Saturday, June 22, 2024

Ranibizumab Recommended for Macular Edema Due to Retinal Vein Occlusion with Conditional Access Scheme

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Ranibizumab is recommended as a treatment option for visual impairment caused by macular edema resulting from either central or branch retinal vein occlusion (RVO). This recommendation applies specifically in cases where laser photocoagulation treatment has not been effective or is deemed unsuitable due to extensive macular hemorrhage. However, access to ranibizumab at a discounted rate is contingent upon the manufacturers offering it at a discount level no lower than what has been agreed upon in the patient access scheme.

Individuals currently undergoing treatment with ranibizumab, whose condition does not meet the specified criteria, are permitted to continue their treatment until they and their healthcare provider deem it appropriate to discontinue. Ranibizumab, marketed under the brand name Lucentis by Novartis, falls within a class of medications that inhibit the action of vascular endothelial growth factor (VEGF)-A. Retinal vein occlusion is a common cause of vision impairment due to retinal vascular disease, where thrombosis in retinal veins leads to increased capillary permeability and subsequent macular edema.

This condition can result in varying levels of ischemia due to reduced perfusion of capillaries, triggering an increase in VEGF levels. By inhibiting the action of VEGF-A, ranibizumab mitigates edema, thus limiting visual loss or improving vision. The United Kingdom (UK) marketing authorization for ranibizumab encompasses the treatment of visual impairment due to macular edema secondary to retinal vein occlusion, whether branch RVO or central RVO.

Ranibizumab Treatment Protocol for Macular Edema: Efficacy, Safety, and Monitoring Guidelines

The recommended treatment regimen involves monthly administration of ranibizumab until maximum visual acuity is achieved, which is determined by visual acuity stability over three consecutive months. Following this, monthly visual acuity monitoring is advised, with treatment resumption if a loss of visual acuity attributable to macular edema secondary to RVO is detected.

However, if there is no improvement in visual acuity after the initial three injections, continued treatment is not recommended. Contraindications to ranibizumab include hypersensitivity to the active substance or any of its excipients, active or suspected ocular or periocular infections, and severe intraocular inflammation.

Although adverse reactions to ranibizumab treatment predominantly manifest as ocular side effects, such as vitritis, vitreous detachment, retinal hemorrhage, and visual disturbances, it’s important to note that other adverse events have been reported as well. Among these, nasopharyngitis, arthralgia, and headaches are commonly observed. These systemic adverse effects, while less frequent, underscore the necessity for thorough patient monitoring and management during ranibizumab therapy.

Macular Edema

Novartis and UK Health Department Enhance Access to Ranibizumab for Macular Edema

To facilitate access to ranibizumab for eligible patients, the manufacturer, Novartis, has collaborated with the Department of Health to establish a patient access scheme. This scheme is designed to ensure that individuals in need of ranibizumab treatment can obtain it at a discounted rate, thereby reducing financial barriers to accessing this essential medication. By participating in the patient access scheme, Novartis aims to support equitable access to ranibizumab therapy for patients across the UK, enhancing their ability to receive timely and effective treatment for visual impairment due to macular edema secondary to retinal vein occlusion.

The implementation of such patient access schemes reflects a broader commitment within the healthcare industry to address issues of affordability and accessibility of vital medications. By working collaboratively with government agencies and healthcare providers, pharmaceutical companies like Novartis can play a pivotal role in ensuring that cost-effective treatments like ranibizumab are available to those who need them most. This proactive approach not only benefits individual patients by reducing financial burdens associated with treatment but also contributes to overall healthcare system sustainability by optimizing resource allocation and improving patient outcomes.

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Moreover, initiatives like patient access schemes serve as a mechanism for fostering collaboration between the public and private sectors to address healthcare disparities and promote health equity. By leveraging their expertise and resources, pharmaceutical companies can complement government efforts to expand access to essential medications, ultimately benefiting patients and society as a whole.

NHS England Ensures Cost-Effective Access to Ranibizumab and Biosimilars for Macular Edema

In addition to the patient access scheme for branded ranibizumab, NHS England has undertaken a national procurement process for medical retinal vascular medicines, including biosimilar versions of ranibizumab. This procurement initiative aims to ensure consistent pricing and availability of ranibizumab and its biosimilars, thereby promoting competitive pricing and facilitating access to cost-effective treatment options for patients with visual impairment due to macular edema secondary to retinal vein occlusion.

By aligning pricing for originator and biosimilar ranibizumab with the national procurement outcome, the National Health Service (NHS) England seeks to optimize resource utilization and promote cost-effectiveness in medication procurement. This strategic approach reflects a commitment to evidence-based decision-making and value-based healthcare delivery, wherein treatments are evaluated not only based on their clinical efficacy but also on their cost-effectiveness and broader societal impact.

Moreover, NHS England has conducted a national procurement for medical retinal vascular medicines, encompassing biosimilar versions of ranibizumab. Prices for originator or biosimilar ranibizumab are expected to align with the national procurement outcome and should not exceed the pricing provided through the original patient access scheme.


Resource: National Institute for Health and Care Excellence, May 20, 2024

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