Med part d ppo vital, sig & pdp a. pa_st-11275

Medicare Plus Blue PPO Vitality, Signature and Prescription Blue PDP Option A
Prior Authorization / Step Therapy Program
2011 Plan Year

BCBSM – Medicare Plus Blue PPO Vitality, Signature and Prescription Blue PDP Option A monitors the use of certain
medications to ensure our members receive the most appropriate and cost-effective drug therapy. Prior authorization (PA) for
these drugs means that either clinical and/or administrative criteria must be met before coverage is provided. Drugs subject to
step therapy (ST) may require previous treatment with one or more formulary drugs prior to coverage. Drugs that must meet
clinical/administrative criteria are identified in the formulary list with (PA) or (ST). If drugs listed below have a (g) noted, the PA or
ST criteria may also apply to the generic version of the drug. In some cases, the brand name drug is listed for reference and the
generic drug is covered. Please refer to the Formulary to verify if your drugs are covered. Your physician can contact our
pharmacy help desk to request prior authorization or step therapy for these drugs.
The clinical criteria for authorization are based on current medical information and the recommendations of the Blues’ Pharmacy
and Therapeutics Committee, a group of physicians, pharmacists and other experts.
Please call the Customer Service number on the back of your BCBSM ID card if you have questions about your drug coverage or
a drug claim.
MEDICATION/ DRUG CLASS
CRITERIA
Actemra® (tocalizumab)
This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination.
Coverage is provided for the diagnosis of rheumatoid arthritis and has tried and failed
Enbrel® and Humira®.
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: must be a rheumatologist.
Age restrictions: patients 18 years of age or older.
Coverage duration: Lifetime.
MEDICATION/ DRUG CLASS
CRITERIA
Advicor®
Coverage requires documentation that the patient has had at least 1 month of treatment with lovastatin and niacin extended release as individual agents when used
concomitantly.
Coverage duration: Lifetime.
Alpha-1 Proteinase Inhibitors
Initial request requires documentation of a congenital deficiency of alpha-1 antitrypsin, demonstrated by a homozygous phenotype of AAT, and must be a nonsmoker, and must have symptomatic emphysema and serum levels of alpha-1 antitrypsin that are less than 80mg/dl and must have deteriorating pulmonary function, as demonstrated by a decline in the fev1 (less than 65% of predictive value).
Renewal of therapy requests will be provided for patients who demonstrate serum
levels of alpha-1 antitrypsin that are above threshold of 80mg/dl.
All FDA-approved indications not otherwise excluded for Part D.
Age restrictions: patients 18 years of age or older.
Coverage duration: Initial approval is for 6 months. Reauthorization is for 1 year.
Amitiza®
Coverage is provided for diagnosis of chronic idiopathic constipation or constipation- irritable bowel syndrome.
All FDA-approved indications not otherwise excluded for Part D.
Age restrictions: patients 18 years of age or older.
Coverage duration: Lifetime.
Ampyra®
Initial coverage is provided to improve walking distance in patients with a diagnosis of Multiple Sclerosis who have the ability to walk a timed 25 foot walk test. Initial requests require documentation of a 25 foot timed walk test.
Renewal of therapy require documentation that the member has shown an
improvement in walking distance of a 25 foot timed walk test compared to
pretreatment.
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: prescribing physician is a neurologist.
Exclusion criteria: patients with a history of seizure or moderate to severe renal
impairment defined by a CrCl of 50ml/min or less.
Coverage duration: Initial approval is for 3 months. Reauthorization is for 1 year.
MEDICATION/ DRUG CLASS
CRITERIA
Anabolic Steroids
Oxandrin requires documentation that use is 1) for therapy to offset protein Oxandrin®(g) (oxandrolone),
catabolism associated with prolonged use of corticosteroids. 2) for bone pain associated with osteoporosis. 3) as prophylactic therapy in patients with hereditary
angioedema.
Anadrol-50 requires documentation of:1) HIV associated wasting.2) prophylactic
therapy for hereditary angioedema.3) clinically diagnosed anemia.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: One year.
