Drug Prior Authorization Guideline NUCALA (mepolizumab)

Transcription

1 Drug Prior Authorization Guideline MB9914 Covered Service: Prior Authorization Required: Additional Information: Yes when meets criteria below Yes as shown below Restricted to Pulmonology, Allergy, and Immunology Specialists with prior authorization through Navitus Prevea360 Health Plan Approved Criteria: 1.0 Diagnosis of eosinophilic asthma with all of the following: 1.1 Age 12 years or older; and 1.2 Documented blood eosinophil count of one of the following: cells/mm 3 at therapy initiation (within 4 weeks of therapy initiation); OR cells/mm 3 in the previous 12 months; and 1.3 Ruled out other causes of eosinophilia such as hypereosinophilic syndromes, neoplastic disease, or parasitic disease; and 1.4 Persistent airflow obstruction as indicated by one of the following: For members 18 years of age, a pre-bronchodilator FEV1 <80% predicted; or For members years of age, a pre-bronchodilator FEV1 <90% predicted or FEV1:FVC ratio < 0.8; and 1.5 FEV1 reversibility of at least 12% and 200 ml after albuterol administration; and 1.6 Patient has failed 3 month trial of high-dose inhaled corticosteroids (see Table 1 below) in combination with a long-acting bronchodilator or leukotriene modifier; and 1.7 Patient is not a current smoker or has received smoking cessation counseling; and 1.8 Symptoms are not well-controlled or poorly controlled based on ONE of the following: Patient must meet at least one of the measures in Table 2 (see below); OR 1 of 5

2 1.8.2 Has experienced 2 exacerbations in the previous 12 months requiring additional medical treatment (oral corticosteroids, emergency department or urgent care visits, or hospitalizations); and 1.9 One of the following: Patient is adherent to standard therapy; OR Patient adherence to standard therapy is suboptimal but is being addressed through consultation or training by clinic staff, and is documented in the medical record and presented during the request; and 1.10 Will not be used in combination with XOLAIR (omalizumab) or CINQAIR (reslizumab); and 1.11 Dose is within the FDA labeled dose 2.0 Diagnosis of eosinophilic granulomatosis with polyangitis (EGPA) requires the following: 2.1 Age 18 years or older TABLE 1. High Dose Corticosteroids Drug Beclomethasone HFA 40 or 80 mcg/puff Budesonide DPI 90, 180, or 200 mcg/inhalation Budesonide inhaled Inhalation for suspension Ciclesonide HFA 80 or 160 mcg Flunisolide HFA 80 mcg/puff Fluticasone HFA/MDI: 44, 110 mcg/puff DPI: 50, 100, 250 mcg/inhalation Mometasone DPI 200 mcg/inhalation High Daily Dose (Adult) > 480 mcg > 1200 mcg N/A > 640 mcg > 640 mcg > 440 mcg > 500 mcg > 400 mcg TABLE 2. Outcome Measure Values for Uncontrolled Asthma Measure Not well controlled Poorly controlled Baseline symptoms (outside of exacerbation) > 2 days/week Throughout the day Nighttime awakening 1-3 times/week 4 times/week Interference with normal activity Some limitation Extremely limited Short acting beta agonist use of symptom control > 2 days/week Several times per day 2 of 5

3 Measure Not well controlled Poorly controlled FEV1 Asthma exacerbations requiring oral steroids 2 times in the past 12 months 60-80% predicted or personal best Yes < 60% predicted or personal best Yes Asthma Control Test (ACT) Comment(s): 1.0 Prevea360 Health Plan considers all other indications and conditions from those listed above as experimental and investigational and are not covered, including (but not limited to: 1.1 Severe allergic asthma (without documentation of severe eosinophilia) 1.2 Use in combination with other anti-asthma monoclonal antibodies, including XOLAIR (omalizumab), CINQAIR (reslizumab), or FASENRA (benralizumab) 1.3 Eosinophilic esophagitis 1.4 Atopic dermatitis 1.5 Nasal polyposis 1.6 Other eosinophilic conditions, such as hypereosinophilic syndrome, allergic granulomatosis 2.0 Initial coverage for 6 months (subject to formulary changes) 3.0 May be authorized in quantities up to: 3.1 For asthma: 100mg every 28 days 3.2 For EGPA: 300mg as 3 separate 100mg injections once every 4 weeks 4.0 Renewal (additional 12 months, subject to formulary changes) requires the prescriber to provide clinical documentation from an office visit in the preceding 6 months showing response to mepolizumab therapy such as: 4.1 Decreased frequency of use, or ability to lower the chronic daily dose, of oral corticosteroids to treat/prevent exacerbations 4.2 Decreased frequency of use of unscheduled emergency department / urgent care visits for exacerbations 4.3 Decreased oral steroid bursts for exacerbations 4.4 Reduction in reported symptoms such as chest tightness, coughing, shortness of breath, or nocturnal awakenings 4.5 Sustained (at least six months) improvement in Asthma Control Test (ACT) scores 3 of 5

4 4.6 FOR EGPA: Decreased EGPA symptoms and/or improved patient quality of life 5.0 Documentation is expected to be maintained in the patient s medical record and to be available to Prevea360 Health Plan. Every page of the record is expected to be legible and include both the appropriate patient identification information (e.g., complete name dates of service(s)), and information identifying the physician or non-physician practitioner responsible for and providing the care of the patient. The patient's medical record must contain documentation that fully supports the medical necessity for services. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. 5.1 The medical record must include the following information: A physician's order The name of the drug or biological administered The route of administration The dosage (e.g., mgs, mcgs, cc's or IU's) When a portion of the drug or biological is discarded, the medical record must clearly document the amount administered and the amount wasted or discarded. 6.0 Coding specifications* *Codes and descriptors listed below are provided for informational purposes only and may not be all inclusive or current. Listing of a code in this drug policy does not imply that the service described by the code is a covered or non-covered service. Benefit coverage for any service is determined by the member s policy of health coverage with Prevea360 Health Plan, Inc. Inclusion of a code in the table below does not imply any right to reimbursement or guarantee claim payment. Other drug or medical policies may also apply. 6.1 NDC and HCPCS codes Medication Name How Supplied National Drug Brand Generic Code (NDC) HCPCS code NUCALA mepolizumab 100mg/vial single dose vial J NOTE: The use of physician samples or manufacturer discounts does not guarantee later coverage under the provisions of the medical certificate and/or pharmacy benefit. All criteria must be met in order to obtain coverage of the listed drug product. 4 of 5

5 Committee/Source Date(s) Originated: Management Division/Pharmacist June 15, 2016 Revised: Reviewed: July 20, 2016 March 15, 2017 August 16, 2017 January 10, 2018 January 17, 2018 July 20, 2016 March 15, 2017 August 16, 2017 January 10, 2018 January 17, 2018 Effective: 04/01/2018 Published: 04/01/ of 5