DUR Board Meeting Minutes - Department of Vermont …dvha.vermont.gov/advisory-boards/dec-1205017-vt-dur-minutes-print...DUR Board Meeting Minutes December 05,2017 Board ... Zail Berry,

1 | P a g e

Department of Vermont Health Access Pharmacy Benefit Management Program

DUR Board Meeting Minutes December 05,2017

Board Members: Present: Joseph Nasca, MD

Zail Berry, MD

Jocelyn VanOpdorp, PharmD

Clayton English, PharmD

Bill Breen, RPh

Louise Rosales, NP

Absent: Renee Mosier, PharmD, Patricia King, MD

Staff: Laurie Brady, RPh, Change HealthCare Jeffrey Barkin, MD, Change Healthcare

Carrie Germaine, DVHA Jason Pope, DVHA Nancy Hogue, PharmD, DVHA Jennifer Egelhof, DVHA

Stacey Baker, DVHA Scott Strenio, MD, DVHA

Guests: Thomas Algozzine, Novartis Adam Denman, GSK Stew Hoover, UCB Sarah Faas, Bristol-Myers Squibb Nicholas Primpas, Indivior Christo Stratos, BMS

Shaffee Bacchus, Janssen Susan Donnelly, Pfizer Vincent Lawler, Genzyme Russell Moyer, Viiv Healthcare Paul Short, Vertex Tina McCann, Sarepta

Thomas Currier, Purdue Bill Eicholzier, Sanofi-Genzyme Brad Martin, Avexis Lance Nicholls, Pfizer Scott Williams, J&J Jameson Crowley, Abbvie

1. Executive Session:

o An executive session was held from 6:00 p.m. until 6:30p.m. 2. Introductions and Approval of DUR Board Minutes:

o Introductions were made around the table. o The October meeting minutes were accepted as printed.

3. DVHA Pharmacy Administration Updates: Nancy Hogue, RPh, DVHA

o The State of Vermont has approved the change to remove the fibrosis score restrictions on Hepatitis C therapies. This change will be effective January 1, 2018. A communication has been drafted and will be sent to prescribers and pharmacies.

o CMS certification has been completed. The state will have an official response from CMS in 60-90 days.

2 | P a g e

4. Medical Director Update: Dr. Scott Strenio, DVHA o No update at this time.

5. Follow-up Items from Previous Meetings: Laurie Brady, RPh, Change Healthcare

o Anti-psychotic Atypical & Combinations (Adult>18 years old) o Move Aristada® (aripiprazole lauroxil) with Quantity Limit = 1 syringe/28

days (441mg, 662mg, 882mg strengths) Quantity Limit = 1 syringe/60 days (1064mg) to preferred.

o Move Invega Sustenna® (paliperidone palmitate) with FDA maximum recommended dose = 234 mg/month to preferred.

o Move Invega Trinza® (paliperidone palmitate) with FDA maximum recommended dose = 819mg/3months to be preferred after clinical criteria is met.

o Clinical criteria o Invega Trinza: The patient is started and stabilized on the

medication OR tolerability has been established with Invega Sustenna for at least 4 months. Note: This is processed via automated step therapy.

o Remove the Aristada criteria.

Board Decision: The Board unanimously approved the above recommendation.

o Gastrointestinal Agent: Inflammatory Bowl Agents (Oral and Rectal) o Remove Asacol from the PDL as it is no longer available. o Move Apriso® (mesalamine capsule extended release) to non-

preferred. o Move Delzicol® (mesalamine capsule delayed-release) to non-

preferred. o Clinical criteria

o Remove the current Asacol HD criteria and replace with Asacol HD, Delzicol, Apriso: The patient has had a documented side effect, allergy, or treatment failure to a preferred oral mesalamine product.

o Add Pentasa 500mg: The patient must be unable to adhere to a dosing regimen comprised of Pentasa 250mg capsules resulting in significant clinical impact.

