Download Pharmacy Policy Updates Feb. 1, 2014

Premera Blue Cross Medicare Advantage
Pharmacy Policy Updates
The following recommendations included on this update have been approved by the
Pharmacy and Therapeutics Committee (P&T). Please note: For Medicare Advantage
plans, most Part D–eligible drugs and drug policies are not effective and administered
until Centers for Medicare and Medicaid Services approval is obtained. Please refer to
the most current approved formulary document, which is available at
premera.com/medicare-advantage/pharmacy-services/
Pharmacy policies are updated and available on the secure provider Medicare
Advantage website at premera.com/wa/provider/medicare-advantage/; simply click on
the Get Started button.
Class Reviews
Colony-Stimulating Agents
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The following drugs were reviewed: Filgrastim (Neupogen®), Pegfilgrastim
(Neulasta®), Sargramostim (Leukine®) and a new drug, TBO-filgrastim (Granix®).
Significant changes:
o TBO-filgrastim added to formulary
o Health plan: Remove filgrastim and pegfilgrastim from prior authorization (PA)
Health Plan: All agents on formulary
Prothrombin Complex Concentrate
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The following drugs were reviewed: Bebulin® VH, Profilnine® SD, and Feiba® NF and
a new drug, Kcentra®).
Significant changes:
o Kcentra® added to Formulary
o Non-formulary: Bebulin®VH and Profinine®SD
Health Plan: All agents covered as medical benefit
ESA Agents
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The following drugs were reviewed: epoetin alfa (Epogen®), epoetin alfa (Procrit®),
darbepoetin alfa (Aranesp®) and peginesatide (Omontys®)
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Significant changes: No changes to current formulary setup
Health Plan: Formulary agents are epoetin alfa (Epogen®), epoetin alfa (Procrit®) and
darbepoetin alfa (Aranesp®)
Ulcerative Colitis Mesalamine Products
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The following drugs were reviewed:
Oral: Asacol®, Delzicol®, Apriso®, Pentasa®, Lialda®
Rectal: Canasa®, Rowasa(r)
Significant changes:
o Health Plan: All agents are now formulary with no restrictions
Health Plan: All agents on formulary
New Drugs:
Granix® (TBO-Filgrastim – syringe)
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Please refer to the Colony-Stimulating Agents class review above
KCentra® (Human Prothromin Complex– kit)
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Please refer to the Prothrombin Complex Concentrate class review above
Xofigo® (Radium-223 dichloride – vial)
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Indication: treatment of patients with castration-resistant prostate cancer (CRPC),
symptomatic bone metastases and no known visceral metastatic disease.
Health Plan: Medical Benefit with criteria for use
Clinical criteria for use:
o Must be prescribed by, or in consultation with, an oncologist
Lymphoseek® (Technetium Tc 99m tilmanocept - injection)
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Indication: indicated for lymphatic mapping with a hand-held gamma counter to assist in
the localization of lymph nodes draining a primary tumor site in patients with breast
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cancer or melanoma.
Health Plan: Medical Benefit
Brintellix® (Vortioxetine HCL - tablet)
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Indication: Treatment of Major Depressive Disorder
Health Plan: Formulary with PA
Criteria for use:
• Documented trial, failure, intolerance or contraindication to at least two
formulary generic SSRI medications
New Strengths & Formulations:
Nymalize® (Nimodipine - oral solution)
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Indication: For the improvement of neurological outcome by reducing the incidence and
severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from
ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition
Health Plan: Medical Benefit
Marqibo® (Vincristine Sulfate - infusion)
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Indication: Treatment of adult patients with Philadelphia chromosome negative (Ph-)
acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has
relapsed following two or more anti-leukemia therapies
Health Plan: Medical Benefit with PA
Criteria for use:
• Must be prescribed by, or in consultation with, an oncologist
Minastrin 24 FE® (Noreth A-ET Estra/FE Fumarate - chewable tablet )
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Indication: indicated for use by women to prevent pregnancy.
Formulary alternatives: Junel Fe, Microgestine Fe, Loestrin Fe 1/20
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Health Plan: Non-formulary
Lo Minastrin FE® (Noreth A-ET Estra/FE Fumarate - chewable tablet )
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Indication: indicated for use by women to prevent pregnancy.
