New Products to Market

Transcription

1 Fee-for-Service Pharmacy Provider Notice #222 **Preferred Drug Status Changes** December 01, 2017 Dear Kentucky Medicaid Provider: As we bring 2017 to a close, below is a recap of the new products to market and a summary of the drug classes that had a change in status for the Kentucky Medicaid Fee-For-Service (FFS) Pharmacy Preferred Drug List (). With regard to drug class changes, the Existing Drug Classes chart below includes a brief description of the actual changes. The listing is based on recommendations and guidance as adopted by the Commissioner of the Department for Medicaid Services of the Cabinet for Health and Family Services. Please refer to the posted ( for the complete list of products and their status. On January 2, 2018, the following changes will be effective: New Products to Market Drugs Requiring PA Zembrace TM SymTouch TM Vraylar TM Zembrace TM SymTouch TM Non-prefer in class: Antimigraines, Triptans Injection, for subcutaneous use is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for: Acute treatment of migraine, with or without, aura in adults. Is there any reason that the patient cannot be switched to a preferred medication? Document the details. Acceptable reasons include: - Adverse reaction to all preferred drugs; - Allergy to all preferred drugs; or - Contraindication to all preferred drugs. Has the patient had a documented therapeutic trial and treatment failure with ALL preferred drugs? If so, document the details. Sumatriptan generic products are covered without PA; clinical reason as to why sumatriptan generic products cannot be used. Quantity Limit = 8 units per month (to match all other pens/cartridges) Vraylar TM Non-prefer in the class: Antipsychotics Vraylar (cariprazine) capsules, for oral use, indicated for: Acute treatment of manic or mixed episodes associated with bipolar I disorder OR treatment of schizophrenia. Page 1 of 13

2 Drugs Requiring PA Zepatier TM Adzenys XR-ODT TM Dyanavel TM XR Has a diagnosis of schizophrenia or acute treatment of manic or mixed episodes associated with bipolar I disorder. Had a failed 14-day trial of BOTH risperidone and 1 other atypical antipsychotic (i.e., Seroquel, Abilify, Clozaril, Invega, Zyprexa, Geodon, HIC3 H7T or H7X) OR medical justification why a trial is not appropriate. Minimum Age = 18 years of age or older Quantity Limit = 1 per day Zepatier TM Non-prefer in class: Hepatitis C Agents Length of Authorization: depends upon regimen Zepatier TM (elbasvir and grazoprevir) tablets, for oral use, is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotypes 1 or 4 infection in adults. Indicated with or without ribavirin for treatment of chronic HCV genotypes 1 or 4 infection in adults. Must supply proof of genotypes 1 or 4 along with documentation of F3 or F4 fibrosis score. Documentation of Readiness to Treat is also required. Test patients with HCV genotype 1a infection for the presence of virus with NS5A resistance associated polymorphisms prior to initiation of treatment with Zepatier to determine dosage regimen and duration. Zepatier is contraindicated in patients with moderate hepatic impairment (Child- Pugh B) and in patients with severe hepatic impairment (Child-Pugh C). Must supply documentation of Child-Pugh classification. Minimum age = 18 years Maximum Quantity Limit = 1 per day Adzenys XR-ODT TM Non-prefer in class: Stimulants & Related Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablets), CII, is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Is there any reason that the patient cannot be switched to a preferred medication? Document the details: - Adverse reaction to preferred drugs - Allergy to preferred drugs - Contraindication to preferred drugs Has the patient had a therapeutic trial and treatment failure with TWO preferred drugs? Document the details. Patient has a swallowing disorder and cannot be given tablets or capsules. Minimum age = 6 years Quantity Limit = 1 per day Dyanavel TM XR Non-prefer in class: Stimulants & Related Dyanavel XR (amphetamine) extended-release oral suspension, CII, is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Page 2 of 13

