Rheumatoid Arthritis Treatment, Product Administration, Training and Patient Assistance/Compassionate Use Program Awareness for the Specialty

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1 Rheumatoid Arthritis Treatment, Product Administration, Training and Patient Assistance/Compassionate Use Program Awareness for the Specialty Pharmacist and the Collaborative Healthcare Team

2 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 University of Florida 2008 Pharmacist in Charge Publix Super Markets National Association of Specialty Pharmacy Specialty Pharmacy Clinical Consultant Michael J Crocco, PharmD, RPh,

3 Faculty Biography University of Florida 2008 Pharmacist in Charge Publix Super Markets National Association of Specialty Pharmacy Specialty Pharmacy Clinical Consultant Michael J Crocco, PharmD, RPh, CSP Specialty Pharmacy Clinical Services National Association of Specialty Pharmacy 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

4 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 3 rd parties Describe the specialty pharmacist and the collaborative healthcare team s role in RA condition management resulting in cost-effective care

5 Other Autoimmune Diseases (Brief Overview)

6 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 e.svg

7 Ulcerative Colitis Inflammatory bowel disease Lining of large intestine Types of UC: Proctitis Proctosigmoiditis Left-sided Colitis Pancolitis Fulminant Colitis pg

8 Psoriatic Arthritis Enthesitis Characteristic feature Signs/Symptoms Similar to RA, plus.. Swollen fingers and toes Foot pain Lower back pain

9 Juvenile Idiopathic Arthritis Children 6 months 16 years old Types of JIA Pauciarticular Polyarticular Systemic

10 Juvenile Idiopathic Arthritis Symptoms Pain Swelling Stiffness Swollen lymph nodes Rash Fever

11 Ankylosing Spondylitis Spine Vertebrae fuse Signs/Symptoms Lower back pain Hip pain

12 Treatment Options Rheumatoid Arthritis

13 DMARDs Methotrexate (Trexall, Rheumatrex) Leflunomide (Arava) Hydroxychloroquine (Plaquenil) Sulfasalazine (Azulfidine)

14 Methotrexate Dosing Once weekly Oral or injection (IM or SQ) Titrate up as necessary Hydration Monitoring LFT s CBC w/diff Platelets BUN/Cr

15 htm Methotrexate SQ Injection 25 Gauge 1/2-5/8 inch

16 Methotrexate IM Injection 25 Gauge inch htm

17 Leflunomide Dosing Loading dose of 100mg x 3 days 20mg daily thereafter With food Monitoring BP Platelets WBC s Hgb/Hct LFT s

18 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

19 Hydroxychloroquine Weight based dosing 6.5mg/kg /day Typically mg daily Monitoring Eye exams Yearly Keep away from children Small doses fatal

20 Sulfasalazine Dosing mg Q12H Up to 4000mg daily Monitoring CBC w/diff LFTs BUN/Cr Caution Sulfonamide allergy Salicylate allergy

21 TNFa Inhibitors Humira (Adalimumab) Enbrel (Etanercept) Cimzia (Certolizumab pegol) Simponi (Golimumab) Remicade (Infliximab)

22 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

23 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 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

24 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 8QaFwE1vRfE/T819tbn5jQI/AAAAAAAAACk/gAjBd3WTGPo/s1600/humira.jpg

25 Humira Patient Assistance Programs myhumira Humira Protection Plan 24/7 on-call nurse support HUMIRA Injection training kit Sharps container Medication reminders On-the-go kit Abbvie Patient Assistance Foundation

26 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

27 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 pg

28 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

29 Enbrel PAP Enbrel Support Card Education Injection training Medication refill reminders Live nurse support ENBREL Starter kit Sharps mail-back program Travel pack

30 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

31 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

32 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

33 Cimzia PAP Cimplicity Treatment and patient support Home Health Nurse CIMZIA Education Injection training Insurance coverage verification Cimzia Co-pay Savings Card Program Up to 12 months at no cost Additional financial assistance

