October 19 2016 August 16 2016 Meeting Minutes Review and Vote 2 Reaching across Arizona to provide comprehensive quality health care for those in need Magellan Class Reviews Classes Antibiotics Inhaled ID: 673161
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Slide1
AHCCCS Pharmacy and Therapeutics Committee
October 19, 2016Slide2
August 16, 2016 Meeting MinutesReview and Vote
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Reaching across Arizona to provide comprehensive
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Magellan Class Reviews
Classes
Antibiotics, Inhaled
Cytokine and CAM Antagonists
Epinephrine, Self-injected
Growth Hormone
Analgesics, Long-Acting Opioid
Makena (hydroxyprogesterone) – Single Product ReviewNew Products (to Magellan PDL classes)Bevespi Aerosphere
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Antibiotics, Inhaled
Sarah Martinez, Pharm D
Provider Synergies
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Antibiotics, Inhaled
Product Update:
Kitabis Pak is now available as a generic
Guideline Update:
The Cystic Fibrosis Foundation guidelines for cystic fibrosis includes both nebulized tobramycin and aztreonam (Cayston) as recommended prophylaxis for
Pseudomonas aeruginosa.
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Antibiotics, Inhaled
The Cystic Fibrosis Foundation also recommends:
The
alternate-month administration of both tobramycin and aztreonam in patients persistently infected with
P. aeruginosa,
although with a grade B recommendation (high certainty that net benefit is moderate or moderate certainty that net benefit is
substantial.
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Antibiotics, Inhaled
Preferred Products:
Kitabis Pak
Bethkis
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Cytokine and CAM Antagonists
Sarah Martinez, Pharm D
Provider Synergies
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Cytokine and CAM Antagonists
New Products/Product Updates:
Taltz (ixekizumab) is indicated for the treatment of moderate to severe plaque psoriasis (reviewed in August)
Cosentyx is now indicated for the treatment of psoriatic arthritis and ankylosing spondylitis in adults (previously indicated only for plaque psoriasis)
Humira is now indicated for the treatment of non-infectious uveitis in adults
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Cytokine and CAM Antagonists
New Products/Product Updates:
Xeljanz XR (tofacitinib) is now available as a once daily administration option (11 mg tablets). Label information is similar for that for Xeljanz.
Caution should be used in patients with pre-existing gastrointestinal narrowing due to rare reports of obstructive symptoms in this population.
Should not be used when dose modifications are required
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Cytokine and CAM Antagonists
Recent Studies:
The CLEAR study was a manufacturer-funded 52-week comparison of Cosentyx and Stelara in patients with plaque psoriasis. Cosentyx treatment resulted in a statistically significant improvement in PASI 90 response compared to Stelara treatment at week 16.
FIXTURE studied Cosentyx vs. placebo and Enbrel in plaque psoriasis. Cosentyx was found to be superior to Enbrel as a secondary endpoint in this manufacturer-sponsored, active-control study.
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Cytokine and CAM Antagonists
Guideline Update:
The American College of Rheumatology 2015 guidelines for treatment of rheumatoid arthritis recommend that non-TNF biologic is preferred in TNF inhibitor failure.
Xeljanz is generally recommended as an option following non-TNF biologic failure. Slide13
Cytokine and CAM Antagonists
Guideline Update:
The
American College of Rheumatology released their first guideline on ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis. NSAIDs are recommended in patients with active AS. Those with active AS despite NSAID treatment should use a TNF blocker. No TNF blocker is listed as preferred over the others except in patients with concomitant irritable bowel disease or recurrent iritis, who should receive Remicade or Humira.
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Cytokine and CAM Antagonists
Guideline Update:
The American Gastroenterology Association (AGA) has created a clinical algorithm:
Recommends an anti-TNF agent with or without a thiopurine; or vedolizumab (Entyvio) with or without thiopurine or methotrexate, for maintenance therapy in high-risk outpatients following induction therapy.
If induction therapy is done with either an anti-TNF agent or vedolizumab, these agents should be continued. Slide15
Cytokine and CAM Antagonists
AGA Guideline Update continued:
In
cases of loss of response to an anti-TNF agent, the anti-TNF dose should be optimized, and a switch within class, the addition of an immunomodulator, or a switch to vedolizumab may be considered.