Board Decision: The Board unanimously approved the above recommendation. 6. RetroDUR/DUR: Laurie Brady, RPh, Change Healthcare

o Introduce: Overuse of Long-Acting Stimulants

3 | P a g e

Long-acting stimulants have been used quite effectively to treat ADD and ADHD in children and

adults. While they are not proven to be more effective than short-acting stimulants, there

dosing frequency improves compliance and adherence to the treatment plan. Occasionally

treatment includes the use of long-acting and short–acting stimulants concomitantly, for

example, using a short-acting stimulant to complete a task such as homework, while using a

long-acting stimulant daily or twice daily.

Most people with ADD or ADHD are diagnosed in childhood, but up to two thirds of children

will exhibit some symptoms into adulthood and approximately one half will exhibit enough

symptoms to require medication. It is estimated that 2-6% of the adult population have

ADHD/ADD. Many adults will not show symptoms of hyperactivity, but still require treatment

for attention deficit issues.

We propose to look at the use of long-acting stimulants in the VT Medicaid population with

diagnosis of ADD/ADHD over the last 2 years, to see if use is increasing, or if long-acting agents

are being used in excessive dosages. We propose looking at several age cohorts, including

children and adults to see how many of those prescribed are on more than 2 dosage units per

day, and if there are concomitant prescriptions for more than one long-acting agent

Board Decision: After discussion the board would like to look at patients receiving multiple scripts to see if they are being prescribed by different providers. Also, they would like to add in those that are on a long-acting stimulant without an ADD/ADHD diagnosis. Instead of 2 years, Change Healthcare will look at 3 years of data. It will be broken out by county and physician. SOV will assist with providing data for those in custody. 7. Clinical Update: Drug Reviews: Jeff Barkin, MD, Change Healthcare, and Laurie Brady RPh, Change Healthcare Abbreviated New Drug Reviews:

o None at this time. Full New Drug Reviews:

a) Arymo® ER (morphine sulfate, extended-release) o Abuse deterrent formulations:

o Have properties that are excepted to meaningfully deter certain kinds of abuse or make abuse more difficult or less rewarding.

o Target the known or expected forms of abuse including crushing or dissolving tablets to snort or inject.

o The most common form of abuse is oral, and abuse deterrent formulations do not address this since the purpose of the opioid is to deliver it orally to patients.

4 | P a g e

o ICER did a completely independent analysis which indicated that abuse deterrent medications resulted in additional costs. The numbers needed to treat are very high before benefit from these medications is seen.

o Morphine sulfate, the active ingredient of Arymo® ER, is a full opioid agonist and

is relatively selective for the mu-opioid receptor; however, it can bind to other opioid receptors at higher doses. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. While the exact mechanism of the analgesic action is not known, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. It is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Arymo® ER is considered a Schedule II controlled substance. Morphine is a substance with a high potential for abuse, and Arymo® ER can be abused and is subject to misuse, addiction, and criminal diversion. Nevertheless, Arymo® ER is formulated with inactive ingredients that make the table more difficult to manipulate for misuse and abuse.

Recommendation: Defer recommendation and criteria until Morphabond ER is

discussed.

Public Comment: No public comment.


b) Morphabond® (morphine sulfate, extended-release)

o Morphine sulfate, the active ingredient of Morphabond® ER, is a full opioid agonist and

is relatively selective for the mu-opioid receptor; however, it can bind to other opioid receptors at higher doses. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. While the exact mechanism of analgesic action is not known, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. It is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Recommendation:

o Add Morphabond® ER (morphine sulfate, extended release) (QL= 90

tablets/strength/30 days) to non-preferred.

o Add Arymo® ER (morphine sulfate, extended release) (QL= 90

tablets/strength/30 days) to non-preferred.

