2015/16 PBR Exclusions – Funding Application for Adalimumab, Etanercept, Golimumab, Infliximab or Ustekinumab for Psoriatic Arthritis

(Final version 2: Last updated 12/08/2015)

Before providing patient identifiable data on this form, please confirm that the patient (or in the case of a minor or vulnerable adult with the parent/legal guardian/carer) has given appropriate explicit consent for sensitive personal information on this form to be passed to the CCG and/or CSU for processing this funding request and validating subsequent invoices. Consent given: Yes
If there is more than one NICE-approved treatment available, a discussion between the responsible clinician and the patient has taken place about the advantages and disadvantages of the treatments available. This has taken into consideration therapeutic need and whether or not the patient is likely to adhere to treatment. The least expensive will be chosen (taking into account administration costs, dosage and price per dose) unless an order of preference is stated in the TAs. Yes
Patient NHS No: / Trust: / GP Name:
Patient Hospital No:
Patient’s birth year: / (yyyy) / Consultant Making Request: / GP code/Practice code:
Confirm patient status:
(* select 1 option) / NHS Private Overseas / Consultant Contact Details: / GP Post code:

Please indicate whether patient meets the following NICE criteria

/

Please tick

/ Only fully completed forms will be accepted by CCGs/CSUs for consideration.
If the answer to any of these questions is NO, please consider if there are patient specific exceptional clinical circumstances demonstrated. If so, a full individual funding request (IFR) form will need to be completed. This may be obtained from the named contact at the relevant CCG/CSU/Trust. Please refer to the individual CCG IFR policy for further details.
Contact details:
Form completed by:
Email:
Phone:
Date of completion:
Additional Information:
1.  Patient is aged 18 years or over / Yes / No
2.  Patient has severe active and progressive psoriatic arthritis and meets all of the following criteria: peripheral arthritis with 3 or more tender joints AND 3 or more swollen joints / Yes / No
3.  Please provide patient’s baseline PsARC and PASI scores (prior to starting any biologic treatment):
PsARC criteria
Patient’s global assessment score (on 0-5 Likert scale): / Date:
Physician global assessment (on 0-5 Likert scale): / Date:
Tender joint score / Date:
Swollen joint score / Date:
PASI score (where applicable) / Date:
4.  Patient has not responded to at least 2 disease-modifying anti-rheumatic drugs administered either individually or in combination. An adequate trial of a DMARD is usually defined as failure to tolerate a drug or active disease despite treatment of at least 12 weeks with a target therapeutic dose. Please list which drugs patient has previously received: / Yes / No
Treatment and Dose / Start date / Stop date / Reason for stopping
5.  Which agent is to be prescribed? Use least expensive agent (taking into account drug administration cost, required dose and price per dose). This may need to be varied for individual patients because of differences in the method of administration and treatment schedules.
Adalimumab (go to 9) Etanercept (go to 9) Golimumab (go to 6) Ustekinumab (go to 7)
Remsima® (infliximab biosimilar)* (go to 9) Inflectra® (infliximab biosimilar)* (go to 9)
Remicade® (Infliximab)* (go to 9)
*Remsima® is the preferred Infliximab brand for all London Trusts. Please provide valid reason, if not using preferred biosimilar:
6.  If Golimumab is to be used, the manufacturer has agreed to provide the 100mg dose at the same cost as the 50mg dose (go to 9). / Yes / No
7.  One of the following scenarios applies:
For Ustekinumab 1st line, treatment with tumour-necrosis factor (TNF) alpha inhibitors is contraindicated but would otherwise be considered (as per NICE technology appraisal guidance 199 and 220). State contraindication:
For Ustekinumab 2nd line, patient has received biologic treatment and had an inadequate or lost response to either Adalimumab, Etanercept, Golimumab or Infliximab. Please provide information below: / Yes / No
Start date / Stop date / Treatment / Criteria / Score on start date / Score on stop date / Reason for stopping
Adalimumab
Etanercept
Golimumab
Infliximab / Patients global assessment
Physician global assessment
Tender joint score
Swollen joint score
PASI score (if applicable)
8.  For Ustekinumab, the manufacturer has agreed to provide the 90mg dose at the same cost as the 45mg dose as agreed in the patient access scheme. (go to 11) / Yes / No
9.  This is the patient’s first biologic drug for psoriatic arthritis: Yes (go to 11) No (go to 10)
10.  Request is for Adalimumab, Etanercept, Golimumab, Infliximab (tick one) and patient experienced one of the following:
Intolerance Contraindication Major difficulties with self administered injections
Sequential treatment with anti-TNF inhibitors (Adalimumab, Etanercept, Golimumab, Infliximab) due to primary or secondary failure is not routinely commissioned. / Yes / No
11.  Drug dose and frequency For Infliximab: Patient weight: kg
12.  What is acquisition cost of drug (including VAT if applicable)?
[Please note that CCGs will not pay more than the London Procurement list price/PAS price. Commercial in confidence for Trust/CCG/CSU.] / £/month
£/dose
FOR CCG/CSU USE ONLY
Funding approved for first 12 weeks (Adalimumab, Etanercept, Golimumab, Infliximab)
Funding approved for first 24 weeks (Ustekinumab) / Yes / No / Funding will only be re-approved if the patient has responded adequately to treatment at 12 weeks (Adalimumab, Etanercept, Golimumab, Infliximab) or 24 weeks (Ustekinumab) i.e. improvement in two out of the four PsARC criteria; one has to be joint tenderness or swelling score, with no worsening in any of the four criteria. If there is not an adequate PsARC response then refer to a dermatologist to assess whether it is appropriate to continue treatment on basis of skin response (see TA103, TA134, TA146 & TA180 for guidance on the use of biologic drugs for the treatment of psoriasis).
Funding re-approved? (12 monthly intervals) / Yes / No