In cases of loss of response to vedolizumab, the dose should be optimized, and a switch to an anti-TNF agent may be considered.
Infliximab may be used in inpatients who have failed IV steroids and for maintenance of remission
.Slide16
Cytokine and CAM Antagonists
Preferred Products:
Enbrel
HumiraSlide17
Epinephrine, Self-injected
Sarah Martinez, Pharm D
Provider Synergies
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Epinephrine, Self-injected
Class Overview
No new clinical information to review
Preferred Products
Epinephrine 0.15 mg and 0.3 mg (generic Adrenaclick)
Epipen
Epipen Jr.
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Growth Hormone
Sarah Martinez, Pharm D
Provider Synergies
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Growth Hormone
Product Updates
Nutropin AQ pen cartridges have been discontinued by Genentech. The NuSpin device will remain available.
Preferred Products
Genotropin
Nutropin
Norditropin
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Analgesics, Long Acting Opioid
Sarah Martinez, Pharm D
Provider Synergies
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Analgesics, Long Acting Opioid
Class Information
Products include:
Buprenorphine
Fentanyl
Hydromorphone
Methadone
Morphine
Oxycodone
Oxymorphone
Tapentadol
Tramadol
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Analgesics, Long Acting Opioid
Abuse -Deterrent Products
Morphine sulfate ER/naltrexone (Embeda) capsules
;
Hydrocodone
ER (Hysingla ER) tablets;
Oxycodone
CR (OxyContin) tablets; Oxycodone ER (authorized generics for OxyContin)
tablets: andOxycodone
ER (Xtampza ER)
capsules.
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Analgesics, Long Acting Opioid
Abuse -Deterrent
Products continued
Hydromorphone
ER (Exalgo
)*
Oxymorphone
ER (Opana ER)*Tapentadol ER (Nucynta ER)*
Hydrocodone
ER (Zohydro ER
)*
*Have
abuse-deterrent properties but have not been approved by the FDA as abuse-deterrent
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Analgesics, Long Acting Opioid
New Product: Belbuca (buprenorphine)
Indicated for the management of severe pain that requires around-the-clock, long-term opioid treatment.
Black box warning regarding addiction, abuse, and misuse; respiratory depression, accidental exposure; neonatal opioid withdrawal syndrome; and accidental exposure to children.
Contraindicated in patients with significant respiratory depression, severe bronchial asthma, and suspected gastrointestinal obstruction.
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Analgesics, Long Acting Opioid
New Product: Belbuca (buprenorphine)
Warnings
include use in elderly, cachectic, or debilitated patients or patients with chronic pulmonary disease; risk of prolonged QTc interval; severe hypotension; and risk of use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness.
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Analgesics, Long Acting Opioid
New Product: Belbuca (buprenorphine)
Belbuca is a CYP3A4 substrate; it should be used with caution when initiating CYP3A4 inhibitors or discontinuing CYP3A4 inducers.
Caution should be exercised when concomitantly giving CNS depressants, benzodiazepines, or mixed agonist/antagonist or partial agonist opioids.
Common adverse effects include constipation, nausea, somnolence, vomiting, headache, and dizziness.
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Analgesics, Long Acting Opioid
New Product: Belbuca (buprenorphine)
There are no data available in pregnant women to inform a drug-associated risk, but limited published data on the use of buprenorphine in pregnant women have not shown increased risk of major malformations.
Belbuca is applied once daily or every 12 hours, as tolerated.
Lower doses are recommended in severe hepatic impairment or in the presence of oral mucositis.
It is available in seven strengths ranging from 75 to 900 mcg buccal films.
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Analgesics, Long Acting Opioid
New Product: Xtampza ER (oxycodone)
Indicated for the management of severe pain that requires around-the-clock, long-term opioid treatment.
Black box warning regarding addiction, abuse, and misuse; respiratory depression, accidental ingestion; neonatal opioid withdrawal syndrome; concomitant use with CYP3A4 inhibitors; and accidental exposure to children.
Contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, and suspected gastrointestinal obstruction.
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Analgesics, Long Acting Opioid
New Product: Xtampza ER (oxycodone)
Other warnings include use in elderly, cachectic, or debilitated patients or patients with chronic pulmonary disease; adrenal insufficiency; severe hypotension; and risk of use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness.
Xtampza ER is a CYP3A4 substrate. It should also be used with caution when used concurrently with CNS depressants, serotonergic drugs, and mixed agonist/antagonist or partial agonist opioids.
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Analgesics, Long Acting Opioid
New Product: Xtampza ER (oxycodone)
Common adverse effects include nausea, headache, constipation, somnolence, and pruritus.
There are no data available in pregnant women to inform a drug-associated risk, but prolonged use can lead to neonatal opioid withdrawal syndrome.
Xtampza ER is given every 12 hours with food. The capsule contents can be sprinkled on food. Lower doses are recommended in severe hepatic impairment.
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Analgesics, Long Acting Opioid
New Product: Xtampza ER (oxycodone)
continued
It
is available in five strengths ranging from 9 to 36 mg extended release capsules.
The abuse deterrent mechanism is the microsphere formulation (inactive ingredients) that makes the capsule contents difficult to manipulate for misuse and abuse.
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Analgesics, Long Acting Opioid
Guideline/Regulatory Updates:
Centers for Disease Control and Prevention (CDC) released guidelines for prescribing opioids for chronic pain outside of active cancer, palliative, and end-of-life care
If opioids are deemed appropriate for a patient’s chronic pain, they recommend initial treatment with immediate-release opioids
Doses of ≥ 50 morphine milligram equivalents (MME)/day should prompt reassessment of the individual’s benefits and risks and use of ≥ 90 MME/day should be avoided
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Analgesics, Long Acting Opioid
Guideline/Regulatory
Updates continued:
A
black boxed warning will be added to all opioid- and benzodiazepine-containing product labels stating that concomitant use of opioids and benzodiazepines has resulted in serious adverse effects, including respiratory depression and death.
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Makena (hydroxyprogesterone)
Sarah Martinez, Pharm D
Provider Synergies
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Makena (hydroxyprogesterone)
Indication: To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
Women who have had a previous preterm birth are at increased risk for premature birth.
Preterm birth, defined as birth of an infant prior to 37 week of gestation, affects nearly 1 of every 9 infants born in the U.S. each year (CDC – July 2016)
There is a higher risk of serious disability or death the earlier the baby is born. Preterm-related causes of death accounted for 35% in 2008 of all infant deaths.
Slide37
Makena (hydroxyprogesterone)
Dosing: Administer 250 mg (1 mL) intramuscular (IM) every 7 days; Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation; Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first
Available as multidose vial: 5 mL (250 mg/mL) and single-dose vial (preservative-free): 1 mL (250 mg/mL) Slide38
New Products (to Magellan PDL classes)
Sarah Martinez, Pharm D
Provider Synergies
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Bevespi Aerosphere (formoterol/glycopyrrolate)
Indicated for the long-term maintenance treatment of airflow obstruction in COPD patients
Black box warning regarding asthma-related death due to its LABA component as well as a notice that the product is not indicated for treatment of asthma
Contraindication with use of LABA without long-term controller medication for asthma despite the lack of asthma indicationSlide40
Bevespi Aerosphere (formoterol/glycopyrrolate)
Other warnings include inappropriate use in acute symptom treatment, paradoxical bronchospasm, hypokalemia/hyperglycemia, worsening of urinary retention and/or narrow-angle glaucoma, and use in patients with cardiovascular disorders, convulsive disorders, thyrotoxicosis, diabetes, and ketoacidosis
Use with caution when concurrently given with MAO inhibitors, tricyclic antidepressants, anticholinergics, xanthine derivatives, diuretics, or beta blockersSlide41
