Affected Medications: PHENOXYBENZAMINE Effective Date: 01/15/2016
Last Review Date: 12/09/2015
Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. Required
Medical Information:
Documentation of use as preoperative medical therapy for diagnosis of pheochromocytoma and anticipated duration of need
If use is projected to be greater than 14 days, documentation of contraindication to selective alpha-1-adrenergic blocking agents (examples: prazosin, terazosin, or doxazosin) is needed as well as documentation of recent myocardial infarction, catecholamine cardiomyopathy, refractory hypertension, and catecholamine-induced vasculitis For diagnosis of metastatic pheochromocytoma where long-term pharmacologic
treatment is indicated, documentation of contraindication or failure to the following selective alpha-1-adrenergic blocking agents: prazosin, terazosin, or doxazosin Appropriate
Treatment Regimen & Other Criteria:
An alpha-adrenergic blocker is given 10 to 14 days preoperatively to normalize blood pressure and expand the contracted blood volume. A longer duration of preoperative alpha-adrenergic blockade is indicated in patients with recent myocardial infarction, catecholamine cardiomyopathy, refractory hypertension, and catecholamine-induced vasculitis
Initial: 10 mg twice daily, increase by 10 mg every other day until optimal blood pressure response is achieved; usual range: 20-40 mg 2-3 times/day. Doses up to 240 mg/day have been reported
Exclusion Criteria:
Age Restriction: 18 years of age or older Prescriber
Restrictions: Coverage Duration:
165 POLICY NAME:
PLEGRIDY
Affected Medications: PLEGRIDY (peglyated interferon beta-1a) Effective Date: 02/08/2015
Last Review Date: 06/10/2015
Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. Required Medical
Information:
Has relapsing form of MS (eg. Relapsing-remitted MS, Progressive-relapsing MS, or secondary progressive MS with relapses) OR,
First clinical episode of MS with MRI scan that demonstrated features consistent with diagnosis of MS (i.e., multifocal white matter disease).
Appropriate Treatment
Regimen & Other Criteria:
Must fail at least one preferred product (Avonex, Copaxone, Extavia, Gilenya, Tecfidera)
Exclusion Criteria: Concurrent use of any of the following medications: interferon-beta therapy (Betaseron, Extavia, or Rebif). Copaxone, mitoxantrone, Tysabri, or fingolimod (Gilenya).
Age Restriction: Prescriber Restrictions:
Prescribed by or after a consultation with a neurologist or a MS specialist. Coverage Duration: Approval = 12 months
166 POLICY NAME:
POMALYST
Affected Medications: Pomalyst (Pomalidomide) Effective Date: 05/01/2014
Last Review Date: 02/12/2014
Covered Uses: All FDA-approved indications not otherwise excluded by benefit design. Required Medical
Information:
Patient has diagnosis of multiple myeloma; AND
The patient has received at least TWO prior therapies for multiple myeloma including lenalidomide (Revlimid) and bortezomib (Velcade); AND
Patient has demonstrated disease progression on or within 60 days of completion of last therapy for multiple myeloma
Appropriate Treatment
Regimen & Other Criteria:
Pomalyst is used in combination with dexamethasone unless patient is steroid- intolerant.
All patients monitored for signs and symptoms of thromboembolism.
Female patients of child-bearing potential and male partners are instructed on the importance of proper utilization of appropriate contraceptive methods.
Documented consideration of risk/benefit ratio for anticoagulation therapy Baseline CBC with documentation of planned weekly CBC monitoring for the first 8
weeks of treatment and monthly thereafter. Exclusion Criteria: Pregnancy
CBC outside of normal limits without documentation of benefit outweighing risk Age Restriction:
≥ 18 years of age
Prescriber Restrictions:
Prescribed by or in consultation with an oncologist
Prescriber must be certified with the Pomalyst REMS program Coverage Duration: Approval = 12 months, unless otherwise specified.
167 POLICY NAME:
PROLIA
Affected Medications: PROLIA (denosumab) (J0897) Effective Date: 01/01/2014
Last Review Date: 06/12/2013
Covered Uses: All FDA approved indications not otherwise excluded by benefit design.
