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MP 5.01.93 Specialty Drugs

Medical Policy    

Section
Prescription Drug

Original Policy Date

05/22/2006

Last Review Status/ Date

Local policy

Last updated/10:2012

Issue

10:2012

 

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

Actemra

tocilizumab

C9264

RX

rheumatoid arthritis

IV

Adcirca

tadalafil

J8499

RX

pulmonary artery hypertension

oral

Afinitor

everolimus

J8499

RX

advanced Renal Cell Carcinoma

Oral

Albuferon

albumin interferon

J3590

MM or RX

chronic hepatitis-C

SQ

 

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

Ampligen

 

J3490

MM

chronic fatigue syndrome

IV

Aralast

alpha 1-proteinase inhibitor

J0256

MM

Alpha 1-Proteinase Deficiency

IV

Arzerra

ofatumumab

C9260

RX

chronic lymphocytic leukemia

IV

Avastin

bevacizumab

J9035 (10mg)
C9257 (0.25mg)

MM

metastatic colorectal cancer, non small-cell lung cancer, advance metastatic breast cancer

IV

Benlysta

belimumab

J3590, Q2044

MM

systemic lupus erythematosus

IV

Berinert

human C1 inhibitor

J0598
C9269

MM

hereditary angioedema

IV

Boniva IV

ibandronate sodium

J7140

MM

postmenopausal osteoporosis

IV

Bosatria

mepolizumab

J3590

MM

hypereosinophilic syndrome

IV

Botox

botulinum toxin type A

J0585

MM

Cervical Dystonia

IM

Dysport

abobotulinumtoxin A, 5 units

J0586

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), 10 units

C9251 (deleted 12/31/09)
J0598 (new code 1/01/10)

MM

angioedema attacks in adolescent and adult patiens with Hereditary Angioedema (HAE)

IV

Cimzia

certolizumab

J0718 (code deleted 12/31/13)

J0717 (new code 1/1/14)

RX

Crohn`s disease, Rheumatoid Arthritis

SQ

Elaprase

idursulfase

J1743

MM

Hunter`s Syndrome

 

Enbrel

etanercept

J1438

RX

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Psoriasis, JIA

SQ

Fabrazyme

agalsidase beta

J0180

MM

Fabry Disease

IV

Factor Products

multiple generics available

Q2023 Q2041 J7185 
J1787 J7189

J7190 J7191

J7192 J7193

J7194 J7195

J7199

MM

Bleeding disorders;

hemophilia

IV

Fampridine SR

 

 

RX

improve walking ability in MS patients

oral

Fentora

fentanyl buccal

J3490*

RX

Breakthrough pain in opioid tolerant adult cancer

oral

Feraheme

ferumoxytol 

Q0138 (non ESRD)
Q0139 (ESRD)

MM

iron deficiency anemia

IV

Ferrlecit

sodium ferric gluconate complex

J2916

MM

anemia

IV

Fingolimod

 

 

RX

relapsing-remitting multiple sclerosis (RRMS)

oral

Flebogamma/Flebogamma DIF

immune globulin, non-lyophilized (IVIG)

J1572

MM

Immunodeficiency

IV

Folotyn

pralatrexate

J9307

MM

peripheral T-cell lymphoma

IV

Forteo

teriparatide

J3110

RX

Osteoporosis

SQ

Gamimune N

immune globulin, non-lyophilize d (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

Gammaplex

immune globulin, non-lyophilized (IVIG)

C9270

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

Hycamtin

topotecan

J8999

RX

Small Cell Lung Cancer

Oral

Ilaris

canakinumab

J3590

MM

cryopyrin-associated periodic syndromes (CAPS), including Muckle-Wells syndrome

IV

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

Iron dextran (Infed, Dexferrum)

 