Bevespi Aerosphere (formoterol/glycopyrrolate)
Common adverse effects include urinary tract infection and cough
It is in pregnancy category C
Given as two inhalations twice daily
It is available as a 4.8 mcg/9 mcg metered dose inhaler
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Suzi Berman
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Oral Oncology Drugs Subcommittee
Follow-upSlide43
HIV Subcommittee Follow-upSuzi Berman
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NEW DRUGS
Xiidra – Lifitegrast Ophthalmic Solutions
Zinbryta - Daclizumab
Ocaliva – Obeticholic Acid
Briviact - Brivaracetam
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Xiidra – Lifitegrast Ophthalmic Solutions
Indicated for dry eye disease
Dosage: 1 drop in eye(s) every 12 hours
Black Box Warning - None
Clinical Trials
Double-blinded
Study
1181 patients – 1067 received Xiidra placed into 4 groupings.Majority of participants were female average age of 59 years.45Reaching across Arizona to provide comprehensive
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Xiidra – Lifitegrast Ophthalmic Solutions
Clinical Trials Continued: Results were based on the:
Eye Dryness Score (EDS)
A score of 100 is maximal discomfort
Baseline EDS scores were:
50 for Study Groups 1 & 2
70 for Study Groups 3 & 4
Over the 12 week trials, the average reductions were:14.5 points for Study Groups 1 & 236.5 points for Study Groups 3 & 4
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Xiidra – Lifitegrast Ophthalmic Solutions
Adverse reactions
Irritation
,
dysgeusia (
foul, salty, rancid, or metallic taste
sensation in the mouth)
and reduced visual acuity in 5-25% of the patientsBlurred vision, conjunctival redness, eye irritation, headache, increased tearing, eye discharge, eye discomfort, eye pruritus and sinusitis in 1-5% of the patients.
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Xiidra – Lifitegrast Ophthalmic Solutions
Recommendation:
Xiidra is the only FDA approved drug to treat the signs and symptoms of dry eye disease. The disease can be mild to severe and other products listed on the AHCCCS Drug List have been tried with success.
AHCCCS does not recommend adding Xiidra to the AHCCCS Drug List at this time.
Xiidra is available with prior authorization.
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Zinbryta - Daclizumab
Indicated
for the treatment of adult patients with relapsing forms of multiple sclerosis (MS).
Due to its
safety
profile
,
Zinbryta should generally be reserved for patients who have had an inadequate response to two or more MS drugs.49Reaching across Arizona to provide comprehensive quality health care for those in needSlide50
Zinbryta - Daclizumab
Dosage: 150mg subcutaneously once monthly
Black Box Warnings:
Zinbryta can cause severe liver injury including life-threatening events including liver failure and autoimmune hepatitis.
Contraindicated for
use in patients with pre-existing hepatic disease or impairment.
Other Immune-Mediated Disorders
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Zinbryta - Daclizumab
Clinical Trial Result:
Comparative trial of Zinbryta to Avonex for up to 144 weeks.
1841 participants chosen by 1 or more relapses and 1 or more new brain lesions ( one of which had to occur in the 12 months prior to the trial)
The trial excludes patients with progressive forms of MS or scores of > 5 on the Expanded Disability Status Scale.
Clinical assessment
were completed
every 12 weeks and after relapse events. MRIs done at weekS 24 & 96.
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Zinbryta - DaclizumabClinical
Trials Results:
Zinbryta
had a statistically significant effect on the annualized relapse rate and on the number of new or newly enlarging T2 hyperintense lesions.
There
was no statistically significant effect on 12-week confirmed disability
progression
Statistically significant but is it clinically significant?52Reaching across Arizona to provide comprehensive quality health care for those in needSlide53
Zinbryta - DaclizumabAdverse Reactions in
>
5% of the participants
Nasopharyngitis
Upper Respiratory Tract Infection
Rash
Influenza
Dermatitis Oropharyngeal Pain & Bronchitis 53Reaching across Arizona to provide comprehensive quality health care for those in needSlide54
Zinbryta - Daclizumab
Recommendation is to not add Zinbryta to the AHCCCS Drug List because it is
a
third line agent.
Zinbryta is available through the prior authorization process.
