Michigan Pharmacy and Therapeutics Committee Tuesday, June 8, 2021 Minutes - Final
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Michigan Pharmacy and Therapeutics Committee
Tuesday, June 8, 2021
Minutes - Final
Committee Members Present: Brad Uren (Pinckney, Livingston County), Andrew Adair (Oakland County), Rony Foumia
(Commerce Township, Oakland County), Jayne Courts (Caledonia, Kent County), Melanie Manary (Petoskey, Emmet
County), Danielle Melford (Stevensville, Berrien County), Barika Butler-Quarles (Grosse Point Park, Wayne County),
Katie Axford (Rockford, Kent County), Eric Roath (Lansing, Ingham County), Anthony Ognjan (Clinton
Township/Macomb County)
Committee Members Absent: Nora Fakhoury
MDHHS/Magellan Present: Trish Bouck, Matt Giering, Michael Melvin, Linda VanCamp, Donna Johnson, Christopher
Pandak
The MDHHS Pharmacy and Therapeutics (P&T) Committee was held via Microsoft Teams web conference with
teleconference only option of participation also.
The meeting was called to order at 6:05pm by Brad Uren (chair) with roll call of the members present. The members
provided the location from which they were attending. Dr. Uren explained that pursuant to the Michigan Open
Meetings Act, as amended, this will be a virtual meeting to mitigate the spread of COVID-19 and protect the health of
the public and members of the Board. Committee quorum was established.
The agenda was reviewed and approved. The minutes of the March 9, 2021 meeting were reviewed and approved.
Committee Business
The conflict of interest (COI) statement was reviewed. None of the members had COI to report.
MDHHS Updates
Ms. Bouck presented an update on the single Medicaid Preferred Drug List (sPDL) which was recommended in
the Governor’s FY21 Executive Budget. The Department implemented the single PDL to maximize drug
manufacturer rebates (both Federal and PDL supplemental) to generate savings starting October 1, 2020.
Implementation went smoothly and appears to be trending positively toward estimated savings with
legislative reports due early June and July 2021. The P&T Committee makes clinical recommendations for
both the Michigan Pharmaceutical Product List (MPPL) and the subset of drugs on the PDL. The MCO
Common Formulary workgroup will provide input and recommendations on single PDL coverage for P&T
Workgroup consideration before each full P&T Committee meeting. Drugs not on the PDL will continue to be
managed by the MCO Common Formulary for Medicaid Health Plan enrollees.
Ms. Bouck presented information on the Vaccines for Children (VFC) pharmacy expansion policy. The policy
expands vaccine administration in the pharmacy setting to mitigate the reduction in vaccine immunization
rates for children as a result of the COVID-19 pandemic. Effective May 8, 2021, pharmacies that have been
approved to participate in the VFC program may administer all recommended vaccines to all beneficiaries
who are 3 through 18 years of age. The VFC pharmacy expanded coverage is billed as a Fee-For-Service
benefit, including Medicaid Health Plan members.
MDHHS reported on the “We Treat Hep C” initiative. MDHHS Public Health Administration has begun
implementing the statewide elimination plan and development of provider training and consultation
resources. This includes MDHHS partnering with Medicaid Health Plans to increase Hepatitis C virus (HCV)
screening/testing rates in accordance with new CDC guidelines. Effective April 1, 2021, MDHHS contracted
with AbbVie to remove all prior authorization and list their pangenotypic Hep C direct-acting antiviral (DAA),
1Michigan Pharmacy and Therapeutics Committee
Tuesday, June 8, 2021
Minutes - Final
Mavyret as the sole preferred product for the Medicaid program. Beneficiaries taking a non-preferred DAA
prior to April 1 were able to continue their course of therapy. All other Hep C DAA non-preferred products
can still be approved when medically necessary via prior authorization. Ms. Bouck presented slides of the
State’s “We Treat Hep C” website. The program’s success depends on getting more providers to treat HCV.
Ms. Bouck noted that the annual national trend reports for both (FFS and MCO) and individual State FFS
historical reports are available on the CMS DUR website at https://www.medicaid.gov/medicaid/prescription-
drugs/drug-utilization-review/index.html. CMS will begin posting individual MCO annual reports starting this
upcoming year. CMS will be publishing the FFY2020 survey templates for FFS and MCO beginning April 1st
with a June 30th due date. CMS placed extra focus this year on opioid safety and best practices.
MDHHS received CMS approval in October 2018 to pursue Outcomes-Based Contracts/Value-Based
Agreements with drug manufacturers. In August 2020, MDHHS executed its first outcomes-based contract
with Novartis Gene Therapies for the gene therapy drug Zolgensma. The April 2021 contract with Abbvie for
the drug Mavyret was the second agreement. Outcomes-Based Contracts/Value-Based Agreements are
encouraged by the Department of Health and Human Services to help address high drug costs. MDHHS
continues to review potential agreements with several drug manufacturers and urges more companies to
contact them if interested.