34 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

35 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 Shot.jpg

Simponi Prefilled Syringe Administration Room temperature 30 minutes Clear/slightly yellow Front of thighs/lower abdomen/back of upper arms Clean area Gently

36 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 PG

37 SimponiOne Support Injection Support Nurse Support MY SIMPONI RN Live Link (on-line discussion) 7 days/wk, 8am-11pm SmartJect Autoinjector Reusable Trainer Included in Welcome Pack Demonstration Videos

Returns Once a year return service Holds 12

com/ulcerative-colitis/sites/admin-simponi.

38 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

39 SimponiOne Support Medication Cost Support Commercial/Private Insurance $5/month up to $8000 benefit/yr Government Insurance independent foundation No insurance Johnson & Johnson Patient Assistance Foundation Other

40 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 $ for one vial (100mg)

41 Remicade Administration Colorless/light yellow By medical professional Infusion Center At least 2 hours

42 Remicade PAP AccessOne Care Coordinator Access-1 M-F, 8am-8pm EST Infusion site locations Newsletters Education materials Appointment reminders Emergency outreach services

43 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

44 Other Biologics Kineret (Anakinra) Orencia (Abatacept) Rituxan (Rituximab) Actemra (Tocilizumab)

45 Kineret Dosing 100mg SQ q24h Refrigerate Monitor Cr ANC Pregnancy Category B Cost ~$3000/28 syringes

Kineret Prefilled Syringe Administration Sit at room temperature 60-90 minutes Clear/colorless Sites Outer area of upper arms Upper outer areas of

46 Kineret Prefilled Syringe Administration Sit at room temperature 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 gif

47 Kineret PAP KineretKare Program Copay assistance Up to $300/month OR $3600/year Delivery of medication Access to KineretKare specialist M-F, 8am-6pm EST

48 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 kg same as above but 750mg IV doses >100kg same as above but 1000mg IV doses Refrigerate Monitor Cost Hepatitis panel PPD at baseline $2100/vial (250mg) $2500/4 syringes (125mg)

49 Orencia Administration IV Medical professional Reconstitute with 10ml sterile water for injection Must use silicone free syringe provided 30 minute infusion

Orencia Administration SQ Clear/colorless/pale yellow Room temperature 30-60 minutes Sites Front of thigh Upper outer arms Abdomen Gently

50 Orencia Administration SQ Clear/colorless/pale yellow Room temperature minutes Sites Front of thigh Upper outer arms Abdomen Gently pinch skin and hold firmly Inject at 45 degree angle Ulnq7gEQ1NM/UqNeD7LnvSI/AAAAAAAATEo/vQpbAc01osY/s1600/orencia.jpg

51 Orencia PAP Orencia On Call Personal care counselor Available 24/ ORENCIA Copay assistance Welcome pack Sharps Disposal Service Drug Replacement If damaged Insurance questions

52 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

53 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)

54 Rituxan Monitoring HBsAg Anti-HBc at baseline CBC Platelets ECG s/sx of hepatitis or HBV reactivation

55 Rituxan Administration IV infusion Medical professional Pre-medicate APAP and antihistamine Methylprednisolone 100mg IV (RA patients only)

56 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

57 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

58 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)

59 Actemra Monitoring PPD at baseline s/x of TB CBC w/differential (ANC s) Platelets LFT s Lipid profile

60 Actemra Administration IV Infusion Clear/colorless/pale yellow Medical professional Room temperature Infuse over 60 minutes Use separate IV line pg

61 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

62 Actemra PAP Actemra Access Sampling Program SQ patients ACT Fast Program 6 months free Support for Medicare Part D patients Refer to LIS Program Genentech Access to Care Foundation Extension

63 Actemra Access Actemra and You Symptom Tracker Calendar Doctor Discussion Guide Nurse Help Line ACTEMRA 6am-12am EST SC Injection tools Travel Pack Sharps Container Injection Reminder Service Treatment Tracker