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Ocaliva – Obeticholic Acid
Is approved for:
the treatment of primary biliary cholangitis (PBC
); and
the treatment of Non-Alcoholic Fatty Liver Disease (NALFD) aka NASH, with fibrosis.
Used
in combination with Ursodiol in adults with an inadequate response to Ursodiol, or as monotherapy in adults unable to tolerate Ursodiol. Dosage: 5mg once daily with a maximum dosage of 10mg once daily.
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Ocaliva – Obeticholic Acid
Black Box Warning – None
Clinical Trials:
R
andomized
, double-blind, placebo-controlled, 12-month trial
– 216 participants
Participants were taking Ursodiol for at least 12 months and stable for least 3 months without Ursodiol because they did not tolerate it. 93% of the patients received Ocaliva or Placebo + Ursodiol and 7% did not receive the Ursodiol.
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Ocaliva – Obeticholic AcidClinical Trial Results
Primary Endpoints:
Reduction of Alkaline Phosphatase of
at least 15%, n (%
)
Normal bilirubin after 12 months of therapy.
46% of trial participants vs. 10% of placebo patients met the endpoint.
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Ocaliva – Obeticholic AcidAdverse Reactions:
The most common adverse
reactions for the 10mg and titrating dose were:
Pruritus: 63%
F
atigue: 22%
A
bdominal pain;15%Rash: 8.5%Oropharyngeal pain: 7.5%Dizziness: 7%Constipation: 7%58
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Ocaliva – Obeticholic AcidRecommendation is to not add Ocaliva to the AHCCCS Drug List at this time.
Ocaliva will be reviewed internally at AHCCCS due to the prevalence of NAFLD and the $70K annual cost of the drug.
In addition, we are expecting other agents to be approved in the near future for the treatment of NAFLD
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Briviact - Brivaracetam
Is indicated as adjunctive therapy for partial-onset seizures
for patients 16
years and older with
epilepsy.
Dosage may be given up to 200mg orally per day.
Black Box Warning – NoneClinical Trials - 3 fixed-dose, randomized, double-blind, placebo-controlled, multicenter studies (Studies 1, 2, and 3), which included 1550 patients. 60
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Briviact - Brivaracetam
Clinical
Trials continued:
All trials had an 8-week baseline period, during which patients were required to have at least 8 partial-onset seizures.
The primary efficacy
outcome in Study 1 and Study 2 was the percent reduction in 7-day partial-onset seizure frequency over
placebo.
The primary outcome for Study 3 was the percent reduction in 28-day partial-onset seizure frequency over placebo. Adverse Reactions61Reaching across Arizona to provide comprehensive quality health care for those in needSlide62
Briviact - Brivaracetam
Clinical Trial Results: Percent reduction in partial-onset seizure frequency over placebo:
7-day Study
50 mg/day dose = 8.5% (n=99)
100 mg/day dose = 17% (n=100)
7-day Titration Dose Study
50 mg/day titrated dose = 16.9% (n=101)
28-day Study 100 mg/day dose = 25.2% (n=252)200 mg/day dose = 25.7% (n=249)62Reaching across Arizona to provide comprehensive
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Briviact - Brivaracetam
Adverse Reactions occurring in
>
10% of study participants:
Abnormal Gail, Ataxia, Dizziness, Drowsiness
Equilibrium Disturbances, Fatigue, Hypersomnia, Lethargy, Malaise, Psychiatric Disturbances, Sedation, Vertigo
Neuromuscular and Skeletal Weakness
Nystagmus63Reaching across Arizona to provide comprehensive quality health care for those in needSlide64
Briviact - Brivaracetam
R
ecommendation is to not add this to the AHCCCS Drug List because there are several medications listed on the AHCCCS Drug List for
use
as
augmentation strategies for epilepsy.
Briviact is available through the prior authorization process.64Reaching across Arizona to provide comprehensive quality health care for those in needSlide65
Opioid 7-day Quantity Limitation
Shana Malone, AHCCCS
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Pill Splitting
Steve Chakmakian, CMO
United Community Plan
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Agenda Items for the January 25, 2017 P&T Meeting
Inhaled Glucocorticoid Drug Class
Generic Drug Pricing
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Thank You.68
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