Medical Policy Last Review: 04/30/2018 Effective Date: 07/01/2018 Section: Prescription Drug Related Policies 5.01.501 Guidelines for Prior Authorization of Pharmacologic Therapies DISCLAIMER Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. POLICY Drug-Specific Prior Authorization Criteria All coverage requests will be reviewed according to the criteria in the Specialty Drug Table. The drug specific criteria will be applied to the specialty drugs listed in the Specialty Drug Table located in Table 1. in the Appendix below. POLICY GUIDELINES are injectable and non-injectable medications that are typically used to treat complex conditions and meet one or more of the following criteria: are biotech-derived or biological in nature; are significantly higher cost than traditional medications; are used in complex treatment regimens; require special delivery, storage and handling; require special medication-administration training for patients; require on-going monitoring of medication adherence, side effects, and dosage changes; are available through limited-distribution channels; and may require additional support and coordinated case management o all medications on the Blue Cross of Idaho (BCI) prior authorization list must go through the prior authorization process. For a list of medications that require a prior authorization, click here o FDA indication alone does not establish the medical necessity of a particular medication for a particular patient. We may review all coverage requests for medical necessity and in accordance with the terms of the member s contract. Criteria Utilized Appropriate clinical documentation must be provided in order to review requests for coverage. Medication requests will be reviewed according to established criteria. Criteria and resources used in coverage determinations may include but not limited to: Eligibility for coverage according to the terms of the member contract
Medical necessity/investigational criteria according to the member contract The Food and Drug Administration (FDA) Blue Cross Blue Shield Association Center for Clinical Effectiveness (CCE ) (formerly Technology Evaluation Center [TEC] assessments) The Blue Cross and Blue Shield Association Medical Policy Reference Manual as adopted by BCI Blue Cross of Idaho Medical Policies McKesson/Change Health InterQual Criteria Criteria established by a designated pharmacy benefits manager such as the Clinical Authorization System (CAS) as adopted from CVS/Caremark The National Comprehensive Cancer Network (see Oncologic Drug Use below) NovoLogix Specialty Guidance Management Criteria Facts & Comparisons Compendium The American Hospital Formulary Service Drug Information Compendium Current published medical literature and peer review publications based upon scientific evidence Evidence-based guidelines developed by national organizations and recognized authorities Other criteria as adopted by the Blue Cross of Idaho Medical Policy Committee or Pharmacy and Therapeutics Committee All requested therapies, supplies and services will be evaluated in accordance with the following criteria: Medically Necessary the Covered Services or supplies required to identify or treat an Insured s condition, Disease, Illness or Accidental Injury and which, as recommended by the treating Physician or other Covered Provider and as determined by Blue Cross of Idaho, are: The most appropriate supply or level of service, considering potential benefits and harms to the Insured. Proven to be effective in improving health outcomes; o For new treatments, effectiveness is determined by scientific evidence; o For existing treatments, effectiveness is determined first by scientific evidence, then by professional standards, then by expert opinion. Not primarily for the convenience of the Insured or Covered Provider. Cost-effective for this condition, compared to alternative treatments, including no treatment. Cost-effectiveness does not necessarily mean lowest price. Investigational any technology (service, supply, procedure, treatment, drug, device, facility, equipment or biological product), which is in a developmental stage or has not been proven to improve health outcomes such as length of life, quality of life, and functional ability. A technology is considered investigational if, as determined by Blue Cross of Idaho, it fails to meet any one of the following criteria: The technology must have final approval from the appropriate government regulatory body. This applies to drugs, biological products, devices, and other products/procedures that must have approval from the U.S. Food and Drug Administration (FDA) or another federal authority before they can be marketed. Interim approval is not sufficient. The condition for which the technology is approved must be the same as that BCI is evaluating. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The evidence should consist of current published medical literature and investigations published in peer-reviewed journals. The quality of the studies and consistency of results will be considered. The evidence should demonstrate that the technology can measure or alter physiological changes related to a Disease, injury, Illness, or condition. In Original Policy Date: April 2018 Page: 2
addition, there should be evidence that such measurement or alteration affects health outcomes. The technology must improve the net health outcome. The technology s beneficial effects on health outcomes should outweigh any harmful effects on health outcomes. The technology must be as beneficial as any established alternatives. The technology must show improvement that is attainable outside the investigational setting. Improvements must be demonstrated when used under the usual conditions of medical practice. These definitions may not apply to some health plans, such as Federal Employee Program (FEP), Medicare Advantage and some self-funded group plans. Blue Cross of Idaho reserves the right to periodically update its definitions. For more specific information on Formulary Exception Requests, Oncologic Drug Use, and Off-Label Drug Use, please see MP 5.01.501 REFERENCES 1. Amgen Manufacturing Limited. Nplate (romiplastin) prescribing information. Thousand Oaks CA: Amgen Manufacturing Limited; 2014. Available from: http://pi.amgen.com/united_states/nplate/nplate_pi_hcp_english.pdf [cited Apr 26 2014]. 2. Black, Dennis M., et al. "Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis." New England Journal of Medicine 356.18 (2007): 1809-1822. 3. Institute for Clinical Systems Improvement (ISCI). Diagnosis and treatment of osteoporosis 2013. Available from: http://www.isci.org/oseoporosis/diagnosis_and_treatment_of_osteoporosis_3.html [cited Jan 6 2014]. 4. Lo, Ernest, and Sean Deane. "Diagnosis and classification of immune-mediated thrombocytopenia." Autoimmunity reviews 13.4 (2014): 577-583. 5. Lyles, Kenneth W., et al. "Zoledronic acid and clinical fractures and mortality after hip fracture." New England Journal of Medicine 357.18 (2007): 1799-1809. 6. Martins, Ana Maria, et al. "Recommendations on diagnosis, treatment, and monitoring for Gaucher disease." The Journal of pediatrics 155.4 (2009): S10-S18. 7. National Institute of Health. Gaucher disease. Current issues in diagnosis and treatment. NIH Technology Assessment Panel on Gaucher Disease. 1996. Available from: www.ncbi.nlm.nih.gov/pubmed/8606477 [cited Nov 4 2013]. 8. Neunert, Cindy, et al. "The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia." Blood 117.16 (2011): 4190-4207. 9. Novartis Pharmaceuticals Corporation. Reclast (zoledronic acid) prescribing information. East Hanover NJ: Novartis Pharmaceutics Corporation; 2013. Available from: http://www.pharma.us.novartis.com/product/pi/pdf/reclast.pdf [cited Jan 6 2014]. Original Policy Date: April 2018 Page: 3
CODES 10. Pastores and Hughes. Gaucher Disease 2011. Available from: http:// ncbi.nlm.nih.gov/books/nbk1269/ [cited Jul 22 2013]. 11. Pfizer Labs. Elelyso (Taliglucerase alfa) prescribing information. New York NY; Pfizer Labs; 2012. Available form: http://labeling.pfizer.com/showlabeling.aspx?id=798 [cited Nov 4 2012]. 12. Provan, Drew, et al. "International consensus report on the investigation and management of primary immune thrombocytopenia." Blood 115.2 (2010): 168-186. 13. Räkel, Agnès, Andrée Boucher, and Louis-Georges Ste-Marie. "Role of zoledronic acid in the prevention and treatment of osteoporosis." Clinical interventions in aging 6 (2010): 89-99. 14. Reid, David M., et al. "Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid- induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial." The Lancet 373.9671 (2009): 1253-1263. 15. Shire Human Genetic Therapies, Inc. VPRIV (velaglucerase) prescribing information. Lexington MA: Shire Human Genetic Therapies, Inc.; 2013. Available from: http://www.vpriv.com/app_presentation/vpriv/images/pdf/vpriv PI Prescribing Information [cited Nov 4 2013]. 16. US Preventive Services Task Force. "Screening for osteoporosis in postmenopausal women: recommendations and rationale." Annals of Internal Medicine 137.6 (2002): 526. 