Anti-diabetic Injectable Agents
Coverage will be provided as adjunctive therapy to improve glycemic control in patients who have a diagnosis of type II diabetes mellitus and are currently taking or have tried and failed 2 of the following: metformin, a sulfonylurea, or a
thiazolidinedione, or one of the following: a combination of metformin and a
sulfonylurea or a combination of metformin and a thiazolidinedione. Documentation of
HbA1c greater than 7% will be required.
All FDA-approved indications not otherwise excluded for Part D.
Exclusion criteria: 1) Coverage will not be provided for weight loss in patients with or
without diabetes. 2) Coverage will not be provided as concurrent therapy with insulin.
Coverage duration: Lifetime.
Aromatase Inhibitors
Coverage is provided for female members. Coverage provided for male members with a diagnosis of ER-positive breast cancer. All FDA-approved indications not otherwise excluded for Part D. Coverage duration: Lifetime.

Arzerra™ (ofatumumab)
This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting
of the drug to make the determination.
Coverage requires documentation of diagnosis of Chronic Lymphocytic Leukemia
(CLL) in patients who are refractory to fludarabine and alemtuzumab therapy.
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: Must be prescribed by an oncologist.
Coverage duration: 1 year.
MEDICATION/ DRUG CLASS
CRITERIA
Berinert®
Coverage is provided for the acute attacks of those with a diagnosis of hereditary angioedema (HAE) established by an immunologist or hematologist. Documentation of diagnosis confirmed with all of the following laboratory findings, i.) C4 level less than
14mg/l, ii.) C1 inha (antigenic) level less than 150 mg, iii.) C1inhf (functional) level less
than or equal to 84 percent.
All FDA-approved indications not otherwise excluded for Part D.
Age restrictions: At least 13 years of age
Prescriber restrictions: Must be prescribed by an Immunologist or Hematologist
Coverage duration: 10 days
Betaseron®
Coverage requires the trial and failure of Extavia®. Coverage duration: 1 year.
Bisphosphonates 1:
Coverage requires trial and failure of or intolerance to Fosamax® (g). Coverage duration: Lifetime.
Atelvia® (risedronate)
Bisphosphonates 2:
Coverage requires trial and failure of or intolerance to Fosamax® (g) and Actonel®. Coverage duration: Lifetime.
Campral®
Coverage is provided for maintenance of abstinence from alcohol in patients with alcohol dependence who have been abstinent at treatment initiation for at least 5 days
post detoxification.
Requires the patient to be enrolled in a comprehensive alcohol management program
which includes psychosocial support, such as a 12-step facilitation, social skills
training or a cognitive-behavioral therapy program.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 1 year.
Cayston®
This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination.
Coverage is provided for treatment to improve respiratory symptoms in cystic fibrosis
patients with Pseudomonas aeruginosa.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 1 month.
MEDICATION/ DRUG CLASS
CRITERIA
Cholesterol-Lowering Therapies 1:
Coverage requires documentation that member has experienced failure (at doses greater than or equal to 40mg) or intolerance to at least one generic statin: Mevacor®
(g), Pravachol® (g), Zocor® (g).
Coverage duration: Lifetime.
Cholesterol-Lowering Therapies 2:
Coverage requires documentation that member has trial and failure, intolerance, contraindication, or adverse reaction to Mevacor ® (g), Pravachol® (g), Zocor® (g), or
member is currently on statin therapy and unable to reach therapeutic target after trial
at maximum tolerated dose (minimum 40mg).
Coverage duration: Lifetime.
Cholesterol-Lowering Therapies 3:
Requires documentation that member has experienced failure (at doses greater than or equal to 40mg) or intolerance to at least one statin: (Mevacor (g), Pravachol (g) Zocor (g)), and trial/failure or intolerance to formulary brand agent Crestor. Livalo (pitavastatin)
Coverage duration: Lifetime
Chorionic Gonadotropins
Coverage will be provided based on documentation of diagnosis. All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 1 year.
