1.5 CHRONIC BOWEL DISORDERS

1.5 Chronic Bowel Disorders

1.5.1 Aminosalicylates

These drugs for chronic bowel disorders are recommended for initiation only on specialist advice.

Mesalazine

Mesalazine is an aminosalicylate that is used routinely to induce and maintain remission in chronic inflammatory bowel

disease -ulcerative colitis (UC) and Crohn’s disease. Mesalazine is commonly given as a modified release (MR) preparation to

target delivery of the drug to the diseased area of the bowel to provide topical anti-inflammatory therapy.

Available formulations have differences in licensed indications, tablet strengths, pharmaceutical, pharmacological and

pharmacokinetic properties. As the delivery characteristics of the different mesalazine preparations may vary: mesalazine

preparations must be prescribed by brand name.

Octasa® is the first line choice across the ELMMB healthcare economy, and where possible 800mg strength tablets should

be prescribed and supplied. Patients currently taking generic mesalazine or Asacol® can be switched to Octasa®. Switching

to Octasa® in patients currently taking other brands of mesalazine can be considered, but response needs to be monitored

as brands are not directly interchangeable.

AMBER Octasa® MR e/c 400mg & 800mg tablets (Mesalazine) - (specify brand when prescribing)

In circumstances when a switch to Octasa® is not clinically appropriate, Asacol® or Mezavant® may be continued.

New patients are not to be initiated on Asacol® or Mezavant®.

AMBER Asacol® MR 400mg e/c tablets (Mesalazine) - (specify brand when prescribing)

AMBER Mezavant® XL 1200mg tablets (once daily) (Mesalazine) - (specify brand when prescribing)

Pentasa® is available for administration via large bore enteral feeding tubes or in swallowing difficulty.

The 500mg tablet will dissolve in water, leaving small beads (0.7mm-1mm diameter) that can be swallowed or administered

whole (beads must not be crushed).

AMBER Pentasa® e/c 500mg tablets (Mesalazine) - (specify brand when prescribing)

Rectal mesalazine preparations

Asacol® foam enemas are licensed for mild to moderate acute exacerbations of ulcerative colitis affecting the distal colon, and

Asacol® suppositories are also licensed for maintenance of remission of distal ulcerative colitis.

AMBER Asacol® foam enema 1gram/metered application (Mesalazine) - (specify brand when prescribing)

AMBER Salofalk® suppositories 500mg, 1g (Mesalazine)

Maintenance of remission of ulcerative colitis, where patient is intolerant or uncontrolled on other 5ASA formulations

AMBER Salofalk® PR granules 500mg, 1000mg, 1500mg, 3000mg (Mesalazine}

Pentasa® liquid enemas are licensed for the treatment of ulcerative colitis affecting the distal colon and rectum

AMBER Pentasa® liquid retention enema 1gram/100mL (Mesalazine) - (specify brand when prescribing)

Ipocol® is not a recommended brand of mesalazine for new patients as it is not interchangeable with Asacol® due to

differences in its site of delivery, even though it is the same strength of mesalazine.

AMBER Balsalazide capsules 750mg

AMBER Sulfasalazine tablets 500mg (not recommended for new patients)

Short Cain Fatty Acid Enema Solution (unlicensed special)

For use in diversion colitis for patients unable to undergo surgical anastomosis. Specialist use only

RED Short Chain fatty Acid Enema Solution 50ml

Pouchitis

VSL#3 Sachets (but no other probiotics)

For specialist gastroenterology use only, where Pouchitis has been diagnosed and all other standard pharmacological

treatments have been tried.

