subcutaneous initially every 4 weeks then every 12 weeks Coverage Criteria: Express Scripts, Inc. monograph dated 02/24/2010

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "subcutaneous initially every 4 weeks then every 12 weeks Coverage Criteria: Express Scripts, Inc. monograph dated 02/24/2010"

Transcription

1 BENEFIT DESCRIPTION AND LIMITATIONS OF COVERAGE ITEM: PRODUCT LINES: COVERED UNDER: DESCRIPTION: CPT/HCPCS Code: Company Supplying: Setting: Humira (adalimumab subcutaneous injection) Commercial HMO/PPO/CDHP HMO/PPO/CDHP: Rx (self-administered) Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor alpha (TNFα). Adalimumab neutralizes the biological activity of TNFα and inhibits binding of TNFα with its receptors. TNF, a naturally occurring cytokine, mediates inflammation and modulates cellular immune responses. Increased levels of TNF are found in the synovial fluid of patients with rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JIA), psoriatic arthritis (PsA), and ankylosing spondylitis. J0135 Abbott Laboratories subcutaneous initially every 4 weeks then every 12 weeks Coverage Criteria: Express Scripts, Inc. monograph dated 02/24/2010 Approval Period: 12 months or as otherwise noted by indication Recommended Authorization Criteria Coverage of adalimumab is recommended in those who meet one of the following criteria: FDA-Approved Indications 1. Adults with rheumatoid arthritis. Approve for 12 months if the patient has tried one DMARD (brand or generic; oral or injectable) for at least 2 months, [this includes patients who have tried other biologic DMARDs for at least 2 months] OR is concurrently receiving MTX. Adalimumab is FDA-approved for moderate or severe active RA in adults and can be used alone or in combination with MTX or other DMARDs. Initiating DMARD therapy with a biologic agent such as adalimumab alone should be rare. Most patients will have received initial therapy with an oral DMARD(s) (e.g., hydroxychloroquine, leflunomide, sulfasalazine, MTX). If MTX is contraindicated, another oral DMARD should be tried. Some patients with important markers of poor prognosis (e.g., functional limitations, rheumatoid factor positivity and/or positive anticyclic citrullinated peptide (CCP) antibodies, extraarticular manifestations of RA [e.g., vasculitis, Sjögren s syndrome, RA lung disease]) or with joint erosions may be started early on biologic agents; patients will be evaluated by a pharmacist and/or physician on a case-by-case basis to determine a coverage recommendation for the client. This criterion is recommended based on the professional opinion of specialized physicians. 2. Juvenile idiopathic arthritis (JIA) or JRA, polyarticular course (regardless of type of onset). Approve for 12 months if the patient has tried MTX or will be 1

2 starting on adalimumab concurrently with MTX. Approve for 12 months without trying MTX if the patient has an absolute contraindication to MTX (e.g., pregnancy, breast feeding, alcoholic liver disease, immunodeficiency syndrome, blood dyscrasias). Adalimumab is FDA-approved for reducing signs and symptoms of moderately to severely active polyarticular JIA in patients ages 4 and older. The evidence for the effectiveness of DMARDs other than MTX for JRA is weak and no other therapy is the first choice once MTX is ineffective or does not produce an adequate response. Patients with aggressive disease, as determined by the prescribing physician, may be started early on a biologic agent (such as adalimumab); patients will be evaluated by a pharmacist and/or physician on a case-by-case basis to determine a coverage recommendation for the client. (professional opinion of specialist physicians) 3. Psoriatic arthritis (PsA). Approve for 12 months. Adalimumab is FDA-approved for PsA and can be used alone or in combination with DMARDs. In clinical trials, adalimumab was effective in patients with active PsA despite therapy with a NSAID. There are few well-controlled, prospective studies with adequate duration that have evaluated the efficacy of the oral DMARDs. In peripheral arthritis the traditional DMARDs, sulfasalazine, leflunomide, MTX, or cyclosporine, may be effective. For patients with peripheral arthritis who do not respond to a traditional DMARD, one of the TNF inhibitors (etanercept, adalimumab, or infliximab) is equally effective for treatment and also for inhibiting radiographic progression and improving physical function in patients with PsA. Patients with a poor prognosis could use a TNF inhibitor even though they have not failed on a traditional DMARD. The traditional DMARDs have not been shown to prevent the progression of radiographic (structural) damage or to have significant impact on axial disease, dactylitis, or enthesitis in PsA. This is in contrast with the newer biological DMARDs which have shown efficacy in well-controlled trials in reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with PsA. 4. Ankylosing spondylitis. Approve for 12 months. FDA-approved indication. According to ASAS/European League Against Rheumatism (EULAR) recommendations for ankylosing spondylitis, all patients should have an adequate trial of at least 2 NSAIDs for pain and stiffness. Recommendations for other therapies before receiving adalimumab (or etanercept or infliximab) vary according to the manifestations of the disease, level of current symptoms, clinical findings, etc. According to these recommendations, patients with pure axial manifestations do not have to try traditional DMARDs before anti-tnf agents such as adalimumab; patients with symptomatic peripheral arthritis should have an insufficient response to at least one local corticosteroid injection, if appropriate; patients with persistent peripheral arthritis must have a trial of sulfasalazine; and patients with enthesitis should try appropriate local therapy (corticosteroid injection in selected cases). 5. Plaque psoriasis in patients. Authorization can be given for 12 months for patients who meet all of the following criteria a and b: a. Patient has minimum body surface area (BSA) involvement with plaque psoriasis of 5%. Exceptions can be made to the requirement for 5% BSA involvement in the following instances (i or ii): i. Patients with plaque psoriasis of the palms, soles, head and neck, nails, intertriginous areas or genitalia are not required to have a minimum BSA involvement OR ii. The patient who meets all three of the following conditions is not required to have a minimum BSA involvement: (patient who meet this criteria are not required to meet 5b) 2