Ms. Bouck presented the Centers for Disease Control (CDC) and the State of Michigan website resources for
the Coronavirus pandemic (i.e. COVID-19). For FAQs, a data dashboard, and communications materials on the
COVID-19 vaccine for providers to share with the public at www.Michigan.gov/covidvaccine. Additional
coverage updates will be communicated via web announcements posted at
https://michigan.magellanrx.com/provider/ and at www.Michigan.gov/MCOPharmacy.
During the cardiac workgroup review of the beta blockers in preparation for the March P&T meeting, the
workgroup requested that the DUR Board perform a utilization review of the beta-blocker, atenolol. They
expressed concern that clinical studies show that atenolol is inferior to other beta-blockers for the treatment
of hypertension. Ms. Bouck informed the Committee that DUR Board performed the review and
recommended no further action is required.
Public Comments:
1. Theresa Ankamah, PharmD, RPh, Vice President, Head of Medical Affairs, on behalf of Covis Pharma US, Inc., on
Inhaled Glucocorticoid – Alvesco® (ciclesonide) Inhaler.
2. Dr. Karen Malamut, DO, Medical Affairs Director, in place of Michael Ferrari, PharmD, Health Science Medical
Account Manager, on behalf of Merck & Co., Inc., on VERQUVO (Vericiguat).
3. Maggie Murphy, PharmD, MS, Senior Medical Outcomes Liaison, on behalf of Teva, on ProAir Digihaler, Airduo
Digihaler and ArmonAir Digihaler.
4. Keely Dahl, Senior Medical Science Liaison, Aurinia, on Lupkynis (voclosporin).
5. Mohammed Saleh, M.D., D.C., Medical Director, on behalf of NEU Urgent Care, on Spravato.
6. Jeff Martin, Pharm.D., MPA, Sr. HOPE Specialist - Medical Affairs, on behalf of Amgen, on apremilast (Otezla).
7. Farhan Bhatti, MD, Care Free Medical in Lansing, MI, speaking on Spravato (intranasal esketamine) requesting
to allow coverage when prescribed by non-psychiatrists.
2Michigan Pharmacy and Therapeutics Committee
Tuesday, June 8, 2021
Minutes - Final
New Drugs
The following new drugs and recommendations were reviewed by the Committee and approved:
1. Eysuvis (loteprednol etabonate) eye drops - Not a PDL class – added to the Michigan Pharmaceutical Product
List (MPPL) with the following prior authorization (PA) criteria:
• Initial:
o Diagnosis of chronic dry eye disease (DED); AND
o Patient ≥ 18 years old; AND
o Must be prescribed by or in consultation with an ophthalmologist; AND
o Trial/failure on over-the-counter (OTC) artificial tears
o Initial length of approval: 2 weeks
• Renewal:
o Patient has had an examination under magnification (e.g., slit lamp) and evaluation of the
intraocular pressure (IOP)
o Renewal length of approval: 2 weeks
2. Gimoti (metoclopramide) nasal spray - Not a PDL class – added to the MPPL with the following prior
authorization (PA) criteria:
• Patient age ≥18 years; AND
• Patient has a diagnosis of diabetic gastroparesis with acute or recurrent symptoms; AND
• Patient has had a trial and failure to an oral metoclopramide dosage form; OR
• Patient is unable to ingest oral dosage forms due to one of the following:
o Oral/motor difficulties; OR
o Dysphagia
• Length of approval: 12 weeks
3. Impeklo (clobetasol propionate) lotion – added to PDL class: Topical Steroids – Very High Potency as non-
preferred with the following criteria:
Allergy to the preferred medications
Contraindication or drug to drug interaction with the preferred medications
History of unacceptable side effects
Therapeutic failure of 14 days with one preferred medication
Length of approval: 6 months
4. Lupkynis (voclosporin) capsules - Not a PDL class – added to the MPPL with the following prior authorization
(PA) criteria:
• Patient age ≥18 years; AND
• Diagnosis of lupus nephritis; AND
• Prescribed by or in consultation with a rheumatologist or nephrologist; AND
• Patient must concomitantly receive background immunosuppressive therapy (mycophenolate mofetil
(MMF) and corticosteroids), with the exception of cyclophosphamide.
• Length of approval: 1 year
5. Minolira ER (minocycline) tablets - Not a PDL class – added to the MPPL with the following prior authorization
(PA) criteria: (Note: Committee request to consider addition of tetracyclines to the PDL in the future.)
• Diagnosis of acne vulgaris; AND
• Patient is 12 years of age or older; AND
• Clinical reason why (covered) generic minocycline cannot be used
• Length of authorization: 1 year
3Michigan Pharmacy and Therapeutics Committee
Tuesday, June 8, 2021
Minutes - Final
6. Nyvepria (pegfilgrastim-apgf) syringe – added to PDL class: Topical Steroids – Very High Potency as preferred
7. Orladeyo (berotralstat) capsules – Not a PDL class – added to the MPPL with the following prior authorization
(PA) criteria:
• Patient age ≥ 12 years; AND
• Diagnosis of Hereditary Angioedema (HAE) type I or type II; AND
• Patient has a history of ONE of the following criteria for long-term hereditary angioedema (HAE)
prophylaxis:
o History of two or more severe HAE attacks per month (i.e., airway swelling, debilitating
cutaneous or gastrointestinal episodes); OR
o Patient is disabled more than five days per month by HAE; OR
o History of recurrent laryngeal attacks caused by HAE; AND
• Prescribed by or in consultation with an allergist, hematologist, pulmonologist or immunologist; AND
• Patient is not using Orladeyo in combination with another FDA-approved product for long-term
prophylaxis of HAE attacks (e.g., Cinryze®, Haegarda®, Takhzyro™)
• Length of approval: 1 year
8. Reditrex (methotrexate/pf) syringe - Not a PDL class – added to the MPPL with the following prior
authorization (PA) criteria:
• Diagnosis of severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (polyarticular juvenile
rheumatoid arthritis) or psoriasis AND
• Trial and failure on generic oral or injectable methotrexate
• Length of approval: 1 year
9. Verquvo (vericiguat) tablet - Not a PDL class – added to the MPPL with the following prior authorization (PA)
criteria:
• Patient is ≥ 18 years of age; AND
• Patient has a diagnosis of heart failure; AND
• Patient’s ejection fraction is < 45%; AND
• Patient meets ≥ 1 of the following criteria:
o Patient has required the use of intravenous diuretics as an outpatient in the past 3 months; OR
o Patient was recently hospitalized for heart failure (within the last 6 months); AND
• Patient is on guideline-directed therapy for heart failure, unless contraindicated (e.g., beta-blocker,
angiotensin-converting enzyme [ACE] inhibitor or angiotensin II receptor blockers [ARB], or
mineralocorticoid receptor antagonists/aldosterone antagonists); AND
• Patient is NOT taking another soluble guanylate cyclase (sGC) stimulator or phosphodiesterase-5 (PDE-
5) inhibitor; AND
• If patient is of childbearing potential, patient is NOT pregnant AND is using contraception.
• Length of approval: 1 year
4Michigan Pharmacy and Therapeutics Committee
Tuesday, June 8, 2021
Minutes - Final
10. Zokinvy (lornafarnib) capsules - Not a PDL class – added to the MPPL with the following prior authorization (PA)
criteria:
• Patient is ≥ 12 months of age; AND
• Patient has a body-surface area of ≥ 0.39 m2; AND
• Must be prescribed by, or in consultation with, a specialist in genetics or metabolic disorders; AND
• Patient has a diagnosis of 1 of the following:
Hutchinson-Gilford progeria syndrome (HGPS); OR
Processing-deficient progeroid laminopathies; AND
• Patient does NOT have other non-laminopathy progeroid syndromes or processing-proficient progeroid
laminopathies or laminopathies with no progeria features (mutation in the LMNA gene with no clinical
characteristic features)
• Length of approval: 1 year
11. Olinvyk (oliceridine) vial - an opioid agonist indicated in adults for the management of acute pain severe
enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. [Not a
PDL class – Typically physician-administered therefore add to MPPL as a covered pharmacy benefit only when
not administered in the physician office/clinic]
12. Oxlumo (lumasiran) vial - a hydroxyacid oxidase 1 (HAO1)-directed small interfering ribonucleic acid (siRNA)
indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric
and adult patients. It is administered by subcutaneous injection by a health care professional.
[Not a PDL class - Typically physician-administered therefore add to MPPL as a covered pharmacy benefit only
when not administered in the physician office/clinic]
5Michigan Pharmacy and Therapeutics Committee
Tuesday, June 8, 2021
Minutes - Final
Preferred Drug List (PDL) Classes
A review of the following Preferred Drug Classes was performed, and the following actions were taken.