Required Medical Information:
For Treatment of Osteoporosis:
Documentation of T Score ≤ -2.5 or FRAX Score indicating Major fracture risk > 20% or HIP Fracture > 3%, or non-traumatic fracture.
For Treatment to Increase Bone Mass in Women at High Risk for Fracture Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer:
Evidence of low bone mass (T-score of -1.0 to -2.5). Appropriate
Treatment
Regimen & Other Criteria:
Prolia may be approved for treatment of osteoporosis:
if the patient has failed an intravenous bisphosphonate (eg, ibandronate [Boniva] or zoledronic acid [Reclast]) OR
if the patient has severe renal impairment (eg, creatinine clearance less than 35 mL/min) OR
if the patient has multiple osteoporotic fractures in the setting of T-scores less than - 3.5.
For Treatment to Increase Bone Mass in Men at High Risk for Fracture Receiving Androgen Deprivation Therapy Prolia may be approved for males: If younger than 70 years: T-score < -1.0 at any location, or a history of osteoporotic fracture.
Documentation of adequate calcium intake and Vitamin D and/or treatment required. Exclusion Criteria: A serum 25-hydroxyvitamin D level = 12 ng/mL.
Concurrent use of bisphosphonate therapy or antineoplastic therapy apart from aromatase inhibitors.
Age Restriction: For Treatment to Increase Bone Mass in Men at High Risk for Fracture Receiving Androgen Deprivation Therapy: Age > 70 years if normal bone mineral density or no history of fracture > 18 years for all other indications.
Prescriber Restrictions: Coverage Duration:
168 POLICY NAME:
PROMACTA
Affected Medications: PROMACTA (eltrombopag) Effective Date: 01/01/2014 Last Review Date: 10/08/2014
Covered Uses: All FDA-approved indications not otherwise excluded by plan design. Required Medical
Information:
All indications
Complete blood count with differential and platelet count Liver function test
Thrombocytopenia in patients with ITP All therapies tried/failed
Documentation of splenectomy status
Thrombocytopenia in patients with chronic hepatitis C
Documentation of plan to initiate interferon-based therapy Child-Pugh score
Severe aplastic anemia
All immunosuppressive therapies tried/failed
Baseline hemoglobin and absolute neutrophil count (ANC)
Appropriate Treatment
Regimen & Other Criteria:
Thrombocytopenia in patients with ITP
Documentation of platelet count less than 30,000/mcl
Must fail at least 2 therapies for ITP, including corticosteroids or immunoglobulins (defined as platelets did not increase to at least 50,000/mcl) OR
Documentation of splenectomy AND
Documentation that degree of thrombocytopenia places patient at increased risk for bleeding
Continuation of therapy requires response to treatment with platelet count of at least 50,000/mcl but less than 200,000/mcl and sustained platelet response (platelet count > 400,000/mcl) for long-term re-approval and no significant liver function abnormalities Thrombocytopenia in patients with chronic hepatitis C
Documentation of platelet count less than 75,000/mcl AND Documentation of compensated liver disease
Continuation of therapy requires response to treatment with platelet count of at least 90,000/mcl but less than 400,000/mcl and no significant liver function abnormalities Severe aplastic anemia
169 Documentation of insufficient response to at least 1 prior immunosuppressive therapy Continuation of therapy after initial approval requires hematologic response to
treatment defined as meeting 1 or more of the following criteria:
1) platelet count increases to 20,000/mcl above baseline, or stable platelet counts with transfusion independence for a minimum of 8 weeks;
2) hemoglobin increase by greater than 1.5 g/dL, or a reduction in greater than or equal to 4 units RBC transfusions for 8 consecutive weeks;
