PiPeline Plus
Ulcerative Colitis and Crohn’s Disease Kunj Gohil, PharmD, RPh; and Brielle Carramusa
U
lcerative colitis (UC) and Crohn’s disease (CD) are severe ailments affecting the digestive system.1 UC is a gastrointestinal (GI) disease that is localized to the large intestine, or colon, where inflammation can affect either the entire organ or a portion of it.2 Approximately 1.86 billion patients have been diagnosed with UC globally, with 1.54 billion patients currently receiving treatment. Traditional therapies have yielded $4.18 billion in annual sales around the world, a figure expected to increase to $6.85 billion by 2022 with the approval of various pipeline drugs.3 CD can affect any part of the GI tract, but most commonly involves both the large and small intestines.2 Although CD Dr. Gohil is a Post Doctoral Fellow with Medical Services at MediMedia Managed Markets in Yardley, Pennsylvania. Ms. Carramusa, a 2016 PharmD candidate, is a Pharmacy Intern with Medical Services at MediMedia Managed Markets in Yardley.
is more severe than UC, the global prevalence is much lower, with only 1.3 million patients diagnosed and 0.8 million who currently receive treatment. Still, traditional therapies have resulted in an impressive $3.17 billion in global market sales, which is predicted to increase to $4.20 billion by 2022.4 Traditional therapies are highly effective in these hard-to-treat diseases. Tumor necrosis factor (TNF) inhibitors are firmly established as treatments but sometimes present problems, such as immunogenicity or an eventual loss of response.4 Vedolizumab (Entyvio, Takeda) is the newest medication for UC and CD, having received FDA approval on May 20, 2014. This novel biologic treatment is not an anti-TNF agent; it is the first gutspecific medication developed solely for UC and CD.5 Future therapies are being developed with the goal of providing patients with highly efficacious options for these complex diseases.3,4
REFERENCES 1.
2.
3. 4. 5.
WebMD. A visual guide to inflammatory bowel disease (IBD). Available at: http:// www.webmd.com/ibd-crohns-disease/ ss/slideshow-inflammatory-bowel-overview. Accessed June 27, 2014. DiPiro J, Talbert RL, Yee G, et al. Inflammatory bowel disease. In: Pharmacotherapy: A Pathophysiologic Approach. 9th ed. New York, New York: McGraw-Hill; 2014:497–516. Global Data. Ulcerative Colitis—Global Drug Forecast and Market Analysis to 2022. Global Data. Crohn’s Disease—Global Drug Forecast and Market Analysis to 2022. FDA. FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease. May 20, 2014. Available at: http://www.fda.gov/ newsevents/newsroom/pressannouncements/ucm398065.htm. Accessed June 27, 2014. ■
Future Therapies Drug Manufacturer
Status
Regimen Information
Pivotal Studies
Expected Approval
Anticipated Peak Year Sales / Pricing
Xeljanz (tofacitinib) Pfizer
Phase 3
Oral (5 mg), twice daily Additional studies are ongoing to support a dose of 10 mg
OCTAVE
2017
$101M in 2022; wholesale price is $2,349 for a 30-day supply, which is about 20%–25% lower than current pricing for Humira
Kappaproct (DIMS 0150) InDeX Pharmaceuticals
Phase 3
Rectal (30 mg) via colonoscopy with microinjections Up to 3 doses may be given
COLLECT
2014 (EU)
$47M in 2022 (5EU); expected to be priced similar to Alicaforsen (Atlantic Healthcare), which is $9,500 per unit
Stelara (ustekinumab) Janssen
Phase 3
One IV injection (approximately 6 mg/kg) at week 0 followed by one SC injection (90 mg) every 8 or 12 weeks thereafter
UNITI CERTIFI
2015
$399.5M in 2022; expected to be priced for CD according to its price per 90-mg dose for its primary indication, psoriasis, which costs $14,747 per dose
Vercimon ChemoCentryx
Phase 3
Oral (500 mg), once or twice daily
SHIELD
2019
$93.6M in 2022; expected to be priced 35% lower than Humira, which costs $1,350 per 40-mg injection
Ulcerative Colitis
Crohn’s Disease
EU = European Union; 5EU = France, Germany, Italy, Spain, and United Kingdom; IV = intravenous; M = million; SC = subcutaneous Sources: GlobalData; Redbook; FDA
576 P&T
®
