Author: GDIT, (800) 688-6696
Effective with date of service Aug. 1, 2019, the North Carolina Medicaid and NC Health Choice programs cover infliximab-abda for injection, for intravenous use (Renflexis) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code Q5104 - Injection, infliximab-abda, biosimilar, (renflexis), 10 mg.
Strength/package size(s): For injection: 100 mg of lyophilized infliximab-abda in a 20 mL vial for intravenous infusion
Indicated for:
Crohn’s Disease:
- Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
- Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.
Pediatric Crohn’s Disease:
Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
Ulcerative Colitis:
Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
Pediatric Ulcerative Colitis:
Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
Rheumatoid Arthritis in combination with methotrexate:
Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.
Ankylosing Spondylitis:
Reducing signs and symptoms in patients with active disease.
Psoriatic Arthritis:
Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.
Plaque Psoriasis:
Treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
Recommended Dose: Renflexis is administered by intravenous infusion over a period of not less than 2 hours.
Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.
Pediatric Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Pediatric Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Rheumatoid Arthritis: In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.
Ankylosing Spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
Psoriatic Arthritis and Plaque Psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
See full prescribing information for further detail.
For North Carolina Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis code(s) required for billing are:
Crohn's Disease:
K50.00 Crohn's disease of small intestine without complications; K50.011 Crohn's disease of small intestine with rectal bleeding; K50.012 Crohn's disease of small intestine with intestinal obstruction; K50.013 Crohn's disease of small intestine with fistula; K50.014 Crohn's disease of small intestine with abscess; K50.018 Crohn's disease of small intestine with other complication; K50.019 Crohn's disease of small intestine with unspecified complications; K50.10 Crohn's disease of large intestine without complications; K50.111 Crohn's disease of large intestine with rectal bleeding; K50.112 Crohn's disease of large intestine with intestinal obstruction; K50.113 Crohn's disease of large intestine with fistula; K50.114 Crohn's disease of large intestine with abscess; K50.118 Crohn's disease of large intestine with other complication; K50.119 Crohn's disease of large intestine with unspecified complications; K50.80 Crohn's disease of both small and large intestine without complications; K50.811 Crohn's disease of both small and large intestine with rectal bleeding; K50.812 Crohn's disease of both small and large intestine with intestinal obstruction; K50.813 Crohn's disease of both small and large intestine with fistula; K50.814 Crohn's disease of both small and large intestine with abscess; K50.818 Crohn's disease of both small and large intestine with other complication; K50.819 Crohn's disease of both small and large intestine with unspecified complications; K50.90 Crohn's disease, unspecified without complications; K50.911 Crohn's disease, unspecified, with rectal bleeding; K50.912 Crohn's disease, unspecified, with intestinal obstruction; K50.913 Crohn's disease, unspecified, with fistula; K50.914 Crohn's disease, unspecified, with abscess; K50.918 Crohn's disease, unspecified, with other complication; K50.919 Crohn's disease, unspecified, with unspecified complications
Ulcerative Colitis:
K51.00 - Ulcerative Colitis Ulcerative (chronic) pancolitis without complications; K51.011 Ulcerative (chronic) pancolitis with rectal bleeding; K51.012 Ulcerative (chronic) pancolitis with intestinal obstruction; K51.013 Ulcerative (chronic) pancolitis with fistula; K51.014 Ulcerative (chronic) pancolitis with abscess; K51.018 Ulcerative (chronic) pancolitis with other complication; K51.019 Ulcerative (chronic) pancolitis with unspecified complications; K51.20 Ulcerative (chronic) proctitis without complications; K51.211 Ulcerative (chronic) proctitis with rectal bleeding; K51.212 Ulcerative (chronic) proctitis with intestinal obstruction; K51.213 Ulcerative (chronic) proctitis with fistula; K51.214 Ulcerative (chronic) proctitis with abscess; K51.218 Ulcerative (chronic) proctitis with other complication; K51.219 Ulcerative (chronic) proctitis with unspecified complications; K51.30 Ulcerative (chronic) rectosigmoiditis without complications; K51.311 Ulcerative (chronic) rectosigmoiditis with rectal bleeding; K51.312 Ulcerative (chronic) rectosigmoiditis with intestinal obstruction; K51.313 Ulcerative (chronic) rectosigmoiditis with fistula; K51.314 Ulcerative (chronic) rectosigmoiditis with abscess; K51.318 Ulcerative (chronic) rectosigmoiditis with other complication; K51.319 Ulcerative (chronic) rectosigmoiditis with unspecified complications; K51.50 Left sided colitis without complications; K51.511 Left sided colitis with rectal bleeding; K51.512 Left sided colitis with intestinal obstruction; K51.513 Left sided colitis with fistula; K51.514 Left sided colitis with abscess; K51.518 Left sided colitis with other complication; K51.519 Left sided colitis with unspecified complications; K51.80 Other ulcerative colitis without complications; K51.811 Other ulcerative colitis with rectal bleeding; K51.812 Other ulcerative colitis with intestinal obstruction; K51.813 Other ulcerative colitis with fistula; K51.814 Other ulcerative colitis with abscess; K51.818 Other ulcerative colitis with other complication; K51.819 Other ulcerative colitis with unspecified complications; K51.90 Ulcerative colitis, unspecified without complications; K51.911 Ulcerative colitis, unspecified with rectal bleeding; K51.912 Ulcerative colitis, unspecified with intestinal obstruction; K51.913 Ulcerative colitis, unspecified with fistula; K51.914 Ulcerative colitis, unspecified with abscess; K51.918 Ulcerative colitis, unspecified with other complication; K51.919 Ulcerative colitis, unspecified with unspecified complications
Rheumatoid Arthritis:
M05.00 Felty's syndrome, unspecified site; M05.011 Felty's syndrome, right shoulder; M05.012 Felty's syndrome, left shoulder; M05.019 Felty's syndrome, unspecified shoulder; M05.021 Felty's syndrome, right elbow; M05.022 Felty's syndrome, left elbow; M05.029 Felty's syndrome, unspecified elbow; M05.031 Felty's syndrome, right wrist; M05.032 Felty's syndrome, left wrist; M05.039 Felty's syndrome, unspecified wrist; M05.041 Felty's syndrome, right hand; M05.042 Felty's syndrome, left hand; M05.049 Felty's syndrome, unspecified hand; M05.051 Felty's syndrome, right hip; M05.052 Felty's syndrome, left hip; M05.059 Felty's syndrome, unspecified hip; M05.061 Felty's syndrome, right knee; M05.062 Felty's syndrome, left knee; M05.069 Felty's syndrome, unspecified knee; M05.071 Felty's syndrome, right ankle and foot; M05.072 Felty's syndrome, left ankle and foot; M05.079 Felty's syndrome, unspecified ankle and foot; M05.09 Felty's syndrome, multiple sites; M05.60 Rheumatoid arthritis of unspecified site with involvement of other organs and systems; M05.611 Rheumatoid arthritis of right shoulder with involvement of other organs and systems; M05.612 Rheumatoid arthritis of left shoulder with involvement of other organs and systems; M05.619 Rheumatoid arthritis of unspecified shoulder with involvement of other organs/systems; M05.621 Rheumatoid arthritis of right elbow with involvement of other organs and systems; M05.622 Rheumatoid arthritis of left elbow with involvement of other organs and systems; M05.629 Rheumatoid arthritis of unspecified elbow with involvement of other organs/systems; M05.631 Rheumatoid arthritis of right wrist with involvement of other organs and systems; M05.632 Rheumatoid arthritis of left wrist with involvement of other organs and systems; M05.639 Rheumatoid arthritis of unspecified wrist with involvement of other organs and systems; M05.641 Rheumatoid arthritis of right hand with involvement of other organs and systems; M05.642 Rheumatoid arthritis of left hand with involvement of other organs and systems; M05.649 Rheumatoid arthritis of unspecified hand with involvement of other organs and systems; M05.651 Rheumatoid arthritis of right hip with involvement of other organs and systems; M05.652 Rheumatoid arthritis of left hip with involvement of other organs and systems; M05.659 Rheumatoid arthritis of unspecified hip with involvement of other organs and