Formulary alternatives: Junel Fe, Microgestine Fe, Loestrin Fe 1/20
Health Plan: Non-formulary
Quartette® (L-norgest-Eth Estr/Ethinyl Estradiol - tablet)
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Indication: Combination oral contraceptive to prevent pregnancy and postcoital
contraception.
Formulary alternatives: generic Jolessa, generic Quasense
Health Plan: Non-formulary
Zenzedi® (Dextroamphetamine Sulfate - tablet )
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Indication: Treatment of ADHD and Narcolepsy
Formulary alternative: generic dextroamphetamine sulfate
Health Plan: Non-formulary
Zubsolv® (Buprenorphine/Naloxone - sublingual tablet)
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Indication: Treatment of opioid dependence
Formulary alternative: generic buprenorphine – naloxone SL tablets
Health Plan: Non-formulary
Kogenate® FS (Antihemophilic Factor VIII – kit)
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Indication: control and prevention of bleeding episodes in adults and children (0-16
years) with hemophilia; peri-operative management in adults and children with
hemophilia A; routine prophylaxis to reduce the frequency of bleeding episodes and the
risk of joint damage in children with hemophilia A with no preexisting joint damage.
Health Plan: Medical Benefit
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Trokendi XR® (Topiramate - capsule)
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Indications:
o Initial monotherapy in patients 10 years of age and older with partial onset or
primary generalized tonic-clonicseizures and adjunctive therapy in patients 6
years of age and older with partial onset or primary generalized tonic-clonic
seizures.
o Adjunctive therapy in patients 6 years of age and older with seizures associated
with Lennox-Gastaut syndrome
Formulary alternatives: generic topiramate immediate release, sodium valproate,
clonazepam, lamotrigine
Health Plan: Non-formulary
Astagraf XL® (Tacrolimus - capsule)
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Indication: Prophylaxis of organ rejection in patients receiving a kidney transplant with
mycophenoloate motefetil and corticosteroids with or without basiliximab induction
Health Plan: Formulary
Valchlor® (Mechlorethamine HCL - gel)
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Indication: topical treatment of Stage IA and IB mycosis fungoides-type cutaneous Tcell
lymphoma in patients who have received prior skin directed therapy
Health Plan: Formulary (Specialty) with PA
Criteria for use
• Must be prescribed by, or in consultation with, an oncologist
• Trial, failure, intolerance or contraindication to one conventional therapy
including, but not be limited to: tazarotene cream or gel, imiquimod,
bexarotene gel or carmustine
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New US Food and Drug (FDA) Approvals:
Pramosone® (Hydrocortisone/Pramoxine - lotion)
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Indication: For the relief of inflammatory and pruritic manifestations of corticosteroidresponsive dermatoses
Formulary alternatives: Proctocream HC, Procto-pak, Proctozone HC
Health Plan: Non-formulary
Analpram® HC (Hydrocortisone/Pramoxine - lotion, cream, cream singles)
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Indication: For the relief of inflammatory and pruritic manifestations of corticosteroidresponsive dermatoses
Formulary alternatives: Proctocream HC, Procto-pak, Proctozone HC
Health Plan: Non-formulary
Pediprox 4-Nail ® (Ciclopirox/Nail Lacquer/Foot Deod. - kit)
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Indication: Topical treatment in immunocompetent patients with mild to moderate
onychomycosis of fingernails and toenails without lunula involvement, due to
Trichophyton rubrum
Formulary alternatives: oral antifungals (e.g. terbinafine, itraconazole, fluconazole)
Health Plan: Non-formulary
Proctofoam HC® (Hydrocortisone/Pramoxine - topical foam)
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Indication: Relief of the inflammatory and pruritic manifestations of corticosteroidresponsive dermatoses of the anal region
Health Plan: Formulary
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Other Formulary Changes:
Vibramycin® (Doxycycline Monohydrate - oral suspension)
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Indication: to treat or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria.
