Rheumatoid Arthritis Treatment, Product Administration, Training and Patient Assistance/Compassionate Use Program Awareness for the Specialty Pharmacist and the Collaborative Healthcare Team Disclaimer The information within this CME/CE activity is for continuing education purposes only, and is not intended to substitute for the medical judgment of the healthcare provider. Recommendations for use of any particular therapeutic agents or methods are based upon the best available scientific evidence and clinical guidelines. Reference in this activity to any specific commercial products, process, service, manufacturer, or company does not constitute its endorsement or recommendation. Developer discloses that he is a speaker, consultant, and provides research support for the National Association of Specialty Pharmacy. He does not intend to discuss non-FDA approved drugs or investigational use of any product/device. Faculty Biography Michael J Crocco, PharmD, RPh, CSP Specialty Pharmacy Clinical Services National Association of Specialty Pharmacy • University of Florida 2008 • Pharmacist in Charge – Publix Super Markets • National Association of Specialty Pharmacy – Specialty Pharmacy Clinical Consultant • Specialty Pharmacy Education Center – Reviewer/author of CE’s • Specialty Pharmacy Certification Board – Subject matter expert in developing Certified Specialty Pharmacy Credential • Certified Specialty Pharmacist Objectives • Recognize the various inflammatory autoimmune disorders and their distinguishing features. • Identify current treatment options for RA and review their appropriate administration • Identify the three biggest barriers to adherence & persistence and how Specialty Pharmacists and the collaborative healthcare team can anticipate & overcome those barriers • Identify RA patient assistance programs from RA manufacturers and 3rd parties • Describe the specialty pharmacist and the collaborative healthcare team’s role in RA condition management resulting in cost-effective care Other Autoimmune Diseases (Brief Overview) Crohn’s Disease • Inflammatory Bowel Disease • • Lining of digestive tract (mouth to anus) Signs/Symptoms • Abdominal pain • Severe diarrhea • Blood in stool • Ulcers • Reduced appetite • Weight loss http://upload.wikimedia.org/wikipedia/commons/b/bf/Patterns_of_Crohn%27s_Diseas e.svg Ulcerative Colitis • Inflammatory bowel disease • • Lining of large intestine Types of UC: • Proctitis • Proctosigmoiditis • Left-sided Colitis • Pancolitis • Fulminant Colitis http://specialityclinic.com/Images/Disease/Ulcerative_%20Colitis.j pg Psoriatic Arthritis • Enthesitis • • Characteristic feature Signs/Symptoms • Similar to RA, plus….. • Swollen fingers and toes • Foot pain • Lower back pain Juvenile Idiopathic Arthritis • Children • • 6 months – 16 years old Types of JIA • Pauciarticular • Polyarticular • Systemic Juvenile Idiopathic Arthritis • Symptoms • Pain • Swelling • Stiffness • Swollen lymph nodes • Rash • Fever Ankylosing Spondylitis • Spine • • Vertebrae fuse Signs/Symptoms • Lower back pain • Hip pain http://www.webmd.com/back-pain/guide/ankylosing-spondylitis Treatment Options Rheumatoid Arthritis DMARDs • Methotrexate (Trexall, Rheumatrex) • Leflunomide (Arava) • Hydroxychloroquine (Plaquenil) • Sulfasalazine (Azulfidine) Methotrexate • Dosing • Once weekly • Oral or injection (IM or SQ) • Titrate up as necessary • Hydration • Monitoring • LFT’s • CBC w/diff • Platelets • BUN/Cr Methotrexate • SQ Injection • 25 Gauge • 1/2 - 5/8 inch http://www.childrenshealthnetwork.org/CRS/CRS/pa_subinjec_art. htm Methotrexate • IM Injection • 25 Gauge • 1 - 1.5 inch http://www.childrenshealthnetwork.org/CRS/CRS/pa_iminject_art. htm Leflunomide • • Dosing • Loading dose of 100mg x 3 days • 20mg daily thereafter • With food Monitoring • BP • Platelets • WBC’s • Hgb/Hct • LFT’s Leflunomide • Drug elimination procedure • Cholestyramine 8g TID x 11 days • Plasma levels <0.02mg/dL • • 2 tests, 14 days apart If no elimination procedure…… • Up to 2 years to reach <0.02mg/dL Hydroxychloroquine • • Weight based dosing • 6.5mg/kg /day • Typically 200-400mg daily Monitoring • Eye exams • • Yearly Keep away from children • Small doses fatal Sulfasalazine • • • Dosing • 500-1000mg Q12H • Up to 4000mg daily Monitoring • CBC w/diff • LFTs • BUN/Cr Caution • Sulfonamide allergy • Salicylate allergy TNFa Inhibitors • Humira (Adalimumab) • Enbrel (Etanercept) • Cimzia (Certolizumab pegol) • Simponi (Golimumab) • Remicade (Infliximab) Humira • Dosing • 40mg SQ q2wk • 40mg SQ qwk if not on MTX • Refrigerate • Monitor • • Hep B antigen • PPD • s/sx TB and HBV Cost • $2400-$2700 • (2 pens/syringes) Humira • Administering Pen • Clear/colorless liquid • No particles • Front of thighs/lower abdomen • Clean area • Gently squeeze skin and hold firmly • Hold pen at 90 degree angle • Push plum colored button until clicks • Hold for 10 seconds • Yellow Indicator = Completed • Do not rub area http://1.bp.blogspot.com/2IpGLsVangU/UEktd63ThII/AAAAAAAAAJw/wmt8vVOYiC8/s1600/humira1.jpg Humira • Administering Prefilled Syringe • Clear/colorless liquid • No particles • Front of thighs/lower abdomen • Clean area • Gently squeeze skin and hold firmly • Insert at 45 degree angle and let go of skin • After injecting, remove at same angle • Do not rub area http://2.bp.blogspot.com/8QaFwE1vRfE/T819tbn5jQI/AAAAAAAAACk/gAjBd3WTGPo/s1600/humira.jpg Humira Patient Assistance Programs • myHumira • Humira Protection Plan • 24/7 on-call nurse support • 1-800-4-HUMIRA • • Injection training kit • Sharps container • Medication reminders • On-the-go kit Abbvie Patient Assistance Foundation Enbrel • • • • Dosing • 50mg SQ qwk OR • 25mg SQ 2x/wk 72-96h apart Storage • Refrigerate • Room temperature – 14 days Monitor • Hep B antigen • PPD • s/sx TB and HBV • Dermatologic exam* Cost • $2200-$3000 Enbrel • Administering SureClick AutoInjector • Clear/colorless liquid • Front of thighs preferred • Abdomen/outer are of upper arms • Clean area • Stretch skin to make it firm and taut • Hold pen at 90 degree angle • Press pen firmly to unlock safety guard • Press and release purple button • Hold firmly for 15 seconds • Purple Indicator = Completed • Do not rub area http://www.rxzone.us/images/products/med/999250.j pg Enbrel • Administering Enbrel PFS • Clear/colorless liquid • Front of thighs/lower abdomen/outer upper arms • Clean area • Gently squeeze skin and hold firmly • Inject at 45 degree angle • Do not rub area http://www.walgreens.com//images/drug/0158406043504 .jpg Enbrel PAP • Enbrel Support Card • Education • Injection training • Medication refill reminders • Live nurse support • 1-888-4ENBREL • Starter kit • Sharps mail-back program • Travel pack Enbrel Support Card • If commercial insurance: • • • $0 for 6 months, $10 afterwards If Government insurance: • Connect with independent foundations • Low-income subsidy assistance If Uninsured: • ENcourage Foundation Cimzia • Dosing • 400mg SQ on