3 Patient has had an inadequate response to 3-month trial of either topical therapy OR localized phototherapy with ultraviolet B (UVB) or oral methoxsalen plus UVA light [PUVA]) for psoriasis and Patient has had an inadequate response to systemic therapy (See d. below) and Patient has significant disability or impairment in physical or mental functioning, according to the treating physician. b. Patient has tried a systemic therapy or phototherapy for 3 months with one of the following agents: MTX, cyclosporine, acitretin (Soriatane ), etanercept, alefacept (Amevive ), infliximab or ustekinumab (Stelara ) or has tried phototherapy with UVB or PUVA for psoriasis. Rarely, a patient may have contraindications to nearly all of these other therapies and patients will be evaluated by a pharmacist and/or a physician on a case-by-case basis to determine a coverage recommendation for the client. Due to its toxicity, adalimumab therapy should be reserved for patients who have not responded well or are intolerant to other standard systemic therapy. In addition, the NSF Clinical Consensus, states that there currently are no prognostic factors that ascertain which therapies will be most efficacious and least toxic.) 6. Crohn s Disease, active (to induce or maintain remission) in adults. Crohn s Disease, active (to induce remission). Approve adalimumab for 12 weeks of therapy in adults if the patient has tried corticosteroids or if corticosteroids are contraindicated or if the patient is currently on corticosteroids (to avoid increasing the dose of the corticosteroid). After 12 weeks (this is following 160 mg at week 0, 80 mg at week 2, and a maintenance dose of 40 mg every other week (EOW) beginning at week 4), patients are evaluated for response and further authorization for maintenance of remission. In patients who do not respond by week 12, additional therapy does not result in significantly more responses. In clinical trials, the first 2 doses of adalimumab were given to induce remission and if patients responded at week 4, then maintenance with EOW adalimumab was started. Crohn s Disease (to maintain remission). If the patient (adult) has received 2 doses of adalimumab to induce remission or has had 12 weeks of therapy with adalimumab (i.e., 160 mg at week 0, 80 mg at week 2, and a maintenance dose of 40 mg EOW) and has had a response to therapy, then authorization is recommended for 12 months. Further authorization is not recommended if there is no response by week 12. In patients who do not respond by week 12, additional therapy does not result in significantly more responses. OR If the patient (adult) has not received adalimumab for induction of remission, then authorize adalimumab for maintenance (i.e., for 12 months) if the patient has tried azathioprine, 6-mercaptopurine, or MTX OR if the patient has tried infliximab (Remicade) or certolizumab pegol (Cimzia ). Patient is already in remission and adalimumab is being used to maintain remission. Adalimumab is FDA-approved for reducing signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn s disease who have had an inadequate response to conventional therapy. Adalimumab is also indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. Note: Patients with fistulizing Crohn s disease must meet the above criteria for Crohn s 3

4 disease, active (to induce or maintain remission), since adalimumab is not FDAapproved for fistulizing Crohn s disease. Other Uses with Supportive Evidence 7. Patient has already been started on adalimumab. Approve for any indication except Crohn s disease. (professional opinion of specialist physicians) For adults or adolescents 15 years of age with Crohn s disease, approve if the patient has had two doses for induction of remission and has responded by week 4 (standard induction dosing in adults for adalimumab is 160 mg at week 0 and then 80 mg at week 2 and is followed at week 4 with maintenance dosing) OR Approve if the patient with Crohn s disease has already received adalimumab, is already in remission, and is continuing therapy for maintenance of remission. Patients who are not in remission for Crohn s disease must meet the criteria #6 above for induction of remission. Level of evidence: Undifferentiated spondylarthritis (undifferentiated arthritis). Approve for 12 months. In a double-blind study conducted at 2 centers in Germany, 46 patients with active axial spondylarthritis without radiographically defined sacroiliitis were randomized to placebo or adalimumab 40 mg EOW for 12 weeks followed by an open-label extension for up to week 52. All patients in the open-label extension received adalimumab EOW. Patients were refractory to treatment with NSAIDs and had baseline BASDAI 4. The adalimumab dosage was increased to every week in 10 patients who did not attain ASAS 40 response after 12 weeks of therapy. At week 12 an ASAS 40 response (primary endpoint) was attained by 54.5% of the patients on adalimumab compared to 12.5% with placebo (P = vs. placebo). Efficacy was maintained at week 52. In the entire study group of 46 patients, 50% attained an ASAS 40 response at week 52. Of note, trials with ankylosing spondylitis include patients who have radiographic changes in the sacroiliac joints which are the consequences of previous inflammation and may take years to become evident. Level of evidence: Crohn s Disease, active (to induce or maintain remission) in adolescents. Crohn s Disease, active (to induce remission). Approve adalimumab for 12 weeks of therapy in adolescents aged 15 to < 18 years, if the patient has tried infliximab (Remicade) AND if the patient has tried corticosteroids or if corticosteroids are contraindicated or if the patient is currently on corticosteroids (to avoid increasing the dose of the corticosteroid). After 12 weeks (this is following an induction dose at week 0 and at week 2 followed by a maintenance dose EOW beginning at week 4), patients are evaluated for response and further authorization for maintenance of remission. In adults who do not respond by week 12, additional therapy does not result in significantly more responses. In clinical trials in adults, the first 2 doses of adalimumab were given to induce remission and if patients responded at week 4, then maintenance with EOW adalimumab was started. Crohn s Disease (to maintain remission). If the patient (adolescent aged 15 to < 18 years) has received 2 doses of adalimumab to induce remission or has had 12 weeks of therapy with adalimumab (i.e., induction dose at week 0 and at week 2, and a maintenance dose EOW) and has had a response to therapy, then authorization is recommended for 12 months. Further authorization is not recommended if there 4

5 is no response by week 12. In adults who do not respond by week 12, additional therapy does not result in significantly more responses. OR If the patient (adolescent aged 15 to < 18 years) has not received adalimumab for induction of remission, then authorize adalimumab for maintenance (i.e., for 12 months) if the patient has tried azathioprine, 6-mercaptopurine, or MTX OR if the patient has tried infliximab (Remicade). Patient is already in remission and adalimumab is being used to maintain remission. Note: there is no information on Cimzia in children. Adalimumab is FDA-approved in adults with moderately to severely active Crohn s disease who have had an inadequate response to conventional therapy and in these patients if they have lost response to or are intolerant to infliximab. Infliximab is FDAapproved in pediatric patients 6 years of age with Crohn s disease. Limited information is available on the use of adalimumab in children with Crohn s disease and published information mostly includes adolescents who have lost response to infliximab or are intolerant to infliximab. Note: Patients with fistulizing Crohn s disease must meet the above criteria for Crohn s disease, active (to induce or maintain remission), since adalimumab is not FDAapproved for fistulizing Crohn s disease. 10. Uveitis (noninfectious) in children or adults. Approve for 12 months if patient has tried topical (ophthalmic) or systemic corticosteroids, MTX, etanercept, infliximab, mycophenolate mofetil, or cyclosporine. Adalimumab has been effective in a small number of children with chronic uveitis (either with rheumatic disease (JIA) or idiopathic) refractory to other therapies. Adalimumab was also effective in the management of refractory uveitis in adults and allowed the dose of concomitant immunosuppressives to be reduced. Further long-term studies are needed. Level of evidence: Uveitis or other systemic manifestations of Behcet s disease in adults. Approve for 12 months if patient has tried topical (ophthalmic) or systemic corticosteroids, azathioprine, interferon alfa, MTX, etanercept, infliximab, mycophenolate mofetil, or cyclosporine. In 3 cases, adalimumab was effective in controlling uveitis in adults with Behcet s disease who were in remission after receiving infliximab. In another case series, 6 adults with Behcet s disease [uveitis (2), central nervous system disease (2), colitis (1), and severe oral ulcers and arthritis (1)] in whom immunosuppressive therapy had failed, adalimumab was effective. These patients had received prior therapy with infliximab which had been discontinued after complete response or acceptable improvement. EULAR recommendations for the management of Behcet disease include either infliximab or cyclosporine in combination with azathioprine and corticosteroids for refractory eye involvement. For gastrointestinal or parenchymal involvement, TNFα antagonists have been used in resistant and complicated case. More study is needed with adalimumab. Level of evidence: Sarcoidosis, cutaneous. Approve for 12 months if patient has tried corticosteroids and immunosuppressive agents (MTX, azathioprine, cyclosporine, chlorambucil) or infliximab, or chloroquine. Well-controlled studies are not available for any therapies. Adalimumab has been effective in case reports of patients who were refractory to standard therapy. A randomized, placebo-controlled trial is underway using adalimumab for cutaneous sarcoidosis. Level of evidence: Pyoderma gangrenosum. Approve for 12 months if patient has tried one other systemic therapy (e.g., intralesional injections of corticosteroids or cyclosporine [for localized pyoderma gangrenosum]; systemic corticosteroids or immunosuppressants 5

