16 October 2019 Welcome and Introductions Sara Salek MD Chief Medical Officer AHCCCS Meeting Minutes 23 May 2019 Review Vote 2 Reaching across Arizona to provide comprehensive quality health care for those in need ID: 776704
Download Presentation The PPT/PDF document " AHCCCS Pharmacy and Therapeutics Commit..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
AHCCCS Pharmacy and Therapeutics Committee
16 October 2019
Slide2Welcome and Introductions
Sara Salek, MD, Chief Medical Officer, AHCCCSMeeting Minutes 23 May 2019ReviewVote
2
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide3Conflict of Interest Training
Robert L. Ellman
3
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide4Magellan Class Reviews
Classes for Review: Non-Supplemental Rebate Class ReviewAntifungals, OralAntifungals, TopicalAntimigraine Agents, TriptansBeta BlockersBPH Treatments
4
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide5Magellan Class Reviews
Classes for Review: Non-Supplemental Rebate Class ReviewCalcium Channel BlockersLeukotriene ModifiersPhosphate BindersSedative HypnoticsTopical Steroids – Low, Medium, High & Very High Potency
5
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide6Magellan Drug Class Reviews
Hind Douiki, Pharm.D.
6
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide7Antifungals, Oral
7
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide8Antifungals, Oral
Class Overview - Product indications include*:Candidiasis (esophageal, oropharyngeal, and vaginal)Cryptococcal infectionsTinea topical infectionsOnychomycosisInvasive aspergillosis
8
Reaching across Arizona to provide comprehensive quality health care for those in need
*Not inclusive of all product indications, all products differ in indication
Slide9Antifungals, Oral
Class Overview:clotrimazole troche - (clotrimazole troche)fluconazole - (Diflucan, fluconazole)flucytosine - (Ancobon, flucytosine)griseofulvin suspension - (griseofulvin suspension)griseofulvin microsized - (griseofulvin microsized)griseofulvin ultramicrosized - (griseofulvin ultramicrosized)isavuconazonium - (Cresmba)itraconazole - (itraconazole, Onmel, Sporanox)itraconazole – (Tolsura)
9
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide10Antifungals, Oral
Class Overviewketoconazole - (ketoconazole)miconazole - (Oravig)nystatin - (nystatin)posaconazole - (Noxafil)terbinafine - (terbinafine)voriconazole - (Vfend, voriconazole)
10
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide11Antifungals, Oral
Antifungal agents have different spectrums of activity and are FDA-approved to treat a variety of infectionsOral antifungal agents are useful in the treatment of a variety of infections in both immunocompetent and immunocompromised patientsFew trials have been performed to compare safety and efficacy profiles of the drugs Many of the agents carry boxed warnings related to adverse events and/or drug interactions
11
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide12Antifungals, Oral
Due to its excellent penetration into many tissues, fluconazole is an effective Candida treatment for a variety of infections, lacking concerns about pH-dependent absorption such as that seen with ketoconazoleEffective therapy for oropharyngeal candidiasis includes fluconazole, itraconazole, ketoconazole, nystatin, and clotrimazoleVoriconazole has been shown to have similar efficacy to fluconazole in the treatment of esophageal candidiasis; however, more adverse effects are reported with voriconazolePosaconazole oral suspension has an indication for treatment of oropharyngeal candidiasis when refractory to itraconazole and/or fluconazole
12
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide13Antifungals, Oral
Nystatin is also used to treat intestinal candidiasis and may be used in infants and childrenIsavuconazonium, posaconazole, flucytosine, voriconazole, itraconazole, and fluconazole have indications for the treatment and/or prophylaxis of various serious fungal infections
13
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide14Antifungals, Oral
Product Updates:Vfend is now indicated to include patients as young as 2 years of age for the treatment of invasive aspergillosis, candidemia, esophageal candidiasis, and serious fungal infections caused by select organisms in patients intolerant of or refractory to other therapyDosing in this population is weight-based and dependent on the indication
14
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide15Antifungals, Topical
15
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide16Antifungals, Topical
Class Overview - Product indications include*:Cutaneous CandidiasisTinea PedisTinea CorporisTinea CrurisTenia VersicolorTopical OnychomycosisSeborrheic Dermatitis
16
Reaching across Arizona to provide comprehensive quality health care for those in need
*Not inclusive of all product indications, all products differ in indication
Slide17Antifungals, Topical
Class Overviewbutenafine - (Mentax)butenafine - (butenafine [OTC], Lotrimin Ultra [OTC])ciclopirox 0.77% - (Ciclodan Cream, Kit; ciclopirox cream; Loprox Cream, Gel, Suspension)ciclopirox 8% - (Ciclodan Solution, ciclopirox 8%, Penlac)clotrimazole - (Alevazol [OTC], clotrimazole [OTC], Lotrimin AF [OTC])clotrimazole/betamethasone - (clotrimazole/betamethasone, DermacinRx Therazole Pak, Lotrisone)econazole cream - (econazole)econazole foam - (Ecoza)
17
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide18Antifungals, Topical
Class Overview:efinaconazole - (Jublia)ketoconazole - (Extina, ketoconazole, Nizoral A-D Shampoo, Nizoral Shampoo, Xolegel)luliconazole - (Luzu)miconazole - (Azolen [OTC], Desenex [OTC] , Fungoid [OTC], Lotrimin AF Spray, [OTC], miconazole [OTC], Zeasorb [OTC])miconazole/zinc oxide/white petrolatum - (Vusion)naftifine - (naftifine, Naftin)nystatin - (nystatin)nystatin/triamcinolone - (nystatin/triamcinolone)
18
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide19Antifungals, Topical
Class Overviewoxiconazole - (oxiconazole, Oxistat)sertaconazole - (Ertazco)sulconazole - (Exelderm)tavaborole - (Kerydin)terbinafine - (Lamisil [OTC], Lamisil AT [OTC], terbinafine [OTC])tolnaftate - (Fungoid-D [OTC], Lamisil AF Defense [OTC], Tinactin [OTC], tolnaftate [OTC])undecylenic acid - (Hongo Cura, Sponix Anti-Fungal [OTC])undecylenic acid/zinc undecylenic - (Fungi-Nail [OTC], Hongo Cura [OTC])
19
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide20Antifungals, Topical
Topical antifungal agents have different spectrums of activity and are FDA-approved to treat a variety of infectionsTopical agents may be formulated as creams, foams, gels, lacquers, lotions, ointments, powders, solutions and spraysMany topical antifungal preparations are available as prescription medications and over-the-counter (OTC) productsLimited data are available regarding comparative efficacy in the treatment of the various fungal infections — tinea cruris, tinea corporis, tinea pedis, and tinea versicolorCombination therapy (antifungal plus corticosteroid) can be considered when inflammation is present
20
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide21Antifungals, Topical
Data are also lacking in comparative efficacy for the treatment of seborrheic dermatitisBased on limited efficacy data, choice of therapy is mainly based on clinical judgment with regard to prior treatments and complicating conditions, such as bacterial growth or intense inflammation
21
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide22Antifungals, Topical
Product Updates:None
22
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide23Antimigraine Agents, Triptans
23
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide24Antimigraine Agents, Triptans
Class Overview:almotriptan malate - (almotriptan)eletriptan - (eletriptan & (AG); Relpax)frovatriptan - (frovatriptan; Frova)naratriptan - (Amerge; naratriptan)rizatriptan - (Maxalt, Maxalt MLT; rizatriptan ODT & tablet)sumatriptan - (Imitrex Kit, Tablet & Vial; Imitrex Nasal; sumatriptan kit, nasal, tablet & vial; Onzetra Xsail; Sumavel DosePro; Zembrace SymTouch)
24
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide25Antimigraine Agents, Triptans
Class Overview:sumatriptan/naproxen - (sumatriptan/naproxen; Treximet)sumatriptan camphor/menthol - (Migranow)zolmitriptan - (zolmitriptan ODT, ODT (AG), tablets, tablets (AG); Zomig, ZMT)
25
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide26Antimigraine Agents, Triptans
Migraines account for 10% to 20% of all headaches in adults and affect over 39 million men, women, and children in the United StatesMigraine headaches must be differentiated from regular tension-type headaches. Key criteria for migraine diagnosis include an episodic headache lasting from 4 to 72 hours with at least two of the following: unilateral pain, throbbing, aggravation of pain upon moving, pain of moderate to severe intensity accompanied by nausea, vomiting, photophobia, or phonophobiaNon-opioid analgesia with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), or caffeinated combinations are considered first-line therapy for mild to moderate migraine pain
26
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide27Antimigraine Agents, Triptans