3 Drugs Requiring PA Is there any reason that the patient cannot be switched to a preferred medication? Document the details: - Adverse reaction to preferred drugs - Allergy to preferred drugs - Contraindication to preferred drugs Has the patient had a therapeutic trial and treatment failure with TWO preferred drugs? Document the details. Patient has a swallowing disorder and cannot be given tablets or capsules. QuilliChew ER TM Viberzi Xtampza ER Minimum age = 6 years Quantity Limit = 20 mg/d (2.5mg/mL) QuilliChew ER TM Non-prefer in the class: Stimulants & Related QuilliChew ER (methylphenidate hydrochloride) extended-release chewable tablets, for oral use, CII: QuilliChew ER is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Is there any reason that the patient cannot be switched to a preferred medication? Document the details: - Adverse reaction to preferred drugs - Allergy to preferred drugs - Contraindication to preferred drugs Has the patient had a therapeutic trial and treatment failure with TWO preferred drugs? Document the details. Quillivant XR and Methylin Chewable Tablets are covered as preferred; clinical reason as to why Quillivant XR and Methylin Chewable Tablets cannot be used. Minimum age = 6 years Quantity Limit = 1 per day (1QAM) Viberzi Clinical Review Clarification of criteria regarding covered antidiarrheals: This agent was initially reviewed as a new product to market during the March 17, 2016 P&T meeting. The Committee voted at that time to table discussion over to the May 19, 2016 agenda and to include step therapy in the revised criteria. Below is the criteria as reviewed at the May 19, 2016 P&T meeting: Non-prefer in the class: GI Motility, Chronic Length of Authorization: 1 Year The safety and effectiveness of Viberzi have not been established in pediatric patients. Indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS- D). Trial and failure of two (2) covered antidiarrheals. (RX: loperamide or diphenoxylate/atropine. OTC: loperamide) Quantity Limit = 2 tablets per day. Xtampza ER Non-prefer in the class: Analgesics Narcotics, Long-Acting, or expected duration of therapy if less than 6 months. Xtampza ER (oxycodone extended-release capsule) is an opioid agonist product indicated for the management of pain severe enough to require daily, around-the- Page 3 of 13

4 Onzetra Xsail Nuplazid Drugs Requiring PA clock, long-term opioid treatment and for which alternative treatment options are inadequate. Trial and failure of two different preferred long-acting narcotics; OR Is there any reason that the patient cannot be switched to a preferred medication? Document the details. Acceptable reasons include: Adverse reaction to preferred drugs Allergy to preferred drugs Contraindication to preferred drugs Must have no history of opioid abuse or illicit drug use within the past 365 days, OR; Patient has current history of extended-release oxycodone use for previous opioid dependence and requires chronic pain management. Quantity Limit = 3 per day for the 9 mg, 13.5 mg, 18 mg, and 27 mg capsules. Quantity Limit = 8 per day for the 36 mg capsules. Maximum Daily Dosage = 288 mg Onzetra Xsail Non-prefer in the class: Anti-Migraine: 5-HT1 Receptor Agonists (Antimigraines, Triptans) Onzetra Xsail (sumatriptan succinate nasal powder) is a serotonin 5-HT1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. It is 11 mg per nosepiece, there are 2 nosepieces per dose; 22 mg is the full dose. This is not an inhaler or spray; the patient is to blow through the mouth into the piece which propels the powder into the nostril. Is there any reason that the patient cannot be switched to a preferred medication? Document the details. Acceptable reasons include: Adverse reaction to all preferred drugs Allergy to all preferred drugs Contraindication to all preferred drugs Documented therapeutic trial and treatment failure with ALL preferred drugs. Sumatriptan generic oral and vial; Imitrex Nasal; and Imitrex Pen and Cartridge are covered without PA; clinical reason as to why sumatriptan generic oral and vial; Imitrex Nasal; and Imitrex Pen and Cartridge cannot be used. Quantity Limit = 16 doses per 30 days (2 kits; each kit has 8 doses) Nuplazid - Non-prefer in the class: Second-Generation Antipsychotics (Antipsychotics) Nuplazid (pimavanserin) tablet for oral use is a Selective Serotonin 5-HT2A Inverse Agonist/antagonist (SSIA). It is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson s disease psychosis. Must have diagnosis of Parkinson s Disease; AND Trial of dose adjustment or withdrawal of antiparkinson s medications prior to treatment with this agent, (ex; anticholinergics, amantadine, dopamine agonists, COMT inhibitors, selegiline) because these are known to cause hallucinations. Quantity Limit = 2 tablets per day (60 tablets per 30 days) Page 4 of 13

