dur board meeting minutes - vermont agency of human...

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Department of Vermont Health Access Pharmacy Benefit Management Program

DUR Board Meeting Minutes October 24,2017

Board Members: Present: Patricia King, MD

Joseph Nasca, MD

Jocelyn VanOpdorp, PharmD

Clayton English, PharmD

Bill Breen, RPh

Absent: Louise Rosales, NP, Renee Mosier, PharmD, Zail Berry, MD

Staff: Laurie Brady, RPh, Change HealthCare Jacquelyn Hedlund, MD, Change Healthcare Mike Ouellette, RPh, 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 Margaret Glassman, Alkermes Jeffrey Olson, Gilead Franco Casagrande, Abbvie Julia Shaw, Healthcare Advocate

Shaffee Bacchus, Janssen Susan Donnelly, Pfizer James Kokoszyna, Allergan Mike Toma, Abbvie Tim Madden, J&J Daniel Shan, Shire

Kristen Chopas, Gilead Rod Francisco, Sunovion Lisa Libera, Teva Sophie Hoang, Novo Nordisk Folger Tuggle, Bioverativ

1. Executive Session:

o An executive session was held from 6:00 p.m. until 6:45p.m. 2. Introductions and Approval of DUR Board Minutes:

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

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

o Final reviews are being done on Cost Control Report. Once completed, this will be posted to the DVHA website.

o 4. Medical Director Update: Dr. Scott Strenio, DVHA

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o DVHA is looking at ways to better communicate with prescribers. One suggestion is a website that prescribers could sign up for and submit an email address. Providers could choose topics which they are interested in receiving notifications about.

o Board recommendations regarding approval of Hepatitis C therapies for all patients regardless of fibrosis stage will need to go in front of the legislator. The timeframe for implementation of any changes is not known at this time.

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

o Emflaza clinical criteria o Add Emflaza (deflazacort) (maximum 30-day supply per fill) to non-

preferred. o Clinical criteria

o The patient must be ≥ 5 years of age AND o The patient must have a diagnosis of Duchenne

Muscular Dystrophy AND o There is documented improvement in muscle function

or strength with use of prednisone, but the patient has experienced weight gain >10% of body weight within 3 months or > 25% within 1 year.

Public Comment: Avator Jones from Artia Solutions: Highlighted the attributes of Emflaza. Board Decision: The Board unanimously approved the above recommendation.

6. RetroDUR/DUR: and Laurie Brady, RPh, Change Healthcare

o Introduce: Use of Fluoroquinolones

Fluoroquinolones are among the most prescribed antibiotics in the outpatient setting. While

they have broad indications for use in respiratory, gastrointestinal, soft-tissue and systemic

infections, it has been recognized that there are a variety of side-effects, some of which are

severe and permanent. The incidence of muscle pain, tendonitis, tendon rupture, joint pain,

neuropathy (potentially irreversible), worsening of myasthenia gravis and central nervous

system effects (confusion and hallucinations) prompted an FDA advisory safety announcement

that these risks generally outweigh the benefits for use in patients with acute sinusitis, acute

bronchitis and uncomplicated urinary tract infections, unless no other antibiotic options exist.

The FDA required drug label changes for all fluoroquinolones to reflect this safety information,

as of May 2016. The black box warnings now state that fluoroquinolones should be reserved for

use in patients who have no alternative treatment options for the indications of acute

exacerbation of chronic bronchitis, acute uncomplicated cystitis and acute sinusitis, and they

should not be used in patients with myasthenia gravis.

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We plan to examine the use of fluoroquinolones in members ages 18-65 with diagnoses of

acute sinusitis, acute exacerbation of chronic bronchitis and uncomplicated UTIs, both before

and after the FDA issued the safety alert and recommendations, to see if there was a

measurable decrease in usage. As the FDA warning was released in May 2016, we will look at

use in fiscal year 2015-2016, and compare with fiscal year 2016-2017.

We will use paid, non-reversed Medicaid pharmacy and medical claims data from FY 2015 and

2016, excluding members with Part D, VMAP, and Healthy Vermonters coverage.

