Specialty Drugs

Select a Secure Log-in

Spotlight

Personal Health Management

Manage your health records and conditions from a single, secure location.

Knowledge Center

Knowledge is power! Information and resources to help you get more from your health insurance coverage.

Health News

Lantus Insulin: Link to Cancer Shaky

Experts say patients should not worry about shaky data suggesting a possible slight cancer risk in people with type 2 diabetes who take Lantus, a long-acting insulin.

Read more / Search Archives

MP 5.01.17

Specialty Drugs

Medical Policy

Section
Prescription Drug

Original Policy Date

05/22/2006

Last Review Status/ Date

Updated/5:2009

Issue

5:2009

Return to Medical Policy Index

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.

Description

Specialty drugs represent an increasing amount of rising health care costs. The average cost per patient year is often over $10,000, but can vary depending on the disease state of the patient. In accordance with the member’s policy, BCI will review and assist the member in receiving the most cost effective, appropriate medication given in the most appropriate setting to treat the member’s condition, disease or illness.

Policy

Blue Cross of Idaho requires Prior Authorization of various medications including specialty drugs that are scientifically engineered medications used to treat complex or rare conditions including, but not limited to, anemia, asthma, cancer, hemophilia, multiple sclerosis, rheumatoid arthritis, psoriasis, and human growth hormone deficiency. Specialty drugs include but are not limited to intravenous, self-injectable, topical and oral medications.

Policy Guidelines

Specialty drugs including but are not limited to, intravenous, self-injectable, topical and oral medications and are considered medically necessary when the following criteria is met:

The most appropriate medication and level of service, considering potential benefits and harms to member.
Proven to be effective in improving health outcomes,
- For new treatments, effectiveness is determined by scientific evidence,
- For existing treatments, effectiveness is determined by first scientific evidence, then by professional standards, then by expert opinion.
Not primarily for the convenience of the member or covered provider.
Cost-effective for this condition, compared to alternative treatments, including no treatment. Cost-effectiveness does not necessarily mean lowest price.

When applied to the care of an Inpatient, it further means that the member’s medical symptoms or condition are such that the services cannot be safely and effectively provided to the member as an Outpatient.

The fact that a Covered Provider may prescribe, order, recommend, or approve a service or supply does not, in and of itself, necessarily establish that such service or supply is Medically Necessary.

The term Medically Necessary as defined and used in the policy is strictly limited to the application and interpretation of this policy, and any determination of whether a service is Medically Necessary hereunder is made solely for the purpose of determining whether services rendered are covered services.

The list of medications is not an all-inclusive list, and is subject to change as new medications become available.

Coverage for growth hormone under major medical versus prescription benefits is solely determined by member contract language.

Benefit Application

May not apply to Medicare Advantage, Medicare Supplement, or Federal Employee Program (FEP) policies, depending on policy and benefit requirements.

May not apply to National or ASC Accounts, please check contract specific language.

Rationale

TEC Criteria 1-5

BCBSA Paper: Outpatient Specialty Drugs Benchmarking Study
FDA approved medication package inserts
BCI member contract definition

Codes

The following drugs, listed with appropriate code(s) require Prior Authorization. In addition to this list, any medication being used for off-label (not FDA approved) use is subject to prior authorization.