RED VSL#3 Sachets (specialist gastroenterology use only) [unlicensed]

Alicaforsen Rectal Solution [unlicensed]

Specialist use only in specific patients,

RED Alicaforsen rectal solution 4mg/mL

1.5.2 Corticosteroids

Treatment of acute attacks of ulcerative colitis and Crohn's disease:

GREEN Prednisolone

tablets 5mg

suppositories 5mg

2nd line option

GREEN Budesonide foam enemas (Budenofalk®)

Budesonide oral capsules

(as an option as per NICE clinical guideline for Crohn's disease, if conventional corticoseteroid is not tolerated)

RED Budesonide multimatrix MMX 9mg prolonged release tablets (Cortiment®▼)

Given that the Budenofalk brand of budesonide offers more flexible dosing than alternative products and is more cost

effective Consultants support using only the Budenofalk brand of budesonide.

All other brands are considered non-formulary.

AMBER Budenofalk capsules 3mg

Eosinophilic Oesophagitis Treatment

Induction of Remission

Budesonide orodispersible tablet [Jorveza®] CCG Commissioned

NICE TA708 Budesonide as an orodispersible tablet is recommended as an option for inducing remission of eosinophilic

oesophagitis in adults. Specialist use only

RED Budesonide orodispersible tablet [Jorveza®]

Maintenance treatment

Off label use of fluticasone 250mcg metered dose inhaler [MDI] or viscous solution of budesonide 500mcg/2mL nebule

AMBER Budesonide 500mcg/2mL nebuliser liquid unit dose vials

AMBER Fluticasone proprionate 250mcg evohaler [mdi]

See Guidance on Eosinophilic Oesophagitis Treatments for Healthcare Professionals

1.5.3 Drugs affecting the immune response

Ciclosporin is occasionally used in the management of severe inflammatory bowel disease (unlicensed). It requires regular

monitoring and should only be prescribed under the direction of a specialist. Azathioprine is used in the maintenance of

remission of acute ulcerative colitis and Chron's disease, and also requires regular monitoring (unlicensed).

Maintenance and symptomatic treatment of ulcerative colitis and Crohn's disease:

AMBER Azathioprine tablets 25mg, 50mg (unlicensed for use in IBD)

AMBER Ciclosporin capsules 10mg, 25mg, 50mg, 100mg (Neoral®) – (unlicensed for use in IBD)

(specify brand when prescribing)

RED Ciclosporin 50mg/ml concentrate for iv infusion– (unlicensed for use in IBD)

Cytokine modulators

RED Vedolizumab SC: Treatment of adult patients with moderately to severely active ulcerative colitis or severely active

Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to

either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

ICB Commissioned

The patient and/or carer must receive adequate training in subcutaneous injection technique if their specialist determines

that it is appropriate to self-inject and with medical follow-up as necessary. Suitability of the patient for subcutaneous home

use should be assessed and patients should be advised to inform their healthcare professional if they experience symptoms

of an allergic reaction before administering the next dose. Patients should seek immediate medical attention if developing

symptoms of serious allergic reactions. Also approved in line with NICE TA 329 and NICE TA352 (see below)

NICE guidance for Ulcerative Colitis updated Feb 2015 (TA329)

Infliximab ( Remicade®, Inflectra® or Remsima®), adalimumab (Humira®) and golimumab (Simponi®) are recommended

as possible treatments for adults with moderate to severe ulcerative colitis if conventional therapy hasn’t worked or isn’t

suitable.

Infliximab is also recommended as a possible treatment for children or young people aged 6–17 years with severe ulcerative

colitis, if conventional therapy hasn’t worked or isn’t suitable.

Infliximab is a treatment option for acute exacerbation of severely active ulcerative colitis where the patient meets the NICE

criteria to start a biologic (TA163).

RED Infliximab ( Remicade®,Inflectra®,Remsima®.) Prescribe by brand

RED Adalimumab (Amgevita (1st line choice in new patients, Humira®,) NHS England Commissioned

RED Golimumab (Simponi®)

NICE guidance for treating moderately to severely active ulcerative colitis (TAG342)

Vedolizumab is recommended as a possible treatment for adults with moderate to severe ulcerative colitis

RED Vedolizumab (Entyvio®)

Concentrate for intravenous infusion 300mg vial

NICE guidance for treating moderately to severely active ulcerative colitis (TA547)

Tofacitinib is recommended, within its marketing authorisation, as an option for treating moderately to severely active

ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated or the disease has responded

inadequately or lost response to treatment.

