrosis stage F2 or greater (Metavir scale or equivalent)
5. No diagnosis of cirrhosis OR compensated liver disease (cirrhosis with a Child Pugh Score = A (5-6))

Limited use benefit (prior approval required).

For:

1. treatment of adult patients with glioblastoma multiforme or anaplastic astrocytoma, and documented evidence of recurrence or progression after standard therapy (resection, radiotherapy, and chemotherapy).
2. treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.