Migraine-specific agents (triptans, dihydroergotamine [DHE]) should be used in patients who experience moderate to severe migraine attacks Due to well-established efficacy, triptans have become the drugs of choice for treating acute migraine attacksThe US Headache Consortium, a multidisciplinary panel of several professional organizations, recognized that all of the triptans are effective agents for the acute treatment of migraineData reviewed did not demonstrate that any specific triptan was superior to others and triptans appear to be equally safe
27
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide28Antimigraine Agents, Triptans
Per the American Academy of Neurology (AAN) and the American Headache Society (AHS), for pharmacologic treatment for episodic migraine prevention in adults:Antiepileptic drugs (divalproex sodium, sodium valproate, topiramate) and beta-blockers (metoprolol, propranolol, timolol) are considered effective in migraine prevention Frovatriptan is established for short-term menstrually-associated migraine (MAM) preventionNaratriptan, zolmitriptan, antidepressants (amitriptyline, venlafaxine), and beta-blockers (atenolol, nadolol) are considered probably effective in migraine prevention
28
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide29Antimigraine Agents, Triptans
In addition to approval in adults, almotriptan, sumatriptan/naproxen, and zolmitriptan nasal spray are FDA-approved for use in patients 12 to 17 years old while rizatriptan is approved in patients 6 to 17 years oldNon-oral routes of administration are available when nausea or vomiting present as significant components of migraine attacks
29
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide30Antimigraine Agents, Triptans
Product Updates:Tosymra (sumatriptan nasal spray) is indicated for the acute treatment of migraine with or without aura in adultsIt is approved as a single 10 mg spray to be administered in one nostril and may be repeated up to a maximum of 30 mg in 24 hours with at least one hour separating dosesTosymra may also be given with at least one hour between other sumatriptan productsContraindications, warnings, drug interactions, and adverse reactions are similar to other sumatriptan productsEndo announced discontinuation of Sumatriptan injection with needle-free delivery system (Sumavel DosePro) 4 mg/0.5 mL (in 2016) and 6 mg/0.5 mL (in February 2018) due to business reasons
30
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide31Antimigraine Agents, Triptans
Product Updates:The AAN and the AHS issued new guidelines on pharmacologic treatment for pediatric migraine prevention as an update to the AAN's 2004 guidelines. Key recommendations include: Counsel patients/caregivers on lifestyle modificationsAdvise patients and caregivers that most trials of preventive medications have failed to show any benefit over placebo in children, except propranolol which may "possibly“ result in a 50% reduction in headache frequencyCounsel patients/caregivers to treat an attack early for most benefit (first-line ibuprofen oral solution [10 mg/kg] in children and adolescents)
31
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide32Antimigraine Agents, Triptans
Product Updates:Sumatriptan/naproxen tablets and zolmitriptan nasal spray are options in adolescentsOffer antiemetics to treat substantial nausea and vomitingCounsel patients/caregivers about medication overuse
32
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide33Beta Blockers
33
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide34Beta Blockers
Class Overview - Product indications include*:HypertensionHeart FailureAngina pectorisMyocardial InfarctionCardiac ArrhythmiasMigraine ProphylaxisTremorHypertrophic subaortic stenosis
34
Reaching across Arizona to provide comprehensive quality health care for those in need
*Not inclusive of all product indications, all products differ in indication
Slide35Beta Blockers
Class Overview: Single Agentsacebutolol - (acebutolol, Sectral)atenolol - (atenolol, Tenormin)betaxolol - (betaxolol)bisoprolol - (bisoprolol)carvedilol - (carvedilol, Coreg)carvedilol extended-release - (carvedilol ER, Coreg CR)labetalol - (labetalol)metoprolol succinate ER - (metoprolol succinate ER, Toprol XL, Kapspargo Sprinkle)metoprolol tartrate - (Lopressor, metoprolol tartrate)
35
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide36Beta Blockers
Class Overview: Single Agentsnadolol - (Corgard, nadolol)nebivolol - (Bystolic)pindolol - (pindolol)propranolol - (propranolol)propranolol - (Hemangeol)propranolol ER - (Inderal XL, Innopran XL)propranolol LA - (Inderal LA, propranolol LA)sotalol - (Betapace, sotalol)
36
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide37Beta Blockers
Class Overview: Single Agentssotalol - (Betapace AF, sotalol AF)sotalol - (Sotylize)timolol - (timolol)Class Overview: Beta-Blocker/Diuretic Combinationsatenolol/chlorthalidone - (atenolol/chlorthalidone, Tenoretic)bisoprolol/HCTZ - (bisoprolol/HCTZ , Ziac)metoprolol succinate/HCTZ - (Dutoprol, metoprolol succinate/HCTZ)metoprolol tartrate/HCTZ - (metoprolol tartrate/HCTZ)
37
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide38Beta Blockers
Class Overview: Beta-Blocker/Diuretic Combinationsnadolol/bendroflumethiazide - (Corzide, nadolol/bendroflumethiazide)propranolol/HCTZ - (propranolol/HCTZ)
38
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide39Beta Blockers
Approximately 75 million (32%) of adults in the United States have hypertensionHighest prevalence is among African American men and women at 43% and 45.7%, respectivelyIt is estimated that hypertension is controlled in only 54% of patients with the conditionHypertension is an independent risk factor for the development of cardiovascular disease (CVD) Beta-blockers are one of the classes suggested as first-line therapy in patients with coronary artery disease (CAD), post-MI, HF, and diabetes
39
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide40Beta Blockers
Beta-blockers have similar efficacy for the treatment of hypertension (HTN)The Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-8) does not recommend beta-blockers as initial treatment of hypertensionThis is due to a demonstrated higher rate of the primary composite outcome of CV death, MI, or stroke compared to use of an ARB with beta blocker use, a finding that was driven largely by an increase in strokeBeta-blockers prevent recurrent ischemia, life-threatening ventricular arrhythmias, reduce the incidence of sudden cardiac death and improve survival in patients with prior MI
40
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide41Beta Blockers
The 2007 ACC/AHA chronic stable angina guidelines recommend indefinite beta-blocker therapy for blood pressure control in patients with CAD, acute coronary syndrome (ACS), or left ventricular dysfunction (LVD), with or without heart failure symptomsBeta-blockers have also been shown to reduce mortality in patients with chronic heart failure (bisoprolol, carvedilol, and metoprolol succinate extended-release)
41
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide42Beta Blockers
Product Updates:The American Academy of Pediatrics published a guideline on the management of infantile hemangiomasFor infants with potentially problematic hemangiomas, early intervention and/or referral is recommendedWhen systemic treatment is indicated, propranolol is the drug of choice as 2 to 3 mg/kg/day for at least 6 months and is often continued until the patient is 12 months of ageSelect cases may be treated with topical timolol
42
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide43BPH Treatments
43
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide44BPH Treatments
Class Overview: Alpha-Blockersalfuzosin ER - (alfuzosin ER, Uroxatral)doxazosin - (Cardura, doxazosin)doxazosin ER - (Cardura XL)silodosin - (Rapaflo, silodosin)tamsulosin - (Flomax, tamsulosin)terazosin - (terazosin)
44
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide45BPH Treatments
Class Overview: 5-Alpha Reductase (5AR) Inhibitors dutasteride - (Avodart, dutasteride)finasteride - (finasteride, Proscar)Class Overview: 5-Alpha Reductase (5AR) Inhibitor/Alpha Blocker Combinationsdutasteride/tamsulosin - (dutasteride/tamsulosin, Jalyn)Class Overview: Phosphodiesterase 5 (PDE5) Inhibitorstadalafil - (Cialis, tadalafil)
45
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide46BPH Treatments
Benign prostatic hyperplasia (BPH) is one of the most common conditions in aging menAs many as 14 million men in the United States have symptoms related to BPHAn estimated 50% of men demonstrate histopathologic BPH by age 60 years; this etiology increases to 90% by 85 years of ageDrugs used in the treatment of BPH relieve lower urinary tract symptoms (LUTS) and prevent complications and, in some cases, are an alternative to surgical interventionAll products are indicated for the treatment of symptomatic BPH but none are indicated for prevention of prostate cancer Various products carry other non-BPH indications
46
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide47BPH Treatments
The American Urological Association (AUA) 2010 standards were reaffirmed in 2014They state patients with mild symptoms of BPH (AUA Symptom Score < 8) and patients with moderate or severe disease (AUA Symptom Score > 8) who are not bothered by their symptoms generally do not require pharmacologic interventionAlpha-adrenergic blocker therapy is an appropriate treatment option for patients with moderate to severe LUTS secondary to BPH The AUA indicates that alfuzosin, doxazosin, tamsulosin, and terazosin have equal clinical effectivenessHowever, selective alpha-blockers such as alfuzosin, tamsulosin, and silodosin may have a decreased incidence of hypotension-related adverse events
