Specialty Drugs Requiring Precertification
Policy Number: Original Effective Date: MM.04.009 09/01/2008 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST Integration 06/27/2014 Section: Prescription Drugs Place(s) of Service: Home; Office; Outpatient; Ambulatory Infusion Suite
I. Description A specialty drug is a drug that is typically high in cost (greater than $600 per month) and has one or more of the following characteristics: Specialized patient training on the administration of the drug (including supplies and devices needed for administration) is required. Coordination of care is required prior to drug therapy initiation and/or during therapy. Unique patient compliance and safety monitoring requirements. Unique requirements for handling, shipping and storage. Restricted access or limited distribution. The intent of this policy is to require precertification of designated specialty drugs on the date of approval by the Food and Drug Administration (FDA). This policy applies to drugs covered under the medical benefit and under the prescription drug rider benefit.
II. Criteria/Guidelines A. Precertification is required for specialty drugs, effective on the date of approval by the FDA. Refer to Appendices A and B for the lists of drugs requiring precertification. B. A specialty drug is covered (subject to Limitations/Exclusions and Administrative Guidelines) when the following criteria are met: 1. It is prescribed for an FDA approved indication. a. Its use is consistent with the manufacturer’s prescribing information. b. When the FDA-approved indication lacks patient selection specificity, the patient meets the eligibility criteria for the clinical study or studies upon which the FDA approval was based. 2. When a specialty drug is requested for an off-label indication, HMSA’s Off-Label Drug Use policy criteria must be met.
Specialty Drugs Requiring Precertification 2
III. Limitations/Exclusions A. When a request for a specialty drug is approved, coverage is based on a trial of therapy concept. The drug will be approved for a specified period during which the patient’s response to therapy will be assessed. Specific measurable response(s) should be identified and documented at the time of initial approval. Continuation of the drug is covered if the patient demonstrates a measurable response. B. This policy does not apply to specialty drugs with an existing policy. If there is an existing policy, coverage will be based on policy criteria. Refer to Appendices C and D for the lists of drugs requiring precertification for which there is a medical policy. C. If there is an existing policy for a drug in the same therapeutic class, coverage will be based on the policy criteria. IV. Administrative Guidelines A. Precertification is required for specialty drugs, effective on the date of approval by the FDA. At the time precertification is being requested, please refer to Appendices A and B for the lists of drugs requiring precertification in accordance with criteria stated in this policy. To precertify, please complete HMSA’s Drug Review Request or the CVS Drug Review Request. For requests submitted to HMSA, include the following documentation: 1. Clinical information supporting the diagnosis. 2. Proposed treatment plan. B. Specialty drugs listed in Appendices A and B will be reviewed on a regular basis and a determination will be made regarding continuation of the precertification requirement and/or development of a policy.
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V. Appendices
APPENDIX A Drugs requiring precertification from HMSA in accordance with criteria stated in this policy: Brand/Generic Name Route of HCPCS Code Precertification Administration Effective Date
