CLINICAL MEDICATION POLICY Policy Name: Opdivo (nivolumab) injection Policy Number: Approved By: Medical Management, Clinical Pharmacy Products: Highmark Health Options Application: All participating hospitals and providers Page Number(s): 1 of 11 Disclaimer Highmark Health Options clinical medication policy is intended to serve only as a general reference resource regarding payment and coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions. POLICY STATEMENT: Highmark Health Options provides coverage under the medical or pharmacy benefits of the Company s Medicaid products for medically necessary Opdivo (nivolumab) intravenous injection. This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person s unique clinical circumstances warrants individual consideration, based upon review of applicable medical records. The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations. DEFINITIONS: Medical Necessity: A service or benefit is medically necessary if it is compensable under the MA program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to prevent the onset of an illness, condition, or disability The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental, or developmental effects of an illness, condition, injury, or disability The service or benefit will assist the member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the member and those functional capacities that are appropriate for members of the same age Prior Authorization: A medication benefit that is approved once established criteria are met. The criteria are medication specific and may be based on FDA and manufacturer guidelines, medical literature, safety, appropriate use, and benefit design. A prior authorization may be established to address appropriate utilization due to patient safety concerns, limited indications, and potential for misuse/abuse.
PROCEDURES: Opdivo is considered medically necessary for the treatment of when the member and prescriber meet the following criteria. Opdivo Prior Authorization Criteria: Benefit coverage is provided for the following conditions: Coverage may be provided when the diagnosis is unresectable or metastatic melanoma, AND o The patient is age 18 years or older, AND o Treatment is prescribed by an oncologist/hematologist, AND o The patient has Stage III (unresectable) or IV (metastatic) disease, AND o Treatment will be used for BRAF V600 mutation positive or wild-type, as a single agent, OR o Treatment will be used in combination with Yervoy (ipilimumab), AND o The dosing is within the following prescribing-supported parameters: Monotherapy: Does not exceed 240 mg every 2 weeks, OR Opdivo in combination with Yervoy: Does not exceed 1 mg/kg (Opdivo), followed by 3 mg/kg (Yervoy) on the same day, every 3 weeks for 4 doses, then 240 mg (Opdivo) every 2 weeks Coverage may be provided when the diagnosis is metastatic non-small cell lung cancer, AND o The patient is age 18 years or older, AND o Treatment is prescribed by an oncologist/hematologist, AND o Treatment will be used for progression on or after platinum-based chemotherapy, AND Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo o The dosing is within the following prescribing-supported parameters: Does not exceed 240 mg every 2 weeks Coverage may be provided when the diagnosis is renal cell carcinoma, AND o The patient is age 18 years or older, AND o Treatment is prescribed by an oncologist/hematologist, AND o Treatment will be used for advanced disease, AND o Treatment will be used in patients who have received prior anti-angiogenic, AND o The dosing is within the following prescribing-supported parameters: Does not exceed 240 mg every 2 weeks Coverage may be provided when the diagnosis is classical Hodgkin Lymphoma, AND o The patient is age 18 years or older, AND o Treatment is prescribed by an oncologist/hematologist, AND o The patient has relapsed or has progressed disease after autologous hematopoietic stem cell transplant AND post-transplant Adcetris (brentuximab vedotin), AND o The dosing is within the following prescribing-supported parameters: Does not exceed 3mg/kg every 2 weeks
Coverage may be provided when the diagnosis is recurrent or metastatic squamous cell carcinoma of the head and neck, AND o The patient is age 18 years or older, AND o Treatment is prescribed by an oncologist/hematologist, AND o Treatment will be used for patients with disease progression on or after a platinumbased therapy, AND o The dosing is within the following prescribing-supported parameters: Does not exceed 3mg/kg every 2 weeks 1. Contraindications None 2. When Opdivo is Not Covered Coverage may be provided for any non-fda labeled indication or a medically accepted indication that is supported by nationally recognized pharmacy compendia or peer-reviewed medical literature for treatment of the diagnosis (es) for which it is prescribed and will be reviewed on a case by case basis to determine medical necessity. 3. Post-Payment Audit Statement The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement. 4. Place of Service The site of service for the administration of Opdivo is outpatient centers. 5. Length of Coverage Initial approval duration will be for 12 weeks Reauthorization will be for 6 months upon receiving documentation that the patient is tolerating and responding to treatment and the patient s liver, thyroid, and kidneys are monitored throughout treatment. Adverse events to treatment should be monitored (e.g. immune-related reactions) and dose modifications made as necessary. Governing Bodies Approval On December 22, 2014 Opdivo was approved for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication was approved under the accelerated approval base on tumor response rate and durability of response. On March 4, 2015 the FDA granted approved for Opdivo for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. On November 23, 2015, the FDA granted approval of Opdivo for the treatment of patients with advanced (metastatic) renal cell carcinoma who have received a prior therapy. On May 16, 2016, the FDA granted accelerated approval to nivolumab (Opdivo) for the treatment of patients with classical Hodgkin lymphoma (chl) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation Brentuximab Vedotin (Adcetris).