Adalimumab, etanercept, golimumab, infliximab and ustekinumab for the treatment of psoriatic arthritis

(NICE TA 199, August 2010 (includes review of TA 104 and 125); NICE TA 220, April 2011; NICE TA 340, June 2015)

Etanercept, infliximab, adalimumab for the treatment of psoriatic arthritis (NICE TA 199)

1.1.  Etanercept, infliximab and adalimumab are recommended for the treatment of adults with active and progressive psoriatic arthritis when the following criteria are met.

·  The person has peripheral arthritis with three or more tender joints and three or more swollen joints, and

·  The psoriatic arthritis has not responded to adequate trials of at least two standard disease-modifying antirheumatic drugs (DMARDs), administered either individually or in combination.

1.2.  Treatment as described in 1.1 should normally be started with the least expensive drug (taking into account drug administration costs, required dose and product price per dose). This may need to be varied for individual patients because of differences in the method of administration and treatment schedules.

1.3.  Etanercept, adalimumab or infliximab treatment should be discontinued in people whose psoriatic arthritis has not shown an adequate response using the Psoriatic Arthritis Response Criteria (PsARC) at 12 weeks. An adequate response is defined as an improvement in at least two of the four PsARC criteria, (one of which has to be joint tenderness or swelling score) with no worsening in any of the four criteria. People whose disease has a Psoriasis Area and Severity Index (PASI) 75 response at 12 weeks but whose PsARC response does not justify continuation of treatment should be assessed by a dermatologist to determine whether continuing treatment is appropriate on the basis of skin response (see ‘Etanercept and efalizumab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 103], ‘Infliximab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 134] and ‘Adalimumab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 146] for guidance on the use of tumour necrosis factor [TNF] inhibitors in psoriasis).

1.4.  When using the PsARC healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect a person’s responses to components of the PsARC and make any adjustments they consider appropriate.

Golimumab for the treatment of psoriatic arthritis (NICE TA220)

1.1. Golimumab is recommended as an option for the treatment of active and progressive psoriatic arthritis in adults only if:

·  it is used as described for other tumour necrosis factor (TNF) inhibitor treatments in ‘Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis’ (NICE technology appraisal guidance 199), and

·  the manufacturer provides the 100mg dose of golimumab at the same cost as the 50mg dose.

1.2. When using the Psoriatic Arthritis Response Criteria (PsARC; as set out in NICE technology appraisal guidance 199), healthcare professionals should take

into account any physical, sensory or learning disabilities, or communication difficulties that could affect a person’s responses to components of the PsARC and make any adjustments they consider appropriate.

Ustekinumab for treating active psoriatic arthritis (rapid review of technology appraisal guidance 313) (NICE TA340)

1.1.  Ustekinumab is recommended as an option, alone or in combination with methotrexate, for treating active psoriatic arthritis in adults only when:

·  treatment with tumour necrosis factor (TNF) alpha inhibitors is contraindicated but would otherwise be considered (as described in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis and golimumab for the treatment of psoriatic arthritis) or

·  the person has had treatment with 1 or more TNF–alpha inhibitors.

Ustekinumab is recommended only if the company provides the 90 mg dose of ustekinumab for people who weigh more than 100 kg at the same cost as the 45 mg dose, as agreed in the patient access scheme.

1.2.  Ustekinumab treatment should be stopped if the person's psoriatic arthritis has not shown an adequate response using the Psoriatic Arthritis Response Criteria (PsARC) at 24 weeks. An adequate response is defined as an improvement in at least 2 of the 4 criteria (1 of which must be joint tenderness or swelling score), with no worsening in any of the 4 criteria. As recommended in NICE technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis, people whose disease has a Psoriasis Area and Severity Index (PASI) 75 response but whose PsARC response does not justify continuing treatment should be assessed by a dermatologist to determine whether continuing treatment is appropriate on the basis of skin response (see NICE technology appraisal guidance on ustekinumab for the treatment of adults with moderate to severe psoriasis).

1.3.  When using the PsARC healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect a person’s responses to components of the PsARC and make any adjustments they consider appropriate.

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