April 26, 2019 Summary of Proposed Clinical Prior Authorizations - - PowerPoint PPT Presentation

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

• f 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
• f 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

*Includes both FFS and MCO data **Costs displayed do not contain any rebates that may be applied

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**

Guidelines for the treatment of Hereditary Angioedema

JTFPP* (2013)

• Recommend all patients have access to at least 2 standard doses of medication for
• n-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) 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

*Includes both FFS and MCO data **Costs displayed do not contain any rebates that may be applied

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**

Guidelines for the treatment of Pseudomonas aeruginosa in Cystic Fibrosis Patients Cystic Fibrosis Foundation (CFF) (2013)

• For individuals with CF, moderate to severe lung disease and

Pseudomonas aeruginosa persistently present in cultures of the airways, the CF Foundation recommends:

• Inhaled tobramycin (A)
• Inhaled aztreonam (A)
• For individuals with CF, mild lung disease and P. aeruginosa

persistently present in cultures of the airways, the CF Foundation recommends:

• Inhaled tobramycin (B)
• Inhaled aztreonam (B)

Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic Fibrosis Pulmonary Guidelines: Chronic Medications for Maintenance of Lung Health. Am J Respir Crit Care Med 2013;187(7):680-689.

Inhaled Antibiotic Agents Clinical PA Proposal

Approval Criteria:

• Client meets age requirements
• Diagnosis of cystic fibrosis found in the last 730 days

Inhaled Antibiotic Agents Utilization

Texas Medicaid Inhaled Antibiotic Agents Data* Calendar Year 2018 Data Description Number of Unique Patients Client < 6 years of age 358 No diagnosis of cystic fibrosis found in the last 730 days 743

*Includes both FFS and MCO data

SGLT2 Inhibitors Clinical Prior Authorization Proposal

SGLT2 Inhibitors

• Farxiga, Invokana, Jardiance and Steglatro are included in this criteria

proposal

• These agents are indicated for use in patients with type 2 diabetes
• Not recommended for use in patients with severe renal impairment
• Costs:
• Farxiga: $591/month
• Invokana: $593/month
• Jardiance: $591/month
• Steglatro: $338/month
• Costs shown do not include any rebates that might be applicable.

Farxiga, Invokana, Jardiance and Steglatro. In: Red Book Online. Greenwood Village (CO): Truven Health Analytics; 2019 [cited 2019 Apr 26]. Available from www.micromedexsolutions.com.

Recommendations for the Treatment of Diabetes

American Association of Clinical Endocrinologists (AACE) (2018)

1. Entry A1C < 7.5%, start with monotherapy: metformin, GLP-1 RA, SGLT-2i, DPP-4i or TZDs. If patient is not at goal in 3 months, proceed to dual

• therapy. Note: metformin is recommended first-line.

2. If patient doesn’t meet goal on monotherapy, or entry A1C ≥ 7.5%, use metformin plus another first-line agent (GLP-1 RA, SGLT-2i, DPP-4i or TZDs). If patient is not at goal in 3 months, proceed to triple therapy. 3. If patient doesn’t meet goal on dual therapy, or entry A1C > 9% (without symptoms), use metformin plus a first-line agent plus a second-line agent. If patient is not at goal in 3 months, proceed to insulin therapy. 4. If patient doesn’t meet goal on triple therapy or if entry A1C > 9% (with symptoms), patient should proceed to insulin therapy (other agents may be added to regimen if needed)

Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2018 Executive Summary. Endocr Pract. 2018 Jan;24(1):91-120.

Recommendations for the Treatment of Diabetes

American Diabetes Association (ADA) (2018)

1. If A1C is < 9%, consider monotherapy. If A1C is ≥ 9%, consider dual therapy. If A1C is ≥ 10%, blood glucose is ≥ 300 mg/dL or patient is markedly symptomatic, consider combination injectable therapy 2. Metformin, if not contraindicated, is the preferred initial pharmacological agent 3. If monotherapy at maximum tolerated dose does not achieve or maintain the A1C target over 3 months, add a second oral agent. a) If the patient has ASCVD, add an agent proven to reduce major adverse cardiovascular events and cardiovascular mortality (currently empagliflozin and liraglutide). b) If the patient does not have ASCVD, consider adding a sulfonylurea, TZD, DPP-4i, SGLT-2i, GLP-1 RA or basal insulin. 4. If dual therapy does not achieve A1C target over 3 months, a third agent can be added 5. If triple therapy does not achieve A1C target after 3 months, patient should try metformin plus basal insulin 6. If initial injectable therapy does not achieve A1C target, patient can try metformin plus basal insulin plus mealtime insulin OR can add a GLP-1 RA to metformin and basal insulin

American Diabetes Association. Standards of Medical Care in Diabetes-2018. Diabetes Care. January 2018;41(1):S1-S159.

SGLT2 Inhibitor Agents Clinical PA Proposal

Approval Criteria:

• Age ≥ 18 years of age
• Diagnosis of type 2 diabetes found in the last 730 days
• No diagnosis of severe renal impairment, ESRD or dialysis

found in the last 365 days

• Daily dose ≤ 1 tablet

Urea Cycle Disorder Agents Clinical Prior Authorization Proposal

Urea Cycle Disorder (UCD) Agents Utilization

• Buphenyl (brand and generic), Carbaglu and Ravicti are included in this

criteria proposal

*Includes both FFS and MCO data **Costs displayed do not contain any rebates that may be applied

TX Medicaid UCD Agents Data* Calendar Year 2018 Total Number of Claims 492 Number of Unique Clients 50 Total Annual Cost $17,739,707** Average Cost per Claim $36,056**

UCD Agents Clinical PA Proposal

Approval Criteria:

• Diagnosis of urea cycle disorder found in the last 730 days

UCD Agents Utilization

Texas Medicaid UCD Agents Data* Calendar Year 2018 Data Description Number of Unique Patients No diagnosis of urea cycle disorder found in the last 730 days 4

*Includes both FFS and MCO data

Questions?