Advanced Control Formulary Change Summary Report Effective

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Dorcas Taylor
5 years ago
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1 This report highlights all changes (additions, deletions, and removals) to the CVS Caremark Advanced Control Formulary. ADDITIONS: Brand Agents: Ajovy (fremanezumabvfrm) subcutaneous injection Aristada Initio (aripiprazole) extendedrelease intramuscular injectable suspension Dupixent (dupilumab) 200 mg/1.14 ml subcutaneous injection Emgality (galcanezumab-gnlm) subcutaneous injection Lokelma (sodium zirconium cyclosilicate) Migraine/ Monoclonal Antibodies Antipsychotics/ Atypicals Respiratory/Severe Asthma Agents Migraine/ Monoclonal Antibodies Potassium Removing Agents Ajovy is indicated for the preventive treatment of migraine in adults. Aristada Initio, in combination with oral aripiprazole, is indicated for the initiation of Aristada when used for the treatment of schizophrenia in adults. Dupixent 200 mg/1.14 ml is indicated as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Emgality is indicated for the preventive treatment of migraine in adults. Lokelma is indicated for the treatment of hyperkalemia in adults. To provide an additional option for the preventive treatment of migraine in adults. To provide an option for the loading dose initiation of Aristada when used for the treatment of schizophrenia in adults. To provide an additional option for the treatment of moderateto-severe asthma. To provide an additional option for the preventive treatment of migraine in adults. To provide an additional option for the treatment of hyperkalemia in adults A Pg. 1 of 10

2 oral powder for suspension Mulpleta (lusutrombopag) Orilissa (elagolix) Retacrit (epoetin alfaepbx) intravenous/ subcutaneous solution for injection Hematologic/ Thrombocytopenia Agents Endometriosis Hematologic/ Hematopoietic Growth Factors Mulpleta is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Orilissa is indicated for the management of moderate to severe pain associated with endometriosis. Retacrit is indicated for: Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis o Zidovudine in patients with HIV-infection o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Reduction of allogeneic RBC transfusions in patients undergoing elective, To provide an option for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. To provide an option for the management of moderate to severe pain associated with endometriosis. To provide an additional erythropoiesis-stimulating agent option A Pg. 2 of 10

3 Sensipar (cinacalcet) Generic Agents: abiraterone noncardiac, nonvascular Calcium Receptor Antagonists Antineoplastic Agents/ Hormonal Antineoplastic Agents/ Antiandrogens surgery. Sensipar is indicated for the treatment of: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis Hypercalcemia in adult patients with parathyroid carcinoma (PC) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. Abiraterone is indicated in combination with prednisone for the treatment of patients with: Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castrationsensitive prostate cancer (CSPC). To provide an option for the management of secondary hyperparathyroidism and hypercalcemia in specific circumstances. To provide an additional generic option for the treatment of metastatic castration-resistant or high-risk castration-sensitive prostate cancer A Pg. 3 of 10

4 budesonide ext-rel extended-release tablet fludrocortisone hydrocortisone liothyronine Gastrointestinal/ Inflammatory Bowel Disease/ Oral Agents Glucocorticoids Glucocorticoids Thyroid Agents/Thyroid Supplements Budesonide ext-rel is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Fludrocortisone acetate is indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome. Hydrocortisone is primarily used for its potent anti-inflammatory effects in disorders of many organ systems. Liothyronine is indicated for the following: As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis As pituitary thyroid-stimulating hormone (TSH) suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid To provide an additional generic option for the induction of remission in patients with active, mild to moderate ulcerative colitis. To provide a generic option for replacement therapy in Addison's disease and for the treatment of salt-losing adrenogenital syndrome. To provide an additional generic glucocorticoid option. To provide an additional generic thyroid supplement option A Pg. 4 of 10

5 luliconazole topical cream pyridostigmine extended-release tablet tadalafil vardenafil nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto s) and multinodular Topical/ Dermatology/ Antifungals Myasthenia Gravis Cardiovascular/ Pulmonary Arterial Hypertension/ Phosphodiesterase Inhibitors Genitourinary/ Erectile Dysfunction/ Phosphodiesterase Inhibitors goiter As diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy. Luliconazole is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. Pyridostigmine is useful in the treatment of myasthenia gravis. Tadalafil is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Vardenafil is indicated for the treatment of erectile dysfunction. To provide an additional generic option for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis. To provide an additional generic option for the treatment of myasthenia gravis. To provide an additional generic option for the treatment of pulmonary arterial hypertension. To provide an additional generic option for the treatment of erectile dysfunction A Pg. 5 of 10

