Advanced Control Formulary Change Summary Report Effective

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1 This report highlights all changes (additions, deletions, and removals) to the CVS Caremark Advanced Control Formulary. ADDITIONS: Brand Agents: Mepron (atovaquone) suspension Mydayis (amphetaminedextroamphetamine) extended-release capsule Orfadin (nitisinone) capsule, suspension Anti-Infectives/ Miscellaneous Central Nervous System/ Attention Deficit Hyperactivity Disorder Endocrine and Metabolic/ Hereditary Tyrosinemia Type 1 Agents/ Metabolic Modifiers Mepron is indicated for: Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprimsulfamethoxazole (TMP-SMX) Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. Mydayis is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. Orfadin is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with To provide an option for the prophylaxis and treatment of Pneumocystis jirovecii pneumonia (PCP). To provide an additional option for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). To provide an option for the treatment of hereditary tyrosinemia type 1 (HT-1) A Pg. 1 of 10

2 Ozempic (semaglutide) subcutaneous solution Generic Agents: alosetron diclofenac sodium gel 1% transdermal gel efavirenz capsule, dietary restriction of tyrosine and phenylalanine. Endocrine and Metabolic/ Antidiabetics/ Incretin Mimetic Agents Gastrointestinal/ Irritable Bowel Syndrome Analgesics/ NSAIDs, Topical Anti-Infectives/ Antiretroviral Agents/ Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alosetron is indicated only for women with severe diarrheapredominant irritable bowel syndrome (IBS) who have: Chronic IBS symptoms (generally lasting 6 months or longer), Had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and Not responded adequately to conventional therapy. Diclofenac sodium gel 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Efavirenz is indicated in combination with other antiretroviral To provide an additional option to improve glycemic control in adults with type 2 diabetes mellitus. To provide a generic option for the treatment of severe diarrhea-predominant irritable bowel syndrome (IBS). To provide an additional generic option for the treatment of joint pain. To provide an additional generic option for the treatment of HIV A Pg. 2 of 10

3 ethinyl estradioldrospirenonelevomefolate linezolid, suspension, intravenous injection Non-Nucleoside Reverse Transcriptase Inhibitors Endocrine and Metabolic/ Contraceptives/ Monophasic Anti-Infectives/ Miscellaneous agents for the treatment of human immunodeficiency virus (HIV) type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg. Ethinyl estradiol-drospirenonelevomefolate is indicated for use by women to: Prevent pregnancy Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control Raise folate levels in women who choose to use an oral contraceptive for contraception. Linezolid is indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia To provide an additional generic contraceptive option. To provide a generic option for the treatment of certain infections caused by susceptible Gram-positive bacteria A Pg. 3 of 10

4 rasagiline testosterone gel 1% transdermal gel Community-acquired pneumonia Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis Uncomplicated skin and skin structure infections Vancomycin-resistant Enterococcus faecium infections. Central Nervous System/ Antiparkinsonian Agents Endocrine and Metabolic/ Androgens Rasagiline is indicated for the treatment of Parkinson s disease. Testosterone is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) Hypogonadotropic hypogonadism. To provide an additional generic option for the treatment of Parkinson s disease. To provide an additional generic option for the treatment of hypogonadism A Pg. 4 of 10

5 DELETIONS: Brand Agents: Azilect (rasagiline) Central Nervous System/ Antiparkinsonian Agents Azilect is indicated for the treatment of Parkinson s disease. Availability of additional generic options for the treatment of Parkinson s disease. Beyaz (ethinyl estradioldrospirenonelevomefolate) Endocrine and Metabolic/ Contraceptives/ Monophasic Beyaz is indicated for use by women to: Prevent pregnancy Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control Raise folate levels in women who choose to use an oral contraceptive for contraception. include rasagiline and selegiline. Availability of additional contraceptive options. include ethinyl estradiol-drospirenone, ethinyl estradioldrospirenone-levomefolate, Lo Loestrin Fe (norethindrone acetate/ee 1/10 and EE 10 and iron), Minastrin 24 Fe (norethindrone acetate/ee 1/20 and iron chewable), and Safyral (drospirenone/ee/levomefolate 3/30 and levomefolate) A Pg. 5 of 10

6 Lotronex (alosetron) Sivextro (tedizolid) Sustiva (efavirenz) capsule, Gastrointestinal/ Irritable Bowel Syndrome Anti-Infectives/ Miscellaneous Anti-Infectives/ Antiretroviral Agents/ Non- Nucleoside Reverse Transcriptase Inhibitors Lotronex is indicated only for women with severe diarrheapredominant irritable bowel syndrome (IBS) who have: Chronic IBS symptoms (generally lasting 6 months or longer), Had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and Not responded adequately to conventional therapy. Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria in adults. Sustiva is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg. Availability of additional options for the treatment of severe diarrhea-predominant irritable bowel syndrome (IBS). include alosetron and Viberzi (eluxadoline). Availability of a generic option for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria in adults. The preferred option on the Advanced Control Formulary is linezolid. Availability of additional non-nucleoside reverse transcriptase inhibitor options for the treatment of HIV. include efavirenz and Edurant (rilpivirine) A Pg. 6 of 10