6 such as azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, chlorambucil, infliximab). In 4 case reports, adalimumab was effective in treating pyoderma gangrenosum. Additional studies are needed. Level of evidence: Hidradenitis suppurativa. Approve for 12 months if the patient has tried one other therapy (e.g., intralesional or oral corticosteroids, antibiotics, isotretinoin). In case reports, adalimumab has been effective in treating hidradenitis suppurativa that was refractory to other therapies. Level of evidence: 5. Exclusions Coverage of adalimumab is not recommended in the following circumstances: 1. Adalimumab should not be given in combination with anakinra or abatacept. Serious infections were seen with concurrent use of etanercept (a tumor necrosis factor (TNF)-blocking agent) and anakinra with no added benefit. Similar toxicities may also occur from combination therapy with anakinra and other TNF-blocking agents such as adalimumab. Increased rates of serious adverse events, including serious infections, have been reported with concomitant administration of TNF blocking agents and abatacept and there was no significant increased efficacy over using the TNF blocking agent alone. 2. Children with Crohn s disease who are less than 15 years of age. Safety and efficacy in pediatric patients have not been established. A phase 3 clinical trial is underway in children with Crohn s disease. Limited information is published on the use of adalimumab in children, mostly adolescents, who could not tolerate infliximab or who lost response to infliximab. 3. Osteoarthritis. In an open-label trial in 12 patients with moderate to severe erosive/inflammatory osteoarthritis of the hands despite therapy with NSAIDs, 12 weeks of therapy with adalimumab 40 mg EOW did not significantly improve signs and symptoms (number of tender joints, grip strength, disability, pain, or global disease assessment). Trends suggested modest improvement. Long-term, placebo-controlled trials that have a specific efficacy outcome for hand or generalized osteoarthritis are needed. 4. Ulcerative colitis. In a 4-week open-label study conducted at 2 centers in France, 10 adults with ulcerative colitis who had lost response or became intolerant to infliximab received adalimumab 160 mg at week 0 and 80 mg at week 2. Disease activity was assessed using the ulcerative colitis clinical activity index (CAI) with scores > 12 indicating severe disease and 4 to 12 representing mild to moderate activity. The primary outcome was a decrease in the CAI score of > 4 at week 4. Other concurrent therapies for ulcerative colitis were allowed. In the 6 patients with severe ulcerative colitis, no remissions resulted and only one patient had clinical improvement. One patient with mild to moderate disease achieved remission. A randomized placebocontrolled trial is needed to determine if adalimumab has a place in the therapy of ulcerative colitis. 6. Intra-articular injection. Large placebo- or corticosteroid-controlled trials are needed to determine which patients might benefit from intra-articular injection and if this therapy is safe and effective. 7. Recurrent spontaneous pregnancy loss (RSPL). In a retrospective analysis, TNF inhibitors (etanercept [n = 3] or adalimumab [n = 14]) were used in combination with 6

7 intravenous immune globulin (IVIG) and anticoagulants plus low dose aspirin in patients with recurrent spontaneous abortion. The authors concluded that the addition of IVIG or a TNF inhibitor plus IVIG to the anticoagulant regimen appears to improve live birth rates compared to therapy with anticoagulants alone. Further prospective clinical trials are needed. According to guidelines from the American College of Obstetricians and Gynecologists, recommended therapy for preventing recurrent early (< 15 weeks of gestation) pregnancy loss does not include IVIG. At the time of these guidelines were written anti- TNF agents were not being studied for this indication. Patients with a positive test for lupus anticoagulant or anticardiolipin antibodies should be treated with heparin and low dose aspirin during the next pregnancy attempt. The American Society for Reproductive Medicine also concluded after reviewing 5 randomized controlled trials which assessed IVIG treatment for RSPL, that IVIG is not effective for primary RSPL. For secondary (indicates an antecedent pregnancy) RSPL, there was a higher percentage of successful pregnancies with IVIG, but the number of patients was not sufficient to rule out a chance finding. They concluded that IVIG as a treatment for RSPL is experimental and should only be used in a randomized clinical trial setting. 8. In vitro fertilization (IVF). In an observational study, use of adalimumab and IVIG improved IVF outcome in young infertile women who were < 38 years of age with Th1/Th2 cytokine elevations who had > 2 IVF embryo transplant failures. In group I, 41 patients used both IVIG and adalimumab; in group II, 23 patients used IVIG; in group III, 6 patients used adalimumab alone; and in group IV, 5 patients did not use either IVIG or adalimumab. Patient groups were formed partly through self selection and partly through differences in initial work up and history. Patients who received adalimumab had two 40 mg doses at 2-week intervals and about 2 to 3 weeks after the second injection, a second Th1/Th assay was done. If the Th1/Th2 was still increased, 2 more dose of adalimumab were given. All patients received enoxapirin daily during their treatment cycles and 75 mg of aspirin daily. The implantation rate (number of gestational sacs per embryo transferred, with an average of two embryos transferred by cycle) was 59% (group I), 47% (group II), 31% (group III), and 0% (group IV). The respective clinical pregnancy rates (fetal heart activity per IVF cycle started) were 80%, 57%, 50%, and 0%. The respective live birth rates were 73%, 52%, 50%, and 0%. These improvements were significant for group I vs. group IV and for group II vs. group IV. Well controlled trials in a larger, well defined group of patients are needed. 9. Other indications. Exceptions not recommended. 10. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available. APPROVAL: ENDORSED BY: Pharmacy & Therapeutics Committee Original Date: Reviewed: 5/19/2010 APPROVED BY: Date 7

First Name. Specialty: Fax. First Name DOB: Duration:

First Name. Specialty: Fax. First Name DOB: Duration: Prescriber Information Last ame: First ame DEA/PI: Specialty: Phone - - Fax - - Member Information Last ame: First ame Member ID umber DOB: - - Medication Information: Drug ame and Strength: Diagnosis:

More information

Remicade (infliximab)

Remicade (infliximab) Criteria for approval Commercial Only Remicade (infliximab) Background: Tumor Necrosis Factor (TNF) alpha is one of two proinflammatory cytokines that appear to play a dominant role in the inflammatory