Cryopyrin-Associated Periodic
Coverage will be provided based on documentation of diagnosis. Syndromes (CAPS) Agents
All FDA-approved indications not otherwise excluded for Part D. Age restrictions: Arcalyst: patients12 years of age and older.
Coverage duration: 1 year.
Durable Medical Equipment (DME)
This drug may be covered under Medicare Part B or D depending upon the Supply Drugs
circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination.
Coverage duration: Lifetime.
Erythropoiesis Stimulating Agents
These drugs may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting Coverage under Medicare Part D requires documentation diagnosis. Hemoglobin less than 13 for prophylactic use during some major surgeries for Epogen. Hemoglobin less than 12mg/dl for remaining covered uses. All FDA-approved indications not otherwise excluded for Part D. MEDICATION/ DRUG CLASS
CRITERIA
Exclusion criteria: Coverage is not provided in the following conditions: a. Anemia
due to folate, vitamin b-12, and iron deficiencies, hemolysis, bleeding, or bone marrow
fibrosis, b. Anemia associated with treatment of acute and chronic myelogenous
leukemias (CML, AML).
Coverage duration: Three months.
Exalgo®
Coverage is provided for moderate to severe pain in opiod tolerant patients requiring continous around the clock opiod analgesia for an extended period of time.
All FDA-approved indications not otherwise excluded for Part D.
Exclusion criteria: Coverage is not provided for the treatment of acute pain or for
opiod naïve patients.
Coverage duration: 1 year.
Exforge HCT®
(amlodipine/valsartan/hydrochlorothiazide)
Coverage duration: Lifetime.
Fibrates
Coverage requires documentation of trial and failure to gemfibrozil (g) and fenofibrate Fibricor®(fenofibric acid)
Coverage duration: Lifetime.
Coverage requires the trial and failure of either glatiramer or an interferon beta product.
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: Must be prescribed by a neurologist.
Coverage duration: 1 year.
Growth Hormone
Initial requests for human growth hormone in pediatric patients: 1) one of the following indications: growth hormone deficiency (GHD), Prader-Willi Syndrome (PWS), Norditropin®, Norditropin Nordiflex ®, Turners Syndrome, chronic renal insufficiency (CRI). And 2.) Initiating therapy in Nutropin® (all), Omnitrope®, Saizen®, children (male less than 16, female less than 15): initial height measurements less than 5th percentile for age (based on initial evaluation), abnormal growth velocity for at least 6 months, initial subnormal growth hormone test. Renewing treatment in children requires growth velocity of at least 2.5cm/yr during first 6 months and at least 4.5cm/yr for each succeeding 6 month period. May be continued until final height or epiphyseal closure is documented. Requests in adult patients: 1.) The diagnosis of growth hormone deficiency with hypopituitarism when one of the following criteria (a or b) are met: a. Two pituitary hormone deficiencies (other than growth hormone) requiring hormone replacement MEDICATION/ DRUG CLASS
CRITERIA
such as TSH, ACTH, gonadotropins and ADH and both of the following i and ii: i. At
least one known cause for pituitary disease or a condition affecting pituitary function,
including pituitary tumor, surgical damage, hypothalamic disease, irradiation, trauma
or infiltrative disease (histoplasmosis, Sheehan Syndrome, autoimmune hypophysitis,
or sarcoidoisis) is documented. And ii. One provocative stimulation less than 5 ng/ml.
The insulin tolerance test is the preferred testing method, but other secretagogoues,
such as arginine, GHRH, clonidine and l-dopa are acceptable. Or b. Three pituitary
hormone deficiencies (other than growth hormone) requiring hormone replacement
and an igf-1 level below 80 ng/ml. Coverage for serostim for the treatment of aids-
related cachexia.
All FDA approved indications not otherwise excluded for Part D.
Prescriber restrictions: Pediatric patients requires for all indications must be
prescribed by a pediatric endocrinologist or pediatric nephrologist.
Coverage duration: Pediatrics equals one year. Adults equals lifetime.