• August 2014 • Vol. 39 No. 8
Pipeline Plus Current Therapies Drug Manufacturer
Approval Date
Indications
Regimen Information
Cost of Course of Therapy
Ulcerative Colitis and Crohn’s Disease Entyvio (vedolizumab) Takeda
May 20, 2014
Adult UC; adult CD
UC/CD: IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter
UC/CD: First-year regimen, $43,371 Subsequent 1-year regimens, $33,733
Humira (adalimumab) AbbVie
UC: September 28, 2012
Adult UC; adult CD; adult RA; pediatric JIA; adult PsA; adult AS; adult Ps
UC/CD: 4 SC injections at week 0, 2 injections at week 2, and 1 injection every 2 weeks thereafter
UC/CD: First-year regimen, $38,790 Subsequent 1-year regimens, $32,534
Adult and pediatric UC; adult and pediatric CD; adult RA; adult AS; adult PsA; adult Ps
UC/CD: IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter
UC/CD: First-year regimen, $31,856 Subsequent 1-year regimens, $24,777
May 15, 2013
Adult UC; adult RA; adult PsA; adult AS
UC: 2 SC injections at week 0, followed by 1 injection at week 2, then 1 injection every 4 weeks thereafter
UC: First-year regimen, $49,874 Subsequent 1-year regimens, $40,523
Cimzia (certolizumab pegol) UCB
April 22, 2008
Adult CD; adult RA; adult PsA; adult AS
CD: 2 SC injections at weeks 0, 2, and 4, then every 4 weeks thereafter
CD: First-year regimen, $83,075 Subsequent 1-year regimens, $71,998
Tysabri (natalizumab) Biogen Idec
January 14, 2008
Adult CD; adult MS
CD: IV infusion every 4 weeks
CD: 1-year regimen, $60,827
CD: February 27, 2007 Remicade (infliximab) Janssen Biotech
UC: September 16, 2005 CD: August 24, 1998
Ulcerative Colitis Only Simponi (golimumab) Janssen Biotech
Crohn’s Disease Only
AS = ankylosing spondylitis; CD = Crohn’s disease; IV = intravenous; JIA = juvenile idiopathic arthritis; MS = multiple sclerosis; PsA = psoriatic arthritis; Ps = plaque psoriasis; RA = rheumatoid arthritis; SC = subcutaneous; UC = ulcerative colitis Sources: GlobalData; Redbook; FDA; prescribing information for Entyvio, Humira, Remicade, Simponi, Cimzia, and Tysabri
Vol. 39 No. 8 • August 2014 • P&T 577 ®
Ulcerative Colitis and Crohn’s Disease Kunj Gohil, PharmD, RPh; and Brielle Carramusa
U
lcerative colitis (UC) and Crohn’s disease (CD) are severe ailments affecting the digestive system.1 UC is a gastrointestinal (GI) disease that is localized to the large intestine, or colon, where inflammation can affect either the entire organ or a portion of it.2 Approximately 1.86 billion patients have been diagnosed with UC globally, with 1.54 billion patients currently receiving treatment. Traditional therapies have yielded $4.18 billion in annual sales around the world, a figure expected to increase to $6.85 billion by 2022 with the approval of various pipeline drugs.3 CD can affect any part of the GI tract, but most commonly involves both the large and small intestines.2 Although CD Dr. Gohil is a Post Doctoral Fellow with Medical Services at MediMedia Managed Markets in Yardley, Pennsylvania. Ms. Carramusa, a 2016 PharmD candidate, is a Pharmacy Intern with Medical Services at MediMedia Managed Markets in Yardley.
is more severe than UC, the global prevalence is much lower, with only 1.3 million patients diagnosed and 0.8 million who currently receive treatment. Still, traditional therapies have resulted in an impressive $3.17 billion in global market sales, which is predicted to increase to $4.20 billion by 2022.4 Traditional therapies are highly effective in these hard-to-treat diseases. Tumor necrosis factor (TNF) inhibitors are firmly established as treatments but sometimes present problems, such as immunogenicity or an eventual loss of response.4 Vedolizumab (Entyvio, Takeda) is the newest medication for UC and CD, having received FDA approval on May 20, 2014. This novel biologic treatment is not an anti-TNF agent; it is the first gutspecific medication developed solely for UC and CD.5 Future therapies are being developed with the goal of providing patients with highly efficacious options for these complex diseases.3,4
REFERENCES 1.
2.
3. 4. 5.