More information

Biologic Treatments for Rheumatoid Arthritis

Biologic Treatments for Rheumatoid Arthritis Biologic Treatments Rheumatoid Arthritis (also known as cytokine inhibitors, TNF inhibitors, IL 1 inhibitor, or Biologic Response Modifiers) Description Biologics are new class of drugs that have been

More information

Rheumatoid Arthritis. Outline. Treatment Goal 4/10/2013. Clinical evaluation New treatment options Future research Discussion

Rheumatoid Arthritis. Outline. Treatment Goal 4/10/2013. Clinical evaluation New treatment options Future research Discussion Rheumatoid Arthritis Robert L. Talbert, Pharm.D., FCCP, BCPS University of Texas at Austin College of Pharmacy University of Texas Health Science Center at San Antonio Outline Clinical evaluation New treatment

More information

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES `I. Requirements for Prior Authorization of Cytokine and CAM Antagonists

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES `I. Requirements for Prior Authorization of Cytokine and CAM Antagonists MEDICAL ASSISTANCE HBOOK `I. Requirements for Prior Authorization of Cytokine and CAM Antagonists A. Prescriptions That Require Prior Authorization All prescriptions for Cytokine and CAM Antagonists must

More information

Drug Therapy Guidelines: Humira (adalimumab)

Drug Therapy Guidelines: Humira (adalimumab) Drug Therapy Guidelines: Humira (adalimumab) Effective Date: 5/1/08 Committee Review Date: 1/6/01, 9/18/01, 1/15/02, 1/7/03, 1/20/04, 1/18/05, 12/7/05, 10/15/06, 7/2/07, 11/5/07, 3/25/08 Policy Statements:

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Health Technology Appraisal Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure

More information

Immune Modulating Drugs Prior Authorization Request Form

Immune Modulating Drugs Prior Authorization Request Form Patient: HPHC member ID #: Requesting provider: Phone: Servicing provider: Diagnosis: Contact for questions (name and phone #): Projected start and end date for requested Requesting provider NPI: Fax:

More information

SECTION 3. Criteria for Special Authorization of Select Drug Products. Section 3 Criteria for Special Authorization of Select Drug Products

SECTION 3. Criteria for Special Authorization of Select Drug Products. Section 3 Criteria for Special Authorization of Select Drug Products SECTION 3 Criteria for Special Authorization of Select Drug Products Section 3 Criteria for Special Authorization of Select Drug Products CRITERIA FOR SPECIAL AUTHORIZATION OF SELECT DRUG PRODUCTS The

More information

Current Rheumatoid Arthritis Treatment Options: Update for Managed Care and Specialty Pharmacists

Current Rheumatoid Arthritis Treatment Options: Update for Managed Care and Specialty Pharmacists Current Rheumatoid Arthritis Treatment Options: Update for Managed Care and Specialty Pharmacists 1. Which of the following matches of biologic targets that contribute to rheumatoid arthritis (RA) and

More information

Evidence-based Management of Rheumatoid Arthritis (2009)

Evidence-based Management of Rheumatoid Arthritis (2009) CPLD reviews its distance learning programmes every twelve months to ensure currency. This update has been produced by an expert and should be read in conjunction with the Evidencebased Management of distance

More information

Psoriatic Arthritis- Second Line Treatments

Psoriatic Arthritis- Second Line Treatments Psoriatic Arthritis- Second Line Treatments Second line treatments for Psoriatic Arthritis (PsA) are usually prescribed by a Rheumatologist, Dermatologist, or in a combined clinic where both the Dermatologist

More information

Page 1 of 5 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016, 07/2016 Developed By: Medical Criteria Committee 09/2014

Page 1 of 5 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016, 07/2016 Developed By: Medical Criteria Committee 09/2014 Moda Health Plan, Inc. Medical Necessity Criteria Subject: Stelara (ustekinumab) Page 1 of 5 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016, 07/2016 Developed By: Medical Criteria Committee

More information

Original Policy Date

Original Policy Date MP 5.01.20 Tysabri (natalizumab) Medical Policy Section Prescription Drug Issue 12:2013 Original Policy Date 12:2013 Last Review Status/Date Local Policy/12:2013 Return to Medical Policy Index Disclaimer

More information

BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC)

BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC) BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC) September 2014 Review date: September 2017 Bulletin 203: Tocilizumab (subcutaneous) in combination with methotrexate or as monotherapy for the treatment

More information

Immune modulation in rheumatology. Geoff McColl University of Melbourne/Australian Rheumatology Association

Immune modulation in rheumatology. Geoff McColl University of Melbourne/Australian Rheumatology Association Immune modulation in rheumatology Geoff McColl University of Melbourne/Australian Rheumatology Association A traditional start to a presentation on biological agents in rheumatic disease is Plasma cell

More information

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY

APPLICATION FOR SUBSIDY BY SPECIAL AUTHORITY APPLICANT (stamp sticker acceptable) Page 1 Fm SA1478 Etanercept INITIAL APPLICATION - juvenile idiopathic arthritis Applications only from a named specialist rheumatologist. Approvals valid f 4 months.

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Multiple Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Multiple Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Multiple Technology Appraisal Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional

More information

DISEASE-MODIFYING ANTIRHEUMATIC DRUG THERAPY FOR RHEUMATOID ARTHRITIS

DISEASE-MODIFYING ANTIRHEUMATIC DRUG THERAPY FOR RHEUMATOID ARTHRITIS DISEASE-MODIFYING ANTIRHEUMATIC DRUG THERAPY FOR RHEUMATOID ARTHRITIS APPLICATIONS OBJECTIVE Purpose of Measure: ELIGIBLE POPULATION Which members are included? STANDARD OF CARE NCQA APPROVED CODES HEDIS

More information

Guidelines for the Pharmaceutical Management of Rheumatoid Arthritis Swedish Society of Rheumatology, April 14, 2011

Guidelines for the Pharmaceutical Management of Rheumatoid Arthritis Swedish Society of Rheumatology, April 14, 2011 Guidelines for the Pharmaceutical Management of Rheumatoid Arthritis Swedish Society of Rheumatology, April 14, 2011 Working party: Eva Baecklund, Helena Forsblad d Elia, Carl Turesson Background Our purpose

More information

påçííáëü=jéçáåáåéë=`çåëçêíáìã==

påçííáëü=jéçáåáåéë=`çåëçêíáìã== påçííáëü=jéçáåáåéë=`çåëçêíáìã== adalimumab 40mg pre-filled syringe for subcutaneous injection (Humira ) No. (218/05) Abbott New indication: treatment of active and progressive psoriatic arthritis in adults

More information

North Carolina Rheumatology Association Position Statements

North Carolina Rheumatology Association Position Statements North Carolina Rheumatology Association Position Statements I. Biologic Agents A. Appropriate delivery, handling, storage and administration of biologic agents B. Indications for biologic agents II. III.

