2014/15 PBR Exclusions - Funding Application forAdalimumab, Etanercept or Golimumab forAnkylosing Spondylitis(Finalversion1:last updated 01/01/14)

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
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. Is the patient aged 18 years or over?
/ Yes / No
  1. Does patient have severe active ankylosing spondylitis?
/ Yes / No
  1. Does the patient’s disease satisfy the modified New York criteria for diagnosis of ankylosing spondylitis? This requires the radiological criterion and at least one clinical criterionto besatisfied as below (please tick):
Radiological criterion
  • Sacroiliitis at least grade 2 bilaterally OR grade 3 or 4 unilaterally
Clinical criteria
  • Low back pain and stiffness for more than 3 months that improves with exercise but is not relieved by rest
  • Limitation of motion of the lumbar spine in both the sagittal & frontal planes
  • Limitation of chest expansion relative to normal values correlated for age and sex
/ Yes / No
  1. Does patient have confirmation of sustained active spinal disease demonstrated by BOTH:
a score of at least 4 units on the Bath Ankylosing Spondyltis Disease Activity Index (BASDAI) and
at least 4 cm on the 0 to 10 cm spinal pain visual analogue scale (VAS)
confirmed on 2 occasions at least 12 weeks apart without any change in treatment?
BASDAI Score 1: Date:
Score 2: Date:
Spinal VAS Score 1: Date:
Score 2: Date:
If BASDAI and/or Spinal VAS cannot be used /are inappropriate (see 1.2 on reverse), please submit full explanation on reasons and explain alternative assessment and results used: / Yes / No
  1. Treatment with two or more NSAIDs taken sequentially at maximum tolerated or recommended dosage for 4 weeks has failed to control symptoms. Please provide details below:
/ Yes / No
Start date / Stop date / Treatment / Reason for stopping
  1. Treatment will be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of this condition
/ Yes / No
  1. Tick which applies:
This is the patient’sfirst biologic drug for ankylosing spondylitis OR
CCG approved anti-TNF treatment had to be stopped due to an adverse event within 12 weeks of initiation. Provide brief details: / Yes / No
  1. Please specify which agent is to be prescribed?
/ Adalimumab (go to 10)Etanercept (go to 10) Golimumab (go to 9) / Patient weight:
Drug dose and frequency:
  1. Will Golimumab 100mg be the same cost as 50mg in accordance with patient access scheme? (go to 10)
/ Yes / No
  1. What is acquisition cost of drug (including VATif applicable)?
/ £/month
FOR CCG/CSU USE ONLY
Funding approved for first 12 weeks / Yes / No / Funding will only be re-approved if there is an adequate response at 12 weeks i.e. Reduction of the BASDAI score to 50% of the pre-treatment value or by 2 or more units AND reduction of the spinal pain VAS by 2cm or more. After initial response, patient’s condition should be monitored at least every 12 weeks. If the response to treatment is not maintained, a repeat assessment should be made after a further 6 weeks. If at this 6-week assessment the response has not been maintained, treatment should be discontinued.
Complete new application if alternative biologic drug has to be used due to adverse events before initial 12 week efficacy assessment.
Funding re-approved? (12 monthly intervals) / Yes / No

Adalimumab, etanercept and infliximab for the treatment of ankylosing spondylitis (NICE TA 143: May 2008)

1.1Adalimumab or etanercept are recommended as treatment options for adults with severe active ankylosing spondylitis only if all of the following criteria are fulfilled.

  • The patient’s disease satisfies the modified New York criteria for diagnosis of ankylosing spondylitis.
  • There is confirmation of sustained active spinal disease, demonstrated by:
  • a score of at least 4units on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and
  • at least 4cm on the 0 to 10cm spinal pain visual analogue scale (VAS).

These should both be demonstrated on two occasions at least 12 weeks apart without any change of treatment.

Conventional treatment with two or more non-steroidal anti-inflammatory drugs taken sequentially at maximum tolerated or recommended dosage for 4 weeks has failed to control symptoms

1.2When using BASDAI and spinal pain VAS scores to inform conclusions about whether or not sustained active spinal disease is present, healthcare professionals should be mindful of the need to secure equality of access to treatment for patients with disabilities and patients from different ethnic groups. There are circumstances in which it may not be appropriate for healthcare professionals to use a patient’s BASDAI and spinal pain VAS scores to inform their conclusion about the presence of sustained active spinal disease. These are:

  • where the BASDAI or spinal pain VAS score is not a clinically appropriate tool to inform a clinician’s conclusion on the presence of sustained active spinal disease because of a patient’s learning or other disabilities (for example, sensory impairments) or linguistic or other communication difficultiesOR
  • where it is not possible to administer the BASDAI or spinal pain VAS questionnaire in a language in which the patient is sufficiently fluent for it to be an appropriate tool to inform a conclusion on the presence of sustained active spinal disease, or there are similarly exceptional reasons why use of a patient’s BASDAI or spinal pain VAS score would be an inappropriate tool to inform a conclusion on the presence of sustained active spinal disease in that individual patient’s case.

In such cases, healthcare professionals should make use of another appropriate method of assessment, which may include adapting the use of the questionnaire to suit the patient’s circumstances.

The same approach should apply in the context of a decision about whether to continue the use of the drug in accordance with sections 3 and 4

1.3It is recommended that the response to adalimumab or etanercept treatment should be assessed 12 weeks after treatment is initiated, and that treatment should be only continued in the presence of an adequate response as defined in section 4.

1.4For the purposes of this guidance, an adequate response to treatment is defined as a:

  • reduction of the BASDAI score to 50% of the pre-treatment value or by 2or more units and
  • reduction of the spinal pain VAS by 2cm or more.
  1. Patients who have experienced an adequate response to adalimumab or etanercept treatment, as defined in section4, should have their condition monitored at 12-week intervals. If the response to treatment, as defined in section4, is not maintained, a repeat assessment should be made after a further 6weeks. If at this 6-week assessment the response defined in section4 has not been maintained, treatment should be discontinued.
  2. For patients who have been shown to be intolerant of adalimumab or etanercept before the end of the 12-week initial assessment period, as in section3, the other one of this pairof TNF-α inhibitor treatments is recommended as an alternative treatment.
  3. Prescription of an alternative TNF-α inhibitor is not recommended in patients who have either not achieved an adequate initial response to treatment with adalimumab or etanercept, as defined in section4, or who experience loss of the initially adequate response during treatment.
  4. It is recommended that the use of adalimumab or etanercept for severe active ankylosing spondylitis should be initiated and supervised only by specialist physicians experienced in the diagnosis and treatment of this condition.
  5. Infliximab is not recommended for the treatment of ankylosing spondylitis.
  6. Patients currently receiving infliximab for the treatment of ankylosing spondylitis should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

Golimumab for the treatment of ankylosing spondylitis (NICE TA 233: August 2011)

1.1Golimumab is recommended as an option for the treatment ofsevere, active ankylosing spondylitis in adults only if:

  • it is used as described for adalimumab and etanercept in‘Adalimumab, etanercept and infliximab for ankylosingspondylitis’ (NICE technology appraisal guidance 143) and
  • the manufacturer provides the 100 mg dose of golimumab at thesame cost as the 50 mg dose in accordance with the patientaccess scheme.

1.2People currently receiving golimumab for the treatment of severe,active ankylosing spondylitis who do not fulfil the criteria fortreatment with adalimumab and etanercept described in NICEtechnology appraisal guidance 143 should have the option tocontinue golimumab until they and their clinician consider itappropriate to stop.

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NICE Ankylosing spondylitis commissioning algorithm (22 November 2011)

(Ref:

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