J&J/Janssen’s Stelara stirs uptakedebate given wavering refractoryneed in Crohn’s, niche potential –experts

J&J/Janssen’s Stelara stirs uptakedebate given wavering refractoryneed in Crohn’s, niche potential –experts

Download our mobile app!

Related Articles by Drug

Related Articles by Company

Published 2016-05-05 Proprietary Intelligence

J&J/Janssen’s Stelara for Crohn’s facesexpected high pricing and payer priorauthorisation hurdles, possible co-paysprograms – experts

Reimbursement scenarios differ between IV and SC formulations

Two anti-TNF failures may be prior authorisation requirement

Acceptable out-of-pocket payments vary between patients

Johnson and Johnson (NYSE:JNJ)/Janssen Biotech's Stelara (ustekinumab) for Crohn's

disease (CD) has expected high pricing that could post obstacles to US payer reimbursement,

experts said. Strict prior authorisation (PA) requirements could be prompted as welll by

Stelara's anticipated nonemergency and anticipated refractory/failed anti-TNF therapy

labelling, they added.

Yet, expected patient assistance programmes (PAPs) may ease out-of-pocket payouts, some

said.

Stelara is a human interleukin-12 and -13 antagonist, approved for adults with moderate-to-

severe plaque psoriasis involving large areas of the body whom may benefit from systemic or

phototherapy, as well as adults with active psoriatic arthritis.

On 21 April, this news service reported promising FDA and EMA approval forecasts for CD

despite underwhelming efficacy, yet an uncertain refractory patient need provoked dubious

uptake prospects. Analysts expect an FDA and EMA verdict in 3Q16.

Analysts predict peak sales forecasts of up to USD 800m.

In anticipation of Stelara's potential FDA approval in CD, Janssen will ensure Stelara's broad

accessibility by keeping the net cost in line with current biologic CD therapies, said a company

spokesperson. Anti-TNF therapy such as AbbVie's (NYSE:ABBV) Humira (adalimumab) is CD

standard-of-care.

High price projections

High pricing, like other biologics, will likely be Stelara's greatest reimbursement hurdle, said Dr

Raymond Cross, investigator and director, Inflammatory Bowel Disease Programme, University

of Maryland Medical Centre, Baltimore. Stelara's CD pricing is unlikely to undercut that of its

expensive current psoriasis indication, added Cross. According to public information, Stelara's

psoriasis price is around USD 9,000 for one syringe; it is administered as an initial dose, then

four weeks later and every subsequent 12 weeks. Although pricing will likely be high, CD and

psoriasis are both debilitating, inflammatory conditions, supporting similar reimbursement

pathways, said Dr Michael Epstein, gastroenterologist, Epstein Associates, Annapolis,

Maryland.

Due to their comparable Phase III trial participants, Stelara will likely be priced similarly to

Takeda Pharmaceutical's (TYO:4502) Entyvio (vedolizumab), said Peter Rheinstein, president,

Severn Health Solutions, Baltimore, Maryland. Entyvio is a CD biologic approved for use in

patients failing at least one common treatment, including anti-TNFs. Its public price is around

USD 25,000 for five vials.

Unlike Stelara's subcutaneous (SC) psoriasis formulation, it is intravenous (IV) during CD's

induction phase, preventing at-home administration, said Rheinstein. He added, however, this

may not negatively influence its formulary tier positioning, which will likely be similar to

Enytvio's. Entyvio is categorised as tier 4 or a specialty tier, usually reserved for the most

expensive drugs, according to public information.

Yet, Stelara is SC during its CD maintenance phase, noted Anita Burrell, founder of her New

Jersey-based eponymous consulting firm. The ongoing Phase III IM-UNITI study

(NCT01369355) includes five SC arms, according to ClinicalTrials.gov.

Whilst Stelara's CD IV induction phase price may vary according to patient weight, its

formulation likely supports higher pricing over SC maintenance, said Burrell. UNITI-1 and -2

administered Stelara at 130mg and approximately 6mg/kg doses.