5 Drugs Requiring PA Bevespi Aerosphere TM Zinbryta TM Bevespi Aerosphere TM - Non-prefer in the class: COPD Agents Bevespi Aerosphere TM (glycopyrrolate and formoterol) is indicated for the long-term maintenance treatment of airflow obstruction in patients with Chronic Obstructive Pulmonary Disease (COPD) including chronic bronchitis and/or emphysema. Must have diagnosis of COPD; AND Documentation of spirometry measurement; AND Must not use the medication for asthma or relief of acute symptoms or be using other LABAs (long acting beta adrenergics); AND Must have rescue therapy on file. Quantity Limit: 1 canister per 30 days Zinbryta TM Non-prefer in class: Multiple Sclerosis Agents Zinbryta TM (daclizumab) is a self-injectable subcutaneous injection of an interleukin-2 receptor blocking antibody indicated for use in adults with relapsing form of multiple sclerosis. Must have documentation of relapsing form of multiple sclerosis (MS) as documented by laboratory report; (e.g. MRI) AND Must have documentation of trial and failure of at least 2 other drugs indicated for the treatment of MS (due to safety profile, try other agents first); AND Must have no history of hepatic impairment (ALT & AST < 2 times ULN) or disease; AND Documentation of baseline transaminases and bilirubin levels and confirmation that levels will be checked monthly; AND Documentation of negative Tb (tuberculosis), Hep B, and Hep C screening. Quantity Limit: 1 syringe (150mg) per 28 days. Page 5 of 13

6 Venclexta Alecensa Drugs Requiring PA Venclexta Non-prefer in class: Oral Oncology, Hematologic Cancer (Oncology Oral Hematologic) Venclexta (venetoclax) tablet for oral use is a BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. Available as a starter pack for the first 4 weeks followed by 4 x 100mg tablets orally per day. Diagnosis of Chronic Lymphocytic Leukemia (CLL); AND Prescriber to submit lab work documenting 17p deletion as detected by an FDA approved test; AND Must have received at least one prior therapy for the treatment of CLL and has either relapsed or developed progressive disease; AND Is assessed for risk of tumor lysis syndrome; AND Is not receiving a strong CYP3A Inhibitor. Quantity Limit = Starter Pack (42 tablets per 28 days one time fill) Then 120 tablets per 30 days thereafter. Maximum Daily Dosing = 400mg Alecensa Non-prefer in class: Oral Oncology, Lung Cancer (Oncology Oral Lung) Alecensa (alectinib) 150 mg capsules is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori ). Must have a diagnosis of metastatic non-small cell lung cancer; AND Must have anaplastic lymphoma kinase (ALK) mutation-positive NSCLC as confirmed by an FDA approved test; AND Must have an intolerance to, or has disease progression while on crizotinib (Xalkori ) Quantity Limit = 8 capsules per day (600 mg twice daily) Tagrisso Tagrisso Non-prefer in the class: Oral Oncology, Lung Cancer (Oncology Oral Lung) Tagrisso (osimertinib) is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy. Available as 40 mg and 80 mg tablets. (The 40 mg tablet is reserved for those who need dose modifications due to adverse effects.) Must have a diagnosis of metastatic non-small cell lung cancer; AND Prescriber must submit lab work documenting the T790M mutation as detected by an FDA-approved test; AND Must have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy (erlotinib, gefitinib, or afatinib). Page 6 of 13

7 Drugs Requiring PA Quantity Limit = 1 tablet per day Cabometyx Cabometyx - Prefer in class: Oral Oncology, Renal Cell Carcinoma (Oncology Oral Renal) Cabometyx (cabozantinib) is a kinase inhibitor, available as 20mg, 40mg, or 60mg tablet. Indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Must have diagnosis of advanced renal cell carcinoma; AND Patient has received prior antiangiogenic therapy; AND Not have severe hepatic impairment (Child-Pugh Class C) Quantity Limit = 2 tablets per day (60mg per day is the recommended dosing) Maximum Daily Dosing = 80 mg per day Cotellic Qbrelis TM Byvalson TM Cotellic - Non-prefer in the class: Oral Oncology, Skin Cancer (Oncology Oral Skin) Cotellic (cobimetinib) 20 mg tablets, indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. Must have diagnosis of unresectable or metastatic melanoma with V600E or V600K mutations in the BRAF gene as determined by an FDA approved diagnostic test; AND Prescriber to submit lab work documenting this mutation; AND Must be used with vemurafenib (Zelboraf ). Quantity Limit = 63 tablets per 28 days with one fill allowed every 28 days Non-prefer in class: Angiotensin Receptor Blockers (Angiotensin Modulators) Qbrelis (lisinopril) oral solution is indicated for the treatment of hypertension in adults and pediatric patients > 6 years old, as adjunct therapy for systolic heart failure in adults, and for reduction of mortality in acute myocardial infarction (AMI) in adults. Approval : 6-17 years of age; AND Have diagnosis of hypertension; AND Have egfr > 30 ml/min/1.73m2; AND Not be able to take an oral capsule or tablet. OR Patient must not be pregnant; AND > 18 years of age; AND Have diagnosis of heart failure, acute myocardial infarction, or hypertension; AND Not be able to take an oral capsule or tablet. Quantity Limit = adults: 40 mg per day; pediatrics mg per kg per day or 40 mg per day, whichever is lower (to be determined during the clinical review of the PA request). Non-prefer in the class: Angiotensin Modulator + Combinations (Angiotensin Modulator Combinations) Page 7 of 13