6 DELETIONS: Brand Agents: Atralin (tretinoin) topical gel Estrace Cream (estradiol) vaginal cream Luzu (luliconazole) topical cream Topical/ Dermatology/ Acne/ Topical Estrogens/ Vaginal Topical/ Dermatology/ Antifungals Atralin is indicated for topical treatment of acne vulgaris. Estrace is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Luzu is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. Availability of other options for the treatment of acne vulgaris. include adapalene, benzoyl peroxide, clindamycin solution, clindamycin-benzoyl peroxide, erythromycin solution, erythromycin-benzoyl peroxide, tretinoin, Differin Cream (adapalene), Differin Gel 0.3% (adapalene), Differin Lotion (adapalene), Epiduo (adapalene-benzoyl peroxide), Retin- A Micro (tretinoin gel microsphere), and Tazorac (tazarotene). Availability of other options for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. include estradiol, Estring (estradiol), and Premarin Cream (conjugated estrogens). Availability of other options for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis. include ciclopirox, clotrimazole, econazole, ketoconazole, luliconazole, oxiconazole, and Naftin (naftifine) A Pg. 6 of 10

7 Mestinon Timespan (pyridostigmine ext-rel) oral extended-release tablet Uceris (budesonide extrel) extended-release tablet REMOVALS: Brand Agents: Epogen (epoetin alfa) intravenous/ subcutaneous solution for injection Myasthenia Gravis Gastrointestinal/ Inflammatory Bowel Disease/ Oral Agents Mestinon Timespan is useful in the treatment of myasthenia gravis. Uceris is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Availability of a generic option for the treatment of myasthenia gravis. The preferred option on the Advanced Control Formulary is pyridostigmine ext-release. Availability of other options for the induction of remission in patients with active, mild to moderate ulcerative colitis. include balsalazide, budesonide-ext-rel, sulfasalazine, sulfasalazine delayed-rel, Apriso (mesalamine ext-rel), Lialda (mesalamine delayed-rel), and Pentasa (mesalamine ext-rel). Hematologic/ Hematopoietic Growth Factors Epogen is indicated for: Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis o Zidovudine in patients with HIV-infection Availability of other erythropoiesis-stimulating agents for the treatment on anemia and reduction of allogeneic RBC transfusions in specific conditions. include Aranesp (darbepoetin alfa) and Retacrit (epoetin alfaepbx) A Pg. 7 of 10

8 Procrit (epoetin alfa) intravenous/ subcutaneous solution for injection Hematologic/ Hematopoietic Growth Factors o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Procrit is indicated for: Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis o Zidovudine in patients with HIV-infection o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Availability of other erythropoiesis-stimulating agents for the treatment on anemia and reduction of allogeneic RBC transfusions in specific conditions. include Aranesp (darbepoetin alfa) and Retacrit (epoetin alfaepbx) A Pg. 8 of 10

9 Zytiga (abiraterone) Generic Agents: benzonatate 150mg oral capsule (NDC only) butalbitalacetaminophen MG oral capsule (NDC only) chlorzoxazone 250 mg (NDC only) Antineoplastic Agents/ Hormonal Antineoplastic Agents/ Antiandrogens Respiratory/ Antitussives Analgesics/Nonopioid Analgesics Musculoskeletal Therapy Agents Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Zytiga is indicated in combination with prednisone for the treatment of patients with: Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castrationsensitive prostate cancer (CSPC). Benzonatate is indicated for the symptomatic relief of cough. Butalbital and acetaminophen is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of Availability of other options for the treatment of metastatic castration-resistant or high-risk castration-sensitive prostate cancer. include abiraterone, bicalutamide, and Xtandi (enzalutamide). Availability of another option for the symptomatic relief of cough. The preferred option on the Advanced Control Formulary is benzonatate (except NDC ). Availability of generic options for the relief of tension headache. include diclofenac sodium, ibuprofen, and naproxen. Availability of other options for the relief of discomfort associated with acute, painful musculoskeletal conditions A Pg. 9 of 10

10 diclofenac sodium gel 1% topical gel (NDC only) hydrocortisone 1% in absorbase topical ointment (NDCs , only) Analgesics/NSAIDS, Topical Topical/Dermatology/Corti costeroids/low Potency discomfort associated with acute, painful musculoskeletal conditions. Diclofenac topical 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. Hydrocortisone in absorbase is for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. include carisoprodol, chlorzoxazone (except NDC ), cyclobenzaprine, metaxalone, methocarbamol, and orphenadrine-aspirin-caffeine. Availability of other options for the treatment of joint pain. include diclofenac sodium, diclofenac sodium gel 1% (except NDC ), diclofenac sodium solution, ibuprofen, meloxicam, and naproxen. Availability of other low potency corticosteroids for the relief of inflammatory and pruritic conditions. include desonide and hydrocortisone A Pg. 10 of 10

Drug Class Prior Authorization Criteria Erythropoiesis Stimulating Agents (ESAs)

Drug Class Prior Authorization Criteria Erythropoiesis Stimulating Agents (ESAs) Line of Business: Medicaid P & T Approval Date: May 16, 2018 Effective Date: July 1, 2018 This policy has been developed