We will identify members on a fluoroquinolone with a diagnosis of acute sinusitis, acute

bronchitis exacerbation of chronic bronchitis or uncomplicated UTI. We will compare usage as

a percentage of members who received a fluoroquinolone in the total member population for

each year and examine the diagnosis associated with the members who received

fluoroquinolones. Because a fluoroquinolone may be ordered appropriately in members who

failed prior antibiotic therapy, we will look to see if other classes of antibiotics had been

prescribed for the same diagnosis, prior to the prescribing of the fluoroquinolone, within the

fiscal year. We expect to see less usage of fluoroquinolones after the FDA safety alert was

published.

Board Decision: No further action is required at this time.

o Present: Calendar of 2018 RetroDUR initiatives

o Schedule of approved RetroDUR topics presented to the DUR board. Board Decision: No action at this time. 7. Clinical Update: Drug Reviews: Jacquelyn Hedlund, MD, Change Healthcare, and Laurie Brady RPh, Change Healthcare Abbreviated New Drug Reviews:

o None at this time. Full New Drug Reviews:

a) Airduo® RespiClick (fluticasone propionate and salmeterol) o AirDuo® Respiclick is a dry powder for oral inhalation combination product

containing fluticasone (a synthetic corticosteroid, with anti-inflammatory activity) and salmeterol (a long-acting beta-2 adrenergic agonist [LABA], causing relaxation of bronchial smooth muscle). It is indicated for the treatment of asthma in patients aged 12 years and older. It is not indicated for the relief of acute bronchospasm. Several trials were performed to assess the safety and

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efficacy of AirDuo® Respiclick, including 2 confirmatory trials, a 26-week safety trial, and 3 dose-ranging trials. The confirmatory trials included 2 double-blind, parallel-group studies that compared AirDuo® Respiclick with ArmonAir® Respiclick or placebo. (ArmonAir® Respiclick is an orally inhaled fluticasone propionate product). Results suggested that the AirDuo® patients had significantly greater improvements in trough FEV1 as compared with fluticasone and placebo. There is some evidence at this time to support that AirDuo® Respiclick is more effective than orally inhaled fluticasone, a component of AirDuo® Respiclick, but there is no evidence that its use is safer or more effective than other combination products or the individual components taken separately.

Recommendation:

o Effective date 1/1/18.

o Add AirDuo Respiclick® (Quantity limit =3 inhalers/90 days) to non-preferred.

o Add Fluticasone/salmeterol (Quantity limit =3 inhalers/90 days) to non-

preferred.

o Move Asmanex® (Quantity limit =3 inhalers/90 days) to non-preferred.

o Move Qvar® 40 mcg/inh (Quantity limit = 17.4 gm (2 inhalers)/90 days) to non-

preferred.

o Move Qvar® 80 mcg/inh (Quantity limit = 58.4 gm (6 inhalers)/90 days) to non-

preferred.

o Clinical criteria:

o Metered-dose inhalers (single agent): The patient has had a

documented side effect, allergy, or treatment failure to one

preferred agent.

o AirDuo Respiclick, Breo Ellipta, Fluticasone/Salmeterol: The

patient has had a documented side effect, allergy, or treatment

failure to any 2 of the following: Advair, Dulera, or Symbicort.

Public Comment: No public comment.

Board Decision: The Board unanimously approved the above recommendation.

b) Seebri® Neohaler (glycopyrrolate)

o Glycopyrrolate, the active ingredient of the Seebri® capsules, is a long-acting

muscarinic antagonist, also known as an anticholinergic. In the airways, glycopyrrolate exerts its effect through inhibition of muscarinic receptor M3 at the smooth muscle, which leads to bronchodilation. It is indicated for the long-

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term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The safety and efficacy of Seebri® Neohaler were assessed in a clinical program that included 2 dose-ranging studies, 4 placebo-controlled 12-week efficacy studies, and a 52-week long-term safety study. Two of the efficacy studies were conducted in support of the Ultibron® Neohaler clinical development program. Therefore, the efficacy of Seebri® Neohaler was based mainly on the dose-ranging studies and 2 confirmatory studies. There is no evidence at this time to support that Seebri® Neohaler is safer or more effective than the currently available, more cost effective, medications.