Antibiotics/Anti-Infectives
(The following antibiotics/anti-infectives workgroup members were recognized: Uren, Courts, Foumia, Ognjan)
1. Antibiotics- Inhaled
a. No change to the current classification of drug products
2. Antifungals – Oral
a. Move ketoconazole tablets to preferred
b. Move nystatin tablets to preferred
3. Antifungals – Topical
a. Move ciclopirox (generic for Loprox and Ciclodan) 0.77% cream to preferred
b. Move ciclopirox (generic for Ciclodan) 8% solution to preferred
c. Move ciclopirox suspension (generic for Loprox) to non-preferred
4. Antivirals – Herpes
a. No change to the current classification of drug products
5. Antivirals – Influenza
a. No change to the current classification of drug products
6. Antivirals – Topical
a. Move Zovirax ointment (acyclovir) to preferred
7. Cephalosporins – 1st Generation
a. No change to the current classification of drug products
8. Cephalosporins – 2nd Generation
a. No change to the current classification of drug products
9. Cephalosporins – 3rd Generation
a. Move cefixime suspension (generic for Suprax) to non-preferred
10. Hepatitis C –
a. a. No change to the current classification of drug products
11. Hepatitis C – Direct Acting Antivirals
a. No further changes. As of 4/1/21, Mavyret is the sole preferred agent.
12. Macrolides
a. Move E.E.S (erythromycin ethylsuccinate) 200mg/5mL suspension to non-preferred
b. Remove age edit on Zithromax (azithromycin) suspension
13. Oxazolidinones
a. No change to the current classification of drug products
14. Quinolones
a. Move ciprofloxacin (generic for Cipro) suspension to preferred
b. Move Cipro (ciprofloxacin) suspension to non-preferred
15. Ophthalmic Fluoroquinolones
a. Move moxifloxacin (generic for Vigamox) to preferred
b. Move Vigamox (moxifloxacin) to non-preferred
16. Ophthalmic Macrolides
a. No change to the current classification of drug products
17. Otic Quinolones
a. No change to the current classification of drug products
18. Topical Antibiotics
a. No change to the current classification of drug products
6Michigan Pharmacy and Therapeutics Committee
Tuesday, June 8, 2021
Minutes - Final
19. Gastrointestinal Antibiotics
a. Move neomycin tablets to preferred
b. Move tinidazole tablets to preferred
20. Vaginal Antibiotics
a. Move clindamycin (generic for Cleocin) 2% cream to preferred
b. Move metronidazole (generic for Metro-gel and Vandazole) 0.75 % gel to preferred
c. Move Clindesse (clindamycin) 2% cream to non-preferred
d. Move Vandazole (metronidazole) 0.75% gel to non-preferred
Asthma/COPD/Allergy
(The following asthma/COPD/allergy workgroup members were recognized: Adair, Axford, Ognjan)
1. Anticholinergic Agents – Short Acting
a. No change to the current classification of drug products
2. Anticholinergic Agents – Long Acting
a. Move Spiriva Respimat (tiotropium) to preferred
b. Move Incruse Ellipta (umeclidinium) to preferred
c. Class criteria recommendation: change length of trial of preferred medication from 1-month to 2-
weeks
3. Beta Adrenergic/ Anticholinergic Inhaler Combinations
a. Move Anoro Ellipta (umeclidinium/vilanterol) to preferred
4. Beta Adrenergic/Anticholinergic/Corticosteroid Inhaler Combinations -create new class for triple combo
products
a. Add to this class and move Trelegy Ellipta (fluticasone/umeclidinium/vilanterol) to preferred
b. Add to this class Breztri Aerosphere (budesonide/glycopyrrolate/formoterol) as non-preferred
5. Beta Adrenergics – Short Acting
a. Move Ventolin HFA (albuterol) inhaler to preferred
b. Move Proventil HFA (albuterol) inhaler to non-preferred and grandfather for 90 days
6. Beta Adrenergics – Long Acting
a. No change to the current classification of drug products
7. Beta Adrenergic/ Corticosteroid Inhaler Combinations
a. No change to the current classification of drug products
b. Add QL Symbicort to allow 2 per 30 days to align with the guidelines as rescue PRN in addition to
daily.
8. Phosphodiesterase-4 (PDE-4) Inhibitors
a. No change to the current classification of drug products
9. Inhaled Glucocorticoids
a. No change to the current classification of drug products
b. Add Quantity Limit of 1 inhaler per 30 days to Asmanex HFA
c. Add Quantity Limit to Pulmicort Flexhaler (180 mcg 2 per 30; 90 mcg = 1 per 30)
d. Class criteria recommendation: change length of trial of preferred medication from 1-month to 2-
weeks
10. Antihistamines – 2nd Generation
a. No change to the current classification of drug products
7Michigan Pharmacy and Therapeutics Committee
Tuesday, June 8, 2021
Minutes - Final
11. Leukotriene Inhibitors
a. No change to the current classification of drug products
12. Nasal Anticholinergics
a. No change to the current classification of drug products
13. Nasal Antihistamines
a. No change to the current classification of drug products
14. Nasal Corticosteroids
a. No change to the current classification of drug products
Meeting adjourned at 8:02pm.
Next Meeting:
Tuesday, September 7, 2021 at 6:00 PM
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