Agenda item

Consideration was given to a report presented by Sue Smith and Helen Hawley from NHS Rotherham, as the Clinical Commissioning Group was considering adopting off-label Avastin as the first line treatment of wet age-related macular degeneration (wet AMD) instead of the currently licensed first line treatment recommended by NICE which was Lucentis®.

Public Health had reviewed the evidence base which indicated that both options were similarly safe and effective.  However, before making any decision, a consultation was being undertaken with relevant stakeholders including patients, public, clinicians and managers to establish the feasibility of commissioning a service based on Avastin.

The Health Select Commission was invited to comment on the consultation process and offer its view on the option that the Clinical Commissioning Group was considering.

Wet Aged-related Macular Degeneration (AMD) was the most common cause of visual loss in people over the age of sixty years and had approximately 26,000 new cases in the UK each year. Rotherham’s Wet Age-related Macular Degeneration (AMD) Service was established in October, 2008 and each week received between four and six new referrals.

Avastin continued to be widely used off-label world-wide to treat a number of eye conditions, including wet AMD. In the United States, practice pattern reports from the American Academy of Ophthalmology and the American Association of Retinal Specialists suggested that most patients received Avastin rather than Lucentis® for the treatment of wet AMD.  

In August, 2008 National Institute Clinical Evidence (NICE) issued guidance on Lucentis®, recommending it as a possible treatment for people with wet AMD. Avastin was not considered as it was not licensed for the treatment of eye conditions, but for certain cancers. NICE were currently reviewing Avastin.

 Avastin and Lucentis® were both monoclonal antibodies that acted as anti-VEGF and were developed by Genentech which was now a wholly owned subsidiary of Roche.  The older drug, Avastin, had been in use for longer which allowed more time for long term side effects to manifest themselves and it was reassuring that they had not done so. The newer drug, Lucentis®, had been through a more systematic process of testing within the licensing process.

At NHS Rotherham, there were general processes and agreements via Medicine Management Committee that covered G.P.s for using off-label drugs.   If Avastin was chosen as a first choice treatment, the liability would be considered as part of a service specification and NHS Rotherham through Medicine Management Committee for approval.

An evidence review (safety and effectiveness), which included most recent comparative clinical and current practice in the UK, was presented at NHS Rotherham’s Commissioning Executive and Medicines Management Committee.

NHS Rotherham was currently undertaking a consultation process to investigate both clinicians and patients’ views of the use of Avastin as the first choice for the treatment of wet AMD.  The Commissioning Executive and the Medicine Management Committee at NHS Rotherham were fully supportive of a move towards Avastin as the first choice treatment for wet AMD. There had been agreement that NHS Rotherham was able to indemnify the provider against any potential litigation from treating patients with an off-label drug.

Clinicians delivering the wet AMD service at Rotherham Foundation Trust (RFT) were supportive of the use of Avastin for the treatment of wet AMD as long as a number of conditions were met.

 
However, they currently felt that they were not at an appropriate stage in discussions to consult with their patients. Therefore, there was a need to establish patient opinion on the use of Avastin via other routes.

The options/recommendations resulting from the consultation would help dictate the next steps in commissioning decisions.

Discussion ensued on the comparative costs, benefits and improvements to patients’ lives and the long term side effects of both drugs.

Members present were supportive of the use of Avastin as a first choice and of further consultation through the route of Area Assemblies.

Resolved:-  (1)  That the finds of the evidence review be noted.

(2)  That the process of consultation include the Area Assemblies.

(3)  That the option being considered by fed back to this Select Commission in due course.