Recommendation:


o Add Seebri Neohaler® to non-preferred.

o Move Combivent® Respimat (ipratropium/albuterol) (Quantity Limit = 1 inhaler

(4 grams)/30 days) to non-preferred.

o Move Bevespi Aerosphere® (Quantity Limit = 3 inhalers/90days) to preferred.

o Move Stiolto Respimat® (Quantity Limit = 3 inhalers/ 90 days) to non-preferred.


o Add Seebri Neohaler to the Incruse Ellipta/Tudorza clinical criteria.

o Remove Bevespi criteria replace with Stiolto Respimat.

o Add Combivent Respimat criteria to the Anoro Ellipta criteria.

o Add Note: Users of Combivent as of 1/1/18 will be grandfathered

until 4/1/18.

Public Comment: Amy Tomasello from Sunovion: Highlighted the attributes of Seebri.

Board Decision: The Board unanimously approved the above recommendation. With the

addition to the clinical criteria for Combivent to add: ADD If a short acting product is

desired, please provide clinical justification for why patient cannot use a combination of

Atrovent HFA and the preferred Albuterol formulation.

c) Synjardy XR® (empagliflozin, metformin Hcl)

o Synjardy® XR is a combination product that contains two active ingredients with complementary mechanisms of action to aid in glycemic control. Empagliflozin is an inhibitor of sodium glucose co-transporter 2 (SGLT2); SGLT2 is the main transporter that works to reabsorb glucose from the glomerular filtrate back into the circulation. With the blocking of SGLT2, empagliflozin increases urinary glucose excretion. Metformin extended-release lowers basal and postprandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose, and improving insulin sensitivity. It is indicated as an

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adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (DM) when treatment with both empagliflozin and metformin is appropriate. Synjardy® XR is not recommended for patients with type 1 DM or for the treatment of diabetic ketoacidosis. There is evolving data regarding SGLT2 inhibitors and cardiovascular disease that may better define a role for these agents. A 2015 study by Zinman et al published in the NEJM suggested that those treated with empagliflozin had a significantly lower rate of the primary composite outcome of death from cardiovascular causes, non-fatal MI, or non-fatal stroke when added to standard care as compared to placebo. The primary outcome occurred in 10.5% in the pooled empagliflozin group (both doses) vs 12.1% in the placebo group (hazard ratio 0.86; p=0.04 for superiority). This study included patients with type 2 DM at high risk for cardiovascular events. Nevertheless, while empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 DM and established cardiovascular disease, the effectiveness of Synjardy® XR on reducing the risk of cardiovascular death in adults with type 2 DM and cardiovascular disease has not been established. There is no evidence at this time to support that Synjardy® XR is safer or more effective than the currently available, more cost effective medications or the individual components taken separately.

Recommendation: o Effective date 1/1/18. o Move Farxiga® (Quantity limit = 1 tablet/day) to preferred after clinical criteria

are met. o Move Synjardy® (Quantity Limit = 2 tablets/day) to non- preferred. o Add Synjardy® XR (Quantity Limit = 1 tablet/day) to non-preferred.

o Clinical criteria: o Remove grandfathering that has been in place for Invokana. o Invokana additional criteria: Patient has a documented side effect,

allergy, or contraindication to Jardiance or Farxiga. o Invokamet/Invokamet XR/Synjardy/Synjardy XR/Xigduo XR®

additional criteria: The patient has documentation of a failure of therapy with Jardiance or Farxiga used in combination with metformin/metformin XR.