8 Drugs Requiring PA Zurampic Relistor, Oral Epclusa Byvalson (nebivolol/valsartan) is the combination of a beta-blocker and an angiotensin II receptor blocker (ARB) available as a 5 mg/ 80 mg tablet. It is indicated for the treatment of hypertension (HTN). Approval : Patient has had a trial and failure of 2 first-line HTN therapies comprised of multiple single agents used in combination (e.g., Calcium Channel Blocker [CCB] + Angiotensin Converting Enzyme Inhibitor [ACEI]). Quantity Limit = 1 tablet per day Non-prefer in class: Antihyperuricemics Zurampic (lesinurad) 200 mg tablets are indicated for use in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone. Approval : 18 years of age; AND Have symptomatic hyperuricemia associated with gout; AND Have documented trial and failure of xanthine oxidase inhibitor monotherapy at maximum tolerated dose; AND Using lesinurad in combination with a xanthine oxidase inhibitor; AND Patient does not have severe renal impairment (CrCl < 45 ml/min), ESRD, kidney transplant, or is on dialysis; AND Patient does not have tumor lysis syndrome or Lesch-Nyhan syndrome. Quantity Limit = 1 tablet per day Non-prefer in class: GI Motility Agents (GI Motility, Chronic) Relistor (methylnaltrexone bromide) tablets are indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. Approval : 18 years of age; AND Patient does not have known or suspected mechanical gastrointestinal obstruction; AND If patient is female, must not currently be breastfeeding; AND Response to standard laxative therapy is inadequate (<3 bowel movements in preceding 7 days). Standard therapy is defined as routine, scheduled use of 3 or more of the following: Dietary changes Stool softeners Stimulant laxatives Osmotic or saline laxatives Bulk forming laxatives Lubricants Quantity Limit = 3 tablets per day Prefer in class: Hepatitis C Agents; Direct-Acting Antivirals Prefer for Genotypes 2 and 3 ONLY. Length of Authorization: 12 weeks Page 8 of 13

9 Otovel TM Drugs Requiring PA Epclusa (sofosbuvir/velpatasvir) 400 mg/100 mg tablets is a fixed-dose combination of a nucleotide analog NS5B polymerase inhibitor (sofosbuvir) and an NS5A inhibitor (velpatasvir) indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection, with or without compensated cirrhosis, or with decompensated cirrhosis in combination with ribavirin. All class criteria must be met for approval. Quantity Limit: 28 tablets per 28 days. Non-prefer in class: Otic Antibiotics Length of Authorization: 7 days Otovel TM (ciprofloxacin/fluocinolone acetonide) solution, for otic use, is a combination of an antibacterial and a corticosteroid. Each single-dose vial contains ciprofloxacin 0.3% along with fluocinolone acetonide 0.025%. Otovel solution is indicated for the treatment of acute otitis media with tympanostomy tubes in pediatric patients aged 6 months and older due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. Approval : Patient > 6 months of age; AND Diagnosis of acute otitis media; AND Patient has tympanostomy tubes; AND Patient does not have a viral infection of the external ear canal or any fungal otic infection. Existing Drug Classes Drug Class Acne Agents, Topical Anticonvulsants will remain preferred products: will become preferred products: Retin-A cream, gel carbamazepine extended-release (Generic Carbatrol ) Tegretol suspension Tegretol XR will become non-preferred products and require prior authorization (PA): Tretinoin cream, gel Sulfacetamine/sulfur cleanser Briviact QL Carbamazepine suspension carbamazepine extended-release Carbatrol will remain non-preferred products and require prior authorization (PA): Topical Antifungal Agents (Antifungals, Topical) clotrimazole/betamet hasone cream Page 9 of 13

