It is important that healthcare professionals have the right of appeal against panel decisions. This is essential to ensuring decisions are fair, just and equitable. Similarly while the NHS Framework is key to delivering treatment stability for patients who require immunoglobulin treatment and value for the NHS, it may not have the adaptability to meet patient needs in exceptional circumstances. This page sets out the processes for appeals and access to immunoglobulin brands designated with 'reserve' status by NHS England.
Reserve Framework criteria and process
Only immunoglobulin products listed on the NHS framework may be prescribed to treat patients with human normal immunoglobulin in the NHS, unless exceptionality can be proven and the suggested alternative product is commercially available with an appropriate funding pathway. Clinicians wishing to request access to the Reserve Framework for Immunoglobulins should follow the process described in the EOEIAP Core Practice Standards. This is to ensure equity in access, engagement with manufacturers who supply product and with NHS England / DHSC. All parties need to plan carefully for any non-Framework product use in order to ensure both availability of product and treatment cost reimbursement.
Exceptionality is considered on a case-by-case basis by the EOEIAP following a submission from the patient's clinical team. While not comprehensive, factors that the panel will take into account when assessing exceptionality include:
1) Failure to tolerate two or more brands of immunoglobulin (SCIG or IVIG), including following change in rate of administration and use of appropriate supportive medicines including antihistamine and paracetamol (IVIG) AND are now stable on current therapy;
2) Properties or particulars of the manufacturing process of a given brand, or information made available for individual batches that are not equivalent or available in alternative NHS Framework brands.
3) Dexterity issues that would affect ability to self-administer using vials, including arthritis in the hand or arm (fingers, wrist, elbow) OR relevant amputation or loss of function of a limb OR peripheral nerve weakness affecting finger(s), hand(s) or arm(s);
4) Relevant sensory impairment (including significant visual impairment);
5) Significant cognitive or psycho-social issues where the patient's well-being or ability to comply with treatment could be impaired following a change to the mode of delivery or administration.
In all cases, the EOEIAP will review applications for access to the Reserve Framework, seeking further information as needed, and are required to approve exceptionality formally before acceptance onto the Reserve Framework.
Submissions should be made in writing to the panel explaining the particulars of treatment, why the range of NHS Framework products cannot be used, and the intended benefit from using a 'reserve' status immunoglobulin product. Please also outline an appropriate timeframe to deal with the request. Requests are presented to the EOEIAP Steering Group which meets monthly, although extraordinary meetings can be arranged where there is clinical need.
Email the panel
Appeals against EoEIAP decisions
A pathway exists for a second opinion to be sought from an associate SRIAP (sub-regional IAP). Where the EoE IAP has declined to support treatment with immunoglobulins, please email the EoE IAP coordinator to formally request a clinical review by an associate SRIAP. Ensure communications are appropriately secure when sending patient identifiable data. We recommend sending from an nhs.net account.
The panel does not review applications where the treating consultant does not support the use of immunoglobulin therapy.
Patients may not appeal panel decisions without the support of the treating consultant.
It is not appropriate for the EOEIAP to enter into clinical discussions with Members of Parliament or other public service figures outwith the NHS, except in the event of legal proceedings.