3) ANC increase of 100% or an ANC increase greater than 0.5 x 109/L
Discontinue therapy if hematologic response not achieved after 16 weeks of treatment, if platelet count > 400,000/mcl, or significant liver function abnormalities
Exclusion Criteria:
All indications
History of hematological malignancy or myelodysplastic syndrome Thrombocytopenia in patients with chronic hepatitis C
Hepatitis C treatment with direct-acting antiviral agents used without interferon Child-Pugh score > 6
History of ascites or hepatic encephalopathy Age Restriction: Age ≥ 18 years
Prescriber Restrictions:
Thrombocytopenia in patients with ITP and patients with severe aplastic anemia Prescribed by or consultation with hematologist
Thrombocytopenia in patients with chronic hepatitis C
Prescribed by or consultation with hematologist, hepatologist, gastroenterologist, or ID specialist
Coverage Duration:
Thrombocytopenia in patients with ITP
Initial: 2 months, Subsequent: 12 months, unless otherwise specified Thrombocytopenia in patients with chronic hepatitis C
Initial: 2 months, Subsequent: 12 months, unless otherwise specified Severe aplastic anemia
170 POLICY NAME:
PROVENGE
Drug Name: PROVENGE (sipuleucel-T) (Q2043) Effective Date: 07/29/2010
Last Review Date: 09/08/2010
Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Prostate Cancer (dx: 185 only)
Required documentation: Documentation of complete & current treatment course required. Evidence of metastases to soft tissue or bone
Testosterone levels < 50 ug
Below lowest level of normal Evidence of disease progression
Two sequential rising PSA levels obtained 2-3 wks apart Other: ______________________________________ Appropriate Treatment
Regimen:
FDA prescribing guidelines:
Up to three infusions, generally two weeks apart Exclusion Criteria: Prior intolerance or allergic reaction to requested medication
Concomitant use of other chemotherapy or immunosuppressive therapy
Age Restriction: Provider Restriction:
171 POLICY NAME:
REBIF
Affected Medications: REBIF (interferon beta-1a) Effective Date: 01/01/2014
Last Review Date: 04/11/2015
Covered Uses: All FDA approved indications not otherwise excluded by benefit design. Required Medical
Information:
Has relapsing form of MS (eg. Relapsing-remitted MS, Progressive-relapsing MS, or secondary progressive MS with relapses) OR,
First clinical episode of MS with MRI scan that demonstrated features consistent with diagnosis of MS (i.e., multifocal white matter disease).
Appropriate Treatment Regimen & Other
Criteria:
Must fail at least one preferred product (Avonex, Copaxone 20, Extavia, Gilenya, Tecfidera)
Exclusion Criteria: Concurrent use of Avonex, Betaseron, Extavia, Copaxone, Mitoxantrone, Tysabri, or fingolimod (Gilenya)
Age Restriction: Prescriber Restrictions:
Prescribed by or after consultation with a neurologist or an MS specialist.
172 POLICY NAME:
REMICADE
Affected Medications: REMICADE (infliximab)(J1745) Effective Date: 01/01/2014
Last Review Date: 06/10/2015
Covered Uses: All FDA-approved indications not otherwise excluded by plan design. NCCN indications with evidence level of 2 or higher
Juvenile idiopathic arthritis (JIA) Behcet’s disease (BD)
Pyoderma gangrenosum (PG)
Wegener granulomatosis (granulomatosis with polyangiitis) Required Medical
Information:
Indication must be documented in chart notes within the last 6 months
Documentation of staging, all prior therapies used, and anticipated treatment course Rheumatoid Arthritis: laboratory test confirming diagnosis of RA (anti-CCP, RF) Documented latent TB screening with either a TB skin test or an interferon gamma
release assay (e.g, QFT-GIT, T-SPOT.TB) with a negative result. Must be receiving or have completed treatment for latent TB prior to initiation.