Operational Guidelines Pharmacy This pharmacy policy will be applied as a prior authorization for both facility and professional providers. Medical This medical policy will be applied on a post-service prepayment basis for both facility and professional providers. CODING REQUIREMENTS: Procedure Codes: HCPCS/CPT Description Codes J9299 Injection, Nivolumab, 1 mg Diagnosis Codes: ICD-10 Codes C00 Description Malignant neoplasm of lip C00.0 Malignant neoplasm of external upper lip C00.1 Malignant neoplasm of external lower lip C00.2 Malignant neoplasm of external lip, unspecified C00.3 Malignant neoplasm of upper lip, inner aspect C00.4 Malignant neoplasm of lower lip, inner aspect C00.5 Malignant neoplasm of unspecified, inner aspect C00.6 Malignant neoplasm of commissure of lip, unspecified C00.8 Malignant neoplasm of overlapping sites of lip C00.9 Malignant neoplasm of lip, unspecified C01 C02 Malignant neoplasm of base of tongue Malignant neoplasm of other and unspecified parts of tongue C02.0 Malignant neoplasm of dorsal surface of tongue C02.1 Malignant neoplasm of border of tongue C02.2 Malignant neoplasm of ventral surface of tongue C02.3 Malignant neoplasm of anterior two-thirds of tongue, part unspecified C02.4 Malignant neoplasm of lingual tonsil C02.8 Malignant neoplasm of overlapping sites of tongue C02.9 Malignant neoplasm of tongue, unspecified C03 Malignant neoplasm of gum C03.0 Malignant neoplasm of upper gum
C03.1 Malignant neoplasm of lower gum C03.9 Malignant neoplasm of gum, unspecified C04 Malignant neoplasm of floor of mouth C04.0 Malignant neoplasm of anterior floor of mouth C04.1 Malignant neoplasm of lateral floor of mouth C04.8 Malignant neoplasm of overlapping sites of floor of mouth C04.9 Malignant neoplasm of floor of mouth, unspecified C05 Malignant neoplasm of palate C05.0 Malignant neoplasm of hard palate C05.1 Malignant neoplasm of soft palate C05.2 Malignant neoplasm of uvula C05.8 Malignant neoplasm of overlapping sites of palate C05.9 Malignant neoplasm of palate, unspecified C06 Malignant neoplasm of other and unspecified parts of mouth C06.0 Malignant neoplasm of cheek mucosa C06.1 Malignant neoplasm of vestibule of mouth C06.2 Malignant neoplasm of retromolar area C06.8 Malignant neoplasm of overlapping sites of other and unspecified parts of mouth C06.80 Malignant neoplasm of overlapping sites of unspecified parts of mouth C06.89 Malignant neoplasm of overlapping sites of other parts of mouth C06.9 Malignant neoplasm of mouth, unspecified C07 C08 Malignant neoplasm of parotid gland Malignant neoplasm of other and unspecified major salivary glands C08.0 Malignant neoplasm of submandibular gland C08.1 Malignant neoplasm of sublingual gland C08.9 Malignant neoplasm of major salivary gland, unspecified C09 Malignant neoplasm of tonsil C09.0 Malignant neoplasm of tonsillar fossa C09.1 Malignant neoplasm of tonsillar pillar (anterior) (posterior) C09.8 Malignant neoplasm of overlapping sites of tonsil C09.9 Malignant neoplasm of tonsil, unspecified C10 Malignant neoplasm of oropharynx C10.0 Malignant neoplasm of vallecula C10.1 Malignant neoplasm of anterior surface of epiglottis C10.2 Malignant neoplasm of lateral wall of oropharynx C10.3 Malignant neoplasm of posterior wall of oropharynx C10.4 Malignant neoplasm of branchial cleft
