Stelara (ustekinumab) Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage POLICY A.INDICATIONS The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. FDA-Approved Indications •Active psoriatic arthritis (PsA) •Moderate to severe plaque psoriasis (PsO) B.REQUIRED DOCUMENTATION The following information is necessary to initiate the prior authorization review: •Current and previous therapies documented in member’s chart or medical record •Pretreatment tuberculosis (TB) screening with TB skin test or an interferon gamma release assay (e.g., QFT-GIT, T-SPOT.TB) and TB treatment status (if applicable) documented in member’s chart or medical record •For plaque psoriasis, the following documentation is also required: oDocumentation supporting a history of plaque psoriasis for at least six months oPercent of body surface area involvement oResults of treatment with methotrexate (MTX) such as ineffective treatment or intolerance, or documentation that MTX is contraindicated oFor continuation of therapy, documentation supporting a decrease in percent of body surface area involvement when compared to baseline •For psoriatic arthritis, the following documentation is also required: oFor continuation of therapy, documentation of positive clinical response in member’s chart or medical record C.EXCLUSIONS •Untreated latent TB infection oTreatment must be initiated or completed prior to starting Stelara. •Active tuberculosis infection oTreatment must be completed prior to starting Stelara. Effective Date: 10/01/2015
Stelara 2 D.CRITERIA FOR APPROVAL 1.Active Psoriatic Arthritis Authorization of 24 months may be granted to members who are 18 years of age and older and who meet ANY of the following criteria: a.Member had an inadequate response to at least a 3-month trial of MTX, sulfasalazine, or leflunomide. b.Member has intolerance or contraindication to MTX, sulfasalazine, or leflunomide. Contraindications to MTX, sulfasalazine, or leflunomide – Examples: •History of intolerance or adverse event •Alcoholic liver disease or other chronic liver disease •Elevated liver transaminases •Interstitial pneumonitis or clinically significant pulmonary fibrosis •Renal impairment •Pregnancy or planning pregnancy (male or female) •Breastfeeding •Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia) •Myelodysplasia •Urinary obstruction •Intestinal obstruction •Porphyria •Hypersensitivity •Significant drug interaction c.Member has had an inadequate response to at least a 3-month trial of a prior biologic DMARD. d.Member has experienced intolerance to a prior biologic DMARD. e.Member’s condition is severely active as evidenced by ANY of the following: i.Multiple swollen joints ii.Structural damage in the presence of inflammation iii.Clinically relevant extra-articular manifestations Extra-articular manifestations of psoriatic arthritis – Examples: •Cutaneous involvement: oPsoriasis oErythema nodosum oKeratoderma blenorrhagicum oCircinate balanitis oPyoderma gangrenosum •Bowel involvement oCrohn’s disease (CD) oUlcerative colitis(UC) oA specific colitis (in presence of inflammatory bowel disease [IBD] that cannot be classified as CD or UC) oSevere and persistent diarrhea •Ocular involvement oUveitis oConjunctivitis •Cardiovascular involvement
Stelara 3 oAortic insufficiency oConduction disturbances (e.g., atrioventricular blocks, bundle branch blocks, and intraventricular blocks) oThrombosis oPhlebitis •Urogenital involvement oUrethritis oProstatitis oBalanitis oVaginitis oCervicitis amyloidosis (AA type) oIgA nephropathy •Pulmonary involvement: Apical pulmonary fibrosis f.Member has active enthesitis and/or active dactylitis (i.e., sausage digit) g.Member has predominant axial disease (i.e., extensive spinal involvement). 2.Moderate to Severe Plaque Psoriasis Authorization of 6 months may be granted to members who are 18 years of age and older and who meet ALL of the following criteria: a.Treatment with Stelara was recommended by a dermatologist b.Member has been diagnosed with moderate to severe chronic plaque psoriasis defined as the following: i.At least 10% of body surface area (BSA) is affected, or crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected, and ii.History of psoriasis 6 months or longer c.Plaque psoriasis is characterized by well-defined patches of red and raised skin d.Member has tried methotrexate (MTX) for at least three months at a therapeutic dose and found it to be ineffective, or the member exhibited intolerance or allergy, or the use of MTX is contraindicated. i.Ineffective treatment is defined as symptoms and/or signs that are not resolved after completion of treatment at the recommended therapeutic dose and duration. If there is no recommended treatment time, the member must have had a meaningful trial. ii.Intolerance is defined as having a recognized and reproducible or repeated adverse reaction that is clearly associated with taking the medication. iii.Allergy is defined as a state of hypersensitivity produced by exposure to a particular antigen resulting in harmful immunologic reactions on subsequent exposures. The most common symptoms are skin rash or anaphylaxis. e.Continuation of therapy is covered (subject to Administrative Guidelines) when initial therapy has been approved and there is a decrease in percent of body surface area involvement when compared to baseline. E.CONTINUATION OF THERAPY For active psoriatic arthritis, authorization of 24 months may be granted to members requesting authorization for continuation of therapy if member has achieved or maintained positive clinical response to treatment with Stelara as evidenced by low disease activity or improvement in signs and symptoms of the condition.
Stelara 4 To receive authorization for an additional 6 months of therapy for plaque psoriasis, documentation supporting a decrease in percent of body surface area involvement when compared to baseline must be submitted. Thereafter, authorization of 12 months may be granted. F.DOSAGE AND ADMINISTRATION Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. G.IMPORTANT REMINDER The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii’s Patients’ Bill of Rights and Responsibilities Act (Hawaii Revised Statutes §432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA’s determination as to medical necessity in a given case, the physician may request that CVS/caremark reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. H.REFERENCES 1.Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; March 2014. 2.Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis 2012;71:4- 12. 3.Gladman DD, Antoni C, P Mease, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005;64(Suppl II):ii14–ii17. 4.Peluso R, Lervolino S, Vitiello M, et al. Extra-articular manifestations in psoriatic arthritis patients. Clin Rheumatol. 2014 May 8. [Epub ahead of print]. Accessed August 22, 2014.