47
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide48BPH Treatments
Silodosin did not have published peer-reviewed studies prior to the guideline updateGuidelines state the 5AR inhibitors are appropriate and effective treatments for patients with LUTS associated with demonstrable prostatic enlargement, but not for men with LUTS who do not have evidence of prostatic enlargement5AR inhibitors may be used to prevent progression of LUTS secondary to BPH and to reduce the risk of urinary retention and future prostate-related surgeryCombination therapy utilizing an alpha blocker and a 5α-reductase inhibitor is an appropriate and effective treatment for patients at highest risk for disease progression and for those who exhibit LUTS symptoms and have definitive prostatic enlargement
48
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide49BPH Treatments
The NIH-funded Medical Therapy of Prostatic Symptoms (MTOPS) and CombaT studies indicated that combination therapy is likely to be more effective at inhibiting disease progression than monotherapy 5ARs are not to be administered to women or children. Women who are pregnant or who may become pregnant should not handle dutasteride capsules or finasteride tablets
49
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide50BPH Treatments
Product Updates:None
50
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide51Calcium Channel Blockers
51
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide52Calcium Channel Blockers
Class Overview - Product indications include*:HypertensionAnginaVasospastic AnginaVentricular Rate ControlUnstable AnginaCoronary Artery DiseaseSubarachnoid hemorrhage
52
Reaching across Arizona to provide comprehensive quality health care for those in need
*Not inclusive of all product indications, all products differ in indication
Slide53Calcium Channel Blockers
Class Overview: Dihydropyridinesamlodipine - (amlodipine, Norvasc)felodipine ER - (felodipine ER, Plendil)isradipine - (isradipine)nicardipine - (Cardene, nicardipine)nicardipine SR - (Cardene SR)nifedipine - (nifedipine, Procardia)nifedipine ER, SA, SR - (Adalat CC; Afeditab CR; Nifediac CC; Nifedical XL; nifedipine ER, SA, SR; Procardia XL)nimodipine - (nimodipine)
53
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide54Calcium Channel Blockers
Class Overview: Dihydropyridinesnimodipine solution - (Nymalize)nisoldipine ER- (nisoldipine ER, Sular)Class Overview: Non-dihydropyridinesdiltiazem - (Cardizem, diltiazem)diltiazem ER - (Cardizem LA, diltiazem ER, Matzim LA)diltiazem ER - (Cardizem CD; Cartia XT; diltiazem ER; Dilacor XR; Dilt CD; Taztia XT; Tiazac)
54
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide55Calcium Channel Blockers
Class Overview: Non-dihydropyridinesdiltiazem ER - (Dilt XR, Diltia XT)verapamil - (Calan, verapamil)verapamil ER - (Covera-HS)verapamil ER - (verapamil ER, Verelan PM)verapamil SR - (Calan SR, Isoptin SR, verapamil ER, Verelan)
55
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide56Calcium Channel Blockers
Calcium channel blockers (CCBs) are widely used in the treatment of hypertension and angina pectorisPer the JNC-8, first-line therapy for HTN in the non-African American population is a thiazide-type diuretic, a CCB, an ACE inhibitor, or an angiotensin receptor blocker (ARB)They recommend a thiazide diuretic or CCB for African AmericansThe benefits of CCBs in controlling angina and hypertension have been clearly documentedNo CCB has demonstrated a clinical advantage over other CCBs in the treatment of hypertension Dihydropyridine CCBs may cause a baroreceptor-mediated reflex increase in heart rate because of their potent peripheral vasodilating effects
56
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide57Calcium Channel Blockers
Diltiazem decreases atrioventricular conduction and heart rateVerapamil decreases heart rate, slows atrioventricular nodal conduction to the greatest extent of the CCBs, and is useful for supraventricular tachyarrhythmias Short-acting nifedipine has been related to increased coronary mortality rates in patients with a history of MI and should not be used for the treatment of hypertension The ALLHAT study enrolled patients with hypertension and with a known risk factor for CADThe study showed that chlorthalidone, amlodipine, and lisinopril had similar outcomes of combined fatal coronary heart disease (CHD) and nonfatal MI
57
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide58Calcium Channel Blockers
Many large trials enrolling patients with hypertension have demonstrated that CCBs have beneficial effects on composite cardiovascular outcomes or individual clinical outcomesHowever, most of the trials only demonstrated equivalence to the comparator antihypertensives rather than superiority
58
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide59Calcium Channel Blockers
Product/Guideline Updates:Consensi, a combination of amlodipine and celecoxib, is indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriateConsensi is approved as tablets in amlodipine/celecoxib strengths 2.5 mg/200 mg, 5 mg/200 mg, or 10 mg/200 mg and is dosed once dailyContraindications, warnings, adverse reactions and drug interactions are consistent with the individual products
59
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide60Leukotriene Modifiers
60
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide61Leukotriene Modifiers
Class Overview:montelukast - (montelukast chewable tablet, granules & tablet; Singulair Chewable Tablet, Granules & Tablet)zafirlukast - (Accolate; zafirlukast)zileuton- (zileuton ER; Zyflo; Zyflo CR)
61
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide62Leukotriene Modifiers
Zafirlukast, zileuton, and zileuton ER are only approved for prophylaxis and chronic treatment of asthmaMontelukast is the only leukotriene modifier that is approved for asthma and allergic rhinitis and can be considered for patients with these two co-morbiditiesNational Asthma Education and Prevention Program (NAEPP) and 2018 Global Initiative for Asthma (GINA) guidelines recommend inhaled corticosteroids (ICS) as the cornerstone for the treatment of asthmaLeukotriene modifiers are included as potential alternatives or add-on therapy in some patientsGINA states that leukotriene modifiers are less effective than ICS, but may be appropriate for initial controller treatment for patients unable or unwilling to use ICS, intolerant to ICS, or who also have allergic rhinitis
62
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide63Leukotriene Modifiers
Leukotriene modifiers are also used as add-on therapy to reduce the dose of the ICS in patients with moderate to severe asthma, and to potentially improve asthma control in patients whose asthma is not controlled with low or high doses of ICSLimited data exist to support the use of leukotriene modifiers in acute asthmaThe American Academy of Allergy, Asthma and Immunology (AAAAI), the American College of Allergy, Asthma, and Immunology (ACAAI), and the American Academy of Otolaryngology, Head and Neck Surgery recommend intranasal corticosteroids (INCS) as first line treatment for patients with seasonal allergic rhinitis (SAR)Montelukast is considered an alternative to first-line therapy with INCS in patients who suffer from both asthma and SAR
63
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide64Leukotriene Modifiers
The International Consensus Statement on Allergy and Rhinology Allergic Rhinitis guidelines state that leukotriene receptor antagonist monotherapy can be a useful alternative in patients with contraindications for INCSs and oral antihistaminesCurrently, high-quality comparative trials of the leukotriene modifiers are limitedMontelukast is the most widely used leukotriene modifier because of its multiple indications, once daily dosing, and ease of administration due to several different dosage forms
64
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide65Leukotriene Modifiers
Product Updates:None
65
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide66Phosphate Binders
66
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide67Phosphate Binders
Class Overview:calcium acetate - (calcium acetate capsule & tablet; Phoslyra)ferric citrate - (Auryxia)lanthanum carbonate - (Fosrenol Chewable Tablet; Fosrenol Powder Pack; lanthanum carbonate chewable tablet)sevelamer carbonate - (Renvela Powder Pack; Renvela Tablet; sevelamer carbonate powder pack, tablet & tablet (AG))sevelamer HCL - (Renagel)sucroferric oxyhydroxide - (Velphoro)
67
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide68Phosphate Binders
Chronic kidney disease (CKD) affects approximately 30 million individuals in the United StatesKidney function deterioration results in decline in the ability to eliminate phosphorus, resulting in hyperphosphatemiaIn end stage renal disease (ESRD), patients are at risk for several complications of hyperphosphatemia, including:Renal bone diseaseSoft and vascular tissue calcificationCardiovascular diseaseIncreased deathThe National Kidney Foundation updated their guidelines in 2017 under The Kidney Disease: Improving Global Outcomes (KDIGO) foundation
68