C10.8 Malignant neoplasm of overlapping sites of oropharynx C10.9 Malignant neoplasm of oropharynx, unspecified C11 Malignant neoplasm of nasopharynx C11.0 Malignant neoplasm of superior wall of nasopharynx C11.1 Malignant neoplasm of posterior wall of nasopharynx C11.2 Malignant neoplasm of lateral wall of nasopharynx C11.3 Malignant neoplasm of anterior wall of nasopharynx C11.8 Malignant neoplasm of overlapping sites of nasopharynx C11.9 Malignant neoplasm of nasopharynx, unspecified C12 C13 Malignant neoplasm of pyriform sinus Malignant neoplasm of hypopharynx C13.0 Malignant neoplasm of post cricoid region C13.1 Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect C13.2 Malignant neoplasm of posterior wall of hypopharynx C13.8 Malignant neoplasm of overlapping sites of hypopharynx C13.9 Malignant neoplasm of hypopharynx, unspecified C14 Malignant neoplasm of other and ill-defined sites of lip, oral cavity and pharynx C14.0 Malignant neoplasm of pharynx, unspecified C14.2 Malignant neoplasm of Waldeyer s ring C14.8 Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx C30.0 Malignant neoplasm of nasal cavity C33 Malignant neoplasm of trachea C34.00 Malignant neoplasm of unspecified main bronchus C31.01 Malignant neoplasm of right main bronchus C31.02 Malignant neoplasm of left main bronchus C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung C34.11 Malignant neoplasm of upper lobe, right bronchus or lung C34.12 Malignant neoplasm of upper lobe, left bronchus or lung C34.2 Malignant neoplasm of middle lobe, bronchus or lung C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung C34.31 Malignant neoplasm of lower lobe, right bronchus or lung C34.32 Malignant neoplasm of lower lobe, left bronchus or lung C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung C34.91 Malignant neoplasm of unspecified part of right bronchus or lung
C34.92 Malignant neoplasm of unspecified part of left bronchus or lung C43.0 Malignant melanoma of lip C43.10 Malignant melanoma of unspecified eyelid, including canthus C43.11 Malignant melanoma of right eyelid, including canthus C43.12 Malignant melanoma of left eyelid, including canthus C43.20 Malignant melanoma of unspecified ear and external auricular canal C43.21 Malignant melanoma of right ear and external auricular canal C43.22 Malignant melanoma of left ear and external auricular canal C43.30 Malignant melanoma of unspecified part of face C43.31 Malignant melanoma of nose C43.39 Malignant melanoma of other parts of face C43.4 Malignant melanoma of scalp and neck C43.51 Malignant melanoma of anal skin C43.52 Malignant melanoma of skin of breast C43.59 Malignant melanoma of other part of trunk C43.60 Malignant melanoma of unspecified upper limb, including shoulder C43.61 Malignant melanoma of right upper limb, including shoulder C43.62 Malignant melanoma of left upper limb, including shoulder C43.70 Malignant melanoma of unspecified lower limb, including hip C43.71 Malignant melanoma of right lower limb, including hip C43.72 Malignant melanoma of left lower limb, including hip C43.8 Malignant melanoma of overlapping sites of skin C43.9 Malignant melanoma of skin, unspecified C64.1 Malignant neoplasm of right kidney, except renal pelvis C64.2 Malignant neoplasm of left kidney, expect renal pelvis C64.9 Malignant neoplasm of unspecified kidney, except renal pelvis C65.1 Malignant neoplasm of right renal pelvis C65.2 Malignant neoplasm of left renal pelvis C65.9 Malignant neoplasm of unspecified renal pelvis C69.90 Malignant neoplasm of unspecified site of unspecified eye C69.91 Malignant neoplasm of unspecified site of right eye C69.92 Malignant neoplasm of unspecified site of left eye C76.0 Malignant neoplasm of head, face and neck C78.00 Secondary malignant neoplasm of unspecified lung C78.01 Secondary malignant neoplasm of right lung C78.02 Secondary malignant neoplasm of left lung C79.31 Secondary malignant neoplasm of brain