Brand Name	Generic Name	Applicable Code	MM or RX	Indications	Route
Afinitor	everolimus	J8499	RX	advanced Renal Cell Carcinoma	Oral
Aldurazyme	laronidase	J1931	MM	Hurler Syndrome	IV
Alferon N	interferon alfa-n3 (human leukocyte derived)	J9215	MM	Venereal/Genital Warts	Intralesion
Amevive	alefacept	J0215	MM	Psoriasis	IM
Aralast	alpha 1-proteinase inhibitor	J0256	MM	Alpha 1-Proteinase Deficiency	IV
Avastin	bevacizumab	J9035	MM	metastatic colorectal cancer, non small-cell lung cancer, advance metastatic breast cancer	IV
Boniva IV	ibandronate sodium	J7140	MM	postmenopausal osteoporosis	IV
Botox	botulinum toxin type A	J0585	MM	Cervical Dystonia	IM
Carimune/Carimune NF	immune globulin, lyophilized (IVIG)	J1566	MM	Immunodeficiency	IV
Celebrex	celecoxib	J8499*	RX	NSAID	Oral
Cerezyme	imiglucerase	J1785	MM	Type 1 Gaucher disease	IV
Cinryze	C1 esterase inhibitor (human)	C9251	MM	angioedema attacks in adolescent and adult patiens with Hereditary Angioedema (HAE)	IV
Cimzia	certolizumab	C9249	RX	Crohn"s disease, Rheumatoid Arthritis	SQ
Elaprase	idursulfase	J1743	MM	Hunter"s Syndrome	IV
Enbrel	etanercept	J1438	RX	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Psoriasis, JIA	SQ
Euflexxa	sodium hyaluronate	J7323	MM	Viscosupplement	IA
Fabrazyme	agalsidase beta	J0180	MM	Fabry Disease	IV
Factor Products	multiple generics available	Q2023 J1787 J7189 J7190 J7191 J7192 J7193 J7194 J7195 J7199	MM	Bleeding disorders; hemophilia	IV
Fentora	fentanyl buccal	J3490*	RX	Breakthrough pain in opioid tolerant adult cancer	oral
Flebogamma/Flebogamma DIF	immune globulin, non-lyophilized (IVIG)	J1572	MM	Immunodeficiency	IV
Forteo	teriparatide	J3110	RX	Osteoporosis	SQ
Gamimune N	immune globulin, non-lyophilized (IVIG)	J1567	MM	Immunodeficiency	IV
Gammagard Solution	immune globulin, non-lyophilized (IVIG)	J1569	MM	Immunodeficiency	IV
Gammagard/Gammagard SD	immune globulin, lyophilized (IVIG)	J1566	MM	Immunodeficiency	IV
Gammar-P	immune globulin, lyophilized (IVIG)	J1566	MM	Immunodeficiency	IV
Gamunex	immune globulin, non-lyophilized (IVIG)	J1561	MM	Immunodeficiency	IV
Genotropin	somatropin	J2941	MM	Growth Hormone	SQ
Gleevec	imatinib mesylate	S0088 or J8999*	RX	Chronic myelocytic leukemia and gastrointestinal stromal tumor (GIST)	Oral
Humatrope	somatropin	J2941	MM	Growth Hormone	SQ
Humira	adalimumab	J0135	RX	Rheumatoid Arthritis, JIA, psoriatic arthritis, ankylosing spondylitis and Crohn"s	SQ
Hyalgan	sodium hyaluronate	J7321	MM	Viscosupplement	IA
Hycamtin	topotecan	J8999	RX	Small Cell Lung Cancer	Oral
Implanon	etanogestrel implant system	J7306	MM	Contraceptive	implant
Increlex	mecasermin	J2170	RX	Growth Hormone	SQ
Intron-A	Interferon alfa-2b, recombinant	J9214	RX	Hepatitis C	SQ or IM
Iplex	mesasermin rinfabate PF	J2170	MM	Growth Hormone	SQ
Iressa	gefitinib	J8565	RX	Non small-cell lung cancer	Oral
Iveegam	immune globulin, lyophilized	J1566	MM	Immunodeficiency	IV
Ixempra	ixabepilone	J9207	MM	Advanced breast cancer	IV
Kineret	anakinra	J3590*	RX	Rheumatoid Arthritis	SQ
Letairis	ambrisentan	J8499*	RX	Pulmonary arterial hypertension	oral
Lovenox	enoxaparin	J1650	RX	blood clots	SQ
Lucentis	ranibizumab	J2778	MM	Neovascular (wet) age-related macular degeneration	Intravitreal
Mircera	epoetin beta	J3490*	RX	anemia in chronic kidney disease	IV or SQ