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

d) Mavyret® (glecaprevir/pibrentasvir)

o Mavyret® is a fixed-dose combination tablet containing glecaprevir (a HCV NS3/4A protease inhibitor) and pibrentasvir (a HCV NS5A inhibitor). Both are direct-acting antiviral agents active against the hepatitis C virus. It is indicated

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for the treatment of adult patients with chronic hepatitis C virus (HCV) with: Genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) or Genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. There were numerous studies to assess the safety and efficacy of Mavyret® per treatment history and cirrhosis status. The studies above do suggest potent antiviral activity of glecaprevir/pibrentasvir for those infected with chronic HCV infection for the various genotypes and for the durations as approved by the FDA. It is also a reasonably cost effective option.

Recommendation:

o Defer until after the Vosevi review.


Board Decision: Defer to after the Vosevi review.

e) Vosevi® (sofosbuvir/velpatasvir/voxilaprevir)

o Vosevi® is a fixed-dose combination tablet containing sofosbuvir (a nucleotide analog HCV NS5B polymerase inhibitor), velpatasvir (an NS5A inhibitor), and voxilaprevir (a NS3/4A protease inhibitor). These are all direct-acting antiviral agents active against the hepatitis C virus. It is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: Genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor or Genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Additional benefit of Vosevi® over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor. There were 2 randomized, phase 3 studies in direct-acting antiviral (DAA) experienced subjects to assess the efficacy of Vosevi®. The studies above do suggest potent antiviral activity for those infected with chronic HCV infection as compared with placebo and as compared with sofosbuvir/velpatasvir for the various genotypes it is indicated for. Multiple regimens are available and some are more cost effective for the same or similar indications.

Recommendation:

o Add Mavyret® to preferred.

o Move Zepatier to preferred.

o Add Vosevi to non-preferred.

o Move Harvoni to non-preferred.

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o Move Technivie to non-preferred.


o Add Mavyret and Vosevi to the direct acting agent’s criteria.

o Remove the note that member must have Metavir fibrosis score of

F2, F3 or F4.

o Draft Hepatitis C PA Form was reviewed.

Public Comment: Franco Casagrande from Abbvie: Highlighted the attributes of Mavyret.

Julia Shaw from Office of the Health Care Advocate: Thanked the

committee for its previous recommendations to expand treatment

access to patients with F2 fibrosis staging. Advocated for patients to

receive HCV therapy regardless of fibrosis score. Requested that this be

implemented as soon as possible and not wait until the legislative

session. Requested that the requirement to see a specialist be waived.

Seth Lipschutz from Defender General: Highlighted the attributes of

Hep C treatment for prisoners.

Jeff Olson from Gilead: Highlighted the attributes of Vosevi.

Peter Jacobsen from VT Cares: Highlighted attributes of Hep C

treatment criteria that were proposed during the meeting.


8. New Therapeutic Drug Classes: Jacquelyn Hedlund, MD and Laurie Brady, RPh, Change Healthcare

a) Movement Disorders o New drug Austedo. Deutetrabenazine (Austedo®) and tetrabenazine (Xenazine®)

are indicated for the treatment of chorea associated with Huntington’s disease. o New drug Ingrezza. Calbenazine (Ingrezza®) is indicated for the treatment of

adults with tardive dyskinesia. o Deutetrabenazine (Austedo®) and tetrabenazine (Xenazine®) have a box warning

regarding the increased risk of depression and suicidality with use in patients with Huntington’s disease. Those considering the use of treatment must balance the risks of depression and suicidality with the clinical need for control of chorea. Patients should be closely monitored for the emergence of or worsening depression, suicidality, or other unusual changes in behavior. Use with caution especially in those with a history of depression or prior suicidality. Both treatments are contraindicated in patients who are actively suicidal or in patients with untreated or inadequately treated depression.

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o To date, no cure for Huntington’s disease (HD) exists; however, tetrabenazine (Xenazine®) is the first FDA approved treatment for this disorder.

o Tardive dyskinesia has been defined as “...a hyperkinetic movement disorder that appears with a delayed onset after prolonged use of dopamine receptor blocking agents, mainly the antipsychotic drugs (also called neuroleptics) and the antiemetic drug, metoclopramide.” It is characterized by displays of chorea, athetosis, dystonia, akathisia, and orofacial dyskinesia, tics and facial grimacing. Other types of dyskinesias, such as acute dyskinesia, parkinsonism, and akathisia, occur quickly after initiating antipsychotic drugs, which contrasts with the tardive dyskinesia which appears later with use. Avoiding the medication has been the only way to prevent tardive dyskinesia. In 2017, the first drug was approved for the treatment of tardive dyskinesia-valbenazine (Ingrezza®). Later in 2017, deutetrabenazine (Austedo®) was also FDA approved for tardive dyskinesia.

