improvement. Unresponsive to intravenous steroid treatment OR The Specialist Working Group noted that Steroid treatment is contraindicated while Rituximab is the treatment of choice for this devastating condition, it is not always AND available or may be contra-indicated, and as A trial of rituximab has failed to demonstrate a response, such, there continues to be limited three months following the last dose. circumstances where Ig therapy is warranted. OR Rituximab is contraindicated or unavailable Alternative treatments include Cyclosporine, Methotrexate, Orbital radiotherapy and AND orbital decompression surgery. A trial of at least two alternative treatments has been undertaken Review Review by an Ophthalmologist is required within 3 months of The initial treatment period has been defined Criteria treatment to determine whether the patient has responded, and six and review criteria to demonstrate a clinical monthly thereafter. If no response has been demonstrated by three response, supported by evidence items, have months, IVIg therapy should be abandoned. been developed. An assessment of each of the Bartelena Documentation of clinical effectiveness is necessary for continuation Activity Score measures of severity will be of IVIg therapy. captured as ‘improved/ worsened/stable’ for monitoring and to inform future On review of the initial authorisation period measurement of clinical response. Patients will be authorised for continuing therapy if Clinical effectiveness of Ig therapy can be demonstrated by: some improvement has been demonstrated. Improvement in the severity and level of activity of eye disease compared to the qualifying assessment AND Prescribers are encouraged to determine the A reduction in dose is planned or if not planned, a valid minimal effective dose for patients. reason is provided.
Unresponsive to intravenous steroid treatment OR Steroid treatment is contraindicated AND A trial of rituximab has failed to demonstrate a response, three months following the last dose. OR Rituximab is contraindicated or unavailable AND A trial of at least two alternative treatments has been undertaken improvement. The Specialist Working Group noted that while Rituximab is the treatment of choice for this devastating condition, it is not always available or may be contra-indicated, and as such, there continues to be limited circumstances where Ig therapy is warranted. Alternative treatments include Cyclosporine, Methotrexate, Orbital radiotherapy and orbital decompression surgery. Review Criteria Review by an Ophthalmologist is required within 3 months of treatment to determine whether the patient has responded, and six monthly thereafter. If no response has been demonstrated by three months, IVIg therapy should be abandoned. Documentation of clinical effectiveness is necessary for continuation of IVIg therapy. On review of the initial authorisation period Clinical effectiveness of Ig therapy can be demonstrated by: Improvement in the severity and level of activity of eye disease compared to the qualifying assessment AND A reduction in dose is planned or if not planned, a valid reason is provided. The initial treatment period has been defined and review criteria to demonstrate a clinical response, supported by evidence items, have been developed. An assessment of each of the Bartelena Activity Score measures of severity will be captured as ‘improved/ worsened/stable’ for monitoring and to inform future measurement of clinical response. Patients will be authorised for continuing therapy if some improvement has been demonstrated. Prescribers are encouraged to determine the minimal effective dose for patients.
Graves-ophthalmopathy2017.docx