Both the College and the British and Eire Association of Medical Retina Specialists (BEAMS) have been receiving queries regarding the switch within England to biosimilar alternatives to anti-VEGF drugs. In this article, we’re answering some common questions from medical retina teams, ophthalmology service managers, pharmacy colleagues and others involved in the switch to resources that can support this transition.
Do patients switching to a biosimilar alternative need to be reconsented?
Consent should be understood as an ongoing process rather than a single event. The focus of consent discussions should remain on the patient’s condition, the intended treatment approach and the potential benefits and risks.
Where a biosimilar contains the same molecule and uses the same delivery mechanism as the originator medicine, it is not generally necessary to obtain a new written consent solely because a patient is being switched to a biosimilar alternative.
However, it is good practice to discuss the planned switch with the patient before treatment is changed. This conversation should explain that the treatment is moving to a biosimilar version of the same medicine and allow the patient the opportunity to ask questions. The discussion should be clearly documented in the medical record.
As part of this conversation, services should inform the patient of the specific biosimilar medicine that will be used. Patients should be offered supporting information, such as an information leaflet or manufacturer’s patient booklet where available. The change in treatment and the information provided should be recorded in the clinic letter.
Consent should also be confirmed at the point of treatment. It is good practice for the clinician or healthcare professional administering the intravitreal injection to verbally check the patient’s ongoing consent at each treatment visit before proceeding. This check forms part of the routine safety process prior to treatment.
Medical retina services may also wish to consider using consent forms that do not specify a particular anti-VEGF product. Where a product name is included on consent documentation, the use of the generic name with reference to biosimilar options may be appropriate, for example aflibercept or aflibercept biosimilar, or anti-VEGF or anti-VEGF biosimilar.
It is important to note that the consent form is not a prescription. Prescribing requirements for biological medicines remain unchanged. Medicines and Healthcare products Regulatory Agency (MHRA) guidance states that biological medicines, including biosimilars, must be prescribed by brand name and the brand specified on the prescription should be dispensed to avoid inadvertent switching. Automatic substitution at the point of dispensing is not appropriate for biological medicines.
The College recommends the use of a separate treatment checklist for use on the day of the intravitreal injection. This checklist should reference the patient’s consent and the prescribed medicine and supports safe verification of treatment before administration.
What is the most cost-effective alternative to my originator anti-VEGF drug?
NHS England has performed data modelling based on the cost of anti-VEGF medicines, the average number of injections and the cost of treatment delivery. Based on this analysis, aflibercept 2 mg biosimilars and ranibizumab biosimilars are currently the most cost-effective options. Further explanation of the cost analysis and a cost calculator are available on the NHS Futures biosimilar hub. The College and BEAMS stress that this modelling is based on national average figures and that local variation may be required.
Our patient mix is significantly different to national averages. How can we ensure that our pathways remain suitable?
Both the College and BEAMS support local adaptation and variation from the national template pathway where clinically necessary. Patients with comorbidities such as idiopathic polypoidal choroidal vasculopathy may require more intensive treatment. Commissioners may therefore need to facilitate variation from the national pathway using local data to guide commissioning decisions and ensure service stability, as highlighted in Unlocking the potential of biosimilars in retina practice in the UK: a BEAMS position statement.
When considering a switch to biosimilar anti-VEGF medicines, services should also take account of pathway sustainability and capacity implications. While national modelling indicates that aflibercept and ranibizumab biosimilars are cost-effective on average, local services may need to consider treatment durability, injection frequency and clinic capacity when designing pathways. This approach aligns with the RCOphth AMD Commissioning Guidance, which emphasises balancing cost-effectiveness with service resilience and the ability to deliver timely and safe care at scale.
Resources to support biosimilar adoption
- NHS Futures Biosimilar Hub
- Commissioning Guidance: Medical Retinal Treatment Pathway in Wet Age-related Macular Degeneration
- nAMD Pathway Calculator
- RCOphth AMD Commissioning Guidance
- RCOphth AMD Consent and Checklist Recommendations
- BEAMS AMD Position Statement on Biosimilar Adoption
- Specialist Pharmacy Service (SPS) Preparing to use aflibercept biosimilar
- Getting It Right First Time (GIRFT) Implementing Ranibizumab Biosimilar Case Studies
- Adopting biosimilar ranibizumab