The HEDS blog has already reported on a whole set of reimbursement guidance produced by NHS England that sits outside the NICE Technology Appraisal process. We have just discovered another process – an Open Consultation by the Department of Health.
This has come to light with a consultation document on “Proposed changes to NHS availability of erectile dysfunction treatments: changing prescribing restrictions for Sildenafil.”
From the DH website:
“This consultation seeks views on our proposals to remove statutory prescribing restrictions for some generic erectile dysfunction (ED) treatments.
In 1999 the department brought in measures to restrict NHS prescribing of a number of ED treatments, including Viagra, because they were considered too costly for routine availability on the NHS. These restrictions mean that only certain men can have ED treatments prescribed on the NHS, for example, men with diabetes or prostate cancer.
Viagra lost its patent protection in the UK in June 2013 so generic drugs, called sildenafil, can now be marketed. Prices have dropped by 93%.
Now it is available more cheaply, we are consulting on proposals to amend the regulations to allow unrestricted prescribing of the generic drug for men with ED.
The impact assessment will be available shortly.”
Is this a sign of things to come for other generics/biosimilars in order to bypass NICE?