April 26, 2019
Summary of Proposed Clinical Prior Authorizations New Business • Arikayce (amikacin) oral inhalation suspension • Presentation of new criteria • Hereditary Angioedema (HAE) Agents • Requesting addition of agents used for acute attacks to current criteria • Requesting addition of Takhzyro, a new agent for prophylaxis, to current criteria • Inhaled Antibiotic Agents • Presentation of new criteria • SGLT2 Inhibitors • Presentation of new criteria • Urea Cycle Disorder Prior Authorization Criteria • Presentation of new criteria These classes were recommended for review by MCOs and/or the Vendor Drug Program to ensure appropriate and safe utilization.
Arikayce (amikacin) oral inhalation suspension Clinical Prior Authorization Proposal
Arikayce (amikacin) • Arikayce is an inhaled aminoglycoside indicated in adults for treatment of Mycobacterium avium complex (MAC) lung disease • Should be used as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. • Arikayce is for use in adults who have limited or no alternative treatment options. Has been approved under accelerated approval (based on patients achieving sputum culture conversion by month 6), but clinical benefit has not yet been established • The recommended dose is once daily inhalation of the contents of one 590mg/8.4mL vial • Approximate cost for a box of 28 vials is $12,197 ($435.61 per vial)* • Costs shown do not include any rebates that might be applicable. *Arikayce. In: Red Book Online. Greenwood Village (CO): Truven Health Analytics; 2019 [cited 2019 Apr 26]. Available from www.micromedexsolutions.com.
Guidelines for the treatment of MAC lung disease ATS/IDSA Guidelines* (2007) • Treatment of MAC pulmonary disease: • For most patients with nodular/bronchiectatic disease: Three-times-weekly regimen of clarithromycin (1000mg) or azithromycin (500mg), rifampin (600mg) and ethambutol (25mg/kg) is recommended • For patients with fibrocavitary MAC lung disease or severe nodular/bronchiectactic disease: Daily regimen of clarithromycin (500-1000mg) or azithromycin (250mg), rifampin (600mg) or rifabutin (150-300mg) and ethambutol (15mg/kg). Should consider three-times-weekly amikacin or streptomycin IV early in therapy • Patients should be treated until culture negative on therapy for 1 year *American Thoracic Society/Infectious Diseases Society of America Griffith DE, Aksamit T, Brown-Elliott BA, et al. An Official ATS/IDSA Statement: Diagnosis, Treatment and Prevention of Nontuberculous Mycobacterial Diseases. Am J Respir Crit Care Med. 2007;175:367-416.
Guidelines for the treatment of MAC lung disease British Thoracic Society (2017) • Treatment of MAC pulmonary disease: • Clarithromycin-sensitive MAC pulmonary disease should be treated with rifampin, ethambutol and clarithromycin or azithromycin using an intermittent (three times per week) or daily oral regimen (Grade D) • An intermittent regimen should not be used in individuals with severe disease or a history of treatment failure (Grade D) • An injectable aminoglycoside (amikacin or streptomycin) should be considered in individuals with severe disease (Grade D) • Clarithromycin-resistant disease should be treated with rifampin, ethambutol and isoniazid or a quinolone, and consider an injectable aminoglycoside. (Grade D) • Nebulized amikacin may be considered in place of an injectable aminoglycoside (Grade D) • Macrolide monotherapy or macrolide/quinolone dual therapy should not be used (Grade D) • Antibiotic treatment should continue for a minimum of 12 months after culture conversion (Grade D) Haworth CS, Banks J, Capstick T, et al. British Thoracic Society guidelines for the management of non- tuberculous mycobacterial pulmonary disease (NTM-PD). Thorax 2017;72:1-64.
Arikayce Clinical PA Proposal Approval Criteria: • Age ≥ 18 years • Diagnosis of MAC lung disease in the last 730 days • 180 days therapy with at least 2 drugs recommended for initial treatment of MAC • Concurrent therapy with at least 2 drugs recommended for treatment of MAC
HAE Agents Clinical Prior Authorization Proposal
HAE Agents • Berinert, Firazyr, Kalbitor and Ruconest are indicated for the treatment of acute HAE attacks • Takhzyro is indicated for the prevention of HAE attacks • Costs: • Berinert: $3546 per kit • Firazyr: $12,987 per 30mg vial (max dose is 90mg/24 hours) • Kalbitor: $17,205 per 30mg dose (max dose is 60mg/24 hours) • Ruconest: $7158 per 2100 unit dose (max dose is 8400 units/24 hours) • Takhzyro: $52,968 per month (normal dose is 300mg sub-q every 2 weeks) • Costs shown do not include any rebates that might be applicable. Berinert, Firazyr, Kalbitor, Ruconest and Takhzyro. In: Red Book Online. Greenwood Village (CO): Truven Health Analytics; 2019 [cited 2019 Apr 26]. Available from www.micromedexsolutions.com.
