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1 Request fr Prir Authrizatin fr Click here t enter text. Website Frm Submit request via: Fax Updated: 05/2018 DMMA Apprved: 05/2018 All requests fr Intravenus Immunglbulin (IVIG) & Subcutaneus Immune Glbulin (SCIG) Therapies require a Prir Authrizatin and will be screened fr medical necessity and apprpriateness using the criteria listed belw. Intravenus Immunglbulin (IVIG) & Subcutaneus Immune Glbulin (SCIG) Therapies: Fr all requests fr Intravenus Immunglbulin (IVIG) & Subcutaneus Immune Glbulin (SCIG) Therapies all f the fllwing criteria must be met: There are dcumented clinical ntes including apprpriate psitive findings n diagnstic testing and/r bipsy results. The requested dse and frequency is in accrdance with FDA-apprved labeling, natinally recgnized cmpendia, and/r evidence-based practice guidelines. Cverage may be prvided with a diagnsis f fr the treatment f primary immundeficiency and the fllwing criteria is met: Fr diagnsis f Cmmn Variable Immundeficiency (CVID): IgG, IgA, IgM level must be belw the nrmal range (mre than 2 standard deviatins belw the age-specific mean) n at least tw ccasins. Dcumented recurrent bacterial infectins Failure f prphylactic antibitic therapy Initial Duratin f Apprval: 3 mnths Reauthrizatin Criteria: Reauthrizatin Duratin f Apprval: 12 mnths Fr diagnsis f Cngenital Agammaglbulinemia (X-linked agmammaglbulinemia): IgA, IgG and IgM levels must be belw the nrmal range (mre than 2 standard deviatins belw the age-specific mean) n at least tw ccasins. Dcumented recurrent bacterial infectins. Initial Duratin f Apprval: 6 mnths Reauthrizatin Criteria: Dcumentatin f IgG trugh level measured prir t therapy.

2 DMMA Apprved: 05/2018 Dcumentatin f IgG trugh levels that has increased r remain stabilized frm baseline within the last 6 mnths. Reauthrizatin Duratin f Apprval: 6 mnths Fr diagnsis f Hypgammaglbulinemia (excluding IgA deficiency): IgG level must be belw the nrmal range (mre than 2 standard deviatins belw the age-specific mean) n at least tw ccasins. Histry f recurrent bacterial sinpulmnary infectins requiring multiple curses r prlnged antibitic therapy r failure f prphylactic antibitic therapy. Attestatin must be prvided that underlying cnditins such as asthma r allergic rhinitis that may predispse member t recurrent infectins are medically managed where applicable. Initial Duratin f Apprval: 3 mnths Reauthrizatin Criteria: Reauthrizatin Duratin f Apprval: 12 mnth Fr diagnsis f Selective IgG subclass deficiency: Deficiency f ne r mre IgG subclasses belw the nrmal range (mre than 2 standard deviatins belw the age-specific mean) assessed n at least tw ccasins. Unexplained recurrent r persistent severe bacterial infectins despite apprpriate treatment. Inadequate respnse t prtein and plysaccharide antigens, as determined by ALL f the fllwing: Dcumented inability t munt an antibdy respnse t prtein antigens (Serum antibdy titers t tetanus and / r diphtheria shuld be btained prir t immunizatin with diphtheria and / r tetanus vaccine and 3 t 4 weeks after immunizatin. An inadequate respnse is defined as less than a 4-fld rise in antibdy titer and lack f prtective antibdy level). Dcumented inability t munt an adequate antibdy respnse t plysaccharide antigens (Serum antibdy titers t 14 pneumcccus sertypes shuld be measured prir t immunizatin and 3 t 6 weeks after immunizatin with plyvalent pneumcccal plysaccharide vaccine. An inadequate respnse is defined as less than a 4-fld rise in titer ver baseline in at least 30 % f sertypes tested (in at least 50 % f sertypes tested in children aged 2 t 5 years) and lack f prtective antibdy level [i.e., specific IgG cncentratin less than 1.3 mcg/ml]). Initial Duratin f Apprval: 3 mnths Reauthrizatin Criteria:

3 DMMA Apprved: 05/2018 Member must be reevaluated fr medical necessity f immune glbulin ne year after initiating therapy. Reauthrizatin Duratin f Apprval: 9 mnths Fr diagnsis f Severe Cmbined Immundeficiency (SCID): Labratry findings f all the fllwing belw the nrmal reference range: T cells, IgA, IgE and IgM Dcumented recurrent r serius bacterial infectins directly attributable t this deficiency. Initial Duratin f Apprval: 6 mnths Dcumentatin f IgG trugh level measured prir t therapy. Dcumentatin f IgG trugh levels that has increased r remain stabilized frm baseline within the last 6 mnths. Reauthrizatin Duratin f Apprval: 6 mnths Fr diagnsis f Specific Antibdy Deficiency (SAD): Dcumented nrmal serum IgG, IgA, and IgM. Nrmal respnses t prtein antigens (tetanus and diphtheria txid r HiB) measured 3 4 weeks after immunizatin. Inadequate respnsiveness t pneumcccal plysaccharide vaccine (Pneumvax 23) 4 8 weeks after vaccinatin as defined by: Age < 6 years, < 50% f sertypes are prtective (i.e., 1.3 mcg/ml per sertype). Age 6 years, < 70% f sertypes are prtective (i.e., 1.3 mcg/ml per sertype). Inadequate respnsiveness t pneumcccal cnjugate vaccine (Prevnar 13 ) 4 8 weeks after vaccinatin as defined by: Age < 6 years, < 50% f sertypes are prtective (i.e., 1.3 mcg/ml per sertype). Age 6 years, < 70% f sertypes are prtective (i.e., 1.3 mcg/ml per sertype). Unexplained recurrent r persistent severe bacterial infectins despite apprpriate treatment. Initial Duratin f Apprval: 3 mnths Reauthrizatin Criteria: Reauthrizatin Duratin f Apprval: 12 mnths Fr diagnsis f Wisktt-Aldrich Syndrme