More information

Rheumatic Diseases, Psoriasis, and Crohn s Disease

Rheumatic Diseases, Psoriasis, and Crohn s Disease Rheumatic Diseases, Psoriasis, and Crohn s Disease What does this handout cover? This handout has information about rheumatic disease, psoriasis, and Crohn s disease. It also has information on how these

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency London, 14 December 2006 Doc. Ref. CHMP/EWP/438/04 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS FOR THE TREATMENT

More information

ustekinumab 45mg solution for injection in pre-filled syringe (Stelara ) SMC No. (944/14) Janssen-Cilag Ltd

ustekinumab 45mg solution for injection in pre-filled syringe (Stelara ) SMC No. (944/14) Janssen-Cilag Ltd ustekinumab 45mg solution for injection in pre-filled syringe (Stelara ) SMC No. (944/14) Janssen-Cilag Ltd 07 February 2014 The Scottish Medicines Consortium (SMC) has completed its assessment of the

More information

Remicade (infliximab)

Remicade (infliximab) DRUG POLICY Remicade (infliximab) Policy Number: 2015D004P Effective Date: 12/1/2015 Table of Contents Page COVERAGE RATIONALE... 1 BENEFIT CONSIDERATIONS... 3 BACKGROUND... 3 CLINICAL EVIDENCE... 4 U.S.

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT European Medicines Agency Evaluation of Medicines for Human Use London, 23 June 2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT GUIDELINE ON CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS

More information

Description of Commitment

Description of Commitment U.S. Postmarketing s Table: Name of Product ANDROGEL (testosterone) CREON (pancrelipase) CREON (pancrelipase) DEPAKOTE (divalproex sodium) NDA/ NDA 22309 NDA 20725 NDA 20725 NDA 22267 125057/0 125057/89

More information

Arthritis and Rheumatology Clinics of Kansas Patient Education. Reactive Arthritis (ReA) / Inflammatory Bowel Disease (IBD) Arthritis

Arthritis and Rheumatology Clinics of Kansas Patient Education. Reactive Arthritis (ReA) / Inflammatory Bowel Disease (IBD) Arthritis Arthritis and Rheumatology Clinics of Kansas Patient Education Reactive Arthritis (ReA) / Inflammatory Bowel Disease (IBD) Arthritis Introduction: For as long as scientists have studied rheumatic disease,

More information

Patient Input Information Clinical Trials Outcomes Common Drug Review

Patient Input Information Clinical Trials Outcomes Common Drug Review CDEC FINAL RECOMMENDATION USTEKINUMAB (Stelara Janssen Inc.) Indication: Psoriatic Arthritis Recommendation: The Canadian Drug Expert Committee (CDEC) recommends that ustekinumab not be listed at the submitted

More information

Rheumatoid Arthritis:

Rheumatoid Arthritis: Rheumatoid Arthritis Update 2014 Mark Hulsey, MD FACR Rheumatoid Arthritis Key Features Symptoms >6 weeks duration Often lasts the remainder of the patient s life Inflammatory synovitis Palpable synovial

More information

Collaborative working between dermatology and rheumatology improves disease management and may reduce cardiovascular risk in psoriatic disease

Collaborative working between dermatology and rheumatology improves disease management and may reduce cardiovascular risk in psoriatic disease Collaborative working between dermatology and rheumatology improves disease management and may reduce cardiovascular risk in psoriatic disease David Burden Department of Dermatology Western Infirmary,

More information

SASKATCHEWAN FORMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary

SASKATCHEWAN FORMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary November 1, 2014 Bulletin #150 ISSN 1923-0761 SASKATCHEWAN FORMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary New Exception Drug Status (EDS) Listings Effective November 1, 2014

More information

Improvement in Quality of Life of Rheumatoid Arthritis Patients on Biologic Therapy

Improvement in Quality of Life of Rheumatoid Arthritis Patients on Biologic Therapy Improvement in Quality of Life of Rheumatoid Arthritis Patients on Biologic Therapy R Adams 1, Ct Ng 2, A Gibbs 2, L Tilson 1, D Veale 2, B Bresnihan 2, O FitzGerald 2, M Barry 1 1. National Centre for

More information

Is Monotherapy Treatment of Etanercept Effective Against Plaque Psoriasis?

Is Monotherapy Treatment of Etanercept Effective Against Plaque Psoriasis? Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Scholarship Student Dissertations, Theses and Papers 2011 Is Monotherapy Treatment of Etanercept

More information

Let s talk about Arthritis

Let s talk about Arthritis Let s talk about Arthritis Osteoarthritis Rheumatoid Arthritis Kam Shojania, MD, FRCPC Clinical Professor and Head, St. Paul s, UBC and VGH Divisions of Rheumatology Slides with thanks to: Cheryl Koehn

More information

CLINICAL POLICY Department: Medical Management Document Name: Rheumatoid & Juvenile Arthritis and Ankylosing Spondylitis Treatments

CLINICAL POLICY Department: Medical Management Document Name: Rheumatoid & Juvenile Arthritis and Ankylosing Spondylitis Treatments Page: 1 of 18 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted

More information

Can Rheumatoid Arthritis treatment ever be stopped?

Can Rheumatoid Arthritis treatment ever be stopped? Can Rheumatoid Arthritis treatment ever be stopped? Robert L. DiGiovanni, DO, FACOI Program Director Largo Medical Center Rheumatology Fellowship robdsimc@tampabay.rr.com Do not pour strange medicines

More information

REFERENCE CODE GDHC503DFR PUBLICAT ION DATE DECEMBER 2014 METHOTREXATE (RHEUMATOID ARTHRITIS) - FORECAST AND MARKET ANALYSIS TO 2023

REFERENCE CODE GDHC503DFR PUBLICAT ION DATE DECEMBER 2014 METHOTREXATE (RHEUMATOID ARTHRITIS) - FORECAST AND MARKET ANALYSIS TO 2023 REFERENCE CODE GDHC503DFR PUBLICAT ION DATE DECEMBER 2014 METHOTREXATE (RHEUMATOID ARTHRITIS) - Executive Summary The table below provides the key metrics for Methotrexate in the 10MM (US, France, Germany,

More information

Roche s RoACTEMRA improved rheumatoid arthritis signs and symptoms significantly more than adalimumab as single-agent therapy

Roche s RoACTEMRA improved rheumatoid arthritis signs and symptoms significantly more than adalimumab as single-agent therapy Media Release Basel, 6 June 2012 Roche s RoACTEMRA improved rheumatoid arthritis signs and symptoms significantly more than adalimumab as single-agent therapy Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced

More information

Psoriasis. Psoriasis. Mark A. Bechtel, M.D. Director of Dermatology The Ohio State University College of Medicine

Psoriasis. Psoriasis. Mark A. Bechtel, M.D. Director of Dermatology The Ohio State University College of Medicine Psoriasis Mark A. Bechtel, M.D. Director of Dermatology The Ohio State University College of Medicine Psoriasis Psoriasis is a chronic skin disorder resulting from a polygenic predisposition combined with