7 Voltaren Gel (diclofenac sodium gel 1%) transdermal gel REMOVALS: Brand Agents: Adzenys XR-ODT (amphetamine) extended-release disintegrating Analgesics/ NSAIDs, Topical Voltaren Gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Availability of additional generic options for the treatment of joint pain. include diclofenac sodium, diclofenac sodium gel 1%, diclofenac sodium solution, ibuprofen, meloxicam, and naproxen. Central Nervous System/ Attention Deficit Hyperactivity Disorder Adzenys XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Availability of additional options for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). include amphetaminedextroamphetamine mixed salts ext-rel, dexmethylphenidate ext-rel, dextroamphetamine ext-rel, methylphenidate ext-rel, Mydayis (amphetaminedextroamphetamine mixed salts ext-rel), Quillivant XR (methylphenidate ext-rel), and Vyvanse (lisdexamfetamine) A Pg. 7 of 10

8 Aptensio XR (methylphenidate) extended-release capsule Bystolic (nebivolol) Contrave (naltrexonebupropion) extendedrelease Central Nervous System/ Attention Deficit Hyperactivity Disorder Cardiovascular/ Beta- Blockers Endocrine and Metabolic/ Antiobesity/ Oral Aptensio XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Bystolic is indicated for the treatment of hypertension, to lower blood pressure. Contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m 2 or greater (obese), or 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related Availability of additional options for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). include amphetaminedextroamphetamine mixed salts ext-rel, dexmethylphenidate ext-rel, dextroamphetamine ext-rel, methylphenidate ext-rel, Mydayis (amphetaminedextroamphetamine mixed salts ext-rel), Quillivant XR (methylphenidate ext-rel), and Vyvanse (lisdexamfetamine). Availability of additional beta-blocker options to lower blood pressure. include atenolol, carvedilol, metoprolol succinate ext-rel, metoprolol tartrate, nadolol, propranolol, and propranolol ext-rel. Availability of additional options for weight management. include Belviq (lorcaserin), Belviq XR (lorcaserin ext-rel), and Saxenda (liraglutide) A Pg. 8 of 10

9 Fragmin (dalteparin) subcutaneous solution Namenda XR (memantine) extendedrelease capsule Pexeva (paroxetine mesylate) comorbidity (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). Hematologic/ Anticoagulants/ Injectable Central Nervous System/ Antidementia Central Nervous System/ Antidepressants/ Fragmin is indicated for: Prophylaxis of ischemic complications of unstable angina and non-q-wave myocardial infarction Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in patients with cancer. Namenda XR is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Pexeva is indicated for the treatment of: Availability of a generic option for the prophylaxis and treatment of certain blood clots and/or ischemic complications associated with angina or heart attacks. The preferred option on the Advanced Control Formulary is enoxaparin. Availability of a generic option for the treatment of dementia of the Alzheimer s type. The preferred option on the Advanced Control Formulary is memantine. Availability of additional options for the treatment of Major Depressive Disorder (MDD), Obsessive A Pg. 9 of 10

10 SynerDerm (emollient) emulsion Advanced Control Formulary Change Selective Serotonin Reuptake Inhibitors (SSRIs) Topical/ Dermatology/ Emollients Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Generalized Anxiety Disorder (GAD). SynerDerm is indicated for the management and relief of burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. Uloric (febuxostat) Analgesics/ Gout Uloric is indicated for the chronic management of hyperuricemia in patients with gout. Vanatol LQ (butalbitalacetaminophen-caffeine) solution Analgesics/ Non-Opioid Analgesics Vanatol LQ is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Compulsive Disorder (OCD), Panic Disorder (PD), Generalized Anxiety Disorder (GAD), and Premenstrual Dysphoric Disorder (PMDD). include citalopram, escitalopram, fluoxetine, paroxetine HCl, paroxetine HCl ext-rel, sertraline, Trintellix (vortioxetine), and Viibryd (vilazodone). Availability of additional generic options for managing and relieving the burning and itching experienced with various types of skin conditions, including atopic and allergic contact dermatitis. include desonide and hydrocortisone. Availability of a generic option for the treatment of gout. The preferred option on the Advanced Control Formulary is allopurinol. Availability of additional generic options for the relief of tension headache. include diclofenac sodium, ibuprofen, and naproxen A Pg. 10 of 10

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