Acthar gel (Corticotropin) IM/SQ J0800 September 1, 2012 Arcalyst (Rilonacept) IM/SQ J2793 January 1, 2010 Benlysta (Belimumab) IV J0490 November 1, 2011 Berinert (C1 Esterase Inhibitor) IV J0597 December 1, 2010 Bexxar (Tositumomab) IV A9545 June 1, 2009 Cerezyme (Imiglucerase) IV J1786 October 1, 2014 Cinryze (Human C1 Esterase Inhibitor) IV J0598 July 1, 2009 Cosentyx (secukinumab) SQ J3490/J3590 February 13, 2015 Cyramza (Ramucirumab) IV J3490/J3590 April 23, 2014 Elelyso (Taliglucerase alfa) IV J3060 February 1, 2013 Entyvio (vedolizumab) IV J3490/J3590 June 12, 2014 Eylea (Aflibercept) for off-label Intravitreous J0178 August 1, 2012 indications
Firazyr (Icatibant) SQ J1744 February 1, 2012 Folotyn (Pralatrexate) IV J9307 May 1, 2010 Gattex (Teduglutide) SQ J3490/J3590 December 1, 2013 Gazyva (Obinutuzumab) IV J9301 May 1, 2014 Ilaris (Canakinumab) SQ J0638 December 1, 2009 Iluvien (fluocinolone acetonide Intravitreous J3490/J3590 February 13, 2015 intravitreal implant) Jetrea (Ocriplasmin) for off-label Intravitreous J7316 June 1, 2013 indications Kadcyla (Trastuzumab emtansine) IV J9354 August 1, 2013 Kalbitor (Ecallantide) SQ J1290 June 1, 2011 Keytruda (pembrolizumab) IV J3490/J3590 September 18, 2014 Specialty Drugs Requiring Precertification 4
Krystexxa (Pegloticase) IV J2507 September 1, 2012 Kynamro (Mipomersen sodium) SQ J3490/J3590 June 1, 2013 Kyprolis (Carfilzomib) IV J9047 February 1, 2013 Lanreotide (Somatuline Depot) SQ J1930 June 1, 2013 Lucentis (Ranibizumab) for off-label Intravitreous J2778 December 1, 2010 indications Macugen (Pegaptanib) for off-label Intravitreous J2503 December 1, 2010 indications Myalept (Metreleptin) SQ J3490/J3590 March 27, 2014 Nplate (Romiplostim) SQ J2796 June 1, 2009 Opdivo (nivolumab) IV J9999 March 16, 2015 Perjeta (Pertuzumab) IV J9306 November 1, 2012 Praluent (alirocumab) Injection J3490/J3590 June 10, 2015 Prolia (Denosumab) for off-label SQ J0897 September 1, 2010 indications Provenge (Sipuleucel T) IV Q2043 September 1, 2010 Repatha (evolucumab) Injection J3490/J3590 June 10, 2015 Rituxan (Rituximab) for non-RA and IV J9310 November 1, 2009 non-oncologic indications Ruconest (recombinant human C1 IV J3490/J3590 September 05, 2014 esterase inhibitor) Signifor (Pasireotide diaspartate) SQ J3490/J3590 June 1, 2013 Soliris (Eculizumab) IV J1300 May 1, 2009 Sylvant (siltuximab) IV J3490/J3590 May 1, 2014 Synribo (Omacetaxine mepesuccinate) SQ J9262 June 1, 2013 Torisel (Temsirolimus) IV J9330 Now in Effect Vimizim (Elosulfase alfa) IV J1322 March 27, 2014 Unituxin (dinutuximab) Injection J3490/J3590 August 21, 2015 VPRIV (Veleglucerase) IV J3385 October 1, 2014 Xgeva (Denosumab) for off-label SQ J0897 September 1, 2011 indications Xofigo (Radium Ra 223 Dichloride) IV A9606 December 1, 2013 Yervoy (Ipilimumab) IV J9228 September 1, 2011 Zaltrap (Ziv-aflibercept) IV J9400 January 1, 2013
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APPENDIX B Drugs requiring precertification from CVS in accordance with criteria stated in this policy: Brand/Generic Name Route of Administration Precertification Effective Date Aubagio (teriflunomide) Oral 08/01/2014 Bosulif (Bosutinib monohydrate ) Oral 08/01/2014 Buphenyl (sodium phenylbutyrate) Oral 08/01/2014 Cerdelga (eliglustat) Oral 09/05/2014 Cometriq (cabozantinib) Oral 08/01/2014 Esbriet (pirfenidone) Oral 10/29/2014 Farydak (panobinostat) Oral 02/23/2015 Gilotrif (afatinib) Oral 10/01/2014 Hetlioz (tasimelteon) Oral 03/27/2014 Iclusig (ponatinib) Oral 01/01/2014 Imbruvica (Ibrutinib) Oral 08/01/2014 Inlyta (axitinib) Oral 08/01/2014 Juxtapid (lomitapide) Oral 12/21/2012 Kitabis Pak (tobramycin) Inhaled 12/02/2014 Mekinist (trametinib) Oral 08/01/2014 Northera (droxidopa) Oral 03/27/2014 Ofev (nintedanib) Oral 10/29/2014 Olysio (simeprevir) Oral 06/01/2014 Opsumit (macitentan) Oral 08/01/2014 Orkambi (lumacaftor/ivacaftor) Oral 07/02/2015 Orenitram (treprostinil) Oral 10/01/2014 Otezla (apremilast) Oral 04/03/2014 Pomalyst (pomalidomide) Oral 08/01/2014 Procysbi (Cysteamine Bitartrate) Oral 08/01/2014 Ravicti (glycerol phenylbutyrate) Oral 08/01/2014 Specialty Drugs Requiring Precertification 6