week 0, 2, 4, then • 200mg SQ q2wk OR • 400mg SQ q4wk • Refrigerate • Monitor • • Hep B antigen • PPD • s/sx TB and HBV • Dermatologic exam* Cost • ~$2500 http://www.pharmatopics.com/wp/wpcontent/uploads/2013/09/UCB_cimzia_.jpg Cimzia • Administration • Room temperature • 30 minutes • Clear/colorless liquid • Front of thighs/lower abdomen • Clean area • Gently squeeze skin and hold firmly • Inject at 45 degree angle • Do not rub area Cimzia PAP • Cimplicity • Treatment and patient support • Home Health Nurse • • 1-866-4-CIMZIA Education • Injection training • Insurance coverage verification • Cimzia Co-pay Savings Card Program • • Up to 12 months at no cost Additional financial assistance Simponi • Dosing • 50mg SQ monthly with MTX • Refrigerate • Monitor • • Hep B antigen • PPD • s/sx TB and HBV • Dermatologic exam* Cost • ~$8300 (5 syringes) Simponi SmartJect Autoinjector • Administration • Room temperature • 30 minutes • Clear/slightly yellow • Front of thighs/lower abdomen/outer area of upper arms • Clean area • Inject at 90 degree angle • Press firmly against skin to unlock safety sleeve • Press button until clicks • • hold until clicks again Do not rub area http://d3hjf51r9j54j7.cloudfront.net/wp-content/uploads/sites/5/2010/09/Simponi-Ire-PackShot.jpg Simponi Prefilled Syringe • Administration • Room temperature • 30 minutes • Clear/slightly yellow • Front of thighs/lower abdomen/back of upper arms • Clean area • Gently squeeze skin and hold firmly • Inject at 45 degree angle • Hold plunger until removed from skin then release • Do not rub area http://www.medhelp.org/drug_images/GOM00700.J PG SimponiOne Support • Injection Support • Nurse Support • 1-877-MY SIMPONI • • RN Live Link (on-line discussion) • 7 days/wk, 8am-11pm SmartJect Autoinjector Reusable Trainer • • Included in Welcome Pack Demonstration Videos SimponiOne Support • Treatment Support • Simponi Welcome Pack • SimponiOne Safe Returns • • Once a year return service • Holds 12 SmartJect autoinjectors • Holds more syringes Travel Pack • Travel Advisory Card https://www.simponi.com/ulcerative-colitis/sites/admin-simponi.jnj.com.ulcerative-colitis/themes/simponi_uc/images/transport-support-bags.p http://www.simponi.com/hcp/sites/www.simponi.com.hcp/files/content_images/simponi_one_image_new.png SimponiOne Support • Medication Cost Support • Commercial/Private Insurance • • Government Insurance • • $5/month up to $8000 benefit/yr independent foundation No insurance • Johnson & Johnson Patient Assistance Foundation • Other Remicade • Dosing • 3mg/kg IV on wk 0, 2, 6 THEN • 3mg/kg IV q8wk • Use with MTX • Max dose 10mg/kg OR 3mg/kg q4wk • Refrigerate • Monitor • • Hep B antigen • PPD • s/sx TB and HBV • Dermatologic exam* Cost • $915.50 for one vial (100mg) http://www.venus-rx.com/img/Rheumatology/Rheumatology-Janssen-Biotech-Remicade.jpg Remicade • Administration • Colorless/light yellow • By medical professional • Infusion Center • At least 2 hours http://www.gastro.higherimages3.com/wpcontent/uploads/2010/05/iStock_000010762269XSmall.jpg Remicade PAP • AccessOne • Care Coordinator • 1-888-Access-1 • M-F, 8am-8pm EST • Infusion site locations • Newsletters • Education materials • Appointment reminders • Emergency outreach services Remicade PAP • • RemiStart Patient Rebate Program • Co-pay assistance • Up to 12 months, 8 infusions, or $8000 RemiStart Extended Access Program • Must meet eligibility requirements Other Biologics • Kineret (Anakinra) • Orencia (Abatacept) • Rituxan (Rituximab) • Actemra (Tocilizumab) Kineret • Dosing • 100mg SQ q24h • Refrigerate • Monitor • Cr • ANC • Pregnancy Category B • Cost • ~$3000/28 syringes http://www.bad-drug.net/wp-content/uploads/2012/10/209x166xkineret.gif.pagespeed.ic.5yhNnxy_j9.jpg Kineret Prefilled Syringe • Administration • Sit at room temperature • 60-90 minutes • Clear/colorless • Sites • Outer area of upper arms • Upper outer areas of buttocks • Abdomen • Front of the middle thighs • Gently pinch fold of skin • Inject at 45 or 90 degree angle http://images.rxlist.com/images/rxlist/anakinra6. gif Kineret PAP • KineretKare Program • Copay assistance • Up to $300/month OR • $3600/year • Delivery of medication • Access to KineretKare specialist • 1-866-547-0644 • M-F, 8am-6pm EST Orencia • Weight based dosing • <60kg – 500mg IV on wk 0, 2, 4, then q4wk OR 500mg IV x1, then 125mg SQ w/in 24hr, then 125mg SQ qwk • 60-100kg – same as above but 750mg IV doses • >100kg – same as above but 1000mg IV doses • Refrigerate • Monitor • • Hepatitis panel • PPD at baseline Cost • $2100/vial (250mg) • $2500/4 syringes (125mg) Orencia Administration • IV • Medical professional • Reconstitute with 10ml sterile water for injection • Must use silicone free syringe provided • 30 minute infusion http://www.bmscanada.ca/static/products/en/product_photo/orencia.jpg Orencia Administration • SQ • Clear/colorless/pale yellow • Room temperature • • 30-60 minutes Sites • Front of thigh • Upper outer arms • Abdomen • Gently pinch skin and hold firmly • Inject at 45 degree angle http://2.bp.blogspot.com/Ulnq7gEQ1NM/UqNeD7LnvSI/AAAAAAAATEo/vQpbAc01osY/s1600/orencia.jpg Orencia PAP • Orencia On Call • Personal care counselor • Available 24/7 • 1-800-ORENCIA • Copay assistance • Welcome pack • Sharps Disposal Service • Drug Replacement • • If damaged Insurance questions Orencia PAP • Orencia Copay Assistance Program • Covers cost of drug only • Infusion patients • $5 out of pocket per infusion • $8000/year max benefit • NOTE: state or federally funded insurance excluded Rituxan • Dosing • 1000mg IV on days 1 and 15 THEN • 1000mg IV q24 weeks • • Q16 weeks In combination with MTX • Refrigerate • Cost • ~$15,600 (one 10ml vial = 10mg/ml) Rituxan • Monitoring • HBsAg • Anti-HBc at baseline • CBC • Platelets • ECG • s/sx of hepatitis or HBV reactivation Rituxan • Administration • IV infusion • Medical professional • Pre-medicate • APAP and antihistamine • Methylprednisolone 100mg IV (RA patients only) http://jlazur.com/WEBSITES/Rituxan/professional/dosage_administration/guide/rituxan_product.gif Rituxan Infusion Rates • • Initial Infusion = 50mg/hr • Increase at 50mg/hr increments q30 minutes • Max 400mg/hr Subsequent infusions = 100mg/hr • Increase at 100mg/hr at 30 minute intervals • Max 400mg/hr Rituxan PAP • Join Rituxan and You • Genentech Rheumatology Access Solutions • Genentech Access to Care Foundation • Genentech Rheumatology Co-pay Card Program • $10,000 over 12 months • $5 per co-pay • May reuse if still eligible after 12 months Actemra • • IV Dosing • 4mg/kg IV over 1 hour q4wks • May increase to 8mg/kg IV q4wks • Do not exceed 800mg per infusion SQ Dosing • 162mg SQ qwk • If pt <100kg, start at 162mg SQ q2wks • Refrigerate • Cost • $340 (4ml vial) • $850 (10ml vial) • $1725 (20ml vial) Actemra • Monitoring • PPD at baseline • s/x of TB • CBC w/differential (ANC’s) • Platelets • LFT’s • Lipid profile Actemra Administration • IV Infusion • Clear/colorless/pale