10 Drug Class Minimally Sedating Antihistamines (Antithistamines, Minimally Sedating) will remain preferred products: will become preferred products: cetirizine RX 5mg/5mL solution levocetirizine tablets will become non-preferred products and require prior authorization (PA): will remain non-preferred products and require prior authorization (PA): cetirizinepseudoephedrine OTC cetirizine OTC capsules and solution Topical Antiparasitic Agents (Antiparasitics, Topical) Natroba Eurax Sklice spinosad Antipsychotics Antivirals, Oral Topical Antiviral Agents (Antivirals, Topical) Aripiprazole ODT, solution CC, QL *Note: Grandfathering allowed for those who were taking either of these formulations prior to the status change. Zovirax susp Acyclovir susp Zovirax cream acyclovir ointment Zovirax ointment Cytokine & CAM Antagonists Self-Injectable Epinephrine (Epinephrine, Self- Injectable) epinephrine 0.3 mg QL epinephrine 0.15 mg QL Taltz CC QL See Complete List on Posted N/A Growth Hormone Immunosuppressa nts Oral CellCept susp Nutropin CC mycophenolate mofetil susp Intranasal Antihistamines, Anticholinergics, Corticosteroids (Intranasal Rhinitis Agents) Nasonex QL Page 10 of 13

11 Drug Class will remain preferred products: Lipotropics, Statins will become preferred products: will become non-preferred products and require prior authorization (PA): amlodipine/atorvastati n QL will remain non-preferred products and require prior authorization (PA): Multiple Sclerosis Agents Avonex QL Extavia QL Gilenya CC,QL Oncology Oral - Other Ophthalmics, Antihistamines, Mast-Cell Stabilizers (Ophthalmics, Allergic Conjunctivitis) Ophthalmics, Antibiotic-Steroid Combinations Cometriq QL Caprelsa QL Pazeo Blephamide S.O.P. Pred-G Pred-G S.O.P. Ophthalmics NSAIDs, Anti- Inflammatory Steroids (Ophthalmics, Anti- Inflammatories) Ophthalmics Immunomodulator (Ophthalmics, Anti- Inflammatories, Immunomodulator s) Ophthalmics Beta- Blockers, Carbonic Anhydrase Inhibitors, Combinations, Direct-Acting Miotics, Prostaglandin Agonists, Sympathomimetics (Ophthalmics, Glaucoma) Otic Antibiotics Durezol Flarex XiidraTM CC, QL See pilocarpine Betimol apraclonidine ciprofloxacin 0.2% ofloxacin 0.3% solution Complete List on Posted Page 11 of 13

12 Drug Class will remain preferred products: will become non-preferred will become preferred products and require prior products: authorization (PA): will remain non-preferred products and require prior authorization (PA): Phosphate Binders Phoslyra RenvelaTM tablet Fosrenol powder pack Steroids Topical High Medium Low Very High Hydrocortisone lotion Betamethasone dipropionate ointment Fluocinonide ointment Hydrocortisone butyrate soln, cream, oint Topical Rosacea Agents (Rosacea Agents, Topical) MetroCream MetroGel metronidazole cream, gel Note: The Existing Drug Classes chart reflects products where a preference/status change occurred during the year. Please refer to the posted ( for the complete list of products and their status. Please visit the provider web portal at Also, please contact Magellan Medicaid Administration at kyproviders@magellanhealth.com for any additional information or questions you may have regarding this notice. Thank you for your continued commitment to the health and wellness of Kentuckians throughout the Commonwealth! We look forward to the new year and our continued partnership. Sincerely, Noah Greenberg, PharmD, CSP, MBA Noah Greenberg, PharmD, CSP, MBA Clinical Pharmacy Manager kyproviders@magellanhealth.com Kentucky Medicaid Fee-for-Service Pharmacy Program s Contact Information Please contact the Clinical Support Center to request a Clinical Support Center PA or to check the status of a request. NOTE: The only Sunday Saturday 24 hours a day drugs that are now required to be submitted via fax are Brand Medically Necessary, Buprenorphine products, Synagis, and Zyvox. Please contact the Pharmacy Support Center when Pharmacy Support Center claims assistance is required. Timely filing, lock-in, and Sunday Saturday 24 hours a day Page 12 of 13

13 Kentucky Medicaid Fee-for-Service Pharmacy Program s Contact Information early refill (ER) overrides can be obtained through this call center. Provider Services Monday Friday 8:00 am 4:30 pm Member Services Monday Friday 8:00 am 5:00 pm Please contact Provider Services if you have questions about enrollment or when updating your license or bank information. Please contact Member Services if you are a member or if you as the provider have questions regarding the member s benefits or eligibility coverage dates. Page 13 of 13