Recommendation:

o Add new PDL category Movement Disorders. o Move Xenazine (Maximum 1 month supply per fill) Quantity limit = 50

mg/day at initial approval (12.5 mg tablets ONLY), up to 100 mg/day at subsequent approvals (12.5 mg or 25 mg tablets) to preferred after clinical criteria are met.

o Add Austedo® (deutetrabenazine) tablets (Maximum 1 month supply per fill) Quantity limit = 48 mg/day to non-preferred.

o Add Ingrezza® (valbenazine tosylate) capsules (Maximum 1 month supply per fill) Quantity limit = 80 mg/ day) to non-preferred.

o Add Tetrabenazine (compare to Xenazine®) (Maximum 1 month supply per fill) Quantity limit = 50 mg/day at initial approval (12.5 mg tablets ONLY), up to 100 mg/day at subsequent approvals (12.5 mg or 25 mg tablets) to non-preferred.

o Clinical criteria: o Austedo: The diagnosis or indication for the requested

medication is Huntington’s Disease (HD)with chorea or Tardive Dyskinesia (TD) AND the patient is ≥ 18 years of age AND the patient has a documented side effect, allergy, contraindication or treatment failure with Xenazine.

o Ingrezza: The diagnosis or indication for the requested medication is Tardive Dyskinesia (TD) AND the patient is ≥ 18 years of age AND the patient has a documented side effect, allergy, contraindication or treatment failure with Xenazine.

o Tetrabenazine: the patient must have a documented intolerance to brand Xenazine.

o Xenazine: The diagnosis or indication for use is Tourette Syndrome OR The diagnosis or indication for use is

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Huntington’s Disease (HD) with chorea or Tardive Dyskinesia (TD) AND the patient is ≥ 18 years of age.

o Note: Austedo, Tetrabenazine, and Xenazine are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Public Comment: Mike Philbin from Teva: Highlighted the attributes of Austedo.


b) Cytokine and CAM antagonists o Due to time restraints review of this category has been moved to the

December meeting.

9. Therapeutic Drug Classes- Periodic Review: and Laurie Brady, RPh, Change Healthcare

c) Multiple Sclerosis o New drug Ocrevus. Ocrelizumab (Ocrevus®) is a recombinant humanized

monoclonal antibody directed against CD20-expressing B-cells. While the exact mechanism of action is not known, it is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. After binding to B lymphocytes, ocrelizumab resulted in antibody-dependent cellular cytolysis and complement-mediated lysis.

o Multiple sclerosis (MS) is a disease of the central nervous system (CNS) where the brain and other parts of the body are not able to appropriately communicate with each other. It is “...the most common immune-mediated inflammatory demyelinating disease of the central nervous system.” Although not an exact number, it has been suggested that the worldwide incidence of MS is 3.6 per 100,000 person-years in women and 2 per 100,000 person-years in men. It is suggested that the ratio of females affected with MS to men is 3 to 1. Initial symptoms of MS tend to occur in young adults; however, there tends to be a delayed diagnosis. In addition, it is reported that approximately 20% of MS cases are familial.

Recommendation:

o Add Glatiramer Acetate 20mg (Quantity limit = 1 kit/30 days) to non-preferred. o Add Ocrevus® (ocrelizumab) (Quantity limit=300mg x 2 doses then 600mg every

6 months thereafter) to non-preferred. o Move Tecfidera® (dimethyl fumarate) (QL = 2 capsules/day, maximum 30 day

supply per fill) to non-preferred. o Clinical Criteria

o Effective date 1/1/18. o Remove Ampyra criteria.