systems; M05.661 Rheumatoid arthritis of right knee with involvement of other organs and systems; M05.662 Rheumatoid arthritis of left knee with involvement of other organs and systems; M05.669 Rheumatoid arthritis of unspecified knee with involvement of other organs and systems; M05.671 Rheumatoid arthritis of right ankle and foot with involvement of other organs/systems; M05.672 Rheumatoid arthritis of left ankle and foot with involvement of other organs/systems; M05.679 Rheumatoid arthritis of unspecified ankle/foot with involvement of other organs/systems; M05.69 Rheumatoid arthritis of multiple sites with involvement of other organs and systems; M05.70 Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement; M05.711 Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement; M05.712 Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement; M05.719 Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement; M05.721 Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement; M05.722 Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement; M05.729 Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement; M05.731 Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement; M05.732 Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement; M05.739 Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement; M05.741 Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement; M05.742 Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement; M05.749 Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement; M05.751 Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement; M05.752 Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement; M05.759 Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement; M05.761 Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement; M05.762 Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement; M05.769 Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement; M05.771 Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement; M05.772 Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement; M05.779 Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement; M05.79 Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement; M05.80 Other rheumatoid arthritis with rheumatoid factor of unspecified site; M05.811 Other rheumatoid arthritis with rheumatoid factor of right shoulder; M05.812 Other rheumatoid arthritis with rheumatoid factor of left shoulder; M05.819 Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder; M05.821 Other rheumatoid arthritis with rheumatoid factor of right elbow; M05.822 Other rheumatoid arthritis with rheumatoid factor of left elbow; M05.829 Other rheumatoid arthritis with rheumatoid factor of unspecified elbow; M05.831 Other rheumatoid arthritis with rheumatoid factor of right wrist; M05.832 Other rheumatoid arthritis with rheumatoid factor of left wrist; M05.839 Other rheumatoid arthritis with rheumatoid factor of unspecified wrist; M05.841 Other rheumatoid arthritis with rheumatoid factor of right hand; M05.842 Other rheumatoid arthritis with rheumatoid factor of left hand; M05.849 Other rheumatoid arthritis with rheumatoid factor of unspecified hand; M05.851 Other rheumatoid arthritis with rheumatoid factor of right hip; M05.852 Other rheumatoid arthritis with rheumatoid factor of left hip; M05.859 Other rheumatoid arthritis with rheumatoid factor of unspecified hip; M05.861 Other rheumatoid arthritis with rheumatoid factor of right knee; M05.862 Other rheumatoid arthritis with rheumatoid factor of left knee; M05.869 Other rheumatoid arthritis with rheumatoid factor of unspecified knee; M05.871 Other rheumatoid arthritis with rheumatoid factor of right ankle and foot; M05.872 Other rheumatoid arthritis with rheumatoid factor of left ankle and foot; M05.879 Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot; M05.89 Other rheumatoid arthritis with rheumatoid factor of multiple sites; M05.9 Rheumatoid arthritis with rheumatoid factor, unspecified; M06.00 Rheumatoid arthritis without rheumatoid factor, unspecified site; M06.011 Rheumatoid arthritis without rheumatoid factor, right shoulder; M06.012 Rheumatoid arthritis without rheumatoid factor, left shoulder; M06.019 Rheumatoid arthritis without rheumatoid factor, unspecified shoulder; M06.021 Rheumatoid arthritis without rheumatoid factor, right elbow; M06.022 Rheumatoid