Patient weight
Negative HBV or treat prior to therapy with positive results Adults with Crohn’s Disease (CD) and Ulcerative Colitis
Initiation – Diagnosis supported by endoscopy/colonoscopy/sigmoidoscopy or biopsy and a Mayo Clinic score obtained at baseline
Continuation – Reduction in Mayo Clinic score of at least 3 points and a decrease of 30% from baseline
Appropriate Treatment
Regimen & Other Criteria:
Rheumatoid arthritis
Has failed ≥ 12 weeks on Humira AND ≥ 12 weeks Enbrel QL – Initial (one time only) – 3mg/kg at 0,2, and 6 weeks QL – Continuation – 3mg/kg per 6 weeks
Juvenile idiopathic arthritis (JIA)
Has failed ≥ 12 weeks on Humira AND ≥ 12 weeks Enbrel QL – Initial (one time only) – 10mg/kg at 0,2, and 6 weeks QL – Continuation – 10mg/kg per 10 weeks
Psoriatic arthritis (PsA)
Has failed ≥ 12 weeks on Humira AND ≥ 12 weeks Enbrel QL – Initial (one time only) – 5mg/kg at 0,2, and 6 weeks QL – Continuation – 5mg/kg per 8 weeks
Plaque psoriasis (PP)
Has failed ≥ 12 weeks on Humira AND ≥ 12 weeks Enbrel QL – Initial (one time only) – 5mg/kg at 0,2, and 6 weeks QL – Continuation – 5mg/kg per 8 weeks
Crohn’s disease (CD)
173 QL – Initial (one time only) – 5mg/kg at 0,2, and 6 weeks
QL – Continuation – 5mg/kg per 8 weeks Ulcerative Colitis (UC)
Has failed ≥ 12 weeks on Humira
QL – Initial (one time only) – 5mg/kg at 0,2, and 6 weeks QL – Continuation – 5mg/kg per 8 weeks
Ankylosing spondylitis (AS)
Has failed ≥ 12 weeks on Humira AND ≥ 12 weeks Enbrel QL – Initial (one time only) – 5mg/kg at 0,2, and 6 weeks QL – Continuation – 5mg/kg per 6 weeks
Pyoderma Gangrenosum (PG)
Has failed 1 systemic therapy: corticosteroids, mycophenolate, cyclosporine or azathioprine
QL – Initial (one time only) – 5mg/kg at 0,2, and 6 weeks QL – Continuation – 5mg/kg per 4 weeks
Wegener granulomatosis (refractory)
Has failed corticosteroids and at least one immunosuppressant: cyclophosphamide, azathioprine, methotrexate, or mycophenolate
QL – Initial (one time only) – 5mg/kg at 0,2, and 6 weeks QL – Continuation – 5mg/kg per 4 weeks
Behcet’s Disease (BD)
Has not responded to 1 conventional treatment (eg, systemic CS, immunosuppressant (eg, AZA, MTX, mycophenolate mofetil (MM), CSA, tacrolimus, chlorambucil,
cyclophosphamide (CPM), or interferon alfa), etanercept or adalimumab QL – Initial (one time only) – 5mg/kg at 0,2, and 6 weeks
QL – Continuation – 5mg/kg per 6 weeks
Subsequent approval: documentation of treatment success
Oncology uses: Documentation of ECOG performance status of 1 or 2 OR Karnofsky performance score greater than 50%
Reauthorization: documentation of disease responsiveness to therapy Exclusion
Criteria:
Concurrent use of biologic DMARDs: Orencia (abatacept), Rituxan (rituximab), Actemra (tocilizumab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Kineret (anakinra), Simponi (golimumab), Xeljanz (tofacitinib)
Positive test for TB; active HZV, HCV, or HBV
Dose > 5 mg/kg in patients with moderate-severe heart failure (NYHA Class III/IV) Age Restriction: RA, PP, PsA, AS: ≥ 18 years of age
CD,UC,JIA: ≥ 6 years of age Prescriber
Restrictions:
CD/UC: prescribed by or in consultation with a GI specialist PP: prescribed by or in consultation with a dermatologist
RA/JIA/PsA/AS: prescribed by or in consultation with a rheumatologist Oncology: Prescribed by an oncologist
174 Coverage Duration: Crohn’s/Ulcerative Colitis
Approval = 4 months Initiation, 12 months continuation with confirmation of improvement
Oncology
Approval = 3 months Initiation, 12 months continuation
175 POLICY NAME: