Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • July 21, 2023
  • July 23, 2021
  • May 24, 2019
  • May 2017
  • June 2015
  • Oct. 2013
  • Dec. 2011
  • Jan. 2010
• Initially developed
  • April 2006

ACIs do not alter the long-term progressive decline of Alzheimer’s disease, but have been shown to delay time to institutionalization, which may be cost-effective. ACIs may be prescribed to stabilize dementia in Alzheimer’s patients, as determined by periodic assessment of functional and cognitive ability. ACIs should be discontinued when dementia becomes unresponsive to therapy and progressively severe, as the efficacy of these agents diminishes due to loss of intact cholinergic neurons.

Combined use of two or more ACIs does not provide enhanced therapeutic benefit and may result in additive adverse effects. Concurrent administration of two or more ACIs is not recommended and will be reviewed.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically relevant for ACIs are summarized in Table 3. Only those drug-drug interactions classified as clinical significance level 1 or those considered life threatening which have not yet been classified will be reviewed.

1. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www-micromedexsolutions-com.libproxy.uthscsa.edu/ (cited: June 2, 2023).
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2023. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed June 2, 2023.
3. Donepezil hydrochloride transdermal patch (Adlarity®) package insert. Corium, LLC. March 2022.
4. Donepezil tablets, orally disintegrating tablets (Aricept®, Aricept® ODT) Package Insert. Eisai Inc., November 2022.
5. Galantamine extended-release capsules package insert. Aurobindo Pharma Limited. November 2022.
6. Galantamine film coated oral tablet package insert. Aurobindo Pharma Limited. August 2021.
7. Galantamine hydrobromide oral solution package insert. Hikma Pharmaceuticals USA, Inc. March 2022.
8. Rivastigmine transdermal system (Exelon® Patch) package insert.  Novartis, December 2020.
9. Rivastigmine tartrate oral capsules package insert. Alembic Pharmaceuticals, Inc. April 2022.
10. Memantine extended-release/donepezil capsules (Namzaric®) package insert. Allergan USA, Inc., January 2019.
11. Battle CE, Abdul-Rahim AH, Shenkin SD, et al. Cholinesterase inhibitors for vascular dementia and other vascular cognitive impairments: a network meta-analysis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD013306.
12. Hershey LA, Coleman-Jackson R. Pharmacological management of dementia with lewy bodies. Drugs Aging. 2019;36(4):309-319.
13. Kim JO, Lee SJ, Pyo JS. Effect of acetylcholinesterase inhibitors on post-stroke cognitive impairment and vascular dementia: A meta-analysis. PLoS One. 2020 Feb 7;15(2):e0227820.
14. Cotter J, Muhlert N, Talwar A, et. al. Examining the effectiveness of acetylcholinesterase inhibitors and stimulant-based medications for cognitive dysfunction in multiple sclerosis: A systematic review and meta-analysis. Neuroscience & Biobehavioral Reviews. 2018;86:99-107.
     

Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • Revised April 23, 2021
  • March 2019
  • March 2017
  • Nov. 2015
  • March 2014
  • Aug. 2012
  • June 2012
  • Oct. 2010
  • Jan. 2008
  • Jan. 2003
  • Jan. 2002
  • Jan. 2001
  • March 2000
  • Jan. 2000
  • Feb. 1999
  • Feb. 1998
  • Feb. 1997
  • Aug. 1995.
• Initially developed
  • January 1995

Inhalational anticholinergic agents are suitable for chronic administration as side effects are minimal and drug effectiveness is maintained over years of regular, continuous use. Since inhalation anticholinergics are indicated in the management of chronic, lifelong diseases, there is no basis for limiting the duration of therapy. However, days’ supply for each MDI anticholinergic canister is limited based on the number of inhalations per canister as well as the maximum recommended dose per day. Days’ supply for inhalational anticholinergic therapy is summarized in Tables 4 and 5, based on the maximum recommended dose and the number of actuations per canister or number of capsules per blister card listed in Tables 1-3. Excessive use may be identified based on refill frequency. Inappropriate supply of inhaled anticholinergic agents will be monitored by reviewing excessive refills.

Legend:

• + calculated based on canister size/blister package size and maximum dose allowed per day

Legend:

• + calculated based on canister size/blister package size and maximum dose allowed per day
• ~ not indicated for use in children

Concurrent administration of inhaled anticholinergics has not been evaluated in controlled studies and may not offer additional clinical benefit but may increase anticholinergic adverse effects. Combined administration of multiple inhaled anticholinergics is not recommended and will be reviewed.

Although inhaled anticholinergic systemic absorption is minimal, adjunctive administration with other anticholinergic medications has the potential to amplify anticholinergic pharmacologic and adverse effects. Combined therapy with inhaled anticholinergics and other anticholinergic dosage forms should be considered cautiously.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug interactions considered clinically relevant for inhaled anticholinergics with beta agonists are summarized in Table 6. Only those drug-drug interactions classified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Legend:

• + CP = Clinical Pharmacology
• *MAOIs = monoamine oxidase inhibitors
• ^TCAs = tricyclic antidepressant 

1. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www-micromedexsolutions-com.libproxy.uthscsa.edu/ (cited: February 17, 2023).
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2021. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed February 17, 2023.
3. Ipratropium bromide HFA inhalation aerosol (Atrovent® HFA) package insert.  Boehringer Ingelheim Pharmaceuticals, Inc., January 2021.
4. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007. (NIH Publication No. 07-4051).  Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf.  Accessed February 17, 2023.
5. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. Available from: https://ginasthma.org/gina-reports/. Accessed February 17, 2023.
6. National Heart, Lung, and Blood Institute. 2020 focused updates to the asthma management guidelines: a report from the national asthma education and prevention program coordinating committee expert panel working group. National Institutes of Health. December 2020. Accessed February 17, 2023.
7. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease. 2023 report. Available at: https://goldcopd.org/2023-gold-report-2/. Accessed February 2023.
8. Tiotropium inhalation powder (Spiriva® HandiHaler®) package insert.  Boehringer Ingelheim Pharmaceuticals, Inc., January 2022.
9. Tiotropium inhalation spray (Spiriva® Respimat®) package insert.  Boehringer Ingelheim Pharmaceuticals, Inc., January 2022.
10. Aclidinium inhalation powder (Tudorza® Pressair®) package insert.  AstraZeneca, February 2021.
11. Umeclidinium inhalation powder (Incruse® Ellipta®) package insert.  GlaxoSmithKline, August 2020.
12. Ipratropium/albuterol inhalation spray (Combivent® Respimat®) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., January 2022.
13. Umeclidinium/vilanterol inhalation powder (Anoro® Ellipta®) package insert.  GlaxoSmithKline, October 2022.
14. Aclidinium/ formoterol fumarate powder (Duaklir Pressair®) metered dose inhaler package insert. Circassia Pharmaceuticals, Inc., January 2022.
15. Tiotropium/olodaterol inhalation spray (Stiolto® Respimat®) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., January 2022.
16. Glycopyrrolate/formoterol inhalation aerosol (Bevespi Aerosphere®) package insert. AstraZeneca, November 2020.
17. Fluticasone/umeclidinium/vilanterol inhalation powder (Trelegy® Ellipta®) package insert. GlaxoSmithKline, December 2022.
18. Budesonide/ glycopyrrolate, formoterol fumarate inhalation spray (Breztri Aerosphere®) package insert. AstraZeneca Pharmaceuticals, LP. January 2022.

Medications listed in the tables and non-FDA approved indications that may be included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • April 28, 2023
  • April 23, 2021
  • March 2019
  • March 2017
  • Nov. 2015
  • March 2014
  • Aug. 2012
  • June 2012
  • Aug. 2010
  • July 2010
  • July 2007
  • Feb. 2003
  • Jan 2002
  • Jan. 2001
  • March 2000
  • Jan. 2000
  • Feb. 1999
  • March 1998
  • Aug. 1997
  • Feb. 1997
• Initially developed
  • Jan. 1995

Because asthma is comprised of both inflammatory and bronchoconstrictive components, asthma treatment plans include routine use of inhaled corticosteroids (ICS) to manage inflammatory processes in asthma patients requiring chronic treatment. Higher ICS doses may contribute to a decrease in linear growth velocity in children, but adult height does not appear to be significantly inhibited following ICS use in childhood. All ICS doses may contribute to decreased bone formation in children and bone mineral density in adults. Close monitoring of growth and bone formation markers in children and fracture risk in adults is warranted with long-term ICS use. The lowest effective ICS dose should be utilized for the shortest required time period.

ICS, both as individual agents and as combination therapy, are FDA-approved for managing chronic asthma and COPD and may be continued indefinitely, as both COPD and asthma are chronic, lifelong processes²². Additionally, current guideline recommendations include the use of combined formoterol and budesonide as maintenance and rescue therapy for most patients with asthma, including the use of this combination as needed²³. However, days’ supply per canister is limited based on the number of actuations per canister combined with the maximum recommended dose per day. Recommended days’ supply for available ICS as monotherapy or combined with long-acting beta2-agonists are summarized in Tables 5 and 6. Fluticasone is available as both the furoate and propionate salts; fluticasone propionate is available as four different formulations in three dosage strengths per formulation. Each dosage strength is associated with a maximum recommended dose (cited in Tables 1 and 3) which is used in combination with the number of actuations per drug canister to calculate days’ supply. Fluticasone/salmeterol inhalation powder formulations have also been approved for asthma management (AirDuo RespiClick and AirDuo Digihaler) with three different dosage formulations available; days’ supply can be calculated using dosages provided in Tables 2 and 4. Combined therapy with fluticasone furoate and vilanterol is available as two blister strips, with fluticasone in one strip and vilanterol in the second strip; similarly, triple therapy with fluticasone furoate, umeclidinium, and vilanterol is available as two blister strips, with fluticasone in one strip and umeclidinium and vilanterol in the second strip. Excessive use of ICS may be identified based on refill frequency. Inappropriate supply of ICS will be reviewed by monitoring refill requests.

Legend:

• + calculated based on canister size and maximum dose allowed per day (summarized in Tables 1 & 3)
• BD = bronchodilator
• ICS = inhaled corticosteroids
• OCS = oral corticosteroids

Legend:

• + calculated based on canister size and maximum allowed dose per day (summarized in Tables 2 & 4)
• * Salmeterol inhalation powder, alone or in combination with fluticasone as Advair Diskus®, may be used in children greater than 4 years of age
• # Budesonide/formoterol indicated in children 6 years of age and older and mometasone/formoterol inhalation aerosols is indicated for children 5 years of age and older
• ^ Fluticasone/salmeterol inhalation aerosol only indicated for children greater than or equal to 12 years of age
• $ Fluticasone/vilanterol powder not indicated for use in children

Concurrent use of inhaled corticosteroids with systemic corticosteroids may result in augmented adverse effects, especially when high doses of inhaled corticosteroids are utilized^1-11.

When using single maintenance and reliever therapy (SMART), the “2020 Focused Updates to the Asthma Management Guidelines” recommends using a single inhaled corticosteroid (ICS)/ long acting beta2-agonist combination inhaler as the preferred therapy as opposed to using a separate ICS inhaler. Additionally, the guidelines recommend intermittent use of a single ICS inhaler for patients 12 years of age and older with mild persistent asthma in certain situations when the patient is not already using ICS controller therapy²⁴. The Global Initiative for Asthma (GINA) “Global Strategy for Asthma Management and Prevention” guidelines recommend the use of combination ICS-LABA with budesonide and formoterol as maintenance and rescue therapy for most patients²³.

The concomitant use of two or more inhaled corticosteroids for the treatment of asthma is not recommended and will be reviewed.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug interactions considered clinically relevant for inhaled corticosteroids with or without beta agonists are summarized in Table 7. Only those drug-drug interactions classified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Legend:

• +CP = Clinical Pharmacology
• COPD = chronic obstructive pulmonary disease
• ECG = electrocardiogram
• MAOIs = monoamine oxidase inhibitors
• TCAs = tricyclic antidepressants

1. IBM Micromedex DRUGDEX (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www-micromedexsolutions-com.libproxy.uthscsa.edu/.
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2023. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/.
3. Beclomethasone dipropionate HFA inhalation aerosol (QVAR Redihaler) package insert. Teva Respiratory, September 2022.
4. Budesonide inhalation powder (Pulmicort Flexhaler) package insert.  AstraZeneca, October 2019.
5. Ciclesonide inhalation aerosol (Alvesco) package insert. Covis Pharma, February 2023.
6. Fluticasone furoate inhalation powder (Arnuity Ellipta) package insert.  GlaxoSmithKline, February 2020.
7. Fluticasone propionate inhalation aerosol (Flovent HFA) package insert.  GlaxoSmithKline, August 2021.
8. Fluticasone propionate inhalation powder (Flovent Diskus) package insert.  GlaxoSmithKline, June 2022.
9. Fluticasone inhalation powder (ArmonAir™ Digihaler) package insert. Teva Respiratory, September 2022.
10. Mometasone furoate HFA inhalation aerosol (Asmanex HFA) package insert.  Merck & Co., June 2021.
11. Mometasone furoate inhalation powder (Asmanex Twisthaler) package insert. Merck & Co., June 2021.
12. Fluticasone/salmeterol inhalation aerosol (Advair HFA) package insert.  GlaxoSmithKline, August 2021.
13. Mometasone furoate/formoterol inhalation aerosol (Dulera) package insert.  Merck & Co., June 2021.
14. Fluticasone/salmeterol inhalation powder (Advair Diskus) package insert.  GlaxoSmithKline, October 2020.
15. Fluticasone/salmeterol inhalation powder (AirDuo RespiClick) package insert. Teva Pharmaceuticals, September 2022.
16. Budesonide/formoterol fumarate inhalation aerosol (Symbicort) package insert. AstraZeneca, July 2019.
17. Fluticasone/vilanterol inhalation powder (Breo Ellipta™) package insert. GlaxoSmithKline, July 2021.
18. Fluticasone/umeclidinium/vilanterol inhalation powder (Trelegy Ellipta) package insert. GlaxoSmithKline, December 2022.
19. Budesonide/ Glycopyrrolate/ formoterol fumarate inhalation aerosol (Breztri Aerosphere) package insert. January 2022.
20. Fluticasone/salmeterol inhalation powder (Wixela Inhub) package insert. Mylan Pharmaceuticals, Inc., August 2022.
21. Fluticasone/salmeterol inhalation powder (AirDuo Digihaler) package insert. Teva Pharmaceuticals, April 2022.
22. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease.  2023 report. Available at: https://goldcopd.org/2021-gold-reports/. Accessed March 20, 2023.
23. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. Available from: https://ginasthma.org/gina-reports/. Accessed March 16, 2023.
24. National Heart, Lung, and Blood Institute. 2020 focused updates to the asthma management guidelines: a report from the national asthma education and prevention program coordinating committee expert panel working group, 2021. Available from: https://www.nhlbi.nih.gov/health-topics/asthma-management-guidelines-2020-updates. Accessed March 20, 2023.

Medications listed in the tables and non-FDA approved indications that may be included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • April 28, 2023
  • April 23, 2021
  • March 2019
  • March 2017
  • Oct. 2014
  • Feb. 2013
  • Oct. 2012
  • Jan. 2011
  • July 2007
  • March 2003
  • April 2002
  • March 2001
  • March 2000
  • Feb. 1999
  • March 1998
  • March 1997
  • Aug. 1995.
• Initially developed
  • Jan. 1995

Long-acting, selective beta2-agonists (LABAs) are FDA-approved for use as adjunctive therapy with long-term asthma control medications, such as inhaled corticosteroids (ICS), in managing reversible obstructive airways disease, including asthma and nocturnal asthma, in patients inadequately controlled with long-term asthma control medications. LABAs are contraindicated for use as monotherapy in asthma management due to an increased risk of asthma-related death as well as increased risks in asthma-related hospitalizations in pediatric and adolescent patients. Serevent Diskus® (salmeterol) is FDA-approved for asthma in adults and children four years and older when used with an ICS, and it is also FDA-approved for use to acutely prevent exercise-induced bronchospasm (EIB) on an as-needed basis. LABAs are FDA-approved for use in adults as maintenance therapy for bronchoconstriction associated with chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis. Striverdi Respimat® (olodaterol) is another LABA available without an ICS, and it is FDA-approved for the management of COPD. It does not have an FDA-approval for asthma.

LABAs combined with ICS are FDA-approved for use in adults and children as asthma maintenance therapy: Advair® HFA metered aerosol (fluticasone propionate/salmeterol) is FDA-approved for use in patients 12 years of age and older, and Dulera® (mometasone/formoterol) inhalation aerosol is FDA-approved for use in patients 5 years of age and older.  Advair Diskus® (fluticasone propionate/salmeterol) inhalation powder is FDA-approved for use in asthma maintenance in patients 4 years of age and older. AirDuo RespiClick® and AirDuo Digihaler® (fluticasone/salmeterol) inhalation powders provide additional dosage strengths, and they have been approved for use in patients with asthma who are 12 years and older. Symbicort® (budesonide/formoterol) inhalation aerosol and Advair Diskus® (fluticasone propionate/salmeterol) are FDA-approved for use in adults as COPD maintenance therapy. Symbicort® is also FDA-approved for the management of asthma in adults and children 6 years of age and older. The combination Breo Ellipta® (fluticasone/ vilanterol) is FDA approved for the management of COPD and asthma in patients 18 years of age and older^1,2,11. The Global Initiative for Asthma (GINA) “Global Strategy for Asthma Management and Prevention” guidelines recommend the use of combination ICS-LABA with budesonide and formoterol as maintenance and rescue therapy for most patients¹².

Anoro Ellipta® (umeclidinium/vilanterol), Bevespi Aerosphere® (glycopyrrolate/formoterol), and Stiolto Respimat® (tiotropium/olodaterol) are indicated for use in adults as maintenance therapy for COPD but are not FDA-approved for use in asthma.

Additionally, a triple therapy inhaler containing fluticasone, umeclidinium and vilanterol, Trelegy Ellipta®, is approved for COPD management to treat airway obstruction and reduce exacerbations and for the maintenance treatment of asthma in patients 18 years and older.

Duaklir Pressair® (aclidinium bromide/ formoterol) is a long-acting beta agonist and long-acting muscarinic antagonist combination product approved for the management of COPD in adults.

Generally, LABAs should only be used as maintenance therapy. Recent guideline updates recommend the combined use of formoterol and budesonide as maintenance and rescue therapy for most patients with asthma, including the use of this combination as needed¹².

For maintenance therapy, daily administration of LABAs alone or in combination with ICS is warranted in asthma and COPD. Formoterol combination products, olodaterol monotherapy and combination products, salmeterol monotherapy and combination products, and vilanterol combination products are metered-dose inhalers designed to deliver a set number of inhalations based on the canister size as well as the medication prescribed. Tables 5 and 6 summarize the number of inhalations available LABA and LABA combination products provide, respectively, and the days’ supply per inhaler or blister package based on the maximum dose allowed per day (see Tables 1 through 4). Excessive use may be identified based on refill frequency. Inappropriate supply of salmeterol metered-dose inhalers, salmeterol/fluticasone blister packages, formoterol blister packages, budesonide/formoterol metered-dose inhalers, or mometasone/formoterol metered-dose inhalers will be monitored by reviewing excessive refills.

Legend:

• + calculated based on canister size/blister package size and maximum dose allowed per day
• * Salmeterol inhalation powder, alone or in combination with fluticasone, may be used in children less than 4 years of age

Legend:

• + calculated based on canister size/blister package size and maximum dose allowed per day
• ~ not indicated for use in children
• * Salmeterol inhalation powder, alone or in combination with fluticasone, may be used in children > 4 years of age
• # Budesonide/formoterol indicated for children > 6 years of age
• ^ Fluticasone/salmeterol inhalation aerosol and fluticasone/salmeterol inhalation powder as AirDuo® RespiClick and AirDuo Digihaler® as well as  mometasone/formoterol inhalation aerosols only indicated for children > 12 years of age
• ! Mometasone furoate/ formoterol 50 mcg/ 5mcg/ inhalation is approved for children 5 years of age and older

Acute asthma exacerbations require treatment with short-acting beta2-adrenergic agents even though maintenance therapy with LABAs may be prescribed concomitantly. Patients may receive a long- and short-acting beta2-adrenergic drug concurrently for short time periods to manage acute attacks. LABAs used in conjunction with frequently administered short-acting beta2-adrenergic drugs (i.e., frequent refill of a short-acting beta2-adrenergic agonist within a 30-day time period) will be reviewed.

Current literature does not support the adjunctive use of multiple LABAs for prevention and control of asthma symptoms. Concomitant LABA use will be reviewed as clinical evidence does not validate improved outcome with conjunctive therapy.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically relevant for LABAs and combination products are summarized in Table 7. Only those drug-drug interactions classified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Legend:

• +CP = Clinical Pharmacology
• COPD = chronic obstructive pulmonary disease
• ECG = electrocardiogram
• MAOIs = monoamine oxidase inhibitors
• TCAs = tricyclic antidepressants

1. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www-micromedexsolutions-com.libproxy.uthscsa.edu/ (cited: March 16, 2023).
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2023. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed March 16, 2023.
3. Salmeterol xinafoate inhalation powder (Serevent® Diskus®) package insert.  GlaxoSmithKline, February 2022.
4. Olodaterol inhalation spray (Striverdi® Respimat®) package insert.  Boehringer Ingelheim Pharmaceutical, Inc., November 2021.
5. Fluticasone/salmeterol inhalation aerosol (Advair® HFA) package insert.  GlaxoSmithKline, August 2021.
6. Mometasone furoate/formoterol inhalation aerosol (Dulera®) package insert.  Merck & Co., June 2021.
7. Fluticasone/salmeterol inhalation powder (Advair Diskus®) package insert.  GlaxoSmithKline, October 2020.
8. Fluticasone/salmeterol inhalation powder (AirDuo RespiClick®) package insert. Teva Pharmaceuticals, September 2022.
9. Fluticasone/salmeterol inhalation powder (AirDuo Digihaler®) package insert. Teva Pharmaceuticals, April 2022.
10. Budesonide/formoterol fumarate inhalation aerosol (Symbicort®) package insert. AstraZeneca, July 2019.
11. Fluticasone/vilanterol inhalation powder (Breo® Ellipta™) package insert. GlaxoSmithKline, July 2021.
12. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. Available from: https://ginasthma.org/gina-reports/. Accessed March 16, 2023.
13. Umeclidinium/vilanterol inhalation powder (Anoro® Ellipta®) package insert.  GlaxoSmithKline, October 2022.
14. Glycopyrrolate/formoterol inhalation aerosol (Bevespi Aerosphere®) package insert. AstraZeneca, November 2020.
15. Tiotropium/olodaterol (Stiolto® Respimat®) package insert. Boehringer-Ingelheim Pharmaceuticals, Inc., November 2021.
16. Fluticasone/umeclidinium/vilanterol inhalation powder (Trelegy® Ellipta®) package insert. GlaxoSmithKline, December 2022.
17. Aclidinium/ formoterol fumarate powder (Duaklir Pressair®) metered dose inhaler package insert. Circassia Pharmaceuticals, Inc., January 2022.
18. Budesonide/ Glycopyrrolate/ formoterol fumarate inhalation aerosol (Breztri Aerosphere®) package insert. January 2022.
19. Fluticasone/salmeterol inhalation powder (Wixela Inhub®) package insert. Mylan Pharmaceuticals, Inc., August 2022.

Medications listed in the tables and non-FDA approved indications that may be included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • April 28, 2023
  • April 23, 2021
  • March 2019
  • March 2017
  • May 2016
  • Feb. 2016
  • July 2014
  • Oct. 2012
  • Oct. 2010
  • Jan. 2008
  • March 2003
  • March 2002
  • March 2001
  • March 2000
  • May 1999
  • Feb. 1999
  • Feb. 1998
  • March 1997
  • Aug. 1995
• Initially developed
  • Jan. 1995

Metered-dose inhalers are designed to deliver a set number of inhalations based on the canister size as well as the medication prescribed. Days’ supply for inhalational beta2-adrenergic agents is summarized in Table 4 and 5, based on the maximum recommended doses listed in Tables 1-3, and the number of actuations per canister or number of capsules per blister card listed in Tables 4 and 5. Excessive use may be identified based on refill frequency. Inappropriate supply of short-acting beta2-adrenergic agents will be monitored by reviewing excessive refills.

Legend:

• + calculated based on canister size and maximum dose allowed per day (summarized in Tables 1 and 2)

The use of two or more metered-dose inhaler short-acting beta₂-adrenergic compounds concurrently for prevention and control of asthma symptoms is not justified and will be reviewed. Nebulized short-acting beta₂-adrenergic therapy is available for pediatric patients who are too ill or too young to obtain medication from an aerosolized metered-dose device.  However, adjunctive administration of a short-acting beta₂-adrenergic agonist metered-dose inhaler with a short-acting beta₂-agonist nebulized bronchodilator is also not recommended and will be reviewed.

Acute asthma exacerbations require treatment with short-acting beta₂-adrenergic agents even though maintenance therapy with a long-acting beta₂-agonist like salmeterol may be prescribed concomitantly. Patients may receive a long- and short-acting beta₂-adrenergic drug concurrently for short time periods to manage acute attacks. Patient profiles containing excessive prescriptions for a short-acting beta₂-adrenergic drug (i.e., frequent refill of short-acting beta₂-adrenergic agonist within a 30-day time period) in conjunction with long-acting beta₂-agonists will be reviewed.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug interactions considered clinically relevant for short-acting beta₂-adrenergic bronchodilators are summarized in Table 6. Only those drug-drug interactions classified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Legend:

• +CP = Clinical Pharmacology
• COPD = chronic obstructive pulmonary disease
• ECG = electrocardiogram
• MAOIs = monoamine oxidase inhibitors
• TCAs = tricyclic antidepressants

1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2023. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed February 23, 2023.
2. Albuterol sulfate HFA aerosol, metered package insert. Preferred Pharmaceuticals Inc., 2022.
3. Albuterol inhalation aerosol (Proventil® HFA) package insert. Sandoz, September 2022.
4. Albuterol inhalation aerosol (Ventolin® HFA) package insert. GlaxoSmithKline, August 2021.
5. Albuterol inhalation powder (ProAir RespiClick®) package insert. Teva Respiratory, September 2022.
6. Albuterol inhalation powder (ProAir Digihaler®) package insert. Teva Respiratory, December 2022.
7. Levalbuterol inhalation aerosol (Xopenex HFA®) package insert. Sunovion Pharmaceuticals Inc., June 2020.
8. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. Available from: https://ginasthma.org/gina-reports/. Accessed February 23, 2023.
9. Expert Panel Working Group of the National Heart, Lung, and Blood Institute (NHLBI) administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC). 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol. 2020 Dec;146(6):1217-1270. 
10. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease. 2023 report. Available at: https://goldcopd.org/2023-gold-report-2/. Accessed February 23, 2023.
11. Ipratropium/albuterol (Combivent® Respimat® Inhalation Spray) package insert.  Boehringer Ingelheim Pharmaceuticals, Inc., December 2021.
     

Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • Jan. 20, 2023
  • Jan. 22, 2021
  • Dec. 2018
  • Dec. 2016
  • Oct. 2014
  • Dec. 2012
  • March 2011
  • April 2008
  • July 2003
  • July 2002
  • Sept. 2001
  • Sept. 2000
  • July 1999
  • June 1998
  • July 1997
  • Dec. 1996
• Initially developed
  • April 1996

There is no basis for limiting therapy duration for ARBs as reduction of cardiovascular mortality post-myocardial infarction, stroke risk reduction, managing hypertension, treating diabetic nephropathy, and managing heart failure requires chronic treatment.

Administration of two or more ARBs concurrently is not justified. Additional therapeutic benefit is not appreciated when multiple ARBs are utilized concomitantly. Patient profiles containing regimens comprised of two or more ARBs administered concurrently will be reviewed.

Recent studies have documented concurrent administration of ARBs and ACE inhibitors may result in an increased incidence of adverse effects (e.g., hypotension, hyperkalemia, syncope, renal failure) in patients with heart failure due to myocardial infarction or left ventricular dysfunction, as well as other patients at high risk for vascular events (e.g., diabetic patients) without added benefit. Additional studies have not documented significant benefit with ACE inhibitor-ARB combination therapy in managing hypertension or diabetic nephropathy. The American College of Cardiology/American Heart Association guidelines state that ARB-ACE inhibitor combination therapy may be considered in heart failure patients, not recently post myocardial infarction, who have not responded to target doses of an ACE inhibitor and beta blocker. The guidelines warn that routine combined use of an ACE inhibitor, an ARB, and an aldosterone antagonist is potentially harmful to patients with heart failure with a reduced ejection fraction. The 2017 focused update recommends an ACE inhibitor OR an ARB, but they do not explicitly address the use of both agents at the same time. Adjunctive administration of ARBs and ACE inhibitors should be considered cautiously, if at all, in these patient populations.

Patient profiles will be assessed to identify those drug regimens, which may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically relevant for ARBs are summarized in Table 4. Only those drug-drug interactions classified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2022. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed October 10, 2022.
2. IMB Micromedex® DRUGDEX® (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com.libproxy.uthscsa.edu. Accessed October 10, 2022.
3. Azilsartan tablets (Edarbi®) package insert. Arbor Pharmaceuticals, March 2020.
4. Candesartan tablets (Atacand®) package insert. ANI Pharmaceuticals, Inc., June 2020.
5. Irbesartan tablets (Avapro®) package insert. Sanofi-Aventis U.S., September 2021.
6. Losartan tablets (Cozaar®) package insert. Organon, October 2021.
7. Olmesartan tablets (Benicar®) package insert. Cosette Pharmaceuticals, Inc., February 2022.
8. Telmisartan tablets (Micardis®) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., July 2020.
9. Valsartan tablets (Diovan®) package insert. Novartis Pharmaceuticals Corporation, April 2021.
10. Valsartan oral solution package insert. Lifsa Drugs, April 2022.
11. Losartan/hydrochlorothiazide tablets (Hyzaar®) package insert. Organon, June 2021.
12. Sacubitril/valsartan tablets (Entresto®) package insert. Novartis Pharmaceuticals Corporation, February 2021.
13. Amlodipine/Olmesartan tablets (Azor®) package insert. Cosette Pharmaceuticals, Inc., February 2022.
14. Amlodipine/valsartan tablets (Exforge®) package insert. Novartis Pharmaceuticals Corporation, April 2021.
15. Amlodipine/valsartan/hydrochlorothiazide tablets (Exforge HCT®) package insert. Novartis Pharmaceuticals Corportation, February 2021.
16. Azilsartan/chlorthalidone tablets (Edarbyclor®) package insert. Arbor Pharmaceuticals, March 2020.
17. Candesartan/hydrochlorothiazide tablets (Atacand HCT®) package insert. ANI Pharmaceuticals, Inc., May 2020.
18. Irbesartan/hydrochlorothiazide tablets (Avalide®) package insert. Sanofi-Aventis U.S., September 2021.
19. Olmesartan/amlodipine/hydrochlorothiazide tablets (Tribenzor®) package insert. Cosette Pharmaceuticals, Inc., February 2022.
20. Olmesartan/hydrochlorothiazide tablets (Benicar HCT®) package insert. Cosette Pharmaceuticals, Inc., February 2022.
21. Telmisartan/amlodipine tablets package insert. Torrent Pharmaceuticals, March 2022.
22. Telmisartan/hydrochlorothiazide tablets (Micardis HCT®) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., August 2020.
23. Valsartan/hydrochlorothiazide tablets (Diovan HCT®) package insert. Novartis Pharmaceuticals Corporation, August 2020.
24. The ONTARGET Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008;358:1547-59.
25. Phillips CO, Kashani A, Ko DK, et al. Adverse effects of combination angiotensin II receptor blockers plus angiotensin-converting enzyme inhibitors for left ventricular dysfunction. A quantitative review of data from randomized clinical trials. Arch Intern Med. 2007;167:1930-6.
26. Heidenreich P, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. J Am Coll Cardiol. 2022 May, 79 (17) e263–e421. 
27. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2018;71:e127-e248.
28. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non–ST-elevation acute coronary syndromes: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;64:e139-e228.

Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.  

• Initially developed
  • June 1996
• Revision history
  • Jan. 20, 2023
  • Jan. 22, 2021
  • Dec. 2018
  • Dec. 2016
  • Dec. 2014
  • March 2013
  • April 2011
  • March 2011
  • April 2008
  • June 2003
  • July 2002
  • Sept. 2001
  • June 2001
  • June 2000
  • July 1999
  • June 1998
  • June 1997

There is no basis for limiting ACE inhibitor therapy duration when utilized to manage hypertension, heart failure, and proteinuria associated with diabetic nephropathy, as these conditions require chronic treatment. The 2017 American College of Cardiology (ACC)/American Heart Association (AHA) focused update supports that ACE inhibitor use reduces cardiovascular morbidity and mortality in heart failure patients with reduced ejection fraction. Additionally, the ACC/AHA 2013 guidelines for ST-elevation myocardial infarction (STEMI) recommend immediate ACE inhibitor therapy within the first 24 hours) in patients with an anterior infarction, heart failure, or ejection fraction less than 0.40 who have no contraindications for ACE inhibitor use as well, as indefinite therapy with ACE inhibitors post-myocardial infarction for these patients. The ACC/AHA 2014 guidelines for unstable angina/non-STEMI patients recommend immediate ACE inhibitor therapy (within first 24 hours) in those with pulmonary congestion or left ventricular ejection fraction less than 0.40, and no hypotension or contraindications to ACE inhibitor therapy. These guidelines also recommend prolonged use of ACE inhibitors in patients with heart failure, left ventricular ejection fraction less than 0.40, hypertension, or diabetes mellitus without contraindications to ACE inhibitor therapy to reduce cardiovascular mortality.

The use of two or more ACE inhibitors concurrently is not justified. Additional therapeutic benefit is not realized when ACE inhibitors are used in combination.  Patient profiles documenting the receipt of multiple ACE inhibitors will be reviewed.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically relevant for ARBs are summarized in Table 4. Only those drug-drug interactions classified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2022. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed October 10, 2022.
2. IMB Micromedex DRUGDEX (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com.libproxy.uthscsa.edu. Accessed October 10, 2022.
3. Benazepril tablets (Lotensin) package insert. Validus Pharmaceuticals, January 2019.
4. Benazepril tablets package insert. Amneal Pharmaceuticals, December 2020.
5. Captopril tablets package insert. Camber Pharmaceuticals, Inc., July 2021.
6. Enalapril tablets (Vasotec) package insert. Bausch Health US, December 2020.
7. Enalapril oral solution (Epaned) package insert. Azurity Pharmaceuticals, Inc., March 2020.
8. Fosinopril tablets package insert. Bryant Ranch Prepack, February 2022.
9. Lisinopril tablets (Zestril) package insert. Almatica Pharma, March 2020.
10. Lisinopril oral solution (Qbrelis) package insert. Azurity Pharmaceuticals, Inc., March 2020.
11. Moexipril tablets package insert. Glenmark Pharmaceuticals, Inc., August 2021.
12. Perindopril tablets package insert. Aurobindo Pharma, September 2019.
13. Quinapril tablets (Accupril) package insert. Parke-Davis Division of Pfizer, Inc., May 2022.
14. Ramipril capsules (Altace) package insert. Pfizer Laboratories Division of Pfizer, Inc., February 2022.
15. Trandolapril tablets package insert. Aurobindo Pharma, July 2022.
16. Benazepril/amlodipine capsules (Lotrel) package insert. Novartis Pharmaceuticals Corp., March 2022.
17. Benazepril/amlodipine capsules package insert. Lupin Pharmaceuticals, Inc., August 2021.
18. Benazepril/hydrochlorothiazide tablets (Lotensin HCT) package insert. Validus Pharmaceuticals, October 2020.
19. Enalapril/hydrochlorothiazide tablets (Vaseretic) package insert. Bausch Health US, August 2020.
20. Enalapril/hydrochlorothiazide tablets package insert. Bryant Ranch Prepack, December 2021.
21. Fosinopril/hydrochlorothiazide tablets package insert. Aurobindo Pharma, February 2022.
22. Lisinopril/hydrochlorothiazide tablets (Zestoretic) package insert. Almatica Pharma, July 2021.
23. Perindopril/amlodipine tablets (Prestalia) package insert. Adhera Therapeutics, Inc., October 2019.
24. Quinapril/hydrochlorothiazide tablets (Accuretic) package insert. Parke-Davis Division of Pfizer, December 2021.
25. Trandolapril/verapamil tablets package insert. Glenmark Pharmaceuticals, Inc., September 2019.
26. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2018;71:e127-e248.
27. O’Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61:e78-e140.
28. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non–ST-elevation acute coronary syndromes: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;64:e139-e228.
29. Heidenreich P, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. J Am Coll Cardiol. 2022 May, 79 (17) e263–e421.

Medications listed in the tables and non-FDA approved indications that may be included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • April 28, 2023
  • April 23, 2021
  • March 2019
  • March 2017
  • April 2015
  • March 2015
  • June 2013
  • July 2011
  • Sep. 2009
  • Aug. 2009
  • March 2009
  • Dec. 2003
  • Nov. 2002
  • Oct. 2002
  • Nov. 2001
  • Sept. 2001
  • Oct. 2000
  • Jan. 2000
  • Oct. 1999
  • Oct. 1998
  • Sept. 1997
  • Dec. 1996
• Initially developed
  • Jan. 1995

There is no basis for limiting antidepressant therapy duration when used to manage MDD, OCD, GAD, PTSD, or PD as these disorders can all be characterized as chronic conditions. NP, CMP, and F are considered chronic conditions and may be used for the duration of the condition.

While clinical trials have not evaluated vilazodone use in MDD beyond 52 weeks, it is accepted that vilazodone therapy may exceed 52 weeks, as acute episodes of MDD require extended (several months or longer) drug therapy. Patients should be periodically assessed for continued need for vilazodone treatment³³.

Duloxetine treatment duration in diabetic NP lasting greater than 6 months has not been evaluated in clinical trials. Additionally, duloxetine efficacy in CMP beyond 13 weeks has not been established in clinical trials.

Duloxetine use lasting greater than 12 months as F therapy has not been evaluated in clinical trials. Recent clinical trials have evaluated milnacipran use for up to one year in F with sustained results in pain management. F patients should be routinely evaluated for treatment effectiveness, with milnacipran therapy tapered and discontinued if positive treatment outcomes are no longer present.

The concurrent use of two antidepressant medications with the same spectrum of activity may not be justified. The concomitant use of two cyclic antidepressants, two MAOIs or two SNRIs will be reviewed.

The concurrent use of three or more antidepressants is not justified. Therefore, the adjunctive use of three or more antidepressants, including MAOIs, SNRIs, SSRIs, cyclic antidepressants, trazodone, bupropion, and nefazodone, will be reviewed.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. The following drug-drug interactions summarized in Table 16 are considered clinically relevant for antidepressants. Only those drug-drug interactions identified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Legend:

• #CP = Clinical Pharmacology
• CNS = central nervous system
• SNRIs = serotonin and norepinephrine reuptake inhibitors
• TCAs = tricyclic antidepressants

1. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www-micromedexsolutions-com.libproxy.uthscsa.edu/ (cited: February 22, 2023).
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2023. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed February 22, 2021.
3. Amitriptyline HCL package insert. Advanced Rx, October 27, 2022.
4. Amitriptyline (Elavil) package insert. Thompson Medical Solutions LLC, April 13, 2016.
5. Amoxapine tablets package insert. Actavis Pharma, Inc., February 28, 2015
6. Clomipramine package insert. Amneal Pharmaceuticals NY LLC, October 26, 2021. 
7. Clomipramine (Anafranil) package insert. SpecGx LLC, February 17, 2020. 
8. Desipramine package insert. Amneal Pharmaceuticals NY LLC, October 26, 2021. 
9. Desipramine (norpramine) package insert. Validus Pharmaceuticals LLC, January 26, 2021. 
10.  Doxepin package insert. Strides Pharma Science Limited, September 7, 2022.
11. Doxepin (Silenor) package insert. Currax Pharmaceuticals LLC, November 2, 2022.
12. Imipramine tablets package insert. Carilion Materials Management, November 22, 2011.
13. Imipramine (Tofranil) capsules package insert. Thompson Medical Solutions LLC, December 23, 2016. 
14. Imipramine capsules package insert. Hikma Pharmaceuticals USA Inc, October 11th, 2021
15. Nortriptyline package insert. Direct Rx, October 5, 2022.
16. Nortriptyline (Pamelor) package insert. SpecGc LLC, February 17, 2020. 
17. Protriptyline package insert. Epic Pharma, LLC, June 10, 2020. 
18. Trimipramine package insert. Breckenridge Pharmaceutical, Inc., October 21, 2022. 
19. Mirtazapine package insert. Apotex Corp., January 30, 2023.
20. Mirtazapine (Remeron) package insert. Organon LLC., June 1, 2022. 
21. Isocarboxazid (Marplan) package insert. Validus Pharmaceuticals LLC, January 28, 2022.
22. Phenelzine package insert. Novel Laboratories, Inc.,September 30, 2014.
23. Phenelzine (Nardil) package insert. Park Davis Div of Pfizer Inc, December 9, 2020.
24. Selegiline (Emsam) package insert. Mylan Specialty L.P., May 15, 2020. 
25. Tranylcypromine (parnate) package insert. Actavis Pharma, Inc., Augist 27, 2021.
26. Desvenlafaxine (Pristiq) package insert. Wyeth Pharmaceuticals LLC, March 25, 2022.
27. Duloxetine(Cymbalta) package insert. Eli Lilly and Company, September 20, 2021.
28. Duloxetine(Drizalma) package insert. Sun Pharmaceutical Industries, Inc., July 28, 2021.
29. Levomilnacipran(Fetzima) package insert. Allergan, Inc., September 20, 2021.
30. Milnicipran (Savella) package insert. Allergan, Inc., December 23, 2022.
31. Venlafaxine (Effexor XR) package insert. Wyeth Pharmaceuticals LLC., August 29, 2022.
32. Venlafaxine (Effexor) package insert. Direct Rx, January 20, 2020.
33. Vilazodone  (Viibryd) package insert. Allergen, Inc., September 1, 2021.  
34. Vortioxetine (Trintellix) package insert/ Takeda Pharmaceuticals America, Inc., November 16, 2022. 
35. Bupropion (Wellbutrin SR) package insert. GlaxoSmithKline LLC, December 6, 2022.
36. Bupropion (Wellbutrin SR) package insert. Bluepoint Laboratories, June 20, 2022.
37. Bupropion (Aplenzin) package insert. Bausch Health US, LLC, March 2, 2022.
38. Bupropion extended-release tablets (Forfivo XL®) package insert. Almatica Pharmaceuticals, December 31,2019.
39. Nefazodone package insert. Ranbaxy Pharmaceuticals Inc., December 24, 2008.
40. Trazodone package insert. Accord Healthcare, Inc., December 23, 2021.
41. Chlordiazepoxide and amitriptyline package insert. Micro Labs Limited, January 19, 2023.
42. Perphenazine and amitriptyline package insert. Mylan Pharmaceuticals Inc., September 26, 2019. 
43. Clomipramine capsules (Anafranil) package insert. Mallinckrodt, January 2023
44. Texas Health and Human Services. Psychotropic medication utilization parameters for children and youth in Texas public behavioral health (6th version), June 2019. Available at: https://hhs.texas.gov/sites/default/files/documents/doing-business-with-hhs/provider-portal/facilities-regulation/psychiatric/psychotropic-medication-utilization-parameters.pdf. Accessed February 5, 2023.

Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • April 28, 2023
  • April 23, 2021
  • March 2019
• Initially developed
  • March 2017

There is no basis for limiting antidepressant therapy duration when used to manage MDD, OCD, GAD, PTSD, or PD as these disorders can all be characterized as chronic conditions.

Clinical trials have documented fluoxetine efficacy in BN management for up to 52 weeks. Fluoxetine has demonstrated efficacy in PMDD for up to 6 months when administered continuously and up to 3 months when administered intermittently. Paroxetine and sertraline have demonstrated efficacy in PMDD for up to 6 months and 12 months, respectively, in clinical trials. Patients should be assessed periodically to determine need for continued treatment. However, the potential exists for PMDD symptoms to worsen with advancing age until patients reach menopause. Patients responding to fluoxetine, paroxetine, or sertraline therapy for PMDD may benefit from chronic administration.

Paroxetine treatment for VMS exceeding 24 weeks has not been evaluated in clinical trials. Additionally, paroxetine dosages used to manage VMS are not FDA-approved to manage psychiatric conditions, as the dose contained in Brisdelle® is lower than the recommended doses used to manage psychiatric disorders. Patients requiring paroxetine for psychiatric disorders should discontinue Brisdelle® and initiate therapy with a paroxetine formulation FDA-approved for psychiatric use.

The concurrent use of two SSRI antidepressant medications with the same spectrum of activity may not be justified and will be reviewed.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. The following drug-drug interactions summarized in Table 6 are considered clinically relevant for SSRI antidepressants. Only those drug-drug interactions identified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Legend:

• MAOI = monoamine oxidase inhibitor
• SNRI = serotonin-norepinephrine reuptake inhibitor
• SSRI= selective serotonin reuptake inhibitor
• # CP = Clinical Pharmacology

1. IBM Micromedex DRUGDEX (electronic version). IBM Watson health, Greenwood Village, Colorado, USA. Available at: www-micromedexsolutions-com.libproxy.uthscsa.edu/ (cited: January 18th, 2023)
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2021. Available at: http://clinicalpharmacologyip.com.ezproxy.lib.utexas.edu/. Accessed January 18, 2023.
3. Citalopram [Package Insert]. Morristown. NJ: Almatica Pharma LLC.https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f815b0c-6da7-cb61-e89c-7de628092d0d&audience=consumer. February 2022.
4. Citalopram capsules [Package Insert]. Morristown. NJ: Almatica Pharma LLC. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f815b0c-6da7-cb61-e89c-7de628092d0d. February 2022.
5. Escitalopram [Package Insert]. East Windsor. NJ: Aurobindo Pharma Limited. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d5fbc8ce-bd41-4bd0-b413-0dea97e596c3&type=display. October 2021.
6. Prozac [Package Insert]. Indianapolis, IN: Dista Products Company. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f815b0c-6da7-cb61-e89c-7de628092d0d&audience=consumer. February 2022.
7. Prozac [Package Insert]. Bachupally, India: Dr. Reddys’ Laboratory Limited. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=887fc670-db67-4cfe-967b-46b38375dae5&type=display. June 2021.
8. Prozac [Package Insert]. Bachupally, India: Dr. Reddys’ Laboratory Limited. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=887fc670-db67-4cfe-967b-46b38375dae5&type=display. June 2021.
9. Fluoxetine [Package Insert]. Indrad, India: Torrent Pharmaceuticals Limited. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=dcebc7cf-6f95-4f7a-a22b-c7d2e0f04d74&type=display. November 2022.
10. Fluvoxamine Maleate Extended Release [Package Insert]. Princeton, NJ: Bion Pharma Inc. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=9924422b-7c90-42bf-a680-ffd92063d5f0&type=display. October 2020.
11. Pexeva [Package Insert]. Roswell, GA: Sebela Pharmaceutics  Inc. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=50fe88bd-f0dd-5fad-e054-00144ff8d46c&type=display. July 5, 2022. 
12. Paxil CR [Package Insert]. Toronto, ON: Apotex Inc. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=483bd97f-c4d0-4e23-aaa8-6334f4471e0c&type=display. December 6, 2022. 
13. Paxil [Package Insert]. Toronto, ON: Apotex Inc. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=584ace29-6e40-432f-950f-ab7e98653d32&audience=professional. December 6, 2022. 
14. Brisdelle [Package Insert]. Roswell, GA: Sebela Pharmaceutics  Inc. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=50361fc8-8fba-1c45-e054-00144ff88e88&type=display. June 16, 2022.
15. Fluvoxamine Maleate [Package Insert]. Toronto, ON: Apotex Inc. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6Eeb14df-6fcf-a737-5359-5744eb4accea&audience=consumer. November 2021.
16. Sertraline [Package Insert]. Morristown, NJ: Almatica Pharma LLC. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8c8bcba9-eaeb-aa44-f9ea-b580de55a439&type=display. October 4, 2021. 
17. Symbyax [Package Insert]. Indianapolis, IN: Lilly USA LLC. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6b28c424-0b7e-4b75-b090-f116b113554e&type=display. December 23, 2021.
18. Texas Health and Human Services. Psychotropic medication utilization parameters for children and youth in Texas public behavioral health (6 version), June 2019. Available at: https://hhs.texas.gov/sites/default/files/documents/doing-business-with-hhs/provider-portal/facilities-regulation/psychiatric/psychotropic-medication-utilization-parameters.pdf. Accessed January 18, 2023.
19. National Institutes of Health. (n.d.). DailyMed. U.S. National Library of Medicine. Retrieved January 18, 2023, from https://dailymed.nlm.nih.gov/dailymed/index.cfm 
20. DRUGS@FDA: FDA-approved drugs. FDA. (n.d.). Retrieved January 18, 2023, from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm 

Oral antidiabetic agents are FDA-approved for use in patients with type 2 diabetes as monotherapy or in combination with other oral antidiabetic agents or insulin, when the single agent alone, in addition to diet and exercise, does not provide sufficient glycemic control.

Acarbose should be avoided in patients with an estimated glomerular filtration rate (eGFR) less than 25 mL/minute/ 1.73m2. Miglitol should be avoided in patients with an eGFR less than 25 mL/minute/ 1.73m2^1-4.

Metformin should be used cautiously in patients with an eGFR below 60 mL/ minute/1.73m2. Renal function should be closely monitored in patients with an eGFR of 30-59 mL/ minute/1.73m2, with doses decreased by 50% in patients with an eGFR of 30-59 mL/ minute/1.73m2. Metformin doses should be discontinued in patients with an eGFR less than 30 mL/ minute/1.73m2^1,2,5-8.

In moderate renal impairment (CrCl 30 to 59 ml/min), alogliptin dosages should be reduced to 12.5 mg daily, while in patients with severe renal impairment (CrCl less than 30 ml/min), alogliptin dosages should not exceed 6.25 mg daily^1,2,10.

Linagliptin dosages do not need to be adjusted for renal insufficiency. Patients on linagliptin combination therapy with a CrCl less than 30 ml/min may have increased risk of hypoglycemia and may need more frequent monitoring and/or dose adjustments^1,2,11.

Saxagliptin dosages should be reduced to 2.5 mg once daily in patients with CrCl less than 45 ml/min or in patients prescribed a strong CYP3A4 inhibitor (e.g., ketoconazole)^1,2,12.

Sitagliptin dosages should be adjusted in adult patients with renal insufficiency.  Patients with CrCl 30 – 44 ml/min should receive sitagliptin 50 mg daily, while patients with severe renal insufficiency CrCl less than 30 ml/min or those patients with end stage renal disease requiring hemodialysis or peritoneal dialysis should receive sitagliptin 25 mg daily^1,2,13.

Repaglinide should be initiated at a dose of 0.5 mg before each meal in patients with a CrCl between 20-39 mL/min^1,2,18.

Canagliflozin doses in patients with renal impairment should be reduced to 100 mg daily when the estimated glomerular filtration rate (eGFR) is 30-59 ml/min/1.73 m2 and avoided when eGFR is less than 30 ml/min/1.73 m2. Patients may continue up to 100 mg daily of canagliflozin when eGFR is less than 30 ml/min/1.73 m2 if they have albuminuria greater than 300 mg/day^1,2,19.

Dapagliflozin dosages should be adjusted in patients with renal impairment. For patients with an eGFR of 25-44 ml/min/1.73m2 the maximum dose is 10 mg daily. Initiating dapagliflozin in patients with an eGFR less than 25 ml/min/1.73m2 is not recommended. However, patients may continue therapy if eGFR declines to less than 25 ml/min/1.73m2. Dapagliflozin is contraindicated in patients on dialysis^1,2,20.

Empagliflozin therapy should not be initiated in patients with eGFR less than 30 ml/min/1.73m2 for glycemic control if they do not have established cardiovascular disease or cardiovascular risk factors. Studies in patients with heart failure enrolled patients with an eGFR equal to or above 20 ml/min/1.73m2, and there is insufficient data to recommend use in patients with an eGFR below 20 ml/min/1.73m2. Empagliflozin is contraindicated in patients with an eGFR less than 20 ml/min/1.73m2^1,2,21.

Ertugliflozin therapy is not recommended in patients with an eGFR less than 45 mL/min/1.73m2^1,2,22.

Glimepiride should be initiated at 1 mg daily and slowly titrated in patients with renal impairment^1,2,23.

Glyburide should be avoided in patients with renal impairment. If use is necessary, start at 1.25 mg daily conventional glyburide, 0.75 mg daily for micronized glyburide. All sulfonylurea medications should be initiated with caution and at a reduced starting dose to minimize the risk of hypoglycemic events^1,2,23-27.

Administering two or more oral sulfonylureas concurrently is not justified. The concomitant use of two or more oral sulfonylureas will be reviewed.

Combined administration of nateglinide or repaglinide and oral sulfonylureas is not justified as both drug classes stimulate insulin secretion. Adjunctive use of meglitinides and oral sulfonylureas will be reviewed.

The risk of hypoglycemia may increase when acarbose or miglitol is added to pre-existing oral hypoglycemic or insulin therapy. Blood glucose levels should be monitored closely when alpha glucosidase inhibitor therapy is initiated in patients already receiving oral hypoglycemic or insulin therapy.

Adjunctive administration of rosiglitazone and insulin is not recommended as a greater incidence of myocardial ischemic events was observed in clinical trials when rosiglitazone was added to insulin therapy.

Concurrent administration of thiazolidinediones or metformin with sulfonylureas may result in an increased frequency of hypoglycemic episodes. Blood glucose levels should be closely monitored if patients are prescribed thiazolidinediones or metformin and oral sulfonylureas concomitantly, and oral sulfonylurea dosage reductions should be considered.

Concurrent administration DDP-4 inhibitors and sulfonylureas, with or without metformin, have resulted in significant reductions in HbA1c and fasting plasma glucose compared to placebo. The risk of hypoglycemia with DDP-4 inhibitors in combination with metformin and TZDs is comparable to that observed with placebo; however, the incidence of hypoglycemia in patients prescribed DDP-4 inhibitors concurrently with sulfonylureas is greater than that seen with placebo. The incidence of hypoglycemia in patients prescribed DDP-4 inhibitors and insulin concurrently has not been adequately evaluated. Therefore, blood glucose levels should be closely monitored if patients are prescribed DDP-4 inhibitors and oral sulfonylureas or insulin concomitantly, and oral sulfonylurea dosage reductions should be considered.

Concomitant use of multiple SGLT2 inhibitors is not recommended due to similar pharmacologic mechanisms and increased risk of adverse events. Combined administration is not advised and will be reviewed.

The concurrent use of oral semaglutide when combined with an insulin secretagogue, such as a sulfonylurea, or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be reduced by decreasing the dose of the insulin secretagogue or insulin.

Patient profiles will be reviewed to identify those drug regimens, which may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically relevant for oral antidiabetic agents are summarized in Table 13. Only those drug-drug interactions classified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Legend:

• *CP = Clinical Pharmacology

1. Clinical Pharmacology [database online]. Tampa, FL: Elsevier; 2022. Available at: http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed September 6, 2022.
2. IMB Micromedex® DRUGDEX® (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com.libproxy.uthscsa.edu. Accessed September 6, 2022.
3. Acarbose tablets (Acarbose®) package insert. Heritage Pharmaceuticals, Inc., March 2022.
4. Miglitol tablets (Glyset®) package insert. Sun Pharmaceuticals, Inc., January 2020.
5. Metformin Hydrochloride tablets package insert. Ascend Laboratories, February 2017.
6. Metformin extended-release tablets (Fortamet®) package insert. Shionogi, Inc., March 2021.
7. Metformin extended-release tablets (Glumetza®) package insert. Santarus, Inc., August 2019.
8. Metformin oral solution (Riomet®) package insert. Sun Pharmaceutical Industries Inc., December 2018.
9. Colesevelam tablets and packets for oral suspension (Welchol®) package insert. Cosette, October 2021.
10. Alogliptin tablets (Nesina®) package insert. Takeda Pharmaceuticals America, Inc., March 2022.
11. Linagliptin tablets (Tradjenta®) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., April 2022.
12. Saxagliptin tablets (Onglyza®) package insert. AstraZeneca AB, July 2021.
13. Sitagliptin tablets (Januvia®) package insert. Merck & Co., Inc., July 2022.
14. Bromocriptine tablets (Cycloset®) package insert. Santarus, Inc., November 2020.
15. Semaglutide (Rybelsus®) tablets package insert. Novo Nordisk, June 2022.
16. Husain M, Birkenfeld AL, Donsmark M, et al. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. New England Journal of Medicine. 2019;381(9):841-851. 
17. Nateglinide tablets package insert. Modavar Pharmaceuticals, LLC., March 2022.
18. Repaglinide tablets package insert. Aurobindo Pharma Limited, February 2022.
19. Canagliflozin tablets (Invokana®) package insert. Janssen Pharmaceuticals, Inc., November 2021. 
20. Dapagliflozin tablets (Farxiga®) package insert. AstraZeneca, July 2022.
21. Empagliflozin tablets (Jardiance®) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., March 2022.
22. Ertugliflozin tablets (Steglatro®) package insert. Merck Sharp & Dohme, LLC., May 2022.
23. Glimepiride tablets (Amaryl®) package insert. Sanofi Aventis US, LLC, January 2021.
24. Glipizide tablets package insert. Actavis Pharma, Inc., April 2022.
25. Glipizide XL extended-release tablets (Glucotrol® XL) package insert. Roerig, November 2021.
26. Glyburide tablets package insert. Amneal Pharmaceuticals of New York, LLC., December 2019.
27. Glyburide tablets (Glynase®) package insert. Pharmacia and Upjohn Company, LLC., October 2017.
28. Pioglitazone tablets (Actos®) package insert. Takeda Pharmaceuticals North America, Inc., December 2021.
29. Rosiglitazone tablets (Avandia®) package insert. GlaxoSmithKline, February 2019.
30. Alogliptin/metformin hydrochloride tablets (Kazano®) package insert. Takeda Pharmaceuticals America, Inc., March 2022.
31. Alogliptin/pioglitazone hydrochloride tablets (Oseni®) package insert. Takeda Pharmaceuticals America, Inc., March 2022.
32. Canagliflozin/metformin tablets (Invokamet®) and canagliflozin/metformin extended-release tablets (Invokamet® XR) package insert. Janssen Pharmaceuticals, Inc., November 2021.
33. Dapagliflozin/metformin hydrochloride extended-release tablets (Xigduo® XR) package insert. AstraZeneca Pharmaceuticals LP., April 2022.
34. Dapagliflozin/saxagliptin tablets (Qtern®) package insert. AstraZeneca Pharmaceuticals LP., March 2022.
35. Empagliflozin/linagliptin tablets (Glyxambi®) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., March 2022.
36. Empagliflozin/metformin hydrochloride tablets (Synjardy®) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., March 2022.
37. Empagliflozin/metformin hydrochloride extended-release tablets (Synjardy® XR) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., March 2022.
38. Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets (Trijardy® XR) package insert. Boehringer Ingelheim Pharmaceuticals, Inc., June 2021.
39. Ertugliflozin/metformin hydrochloride tablets (Segluromet®) package insert. Merck & Co., Inc., May 2022.
40. Ertugliflozin/sitagliptin phosphate tablets (Steglujan®) package insert. Merck Sharp & Dohme, LLC., June 2022.
41. Glipizide/metformin hydrochloride tablets package insert. Heritage Pharmaceuticals Inc., December 2020.
42. Glyburide/metformin hydrochloride tablets package insert. Actavis Pharma, Inc., May 2020.
43. Linagliptin/metformin hydrochloride tablets (Jentadueto®) package insert.  Boehringer Ingelheim Pharmaceuticals, Inc., April 2022.
44. Linagliptin/metformin hydrochloride extended-release tablets (Jentadueto® XR) package insert.  Boehringer Ingelheim Pharmaceuticals, Inc., October 2021.
45. Glimepiride/pioglitazone tablets (Duetact®) package insert. Takeda Pharmaceuticals America, Inc., December 2021.
46. Metformin hydrochloride/pioglitazone hydrochloride tablets (Actoplus Met®) package insert. Takeda Pharmaceuticals America, Inc., December 2021.
47. Saxagliptin/metformin hydrochloride extended-release tablet (Kombiglyze® XR) package insert. AstraZeneca Pharmaceuticals LP., October 2019.
48. Sitagliptin/metformin hydrochloride (Janumet®) package insert. Merck & Co., Inc., July 2022.
49. Sitagliptin/metformin extended-release tablets (Janumet® XR) package insert. Merck & Co., Inc., July 2022.
50. American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes -2022. Diabetes Care. 2022;45(Suppl. 1):S125–S143.

Attention-deficit/hyperactivity disorder (ADHD) is defined in DSM-V-TR as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development⁴¹ . While many of the approved medications improve inattention, hyperactivity, and impulsivity, symptoms may persist lifelong with less pronounced hyperactivity. Therefore, treatment often lasts well into adulthood, and ADHD is considered a chronic disorder.

The use of two or more psychostimulants concurrently for ADD/ADHD management is not justified. Additional therapeutic benefit is not realized when ADHD stimulant medications are used in combination. Additionally, guanfacine extended-release tablets should not be prescribed concurrently with other guanfacine-containing products due to increased risks of additive pharmacologic/adverse effects, including hypotension. Extended-release guanfacine and extended-release clonidine have supporting evidence and FDA approval for use as adjunctive therapy with stimulant medications. Additionally, there is limited evidence supporting the efficacy and safety of using atomoxetine as adjunctive therapy to stimulant medications in the management of ADHD.42 Patient profiles documenting receipt of multiple ADHD medications or multiple guanfacine-containing products will be reviewed.

Patient profiles will be assessed to identify those drug regimens that may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically significant for ADD/ADHD medications are summarized in Table 7. Only those drug-drug interactions identified as clinical significance level 1 or those considered life-threatening which have not yet been classified will be reviewed.

Legend:

• * CP = Clinical Pharmacology, Micromedex, product labeling

1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2022. Available at:  http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed September 21, 2022.
2. IMB Micromedex® DRUGDEX® (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com.libproxy.uthscsa.edu. Accessed September 21, 2022.
3. Amphetamine mixed salts tablets (Adderall®) package insert. Teva Pharmaceuticals USA, Inc., February 2022.
4. Amphetamine mixed salts extended-release capsules (Adderall XR®) package insert.  Takeda Pharmaceuticals America, Inc., March 2022.
5. Amphetamine mixed salts extended-release capsules (Mydayis®) package insert. Takeda Pharmaceuticals America, Inc., March 2022.
6. Amphetamine extended-release orally disintegrating tablets (Adzenys XR-ODT®) package insert. Neos Therapeutics, Inc., March 2022.
7. Amphetamine extended-release oral suspension (Dyanavel® XR) package insert. Nextwave Pharmaceuticals, Inc., May 2022.
8. Dexmethylphenidate tablets (Focalin®) package insert. Novartis Pharmaceuticals Corp., June 2022.
9. Dexmethylphenidate extended-release capsules (Focalin® XR) package insert. Novartis Pharmaceuticals Corp., June 2021.
10. Dextroamphetamine transdermal system (Xelstrym®) package insert. Noven Therapeutics, LLC., March 2022.
11. Lisdexamfetamine capsule and chewable tablets (Vyvanse®) package insert. Takeda Pharmaceuticals America, Inc., March 2022.
12. Methylphenidate extended release capsules (Adhansia XR®) package insert. Adlon Therapeutics LP, July 2022.
13. Methylphenidate extended-release capsules (Aptensio XR®) package insert.  Rhodes Pharmaceuticals, June 2021.
14. Methylphenidate extended-release tablets (Concerta®) package insert. Janssen Pharmaceuticals, Inc., April 2022.
15. Methylphenidate extended-release capsules (Jornay PM®) package insert. Ironshore Pharmaceuticals, Inc., March 2022.
16. Methylphenidate extended-release capsules (Metadate CD®) package insert. Lannett Company, Inc., April 2022.
17. Methylphenidate extended-release tablets package insert. KVK-Tech, Inc., April 2021.
18. Methylphenidate oral solution (Methylin®) package insert. Shionogi Pharma, Inc., July 2021.
19. Methylphenidate chewable tablets package insert. Camber Pharmaceuticals, Inc., August 2021. 
20. Methylphenidate extended-release tablets (Relexxii®) package insert. Vertical Pharmaceuticals, LLC. November 2021.
21. Methylphenidate tablets (Ritalin®) package insert. Novartis Pharmaceuticals Corp., June 2021.
22. Methylphenidate extended-release capsules (Ritalin LA®) package insert.  Novartis Pharmaceuticals Corp., June 2021.
23. Methylphenidate tablets, extended-release tablets package insert. Ascend Laboratories, LLC., December 2019. 
24. Methylphenidate extended-release chewable tablets (QuilliChew® XR) package insert. NextWave Pharmaceuticals, Inc. June 2021.
25. Methylphenidate extended-release oral suspension (Quillivant® XR) package insert. NextWave Pharmaceuticals, Inc. June 2021.
26. Serdexmethylphenidate and dexmethylphenidate capsules (Azstarys®) package insert. Corium, Inc., May 2022.
27. Atomoxetine (Strattera®) package insert. Eli Lilly and Company, January 2022.
28. Viloxazine extended-release capsules (Qelbree®) package insert. Supernus Pharmaceuticals, Inc., May 2022.
29. Guanfacine extended-release tablets (Intuniv®) package insert. Takeda Pharmaceuticals America Inc., January 2021.
30. Texas Health and Human Services. Psychotropic medication utilization parameters for children and youth in Texas Public Behavioral Health (6th version). June 2019. Accessed September 22, 2022. Available at: https://www.hhs.texas.gov/sites/default/files/documents/doing-business-with-hhs/provider-portal/facilities-regulation/psychiatric/psychotropic-medication-utilization-parameters.pdf.
31. Amphetamine sulfate tablets (Evekeo®) package insert. Arbor Pharmaceuticals. January 2022.
32. Amphetamine sulfate oral disintegrating tablets (Evekeo ODT®) package insert. Arbor Pharmaceuticals. March 2022.
33. Dextroamphetamine tablets package insert. Aurolife Pharma, LLC., January 2022.
34. Dextroamphetamine extended-release capsules (Dexedrine® Spansule) package insert. Amneal Pharmaceuticals, LLC., January 2022.
35. Dextroamphetamine oral solution (ProCentra®) package insert.  Independence Pharmaceuticals, June 2022.
36. Dextroamphetamine tablets (Zenzedi®) package insert. Arbor Pharmaceuticals, LLC, January 2022.
37. Methamphetamine tablets (Desoxyn®) package insert. Key Therapeutics, September 2022.
38. Methylphenidate extended-release orally disintegrating tablets (Cotempla XR-ODT®) package insert. Neos Therapeutics, Inc., July 2021.
39. Methylphenidate transdermal system (Daytrana®) package insert. Noven Pharmaceuticals, June 2021.
40. Clonidine extended-release tablets (Kapvay®) package insert. Concordia Pharmaceuticals, Inc., August 2021.
41. Diagnostic and Statistical Manual of Mental Disorders: DSM-5-TR. 5th ed., American Psychiatric Association, 2022.
42. Wolraich ML, Hagan JF, Allan C, et. al. Subcommittee on Children and Adolescents with Attention-Deficit/Hyperactive Disorder; clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. October 2019; 144 (4): e20192528. 10.1542/peds.2019-2528.

Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • Oct. 13, 2023
  • Oct. 22, 2021
  • Sept. 2019
• Initially developed
  • Sept. 2017

If the patient is tolerating the LAI atypical antipsychotic, then there is no basis for limiting treatment length for approved psychiatric disorders as schizophrenia, schizoaffective disorder, and bipolar I disorder are chronic, lifelong diseases ^1-13.

Co-administration of two or more LAI atypical antipsychotics is not justified due to limited additional therapeutic benefit and increased risk of adverse effects ^1-13.

Patient profiles containing concomitant prescriptions for two or more LAI atypical antipsychotics will be reviewed.

Patient profiles will be assessed to identify those drug regimens which may result in clinically significant drug-drug interactions. Drug-drug interactions considered clinically relevant for LAI atypical antipsychotics are summarized in Table 6. Only those drug-drug interactions classified as clinical significance of severe  or those considered life-threatening which have not yet been classified will be reviewed ^1-13.

1. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www-micromedexsolutions-com.libproxy.uthscsa.edu/ (cited:  September 11, 2023).
2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2023. Available at:  http://clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed September 11, 2023.
3. Paliperidone palmitate extended-release injection suspension (Invega® Sustenna®) package insert. Janssen Pharmaceuticals, July 2022.
4. Aripiprazole intramuscular extended-release injection (Abilify Asimtufii®) package insert. Otsuka America Pharmaceutical, Inc., August 2023.
5. Aripiprazole intramuscular extended-release injection (Abilify Maintena®) package insert. Otsuka America Pharmaceutical, Inc., February 2023.
6. Risperidone long-acting injection (Risperdal Consta®) package insert. Janssen Pharmaceuticals, Inc., February 2021.
7. Risperidone extended-release intramuscular microsphere injection (Rykindo®) package insert. Shandong Luye Pharmaceutical Co., ltd., May 2023.
8. Risperidone extended-release subcutaneous injection (Uzedy®) package insert. Teva Pharmaceuticals, Inc., May 2023.
9. Aripiprazole lauroxil intramuscular extended-release injection (Aristada®) package insert. Alkermes, Inc., March 2021.
10. Aripiprazole lauroxil intramuscular extended-release (Aristada Initio®) package insert. Alkermes, Inc., March 2021.
11. Olanzapine extended release injectable suspension (Zyprexa® Relprevv™) package insert. Eli Lilly and Company, November 2021.
12. Paliperidone palmitate extended-release injection suspension (Invega Hafyera®) package insert. Janssen Pharmaceuticals, August 2021.
13. Paliperidone palmitate extended-release suspension (Invega Trinza®) package insert. Janssen Pharmaceuticals, August 2021.
14. Risperidone long-acting injection (Perseris®) package insert. Indivior Inc., December 2022.
15. The Parameters Workgroup of the Psychiatric Executive Formulary Committee, Health and Specialty Care Division, Texas Health and Human Services Commission. Psychotropic medication utilization parameters for children and youth in Texas public behavioral health (6th version). (June 2019) Available at: https://hhs.texas.gov/sites/default/files/documents/doing-business-with-hhs/provider-portal/facilities-regulation/psychiatric/psychotropic-medication-utilization-parameters.pdf. Accessed September 17, 2023. 

Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Texas Vendor Drug Program formulary coverage.

• Revision history
  • Oct. 13, 2023
  • Oct. 22, 2021
  • Sept. 2019
  • Sept. 2017
  • Sept. 2015
  • Dec. 2013
  • Feb. 2012
  • June 2010
  • May 2010
  • March 2007
  • Dec. 2006
  • Oct. 2006
  • May 2003
  • April 2002
  • April 2001
  • April 2000
  • March 1999
  • March 1998
• Initially developed
  • Feb. 1997