J1750

MM

anemia

IV

Istodax

romidepsin

C9265

MM

cutaneous T-cell lymphoma

IV

Iveegam

immune globulin, lyophilized

J1566

MM

Immunodeficiency

IV

Ixempra

ixabepilone

J9207

MM

Advanced breast cancer

IV

Kalbitor

ecallantide

C9263

MM

Hereditary angioedema

SQ

Kineret

anakinra

J3590*

RX

Rheumatoid Arthritis

SQ

Letairis

ambrisentan

J8499*

RX

Pulmonary arterial hypertension

oral

Leustatin

cladribine

J9065

RX

relapsing-remitting multiple sclerosis (RRMS)

oral

Lovenox

enoxaparin

J1650

RX

blood clots

SQ

Lucentis

ranibizumab

J2778

MM

Neovascular (wet) age-related macular degeneration

Intravitreal

Lumizyme

alglucosidase alfa

J3590

MM

Pompe disease

IV

Makena hydroxyprogesterone caproate

Q2042

MM

reduce risk of repeat preterm birth

IM

Mircera

epoetin beta

J3490*

RX

anemia in chronic kidney disease

IV or SQ

Mozobil

plerixafor, 1mg

C9252 (deleted 12/31/09)
J2562 (new code 1/01/10)

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 (deleted 12/31/09)
J2796 (new code 1/01/10)

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

Onrigin

laromustine

J3490

MM

remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML)

IV

Orencia

abatacept

J0129

MM

Rheumatoid Arthritis, JIA

IV

Panglobulin/Panglobulin NF

immune globulin, lyophilized (IVIG)

J1566

MM

Immunodeficiency

IV

Perjeta pertuzumab, 10mg C9292 MM HER-2 metastatic breast cancer IV

Polygam SD

immune globulin, lyophilized (IVIG)

J1566

MM

Immunodeficiency

IV

Prialt

ziconotide acetate

J2278

MM

Severe Chronic Pain

Intrathecal

Prolastin

alpha 1-proteinase inhibitor

J0256

MM

Alpha 1-Proteinase Deficiency

IV

Prolia

denosumab

C9272

MM or RX

postmenopausal osteoporosis

SQ

Protropin

sometrem

J2940

MM

Growth Hormone

SQ

Provenge

sipuleucel-T

C9273, Q2043

MM

hormone refractory prostate cancer

IV

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

Revimmune

high-dose cyclophosphamide

J3590

MM

refractory multiple sclerosis

IV

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

Sandostatin

octreotide prolonged release

J2353 (IM)
J2354 (IV/SQ)

MM or RX

acromegaly

IV, IM, SQ

Serostim

somatropin

J2941

MM

Growth Hormone

SQ

Simponi

golimumab

J3490*
C9399 (IV)

MM or RX

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylosis

SQ, IV

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

Stelara

ustekinumab

C9261

MM or RX

moderate to severe psoriasis

SQ

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

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
J9328

RX
MM

brain tumors

Oral
IV

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

Uplyso

taliglucerase alfa

J3590

MM

Gaucher disease

IV

Vpriv

velaglucerase alfa (GA-GCB)

C9271
J3490

MM

Gaucher disease

IV

Velcade

bortezomib

J9041

MM

Multiple Myeloma

IV

Venofer

iron sucrose

J1756

MM

Chronic kidney disease

IV

Venoglobulin-S

immune globulin, non-lyophilized

J1567

MM

Immunodeficiency

IV

Vivaglobin

subcutaneous immune globulin

J1562

MM

Immunodeficiency

IV

Voraxaze glucarpidase, 10units C9293 MM toxic methotrexate levels IV

Votrient

pazopanib

C9399
J8999

RX

advanced renal cell carcinoma

oral

Xeloda

capecitabine

J8520, J8521

RX

Metastatic breast or metastatic colorectal cancer

oral

Xgeva

denosumab

J3590

MM

Skeletal related events from solid tumors

SQ

Xiaflex

clostridial collagenase

J3590

MM

Dupuyten's contracture

IV

Xigris

drotrecogin alfa

J3490*

MM

Severe sepsis

oral

Xolair

omalizumab

J2357

RX

Asthma

SQ

Yervoy ipilimumab

C9284

MM

melanoma

IV

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
04/01/10 update policy added iron sucrose
06/01/10 update policy added all IV iron
07/28/10 update policy added Kalbitor
10/13/10 replace policy remove viscosupplement as requiring prior authorization
5/13/11 update policy add Xgeva
7/14/11 update policy add Yervoy
9/7/11 update policy add new (7/1/11) codes
10/1/12 update policy add Voraxaze, Perjeta