Prior authorisation expected

Further to potential pricing hurdles, PA is another expected issue, said Burrell, Rheinstein and

Rhonda Greenapple, founder, reimbursement consultancy Access First, Bernardsville, New

Jersey. Any nonemergency drug labelled for use after a refractory or failed treatment

response prompts PA possibility, Rheinstein explained.

If reasonably priced with a broad label, payers may recommend Stelara's early administration

View Contacts

View Contacts

View Contacts

View Contacts

*Johnson & Johnson

Abbott Laboratories

Abbvie Inc.

Takeda Pharmaceutical Company Limited

*Stelara

Entyvio

Humira

Product Development

Inflammatory Bowel Disease

USA

NCT01369355

Cytokine Suppressor

Interleukin-1 (IL-1) Blocker

Strong evidence

Email Analyst

Company

Drug(s)

Topic

Indications

Country

Clinical Trials

Mechanism(s)

Intelligence Grade

BioPharm Insight - Powered by Infinata (www.biopharminsight.com)

1 of 2

About Alexandra Thompson

Email the journalist team at editorialfeedback@biopharminsight.com

after anti-TNF therapy refraction or failure, Cross said. Such labelling is unlikely, however, as it

is expected to mirror the narrow patient groups recruited into Stelara's Phase III trials, Cross

added. This news service previously reported Stelara's label will likely indicate refractory or

failed anti-TNF therapy patients as included in Stelara's Phase III UNITI-1 and -2 trials.

Assuming patient anti-TNF intolerance is predictable ahead of treatment, intolerant patients

may be prescribed Stelara first-line, said Greenapple. Cross added, however, diagnostic tests

are insufficiently developed to preassess patient anti-TNF suitability. Patients may be required

to fail at least two anti-TNF therapies before Stelara considerations, said Burrell and

Greenapple.

PA requirements may also be stricter for Stelara than Entyvio due to concerns surrounding the

former's infection risk, said Burrell. One case of Listeria meningitis infection was reported in

Stelara's Phase III UNITI-1 6mg/kg cohort.

Furthermore, anti-TNF refraction numbers likely exceed anti-TNF intolerance, suggesting PA

may favour refractory over intolerant patients initially, said Burrell.

Additional to PA, Stelara's expected steep pricing will likely prompt step edits and quantity

management- patient reassessment a year after treatment refusal, said Burrell.

This news service previously reported physicians may prescribe other anti-TNF therapies over

Stelara due to greater comfort with the former drug class. Postmarket comparative efficacy

trials should assess Stelara's effectiveness relative to second-line anti-TNF therapies, as well

as whether Stelara could mitigate surgery need; however, the latter may be difficult to

demonstrate, said Greenapple. Such trials will unlikely occur due to their cost, long duration

and often strict inclusion criteria hindering recruitment, said Cross.

Co-pay assistance anticipated

Referring to public information, Stelara in psoriasis offers patient co-pay assistance,

supporting a similar outcome for the agent during CD maintenance, said Burrell. Janssen will

offer a number of patient support programs to ensure Stelara's broad accessibility and

affordability, the spokesperson added.

The amount patients will likely be willing to pay out-of-pocket for Stelara for CD varies

according to income and co-pay assistance, said Cross and Epstein. Most will be unwilling to

pay USD 1,000 monthly, however, said Cross. Yet, Epstein argued, CD's unmet need supports

Stelara's use regardless of price. Poorly uncontrolled CD is also expensive, leading to surgery,

repeated hospitalisation and IV feeding, he added.

Psoriasis patients are eligible for manufacturer coupons, allowing co-pays down to zero for the

first six doses, which may also apply in CD, said Burrell, referring to public information. She

added, however, Stelara's CD IV induction dose is a one-off treatment, whilst its SC

maintenance dose is being trialled at eight or 12 weeks, in contrast to psoriasis' every four

weeks, therefore patients could overall pay more for Stelara psoriasis treatment than CD, she

added.

To overcome Stelara's potential pricing hurdles, J&J/Janssen Biotech will likely offer use

incentives, including sample distribution and drug administration training, said Cross.

J&J has a market cap of USD 309.7b.

by Alexandra Thompson in London

© Infinata 2014 Site Map For assistance call BioPharm Insight Support at +1 866 501 6948 or +44 (0) 203 741 1038

2 of 2