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o Add Glatiramer to the Glatopa 20mg criteria. o Add Ocrevus: Patient is ≥ 18 years AND has a diagnosis of

relapsing multiple sclerosis AND has a documented side effect, allergy, treatment failure, or contraindication to at least two preferred drugs and Tysabri. OR Diagnosis of relapsing multiple sclerosis and the patient has a documented side effect, allergy, treatment failure, or contraindication to two preferred drug and has tested positive for anti-JCV antibodies. OR Patient is ≥ 18 years AND has a diagnosis of primary progressive multiple sclerosis.

o Add Tecfidera: The patient is started and stabilized on the requested medication (Note: Samples are not considered adequate justification for stabilization.) OR Patient is ≥ 18 years AND has a diagnosis of relapsing forms of Multiple Sclerosis AND the patient has a documented side effect, allergy, treatment failure, or contraindication to at least two preferred drugs.

o Clarify Tysabri: Patient has a diagnosis of relapsing multiple sclerosis and has already been stabilized on Tysabri OR Diagnosis is relapsing multiple sclerosis and the patient has a documented side effect, allergy, treatment failure, or contraindication to at least two preferred drugs.

Public Comment: Mike Philbin from Teva: Highlighted the attributes of Copaxone. Board Decision: The Board unanimously approved the above recommendation.

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

ADHD Long Acting Stimulants

o Effective date 1/1/18. o Move Adzenys XR®ODT (amphetamine SR 24 HR, IR/ER, 50:50%) (QL= 1 cap/day) o Clarify Vyvanse add Cap and chewable tablet to preferred formulations.

o Clinical criteria o Add Adzenys XR ODT to the clinical criteria of Dexedrine CR,

dextroamphetamine SR, Dyanavel.



ADHD Miscellaneous

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o Effective date 1/1/18. o Move Armodafinil (compare to Nuvigil®) Qty Limit:50mg = 2 tabs/day

150mg/200mg/250mg = 1 tab/day (Max days supply = 30 days) to preferred. o Move Modafinil (compare to Provigil®) Qty limit: 100 mg = 1.5 tablets/day;200

mg = 2 tablets/day Maximum Daily Dose = 400 mg (Max days supply = 30 days) to preferred.

o Add Atomoxetine (compare to Strattera®) (authorized generic, labeler 66963 is the only preferred form) Qty limit:10, 18, 25 and 40 mg = 2 capsules/day 60, 80 and 100 mg = 1 capsule/day FDA maximum recommended dose = 100 mg/day to preferred.

o Add Atomoxetine (compare to Strattera®) (non-authorized generic forms) Qty limit:10, 18, 25 and 40 mg = 2 capsules/day 60, 80 and 100 mg = 1 capsule/day FDA maximum recommended dose = 100 mg/day to non-preferred.

o Move Strattera (atomoxetine) Qty limit:10, 18, 25 and 40 mg = 2 capsules/day 60, 80 and 100 mg = 1 capsule/day FDA maximum recommended dose = 100 mg/day to non-preferred

o Clinical criteria o Remove current Intuniv, Nuvigil, Armodafinil, Provigil, Modafinil

criteria. Replace with: Intuniv, Nuvigil, Provigil: patient must have a documented intolerance to the generic equivalent.

o Add Strattera and non-authorized generic: patient must have a documented intolerance to authorized generic atomoxetine.



Antidiabetics/Peptide Hormones

o Effective 1/1/18. o Move Byetta to non-preferred.

o Clinical criteria o Add Byetta to the Adlyxin, Trulicity, Tanzeum criteria.



Antidepressants/SNRI’s

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o Move Duloxetine (compare to Cymbalta®) Capsule FDA maximum recommended dose = 120 g/day (MDD and GAD), 60 mg/day all others Quantity limit = 2 capsules/day to preferred.

o Clinical criteria o Remove all Duloxetine clinical criteria.



Antihemophilic Factor VIII

o Effective date 1/1/18. o Move Recombinate and Xyntha to non-preferred.

