Bevacizumab gamma for treating wet age-related macular degeneration

Bevacizumab gamma is recommended as an option for treating wet age-related macular degeneration in adults, only if: • the eye has a best-corrected visual acuity between 6/12 and 6/96 • there is no permanent structural damage to the central fovea • the lesion size is 12 disc areas or less in greatest linear dimension • there are signs of recent disease progression (for example, blood vessel growth as shown by fluorescein angiography, or recent visual acuity changes) • the company provides it according to the commercial arrangement . the eye has a best-corrected visual acuity between 6/12 and 6/96 there is no permanent structural damage to the central fovea the lesion size is 12 disc areas or less in greatest linear dimension there are signs of recent disease progression (for example, blood vessel growth as shown by fluorescein angiography, or recent visual acuity changes) the company provides it according to the commercial arrangement .

Use the least expensive option of the available treatments (including bevacizumab gamma, aflibercept, faricimab and ranibizumab). Take account of administration costs, dosages, price per dose and commercial arrangements. If the least expensive option is unsuitable, people with the condition and their healthcare professional should discuss the advantages and disadvantages of other treatments.

Only continue bevacizumab gamma treatment if an adequate response is maintained. Criteria for stopping should include persistent deterioration in visual acuity and anatomical changes in the retina.

These recommendations are not intended to affect treatment with bevacizumab gamma that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. Why these recommendations were made NICE already recommends aflibercept, faricimab and ranibizumab as treatment options for wet age-related macular degeneration. Bevacizumab gamma works in a similar way to these treatments and would be offered to the same population. Evidence from clinical trials shows that more people having bevacizumab gamma gain at least 15 letters in best-corrected visual acuity than those having ranibizumab. And an indirect comparison of bevacizumab gamma with ranibizumab, aflibercept and faricimab suggests similar clinical effectiveness. Using NICE's cost-comparison methods , bevacizumab gamma only needs to provide similar or greater health benefits at similar or lower costs to 1 relevant comparator to be recommended as a treatment option. The total cost of bevacizumab gamma is similar to the cost of aflibercept. So bevacizumab gamma is recommended. For all evidence see the committee papers . For more information on NICE's evaluation of aflibercept, see the committee discussion section in NICE's technology appraisal guidance on aflibercept for treating wet age‑related macular degeneration .

Bevacizumab gamma (Lytenava, Outlook Therapeutics) is 'indicated in adults for treatment of neovascular (wet) age-related macular degeneration (nAMD)'.

The dosage schedule is available in the summary of product characteristics for bevacizumab gamma .

The list price of bevacizumab gamma is £470 for 1 vial of 7.5 mg per 0.3 ml solution (excluding VAT; company submission, accessed September 2024).

The company has a commercial arrangement. This makes bevacizumab gamma available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication. Because bevacizumab gamma has been recommended through the cost-comparison process , NHS England and integrated care boards have agreed to provide funding to implement this guidance 30 days after publication.

The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final draft guidance.

When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has wet age-related macular degeneration and the healthcare professional responsible for their care thinks that bevacizumab gamma is the right treatment, it should be available for use, in line with NICE's recommendations.

Bevacizumab gamma is recommended as an option for treating wet age-related macular degeneration in adults, only if: • the eye has a best-corrected visual acuity between 6/12 and 6/96 • there is no permanent structural damage to the central fovea • the lesion size is 12 disc areas or less in greatest linear dimension • there are signs of recent disease progression (for example, blood vessel growth as shown by fluorescein angiography, or recent visual acuity changes) • the company provides it according to the commercial arrangement . the eye has a best-corrected visual acuity between 6/12 and 6/96 there is no permanent structural damage to the central fovea the lesion size is 12 disc areas or less in greatest linear dimension there are signs of recent disease progression (for example, blood vessel growth as shown by fluorescein angiography, or recent visual acuity changes) the company provides it according to the commercial arrangement .

Use the least expensive option of the available treatments (including bevacizumab gamma, aflibercept, faricimab and ranibizumab). Take account of administration costs, dosages, price per dose and commercial arrangements. If the least expensive option is unsuitable, people with the condition and their healthcare professional should discuss the advantages and disadvantages of other treatments.

Only continue bevacizumab gamma treatment if an adequate response is maintained. Criteria for stopping should include persistent deterioration in visual acuity and anatomical changes in the retina.

These recommendations are not intended to affect treatment with bevacizumab gamma that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. Why these recommendations were made NICE already recommends aflibercept, faricimab and ranibizumab as treatment options for wet age-related macular degeneration. Bevacizumab gamma works in a similar way to these treatments and would be offered to the same population. Evidence from clinical trials shows that more people having bevacizumab gamma gain at least 15 letters in best-corrected visual acuity than those having ranibizumab. And an indirect comparison of bevacizumab gamma with ranibizumab, aflibercept and faricimab suggests similar clinical effectiveness. Using NICE's cost-comparison methods , bevacizumab gamma only needs to provide similar or greater health benefits at similar or lower costs to 1 relevant comparator to be recommended as a treatment option. The total cost of bevacizumab gamma is similar to the cost of aflibercept. So bevacizumab gamma is recommended. For all evidence see the committee papers . For more information on NICE's evaluation of aflibercept, see the committee discussion section in NICE's technology appraisal guidance on aflibercept for treating wet age‑related macular degeneration .

Bevacizumab gamma is recommended as an option for treating wet age-related macular degeneration in adults, only if: • the eye has a best-corrected visual acuity between 6/12 and 6/96 • there is no permanent structural damage to the central fovea • the lesion size is 12 disc areas or less in greatest linear dimension • there are signs of recent disease progression (for example, blood vessel growth as shown by fluorescein angiography, or recent visual acuity changes) • the company provides it according to the commercial arrangement . the eye has a best-corrected visual acuity between 6/12 and 6/96 there is no permanent structural damage to the central fovea the lesion size is 12 disc areas or less in greatest linear dimension there are signs of recent disease progression (for example, blood vessel growth as shown by fluorescein angiography, or recent visual acuity changes) the company provides it according to the commercial arrangement .

Use the least expensive option of the available treatments (including bevacizumab gamma, aflibercept, faricimab and ranibizumab). Take account of administration costs, dosages, price per dose and commercial arrangements. If the least expensive option is unsuitable, people with the condition and their healthcare professional should discuss the advantages and disadvantages of other treatments.

Only continue bevacizumab gamma treatment if an adequate response is maintained. Criteria for stopping should include persistent deterioration in visual acuity and anatomical changes in the retina.

These recommendations are not intended to affect treatment with bevacizumab gamma that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. Why these recommendations were made NICE already recommends aflibercept, faricimab and ranibizumab as treatment options for wet age-related macular degeneration. Bevacizumab gamma works in a similar way to these treatments and would be offered to the same population. Evidence from clinical trials shows that more people having bevacizumab gamma gain at least 15 letters in best-corrected visual acuity than those having ranibizumab. And an indirect comparison of bevacizumab gamma with ranibizumab, aflibercept and faricimab suggests similar clinical effectiveness. Using NICE's cost-comparison methods , bevacizumab gamma only needs to provide similar or greater health benefits at similar or lower costs to 1 relevant comparator to be recommended as a treatment option. The total cost of bevacizumab gamma is similar to the cost of aflibercept. So bevacizumab gamma is recommended. For all evidence see the committee papers . For more information on NICE's evaluation of aflibercept, see the committee discussion section in NICE's technology appraisal guidance on aflibercept for treating wet age‑related macular degeneration .