RED Tofacitinib (Xeljanz®) tablets CCG Commissioned - Bluetec form required

NICE guidance for treating moderately to severely active ulcerative colitis (TA633)

Ustekinumab is recommended as an option for treating moderately to severely active ulcerative colitis in adults when

conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response

to treatment, only if:

° a tumour necrosis factor-alpha inhibitor has failed (that is the disease has responded inadequately or has lost response

to treatment) or

° a tumour necrosis factor-alpha inhibitor canot be tolerated or is not suitable, and

° the company provides ustekinumab at the same price or lower than that agreed with the Commercials Medicines UNIT

RED Ustekinumab (Stelara®) CCG Commissioned - Bluetec form required

NICE guidance for treating moderately to severely active ulcerative colitis TA792

Filgotinib is recommended, within its marketing authorisation, as an option for treating moderately to severe active

ulcerative colitis in adults:

> when conventional or biological treatment cannot be tolerated, or

> if the disease has not responded well enough, or has stopped responding to these treatments, and

> if the company provides filgotinib according to the commercial arrangement

RED Filgotinib tablets 100mg, 200mg (Jyseleca®)

NICE guidance for treating moderately to severely active ulcerative colitis NICE TA856

Upadacitinib is recommended, within its marketing authorisation, as an option for treating moderately to severely active

ulcerative colitis in adults:

> when conventional or biological treatment cannot be tolerated, or

> if the condition has not responded well enough or has stopped responding to these treatments, and

> if the company provides upadictinib according to the commercial arrangement

ICS Commissioned, Blueteq required

NICE guidance for treating for moderately to severely active Crohn's disease after prior therapy (TA352)

RED Vedolizumab (Entyvio®)

Concentrate for intravenous infusion 300mg vial

NICE guidance for treating for moderately to severely active Crohn's disease after previous therapy (NICE TA456)

RED Ustekinumab (Stelara®) CCG Commissioned

Solution for injection, solution for injection pre-filled syringes 45mg/0.5ml

Solution for injection pre-filled syringes 90mg/1ml

NICE guidance for previously treated moderately to severely active active Crohn's disease in adults (NICE TA905)

Upadactinib is recommended as an option for treating moderately to severely active Crohn's disease in adults, only if:

> the disease has not responded well enough or lost response to a previous biological treatment or

> a previous biological treatment was not tolerated or

> tumour necrosis factor (TNF)-alpha inhibitors are contraindicated.

Upadacitinib is only recommended if the company provides it according to the commercial arrangement.

RED Upadactinib (Rinvoq)

NICE guidance for Crohn's disease (TAG187)

> Adalimumab, within its licensed indications, is recommended as a treatment option for adults with severe active non-

fistulising Crohn's disease as induction treatment followed by maintenance treatment. Maintenance treatment with

adalimumab should continue until treatment failure (which includes the need for surgery), or until 12 months after the

start of treatment, whichever is the shorter. The patient's disease should then be reassessed. Maintenance should o

only then be continued if there is clear evidence of ongoing disease, as determined by clinical symptoms and

investigation, including endoscopy if necessary. People whose disease relapses after maintenace treatment is stopped

should have the option to resume treatment for a further 12 months. They should then be reassessed to determine

whether ongoing treatment is still clinically appropriate.

> Infliximab is a treatment option for severe Crohn's disease when there is clear evidence of primary intolerance to

adalimumab, or if Crohn's disease is fistulising, or if the patient is either a child or adolescent.

Please see the full guidance for further information.

RED Adalimumab pre-filled pen/syringe 40mg (Amgevita (1st line choice in new patients, Humira®,)

RED Infliximab vial for infusion 100mg

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