yellow • Medical professional • Room temperature • Infuse over 60 minutes • Use separate IV line https://www.besse.com/PublishingImages/Actemra/Actemraprod.j pg Actemra Administration • SQ • Room temperature • • 30 minutes Sites • Front of thigh • Outer area of upper arm • Abdomen • Gently pinch skin • Inject at 45 or 90 degree angle • Release pinched skin and inject Actemra PAP • Actemra Access • Sampling Program • • ACT Fast Program • • SQ patients 6 months free Support for Medicare Part D patients • Refer to LIS Program • Genentech Access to Care Foundation Extension Actemra Access • Actemra and You • Symptom Tracker Calendar • Doctor Discussion Guide • Nurse Help Line • 1-800-ACTEMRA • 6am-12am EST • • SC Injection tools • Travel Pack • Sharps Container • Injection Reminder Service Treatment Tracker Actemra Access • • Genentech Rheumatology Co-pay Card Program • $10,000 per 12 months • $5 co-pay Genentech Rheumatology Access Solutions JAK inhibitor • Xeljanz (Tofacitinib) Xeljanz • Dosing • 5mg PO BID • With or w/o food • Room temperature • Monitoring • • CBC w/diff • Lipid panel • LFT’s Cost • ~$2,000 (60 tablets) XelSource • Private Insurance • Free Trial Offer • Personal Support • 1-855-493-5526 • M-F, 8am-8pm EST • • Xeljanz Copay Savings Card • $0 copay • $8,000 benefit per calendar year Uninsured • XelSource Patient Assistance Program Xeljanz • • Government Insurance • Personal Support • Financial Assistance • State Pharmaceutical Companies • Low-income subsidies • Charitable foundations • Hardship support Xeljanz + You • Welcome Kit • Refill reminders • Tips, Tools, and Resources Other Patient Assistance Programs • NeedyMeds • Diplomat’s Co-pay Assistance Navigator • HealthWell Foundation • Patient Access Network Foundation • Bristol-Myers Squibb Patient Assistance Foundation • • Orencia Pfizer Pfriends • Xeljanz Other Patient Assistance Programs • Partnership for Prescription Assistance • • MedLink Prescription Assistance • • Enbrel Janssen Prescription Assistance • • Humira Simponi, Remicade Johnson & Johnson Prescription Assistance Foundation • Remicade Barriers to Adherence • • Cost • Direct • Indirect Administration • • Transportation/Time • • Complicated/intimidating Infusions Side effects • Cancer • Infertility • Pain Overcoming Barriers • Treatment management • Counsel/Educate • • Side effects • Self injections Insurance • No more pre-existing condition • Use assistance programs • Home health nurse • Specialty Pharmacist Conclusion • Multiple treatment options • Biologics are expensive • All have assistance programs • • Make patients aware Need to educate/counsel all patients References Mayoclinic. Crohn’s Disease. http://www.mayoclinic.com/health/crohnsdisease/DS00104. Accessed on November 19, 2013. Crohn’s and Colitis Foundation of America. What is Crohn’s Disease? http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease/. Accessed on November 19, 2013. Mayoclinic. Ulcerative Colitis. http://www.mayoclinic.com/health/ulcerativecolitis/DS00598. Accessed on November 19, 2013. Crohn’s and Colitis Foundation of America. What is Ulcerative Colitis. http://www.ccfa.