NHS England has announced a further example of its negotiations with companies, and emphasised its willingness to make use of managed access agreements to ensure the cost-effectiveness of a product.
NHS England has agreed a reimbursement deal including a Managed Access Agreement (MAA) for the drug Spinraza made by Biogen, which is the first treatment to target the underlying cause of spinal muscular atrophy (SMA).
This a significant milestone for SMA sufferers, as in 2018 Spinraza was rejected at the Appraisal Consultation Document (ACD) stage due to concerns about the high price. The involvement of NHS England has broken the negotiation deadlock, with both sides demonstrating flexibility and a willingness to compromise to secure patient access, and NICE have announced that they have concluded their guidance development and that they will be recommending the product.
Chief Executive of NHS England, Simon Stevens, commented that:
“This latest deal coming on the heels of a number of other recent successful negotiations demonstrates that there is no reason for other companies not to show equivalent flexibility in order to benefit NHS patients, taxpayers and indeed themselves.”
Under the MAA, the treatment will be funded for a limited period of time and Biogen will continue to collect evidence to demonstrate the treatment’s efficacy. At the end of the MAA term, this evidence will be considered when making a decision about whether to formally approve.
Director of the Centre for Health Technology Evaluation at NICE, Meindert Boysen, commented that:
“The committee has recognised that Spinraza is a promising treatment that has been shown to improve a range of outcomes important to patients. But it also recognised that there are significant uncertainties, particularly around its long-term benefits.”
For further information, you can read the NHS England press release.