Formulary alternatives: doxycycline tablets or capsules
Health Plan: Non-formulary
New Generic Medications
First time generics to market
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Lidocaine patch (Lidoderm®)
- Keep formulary with prior authorization (PA) and quantity limits
• Sulfacetamide Sodium lotion (Ovace Plus®)
- Benefit exclusion (non-FDA approved)
• Sulfacetamide Sodium lotion (Ovace Plus Wash®)
- Benefit exclusion (non-FDA approved)
• Niacin (Niaspan®)
- Formulary
• Voriconazole (VFend®)
- Add to formulary
• Azacitidine (Vidaza®)
- Formulary with PA
• Sulfacetamide sodium/sulfur (Avar-E LS cream®)
- Benefit exclusion (non-FDA approved)
• Sulfacetamide sodium/sulfur (Avar LS®)
- Benefit exclusion (non-FDA approved)
• PNV59/IRON, carbonyl/FA/DSS/DHA (CitraNatal Harmony®)
- Benefit exclusion (prenatals with DHA are not covered)
• Butalbit/acetamin/caff/codeine (Fioricet with codeine®)
- Keep non-formulary
• Adenosine (Adenoscan®)
- Medical benefit
• Paricalcitol (Zemplar®)
- Formulary with PA to determine Part B vs Part D benefit and step therapy
• Gatifloxacin (Zymaxid®)
- Add to formulary
• Clonidine HCL (Kapvay ER®)
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- Formulary with PA
Ceftibuten dihydrate (Cedax®)
- Add to formulary
PNV/FA/b6/calcium phos/ginger (B-Nexa®)
- Not added to formulary – exceeds cost limit of adding new vitamins to formulary
PNV NO.66/iron, carbonyl/FA/DHA (Active OB®)
- Benefit exclusion (prenatals with DHA are not covered)
Rabeprazole (Aciphex®)
- Add to formulary, remove restrictions
Dexmethylphenidate (Focalin XR®)
- Add to formulary, remove PA
Tobramycin (TOBI®)
- Non-formulary
Health Plan – Clinical Policy Updates:
Policy Name
Zostavax®
Neupogen®
Neulasta®
Estrogen for Men
Cimzia®
Stelara®
Tykerb®
Oxycontin®
Potiga®
Colcrys®
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Criteria Changes
Policy has been retired
Policy has been retired
Policy has been retired
Policy has been retired
Policy updated with the new indication (treatment of adult
patients with active psoriatic arthritis and for the
treatment of adult patients with active ankylosing
spondylitis).
Policy updated with the new indication (active psoriatic arthritis,
alone or in combination with methotrexate).
Policy position statement updated with the new FDA limitation
of use (Patients should have disease progression on
trastuzumab prior to initiation of treatment with
Tykerb® in combination with capecitabine).
Added “documentation of persistent pain (expected to last
longer than three months)” to criteria. Also added “as
needed use” to exclusion criteria
Policy updated to include requirement of documentation that
benefit outweighs risk and that visual function testing
will be completed at baseline and every 6 months.
Removed age restriction
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Medication Safety Alerts
Sept. 1, 2013 through Oct. 31, 2013 Source: US Food and Drug Administration website
Tygacil® (tigecycline): Drug Safety Communication - Increased Risk of Death
Posted 9/27/2013
Infectious disease, critical care, pharmacy
Audience
The FDA notified health professionals and their medical care
Issue
organizations of a new Boxed Warning describing an increased risk
of death when intravenous Tygacil is used for FDA-approved uses as
well as for non-approved uses. These changes to the Tygacil
Prescribing Information are based on an additional analysis that was
conducted for FDA-approved uses after FDA issuing a Drug Safety
Communication about this safety concern in September 2010.
Tygacil is FDA-approved to treat complicated skin and skin
Background
structure infections , complicated intra-abdominal infections , and
community-acquired bacterial pneumonia .
Healthcare professionals should reserve Tygacil for use in situations
Recommendation
when alternative treatments are not suitable.
P&T Action: Providers will be notified through Medical Policy
Updates.
Iclusig® (Ponatinib): Drug Safety Communication - Increased Reports of Serious Blood
Clots in Arteries and Veins
Posted 10/11/2013, 10/31/13, 11/5/13
Health professional, oncology
Audience
The FDA is investigating an increasing frequency of reports of
Issue
serious and life-threatening blood clots and severe narrowing of
blood vessels (arteries and veins) of patients taking the leukemia
chemotherapy drug Iclusig (ponatinib). Data from clinical trials and
postmarket adverse event reports show that serious adverse events
have occurred in patients treated with Iclusig, including heart attacks
resulting in death, worsening coronary artery disease, stroke,
narrowing of large arteries of the brain, severe narrowing of blood
vessels in the extremities, and the need for urgent surgical
procedures to restore blood flow. The FDA is actively working to
further evaluate these adverse events and will notify the public when
more information is available.