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/. Accessed on November 19, 2013. American College of Rheumatology. Psoriatic Arthritis. http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/ Psoriatic_Arthritis/. Accessed on November 21, 2013. Mayoclinic. Psoriatic Arthritis. http://www.mayoclinic.com/health/psoriaticarthritis/DS00476. Accessed on November 21, 2013. References Mayoclinic. Juvenile Rheumatoid Arthritis. http://www.mayoclinic.com/health/juvenile-rheumatoid-arthritis/DS00018. Accessed on November 21, 2013. National Institute of Arthritis and Musculoskeletal and Skin Diseases. What is Juvenile Arthritis? http://www.niams.nih.gov/Health_Info/Juv_Arthritis/juvenile_arthritis_ff.asp. Accessed on November 21, 2013. WebMD. Understanding Juvenile Rheumatoid Arthritis. http://www.webmd.com/rheumatoid-arthritis/understanding-juvenilerheumatoid-arthritis-basics. Accessed on November 21, 2013. Mayoclinic. Ankylosing Spondylitis. http://www.mayoclinic.com/health/ankylosingspondylitis/DS00483. Accessed on November 22, 2013. American College of Rheumatology. Methotrexate. http://www.rheumatology.org/Practice/Clinical/Patients/Medications/Methotre xate_(Rheumatrex,_Trexall)/. Accessed on November 22, 2013. References Brooks PJ, Spruill WJ, Parish RC, Birchmore DA. Pharmacokinetics of methotrexate administered by intramuscular and subcutaneous injections in patients with rheumatoid arthritis. Department of Pharmacy Practice, University of Georgia College of Pharmacy, Athens. Arthritis Rheum. 1990 Jan;33(1):91-4. Mayoclinic. Leflunomide. http://www.mayoclinic.com/health/druginformation/DR601555. Accessed on November 24, 2013. Sanofi-Aventis. Arava Package Insert. http://products.sanofi.us/arava/arava.html. Accessed on November 24, 2013. Mayoclinic. Hydroxychloroquine. http://www.mayoclinic.com/health/druginformation/DR600761. Accessed on December 5, 2013. Mayoclinic. Sulfasalazine. http://www.mayoclinic.org/drugssupplements/sulfasalazine-oral-route/description/drg-20066179. Accessed on December 5, 2013. References Patient Assistance Programs. www.needymeds.com. Accessed January 20, 2014 – February 27, 2014. Humira Product Information and Patient Assistance Programs. www.humira.com. Accessed on January 15, 2014. Enbrel Product Information and Patient Assistance Programs. www.enbrel.com. Accessed on January 15, 2014. Cimzia Product Information and Patient Assistance Programs. www.cimzia.com. Accessed on January 16, 2014. Simponi Product Information and Patient Assistance Programs. www.simponi.com. Accessed on January 16, 2014. Remicade Product Information and Patient Assistance Programs. www.remicade.com. Accessed on January 18, 2014. Kineret Product Information and Patient Assistance Programs. www.kineret.com. Accessed on January 24, 2014. References Orencia Product Information and Patient Assistance Programs. www.orencia.com. Accessed on January 31, 2014. Rituxan Product Information and Patient Assistance Programs. www.rituxan.com. Accessed on February 10, 2014. Actemra Product Information and Patient Assistance Programs. www.actemra.com. Accessed on February 12, 2014. Xeljanz Product Information and Patient Assistance Programs. www.xeljanz.com. Accessed on February 15, 2014. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Epocrates. 2013. Epocrates Mobile Application. Retrieved from http://www.epocrates.com/mobile/android. Q &A This program has been brought to you by The National Association of Specialty Pharmacy and its education provider The Specialty Pharma Education Center. Claim Credit Instructions: Visit www.specialtycme.org & type session code: (session codes are also located in your program guide on the activity sheet page) *All users must complete the pre AND post test to receive statement of credit. Credit must be claimed within 30 days of this program.