5 | P a g e

o Remove Opana ER from the PDL.

o On the preferred side of the PDL remove Buprenorphine, Tramadol,

Hydromorphone, Methadone and Morphine sub-categories.

o Clinical criteria:

o Oral Non-Preferred (except methadone & tramadol containing

products): the patient has had a documented side effect,

allergy, or treatment failure to morphine sulfate CR 12hr tablet

(generic) AND generic fentanyl patch. (If a product has an AB

rated generic, there must have been a trial of the generic). AND

the patient must have a documented side effect, allergy, or

treatment failure to the preferred abuse deterrent formulation

(Embeda) before Arymo ER, Morphabond ER, OxyContin or

Xtampza ER will be approved.



c) Benlysta® (belimumab)

o Belimumab, the active ingredient of Benlysta®, is a human IgG1 lambda monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BLyS). It is a BLyS-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptor on B cells. Benlysta® does not bind B cells directly, but by binding BLyS, Benlysta® inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. It is indicated for the treatment of adults with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. The efficacy of Benlysta® has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. It has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta® is not recommended in these situations. Benlysta® has been available for intravenous administration by a healthcare professional. It is now available for self-administration as a subcutaneous injection.

Recommendation: Defer recommendation and criteria until after Brineura, Xatmep, and

Zinplava are discussed.



6 | P a g e

Brineura® (cerliponase alfa)

o Cerliponase alfa, the active ingredient of Brineura®, is a purified human enzyme produced by recombinant DNA technology. The active substance is a recombinant human tripeptidyl peptidase-1 (rhTPP1), a lysosomal exopeptidase. Ceroid lipofuscinosis type 2 disease is a neurodegenerative disease caused by deficiency of the lysosomal enzyme tripeptidyl peptidase-1 (TPP1), which catabolizes polypeptides in the CNS. Deficiency in TPP1 activity results in the accumulation of lysosomal storage materials normally metabolized by this enzyme in the CNS, leading to progressive decline in motor function. Cerliponase alfa, a proenzyme, is taken up by target cells in the CNS and translocated to the lysosomes, where it is activated. The active form cleaves tripeptides from the N-terminus of proteins. It is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase (TPP1) deficiency.

Recommendation: Defer recommendation and criteria until after Xatmep, and Zinplava are discussed. Public Comment: No public comment. Board Decision: The Board unanimously approved the above recommendation.

d) Tymlos® (abaloparatide)

o Abaloparatide, the active ingredient of Tymlos®, is a synthetic 34 amino acid peptide. It is an analog of human parathyroid hormone related peptide (PTHrP [1-34]) that acts as an agonist at the PTH1 receptor. This results in activation of the cAMP signaling pathway in target cells. In animals, abaloparatide had an anabolic effect on bone, with increases in bone mineral density (BMD) and bone mineral content that correlated with increases in bone strength at vertebral and/or nonvertebral sites. It is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Tymlos® reduces the risk of vertebral fractures and nonvertebral fractures. Recommendation:

o Add Tymlos® (abaloparatide) injection (Quantity Limit = 1 pen (1.56ml)/30 days)

(Lifetime max duration of treatment = 2 years) to non-preferred.

o Update the quantity limit of Forteo to 2.4ml/30days

7 | P a g e


o Tymlos: patient has a diagnosis/indication of postmenopausal

osteoporosis in females AND patient has had a documented side

effect, allergy, or treatment failure** to an oral bisphosphonate

and Forteo AND prescriber has verified that the patient has been

counseled about osteosarcoma risk.



e) Zinplava® (bezoltoxumab)

o Bezlotoxumab, the active ingredient of Zinplava®, is an IgG1 immunoglobulin. It is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. It inhibits the binding of toxin B and prevents its effects on cells. Zinplava® does not bind to C. difficile toxin A. It is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence. It is not indicated for the treatment of CDI. Zinplava® is not an antibacterial drug and it should only be used in conjunction with antibacterial drug treatment of CDI.