Hepatitis Vaccine
This drug may be covered under Medicare Part B or D depending upon the Comvax®,
circumstances. Information may need to be submitted describing the use and setting Engerix-B®,
Pediarix®,
Coverage duration: 1 year.
Recombivax HB®
Horizant®
Requires trial and failure of or intolerance to Requip (g) and Mirapex (g). Coverage duration: Lifetime.
Immunosuppressive Therapy for an
This drug may be covered under Medicare Part B or D depending upon the Organ Transplant
circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination.
Coverage duration: Lifetime.
Ilaris® (canakinumab)
Coverage requires diagnosis of cryopyrin-associated periodic syndromes (CAPS)
including familial cold auto-inflammatory syndrome (FCAS) and Muckle–Wells
syndrome (MWS) AND a patient age of 4 years or older. As new FDA approved
indications become available plan will consider coverage accordingly.
Age restrictions: Patients 4 years or older.
Coverage duration: 1 year.
MEDICATION/ DRUG CLASS
CRITERIA
Immune Thrombocytopenic Purpura
Promacta requires a diagnosis of chronic immune thrombocytopenia (ITP) and (ITP) Agents
persistent thrombocytopenia. Requires inadequate response or patient must not be a candidate for corticosteroids, immunoglobulins or splenectomy. Documentation of a current platelet count less than 50,000mcl. Renewal of therapy is provided in patients
who meet all of the following criteria: recent platelet count between 30,000 - 150,000
mcl.
All FDA-approved indications not otherwise excluded for Part D
Prescriber restrictions: Must be prescribed by hematologist or in consultation with a
hematologist.
Age restrictions: patients 18 years of age or older.
Coverage duration: Initial request approve for 3 months. Renewal of therapy
approve for 12 months.
Inhaled Nasal Steroids 1:
Coverage requires trial and failure of or intolerance to Nasarel® (g)/ Nasalide® (g) or Flonase ® (g).
Coverage duration: Lifetime.
Inhaled Nasal Steroids 2:
Coverage requires trial and failure of or intolerance to Nasacort AQ and either Nasalide® (g) / Nasarel® (g) or Flonase® (g). Coverage duration: Lifetime.
Omnaris® (ciclesonide),
Rhinocort Aqua® (budesonide),
Veramyst® (fluticasone)

Innohep®
Coverage is provided for the diagnosis and treatment of acute symptomatic DVT, with or without pulmonary embolism (PE), when administered in conjunction with warfarin.
All FDA-approved indications not otherwise excluded for Part D.
Exclusion criteria: Documentation of history of heparin- induced thrombocytopenia.
Coverage duration: 1 month.
Intravenous Immune Globulin (IVIG)
These drugs may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting Coverage under Medicare Part D requires documentation of diagnosis of Inflammatory MEDICATION/ DRUG CLASS
CRITERIA
Demyelinating Polyneuropathy (acute or chronic), chronic ITP and Kawasaki syndrome.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: Lifetime.
Jevtana®
Coverage requires documentation of diagnosis. Coverage is provided for the treatment of patients, in combination with prednisone, with hormone-refractory metastatic
prostate cancer previously treated with a docetaxel- containing treatment regimen.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 1 year.
Kalbitor®
Coverage is provided for a diagnosis of acute attacks of Hereditary Angioedema (HAE) that have been confirmed by an Immunologist or Hematologist. Documentation
of diagnosis confirmed with all of the following laboratory findings, i.) C4 level less than
14mg/l, ii.) C1 inha (antigenic) level less than 150 mg, iii.) C1inhf (functional) level less
than or equal to 84 percent.
All FDA-approved indications not otherwise excluded for Part D.
Age restriction: Patients 16 years and older.
Prescriber restrictions: Must be prescribed by an Immunologist or Hematologist.
Coverage duration: 10 days.
Lotronex®
Coverage is provided for the diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS), and unresponsive to a trial of conventional IBS therapy such as
Bentyl® (g). Also required is documentation of patient-physician agreement for
Lotronex and physician attestation of qualifications and acceptance of responsibilities
signatures have been attained as recommended in product labeling.