C80.0 Disseminated malignant neoplasm, unspecified C80.1 Malignant (primary) neoplasm, unspecified C81.00 Nodular lymphocyte predominate Hodgkin lymphoma, unspecified site C81.01 Nodular lymphocyte predominate Hodgkin lymphoma, lymph nodes of head, face and neck C81.02 Nodular lymphocyte predominate Hodgkin lymphoma, intrathoracic lymph nodes C81.03 Nodular lymphocyte predominate Hodgkin lymphoma, intra-abdominal lymph nodes C81.04 Nodular lymphocyte predominate Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.05 Nodular lymphocyte predominate Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.06 Nodular lymphocyte predominate Hodgkin lymphoma, intrapelvic lymph nodes C81.07 Nodular lymphocyte predominate Hodgkin lymphoma, spleen C81.08 Nodular lymphocyte predominate Hodgkin lymphoma, lymph nodes of multiple sites C81.09 Nodular lymphocyte predominate Hodgkin lymphoma, extranodal and solid organ sites C81.10 Nodular sclerosis classical Hodgkin lymphoma, unspecified site C81.11 Nodular sclerosis classical Hodgkin lymphoma, lymph nodes of head, face and neck C81.12 Nodular sclerosis classical Hodgkin lymphoma, intrathoracic lymph nodes C81.13 Nodular sclerosis classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.14 Nodular sclerosis classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.15 Nodular sclerosis classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.16 Nodular sclerosis classical Hodgkin lymphoma, intrapelvic lymph nodes C81.17 Nodular sclerosis classical Hodgkin lymphoma, spleen C81.18 Nodular sclerosis classical Hodgkin lymphoma, lymph nodes of multiple sites C81.19 Nodular sclerosis classical Hodgkin lymphoma, extranodal and solid organ sites C81.20 Mixed cellularity classical Hodgkin lymphoma, unspecified site C81.21 Mixed cellularity classical Hodgkin lymphoma, lymph nodes of head, face and neck C81.22 Mixed cellularity classical Hodgkin lymphoma, intrathoracic lymph nodes C81.23 Mixed cellularity classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.24 Mixed cellularity classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.25 Mixed cellularity classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.26 Mixed cellularity classical Hodgkin lymphoma, intrapelvic lymph nodes C81.27 Mixed cellularity classical Hodgkin lymphoma, spleen C81.28 Mixed cellularity classical Hodgkin lymphoma, lymph nodes of multiple sites C81.29 Mixed cellularity classical Hodgkin lymphoma, extranodal and solid organs C81.30 Lymphocyte depleted classical Hodgkin lymphoma, unspecified site
C81.31 Lymphocyte depleted classical Hodgkin lymphoma, lymph nodes of head, face and neck C81.32 Lymphocyte depleted classical Hodgkin lymphoma, intrathoracic lymph nodes C81.33 Lymphocyte depleted classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.34 Lymphocyte depleted classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.35 Lymphocyte depleted classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.36 Lymphocyte depleted classical Hodgkin lymphoma, intrapelvic lymph nodes C81.37 Lymphocyte depleted classical Hodgkin lymphoma, spleen C81.38 Lymphocyte depleted classical Hodgkin lymphoma, lymph nodes of multiple sites C81.39 Lymphocyte depleted classical Hodgkin lymphoma, extranodal and solid organ sites C81.40 Lymphocyte-rich classical Hodgkin lymphoma, unspecified site C81.41 Lymphocyte-rich classical Hodgkin lymphoma, lymph nodes of head, face and neck C81.42 Lymphocyte-rich classical Hodgkin lymphoma, intrathoracic lymph nodes C81.43 Lymphocyte-rich classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.44 Lymphocyte-rich classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.45 Lymphocyte-rich classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.46 Lymphocyte-rich classical Hodgkin lymphoma, intrapelvic lymph nodes C81.47 Lymphocyte-rich classical Hodgkin lymphoma, spleen C81.48 Lymphocyte-rich classical Hodgkin