Mozobil	plerixafor	C9252	MM	with GCSF for NHL and multiple myeloma	IV
Myobloc	botulinum toxin type B	J0587	MM	Cervical Dystonia	IM
Myozyme	alglucosidase alfa	J0220	MM	Pompe disease	IV
Naglazyme	galsulfase	J1458	MM	Maroteaux-Lamy syndrome (MPS VI)	IV
Nexavar	sorafenib tosylate	J8999*	RX	Liver and Kidney Cancer	Oral
NordiFlex	somatropin	J2941	MM	Growth Hormone	SQ
Norditropin	somatropin	J2941	MM	Growth Hormone	SQ
Nplate	romiplostim	C9245	MM	chronic immune (idiopathic)thrombocytopenic purpura ITP	SQ
Nutropin/Nutropin AQ	somatropin	J2941	MM	Growth Hormone	SQ
Octagam	immune globulin, non-lyophilized (IVIG)	J1568	MM	Immunodeficiency	IV
Orencia	abatacept	J0129	MM	Rheumatoid Arthritis, JIA	IV
Orthovisc	sodium hyaluronate	J7324	MM	Viscosupplement	IA
Panglobulin/Panglobulin NF	immune globulin, lyophilized (IVIG)	J1566	MM	Immunodeficiency	IV
Polygam SD	immune globulin, lyophilized (IVIG)	J1566	MM	Immunodeficiency	IV
Prialt	ziconotide acetate	J2287	MM	Severe Chronic Pain	Intrathecal
Prolastin	alpha 1-proteinase inhibitor	J0256	MM	Alpha 1-Proteinase Deficiency	IV
Protropin	sometrem	J2940	MM	Growth Hormone	SQ
Reclast	zoledronic acid	J3488	MM	Osteoporosis	IV
Regranex	becaplermin gel	S0157	RX	Lower extremity, Diabetic ulcers	Topical
Remicade	infliximab	J1745	MM	Rheumatoid Arthritis, Crohn"s Disease, Ulcerative Colitis, Ankylosing Spondylitis, Psoriatic Arthritis	IV
RespiGam	respiratory syncytial virus immune globulin (RSV-IVIG)	J1565	MM	RSV	IV
Revatio	sildenafil citrate	J8499*	RX	pulmonary arterial hypertension	oral
Revlimid	lenalidomide	J8499*	RX	Multiple Myeloma	oral
Rituxan	rituximab	J9310	MM	Rheumatoid Arthritis, Non-Hodgkin"s lymphoma	IV
Saizen	somatropin	J2941	MM	Growth Hormone	SQ
Serostim	somatropin	J2941	MM	Growth Hormone	SQ
Simponi	golimumab	J3490*	RX	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylosis	SQ
Soliris	eculizumab	J1300	MM	Paroxysmal nocturnal hemoglobinuria (PNH)	IV
Somatuline	lanreotide acetate	J1930	MM or RX	Adult acromegaly	SQ
Sprycel	dasatinib	J8999*	RX	CML	Oral
Supartz	sodium hyaluronate	J7321	MM	Viscosupplement	IA
Sutent	sunitinib malate	J8999*	RX	Advanced Renal Cell or gastrintestinal stromal tumor	Oral
Synagis	respiratory syncytial virus immune globulin (RSV-IgIM)	90378	MM	RSV	IM
Synvisc	hylan G-F 20	J7322	MM	Viscosupplement	IA
Tarceva	erlotinib	J8999*	RX	Non small-cell lung cancer (NSCLC) and advanced pancreatic cancer	oral
Tasigna	nilotinib	J8999*	RX	Philadelphia Chromosome Positive Chronic Myeloid Leukemia	oral
Tev-Tropin	somatropin	J2941	MM	Growth Hormone	SQ
Temodar	temozolomide	J8700	RX	brain tumors	Oral
Torisel	temsirolimus	J3490*	RX	Advanced renal cell carcinoma	oral
Tykerb	lapatinib	J8999*	RX	HER2+ early breast cancer	oral
Tysabri	natalizumab	J2323	MM	Relapsing/remitting multiple sclerosis	IV
Velcade	bortezomib	J9041	MM	Multiple Myeloma	IV
Venoglobulin-S	immune globulin, non-lyophilized	J1567	MM	Immunodeficiency	IV
Vivaglobin	subcutaneous immune globulin	J1562	MM	Immunodeficiency	IV
Xeloda	capecitabine	J8520, J8521	RX	Metastatic breast or metastatic colorectal cancer	oral
Xigris	drotrecogin alfa	J3490*	MM	Severe sepsis	oral
Xolair	omalizumab	J2357	RX	Asthma	SQ
Zemaira	alpha 1-proteinase inhibitor	J0256	MM	Alpha 1-Proteinase Deficiency	IV
Zolinza	vorinostat	J8499*	RX	cutaneous T cell lymphoma	oral
Zorbtive	somatropin	J2941	MM	Growth Hormone	SQ