All FDA-approved indications not otherwise excluded for Part D.
Age restriction: Greater than or equal to 18 years of age.
Coverage duration: 1 year.
Lyrica®
Coverage is provided for the diagnosis and treatment of 1) seizures/epilepsy. 2) diabetic peripheral neuropathy. 3) fibromyalgia characterized by pain in all 4 body quadrants, for at least 3 months. 4) post-herpetic neuralgia after a 30 day trial of gabapentin. For off-label uses: trigeminal neuralgia: patient must try and fail carbamazepine and gabapentin. For chemotherapy induced peripheral neuropathy: patient must try and fail gabapentin. MEDICATION/ DRUG CLASS
CRITERIA
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 1 year or lifetime.
Migraine Combination Products
Coverage requires documentation of medical necessity. Trial and failure of naproxen Treximet® (sumatriptan/naproxen sodium) and either Maxalt® or sumatriptan, and documentation as to why use of the individual
agents (naproxen and sumatriptan) is harmful to the patient.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: Lifetime.
Miscellaneous Vaccine: BCG Live
Approved under Medicare Part B if given to treat an injury or as a result of direct Vaccine, Hepatitis A Vaccine, Measles
Virus Vaccine, Rabies Vaccine, Tetanus Approved under Medicare Part D for prophylactic use.
Toxoid Vaccine
Coverage duration: 1 year.
Coverage requires documentation of diagnosis and is provided in combination with granulocyte colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to
the peripheral blood for collection and subsequent autologous transplantation in
patients with non-hodgkin's lymphoma (NHL) and multiple myeloma (MM).
Documentation of G-CSF prior to initiation of Mozobil® for 4 days is also required.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 1 month.
Narcolepsy Agents
Provigil requires documentation of diagnosis of narcolepsy, obstructive sleep apnea,or Nuvigil® (armodafinil)
Provigil® (modafinil)
Nuvigil requires documentation of diagnosis of narcolepsy, obstructive sleep apnea, or shift work sleep disorder and has tried and failed Provigil.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: Lifetime.
Narcotic analgesics
Coverage is provided for breakthrough pain only in patients diagnosed with cancer currently receiving a long acting narcotic with documented tolerance to high dose Abstral®
Documentation of medical diagnosis and tolerance to high dose narcotics is required. Fentora®
All FDA-approved indications not otherwise excluded for Part D. Onsolis®
Coverage duration: 1 year.
MEDICATION/ DRUG CLASS
CRITERIA
Nplate®
Requires a diagnosis of chronic immune thrombocytopenia (ITP) and persistent thrombocytopenia. Documentation of platelet count less than 150,000 mcL for greater
than or equal to 2 months and a current platelet count less than 30,000 mcL.
Must be prescribed by Hematologist or in consultation with a hematologist. Requires
inadequate response or patient must not be a candidate for corticosteroids,
immunoglobulins or splenectomy.
All FDA-approved indications not otherwise excluded for Part D.
Age restrictions: Patients 18 years of age or older.
Prescriber restrictions: Must be prescribed by a Hematologist or in consultation.
Coverage duration: 3 months.
Nuedexta®
Coverage is provided for the treatment of pseudobulbar affect in patients with Requires diagnosis of pseudobulbar affect (PBA).
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 1 year.
Oleptro®
Coverage is provided for the treatment of major depressive disorder and requires the trial and failure of immediate release trazodone and documentation that the continued use of immediate release trazodone will adversely affect the member's health.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: Lifetime.
Oral Anti-emetics Agents
This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting
of the drug to make the determination.
Coverage duration: 1 year.
Oral Chemotherapeutic Agents
This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting
of the drug to make the determination.
Coverage duration: Lifetime.
MEDICATION/ DRUG CLASS
CRITERIA
Osteoporosis Agents
Coverage requires documentation of diagnosis: postmenopausal women with osteoporosis, glucocorticoid induced osteoporosis, or men with primary or hypogonadal osteoporosis, all of who are at high risk for fracture and 1) have tried and
failed, or have a documented intolerance, to a bisphosphonate for a 12 month period
and 2) have a bone mineral density that is 2.5 standard deviations or more below the
mean (t-score at or below -2.5).
