2 The technology

2 The technology

Description of the technology

Ex vivo expanded autologous human corneal epithelial cells containing stem cells (Holoclar, Chiesi Farmaceutici) is a treatment used in the eye to replace damaged cells on the corneal surface.

Marketing authorisation

It has a conditional marketing authorisation for 'the treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least 2 corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns'. At least 1 to 2 mm2 of undamaged limbus is needed for biopsy before it can be used.

Adverse reactions

For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Exact dosage depends on the size of the corneal surface: the recommended dose is 79,000 to 316,000 cells/cm2.

A biopsy is first taken of the eye, which needs at least 1 to 2 mm2 of undamaged tissue. The treatment is then implanted in the eye.

Price

According to the company's submission, a single treatment for 1 eye costs £80,000 excluding VAT.

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of Holoclar, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)