The following drugs, listed with appropriate code(s) may be reviewed (pre-service and post-service) for most cost-effective procurement and/or setting.

Brand Name	Generic Name	Applicable Code	MM or RX	Indications	Route
Actimmune	interferon gamma-1b, 3 million units	J9216	RX	Chronic Granulomatous Disease	SQ or IM
Actiq	fentanyl citrate lozenge	J8499*	RX	Oncology, pain	Oral
Apokyn	apomorphine	S0167	RX	Parkinson"s Disease	SQ or IM
Aranesp	darbopoetin alpha (non-ESRD)	J0881	RX	Anemia	SQ
Arixtra	fondaparinux	J1652	RX	Blood Clots	SQ
Avonex	interferon beta-1a	J1825	RX	Multiple Sclerosis	IM
Betaseron	interferon beta-1b	J1830	RX	Multiple Sclerosis	IM
Copaxone	glatiramer	J1595	RX	Multiple Sclerosis	IM
Eligard	leuprolide acetate, depot	J9217	RX	LHRH Agonist, Oncology	SQ
Epogen	epoetin alpha (non-ESRD)	J0885	RX	Anemia	SQ
Flolan	epoprostenol	J1325	MM	Pulmonary Hypertension	IV
Fragmin	dalteparin	J1645	RX	Blood Clots	SQ
Infergen	interferon alfacon-1, recombinant, 1 microgram	J9212	RX	Hepatitis C	SQ
Innohep	tinzaparin sodium	J1655	RX	Blood Clots	SQ
Leukine	sargramostim (GM-CSF)	J2820	RX or MM	Hematopoietics, Neutrophil Stimulating	SQ or IV
Leuprolide Acetate	leuprolide acetate, non-depot	J9218	RX	LHRH Agonist, Oncology	SQ
Lupron Depot	leuprolide acetate, depot	J1950 or J9217	RX	LHRH Agonist, Oncology	SQ
Neulasta	pegfilgrastim	J2505	RX	Hematopoietics, Neutrophil Stimulating	SQ
Neumega	oprelvekin	J2355	RX	Thrombocytopenia	SQ
Neupogen	filgrastim (G-CSF)	J1440 or J1441	RX	Hematopoietics, Neutrophil Stimulating	SQ or IM
Peg Intron	peginterferon alfa-2b	S0146	RX	Hepatitis C	SQ
Pegasys	peginterferon alfa-2a	S0145	RX	Hepatitis C	SQ
Procrit	epoetin alpha (non-ESRD)	J0885	RX	Erythropoietin for Anemia	SQ
Rebetron	interferon alfa-2b/ribavirin	J9214	RX	Hepatitis C	SQ
Rebif	interferon beta-1a	J1825	RX	Multiple Sclerosis	SQ
Remodulin	treprostinil	J3285	MM	Pulmonary Hypertension	SQ
Roferon-A	Interferon alfa-2a, recombinant, 3 million units	J9213	RX	Hepatitis C	SQ
Tracleer	bosetan	J8499*	RX	Pulmonary Hypertension	Oral
Trelstar	triptorelin pamoate	J3315	RX	LHRH Agonist, Oncology	IM
Vantas	histrelin implant	J9225	MM	LHRH Agonist, Oncology	Implant
Ventavis	iloprost, inhalation solution	Q4080 or J7699*	RX	Pulmonary Hypertension	Inhalation
Viadur	leuprolide acetate implant	J9219	MM	LHRH Agonist, Oncology	Implant
Zoladex	goserelin acetate implant	J9202	MM	LHRH Agonist, Oncology	Implant

*J3490, J3590, J7699, J8499 & J8999 require name, strength and NDC# of medication when billed.

Index

Specialty drugs
Drugs that require Prior Authorization

Policy History

Date	Action	Reason
05/22/2006	Add to Prescription Drug Section	New policy
08/30/2006	Replace Policy	Revised medication listings and updated codes
01/17/08	Update policy	corrected HCPCS codes for 2008
08/27/08	Update policy	added several medications to prior-auth list
05/21/09	Update policy	added new medications and updated coding and indications
06/01/09	Update policy	added new medications

Search for Policies

Policy Feedback

Resource Center

Find a Provider	Medicare
Prescription Drugs	Medicare Formulary