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: Austedo (deutetrabenazine) tablet Cystagon (cysteamine bitartrate) Estring (estradiol) vaginal ring Fiasp (insulin aspart) subcutaneous solution Fiasp FlexTouch (insulin aspart) subcutaneous solution pen-injector Kyleena (levonorgestrel) intrauterine device Central Nervous System/ Huntington's Disease Agents Metabolic/ Miscellaneous Metabolic/ Estrogens/ Vaginal Metabolic/ Antidiabetics/ Insulins Metabolic/ Antidiabetics/ Insulins Metabolic/ Austedo is indicated for the treatment of: Chorea associated with Huntington s disease Tardive dyskinesia in adults. Cystagon is indicated for the management of nephropathic cystinosis in children and adults. Estring is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Fiasp is indicated to improve glycemic control in adults with diabetes mellitus. Fiasp is indicated to improve glycemic control in adults with diabetes mellitus. Kyleena is indicated for prevention of pregnancy for up to 5 years. To provide an additional option for the treatment of chorea associated with Huntington s disease and tardive dyskinesia. To provide an option for the management of nephropathic cystinosis. To provide an additional option for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. To provide an additional insulin option to improve glycemic control in adults with diabetes mellitus. To provide an additional insulin option to improve glycemic control in adults with diabetes mellitus. To provide an additional option for the prevention of pregnancy A Pg. 1 of 9

2 Mirena (levonorgestrel) intrauterine device Odomzo (sonidegib) Skyla (levonorgestrel) intrauterine device Tolak (fluorouracil) cream Contraceptives/ Progestin Intrauterine Devices Metabolic/ Contraceptives/ Progestin Intrauterine Devices Antineoplastic Agents/ Miscellaneous Metabolic/ Contraceptives/ Progestin Intrauterine Devices Topical/ Dermatology/ Actinic Keratosis Mirena is indicated for: Intrauterine contraception for up to 5 years Treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception. Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Skyla is indicated for prevention of pregnancy for up to 3 years. Tolak is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. To provide an additional option for the prevention of pregnancy. To provide an option for the treatment of advanced basal cell carcinoma. To provide an additional option for the prevention of pregnancy. To provide an additional option for the treatment of actinic keratosis lesions A Pg. 2 of 9

3 Trelegy Ellipta (fluticasone furoate/umeclidinium/vilant erol) aerosol powder for inhalation Generic Agents: lanthanum carbonate chewable tablet oseltamivir, powder for suspension Respiratory/ Anticholinergic / Beta Agonist/ Steroid Inhalant Combinations Metabolic/ Phosphate Binder Agents Anti-Infectives/ Antivirals/ Influenza Agents Trelegy Ellipta is indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. Lanthanum carbonate is indicated to reduce serum phosphate in patients with end stage renal disease (ESRD). Oseltamivir is indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours To provide an additional option for the maintenance treatment of COPD. To provide an additional generic option to reduce serum phosphate levels. To provide a generic option for the treatment and prophylaxis of influenza A and B A Pg. 3 of 9

4 paroxetine mesylate sevelamer carbonate powder for suspension, tablet sodium phenylbutyrate tablet, powder DELETIONS: Brand Agents: Prophylaxis of influenza A and Central Nervous System/ Psychotherapeutic - Miscellaneous/ Vasomotor Symptom Agents Metabolic/ Phosphate Binder Agents Metabolic/ Urea Cycle Disorders/ Metabolic Modifiers B in patients 1 year and older. Paroxetine mesylate is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. Sevelamer carbonate is indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. Sodium phenylbutyrate is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders (UCDs) involving deficiencies of several specific enzymes. To provide a non-hormonal generic option for the treatment of moderate to severe vasomotor symptoms associated with menopause. To provide an additional generic option for the control of serum phosphorus. To provide a generic option for the management of urea cycle disorders A Pg. 4 of 9