lymphoma, lymph nodes of multiple sites C81.49 Lymphocyte-rich classical Hodgkin lymphoma, extranodal and solid organ sites C81.70 Other classical Hodgkin lymphoma, unspecified site C81.71 Other classical Hodgkin lymphoma, lymph nodes of head, face and neck C81.72 Other classical Hodgkin lymphoma, intrathoracic lymph nodes C81.73 Other classical Hodgkin lymphoma, intra-abdominal lymph nodes C81.74 Other classical Hodgkin lymphoma, lymph nodes of axilla and upper limb C81.75 Other classical Hodgkin lymphoma, lymph nodes of inguinal region and lower limb C81.76 Other classical Hodgkin lymphoma, intrapelvic lymph nodes C81.77 Other classical Hodgkin lymphoma, spleen C81.78 Other classical Hodgkin lymphoma, lymph nodes of multiple sites C81.79 Other classical Hodgkin lymphoma, extranodal and solid organ sites C81.90 Hodgkin lymphoma, unspecified, unspecified site C81.91 Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck C81.92 Hodgkin lymphoma, unspecified, intrathoracic lymph nodes C81.93 Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes C81.94 Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb C81.95 Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb
C81.96 Hodgkin lymphoma, unspecified, intrapelvic lymph nodes C81.97 Hodgkin lymphoma, unspecified, spleen C81.98 Hodgkin lymphoma, unspecified, lymph nodes of multiple sites C81.99 Hodgkin lymphoma, unspecified, extranodal and solid organ sites D03.0 Melanoma in situ of lip D03.10 Melanoma in situ of unspecified eyelid, including canthus D03.11 Melanoma in situ of right eyelid, including canthus D03.12 Melanoma in situ of left eyelid, including canthus D03.2 Melanoma in situ of ear and external auricular canal D03.20 Melanoma in situ of unspecified ear and external auricular canal D03.21 Melanoma in situ of right ear and external auricular canal D03.22 Melanoma in situ of left ear and external auricular canal D03.3 Melanoma in situ of other and unspecified parts of face D03.30 Melanoma in situ of unspecified part of face D03.39 Melanoma in situ of other parts pf face D03.4 Melanoma in situ of scalp and neck D03.5 Melanoma in situ of trunk D03.51 Melanoma in situ of anal skin D03.52 Melanoma in situ of breast (skin) (soft tissue) D03.59 Melanoma in situ of other parts of trunk D03.6 Melanoma in situ of upper limb, including shoulder D03.60 Melanoma in situ of unspecified upper limb, including shoulder D03.61 Melanoma in situ of right upper limb, including shoulder D03.62 Melanoma in situ of left upper limb, including shoulder D03.7 Melanoma in situ of lower limb, including hip D03.70 Melanoma in situ of unspecified lower limb, including hip D03.71 Melanoma in situ of right lower limb, including hip D03.72 Melanoma in situ of left lower limb, including hip D03.8 Melanoma in situ of other sites D03.9 Melanoma in situ, unspecified Z85.118 Personal history of other malignant neoplasm of bronchus and lung Z85.528 Personal history of other malignant neoplasm of kidney Z85.53 Personal history of malignant neoplasm of renal pelvis Z85.71 Personal history of Hodgkin lymphoma Z85.820 Personal history of malignant melanoma of skin REMBURSEMENT:
Participating facilities will be reimbursed per their Highmark Health Options contract. POLICY SOURCE: 1) NCCN Guidelines Version 2.2016: Head and Neck Cancers. 2) NCCN Guidelines Version 3.2016: Hodgkin Lymphoma. 3) NCCN Guidelines Version 2.2017: Kidney Cancer. 4) NCCN Guidelines Version 1.2017: Melanoma. 5) NCCN Guidelines Version 3.2017: Non-Small Cell Lung Cancer. 6) Opdivo [package insert]. Bristol-Myers Squibb Company; 2016. Policy History: Date Activity Initial policy developed QI/UM Committee approval Provider effective date 2/14/2017 Revisions: Annual review