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide69Phosphate Binders
Treatment of hyperphosphatemia includes the reduction of dietary phosphorus, phosphate binding therapy, and removal of phosphorus by dialysisStudies have shown control of hyperphosphatemia is critical in the prevention and delay of renal osteodystrophy and soft tissue calcificationsAll phosphate binders are considered efficacious in reducing serum phosphate levelsGuidelines do not strongly prefer one type of phosphate binder over another for adultsSelection of an appropriate phosphate binder should be based on various clinical parameters and should be individualized to meet each patient’s unique medical needs
69
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide70Phosphate Binders
Product Updates:None
70
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide71Sedative Hypnotics
71
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide72Sedative Hypnotics
Class Overview: Benzodiazepine Agentsestazolam - (estazolam)flurazepam - (flurazepam)quazepam – (Doral; quazepam)temazepam - (Restoril; temazepam; temazepam 7.5mg & 22.5mg)triazolam - (Halcion; triazolam)
72
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide73Sedative Hypnotics
Class Overview: Non-Benzodiazepine Agentsdoxepin - (Silenor)eszopiclone - (eszopiclone; Lunesta)ramelteon - (ramelteon; Rozerem) suvorexant - (Belsomra)tasimelteon - (Hetlioz)zaleplon - (Sonata; zaleplon)zolpidem - (Ambien; Ambien CR; Edluar; Intermezzo; zolpidem;zolpidem SL; zolpidem ER; Zolpimist)
73
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide74Sedative Hypnotics
Insomnia is a symptom complex that comprises difficulties falling asleep, staying asleep, or non-refreshing sleep in combination with daytime dysfunction or distressNon-pharmacological measures should be used first to treat insomniaThe updated 2017 American Academy of Sleep Medicine (AASM) guidelines recommend psychological and behavioral strategies, as well as pharmacological interventions The guidelines recommend that initial behavioral interventions should include stimulus control or relaxation therapy, or a combination of therapies referred to as cognitive behavioral therapy (CBT) for insomnia
74
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide75Sedative Hypnotics
AASM guideline recommends that pharmacotherapy should be used to treat patients who failed to respond to CBT AASM recommends:Zaleplon, triazolam, and ramelteon versus no treatment for sleep onset insomniaSuvorexant and doxepin over no treatment for sleep maintenance insomnia Eszopiclone, zolpidem, and temazepam for both sleep onset and sleep maintenance insomniaAgainst the use of trazodone or tiagabine for sleep onset or for sleep maintenance insomnia in adults Against the use of OTC medications, supplements, or herbal products as a treatment for sleep onset or sleep maintenance for chronic insomnia
75
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide76Sedative Hypnotics
Current treatment guidelines for insomnia do not recommend one agent within this class over another, suggesting treatment be individualizedChoice of agent should be based on:Symptom patternTreatment goalsPast treatment responsePatient preference Cost
76
Reaching across Arizona to provide comprehensive quality health care for those in need
Availability of other treatments options
Comorbid conditions
Contraindications
Potential interactions with concurrent medications
Adverse effects
Slide77Sedative Hypnotics
Non-24-hour sleep-wake disorder (N24SWD or non-24) is a chronic circadian rhythm disorder that causes problems with the timing of sleep and sleep patterns. Hetlioz is only indicated for use in N24SWDWith the exception of zolpidem SL, all agents should be administered immediately before going to bed or after the patient has gone to bed and experienced difficulty falling asleepZolpidem SL should be utilized for middle of the night awakenings when the patient still has more than 4 hours before planned waking time Due to gender differences in zolpidem clearance, women generally require lower doses of zolpidem
77
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide78Sedative Hypnotics
Doxepin, ramelteon, and tasimelteon are the only agents in this class that are not controlled substances and are not associated with abuse or physical dependenceAll drugs in this class should be used at the lowest effective doseAll sedative/hypnotics should be administered with caution in patients exhibiting signs and symptoms of depressionPatients whose insomnia fails to remit after 7 to 10 days of treatment may need to be evaluated for other medical or psychological issues Continuous use should be avoided; patients should be encouraged to use these medications only when necessary
78
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide79Sedative Hypnotics
In 2016, the FDA informed healthcare professionals that concurrent use of opioids and benzodiazepines or other CNS depressants may result in serious adverse reactions such as profound sedation, respiratory depression, coma, and deathProviders should limit prescribing opioids with benzodiazepines to only patients without alternative treatment options
79
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide80Sedative Hypnotics
Treatment Updates:The FDA is requiring a boxed warning be added to the prescribing information for eszopiclone, zaleplon, and zolpidem regarding serious injuries and death from complex sleep behaviors, in addition to a contraindication in patients who have previously experienced an episode of complex sleep behavior with these medications
80
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide81Steroids, Topical
81
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide82Steroids, Topical
Class Overview: Low Potency Topical Steroid Productsalclometasone dipropionate – (alclometasone dipropionate cream & ointment)desonide – (Desonate Gel; Desowen Cream; desonide cream, lotion & ointment; Tridesilon; Verdeso)fluocinolone acetonide – (Capex Shampoo; Dema-Smoothe-FS; fluocinolone 0.01% oil)fluocinolone acetonide/Cetaphil cleanser lotion (Xilapak Kit)fluocinolone acetonide/ urea* (NoxiPak Kit)
82
Reaching across Arizona to provide comprehensive quality health care for those in need
Slide83Steroids, Topical
Class Overview: Low Potency Topical Steroid Productshydrocortisone (Advanced Allergy Collection Kit, Ala-Cort, Ala-Scalp, Aquanil, Anti-Itch, Aqua Glycolic HC Kit, Beta HC, Cortaid, Cortisone, Cortizone, Dermarest Eczema, Dermasorb HC Complete Kit, GS Anti-Itch, MiCort HC, Noble Formula HC, QC Anti-Itch, Scalacort, Scalacort-DK Kit, Scalp Relief, Scalpicin, Soothing Care, Texacort, Vanicream; hydrocortisone)hydrocortisone/aloe vera (Cortisone-10, Cortisone Plus Aloe, Nucort, QC Anti-Itch with Aloe, SM Hydrocortisone-Aloe, SM Hydrocortisone Plus; hydrocortisone/aloe vera)
83
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide84Steroids, Topical
Class Overview: Medium Potency Topical Steroid Productsbetamethasone valerate - (betamethasone valerate foam; Luxiq)clocortolone pivalate - (clocortolone cream (AG); Cloderm)fluocinolone acetonide - (fluocinolone acetonide cream, ointment & solution; Synalar Ointment & Solution) flurandrenolide - (Cordran Tape; flurandrenolide cream, lotion, lotion (AG) & ointment; Nolix)fluticasone propionate - (Cutivate Cream & Lotion; fluticasone cream, lotion & ointment)
84
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide85Steroids, Topical
Class Overview: Medium Potency Topical Steroid Productshydrocortisone butyrate - (hydrocortisone butyrate cream, cream (AG), lotion, ointment, ointment (AG), solution & solution (AG); Locoid / Lipocream) hydrocortisone probutate - (Pandel) hydrocortisone valerate - (hydrocortisone valerate cream & ointment)mometasone furoate - (Elocon Cream & Ointment; mometasone furoate cream, ointment & solution )prednicarbate - (Dermatop; prednicarbate cream & ointment)
85
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide86Steroids, Topical
Class Overview: High Potency Topical Steroid Productsamcinonide - (amcinonide cream & lotion)betamethasone dipropionate - (betamethasone dipropionate cream, gel, lotion & ointment; Sernivo Spray)betamethasone valerate - (betamethasone valerate cream & ointment) betamethasone dipropionate augmented cream (Diprolene AF)desoximetasone - (desoximetasone cream, gel & ointment; Topicort Ointment & Spray)diflorasone diacetate - (diflorasone diacetate cream & ointment)fluocinonide - (fluocinonide cream, gel, ointment & solution; Vanos)
86
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide87Steroids, Topical
Class Overview: High Potency Topical Steroid Productsfluocinonide/emollient - (fluocinonide emollient)halcinonide - (Halog Cream & Ointment)triamcinolone acetonide/dimethicone - (Ellzia Pak) triamcinolone acetonide/silicones - (DermacinRx Silazone; Silazone-II)triamcinolone acetonide - (Kenalog Aerosol; triamcinolone acetonide aerosol, cream, lotion & ointment; Trianex Ointment)triamcinolone acetonide/dimethicone/silicones - (DermacinRx Silapak; triamcinolone acetonide/dimethicone)triamcinolone/emollient - (Dermasorb TA)
87
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide88Steroids, Topical
