COVID-19 (coronavirus) and the asfotase alfa (Strensiq) Managed Access Agreement

NICE and NHS England and NHS Improvement have taken advice from clinical experts to review the potential impact of COVID-19 on the delivery of the Managed Access Agreement (MAA) asfotase alfa (Strensiq) for treating paediatric-onset Hypophosphatasia (HPP) [HST6]. This statement sets out considerations for patients who are already receiving treatment and those patients who have not yet started treatment. We have considered the unprecedented demand on the NHS in the coming months and that some patients may want to self-isolate.

While we would like to provide general information about likely access to treatment and suggested adjustments to clinical monitoring, some hospitals may have to take additional local decisions to further prioritise resources to tackle COVID-19. For questions about your individual circumstances and to understand what is available at your usual treatment centre, please contact the team who manage your treatment.

 

For existing managed access patients

  1. Patients who are already receiving treatment as part of the MAA
  • Where safe and appropriate to do so, treatment with asfotase alfa will continue to be delivered via homecare.
  • If you are self-isolating and have concerns about healthcare professionals entering your home, please review the UK Government advice on self-isolation and shielding, and speak with your homecare provider about the precautionary measures in place to protect you and others. The homecare team will assess whether a patient or a family member has any potential COVID-19 symptoms via telephone before arranging any visits.
  • Homecare providers are already experiencing higher demand for their services and it is likely that existing scheduled treatments and/or the frequency of future treatments may need to change. Your homecare provider will be able to provide the most up to date information concerning their schedules.
  • We aim to ensure that no patient will be disadvantaged if they are unable to receive regular treatment during this period. The treatment stopping criteria for missed treatments (missing 1 visit in any 18-month period) will be flexed to take account of each patient’s personal circumstances during this period.
  • Patients will be allowed to restart treatment where clinically appropriate under the MAA if treatment is interrupted during this period.

 

  1. Ongoing monitoring of existing managed access patients
  • If patients are unable to complete ongoing assessments as required by the MAA (e.g. because it is unsafe, or circumstances do not allow), these should be deferred until they can be performed safely under valid and standardised conditions. With these measures, we aim to ensure that no patient will be disadvantaged if they are unable to complete monitoring assessments as a direct result of COVID-19.
  • If it is not possible for patients to attend hospital for monitoring assessments, it is recommended that the analgesia log be completed via telephone consultation as well as any other information possible (e.g. body weight, height) where feasible and appropriate.
  • Clinical teams must record when assessments have been conducted via video or telephone consultation within the managed access data collection records. The data collection monitoring and data queries resolution will be done remotely as needed.
  • Where possible, Quality of Life interviews will be conducted via telephone or Skype temporarily during this period if appropriate for the patient and/or family member. It is recognised that outcomes may decline during this period due to heightened anxiety and this will be taken into account by the National Authorisation Panel (NAP) at subsequent clinical reviews.

 

For new patients starting treatment under the MAA

  1. Adjustments to baseline assessments and treatment initiation
  • All patients considered eligible for treatment must continue to be discussed and authorised by the NAP, with the exception of neonates where HPP constitutes a medical emergency.
  • As per the usual practice for initiating asfotase alfa in neonates, the treating clinician should discuss the case with the other two national paediatric centres, inform the committee of the intention to treat and then forward the referral details to the NAP for noting.
  • For all other categories of patients, referrals should be made to the NAP using the age-specific form in the usual way.
  • For new patients starting treatment under the MAA, completion of the following baseline tests is a priority:
    • Blood tests
    • X-rays
  • If it is not possible to conduct the other baseline tests required by the MAA, these can be deferred until they can be performed safely under valid and standardised conditions. Patients will not be disadvantaged if their baseline tests are performed after their first treatment; the NAP will take this into account at subsequent clinical reviews.
  • There is an increasing demand on homecare teams at this time. The treating clinician should complete the homecare registration as normal and send to the local homecare pharmacist who will work with the regional homecare pharmacist (National Homecare Medicines Committee member) to determine if the patient meets the criteria to be registered onto homecare. If the patient meets the criteria for homecare it will be for the regional homecare pharmacist to determine which homecare provider has the capacity in that region to take the patient and communicate this to the treating clinician.

 

Patients and their families should contact their clinical team if they have any concerns about their treatment while these measures are in place.

 

We will regularly review this information and share updates as these become available.