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2012/13 PBR Exclusions - Funding Application for Rituximab for the treatment of Rheumatoid Arthritis after the failure of a TNF inhibitor
(Final version 1: last updated 01/04/12)
Patient NHS No: Trust: GP Name:
Patient Hospital No:
Patient initials & DoB: Consultant Making GP code /
Request: Practice code:
Confirm patient status: Consultant Contact GP Post code:
(*select 1 option) Details:
Please indicate whether patient meets the following NICE criteria Please tick Only fully completed forms will be accepted by PCTs for
1.Patient is aged 18 years or over Yes No consideration.
2. Does patient have severe active rheumatoid arthritis with DAS28 score >5.1. Please If the answer to any of these questions is NO, please
give scores (BSR recommend 2 measurements at least one month apart): consider if there are patient specific exceptional clinical
Yes No circumstances demonstrated. If so, a full individual
Score 1: Date: Score 2: Date: funding request (IFR) form will need to be completed.
3. Patient has had an inadequate response to or intolerance of other disease-modifying This may be obtained from the named contact at the
anti-rheumatic drugs (DMARDs), including treatment with at least one tumour necrosis relevant PCT/Trust. Please refer to the individual PCT
factor α (TNF-α) inhibitor therapy. Please provide details of treatment history below: IFR policy for further details.
Start date Stop date Treatment Reason for stopping
Contact details:
Form completed by
Yes No Email:
Phone:
Date of completion:
4. Has patient received Rituximab before? No (go to 8) Yes (go to 5) Additional Information (for PCT use only):
5. Was last Rituximab infusion > 6 months ago? Date of last infusion: Yes No
6. Did DAS28 improve by ≥1.2 with previous Rituximab treatment? (provide scores)
Yes No
Baseline DAS28 score: DAS28 after 2 Rituximab doses:
7. Does patient have residual disease activity (i.e. DAS28 score≥ 2.6)? Yes No
8. Is Rituximab to be used with Methotrexate? Yes No
9.Treatment is to be initiated, supervised and treatment response assessed by
Yes No
specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis
10. What is acquisition cost of drug including VAT (if applicable)? £ /2x1000mg
FOR PCT USE ONLY
Treatment with rituximab plus methotrexate should be continued only if there is
an adequate response following initiation of therapy. An adequate response is
Funding approved (max. TWO 1000mg infusions 2 weeks
Yes No defined as an improvement in disease activity score (DAS28) ≥ 1.2. Trusts may
apart).
apply for repeat courses of treatment with rituximab plus methotrexate by
completing another application no more frequently than every 6 months.
Participating PCTs: Barking and Dagenham; Barnet; Brent; Camden; City and Hackney; Croydon; Ealing; Enfield; Hammersmith&Fulham; Haringey; Harrow; Havering; Hillingdon;
Hounslow; Islington; Kensington&Chelsea; Kingston; Newham; Redbridge; Richmond; Sutton&Merton; Tower Hamlets; Waltham Forest; Wandsworth; Westminster.
This form should be returned to the named contact at the relevant PCT
Adalimumab, etanercept, infliximab rituximab and abatacept for the treatment of Rheumatoid Arthritis
after the failure of a TNF inhibitor (NICE TA 195: Aug 2010)
Guidance
1.1 Rituximab in combination with methotrexate is recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an
inadequate response to, or are intolerant of, other disease-modifying anti-rheumatic drugs (DMARDs), including at least one tumour necrosis factor (TNF)
inhibitor. Treatment with rituximab should be given no more frequently than every 6 months.
1.2 Treatment with rituximab in combination with methotrexate should be continued only if there is an adequate response following initiation of therapy and if an
adequate response is maintained following retreatment with a dosing interval of at least 6 months. An adequate response is defined as an improvement in
disease activity score (DAS28) of 1.2 points or more.
1.3 Adalimumab, etanercept, infliximab and abatacept, each in combination with methotrexate, are recommended as treatment options only for adults with severe
active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who
cannot receive rituximab therapy because they have a contraindication to rituximab, or when rituximab is withdrawn because of an adverse event.
1.4 Adalimumab monotherapy and etanercept monotherapy are recommended as treatment options for adults with severe active rheumatoid arthritis who have had
an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab therapy because
they have a contraindication to methotrexate, or when methotrexate is withdrawn because of an adverse event.
1.5 Treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response (as defined in 1.2) 6 months after
initiation of therapy. Treatment should be monitored, with assessment of DAS28, at least every 6 months and continued only if an adequate response is
maintained.
1.6 When using DAS28, healthcare professionals should take into account any physical, sensoryor learning disabiliies, communication difficilaies, or disease
characteristics that could adversely affect patient assessment and make any adjustments they consider appropriate.
1.7 A team experienced in the diagnosis and treatment of rheumatoid arthritis and working under the supervision of a rheumatologist should initiate, supervise and
assess response to treatment with rituximab, adalimumab, etanercept, infliximab or abatacept.
Disease severity
2.10 …”A DAS28 score greater than 5.1 indicates high disease activity, between 3.2 and 5.1 moderate disease activity, and less than 3.2 low disease activity. A
score less than 2.6 indicates disease remission. A improvement in DAS28 score of 0.6 or less is considered a poor response, and improvements greater than 1.2
points indicate a good response The European League Against Rheumatism (EULAR) response criteria are based on the DAS measure. …”
Summary of Product Characteristics- Rituximab (Mabthera ®) (ref: http://www.medicines.org.uk, accessed 13/03/12, last updated on the eMC: 10/01/2012)
A course of MabThera consists of two 1000 mg intravenous infusions. The recommended dosage of MabThera is 1000 mg by intravenous infusion followed by a
second 1000 mg intravenous infusion two weeks later. The need for further courses should be evaluated 24 weeks following the previous course. Retreatment
should be given at that time if residual disease activity remains, otherwise retreatment should be delayed until disease activity returns.
Available data suggest that clinical response is usually achieved within 16 - 24 weeks of an initial treatment course. Continued therapy should be carefully
reconsidered in patients who show no evidence of therapeutic benefit within this time period.
2
NICE Rheumatoid arthritis commissioning algorithm (22 February 2012)
(Ref: http://www.nice.org.uk/media/A44/49/RA42WithTocilizumabRR.pdf)
3
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