WebMD. A visual guide to inflammatory bowel disease (IBD). Available at: http:// www.webmd.com/ibd-crohns-disease/ ss/slideshow-inflammatory-bowel-overview. Accessed June 27, 2014. DiPiro J, Talbert RL, Yee G, et al. Inflammatory bowel disease. In: Pharmacotherapy: A Pathophysiologic Approach. 9th ed. New York, New York: McGraw-Hill; 2014:497–516. Global Data. Ulcerative Colitis—Global Drug Forecast and Market Analysis to 2022. Global Data. Crohn’s Disease—Global Drug Forecast and Market Analysis to 2022. FDA. FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease. May 20, 2014. Available at: http://www.fda.gov/ newsevents/newsroom/pressannouncements/ucm398065.htm. Accessed June 27, 2014. ■
Future Therapies Drug Manufacturer
Status
Regimen Information
Pivotal Studies
Expected Approval
Anticipated Peak Year Sales / Pricing
Xeljanz (tofacitinib) Pfizer
Phase 3
Oral (5 mg), twice daily Additional studies are ongoing to support a dose of 10 mg
OCTAVE
2017
$101M in 2022; wholesale price is $2,349 for a 30-day supply, which is about 20%–25% lower than current pricing for Humira
Kappaproct (DIMS 0150) InDeX Pharmaceuticals
Phase 3
Rectal (30 mg) via colonoscopy with microinjections Up to 3 doses may be given
COLLECT
2014 (EU)
$47M in 2022 (5EU); expected to be priced similar to Alicaforsen (Atlantic Healthcare), which is $9,500 per unit
Stelara (ustekinumab) Janssen
Phase 3
One IV injection (approximately 6 mg/kg) at week 0 followed by one SC injection (90 mg) every 8 or 12 weeks thereafter
UNITI CERTIFI
2015
$399.5M in 2022; expected to be priced for CD according to its price per 90-mg dose for its primary indication, psoriasis, which costs $14,747 per dose
Vercimon ChemoCentryx
Phase 3
Oral (500 mg), once or twice daily
SHIELD
2019
$93.6M in 2022; expected to be priced 35% lower than Humira, which costs $1,350 per 40-mg injection
Ulcerative Colitis
Crohn’s Disease
EU = European Union; 5EU = France, Germany, Italy, Spain, and United Kingdom; IV = intravenous; M = million; SC = subcutaneous Sources: GlobalData; Redbook; FDA
576 P&T
®
• August 2014 • Vol. 39 No. 8
Pipeline Plus Current Therapies Drug Manufacturer
Approval Date
Indications
Regimen Information
Cost of Course of Therapy
Ulcerative Colitis and Crohn’s Disease Entyvio (vedolizumab) Takeda
May 20, 2014
Adult UC; adult CD
UC/CD: IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter
UC/CD: First-year regimen, $43,371 Subsequent 1-year regimens, $33,733
Humira (adalimumab) AbbVie
UC: September 28, 2012
Adult UC; adult CD; adult RA; pediatric JIA; adult PsA; adult AS; adult Ps
UC/CD: 4 SC injections at week 0, 2 injections at week 2, and 1 injection every 2 weeks thereafter
UC/CD: First-year regimen, $38,790 Subsequent 1-year regimens, $32,534
Adult and pediatric UC; adult and pediatric CD; adult RA; adult AS; adult PsA; adult Ps
UC/CD: IV infusion at weeks 0, 2, and 6, then every 8 weeks thereafter
UC/CD: First-year regimen, $31,856 Subsequent 1-year regimens, $24,777
May 15, 2013
Adult UC; adult RA; adult PsA; adult AS
UC: 2 SC injections at week 0, followed by 1 injection at week 2, then 1 injection every 4 weeks thereafter
UC: First-year regimen, $49,874 Subsequent 1-year regimens, $40,523
Cimzia (certolizumab pegol) UCB
April 22, 2008
Adult CD; adult RA; adult PsA; adult AS
CD: 2 SC injections at weeks 0, 2, and 4, then every 4 weeks thereafter
CD: First-year regimen, $83,075 Subsequent 1-year regimens, $71,998
Tysabri (natalizumab) Biogen Idec
January 14, 2008
Adult CD; adult MS
CD: IV infusion every 4 weeks
CD: 1-year regimen, $60,827
CD: February 27, 2007 Remicade (infliximab) Janssen Biotech
UC: September 16, 2005 CD: August 24, 1998
Ulcerative Colitis Only Simponi (golimumab) Janssen Biotech
Crohn’s Disease Only
AS = ankylosing spondylitis; CD = Crohn’s disease; IV = intravenous; JIA = juvenile idiopathic arthritis; MS = multiple sclerosis; PsA = psoriatic arthritis; Ps = plaque psoriasis; RA = rheumatoid arthritis; SC = subcutaneous; UC = ulcerative colitis Sources: GlobalData; Redbook; FDA; prescribing information for Entyvio, Humira, Remicade, Simponi, Cimzia, and Tysabri
Vol. 39 No. 8 • August 2014 • P&T 577 ®