More information

New Post Hoc Analyses of Phase 3b Data Examine Treatment with Orencia

New Post Hoc Analyses of Phase 3b Data Examine Treatment with Orencia June 12, 2015 New Post Hoc Analyses of Phase 3b Data Examine Treatment with Orencia (abatacept) Plus Methotrexate (MTX) in Patients with Early Moderate to Severe Rheumatoid Arthritis (RA) and Markers of

More information

IBD: Outside the Gut

IBD: Outside the Gut IBD: Outside the Gut C C FA PAT I E N T E D U C AT I O N S Y MP O S I U M 2 0 1 4 Berkeley Limketkai, MD Division of Gastroenterology & Hepatology Stanford University School of Medicine Extraintestinal

More information

Media Release. Basel, 11 June 2009. RA patients with enhanced response identified

Media Release. Basel, 11 June 2009. RA patients with enhanced response identified Media Release Basel, 11 June 2009 New data demonstrate the ability of MabThera to reduce the progression of joint damage when used as a first-line biologic treatment in rheumatoid arthritis RA patients

More information

Methotrexate Dose For Juvenile Rheumatoid Arthritis

Methotrexate Dose For Juvenile Rheumatoid Arthritis Methotrexate Dose For Juvenile Rheumatoid Arthritis should i take methotrexate for my ra methotrexate 50 mg/ml methotrexate sodium 2.5mg tablets what is the usual dosage of methotrexate for ra methotrexate

More information

MEDICATION GUIDE HUMIRA

MEDICATION GUIDE HUMIRA MEDICATION GUIDE HUMIRA (Hu-MARE-ah) (adalimumab) injection Read the Medication Guide that comes with HUMIRA before you start taking it and each time you get a refill. There may be new information. This

More information

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management Prior Authorization, Pharmacy and Health Case Management Information The purpose of this information sheet is to provide you with details on how Great-West Life will be assessing and managing your claim

More information

biologics for the treatment of psoriasis

biologics for the treatment of psoriasis How to contact us The Psoriasis Association Dick Coles House 2 Queensbridge Northampton NN4 7BF tel: 08456 760 076 (01604) 251 620 fax: (01604) 251 621 email: mail@psoriasis-association.org.uk www.psoriasis-association.org.uk

More information

Psoriatic Arthritis. having psoriatic arthritis.

Psoriatic Arthritis. having psoriatic arthritis. Psoriatic Arthritis having psoriatic arthritis. Psoriatic arthritis is a chronic disease characterized by a form of inflammation of the skin (psoriasis) and joints (inflammatory arthritis). Psoriasis is

More information

MEDICATION GUIDE REMICADE (Rem-eh-kaid) (infliximab) Read the Medication Guide that comes with REMICADE before you receive the first treatment, and

MEDICATION GUIDE REMICADE (Rem-eh-kaid) (infliximab) Read the Medication Guide that comes with REMICADE before you receive the first treatment, and MEDICATION GUIDE REMICADE (Rem-eh-kaid) (infliximab) Read the Medication Guide that comes with REMICADE before you receive the first treatment, and before each time you get a treatment of REMICADE. This

More information

Rheumatoid Arthritis Information

Rheumatoid Arthritis Information Rheumatoid Arthritis Information Definition Rheumatoid arthritis (RA) is a long-term disease that leads to inflammation of the joints and surrounding tissues. It can also affect other organs. Alternative

More information

Maximum Dose Of Methotrexate For Ra

Maximum Dose Of Methotrexate For Ra Maximum Dose Of Methotrexate For Ra 1 methotrexate oral versus injection 2 methotrexate dose crohn's disease 3 methotrexate in juvenile arthritis 4 methotrexate dose in rheumatoid arthritis 5 methotrexate

More information

Recognizing the Value of Innovation in the Treatment of Rheumatoid Arthritis

Recognizing the Value of Innovation in the Treatment of Rheumatoid Arthritis White Paper March 2013 Recognizing the Value of Innovation in the Treatment of Rheumatoid Arthritis Catherine Augustyn, Brigham Walker, and Thomas F. Goss, PharmD Boston Healthcare Associates, Inc., Boston,

More information

Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients in a dose-dependent manner

Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients in a dose-dependent manner 8b Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients in a dose-dependent manner Charlotte Krieckaert Mike Nurmohamed Gertjan Wolbink ANNALS OF RHEUMATIC DISEASES Vol.

More information

Rheumatoid Arthritis

Rheumatoid Arthritis Rheumatoid Arthritis While rheumatoid arthritis (RA) has long been feared as one of the most disabling types of arthritis, the outlook has dramatically improved for many newly diagnosed patients. Certainly

More information

FastTest. You ve read the book... ... now test yourself

FastTest. You ve read the book... ... now test yourself FastTest You ve read the book...... now test yourself To ensure you have learned the key points that will improve your patient care, read the authors questions below. Please refer back to relevant sections

More information

Speaking Plainly. Biologic treatment options for rheumatoid arthritis

Speaking Plainly. Biologic treatment options for rheumatoid arthritis in association with Plain English Campaign Speaking Plainly Biologic treatment options for rheumatoid arthritis A guide to help healthcare professionals talking to patients with rheumatoid arthritis Foreword

More information

Critical Issues in School Health Arthritis in the School Setting. Lawrence Zemel MD Tegan Willard RN Connecticut Children s

Critical Issues in School Health Arthritis in the School Setting. Lawrence Zemel MD Tegan Willard RN Connecticut Children s Critical Issues in School Health Arthritis in the School Setting Lawrence Zemel MD Tegan Willard RN Connecticut Children s Juvenile Rheumatoid Idiopathic Arthritis Definition of JRA (JIA) Persistent arthritis

More information

Spondyloarthritis is a general term for a group of rheumatic

Spondyloarthritis is a general term for a group of rheumatic Rheumatic Disease Clinics of North America Supplement 1 11 Current Treatment for Psoriatic Arthritis and Other Spondyloarthritides Spondyloarthritis is a general term for a group of rheumatic diseases,

More information

A Patient s Guide to Psoriatic Arthritis. Foot and Ankle Center of Massachusetts, P.C.