Recommendation:

o Add Brineura™ (cerliponase alfa) (QL=1 package per 14 days (Brineura Injection, 2

vials of 150mg/5ml, and Intraventricular Electrolytes Injection, 1 vial of 5ml) to

non-preferred.

o Add Zinplava™ (bezlotoxumab) injection to non-preferred.

o Remove Solesta, Glycate, Robinul, and Robinul Forte from the PDL.


o Add additional criteria to Benylsta: Initial approval will be granted

for 3 months. For therapy continuation, clinical documentation

must be submitted documenting stable disease activity OR

reduction in disease activity or corticosteroid dose.

o Add Brineura: Patient is 3 years of age or older AND The diagnosis

or indication is late infantile neuronal ceroid lipofuscinosis type 2

(CLN2), confirmed by deficiency of the lysosomal enzyme

tripeptidyl peptidase-1 (TPP1) (results of genetic testing must be

submitted) AND The prescriber is a neurologist or other physician

specializing in intraventricular administration Note: Brineura will

8 | P a g e

be approved as a medical benefit ONLY and will NOT be approved

if billed through pharmacy point of sale. Initial approval will be

granted for 3 months. Renewal may be granted for up to 12

months. For therapy continuation, clinical documentation must be

submitted documenting improvement or maintenance of motor

ability OR slower progression of disease than would otherwise be

expected AND a 12-lead ECG evaluation is performed every 6

months.

o Remove “Note: after preliminary review by the Clinical Call Center,

the request will be forwarded to the DVHA Medical Director for

final approval.” from Carbaglu, Korlym, Myalept and Signifor

criteria.

o Remove Glycate and Solesta clinical criteria.

o Add Zinplava: The patient is 18 years of age or older AND The

patient has a diagnosis of Clostridium difficile infection (CDI)

confirmed by a positive stool test collected within the past 7 days

AND The patient is or will receive concomitant Standard of Care

antibacterial therapy for CDI (e.g. metronidazole, vancomycin, or

fidaxomicin) AND The patient is at high risk for recurrence based

on at least one of the following: Age ≥ 65 years, Two or more

episodes of CDI within the past 6 months, The patient is

immunocompromised, The patient has clinically severe CDI (e.g.

fever, abdominal tenderness, WBC ≥ 15,000 cells/mm³, albumin

<30g/L, or renal failure) Note: A single-dose of 10mg/kg will be

approved per active CDI. A repeat dose will not be approved for

recurrence of the same active infection.



8. New Therapeutic Drug Classes: Jeff Barkin, MD, Change Healthcare and Laurie Brady, RPh, Change Healthcare

a) Pseudobulbar Affect Agents o New category for the state of Vermont.

Recommendation:

o Add Pseudobulbar Affect Agents as a new category on the PDL.

9 | P a g e

o Add Nuedexta into this category as a non-preferred agent. The current clinical criteria will remain the same.

o All products in this category will require a PA. Public Comment: from: No public comment.

Board Decision: The Board unanimously approved the above recommendation. 9. Therapeutic Drug Classes- Periodic Review: Jeff Barkin, MD, Change Healthcare and Laurie Brady, RPh, Change Healthcare

a) Alzheimer’s Agents

o New generic available: Rivastigmine patch (compare to Exelon®). o No new significant clinical changes.

Recommendation:

o Add Rivastigmine (compare to Exelon® patch (QL = 1 patch/day) to non-

preferred. o Clinical criteria:

o Add Rivastigmine Patch: the patient has a documented intolerance to brand Exelon patch.

Public Comment: from: No public comment.


b) Analgesics Topical

o No new drugs o No new significant clinical changes.

Recommendation:

o Add Lidocaine 3% Cream to preferred. o Add Lidocaine 4% solution to preferred. o Add Lidocaine 5% Ointment, Cream to preferred. o Add Lidocaine/Prilocaine 2.5-2.5% Cream to preferred. o Add Synera® (lidocaine/tetracaine) patch to preferred.


10 | P a g e


c) Anticoagulants Agents o No new drugs o No new significant clinical changes. o Eliquis is leading the market share currently.

Recommendation: No changes.

Public Comment: Lance Nichols from Pfizer: Highlighted the attributes of Eliquis.

Board Decision: None needed.

d) Antiparkinson’ s Agents

o Xadago is an MAO2-B inhibitor indicated for Parkinson’s disease. It is recommended to periodically monitor patients for visual changes in individuals with a history of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, or any active retinopathy with safinamide (Xadago®) use. Those with a major psychotic disorder should generally not be treated with rasagiline (Azilect®) or safinamide (Xadago®) owing to the risk of exacerbating psychosis. The MAO-B inhibitor safinamide (Xadago®) is only approved for use as adjunctive treatment to levodopa/carbidopa. As with the dopamine agonists, the choice of which MAO-B inhibitor to use should be based on individual patient factors. Rasagiline (Azilect®) and safinamide (Xadago®) require dosage adjustment in hepatic dysfunction.

o No new significant clinical changes.

