Important News

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Prior Review Required for Androgens
(testosterone, methyltestosterone, fluoxymesterone)

Effective April 1, 2011, androgen (testosterone, methyltestosterone, and fluoxymesterone) products will require prior review/certification. These products include:

  • Fluoxymesterone (Androxy)
  • Methyltestosterone (Android, Methitest, Testred)
  • Testosterone, topical (Androderm, Androgel, Testim)
  • Testosterone, buccal (Striant)
  • Testosterone cypionate (Depo-Testosterone)
  • Testosterone enanthate (Delatestryl)

Effective April 1, coverage will be provided for these drugs for the following conditions and indications:

  • Males for the treatment of hypogonadism (low testosterone):
    • patient has symptoms of androgen deficiency AND
    • has a baseline (pre-treatment) morning serum total testosterone level of less than or equal to 300 ng/dL (less than 10.4 nmol/L) OR
    • baseline morning serum free testosterone level, measured by the equilibrium dialysis method, of less than or equal to 50 pg/ml (0.17 nmol/liter), OR
    • baseline morning testosterone level below the normal reference level provided by the physician laboratory.
  • Women for palliative treatment of metastatic inoperable breast cancer
  • Boys with delayed puberty

Prior Review Required for Anabolic Steroids
(oxandrolone, oxymetholone)

Effective April 1, 2011, the anabolic steroids oxandrolone and oxymetholone will require prior review/certification. These products include:

  • Oxandrolone (Oxandrin)
  • Oxymetholone (Anadrol-50)

Oxandrolone (Oxandrin)
Effective April 1, coverage will be provided for oxandrolone (Oxandrin) for the following conditions and indications:

  • Relief of bone pain accompanying osteoporosis
  • Protein catabolism associated with chronic administration of corticosteroids
  • Promotion of weight gain after weight loss
    • following extensive surgery;
    • chronic infections;
    • severe trauma;
    • in patients who otherwise fail to gain or maintain normal weight.
  • HIV cachexia (unintentional weight loss of at least 10% of baseline weight, or body mass index (BMI) less than 20 kg/m2, not attributable to other causes, when optimal antiviral therapy has been instituted)
  • Alcoholic hepatitis
  • Severe burns

Oxandrolone (Oxandrin) is NOT covered for the following conditions:

  • Weight gain for cosmetic reasons
  • To develop muscle mass in otherwise healthy patients

Oxymetholone (Anadrol-50)
Effective April 1, coverage will be provided for oxymetholone (Anadrol-50) for the following conditions and indications:

  • Anemias caused by deficient red cell production associated with the following conditions:
    • acquired aplastic anemia
    • congenital aplastic anemia
    • anemia of chronic renal failure
    • pure red cell aplasia
    • myelofibrosis
    • Fanconi's anemia
    • hypoplastic anemias caused by the administration of myelotoxic drugs, or myelosuppression due to chemotherapy
  • HIV cachexia (unintentional weight loss of at least 10% of baseline weight, or body mass index (BMI) less than 20 kg/m2, not attributable to other causes, when optimal antiviral therapy has been instituted)

Oxymetholone (Anadrol-50) is NOT covered for the following conditions:

  • Weight gain for cosmetic reasons
  • To develop muscle mass in otherwise healthy patients

Prior Review Required for Singulair (montelukast)

Effective April 1, 2011, Singulair (montelukast) will require prior review/certification. Singulair is a leukotriene-modifying agent approved for the prophylaxis and chronic treatment of asthma; for the relief of symptoms of allergic rhinitis; and for the prevention of exercise-induced bronchoconstriction (EIB).

Effective April 1, coverage will be provided for this drug for the following conditions and indications:

  • Use of montelukast will be covered in any patient who has a diagnosis of asthma, or at least one prescription drug claim over the previous 18 months for a drug (non-leukotriene modifying agent) used to treat asthma.
  • Use of montelukast will be covered in any patient who is younger than age 12 years who has a diagnosis of seasonal or perennial allergic rhinitis.
  • Patients 12 years of age and older being treated with montelukast for seasonal or perennial allergic rhinitis must have previously tried at least one intranasal corticosteroid OR intranasal antihistamine, and was either intolerant to the drug or the drug was ineffective or inadequately effective in treating the patient's condition.