64 Actemra Access Genentech Rheumatology Co-pay Card Program $10,000 per 12 months $5 co-pay Genentech Rheumatology Access Solutions

65 JAK inhibitor Xeljanz (Tofacitinib)

66 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)

67 XelSource Private Insurance Free Trial Offer Personal Support M-F, 8am-8pm EST Xeljanz Copay Savings Card $0 copay $8,000 benefit per calendar year Uninsured XelSource Patient Assistance Program

68 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

69 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

70 Other Patient Assistance Programs Partnership for Prescription Assistance Humira MedLink Prescription Assistance Enbrel Janssen Prescription Assistance Simponi, Remicade Johnson & Johnson Prescription Assistance Foundation Remicade

71 Barriers to Adherence Cost Direct Indirect Administration Complicated/intimidating Transportation/Time Infusions Side effects Cancer Infertility Pain

72 Overcoming Barriers Treatment management Counsel/Educate Side effects Self injections Insurance No more pre-existing condition Use assistance programs Home health nurse Specialty Pharmacist

73 Conclusion Multiple treatment options Biologics are expensive All have assistance programs Make patients aware Need to educate/counsel all patients

74 References Mayoclinic. Crohn s Disease. Accessed on November 19, Crohn s and Colitis Foundation of America. What is Crohn s Disease? Accessed on November 19, Mayoclinic. Ulcerative Colitis. Accessed on November 19, Crohn s and Colitis Foundation of America. What is Ulcerative Colitis. Accessed on November 19, American College of Rheumatology. Psoriatic Arthritis. Psoriatic_Arthritis/. Accessed on November 21, Mayoclinic. Psoriatic Arthritis. Accessed on November 21, 2013.

75 References Mayoclinic. Juvenile Rheumatoid Arthritis. Accessed on November 21, National Institute of Arthritis and Musculoskeletal and Skin Diseases. What is Juvenile Arthritis? Accessed on November 21, WebMD. Understanding Juvenile Rheumatoid Arthritis. Accessed on November 21, Mayoclinic. Ankylosing Spondylitis. Accessed on November 22, American College of Rheumatology. Methotrexate. xate_(rheumatrex,_trexall)/. Accessed on November 22, 2013.

76 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 Jan;33(1):91-4. Mayoclinic. Leflunomide. Accessed on November 24, Sanofi-Aventis. Arava Package Insert. Accessed on November 24, Mayoclinic. Hydroxychloroquine. Accessed on December 5, Mayoclinic. Sulfasalazine. Accessed on December 5, 2013.

77 References Patient Assistance Programs. Accessed January 20, 2014 February 27, Humira Product Information and Patient Assistance Programs. Accessed on January 15, Enbrel Product Information and Patient Assistance Programs. Accessed on January 15, Cimzia Product Information and Patient Assistance Programs. Accessed on January 16, Simponi Product Information and Patient Assistance Programs. Accessed on January 16, Remicade Product Information and Patient Assistance Programs. Accessed on January 18, Kineret Product Information and Patient Assistance Programs. Accessed on January 24, 2014.

78 References Orencia Product Information and Patient Assistance Programs. Accessed on January 31, Rituxan Product Information and Patient Assistance Programs. Accessed on February 10, Actemra Product Information and Patient Assistance Programs. Accessed on February 12, Xeljanz Product Information and Patient Assistance Programs. Accessed on February 15, Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Epocrates Epocrates Mobile Application. Retrieved from

79 Q & A

80 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 & 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.

RHEUMATOID ARTHRITIS DRUGS

Rheumatology Biologics Criteria from the Exceptional Access Program RHEUMATOID ARTHRITIS DRUGS DRUG NAME BRS REIMBURSED DOSAGE FORM/ STRENGTH Adalimumab Humira 40 mg/0.8 syringe and 40mg/0.8 pen for Anakinra