4 DMMA Apprved: 05/2018 IgG level must be belw the nrmal range (mre than 2 standard deviatins belw the age-specific mean) n at least tw ccasins. Dcumented recurrent r serius bacterial infectins. Initial Duratin f Apprval: 6 mnths Reauthrizatin Criteria Dcumentatin f IgG trugh level measured prir t therapy. Dcumentatin f IgG trugh levels that has increased r remain stabilized frm baseline within the last 6 mnths. Reauthrizatin Duratin f Apprval: 6 mnths Fr diagnsis f X-linked immundeficiency with hyperimmunglbulin M IgG levels must be belw the nrmal range (mre than 2 standard deviatins belw the age-specific mean) n at least tw ccasins. Dcumented recurrent bacterial infectins. Initial Duratin f Apprval: 6 mnths Reauthrizatin Criteria Dcumentatin f IgG trugh level measured prir t therapy. Dcumentatin f IgG trugh levels that has increased r remain stabilized frm baseline within the last 6 mnth. Reauthrizatin Duratin f Apprval: 6 mnths. Cverage may be prvided with a diagnsis f fr the treatment f Acute Idipathic Thrmbcytpenia Purpra and the fllwing criteria is met: Member must meet ONE f the fllwing Member is using medicatin fr management f acute bleeding due t severe thrmbcytpenia (platelet cunts less than 30,000/μl) and t increase platelet cunts prir t invasive majr surgical prcedures. Member has severe thrmbcytpenia (platelet cunts less than 20,000/μl) cnsidered t be at risk fr intracerebral hemrrhage. Initial Duratin f Apprval: 5 days, must be reevaluated fr medical necessity fr reauthrizatin. Cverage may be prvided with a diagnsis f fr the treatment f Chrnic Idipathic Thrmbcytpenia Purpra and the fllwing criteria is met: Other causes f thrmbcytpenia have been ruled ut by histry and peripheral smear. Member is unrespnsive t fur days f crticsterid therapy.

5 DMMA Apprved: 05/2018 Member must meet ONE f the f the fllwing: Member has had a splenectmy. Member is btaining IVIG t defer r avid splenectmy. Platelet cunts persistently at r belw 20,000/μl. Initial Duratin f Apprval: 5 days Reauthrizatin Criteria: Member must have dcumentatin f clinical benefit frm immune glbulin therapy Reauthrizatin Duratin f Apprval: 12 mnths Cverage may be prvided with a diagnsis f bacterial infectin prphylaxis in immuncmprmised patients fr the preventin f bacterial infectins in patients with hypgammaglbulinemia and/r recurrent bacterial infectins assciated with B-cell Chrnic Lymphcytic Leukemia (CLL) and the fllwing criteria is met: Member has an immunglbulin G (IgG) levels f less than 600mg/dl r evidence f specific antibdy deficiency. Member has recurrent bacterial infectin as evidenced by ne severe bacterial infectin within preceding 6 mnths r at least tw bacterial infectins in a 1-year perid. Initial Duratin f Apprval: 3 mnths Reauthrizatin Criteria: Member must have dcumentatin f active disease. Reauthrizatin Duratin f Apprval: 12 mnths Cverage may be prvided fr the treatment f Kawasaki disease and the fllwing criteria is met: Fever present fr at least 5 days. Treatment is initiated within ten days f nset f fever. Fur f the fllwing five symptms are present: Mucus membrane changes such as a red tngue and dry fissured lips Swelling f the hands and feet Enlarged lymph ndes in the neck Diffuse red rash cvering mst f the bdy Redness f the eyes Oral aspirin is used cncurrently as fllws: ral aspirin 100 mg/kg daily until the 14th day f illness, then 3-5 mg/kg fr a perid f five weeks. Initial Duratin f Apprval: 2 weeks Reauthrizatin Criteria: Member must have dcumentatin that treatment with first infusin failed. Reauthrizatin Duratin f Apprval: 2 weeks

6 DMMA Apprved: 05/2018 Cverage may be prvided fr the treatment f chrnic inflammatry demyelinating plyneurpathy (CIDP) t imprve neurmuscular disability and impairment: Symmetric r fcal neurlgic deficits with slwly prgressive r relapsing curse ver 2 mnths r lnger with neurphysilgical abnrmalities. Nerve cnductin study shwing diffuse demyelinatin. Member is intlerant r refractry t therapeutic dses f crticsterids fr a duratin f 1 mnth. Initial Duratin f Apprval: 3 mnths Reauthrizatin Criteria: Member must have dcumentatin f clinical benefit frm immune glbulin therapy Reauthrizatin Duratin f Apprval: 12 mnths Cverage may be prvided with a fr the maintenance treatment f multifcal mtr neurpathy t imprve muscle strength and disability: Member must be 18 years f age r lder. Member has ONE f the fllwing prgressive symptms present fr at least 2 mnths: Asymmetric limb weakness, Mtr invlvement having a mtr nerve distributin in tw r mre nerves. Member has n bjective sensry abnrmalities except fr minr vibratin sense abnrmalities in the lwer limbs. Member has definite cnductin blck n ne nerve r prbable cnductin blck n tw nerves. Nrmal sensry nerve cnductin in upper limb segments with CB and nrmal sensry nerve actin ptential (SNAP) amplitudes. Initial Duratin f Apprval: 3 mnths Reauthrizatin Criteria: Member must have dcumentatin f clinical benefit frm immune glbulin therapy Reauthrizatin Duratin f Apprval: 12 mnths