A Patient s Guide to Psoriatic Arthritis. Foot and Ankle Center of Massachusetts, P.C. A Patient s Guide to Psoriatic Arthritis Welcome to Foot and Ankle Center of Massachusetts, where we believe in accelerating your learning curve with educational materials that are clearly written and

More information

(THE CHANGING LANDSCAPE)

(THE CHANGING LANDSCAPE) Updating the therapeutic strategy in RA What is effective, what is changing in daily practice regarding the use of DMARDs and biological agents in the Balkan countries The Greek experience (THE CHANGING

More information

Psoriasis Treatment Transition Pathway

Psoriasis Treatment Transition Pathway Psoriasis Treatment Transition Pathway A Treatment Support Tool Adapted from Circle Nottingham NHS Treatment Centre Psoriasis Pathway (under consultation) with support from Abbvie Ltd Treatment Pathways

More information

Martin Keefe Consultant Dermatologist and Senior Clinical Lecturer, Christchurch And Bridge Street Dermatology, Nelson

Martin Keefe Consultant Dermatologist and Senior Clinical Lecturer, Christchurch And Bridge Street Dermatology, Nelson Martin Keefe Consultant Dermatologist and Senior Clinical Lecturer, Christchurch And Bridge Street Dermatology, Nelson Conflicts of Interest Advisor to Abbott Previously advisor to Leo, Valeant Sponsorship

More information

PART III: CONSUMER INFORMATION

PART III: CONSUMER INFORMATION PART III: CONSUMER INFORMATION Pr REMICADE (Infliximab) This leaflet is part III of a three-part "Product Monograph" published when REMICADE was approved for sale in Canada and is designed specifically

More information

NATIONAL PSORIASIS FOUNDATION SYSTEMIC MEDICATIONS. for psoriasis and psoriatic arthritis including biologics and new oral treatments

NATIONAL PSORIASIS FOUNDATION SYSTEMIC MEDICATIONS. for psoriasis and psoriatic arthritis including biologics and new oral treatments NATIONAL PSORIASIS FOUNDATION SYSTEMIC MEDICATIONS for psoriasis and psoriatic arthritis including biologics and new oral treatments Introduction to psoriasis and psoriatic arthritis WHAT IS PSORIASIS?

More information

Pharmacotherapy of Autoimmune Disorders

Pharmacotherapy of Autoimmune Disorders PHARMACY / MEDICAL POLICY POLICY RELATED POLICIES POLICY GUIDELINES DESCRIPTION SCOPE BENEFIT APPLICATION RATIONALE REFERENCES CODING APPENDIX HISTORY Pharmacotherapy of Autoimmune Disorders Number 5.01.550

More information

Synopsis. Adalimumab M Abbreviated Clinical Study Report R&D/08/1036. (For National Authority Use Only) to Part of Dossier: Volume:

Synopsis. Adalimumab M Abbreviated Clinical Study Report R&D/08/1036. (For National Authority Use Only) to Part of Dossier: Volume: Synopsis Abbott Laboratories Name of Study Drug: Adalimumab Name of Active Ingredient: Adalimumab Title of Study: Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority

More information

Issue date: August 2010

Issue date: August 2010 Issue date: August 2010 Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor Part review of NICE technology appraisal

More information

Page 1 of 15 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016 Developed By: Medical Criteria Committee 10/28/2015

Page 1 of 15 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016 Developed By: Medical Criteria Committee 10/28/2015 Moda Health Plan, Inc. Medical Necessity Criteria Subject: Actemra (tocilizumab) Page 1 of 15 Origination Date: 09/14 Revision Date(s): 10/2015, 02/2016 Developed By: Medical Criteria Committee 10/28/2015

More information

ABOUT RHEUMATOID ARTHRITIS

ABOUT RHEUMATOID ARTHRITIS MEDIA BACKGROUNDER ABOUT RHEUMATOID ARTHRITIS Rheumatoid arthritis (RA) is a type of arthritis (chronic inflammatory polyarthritis) that typically affects hands and feet, although any joint in the body

More information

Early Diagnosis of Rheumatoid Arthritis & Axial Spondyloarthritis

Early Diagnosis of Rheumatoid Arthritis & Axial Spondyloarthritis Early Diagnosis of Rheumatoid Arthritis & Axial Spondyloarthritis 奇 美 醫 院 過 敏 免 疫 風 濕 科 陳 宏 安 Rheumatoid arthritis Most common chronic inflammatory joint disease Multisystem autoimmune disease of unknown

More information

Medicines for Psoriatic Arthritis. A Review of the Research for Adults

Medicines for Psoriatic Arthritis. A Review of the Research for Adults Medicines for Psoriatic Arthritis A Review of the Research for Adults Is This Information Right for Me? Yes, this information is right for you if: Your doctor* has told you that you have psoriatic (pronounced

More information

2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY

2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY Measure #337: Tuberculosis Prevention for Psoriasis,Psoriatic Arthritis and Rheumatoid Arthritis Patients on a Biological Immune Response Modifier National Quality Strategy Domain: Effective Clincal Care

More information

SYNOPSIS. 2-Year (0.5 DB + 1.5 OL) Addendum to Clinical Study Report

SYNOPSIS. 2-Year (0.5 DB + 1.5 OL) Addendum to Clinical Study Report Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Abatacept () Name of Active Ingredient: Abatacept () Individual Study Table Referring to the Dossier (For National Authority Use

More information

Rheumatoid Arthritis

Rheumatoid Arthritis What is Rheumatoid Arthritis? Rheumatoid Arthritis (RA) is a chronic and systemic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Though joints

More information

PAR Joint Health. Inflammation and Joint

PAR Joint Health. Inflammation and Joint PAR ARACTIN Joint Health Inflammation and Joint Arthritis affects more than 7 million Americans. Arthritis is a disease that results in inflammation, pain and stiffness, primarily in the joints and connective

More information

Basic principles of systemic therapies Uveitis Course Antalya Miles Stanford, Medical Eye Unit, St Thomas Hospital

Basic principles of systemic therapies Uveitis Course Antalya Miles Stanford, Medical Eye Unit, St Thomas Hospital Basic principles of systemic therapies Uveitis Course Antalya 2013 Miles Stanford, Medical Eye Unit, St Thomas Hospital In this talk Conventional treatments The problems with the design of current trials

More information

Rheumatoid Arthritis monitoring of DMARDs

Rheumatoid Arthritis monitoring of DMARDs www.bpac.org.nz keyword: DMARDS Rheumatoid Arthritis monitoring of DMARDs Key reviewers: Professor John Highton, Head of Section, Department of Medical and Surgical Sciences, Dunedin School of Medicine,

More information

Medicines for Rheumatoid. Arthritis. A Review of the Research for Adults

Medicines for Rheumatoid. Arthritis. A Review of the Research for Adults Medicines for Rheumatoid Arthritis A Review of the Research for Adults Is This Information Right for Me? Yes, this summary is for you if: Your doctor* has told you that you have rheumatoid (pronounced

More information

Once the immune system is triggered, cells migrate from the blood into the joints and produce substances that cause inflammation.