Recommendation:

o Add Pramipexole ER (compare to Mirapex ER®) to non-preferred. o Add Rasagiline (compare to Azilect®) (QL = 1 mg/day) to non-preferred. o Add Xadago® (safinamide) (QL= 1 tab/day) to non-preferred. o Move Amantadine tablets to preferred.

o Clinical criteria: o Remove Amantadine tablet criteria from the PDL. o Add Rasagiline to the Azilect criteria. o Add pramipexole ER for the Mirapex ER, Requip XL, ropinirole

XL criteria. o Add Xadago: The diagnosis or indication is Parkinson’s disease

AND The patient is on current therapy with levodopa/carbidopa AND The patient has had a documented side effect, allergy, or treatment failure with selegiline. Note: Xadago will not be approved for monotherapy.

11 | P a g e



e) Cytokine and CAM antagonist

o Sarilumab (Kevzara®) is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor, and has been shown to inhibit IL-6-mediated signaling through these receptors.

o Brodalumab (Siliq®) is a human monoclonal IgG2 antibody that selectively binds to human interleukin-17 receptor A (IL-17RA) and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F and IL-25. Blocking IL-17RA inhibits IL-17 cytokine-induced responses including the release of pro-inflammatory cytokines and chemokines.

o Guselkumab (Tremfya®) is a human monoclonal immunoglobulin G1 lambda (igG1λ) that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interactions with the IL-23 receptors.

o Renflexis™ (infliximab-abda), a biosimilar to Remicade, is now available. This is the second biosimilar to Remicade on the market.

o Methotrexate (Xatmep®) is indicated for pediatric patients with acute lymphoblastic leukemia (ALL) or with active pJIA.

Recommendation: Ankylosing Spondylitis: Injectables

o Remove quantity limit on Cosentyx. o Add Renflexis™ (infliximab-abda) biosimilar to Remicade to non-preferred.

o Clinical criteria: o Remove Enbrel clinical criteria. o Add Enbrel to the Humira criteria. o Add Renflexis to the Cimzia, Cosentyx, Inflectra, Remicade, and

Simponi criteria as well as to the additional criteria for Inflectra. o Add to the additional criteria for Cosentyx and Simponi. Note:

Cosentyx approvals for 300mg dose(s) must use “300DOSE” package (containing 2 x 150mg pens or syringes). Approval will not be granted for 2 separate 150mg packages.

Psoriasis: Injectables

o Remove Quantity limit on Cosentyx. o Add Quantity limit = 45 mg (0.5 ml) or 90 mg (1 ml) per dose) (90 mg dose

only permitted if pt weight > 100 kg) on Stelara. o Add Renflexis™ (infliximab-abda) biosimilar to Remicade to non-preferred.

12 | P a g e

o Add Siliq™ (brodalumab) Injection (Quantity limit = 6 ml (4 syringes) for the first month then 3 ml (2 syringes)/28 days subsequently) to non-preferred.

o Add Tremfya® (guselkumab) (Quantity limit = 2 syringes/28 days for the first month, then 1 syringe every 56 days thereafter) to non-preferred.

o Clinical criteria: o For all drugs criteria add that a rheumatologist can write the

prescription. o Add Siliq and Tremfya to the Additional Criteria for Remicade,

Stelara, and Taltz. Add Note: Siliq is contraindicated in patients with Crohn’s disease.

o Add Renflexis to the Additional Criteria for Inflectra. o Add Note: Cosentyx approvals for 300mg dose(s) must use

“300DOSE” package (containing 2 x 150mg pens or syringes). Approval will not be granted for 2 separate 150mg packages.