Stivarga (regorafenib) Oral 08/01/2014 Tafinlar (dabrafenib) Oral 08/01/2014 Tecfidera (dimethyl fumarate) Oral 08/01/2014 Xeljanz (tofactinib citrate) Oral 08/01/2014 Xtandi (enzalutamide) Oral 08/01/2014 Xyrem (sodium oxybate) Oral 08/01/2014 Zydelig (idelalsib) Oral 07/25/2014 Zykadia (ceritinab) Oral 05/01/2014
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APPENDIX C HMSA Medical Policies for drugs requiring precertification (click on drug name to link to specific policy):
Alimta (Pemetrexed)
Avastin (Bevacizumab)
Biological Agents for the Treatment of Plaque Psoriasis
Botolinum Toxins (BOTOX, DYSPORT, MYOBLOC and XEOMIN)
Direct Acting Antiviral Medications for Treatment of Hepatitis C
Erbitux (Cetuximab)
Forteo (Teriparatide)
Growth Hormone Therapy
Immune Globulin Therapy
Low-Molecular-Weight Heparin
Lupron (Leuprolide Acetate) and Supprelin LA (Histrelin Acetate) Subcutaneous Implant
Off-Label Drug Use Policy
Provigil (Modafinil) and Nuvigil (Armodafinil)
Pulmonary Hypertension Drugs
Remicade (Infliximab)
Synagis (Palivizumab)
Vectibix (Panitumumab)
Velcade (Bortezomib)
Xolair (Omalizumab)
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Zevalin (Ibritumomab tiuxetan)
Appendix D
CVS Medical Policies for drugs requiring precertification (click on this link to access all drug polices and applicable line of business):
Adcirca (Tadalafil)
Affinitor (Everolimus)
Ampyra (Dalfampridine)
Bosulif (Bosutinib)
Cayston (Aztreonam Inhalation)
Copegus (Ribavirin)
Cystagon (Cysteamine Bitartrate)
Enbrel (Etanercept)
Erivedge (Vismodegib)
Exjade (Deferasirox)
Forteo (Teriparatide)
Genotropin (Somatropin [rDNA origin])
Gilenya (Fingolimod)
Gleevec (Imatinib Mesylate)
Humatrope (Somatropin [rDNA origin])
Humira (Adalimumab)
Hycamtin (Topotecan Hydrochloride) Specialty Drugs Requiring Precertification 9
Incivek (Telaprevir)
Infergen (Interferon Alfacon-1)
Inlyta (Axitinib)
Jakafi (Ruxolitinib)
Kalydeco (Ivacaftor)
Kuvan (Sapropterin)
Letairis (Abrisentan)
Nexavar (Sorafenib)
Norditropin (Somatropin Injection)
Nutropin (Somatropin [rDNA origin])
Omnitrope (Somatropin [rDNA origin])
Orfadin (Nitisinone)
Pegasys (Peginterferon Alfa-2a)
Peg Intron (Peginterferon Alfa-2b)
Promacta (Eltrombopaq)
Pulmozyne (Dornase Alfa)
Rebetol (Ribavirin)
Revatio (Sildenafil Citrate)
Revlimid (Lenalidomide)
Ribapak (Ribavirin)
RibaTab (Ribavirin) Specialty Drugs Requiring Precertification 10
Ribasphere (Ribavirin)
Ribavirin
Sabril (Vigabatrin)
Saizen (Somatropin)
Samsca (Tolvaptan)
Sensipar (Cinacalcet)
Serostim (Somatropin [rDNA origin])
Simponi (Golimumab)
Sprycel (Dasatinib)
Stivarga (Regorafenib)
Sutent (Sunitinib Malate)
Tarceva (Erlotinib)
Targretin (Bexarotene)
Tasigna (Nilotinib)
Temodar (Temozolomide)
Tev –Tropin (Somatropin [rDNA origin])
Thalidomide
Tikosyn (Dofetilide)
TOBI (Tobramycin Inhalation Solution)
Tracleer (Bosentan)
Tykerb (Lapatinib) Specialty Drugs Requiring Precertification 11
Tyvaso (Treprostinil)
Ventavis (Iloprost)
Victrelis (Boceprevir)
Votrient (Pazopanib)
Xalkori (Crizotinib)
Xeloda (Capecitabine)
Xenazine (Tetrabenazine)
Xtandi (Enzalutamide)
Xolair (Omalizumab)
Zavesca (Miglustat)
Zelboraf (Vemurafenib)
Zolinza (Vorinostat)
Zorbtive (Somatropin [rDNA origin])
Zytiga (Abiraterone Acetate)