17. World Health Organization Scientific Group. Assessment of osteoporosis at the primary care level. Technical Report 2007. Available from: http://www.who.int/chp/topics/osteoporosis.pdf [cited Jan 6 2014]. 18. Zeng, Yan, et al. "TPO receptor agonist for chronic idiopathic thrombocytopenic purpura." Cochrane Database Syst Rev 7 (2011). 19. Zimran et al. Pivotal trial with plant-cell expressed recombinant glucocerebrosidase, Taliglucerase alfa, a novel enzyme replacement therapy for Gaucher disease. Blood 2011 118(22). Available from: http://www.ncbi.nlm.nih.gov/pubmed/21900191 [cited Nov 4 2013]. Codes Number Description HCPCS J2796 Injection, romiplostim, Nplate, 10 mcg J3060 Injection, taliglucerase alfa, Elelyso, 10 units J3385 Injection, velaglucerase alfa, VPRIV, 100 units J3489 Injection, zoledronic acid, Reclast, 1 mg Original Policy Date: April 2018 Page: 4
POLICY HISTORY Date Action Reason 06/15/16 Added to Prescription Drug section New policy to address DMARD and biologic specialty drugs. 06/22/17 Replace policy Blue Cross of Idaho annual update; no changes to policy statement. 07/26/17 Replace policy Added Cost Effective DMARD alternatives to policy guidelines, effective 10/01/2017. 09/28/17 Replace policy Added cost effective Alpha 1-Proteinase Inhibitors and Gaucher Disease Agents alternatives to policy guidelines, effective 12/01/2017. 12/27/17 Replace policy Added cost-effectiveness language for Gaucher s Disease Agents and MAB therapy for MS; Effective 03/15/2018. 04/30/18 Replace policy Removed cost effectiveness language for: DMARD alternatives, Alpha 1-Proteinase Inhibitors, MAB therapy for MS, and Gaucher Disease Agents. Removed the following specialty drugs from the specialty drug table: Abatacept, Alpha 1- Proteinase Inhibitors, Denosumab, Golimumab, Natalizumab, Tocilizumab, and Vedolizumab. References 1-2, 4-8, 10-20, 22-24, 27, 29-32, 38, 40, 42, 44-46, 48-55, and 57-58. Remaining references renumbered in references and Specialty Drug table. Policy renumbered from 5.01.93 to 5.01.593. Changes to policy will become effective 07/01/2018. Original Policy Date: April 2018 Page: 5
APPENDIX Table 1. Drug Name Medically Necessary (if all the following criteria apply): Contraindications/ Exclusions: Step Therapy Required: Additional Required Clinical Criteria: References: Romiplostin (Nplate) Immune Thrombocytopenia (ITP) 1. Confirmed by a specialist 2. Maintenance therapy for platelet count < 30 x10 (9)/L 3. Over age 18 Bleeding episode (urgent) Prior therapy with: Corticosteroid and/or immune globulin with treatment failure, due to one of the following: 1. Significant intolerance 2. Continued platelet count < 30 x10 (9)/L 3. Allergic response Risk of thrombosis discussed with patient or caregiver 1, 4, 8, 12, 18 Taliglucerase alfa (Elelyso) Type 1 Gaucher disease (confirmed by Betaglucosylceramidase activity or GBA gene test) Age 18 and 65 Type 2 Gaucher Disease Type 3 Gaucher disease With one of the following: 1. Anemia 2. Thrombocytopenia 3. Splenomegaly 4. Hepatomegaly 5. Bone disease 7, 10, 11, 18 Original Policy Date: April 2018 Page: 6
Velaglucerase Alfa (VPRIV) Type 1 Gaucher disease (confirmed by Betaglucosylceramidase activity or GBA gene test) Age 18 and 65 Type 2 Gaucher Disease Type 3 Gaucher disease With one of the following: 1. Anemia 2. Thrombocytopenia 3. Splenomegaly 4. Hepatomegaly 5. Bone disease 6, 10, 15, 19 Zoledronic Acid (Reclast) Osteoporosis or Osteopenia treatment in post-menopausal women Osteoporosis in men Paget s Disease 1. With consistent radiographic findings 2. Elevated serum alkaline phosphatase Glucocorticoid-induced osteoporosis (GIO) or treatment with glucocorticoids for more than 3 months Current treatment with similar medication (e.g., Zometa, Xgeva, or Prolia) Pregnancy Under 18 years of age Treatment with zoledronic acid within the past year Hypocalcemia Tried and/or failed oral bisphosphonates Patients with creatinine clearance of 35mL/min and in those with evidence of acute renal impairment Osteopenic (T-score -1.0 to -2.5) or osteoporotic (T-score below -2.5) by dual x-ray absorptiometry (DXA), or low impact fracture Renal function evaluated and no evidence of renal impairment Normal phosphorus and magnesium levels Planned supplementation with calcium and Vitamin-D Osteoporosis treatment (postmenopausal females, males) and GIO treatment: 5 mg once a year Osteoporosis prevention (postmenopausal women) treatment: 5 mg once every two years Paget s disease treatment: a single 5 mg infusion 2, 3, 5, 9, 13, 14, 16, 17 Original Policy Date: April 2018 Page: 7