According to the Association of the British Pharmaceutical Industry's (ABPI) current president, AstraZeneca UK chairman Chris Brinsmead, a frank, open, and honest debate is in the best interests of patients. "We are calling for the patient groups, healthcare charities, doctors, government, NICE, and the NHS to join with the pharmaceutical industry to debate these crucial issues and hammer out a lasting solution," said Brinsmead. "The time has come to discuss how we best resolve the issue, and where better than on a public platform?"
NICE and its decisions have been the subject of much public scrutiny throughout its nine-year existence, but in recent weeks the level of outrage has grown. Hot on the heels of its refusal to recommend reimbursement for four kidney cancer drugs comes a U-turn on Lucentis (ranibizumab), the Novartis drug to treat wet age-related macular degeneration.NICE's initial ruling on Lucentis last year was that patients would only be able to have the drug paid for once they had gone blind in one eye. Now all who might benefit can have Lucentis, but a second drug in the same class, Pfizer's Macugen (pegaptanib), is not being recommended.
The change of heart over Lucentis was accompanied by an apology from NICE chief executive Andrew Dillon about the delay. But in an interview on BBC Radio, he appeared to shift some of the blame onto patients themselves, claiming that their protests had slowed his agency's review. "Everybody involved needs to look back to see if there was anything they could have done to speed up the process," he said. "Once you start consulting, once you start giving people the opportunity to appeal. All these things add time."
This is one of many cases where a NICE decision has been challenged in court by disgruntled patients. With the backing of the Royal National Institute for Blind People (RNIB), three pensioners took their local Primary Care Trust (the local organizations that ultimately decide where NHS money is spent) all the way to the High Court in July to force them to pay for the drug; this is in addition to almost 1,000 other patients whom RNIB backed in battles with their local Primary Care Trusts.
Yet another court case is on the docket—this time featuring a terminally ill patient with multiple myeloma who can no longer tolerate the side effects of either Velcade (bortezomib) or thalidomide, and whose PCT is refusing to pay for Celgene's Revlimid (lenalidomide). This is an extreme example of the "post code lottery," where access to drugs depends on where patients live. (In this case, if the patient lived just a mile and a half in either direction, the PCT there would have allowed the drug.)
Such legal action has already forced NICE to make changes to some of its decisions. The agency, however, appears to be trying to shift the blame for its negative guidelines onto the industry. Its chairman, Sir Michael Rawlins, told The Observer that companies charge what they think they can get away with for drugs. He also said that linking the pay of pharma executives to share prices means there are perverse incentives to keep the prices of new drugs high and increase profits. He believes that the kidney cancer drugs that NICE won't pay for could be produced for about a tenth of what they cost. While admitting that research and clinical trials costs add to this, Rawlins said the industry's desire to cushion the impact of patent expirations and marketing costs inflate prices.
Industry has hit back at these claims. "[We] are committed to developing innovative approaches to pricing, ensuring that patients receive the medicines that they need," claimed ABPI's Brinsmead. "All the [four kidney cancer] medicines are widely available to patients throughout Europe—where the prices are higher than in the UK."
These are all issues that ABPI will want to include in its proposed public debate. Plans for this are "moving forward," according to a spokeswoman for the organization.
Sarah Houlton is Pharmaceutical Executive's global correspondent. She can be reached at [email protected]