HAE Agents Utilization TX Medicaid HAE Agents Data* Calendar Year 2018 Total Number of Claims 69 Number of Unique Clients 13 Total Annual Cost $3,896,932** Average Cost per Claim $56,477** *Includes both FFS and MCO data **Costs displayed do not contain any rebates that may be applied
Guidelines for the treatment of Hereditary Angioedema JTFPP* (2013) • Recommend all patients have access to at least 2 standard doses of medication for on-demand treatment of acute HAE attacks – all available agents have been shown to be safe and efficacious for the treatment of acute HAE attacks (A) • Standard angioedema treatment modalities, such as epinephrine, steroids or antihistamines do not have a significant effect on the swelling in patients with HAE (C) • Patients should be considered for long-term prophylaxis based on attack frequency, severity, comorbid conditions and access to emergent treatment. (D) • Treatment with replacement plasma-derived C1-INH provides effective and safe long- term HAE prophylaxis (A) *Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma and Immunology. Zuraw BL, Banerji A, Bernstein JA, et al. US Hereditary Angioedema Association Medical Advisory Board 2013 Recommendations for the Management of Hereditary Angioedema Due to C1 Inhibitor Deficiency. J Allergy Clin Immunol 2013;1(5):458-4467.
Guidelines for the treatment of Hereditary Angioedema WAO/EAACI* (2017) • Recommend that all attacks are considered for on-demand treatment and that any attack affecting the upper airway is treated (Grade D, Strong) • Recommend that HAE attacks are treated with either C1-INH, ecallantide or icatibant (Grade A, Strong) • Recommend that all patients have sufficient medication for on-demand treatment of two attacks and carry on-demand medication at all times (Grade D, Strong) • Recommend that patients be evaluated long-term prophylaxis be considered at every visit (Grade D, Strong) • Recommend use of C1-inhibitor for first line long term prophylaxis (Grade A, Strong) • Recommend C1-INH be used for the treatment of HAE attacks in children under the age of 12 (Grade C, Strong) *World Allergy Organization/European Academy of Allergy and Clinical Immunology Maurer M, Magerl M, Ansotegui I, et al. The international WAO/EAACI guideline for the management of hereditary angioedema – the 2017 revision and update. World Allergy Org J 2018;11:5.
HAE Clinical PA Proposal Approval Criteria: • Client meets age requirements • Stable therapy (defined as 2 claims for the requested agent in the last 180 days), OR a diagnosis of HAE in the last 730 days.
HAE Agents Utilization Texas Medicaid HAE Agents Data* Calendar Year 2018 Data Description Number of Unique Patients Client < 18 years of age (Firazyr) 1 Client < 13 years of age (Ruconest) 1 Client < 5 years of age (Berinert) 0 No diagnosis of HAE found in the last 730 days 2 *Includes both FFS and MCO data
Inhaled Antibiotics Clinical Prior Authorization Proposal
Inhaled Antibiotic Agents • Bethkis, Cayston, Kitabis, Tobi, Tobi Podhaler and inhaled tobramycin are the agents included in this criteria proposal • These agents are recommended for adult and pediatric patients with cystic fibrosis that have Pseudomonas aeruginosa • Recommended that these agents be used for 28 days on and 28 days off • Costs: • Bethkis: $7423/28 days • Cayston: $10,755/28 days • Tobi: $8805/28 days • Tobi Podhaler: $12,164/28 days • Inhaled tobramycin solution: $7211/28 days • Costs shown do not include any rebates that might be applicable. Bethkis, Cayston, Tobi, Tobi Podhaler and inhaled tobramycin solution. In: Red Book Online. Greenwood Village (CO): Truven Health Analytics; 2019 [cited 2019 Apr 26]. Available from www.micromedexsolutions.com.
Inhaled Antibiotic Agents Utilization TX Medicaid Inhaled Antibiotic Agents Data* Calendar Year 2018 Total Number of Claims 4484 Number of Unique Clients 1155 Total Annual Cost $22,292,498** Average Cost per Claim $4972** *Includes both FFS and MCO data **Costs displayed do not contain any rebates that may be applied
Recommend
More recommend