Class Overview: Very High Potency Topical Steroid Productsclobetasol propionate - (clobetasol lotion; clobetasol propionate cream, gel, ointment, solution, spray & spray (AG); clobetasol shampoo; Clobex Lotion, Shampoo & Spray; Olux; Temovate Cream)clobetasol propionate/clobetasol propionate/emollient - (clobetasol propionate foam)clobetasol propionate/emollient - (clobetasol propionate/emollient )clobetasol propionate/skin cleanser - (Clodan Kit)diflorasone diacetate/emollient - (Apexicon E)
88
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide89Steroids, Topical
Class Overview: Very High Potency Topical Steroid Productshalobetasol propionate - (halobetasol propionate cream & ointment; Ultravate Lotion) halobetasol/lactic acid - (Ultravate X Pac Cream & Ointment)Halobetasol propionate foam - (Lexette) halobetasol propionate lotion - (Bryhali)
89
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide90Steroids, Topical
Topical corticosteroids are used in a variety of inflammatory skin conditionsAtopic dermatitis (AD) is a chronic, inflammatory dermatologic condition and is often referred to as “eczema”AD commonly occurs in patients affected by asthma and/or allergic rhinitis and is associated with elevated serum IgE levelsAD can present at any age, but prevails most frequently in childrenPsoriasis is another inflammatory skin condition, with plaque psoriasis being the most common type frequently forming on the elbows, knees, lower back, and scalpControlling symptoms of plaque psoriasis typically requires lifelong therapy
90
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide91Steroids, Topical
Seborrheic dermatitis is an inflammatory disorder affecting areas of the head and trunk, where sebaceous glands are most prominentPharmacotherapy choices for these conditions include emollients and topical corticosteroidsEmollients remain the cornerstone of any AD treatment regimenTopical corticosteroids are the standard of care to which other treatments are comparedThe selection of medication and potency should depend on:Medication efficacySeverity of diseaseLocation and surface area of affected skinIntended duration of treatment
91
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide92Steroids, Topical
Medication vehiclePatient preferencePatient age In short-term durations of treatment, high potency medications have greater efficacy when compared to less potent medications, but with an increased risk in side effectsIncreased incidences of adverse dermatologic reactions are positively correlated with the medication’s frequency and duration of use True efficacy and risk of long-term topical corticosteroid use is unknown because most clinical trials only involved short-term studies
92
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide93Steroids, Topical
Treatment guidelines from the American Academy of Dermatology recommend that continued therapy be supervised and a gradual reduction in utilization is appropriate once a clinical response is demonstratedThere are differing compendia listings for corticosteroid potenciesEfficacy of topical corticosteroids is relative to their potency, but individual agents within a potency category are not distinguishable from each other
93
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide94Steroids, Topical
Product/Guideline Updates:Bryhali is a corticosteroid lotion indicated for the topical treatment of plaque psoriasis in adultsIt is approved as a 0.01% halobetasol propionate lotion available in 45g, 60g, and 100g tubesIt is dosed as a thin layer applied topically to affected area(s) once daily for up to 8 consecutive weeksWarnings and adverse reactions are similar to other halobetasol products
94
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide95Steroids, Topical
Product/Guideline Updates:Merck has made a business decision to discontinue Elocon 0.1% in 15g and 50g tubes. Other formulations of mometasone 0.1% cream are availableJanssen announced the discontinuation of Nizoral 2% shampoo (ketoconazole). The last production was in October 2018 with an expiration date of September 2020
95
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide96New Drug Reviews
Hind Douiki, Pharm.D.
96
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide97New Products
Mayzent (siponimod)Rocklatan (netarsudil/latanoprost)Mavenclad (cladribine)Evenity (romosozumab-aqqg)Diacomit (stiripentol) Skyrizi (risankizumab)
97
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide98New Products
Cutaquig (immune globulin)Egaten (triclabendazole)Sunosi (solriamfetol)Rinvoq (upadacitinib)Vyndamax (tafamidis)
98
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide99Mayzent (siponimod)
Indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive diseaseBefore initiation of treatment with Mayzent, CYP2C9 Genotype Determination Test must be completed to determine CYP2C9 genotypeThe following must also be obtained and assessed:Complete Blood Count Ophthalmic evaluation Cardiac evaluation Current or prior medications Vaccinations Liver function tests
Reaching across Arizona to provide comprehensive quality health care for those in need
99
Slide100Mayzent (siponimod)
Titration is required for treatment initiation and the dose depends on the genotypeIt is available as 0.25 mg and 2 mg tabletsContraindications:Patients with a CYP2C9*3/*3 genotypeIn the last 6 months, patient experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker
Reaching across Arizona to provide comprehensive quality health care for those in need
100
Slide101Mayzent (siponimod)
Warnings:InfectionsMacular edemaBradyarrhythmia and atrioventricular conduction delaysRespiratory effectsLiver injuryIncreased blood pressure Fetal riskMost common adverse reactions (incidence greater than 10%):HeadacheHypertensionTransaminase increases
Reaching across Arizona to provide comprehensive quality health care for those in need
101
Slide102Mayzent (siponimod)
Drug interactions:AntineoplasticsImmunumodulatorsImmunosuppressivesAntiarrhythmicsQT-prolonging drugsDrugs that may decrease heart rateVaccinationsCYP2C9 and CYP3A4 inhibitors CYP2C9 and CYP3A4 inducers
Reaching across Arizona to provide comprehensive quality health care for those in need
102
Slide103Mayzent (siponimod)
No comparative data are availableThe FDA approval of Mayzent was based on the randomized, double-blind, placebo-controlled phase III EXPAND trialThe efficacy and safety of Mayzent versus placebo was compared in 1,651 subjects with secondary progressive multiple sclerosis (SPMS)Inclusion criteria also included the following: evidence of disability progression in the prior 2 years, no evidence of relapse in 3 months prior to study enrollment, and an Expanded Disability Status Scale (EDSS) score of 3-6.5 at study entryEvaluations were performed at screening, every 3 months during the study, and at the time of a suspected relapse; MRI evaluations were performed at screening and every 12 months
Reaching across Arizona to provide comprehensive quality health care for those in need
103
Slide104Mayzent (siponimod)
Mayzent significantly reduced the risk of three-month confirmed disability progression (which was the primary endpoint; 21% reduction versus placebo, p=0.013; 33% reduction versus placebo in patients with relapse activity in the two years prior to screening, p=0.01)Mayzent also reduced the annualized relapse rate by 55%
Reaching across Arizona to provide comprehensive quality health care for those in need
104
Slide105Rocklatan (netarsudil/latanoprost)
Indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertensionDose is one drop into the affected eye(s) once daily in the evening Warnings:PigmentationEyelash changes Intraocular inflammation Macular edema Herpetic and bacterial keratitis
Reaching across Arizona to provide comprehensive quality health care for those in need
105
Slide106Rocklatan (netarsudil/latanoprost)
The most common adverse reaction is conjunctival hyperemia (59%)Other common adverse reactions were instillation site pain (20%), corneal verticillata (15%), and conjunctival hemorrhage (11%)The FDA approval of Rocklatan was based on two Phase III registration trials, MERCURY 1 and MERCURY 2Studies 301 and 302 enrolled subjects with IOP < 36 mmHg and compared IOP lowering effect of Rocklatan dosed once daily to individually administered netarsudil 0.02% once daily and latanoprost 0.005% once dailyThe treatment duration was 12 months for MERCURY 1; 3 months for MERCURY 2
Reaching across Arizona to provide comprehensive quality health care for those in need
106
Slide107Rocklatan (netarsudil/latanoprost)
In these studies, Rocklatan achieved its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy resultsRocklatan demonstrated statistically greater IOP reduction over latanoprost and netarsudil at every measured time pointMore than 60% of patients taking Rocklatan in the two MERCURY studies achieved an IOP reduction of 30% or more; nearly twice that achieved by patients taking latanoprost aloneRocklatan also helped more patients get to low target pressuresNearly twice as many patients taking Rocklatan reached 16 mmHg or lower and nearly three times as many reached 14 mmHg or lower compared to latanoprost
Reaching across Arizona to provide comprehensive quality health care for those in need
107
Slide108Mavenclad (cladribine)
Indicated for the treatment of relapsing forms of MS, to include relapsing-remitting disease and active secondary progressive disease in adultsBecause of its safety profile, use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MSNot recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile
Reaching across Arizona to provide comprehensive quality health care for those in need
108
Slide109Mavenclad (cladribine)
Assessments prior to starting each Mavenclad treatment course: Cancer ScreeningPregnancyComplete Blood Count (CBC) with differential including lymphocyte countInfectionsVaccinationsA baseline MRI must be obtained prior to the first treatment course because of the risk of progressive multifocal leuko-encephalopathy Liver function
Reaching across Arizona to provide comprehensive quality health care for those in need
109
Slide110Mavenclad (cladribine)
The recommended cumulative dosage is 3.5 mg per kg body weight administered orally and divided into 2 yearly treatment courses of 1.75 mg per kg per treatment courseIt is available as 10 mg tablets
Reaching across Arizona to provide comprehensive quality health care for those in need
110
Slide111Mavenclad (cladribine)
Contraindications:Patients with current malignancyPregnant womenWomen and men of reproductive potential who do not plan to use effective contraception during Mavenclad therapy and for 6 months after the last doseHIV infectionActive chronic infectionsHistory of hypersensitivity to cladribineWomen intending to breastfeed on a Mavenclad treatment and for 10 days after the last dose
Reaching across Arizona to provide comprehensive quality health care for those in need
111
Slide112Mavenclad (cladribine)
Carries a boxed warning regarding malignancies and risk of teratogenicityOther warnings:LymphopeniaInfectionsHematologic toxicityGraft-versus-host-disease with blood transfusionLiver injuryMost common adverse reactions (incidence > 20%):Upper respiratory tract infectionHeadacheLymphopenia
Reaching across Arizona to provide comprehensive quality health care for those in need
112
Slide113Mavenclad (cladribine)
No comparative data are availableThe FDA approval of Mavenclad was based on a randomized, double-blind, placebo-controlled study in patients with relapsing forms of MSPatients were required to have at least 1 relapse in the previous 12 monthsThe trial enrolled 1,326 patients who were randomized to receive either placebo or a cumulative oral dosage of Mavenclad 3.5 mg per kg or 5.25 mg per kg body weight over the 96-week study period in 2 treatment coursesPatients randomized to the 3.5 mg per kg cumulative dose received a first treatment course at Weeks 1 and 5 of the first year and a second treatment course at Weeks 1 and 5 of the second year
Reaching across Arizona to provide comprehensive quality health care for those in need
113
Slide114Mavenclad (cladribine)
Patients randomized to the 5.25 mg per kg cumulative dose received additional treatment at Weeks 9 and 13 of the first yearHigher cumulative doses did not add any clinically meaningful benefit, but were associated with a higher incidence in grade 3 lymphopenia or higher The primary outcome was the annualized relapse rate (ARR)Mavenclad 3.5 mg per kg cumulative dose significantly lowered the ARR; patients experienced a 58% relative reduction compared to placebo (0.14 vs. 0.33, p<0.001)In addition, 81% of patients were free of relapses after two years of short-course oral treatment with Mavenclad, compared to 63% of patients who received placebo (p<0.05)
Reaching across Arizona to provide comprehensive quality health care for those in need
114
Slide115Mavenclad (cladribine)
Patients treated with Mavenclad had a 33% reduction in risk of 3-month confirmed disability progression as measured by EDSS compared to placebo (p<0.05)Patients taking Mavenclad experienced a lower median number of T1-weighted gadolinium-enhanced brain lesions and new or enlarging T2 brain lesions compared to patients with placebo (0 vs. 0.33 and 0 vs. 0.67 p<0.001)
Reaching across Arizona to provide comprehensive quality health care for those in need
115
Slide116Evenity (romosozumab-aqqg)
Indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapyThe anabolic effect of Evenity wanes after 12 monthly doses of therapy; therefore, the duration of Evenity use should be limited to 12 monthly dosesTwo separate syringes and subcutaneous injections are needed to administer the total dose of 210 mg of Evenity every monthAvailable as 105 mg/1.17 mL prefilled syringes
Reaching across Arizona to provide comprehensive quality health care for those in need
116
Slide117Evenity (romosozumab-aqqg)
Patients should be adequately supplemented with calcium and vitamin D during treatment with Evenity Contraindicated in patients with hypocalcemiaCarries a boxed warning regarding potential risk of myocardial infarction, stroke, and cardiovascular deathOther warnings:Major Adverse Cardiac Events (MACE)Hypersensitivity reactionsHypocalcemiaOsteonecrosis of the jaw Atypical femoral fracture
Reaching across Arizona to provide comprehensive quality health care for those in need
117
Slide118Evenity (romosozumab-aqqg)
The most common adverse reactions (≥ 5%) reported in clinical trials were arthralgia and headacheThe FDA approval of Evenity was based on two phase III trials, FRAME and ARCHFRAME was a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosisThe study evaluated the efficacy of Evenity treatment (at 210 mg administered monthly), compared with placebo, in reducing the incidence of new vertebral fractures through 12 monthsThe study also evaluated the efficacy of treating with Evenity for 12 months followed by Prolia for 12 months, compared with placebo followed by Prolia, in reducing the incidence of new vertebral fractures through 24 months
Reaching across Arizona to provide comprehensive quality health care for those in need
118
Slide119Evenity (romosozumab-aqqg)
Treatment with Evenity resulted in a significant reduction of new vertebral fracture at 12 months compared to placeboThis significant reduction in fracture risk persisted through the second year in women who received Evenity during the first year and transitioned to Prolia compared to those who transitioned from placebo to ProliaIn addition, Evenity significantly increased bone mineral density (BMD) at the lumbar spine, total hip and femoral neck compared to placebo at 12 monthsFollowing the transition from Evenity to Prolia at month 12, BMD continued to increase through month 24
Reaching across Arizona to provide comprehensive quality health care for those in need
119
Slide120Evenity (romosozumab-aqqg)
ARCH was a randomized, double-blind, alendronate-controlled study of Evenity in 4,093 postmenopausal women with osteoporosis and previous fracture historyThis event-driven study evaluated 12 months of Evenity treatment followed by at least 12 months of alendronate treatment, compared with alendronate treatment aloneThe objective was to assess Evenity’s efficacy in reducing the risk of clinical fracture through the primary analysis period and the incidence of new vertebral fracture at 24 monthsTreatment with Evenity for 12 months followed by 12 months of alendronate significantly reduced the incidence of new vertebral fracture at 24 months
Reaching across Arizona to provide comprehensive quality health care for those in need
120
Slide121Evenity (romosozumab-aqqg)
Evenity followed by alendronate significantly reduced the risk of clinical fracture after a median follow-up of 33 monthsEvenity also significantly increased BMD at the lumbar spine, total hip and femoral neck at 12 months compared to alendronate
Reaching across Arizona to provide comprehensive quality health care for those in need
121
Slide122Diacomit (stiripentol)
Indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazamThere are no clinical data to support the use of Diacomit as monotherapy in Dravet syndromeDose is 50 mg/kg/day by mouth in 2 or 3 divided dosesAvailable as 250 mg or 500 mg capsules and 250 mg or 500 mg powder for oral suspension
Reaching across Arizona to provide comprehensive quality health care for those in need
122
Slide123Diacomit (stiripentol)
Warnings:SomnolenceDecreased appetite and decreased weightNeutropenia and thrombocytopeniaWithdrawalRisks in patients with phenylketonuriaSuicidal behavior and ideation
Reaching across Arizona to provide comprehensive quality health care for those in need
123
Slide124Diacomit (stiripentol)
Adverse reactions that occurred in at least 10% of Diacomit-treated patients and more frequently than with placebo: SomnolenceDecreased appetiteAgitationAtaxiaWeight decrease
Reaching across Arizona to provide comprehensive quality health care for those in need
124
Hypotonia
Nausea
Tremor
Dysarthria
Insomnia
Slide125Diacomit (stiripentol)
No comparative data are availableThe FDA approval of Diacomit was based on two multicenter placebo-controlled trials, Study 1 and, Study 2, which enrolled a combined total of 64 subjectsThe primary efficacy endpoint in both trials was the responder rateThis was defined as a patient who experienced a greater than 50% decrease in the frequency (per 30 days) of generalized clonic or tonic-clonic seizures during the double-blind treatment period compared to the 4-week baseline periodIn Study 1, the responder rate for patients receiving Diacomit was 71%, compared to 5% for patients receiving placeboIn Study 2, the responder rate for patients receiving Diacomit was 67%, compared to 9.1% for patients receiving placebo
Reaching across Arizona to provide comprehensive quality health care for those in need
125
Slide126Skyrizi (risankizumab-rzaa)
Indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Dosage is 150 mg (two 75 mg injections) administered by subcutaneous injection at Week 0, Week 4 and every 12 weeks thereafter WarningsInfectionsTuberculosisImmunizations
Reaching across Arizona to provide comprehensive quality health care for those in need
126
Slide127Skyrizi (risankizumab-rzaa)
Most common adverse reactions (≥ 1%): Upper respiratory infectionsHeadacheFatigueInjection site reactionsTinea infections The safety and efficacy of Skyrizi in adults with moderate to severe plaque psoriasis was assessed across four randomized, placebo and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent
Reaching across Arizona to provide comprehensive quality health care for those in need
127
Slide128Skyrizi (risankizumab-rzaa)
The co-primary endpoints of these studies were Psoriasis Area and Severity Index (PASI 90) and static Physician Global Assessment [sPGA] score of clear or almost clear [sPGA 0/1] at 16 weeks versus placeboIn ULTIMMA-1 and ULTIMMA-2, 997 subjects were randomized to the Skyrizi 150 mg group, to the placebo group, and to the biologic active control groupSubjects received treatment at Weeks 0, 4, and every 12 weeks thereafterIn ultIMMa-1 and ultIMMa-2 at 16 weeks, PASI 90 was achieved in 75 percent of patients treated with Skyrizi, compared to 5 and 2 percent receiving placebo, respectively (p<0.001)
Reaching across Arizona to provide comprehensive quality health care for those in need
128
Slide129Skyrizi (risankizumab-rzaa)
PASI 100 was achieved in 36 and 51 percent of patients treated with Skyrizi, compared to 0 and 2 percent receiving placebo, respectively (p<0.001)At 52 weeks, 82 and 81 percent of patients treated with Skyrizi achieved PASI 90, and 56 and 60 percent achieved PASI 100, respectively (p<0.001)An integrated analysis of ultIMMa-1 and ultIMMa-2 showed most patients treated with Skyrizi who achieved PASI 90 and PASI 100 at week 16 maintained this response at 52 weeks (88 and 80 percent, respectively)
Reaching across Arizona to provide comprehensive quality health care for those in need
129
Slide130Skyrizi (risankizumab-rzaa)
IMMHANCE enrolled 507 subjects who were randomized to Skyrizi 150 mg and to placeboParticipants received treatment at Weeks 0, 4, and every 12 weeks thereafterAt Week 16, Skyrizi was superior to placebo on the co-primary endpoints of sPGA 0 or 1 (84% Skyrizi and 7% placebo) and PASI 90 (73% Skyrizi and 2% placebo)The respective response rates for Skyrizi and placebo at Week 16 were: sPGA 0 (46% Skyrizi and 1% placebo); PASI 100 (47% Skyrizi and 1% placebo); and PASI 75 (89% Skyrizi and 8% placebo)
Reaching across Arizona to provide comprehensive quality health care for those in need
130
Slide131Skyrizi (risankizumab-rzaa)
IMMvent was a multinational, phase 3, randomized, double-blind, double-dummy, active-controlled trialIn Part A, patients were randomized 1:1 to receive Skyrizi 150 mg at weeks 0 and 4 or adalimumab 80 mg at week 0 and 40 mg every 2 weeks from week 1 to week 15In Part B (weeks 16-44), patients initially randomized to receive adalimumab who achieved PASI 50 to <90 at week 16 were re-randomized 1:1 to receive Skyrizi 150 mg at weeks 16, 20, and 32 or ADA 40 mg every 2 weeks up to week 41Skyrizi demonstrated superiority versus adalimumab, with 72 percent of patients achieving PASI 90 compared to 47 percent of patients treated with adalimumab at Week 16 (p<0.001)
Reaching across Arizona to provide comprehensive quality health care for those in need
131
Slide132Skyrizi (risankizumab-rzaa)
Following re-randomization at Week 16, 66 percent of patients who started on adalimumab and switched to Skyrizi achieved PASI 90, compared to 21 percent who continued on adalimumab at Week 44 (p<0.001)The co-primary endpoints of sPGA 0/1 and PASI 90 at Week 16 were met (p<0.001)
Reaching across Arizona to provide comprehensive quality health care for those in need
132
Slide133Cutaquig (immune globulin)
Indicated for treatment of primary humoral immunodeficiency (PI) in adultsThe dose is to be individualized based on the patient’s pharmacokinetic and clinical responseTrough Serum IgG levels should be monitored regularly to guide subsequent dose adjustments as neededContraindications:Patients who have had an anaphylactic or severe systemic reaction to human immune globulin or to any of the components of CutaquigIgA-deficient patients with antibodies against IgA and a history of hypersensitivity to human globulin treatment
Reaching across Arizona to provide comprehensive quality health care for those in need
133
Slide134Cutaquig (immune globulin)
Carries a boxed warning regarding the risk of thrombosisOther warnings:HypersensitivityFalsely elevated glucose readingsAseptic Meningitis SyndromeRenal dysfunction/failureHemolysisTransfusion-related acute lung injuryTransmittable infectious agentsInterference with laboratory tests
Reaching across Arizona to provide comprehensive quality health care for those in need
134
Slide135Cutaquig (immune globulin)
The most common adverse reactions observed in ≥ 5% of study subjects:Local infusion site adverse reactionsHeadacheFeverDiarrheaDermatitisAsthmaSkin abrasion
Reaching across Arizona to provide comprehensive quality health care for those in need
135
Slide136Cutaquig (immune globulin)
FDA approval was based on a prospective, open-label, single-arm phase 3 study involving adult and pediatric patients with Primary Immune Deficiency to investigate the efficacy, safety and tolerability of Cutaquig The trial included 61 (adult and pediatric) patients who were previously treated with IVIGResults:No serious bacterial infections developed during the studyThe rate of other infections per person-year during the primary observation period was 3.43 (upper 95% CI 4.57)18.0% of patients experienced 14 mild or moderate systemic adverse events related to CutaquigIn 77% of infusions, no infusion site reactions were observed; 0.3% of the reactions were deemed severe
Reaching across Arizona to provide comprehensive quality health care for those in need
136
Slide137Egaten (triclabendazole)
Indicated for the treatment of fascioliasis in patients 6 years of age and olderDosage is 2 doses of 10 mg/kg given 12 hours apart; it is available as 250 mg tabletsContraindicated in patients with known hypersensitivity to triclabendazole, other benzimidazole derivatives or any of the excipientsCarries a QT Prolongation warningMost common adverse reactions (greater than 2%) are abdominal pain, hyperhidrosis, nausea, decreased appetite, headache, urticaria, diarrhea, vomiting, musculoskeletal chest pain, and pruritus
Reaching across Arizona to provide comprehensive quality health care for those in need
137
Slide138Egaten (triclabendazole)
An open label, randomized trial, conducted in Vietnam compared the efficacy of Egaten to oral artesunate100 (pediatric and adult) patients with acute symptomatic fascioliasis were randomizedAt 3 months after treatment, 92% and 76% of patients in the Egaten and artesunate arms respectively, reported no clinical symptomsIn addition to this trial, the clinical development program of Egaten for the treatment of fascioliasis included 6 non-randomized, open label studies similar in designThese were performed in Cuba, Bolivia, Peru, Chile, and Iran in a total of 245 adult and pediatric patients with stool-confirmed fascioliasis
Reaching across Arizona to provide comprehensive quality health care for those in need
138
Slide139Egaten (triclabendazole)
The studied Egaten doses ranged from 5 mg/kg to 20 mg/kg administered on days 1-3Cure was defined as absence of Fasciola eggs in the stool based on the Kato-Katz method at Day 60 in patients who were positive at baselineAcross these studies, there was a finding of a dose responseSpecifically, the Day 60 cure rate was highest for the 20 mg/kg dose, which was given in 2 divided doses, followed by cure rates of 88%, 80% and 50% in the 15 mg/kg, 10 mg/kg, and 5 mg/kg dose groups, respectively
Reaching across Arizona to provide comprehensive quality health care for those in need
139
Slide140Sunosi (solriamfetol)
Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)Starting dose for patients with narcolepsy and with OSA is 75 mg and 37.5 mg once daily, respectively; maximum dose is 150 mg once dailyAvailable as 75 mg and 150 mg tablets Contraindications:Concurrent treatment with a monoamine oxidase inhibitor (MAOI) Use of an MAOI within the preceding 14 daysWarnings:Blood pressure and heart rate increasesPsychiatric symptoms
Reaching across Arizona to provide comprehensive quality health care for those in need
140
Slide141Sunosi (solriamfetol)
Most common adverse reactions (≥ 5% and greater than placebo): HeadacheNauseaDecreased appetiteInsomniaAnxiety No comparative data are availableFor narcolepsy, the efficacy of Sunosi was demonstrated in a 12-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in adult patients with a diagnosis of narcolepsyA total of 239 patients were randomized to receive Sunosi 75 mg, 150 mg, or 300 mg, or placebo once daily
Reaching across Arizona to provide comprehensive quality health care for those in need
141
Slide142Sunosi (solriamfetol)