Public Comment: Elaine Warna from Bayer: Highlighted attributes of Kovaltry and Koate. Sophie Hoang from Novo Nordisk: Highlighted the attributes of Antihemophilic Factor VIII. Board Decision: The Board unanimously approved the above recommendation.

Antipsychotics/Children <18 years

o Add Latuda® (lurasidone) FDA maximum recommended dose = 160 mg/day Quantity limit = 1 tablet/day all strengths except 80 mg= 2 tablets/day to non-preferred.

o Clinical criteria o Latuda: patient has a diagnosis of schizophrenia AND is ≥ 13

years of age or older AND patient has had a documented side effect, allergy or treatment failure with at least two preferred products (typical or atypical antipsychotics)

Public Comment: John Reena from Sunovion: Highlighted attributes of Latuda

Board Decision: The Board unanimously approved the above recommendation

with the change to the FDA maximum recommended dose (80mg for this age group) and with the addition to clinical criteria that pregnancy would qualify the patient for approval if they have a diagnosis of schizophrenia.

Antipsychotics/Long-acting injectables


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o Move Abilify Maintena® (aripiprazole monohydrate) FDA maximum recommended dose = 400 mg/month Quantity limit = 1 vial/28 days to preferred.

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

o Move Invega Trinza® (paliperidone palmitate) FDA maximum recommended dose = 819mg/3months to preferred.

o Move Risperdal® Costa (risperidone microspheres) FDA maximum recommended dose = 50 mg/14 days to preferred.

o Clarify strengths and quantity limit for Aristada® (aripiprazole lauroxil) Quantity Limit = 1 syringe/28 days (441mg, 662mg, 882mg strengths) and 1 syringe/60 days (1064mg) under non-preferred agents.

o Clinical criteria o Remove Long- acting injectable products, Risperdal Consta Inj,

Invega Sustenna Inj, Invega Trinza, Abilify Maintena criteria. o Clarify Zyprexa Relprevv: Medical necessity for a specialty

dosage form has been provided (non-compliance with oral medications) AND Tolerability has been established previously with oral olanzapine AND the patient is unable to tolerate a preferred long-acting injectable product.

o Add Aristada: Tolerability has been established previously with oral aripiprazole for at least 2 weeks AND the patient has documented treatment failure with Abilify Maintena.

Public Comment: Shaffee Bacchus from Janssen: Highlighted the attributes of Invega Trinza.

Board Decision: The Board discussed leaving the criteria for Invega Trinza in place. Change Healthcare will review the offer for both Invega Sustenna and Invega Trinza and bring the information back to the board for the December meeting. All other recommendations were unanimously approved.

GI/Antiemetics

o Remove listing the strengths 4mg and 8mg from both Ondansetron tablet and ODT.

o Add Quantity Limit = 3 tabs/day, maximum of 30 days per fill on both Ondansetron tablet and ODT

o Clinical criteria o Under Criteria for Approval (to exceed quantity limit) remove

Ondansetron/Zofran 4mg and 8mg tablets and ODT.



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GI/Irritable Bowel Syndrome with Constipation & Opioid Induced Constipation

o Effective date 1/1/18. o Move Amitiza® (lubiprostone) (Qty Limit = 2 capsules/day) to preferred

under new sub-heading CIC-2 Chloride Channel Activators. o Add Linzess® (linaclotide) 145mcg and 290mcg (Qty limit = 1 capsule/day) to

preferred under new sub-heading Guanylate Cyclase-C Agonists. o Add sub-heading Opioid Antagonists: All products require PA.

o Clinical criteria o Remove Amitiza criteria. o Clarify Linzess 72mcg: The patient is 18 years of age or older.