Once the immune system is triggered, cells migrate from the blood into the joints and produce substances that cause inflammation. HealthExchange Points For Your Joints An Arthritis Talk Howard Epstein, MD Orthopaedic & Rheumatologic Institute Rheumatic & Immunologic Disease Cleveland Clinic Beachwood Family Health & Surgery Center

More information

PRODUCT MONOGRAPH. HUMIRA adalimumab 40 mg in 0.8 ml sterile solution (50 mg/ml) subcutaneous injection

PRODUCT MONOGRAPH. HUMIRA adalimumab 40 mg in 0.8 ml sterile solution (50 mg/ml) subcutaneous injection PRODUCT MONOGRAPH Pr HUMIRA adalimumab 40 mg in 0.8 ml sterile solution (50 mg/ml) subcutaneous injection Biological Response Modifier HUMIRA (adalimumab) treatment should be initiated and supervised by

More information

Top Down vs. Step Up Therapy Biologics in IBD: Treatment Algorithms. Stephen B. Hanauer, M.D. University of Chicago

Top Down vs. Step Up Therapy Biologics in IBD: Treatment Algorithms. Stephen B. Hanauer, M.D. University of Chicago Top Down vs. Step Up Therapy Biologics in IBD: Treatment Algorithms Stephen B. Hanauer, M.D. University of Chicago Treatment Goals c.2008 Induce and maintain response/remission Prevent complications Disease

More information

Methods for Measuring Dose Escalation in TNF Antagonists for Rheumatoid Arthritis Patients Treated in Routine Clinical Practice

Methods for Measuring Dose Escalation in TNF Antagonists for Rheumatoid Arthritis Patients Treated in Routine Clinical Practice Methods for Measuring Dose Escalation in TNF Antagonists for Rheumatoid Arthritis Patients Treated in Routine Clinical Practice Gu NY 1, Huang XY 2, Globe D 2, Fox KM 3 1 University of Southern California,

More information

Rheumatoid Arthritis: Constantly Evolving Treatment Approaches

Rheumatoid Arthritis: Constantly Evolving Treatment Approaches Rheumatoid Arthritis: Constantly Evolving Treatment Approaches Jody Garry, Pharm.D. Primary Care Pharmacy Resident VA Medical Center - Iowa City Presentation Overview Pathophysiology & epidemiology Diagnostic

More information

Adalimumab for the treatment of psoriasis

Adalimumab for the treatment of psoriasis DOI: 10.3310/hta13suppl2/07 Health Technology Assessment 2009; Vol. 13: Suppl. 2 Adalimumab for the treatment of psoriasis D Turner, J Picot,* K Cooper and E Loveman Southampton Health Technology Assessments

More information

Master Thesis in Medicine

Master Thesis in Medicine RISK OF INFECTIONS IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOCILIZUMAB IN CLINICAL PRACTICE Master Thesis in Medicine Joyce Åkerlund Supervisor: Catharina Lindholm, MD, PhD, Associate Professor Department

More information

Recognizing the Value of Innovation in the Treatment of Rheumatoid Arthritis

Recognizing the Value of Innovation in the Treatment of Rheumatoid Arthritis White Paper March 2013 Recognizing the Value of Innovation in the Treatment of Rheumatoid Arthritis Catherine Augustyn, Brigham Walker, and Thomas F. Goss, PharmD Boston Healthcare Associates, Inc., Boston,

More information

Prior Authorization Guideline

Prior Authorization Guideline Prior Authorization Guideline Guideline: Enbrel Therapeutic Class: Miscellaneous Therapeutic Agents Therapeutic Sub-Class: Disease-modifying Antirheumatic Drugs Client: 2007 AARP Medicare Rx Inj, 2007

More information

New Evidence reports on presentations given at EULAR 2010. Further Development of Rituximab for the Treatment of Rheumatoid Arthritis

New Evidence reports on presentations given at EULAR 2010. Further Development of Rituximab for the Treatment of Rheumatoid Arthritis New Evidence reports on presentations given at EULAR 2010 Further Development of Rituximab for the Treatment of Rheumatoid Arthritis Report on EULAR 2010 presentations Rituximab in combination with MTX

More information

Cytokine and CAM Antagonists

Cytokine and CAM Antagonists Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Clinical Edit Information Included in this Document Actemra (Tocilizumab) Drugs requiring prior authorization: the list of drugs

More information

EVIDENCE BASED TREATMENT OF CROHN S DISEASE. Dr E Ndabaneze

EVIDENCE BASED TREATMENT OF CROHN S DISEASE. Dr E Ndabaneze EVIDENCE BASED TREATMENT OF CROHN S DISEASE Dr E Ndabaneze PLAN 1. Case presentation 2. Topic on Evidence based Treatment of Crohn s disease - Introduction pathology aetiology - Treatment - concept of

More information

Rheumatoid Arthritis Medicines. A Guide for Adults

Rheumatoid Arthritis Medicines. A Guide for Adults Rheumatoid Arthritis Medicines A Guide for Adults Fast Facts Medicines for rheumatoid arthritis (RA) can slow down the disease and reduce damage to joints. They can relieve pain and make it easier to do

More information

Anti-TNF and tuberculosis

Anti-TNF and tuberculosis Anti-TNF and tuberculosis A rheumatologist point of view Dr Jean Dudler, PD MER Service de Rhumatologie Département de l appareil locomoteur CHUV - 1011 Lausanne Risk of active tuberculosis Anti-TNF therapy

More information

Psoriasis and Psoriatic Arthritis Alliance

Psoriasis and Psoriatic Arthritis Alliance Psoriasis and Psoriatic Arthritis Alliance A principal source of information on psoriasis and psoriatic arthritis ) Treatments for Psoriatic Arthritis overview Although psoriatic arthritis is a chronic

More information

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES I. Requirements for Prior Authorization of Tysabri

MEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES I. Requirements for Prior Authorization of Tysabri MEDICAL ASSISTANCE HBOOK PRI AUTHIZATION OF I. Requirements for Prior Authorization of Tysabri A. Prescriptions That Require Prior Authorization All prescriptions for Tysabri must be prior authorized.

More information

Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis

Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis Etanercept, infliximab and adalimumab for the treatment of Issued: August 2010 guidance.nice.org.uk/ta199 NICE has accredited the process used by the Centre for Health Technology Evaluation at NICE to

More information

to Part of Dossier: Name of Active Ingredient: Title of Study: Quality of life study with adalimumab in rheumatoid arthritis. ESCALAR.

to Part of Dossier: Name of Active Ingredient: Title of Study: Quality of life study with adalimumab in rheumatoid arthritis. ESCALAR. 2.0 Synopsis Abbott Laboratories Name of Study Drug: Individual Study Table Referring to Part of Dossier: Adalimumab (HUMIRA) (For National Authority Use Only) Name of Active Ingredient: Adalimumab Title

More information

Dr Sarah Levy Consultant Rheumatology Croydon University Hospital

Dr Sarah Levy Consultant Rheumatology Croydon University Hospital Dr Sarah Levy Consultant Rheumatology Croydon University Hospital Contents Definition/ epidemiology Diagnosis Importance of early diagnosis/ treatment Guidelines Evidence based treatment protocol Current

More information

REMICADE (infliximab)

REMICADE (infliximab) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use REMICADE safely and effectively. See full prescribing information for REMICADE. REMICADE (infliximab)

More information

Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis Juvenile Rheumatoid Arthritis (JRA; Juvenile Chronic Polyarthritis; Still s Disease) Pronounced: jew-va-nigh-el roo-mah-toyd arth-ri-tis by Jacquelyn Rudis En Español (Spanish Version) Definition Juvenile

More information