5 Brisdelle (paroxetine mesylate) Juxtapid (lomitapide mesylate) Renvela (sevelamer carbonate) powder for suspension, tablet Tamiflu (oseltamivir) Central Nervous System/ Psychotherapeutic - Miscellaneous/ Vasomotor Symptom Agents Cardiovascular/ Antilipemics/ Microsomal Triglyceride Transfer Protein Inhibitors Metabolic/ Phosphate Binder Agents Anti-Infectives/ Antivirals/ Influenza Agents Brisdelle is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause. Juxtapid is indicated as an adjunct to a low-fat diet and other lipidlowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-hdl- C) in patients with homozygous familial hypercholesterolemia (HoFH). Renvela is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Tamiflu is indicated for: Treatment of acute, uncomplicated influenza A Availability of a non-hormonal generic option for the treatment of moderate to severe vasomotor symptoms associated with menopause. is paroxetine mesylate. Availability of an additional option for the treatment of homozygous familial hypercholesterolemia. is Repatha (evolocumab). Availability of additional options for control of serum phosphorus. include calcium acetate, lanthanum carbonate, sevelamer carbonate, Phoslyra (calcium acetate), and Velphoro (sucroferric oxyhydroxide). Availability of additional options for the treatment and prophylaxis of influenza A and B A Pg. 5 of 9

6 Tamiflu (oseltamivir) powder for suspension REMOVALS: Brand Agents: Alevicyn (emollient) gel Anti-Infectives/ Antivirals/ Influenza Agents and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours Prophylaxis of influenza A and B in patients 1 year and older. Tamiflu is indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours Prophylaxis of influenza A and B in patients 1 year and older. include oseltamivir and Relenza (zanamivir). Availability of a generic option for the treatment and prophylaxis of influenza A and B. is oseltamivir. Topical/ Dermatology/ Wound Care s Alevicyn gel is intended for management of itch and pain associated with dermal irritations Availability of generic options for the management of itch and pain associated with dermal irritations and wounds A Pg. 6 of 9

7 Alevicyn (emollient) dermal spray Alevicyn Antipruritic SG (emollient) liquid Topical/ Dermatology/ Wound Care s Topical/ Dermatology/ Wound Care s and wounds, such as sores, injuries and ulcers of dermal tissue. Alevicyn dermal spray is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, firstand second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. Alevicyn Antipruritic SG is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. Alevicyn Antipruritic SG may also be used to relieve the pain of first and second degree burns. Alevicyn Antipruritic SG helps to include desonide and hydrocortisone. Availability of generic options for cleansing, irrigation, moistening, debridement and removal of foreign material from wounds. include desonide and hydrocortisone. Availability of generic options to manage and relieve the burning, itching and pain experienced with various types of dermatoses include desonide and hydrocortisone A Pg. 7 of 9

8 Buphenyl (sodium phenylbutyrate) tablet, powder Liletta (levonorgestrel) intrauterine device Procysbi (cysteamine bitartrate) delayedrelease Ravicti (glycerol phenylbutyrate) liquid relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Metabolic/ Urea Cycle Disorders/ Metabolic Modifiers Metabolic/ Contraceptives/ Progestin Intrauterine Devices Metabolic/ Lysosomal Storage Disorders Metabolic/ Urea Cycle Disorders/ Metabolic Modifiers Buphenyl is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of several specific enzymes. Liletta is indicated for prevention of pregnancy for up to 4 years. Procysbi is indicated for the treatment of nephropathic cystinosis in adult and pediatric patients 2 years of age and older. Ravicti is indicated for use as a nitrogen-binding agent for chronic management of patients 2 months of age and older with urea cycle disorders (UCDs) who cannot be managed by dietary protein Availability of a generic option for the management of urea cycle disorders. is sodium phenylbutyrate. Availability of additional intrauterine device options for the prevention of pregnancy. include Kyleena (levonorgestrel), Mirena (levonorgestrel), and Skyla (levonorgestrel). Availability of another option for the management of nephropathic cystinosis. is Cystagon (cysteamine bitartrate). Availability of a generic option for the management of urea cycle disorders. is sodium phenylbutyrate A Pg. 8 of 9

9 Serevent (salmeterol xinafoate) aerosol powder for inhalation Tivorbex (indomethacin) Vivlodex (meloxicam) restriction and/or amino acid supplementation alone. Respiratory/ Beta Agonists, Inhalants/ Long Acting/ Hand-held Active Inhalation Analgesics/ NSAIDs Analgesics/ NSAIDs Serevent is indicated for: Treatment of asthma in patients aged 4 years and older Prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Tivorbex is indicated for treatment of mild to moderate acute pain in adults. Vivlodex is indicated for management of osteoarthritis pain. Availability of another option for the maintenance treatment of bronchospasm associated with COPD. is Striverdi Respimat (olodaterol). Availability of generic options for the treatment of mild to moderate acute pain. include celecoxib, diclofenac sodium, ibuprofen, meloxicam, and naproxen. Availability of generic options for the management of osteoarthritis pain. include celecoxib, diclofenac sodium, ibuprofen, meloxicam, and naproxen A Pg. 9 of 9

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