Iclusig is a prescription medicine used to treat adults diagnosed with
Background
chronic phase, accelerated phase, or blast phase chronic myeloid
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Recommendation
leukemia or Philadelphia chromosome-positive (Ph+) acute
lymphoblastic leukemia, who are no longer benefiting from previous
treatment or who did not tolerate other treatment. At the time of
Iclusig’s approval in December 2012, the drug label contained
information about the risks of blood clots in the Boxed Warning and
Warnings and Precautions sections. In clinical trials conducted
before approval, serious arterial blood clots occurred in 8 percent of
Iclusig-treated patients, and blood clots in the veins occurred in 3
percent of Iclusig-treated patients. In the most recent clinical trial
data submitted by the manufacturer to FDA, at least 20 percent of all
participants treated with Iclusig have developed blood clots or
narrowing of blood vessels.
Healthcare professionals should consider for each patient whether
the benefits of Iclusig treatment are likely to exceed the risks of
treatment. Patients taking Iclusig should seek immediate medical
attention if they experience symptoms suggesting a heart attack,
such as chest pain or pressure, pain in their arms, back, neck or jaw,
or shortness of breath; or symptoms of a stroke, such as numbness or
weakness on one side of the body, trouble talking, severe headache,
or dizziness.
The FDA has asked the manufacturer of the leukemia chemotherapy
drug Iclusig (ponatinib) to suspend marketing and sales of Iclusig
because of the risk of life-threatening blood clots and severe
narrowing of blood vessels. We will continue to evaluate the drug to
further understand its risks and potential patient populations in
which the benefits of the drug may outweigh the risks. Patients
currently receiving Iclusig should discuss with their healthcare
professionals the risks and benefits of continuing treatment with the
drug.
ARIAD Pharmaceuticals has agreed to this request to suspend
marketing and sales of Iclusig while they continue to evaluate the
safety of the drug. At this time, patients and healthcare professionals
should follow FDA’s new recommendations:
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Patients currently taking Iclusig who are not responding to
the drug should immediately discontinue treatment and
discuss alternative treatment options with their healthcare
professionals.
Patients who are currently taking Iclusig and responding to
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the drug and whose healthcare professionals determine that
the potential benefits outweigh the risks should be treated
under a single-patient Investigational New Drug (IND)
application or expanded access registry program while
FDA’s safety investigation continues. FDA will work with
the manufacturer on a plan to quickly transition these
patients to a program that will allow access under an IND or
expanded access registry program
Healthcare professionals should not start treating new
patients with Iclusig unless no other treatment options are
available and all other available therapies have failed. Upon
the determination of their healthcare professional, these
patients can be considered for treatment under an IND or
expanded access registry program.
P&T Action: Ambulatory policy has been updated. Providers will
be notified through the Medical Policy Updates.
Potiga (Ezogabine): Drug Safety Communication - Linked to Retinal Abnormalities and
Blue Skin Discoloration
Posted 4/26/2013
Health professional, neurology, patient
Audience
The FDA is warning the public that the anti-seizure medication
Issue
Potiga (Ezogabine) can cause blue skin discoloration and eye
abnormalities characterized by pigment changes in the retina. The
FDA does not currently know if these changes are reversible. The
FDA is working with the manufacturer to gather and evaluate all
available information to better understand these events. The FDA
will update the public when more information is available.
Potiga is approved as adjunctive (added on to other anti-seizure
Background
medications) treatment of partial-onset seizures in adult patients 18
years and older. Pigment changes in the retina have the potential to
cause serious eye disease with loss of vision. It is not yet known
whether the retinal pigment changes caused by Potiga lead to visual
impairment, although several patients have been reported to have
impaired visual acuity. In some cases, retinal abnormalities have
been observed in the absence of skin discoloration. The skin
discoloration in the reported cases appeared as blue pigmentation,
predominantly on or around the lips or in the nail beds of the fingers
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or toes, but more widespread involvement of the face and legs has
also been reported. Scleral and conjunctival discoloration, on the
white of the eye and inside eyelids, has been observed as well. The
skin discoloration generally occurred after four years of treatment
with Potiga, but has appeared sooner in some patients.
Recommendation
P&T Action: Ambulatory policies have been updated to strengthen
criteria for new starts:
• Require documentation that benefit outweighs risk
• Require documentation that visual function testing will be
completed at baseline and every six months
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