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 2 years.
Parenteral Nutrition
This drug may be covered under Medicare Part B or D depending upon the (Numerous ingredients may be reflected in circumstances. Information may need to be submitted describing the use and setting various products) of the drug to make the determination.
Coverage duration: Lifetime.
Prolia®
Requires diagnosis of postmenopausal osteoporosis, who have a high risk for fracture. Requires a 12 month trial and failure, or have a documented intolerance, to a bisphosphonate.
All FDA-approved indications not otherwise excluded for Part D.
Exclusion criteria: Coverage is not provided for Hypocalcemia.
Coverage duration: Lifetime.
Pulmonary Arterial Hypertension (PAH)
Adcirca® and Revatio® (oral): coverage is provided for a diagnosis of Pulmonary Arterial Hypertension (PAH). Coverage for Revatio® or Adcirca® is also provided if used in combination with bosentan (Tracleer®), epoprostenol (Flolan®), treprostinil (Remodulin®) or iloprost (Ventavis®) after monotherapy with one of these agents has been found to be inadequate in the treatment of the patients symptoms. Revatio® IV: coverage is provided for the continued treatment of patients with Pulmonary Arterial Hypertension who are currently prescribed Revatio® tablets but
who are temporarily unable to take oral medication.
Tracleer®: coverage is provided for the diagnosis of Pulmonary Arterial Hypertension
(PAH) in patients with world health organization (WHO) class ii to iv symptoms.
Letairis®: coverage is provided for the diagnosis of Pulmonary Arterial Hypertension
(PAH) in patients with WHO class ii or iii symptoms.
All FDA-approved indications not otherwise excluded for Part D.
MEDICATION/ DRUG CLASS
CRITERIA
Exclusion criteria: Coverage is not provided for sildenafil (Revatio®) and tadalafil
(Adcirca®) in situations where patients are receiving nitrate therapy.
Coverage duration: Injectable agents for 3 months. Oral agents for Lifetime.
Relistor®
Requires a diagnosis of opioid induced constipation in members with advanced illness who are receiving palliative care when response to laxative therapy has not been
sufficient. A member must be stable on opioid therapy for greater than 2 weeks.
All FDA-approved indications not otherwise excluded for Part D.
Exclusion criteria: Coverage is not provided for patients with known or suspected
mechanical gastrointestinal obstruction.
Coverage duration: 3 months.
Renal Cell Carcinoma Agents
Afinitor®:
Initial requests require the diagnosis of advanced renal cell carcinoma and the documented failure of treatment, described as disease progression, with the use of Nexavar® or Sutent®. Maximum dose equals 20mg.
Renewal of therapy is provided in patients who meet all of the following criteria:
confirmation that current medical necessity criteria are met and the medication is
effective.
Votrient: ®
Initial requests require the diagnosis of advanced renal cell carcinoma.
Renewal of therapy is provided in patients who meet all of the following criteria:
confirmation that current medical necessity criteria are met and the medication is
effective.
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: Must be prescribed by an oncologist.
Exclusion criteria: Will not be covered in combination with Nexavar® or Sutent®. Will
not be covered for unapproved or investigational indications.
Coverage duration: Initial and Renewal requests approve for 12 months.
Savella® (milnacipran)
Coverage is provided for the diagnosis of fibromyalgia characterized by pain in all 4
body quadrants, for at least 3 months, with or without fatigue and sleep disturbance.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: requested duration or lifetime.
MEDICATION/ DRUG CLASS
CRITERIA
Sedative Hypnotics (ST):
Coverage requires trial and failure of or intolerance to Ambien® (g), or Sonata® (g). Coverage duration: Lifetime.
Select Cholesterol Combination
Coverage requires documentation that the member has had at least 1 month of Products:
treatment with simvastatin or Vytorin® and either niacin extended release or Advicor®, as individual agents when used concomitantly. Coverage duration: Lifetime.
