Prior Authorization Required: Yes as shown below

Transcription

1 PROLIA, XGEVA (denosumab) MB9409 Covered Service: Prior Authorization Required: Additional Information Medicare Policy: BadgerCare Plus Policy: Yes when meets criteria below Yes as shown below Must be prescribed by (or prescribed in consultation with) Oncology, Rheumatology, Internal Medicine, Family Medicine, Orthopedic Surgery, or Endocrinology specialists. Prior authorization is dependent on the member s Medicare coverage. Prior authorization is not required for Medicare Cost (Dean Care Gold) and Medicare Supplement (Select) when this service is provided by participating providers. Prior authorization is required if a member has Medicare primary and Dean Health Plan secondary coverage. This policy is not applicable to our Medicare Replacement products. Prescription drug benefits are administered by the Wisconsin Medicaid program. Office administered pharmacy benefits are covered by Dean Health Plan when covered under the Wisconsin Medicaid fee-forservice program and not paid on a fee-for-service basis by the State of Wisconsin Medicaid program. Dean Health Plan Approved Criteria: 1.0 PROLIA (denosumab) requires prior authorization and is considered medically appropriate for those meeting criteria 1.1, 1.2, and 1.3: 1.1 Patients are 12 years of age or older; 1.2 Patients are at high risk for fracture defined by meeting at least ONE of the following: Have a bone mineral density that is 2.5 or more standard deviations below that of a young normal adult (T-score at or below -2.5) Have osteopenia (T-score between -1 and -2.5) and glucocorticoid use for at least 3 months at a dose of 5 mg per day or greater, of prednisone (or equivalent) Receiving systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months PROLIA, XGEVA (denosumab) Page 1 of 5

2 1.2.4 History of osteoporotic fracture Men receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer Women receiving adjuvant aromatase inhibitor therapy for breast cancer The probability is 20% for an occurrence of a major osteoporotic fracture or 3% for hip fracture, based on the USadapted WHO algorithm Fracture Risk Assessment Tool (FRAX tool); 1.3 Step therapy of at least one of the following: At least one bisphosphonate or raloxifene after at least a 24- month treatment period based on objective documentation Raloxifene or bisphosphonates (both oral and IV) are not tolerated due to documented clinical side effects Raloxifene and bisphosphonates (both oral and IV) are contraindicated based on current medical literature and objective documentation describing the contraindication is provided (including, but not limited to, creatinine clearance of less than 35 ml/min) (Documentation required) 2.0 XGEVA (denosumab) requires prior authorization and is considered medically appropriate when the following criteria for 2.1, and either 2.2, 2.3, 2.4, or 2.5 are met: 2.1 Patients are 12 years of age or older; and ONE of the following: 2.2 For prevention of skeletal-related events (SRE) in patients with ONE of the following: Bone metastases from breast cancer or any other solid tumor; and prior treatment with an IV bisphosphonate (e.g. pamidronate or zoledronic acid [Zometa]) has been ineffective, contraindicated, or not tolerated; or Multiple myeloma 2.3 For treatment of giant cell tumor of the bone when: The tumor is unresectable; or The tumor is resectable, but surgical resection is contraindicated; 2.4 Treatment of hypercalcemia of malignancy that is refractory to intravenous bisphosphonate therapy (defined as an albumin-corrected serum calcium level greater than 12.5 mg/dl despite recent (within 30 days) intravenous bisphosphonate treatment); OR PROLIA, XGEVA (denosumab) Page 2 of 5

3 2.5 Diagnosis of NCCN category 1, 2a, or 2b ( recommended ) for off-label uses or FDA indications Comments: 1.0 Quantity limits are to maximum daily doses based on the package insert or NCCN recommendations 2.0 If approved, may be authorized in quantities: 2.1 XGEVA: 2.2 PROLIA: Up to 13 of the 120 mg injections per year for the prevention of complications of bone metastases from solid tumor cancers Up to 15 of the 120 mg injections per year for the treatment of giant cell tumor of the bone and hypercalcemia of malignancy Two 60 mg injections per year 3.0 Initial authorization duration of up to 1 year (subject to formulary changes) 4.0 Renewal authorization duration up to 1 year (subject to formulary changes) with documentation indicated disease stability or improvement 5.0 Diagnoses not listed under FDA approved indications or NCCN recommendations, or an NCCN recommendation grade of 3 are considered experimental/ investigational and are not approvable 6.0 Documentation is expected to be maintained in the patient s medical record and to be available to Dean 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. 6.1 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. 7.0 The following are key points to remember when billing for denosumab (J0897): PROLIA, XGEVA (denosumab) Page 3 of 5

4 7.1 J0897 is defined in the HCPCS manual as: injection, denosumab 1mg 7.2 Coverage only when an FDA approved indication or an approved offlabeled indication accompanies J Unit limits are as follows: units per date of service when the diagnosis is not prevention of skeletal-related events in patients with bone metastases from solid tumors units per date of service units per date of service when the diagnosis is not prevention of skeletal-related events in patients with bone metastases from solid tumors or treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity 7.4 Coverage denied when: 8.0 Coding specifications* Billed and patient s age is less than 12 years Billed by any provider more than once per 28 days (except during initiation) *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 noncovered service. Benefit coverage for any service is determined by the member s policy of health coverage with Dean 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. 8.1 NDC and HCPCS codes Medication Name How Supplied National Drug Brand Generic Code (NDC) HCPCS code PROLIA denosumab 60 mg/1 ml single-use prefilled syringe XGEVA denosumab 120 mg/1.7 ml single use vial J 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. PROLIA, XGEVA (denosumab) Page 4 of 5

5 Committee/Source Date(s) Originated: Medical Director Committee/ Medical Affairs November 18, 2010 Revised: Reviewed: Deleted: Reinstated and Revised: Effective: 11/01/2018 Published: 11/01/2018 Management Division Medical Policy Committee/Health Services Division/Pharmacy Services Medical Policy Committee/Health Services Division/Pharmacy Services Medical Director Committee/Medical Affairs/Pharmacist Medical Director Committee/Medical Affairs/Pharmacist November 30, 2011 September 19, 2012 October 16, 2013 October 31, 2016 September 20, 2017 January 10, 2018 July 18, 2018 October 17, 2018 November 30, 2011 August 15, 2012 September 19, 2012 October 16, 2013 October 21, 2015 October 31, 2016 September 20, 2017 January 10, 2018 July 18, 2018 October 17, 2018 October 17, 2014 November 19, 2014 PROLIA, XGEVA (denosumab) Page 5 of 5