Change in Prior Review Requirements for Cimzia (certolizumab pegol) and Simponi (golimumab)

Effective April 1, 2011, coverage of Cimzia and Simponi require use of Enbrel or Humira first (new users).

DRUG CLASS: Disease Modifying Anti-Rheumatic Drug (DMARD)
DRUG NAMES: Certolizumab pegol (Cimzia)
Golimumab (Simponi)

Effective April 1, 2011, coverage of certolizumab pegol (Cimzia) and golimumab (Simponi) require physician written certification as follows: In addition to meeting specific clinical coverage criteria for each drug, new users of these medications must have previously used either etanercept (Enbrel) or adalimumab (Humira) and such drug was detrimental to the patient's health or was ineffective in treating the patient's condition, and is likely to be detrimental to the patient's health or ineffective in treating the condition again.

This new requirement is in addition to the current prior review criteria for Cimzia and Simponi. Please see http://www.bcbsnc.com/content/providers/ppa/prescriptions.htm for information on current criteria. Note: the fax request forms for Cimzia and Simponi will change effective April 1, 2011.

Change in Prior Review Requirements for oral drugs for Pulmonary Arterial Hypertension

Effective April 1, 2011, utilization management criteria for the coverage of oral drugs for pulmonary arterial hypertension will change as below (for new users).

DRUG CLASS: ORAL DRUGS FOR PULMONARY ARTERIAL HYPERTENSION (PAH)
BRAND (generic) NAMES: Tracleer (bosentan) tablet
Letairis (ambrisentan) tablet
Revatio (sildenafil) tablet
Adcirca (tadalafil) tablet

Effective April 1, 2011, the following will be ADDED to the current prior review criteria for oral drugs for pulmonary arterial hypertension and apply to new users:

  • Combination therapy with more than one drug for PAH is considered investigational at this time and not covered, unless drugs overlap temporarily when changing from one treatment to another.
  • Use is considered investigational and not covered for the treatment of pulmonary hypertension conditions (WHO Groups 2-5), including but not limited to:
    • Pulmonary hypertension associated with left heart diseases;
    • Pulmonary hypertension associated with lung diseases and/ or hypoxemia (including chronic obstructive pulmonary disease);
    • Pulmonary hypertension due to chronic thrombotic and/or embolic disease;
    • Miscellaneous group (i.e. sarcoidosis, histiocytosis X and lymphangiomatosis)

This new requirement is in addition to the current prior review criteria for Tracleer, Letairis, Revatio, and Adcirca. Please see http://www.bcbsnc.com/content/providers/ppa/prescriptions.htm for information on current criteria. Note: the fax request forms for PAH drugs will change effective April 1, 2011.

Change in Coverage for Silenor (doxepin)

Effective April 1, 2011, Blue Cross and Blue Shield of North Carolina (BCBSNC) is changing the administrative process regarding coverage of Silenor (doxepin), recently approved for the treatment of insomnia. Reimbursement of Silenor will be considered only after a member's physician certifies in writing to BCBSNC that the member has previously used at least one preferred hypnotic agent and such drug was ineffective in treating the condition or was detrimental to the member's health.

1NON-PREFERRED MEDICATIONS:
Physician certification required as of April 1, 2011
PREFERRED MEDICATIONS
Hypnotics: NON-PREFERRED MEDICATIONS:
  • Edluar
  • Lunesta
  • Rozerem
  • Silenor
  • Zolpimist
Hypnotics: PREFERRED MEDICATIONS:
  • Zaleplon (generic Sonata)
  • Zolpidem (generic Ambien)
A benefit limit may also apply to hypnotic agents for some members.
1Only the non-preferred drugs listed are subject to physician certification requirement.

Members will be notified of this change by early March 2011. After April 1, if a member attempts to fill a prescription for Silenor, the claim will reject at the pharmacy as prior review/certification by BCBSNC will be required. As a result of the claim rejection, the member may contact their physician to discuss if a preferred generic option would be appropriate for their condition. If the physician believes that the non-preferred medication is necessary, the physician must submit the above-referenced written certification to BCBSNC for review. Fax request forms will be available on the Web on or before April 1, 2011.

For a complete listing of prescription medications that require prior review, please visit http://www.bcbsnc.com/content/providers/ppa/prescriptions.htm.