Selective Reuptake Inhibitor –
Coverage requires step therapy with at least one of the following formulary antidepressants (SRI 1):
alternatives: Celexa® (g), Effexor® (g), Effexor XR® (g), Luvox® (g), Paxil®/CR (g), Prozac® (g), Remeron® (g), Venlafaxin OSM® (g), Wellbutrin®/SR/XL (g), or Zoloft® (g).
Coverage duration: Lifetime.
Selective Reuptake Inhibitor –
Coverage requires step therapy with at least two formulary agents. antidepressants (SRI 2):
Coverage duration: Lifetime.
Pristiq® (desvenlafaxine)
Viibryd® (vilazodone)
Somavert®
Coverage is provided for patients diagnosed with acromegaly who have had an inadequate response to surgery or radiation therapy. All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 1 year.
Stelara®
Coverage is provided for the diagnosis of moderate to severe plaque psoriasis and requires the trial and failure of PUVA and either Enbrel® or Humira®.
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: prescribing physician is a dermatologist.
Age restrictions: patients 18 years of age or older.
Coverage duration: Lifetime.
Strattera®
For members age 5-21: Coverage requires documentation that member has experienced failure of or intolerance to both Ritalin® (g) and Adderall® (g).
For members age greater than 21: Coverage requires documentation that the member
has experienced failure of or intolerance to either Ritalin®(g) or Adderall® (g).
Approvable when stimulants are contraindicated by medical history.
MEDICATION/ DRUG CLASS
CRITERIA
Age restrictions: 5 -21 years old and greater than 21 years old.
Coverage duration: Lifetime.
Suboxone®
Coverage is provided for the treatment of clinically diagnosed opioid dependence with documented use of validated screening tools to identify patients who may have an opioid use problem.
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: Physicians must be certified with a data 2000 waiver.
Age restrictions: 16 years of age or older.
Exclusion criteria: coverage is not provided for pain management.
Coverage duration: 6 months.
Subutex® (g)
Coverage is provided for the treatment of clinically diagnosed opioid dependence with documented use of validated screening tools to identify patients who may have an
opioid use problem.
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: Physicians must be certified with a data 2000 waiver.
Age restrictions:: 16 years of age or older.
Exclusion criteria: coverage is not provided for pain management.
Coverage duration: 1 month.
Tekturna® (aliskiren):
Requires trial of an ace inhibitor and an angiotensin receptor blocker. Tekturna® ,
Coverage duration: Lifetime.
Tekturna HCT®
TNF agents 1:
Following criteria are used in reviewing Enbrel: 1. Diagnosis of psoriatic arthritis. 2. Diagnosis of rheumatoid arthritis or juvenile arthritis, which requires a trial on two concurrent nonbiologic disease modifying anti-rheumatic drugs (dmards), one of which must be methotrexate unless contraindicated. 3. Diagnosis of plaque psoriasis, requires a trial with a topical steroid and treatment with puva (unless puva contraindicated). 4. Diagnosis of ankylosing spondylitis. The following criteria are used in reviewing Humira: 1. For diagnosis of psoriatic arthritis or 2) for diagnosis of rheumatoid arthritis or juvenile arthritis requires a trial on two concurrent nonbiologic disease modifying anti-rheumatic drugs (dmards), one of which must be methotrexate unless contraindicated. 3. For diagnosis of moderately to severely active crohn's disease for patients with a with a history of inadequate MEDICATION/ DRUG CLASS
CRITERIA
response to entocort ec. 4. For diagnosis of ankylosing spondylitis. 5. For diagnosis of
plaque psoriasis, requires a trial with a topical steroid and treatment with puva (unless
puva contraindicated).
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: for ankylosing spondylitis, requires therapy is being
supervised by rheumatologist. For moderate to severe psoriasis, requires therapy is
being supervised by dermatologist
Age restrictions: 18 years or older for crohn's disease.
Coverage duration: Lifetime.