AND The patient has a diagnosis of chronic idiopathic constipation (CIC) AND the patient is unable to tolerate the 145mcg dose.

o Clarify Movantik: The patient is current using an opiate for at least 4 weeks AND has documented opioid-induced constipation AND The patient has had a documented side effect, allergy or treatment failure to a 1 week trial of at least 2 preferred laxatives, one of which must be from the Osmotic Laxative category AND the patient has had a documented side effect, allergy, or treatment failure to Amitiza.

o Clarify Relistor Tablets: The patient is current using an opiate for at least 4 weeks AND has documented opioid-induced constipation AND The patient has had a documented side effect, allergy or treatment failure to a 1 week trial of at least 2 preferred laxatives, one of which must be from the Osmotic Laxative category AND the patient has had a documented side effect, allergy, or treatment failure to Amitiza and Movantik.

o Clarify Trulance: The patient is 18 years of age or older. AND The patient has had a diagnosis of chronic idiopathic constipation (CIC)AND The patient has had a documented treatment failure to lifestyle and dietary modification (increased fiber and fluid intake and increased physical activity) AND The patient has had a documented side effect, allergy or treatment failure to a 1 week trial of at least 2 preferred laxatives, one of which must be from the Osmotic Laxative category AND the patient has had a documented side effect, allergy, or treatment failure to Amitiza and Linzess.



GI/Ulcerative Colitis (oral and rectal product)

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o Effective date 1/1/18. o Remove Asacol and Pentasa ER 250mg from preferred. o Move Delzicol® (mesalamine capsule delayed-release) to non-preferred. o Move Lialda® (mesalamine tablet extended-release) to non-preferred. o Remove 500mg from Pentasa ER on the non-preferred.

o Clinical criteria o Clarify Asacol HD, Delzicol, Lialda, Pentasa: The patient has

had a documented side effect, allergy, or treatment failure to Apriso.

o Remove Pentasa 500mg current users as of 8/7/2015 will be grandfathered comment.


Board Decision: Vote was deferred until the December meeting for Change Healthcare

to review category to look at medications that are approved for induction and

maintenance.

Long-Acting Reversible Contraceptives

o Effective date 1/1/18. o Add Paragard IUD to preferred. o Move Kyleena IUD to preferred.

o Clinical criteria o Remove the current clinical criteria.

Public Comment: Richard Lynen from Bayer Healthcare: Highlight the attributes of Kyleena.

Board Decision: The Board approved the above recommendation with one abstention.

Ophthalmic/ Dry Eye Syndrome

o Effective date 1/1/18. o Add sub-heading Immunomodulators. Under that, add Restasis®

(cyclosporine ophthalmic emulsion) 0.05% droperette (NDC 00023916330 and 0023916360 are the only preferred NDC’s) QL = 180 vials per 90 days to preferred.

o Add sub-heading Ocular Lubricants for other preferred agents. o Clinical criteria

o Remove current Restasis criteria.

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o Add Restasis Multidose: Both package sizes of the droperettes must be on a long-term backorder and unavailable from the manufacturer.



Prenatal Vitamins

o Effective 1/1/18. o Remove Citranatal Harmony, Prenate Chew .6-.4, Citranatal 90 DHA, Citranatal B-

Calm, Citranatal RX, Citranatal Assure, Citranatal DHA. o Add Inatal Ultra, Niva-Plus, O-Cal-FA, O-Cal Prenatal, PNV, Pretab, Trinatal GT,

Trinatal RX 1, Virt-Vite GT, Virt-Advance, Vol-Nate to preferred.



Urinary Antispasmodics

o Effective date 1/1/18. o Clean-up on category removing former drug names. o Move Vesicare to non-preferred.

o Clinical criteria o Add Vesicare to the Detrol, Detrol LA, Ditropan XL, Enablex,

tolterodine (generic), tolterodine SR (generic), trospium (generic), trospium ER (generic) clinical criteria.

Public Comment: No public comment. Board Decision: The Board unanimously approved the above recommendation with the change that only one preferred long- acting agent trial is needed.

11. General Announcements: Selected FDA Safety Alerts

Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574347.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA Drug Safety Communication: FDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs https://www.fda.gov/Drugs/DrugSafety/ucm572484.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574347.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574347.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

https://www.fda.gov/Drugs/DrugSafety/ucm572484.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

https://www.fda.gov/Drugs/DrugSafety/ucm572484.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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

dur board meeting minutes - vermont agency of human...

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