Promising new drugs could bypass UK approval process
pharmafile | December 23, 2009 | News story | Sales and Marketing | MHRA, MISG, hta, market access
UK patients could next year be given access to drugs that are still in the later stages of clinical development, if a new market access scheme is adopted.
The MHRA will put its Earlier Access Scheme out to consultation in January, with a view to it being available to pharmaceutical and biotech companies before the end of 2010.
Only one or two authorisations a year are likely. They would come before the formal drug approval process and be valid for 12 months at a time, with the possibility of renewal if necessary.
The UK regulator anticipates the scheme would usually apply to medicines that have completed phase III trials, although in exceptional circumstances authorisations could also be made on phase II data.
It was the brainchild of the high-level Ministerial Industry Strategy Group, which charged the MHRA and UK industry association the ABPI with drawing up the plans.
A joint MHRA-ABPI working group concluded: “Such a scheme would offer significant benefit to patients suffering from life threatening or seriously debilitating conditions for which medicines are being developed but cannot yet be made available as licensed treatments.
“Whilst access to such medicines will – at least in most cases – be at the end of the formal development stage, the scheme could still provide potentially life-saving treatments for around one year earlier than at present.”
The working group, which is co-chaired by MHRA director of policy Shaun Gallagher and UCB’s UK and Ireland managing director Matthew Speers, includes industry representation from Wyeth Pharmaceuticals (now part of Pfizer), Amgen, Lilly and Janssen-Cilag.
The rationale behind the move is to give patients early access to new, promising medicines “that will treat, diagnose or prevent life threatening, chronic or seriously debilitating conditions without adequate treatment options”.
Manufacturers would set prices for their drugs successfully entered into the proposed scheme, but because the scheme does not involve any NICE appraisal there would be no right to central funding as applies to NICE-approved products.
This means PCTs will ultimately be responsible for making funding decisions and therefore accusations from patients of a “postcode lottery” are likely.
There are significant concerns at PCT level about the issue of liability, but the working group said that the absence of absolute guarantees was no different from the position that applies to the supply of any unlicensed medicine.
Under the new proposals, pharma firms would apply for their drug to be considered, and the MHRA would review it, for a fee, in a maximum of 75 days.
This would comprise a 30-day initial assessment with a possibility of a single round of questions to the applicant, followed by 15 days for their response plus a further 30 days to review.
The MHRA website will carry information on drugs which have been entered into the scheme and whether they have been approved or not.
The working group acknowledges that patients will require “all relevant information available” about the medicine, as well as unknowns such as possible long-term side effects.
Doctors will be reminded of their duty to explain risks when discussing treatment with patients.
The three-month consultation will start next year, with a view to introducing the new scheme later in 2010.
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