TNF agents 2:
Following criteria are used in reviewing Kineret®: For diagnosis of rheumatoid arthritis, Kineret® requires treatment failure or contraindication to Enbrel® and Humira®. Following criteria are used in reviewing Simponi®: 1. For the treatment of rheumatoid
arthritis or psoriatic arthritis when there has been treatment failure or a
contraindication to both adalimumab (Humira®) and etanercept (Enbrel®). 2. For
ankylosing spondylitis, requires treatment failure or contraindication to both
adalimumab (Humira®) and etanarcept (Enbrel®).
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: For ankylosing spondylitis, requires therapy is being
supervised by Rheumatologist.
Age restrictions: 18 years or older.
Coverage duration: Lifetime.
TNF agents 3:
Coverage will be provided for the diagnosis of acute exacerbation of moderate to severe Crohn’s disease when both of the following criteria are met: 1) treatment with
adequate course of systemic corticosteroids has been ineffective, contraindicated,
patient has been unable to taper, or is experiencing breakthrough disease while
stabilized on an immunomodulatory medication for at least two months and, 2) patient
has had previous trial and failure or contraindication to Humira®.
Coverage is provided for the diagnosis of moderate to severe rheumatoid arthritis
when there has been the trial and failure or contraindication of Humira® and Enbrel®
All FDA-approved indications not otherwise excluded for Part D.
Age restrictions: 18 years or older.
Coverage duration: 1 year.
MEDICATION/ DRUG CLASS
CRITERIA
Topical Anti-emetics
Coverage is provided for use in the prevention and/or treatment of nausea/vomiting associated with chemotherapy and/or radiation therapy and requires treatment failure
with generic ondansetron and generic granisetron. Patient must not be a candidate for
IV granisetron.
All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: 3 months.
Triptans 1
Coverage requires trial and failure with sumatriptan. Coverage duration: Lifetime.
Triptans 2
Requires trial and failure with sumatriptan and Maxalt. (Axert® , Frova® , Relpax® , Zomig®, Zomig Coverage duration: Lifetime.
ZMT®)
Tysabri® (natalizumab)
These drugs may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. Coverage under Medicare Part D requires documentation diagnosis. Coverage is provided for the following 1) diagnosis of a relapsing-remitting form of Multiple Sclerosis and has had a trial of Copaxone® and at least one other interferon beta product unless contraindicated. 2) diagnosis of Crohn’s disease with an elevated baseline c-reactive protein (CRP) levels and has had a trial and failure of Humira® and either Simponi® or Cimzia® unless contraindicated. Documentation of c-reactive protein levels in patients with Crohn’s. All FDA-approved indications not otherwise excluded for Part D.
Coverage duration: Crohn’s disease: 1 year; relapsing-remitting Multiple Sclerosis: 6
months.
Uloric®
Coverage requires treatment failure, intolerance or contraindication with allopurinol. Coverage duration: Lifetime
Vytorin®
Requires trial with Zocor (g) or Simcor, and Zetia, as individual agents when used concomitantly.
Coverage duration: Lifetime.
MEDICATION/ DRUG CLASS
CRITERIA
Xenazine®
Coverage requires a diagnosis of chorea associated with Huntington’s disease. (tetrabenazine)
Documentation of the CYP2D6 genotype of the patient will be required for doses above 50mg per day. All FDA-approved indications not otherwise excluded for Part D.
Exclusion criteria: coverage will not be provided in the following situations, 1) hepatic
function impairment, 2) actively suicidal or who have untreated or inadequately treated
depression, 3) taking monoamine oxidase inhibitors or Reserpine®, 4) treatment of
tardive dyskinesia.
Coverage duration: 1 year.
Xiaflex®
Coverage is provided for the treatment of adult patients with Dupuytren's contracture with a palpable cord.
All FDA-approved indications not otherwise excluded for Part D.
Prescriber restrictions: Physician must have completed the Xiaflex Xperience™
training and their facility is currently enrolled as a healthcare site to receive Xiaflex
orders.
Age restrictions: 18 years and older.
Coverage duration: 1 month.

Source: http://mibcn.net/pdf/medicare/2011/vitality-signature-pdp-a-prior-auth.pdf