Wakefulness and sleepiness were assessed using the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS)The co-primary efficacy endpoints were change from baseline in MWT and ESS at Week 12. Compared to the placebo group, patients randomized to 150 mg Sunosi showed statistically significant improvements on the MWT (treatment effect difference: 7.7 minutes) and on the ESS (treatment effect difference: 3.8 points) at Week 12These effects were apparent at Week 1 and consistent with the results at Week 12
Reaching across Arizona to provide comprehensive quality health care for those in need
142
Slide143Sunosi (solriamfetol)
For OSA, the efficacy of Sunosi was demonstrated in a 12-week multi-center, randomized, double-blind, placebo-controlled study in adultsThe co-primary efficacy endpoints were change from baseline in MWT and ESS at Week 12A total of 476 patients with OSA were randomized to receive Sunosi 37.5 mg, 75 mg, 150 mg, or 300 mg, or placebo once dailyCompared to the placebo group, patients randomized to 37.5 mg, 75 mg, and 150 mg Sunosi showed statistically significant improvements on the MWT (treatment effect difference: 4.5 minutes, 8.9 minutes, and 10.7 minutes respectively) and ESS (treatment effect difference: 1.9 points, 1.7 points, and 4.5 points respectively) at Week 12These effects were apparent at Week 1 and consistent with the results at Week 12
Reaching across Arizona to provide comprehensive quality health care for those in need
143
Slide144Sunosi (solriamfetol)
For maintenance of efficacy in narcolepsy and OSA, Sunosi was assessed in two randomized-withdrawal, placebo-controlled studies, Study 3 and Study 4Study 3 was a 6-week, multi-center, double-blind, placebo-controlled, randomized-withdrawal study in 174 adult patients with a diagnosis of OSAThe co-primary efficacy endpoints were change from the beginning to the end of the randomized withdrawal period in MWT and ESSPatients were started on Sunosi 75 mg once daily, and were titrated to the maximum tolerable dose between 75 mg and 300 mg per day
Reaching across Arizona to provide comprehensive quality health care for those in need
144
Slide145Sunosi (solriamfetol)
124 patients who reported “much” or “very much” improvement on the PGIc and who showed improvements on the MWT and ESS entered a double-blind withdrawal phase and were randomized 1:1 to either continue Sunosi at the dose received in the stable-dose phase or switch to placeboCompared to patients who remained on Sunosi, patients randomized to placebo experienced statistically significant worsening of sleepiness as measured by the MWT and ESS
Reaching across Arizona to provide comprehensive quality health care for those in need
145
Slide146Sunosi (solriamfetol)
Study 4 was a 52-week, open-label study in 638 patients with either narcolepsy or OSA who had completed a prior trialPatients were started on Sunosi 75 mg once daily, and were titrated to the maximum tolerable dose between 75 mg and 300 mg per dayPatients remained on this dose during a subsequent open-label treatment period of either 38 (for patients previously enrolled in Study 1 or Study 2) or 50 weeks (all others)282 patients (79 with narcolepsy; 203 with OSA) entered the randomized-withdrawal periodPatients were randomized 1:1 to either continue to receive Sunosi at the dose received in the maintenance phase or to switch to placebo.
Reaching across Arizona to provide comprehensive quality health care for those in need
146
Slide147Sunosi (solriamfetol)
The primary efficacy endpoint was change from the beginning to the end of the randomized-withdrawal period in ESSCompared to patients who remained on Sunosi, patients randomized to placebo experienced statistically significant worsening of sleepiness as measured by the ESS
Reaching across Arizona to provide comprehensive quality health care for those in need
147
Slide148Rinvoq (upadacitinib)
Indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (MTX)Use of Rinvoq in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended Dose is 15 mg once daily; it is available as 15 mg extended-release tabletsMay be used as monotherapy or in combination with MTX or other nonbiologic DMARDs Interruption, or initiation avoidance, should occur if absolute lymphocyte count <500 cells/mm3, absolute neutrophil count <1000 cells/mm3, or hemoglobin level <8 g/dL
Reaching across Arizona to provide comprehensive quality health care for those in need
148
Slide149Boxed warnings:Serious infectionsMalignancyThrombosis
Additional warnings:Serious infectionsMalignancyThrombosisGastrointestinal perforationsLaboratory parametersEmbryo-fetal toxicityVaccination
Rinvoq (upadacitinib)
149
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide150Adverse reactions (greater than or equal to 1%): Upper respiratory tract infectionsNauseaCoughPyrexia
Drug interactions:Should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors Coadministration with strong CYP3A4 inducers is not recommended
Rinvoq (upadacitinib)
150
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide151Rinvoq (upadacitinib)
The FDA approval of Rinvoq was based on data from the SELECT program, with approximately 4,400 patients evaluated across all treatment arms in five studiesThe studies include assessments of efficacy, safety and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic DMARDs and who were naïve or inadequate responders to MTXAcross the SELECT Phase 3 studies, Rinvoq met all primary and ranked secondary endpoints
Reaching across Arizona to provide comprehensive quality health care for those in need
151
Slide152Rinvoq (upadacitinib)
In SELECT-EARLY, 52 percent of MTX-naïve patients treated with Rinvoq 15 mg achieved ACR50 vs 28 percent treated with MTX at week 12In SELECT-MONOTHERAPY, 68 percent of MTX-IR patients treated with Rinvoq 15 mg achieved ACR20 vs 41 percent treated with continued MTX at week 14In SELECT-COMPARE, 71 percent of MTX-IR patients treated with Rinvoq 15 mg plus MTX achieved ACR20 vs 36 percent treated with placebo plus MTX at week 12In SELECT-NEXT, 64 percent of csDMARD-IR patients treated with Rinvoq 15 mg plus csDMARDs achieved ACR20 vs 36 percent treated with placebo plus csDMARDs at week 12
Reaching across Arizona to provide comprehensive quality health care for those in need
152
Slide153Rinvoq (upadacitinib)
In SELECT-BEYOND, 65 percent of biologic-IR patients treated with Rinvoq 15 mg plus csDMARDs achieved ACR20 vs 28 percent treated with placebo plus csDMARDs at week 12
Reaching across Arizona to provide comprehensive quality health care for those in need
153
Slide154Vyndamax (tafamidis)
Indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalizationDose is 61 mg orally once daily; it is available as 61 mg capsulesVyndamax and Vyndaquel are not substitutable on a per mg basisIn clinical trials, the frequency of adverse events was similar to placebo, and similar proportions discontinued the study drug due to an adverse event
Reaching across Arizona to provide comprehensive quality health care for those in need
154
Slide155Vyndamax (tafamidis)
There are no comparative data availableThe FDA approval was based on a multicenter, international, randomized, double-blind, placebo-controlled study in 441 patients with wild type or hereditary ATTR-CMPatients were randomized in a 1:2:2 ratio to receive Vyndaqel 20 mg, Vyndaqel 80 mg, or matching placebo once daily for 30 months, in addition to standard of careTreatment assignment was stratified by the presence or absence of a variant TTR genotype as well as baseline disease severity (NYHA Class)Transplant patients were excluded from this study
Reaching across Arizona to provide comprehensive quality health care for those in need
155
Slide156Vyndamax - Tafamidis
The analysis demonstrated a significant reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations in the pooled Vyndaqel 20 mg and 80 mg arms versus placeboAnalysis of the individual components of the primary analysis (all-cause mortality and cardiovascular-related hospitalizations) also demonstrated significant reductions for Vyndaqel versus placebo
Reaching across Arizona to provide comprehensive quality health care for those in need
156
Slide157Executive Session
157
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide158Public Therapeutic Class Votes
158
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide159Biosimilar Update
159
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide160Biosimilar Update
HerceptinHerzuma (trastuzumab-pkrb): FDA approved December 2018; anticipated availability is currently unknownOgivri (trastuzumab-dkst): FDA approved December 2017; anticipated availability is currently unknownOntruzant (trastuzumab-dttb): FDA approved January 2019; availability anticipated in June 2019Trazimera (trastuzumab-qyyp): FDA approved March 2019; anticipated availability is currently unknownKanjinti (Trastuzumab-Anns): available
160
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide161Biosimilar Update
AvastinZirabev (bevacizumab-bvzr): FDA approved June 2019; anticipated availability is currently unknownMvasi (Bevacizumab-awwb): availableAs a reminder – per AHCCCS Policy 310-V: AHCCCS Contractors shall not transition to a biosimilar drug until AHCCCS has determined that the biosimilar drug is overall more cost-effective to the state than the continued use of the brand name drug.
161
Reaching across Arizona to provide comprehensive
quality health care for those in need
Slide162P&T Meeting Dates
2020 Meeting Dates:January 22, 2020May 19 and 29, 2020
162
Reaching across Arizona to provide comprehensive
quality health care for those in need