Inflammatory Bowel Disease Injectables

o Add Renflexis™ (infliximab-abda) biosimilar to Remicade to non-preferred. o Clinical criteria:

o Add Renflexis to the Humira, Remicade, Cimzia, Tysabri, Entyvio, Inflectra and Stelara criteria as well as to the Inflectra additional criteria for Crohn’s disease.

o Add Renflexis to the Inflectra criteria for Ulcerative Colitis. Rheumatoid, Juvenile & Psoriatic arthritis

o Add Kevzara® (sarilumab) (Quantity limit = 2 syringes/28 days) to non-preferred.

o Add Renflexis™ (Infliximab-abda) biosimilar to Remicade to non-preferred. o Clinical criteria:

o Combine criteria Actemra, Cimzia, Kevzara, Remicade, Simponi (subcutaneous), and Stelara additional criteria: The prescriber must provide a clinically valid reason why both Humira and Enbrel cannot be used.

o Add Orencia to the Kineret additional criteria. o Add Renflexis to the Inflectra additional criteria.

Miscellaneous o Add Xatmep™ (methotrexate) oral solution to non-preferred.

o Clinical criteria: o Add Xatmep: The patient has a diagnosis of polyarticular

juvenile idiopathic arthritis or acute lymphoblastic leukemia (ALL) AND patient has a requirement for an oral liquid dosage form (i.e. swallowing disorder, inability to take oral medications).

13 | P a g e

Public Comment: Thomas Algozzine, from Novartis: Highlighted the attributes of Cosentyx®.

Shaffee Bacchus, from Janssen: Highlighted the attributes of Tremfya®.


f) Gaucher Disease o No new drugs o No new significant clinical changes.

Recommendation:


o Cerezyme/Vpriv additional criteria: Failure, intolerance or other contraindication to enzyme replacement therapy with Elelyso.

Public Comment: Julie from: Highlighted the attributes of Cerdelga® and Cerezyme®.


g) NSAIDs

o No new drugs o No new significant clinical changes.

Recommendation:

o Remove Anaprox DS®* (naproxen sodium), meloxicam suspension, Mobic®

(meloxicam) suspension, and Voltaren XR®* (diclofenac sodium SR) from the PDL.

o Move Etodolac ER, Ketoprofen ER, and Naproxen sodium ER to non-preferred.

o Move Voltaren® (diclofenac) 1 % Gel (under Topical sub-category) to the preferred side of PDL.

o Clinical criteria: o Remove Voltaren Gel criteria and revise Diclofenac 1% Gel:

the patient must have had a documented intolerance to Brand Voltaren.

o Revise All other PA requiring NSAIDs: patient has had a documented side effect or treatment failure to 2 or more preferred generic NSAIDS. (If a product has an AB rated generic, one trial must be the generic.) AND if the request is

14 | P a g e

for a non-preferred extended release formulation, the patient has not been able to be adhere to the dosing schedule of the immediate release formulation resulting in significant clinical impact.



10. Newly Developed/Revised Criteria: Laurie Brady, RPh, Change Healthcare

o Chemical Dependency o Vivitrol: There must be a documented trial of oral naltrexone to establish

tolerability AND Patient should be opiate free for > 7 -10 days prior to initiation of Vivitrol. If the diagnosis is alcohol dependence, the patient should not be actively drinking at the time of initial Vivitrol administration.

o Limitations: Effective 4/1/17, Evzio® is not classified as a covered outpatient drug and is therefore not covered by Vermont Medicaid

Public Comment: No public comment. Board Decision: The Board unanimously approved the above recommendation

11. General Announcements: Selected FDA Safety Alerts

FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic

acid) for rare chronic liver disease.

https://www.fda.gov/Drugs/DrugSafety/ucm576656.htm

12. Adjourn: Meeting adjourned at 8:15 p.m.

https://www.fda.gov/Drugs/DrugSafety/ucm576656.htm

Documents

DUR Board Meeting Minutes - Department of Vermont …dvha.vermont.gov/advisory-boards/dec-1205017-vt-dur-minutes-print...DUR Board Meeting Minutes December 05,2017 Board ... Zail Berry,