arthritis without rheumatoid factor, left elbow; M06.029 Rheumatoid arthritis without rheumatoid factor, unspecified elbow; M06.031 Rheumatoid arthritis without rheumatoid factor, right wrist; M06.032 Rheumatoid arthritis without rheumatoid factor, left wrist; M06.039 Rheumatoid arthritis without rheumatoid factor, unspecified wrist; M06.041 Rheumatoid arthritis without rheumatoid factor, right hand; M06.042 Rheumatoid arthritis without rheumatoid factor, left hand; M06.049 Rheumatoid arthritis without rheumatoid factor, unspecified hand; M06.051 Rheumatoid arthritis without rheumatoid factor, right hip; M06.052 Rheumatoid arthritis without rheumatoid factor, left hip; M06.059 Rheumatoid arthritis without rheumatoid factor, unspecified hip; M06.061 Rheumatoid arthritis without rheumatoid factor, right knee; M06.062 Rheumatoid arthritis without rheumatoid factor, left knee; M06.069 Rheumatoid arthritis without rheumatoid factor, unspecified knee; M06.071 Rheumatoid arthritis without rheumatoid factor, right ankle and foot; M06.072 Rheumatoid arthritis without rheumatoid factor, left ankle and foot; M06.079 Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot; M06.08 Rheumatoid arthritis without rheumatoid factor, vertebrae; M06.09 Rheumatoid arthritis without rheumatoid factor, multiple sites; M06.80 Other specified rheumatoid arthritis unspecified site; M06.811 Other specified rheumatoid arthritis, right shoulder; M06.812 Other specified rheumatoid arthritis, left shoulder; M06.819 Other specified rheumatoid arthritis, unspecified shoulder; M06.821 Other specified rheumatoid arthritis, right elbow; M06.822 Other specified rheumatoid arthritis, left elbow; M06.829 Other specified rheumatoid arthritis, unspecified elbow; M06.831 Other specified rheumatoid arthritis, right wrist; M06.832 Other specified rheumatoid arthritis, left wrist; M06.839 Other specified rheumatoid arthritis, unspecified wrist; M06.841 Other specified rheumatoid arthritis, right hand; M06.842 Other specified rheumatoid arthritis, left hand; M06.849 Other specified rheumatoid arthritis, unspecified hand; M06.851 Other specified rheumatoid arthritis, right hip; M06.852 Other specified rheumatoid arthritis, left hip; M06.859 Other specified rheumatoid arthritis, unspecified hip; M06.861 Other specified rheumatoid arthritis, right knee; M06.862 Other specified rheumatoid arthritis, left knee; M06.869 Other specified rheumatoid arthritis, unspecified knee; M06.871 Other specified rheumatoid arthritis, right ankle and foot; M06.872 Other specified rheumatoid arthritis, left ankle and foot; M06.879 Other specified rheumatoid arthritis, unspecified ankle and foot; M06.88 Other specified rheumatoid arthritis, vertebrae; M06.89 Other specified rheumatoid arthritis, multiple sites; M06.9 Rheumatoid arthritis, unspecified
Ankylosing Spondylitis:
M45.0 - Ankylosing spondylitis of multiple sites in spine; M45.1 - Ankylosing spondylitis of occipito-atlanto-axial region; M45.2 - Ankylosing spondylitis of cervical region; M45.3 - Ankylosing spondylitis of cervicothoracic region; M45.4 - Ankylosing spondylitis of thoracic region; M45.5 - Ankylosing spondylitis of thoracolumbar region; M45.6 - Ankylosing spondylitis lumbar region; M45.7 - Ankylosing spondylitis of lumbosacral region; M45.8 - Ankylosing spondylitis sacral and sacrococcygeal region; M45.9 - Ankylosing spondylitis of unspecified sites in spine
Plaque Psoriasis:
L40.50 - Arthropathic psoriasis, unspecified; L40.51 - Distal interphalangeal psoriatic arthropathy; L40.52 - Psoriatic arthritis mutilans; L40.53 - Psoriatic spondylitis; L40.59 - Other psoriatic arthropathy; L40.0 - Psoriasis vulgaris
- Providers must bill with HCPCS code: Q5104 - Injection, infliximab-abda, biosimilar, (renflexis), 10 mg
- One Medicaid and NC Health Choice unit of coverage is: 10 mg
- The maximum reimbursement rate per unit is: $54.65
- Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs is: 00006-4305-02
- The NDC units should be reported as "UN1".
- For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update.
- For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on DHB's website.
- Providers shall bill their usual and customary charge for non-340B drugs.
- PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
The fee schedule for the Physician Administered Drug Program is available on DHB's PADP web page.