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Cancer drugs should be licensed on smaller trials to cut prices

Promising cancer drugs should be licensed earlier, without needing extensive data from expensive large-scale trials, to speed up progress against cancer and drive down the cost of new medicines – according to leading cancer experts.

Pharmaceutical companies should cut the initial prices of cancer drugs to reflect lower development costs, but be allowed to raise prices for the best drugs once evidence builds that they have major benefits for patients.

Twenty global cancer leaders who sit on the World Oncology Forum – including one of the UK’s top cancer researchers – have released a statement at the World Economic Forum in Davos, Switzerland, calling for urgent reform to the system for developing cancer drugs.

Their statement, presented today (Friday), urges action to accelerate the development of truly innovative cancer drugs that can deliver major benefits for patients, and to make new medicines more affordable for taxpayers.

The UK’s signatory to the statement is Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, who gave the keynote lecture on which many of the proposals were based. He argues that promising drugs could be licensed on the basis of trials of just a hundred or so patients, rather than the several hundreds or more commonly required in phase III trials.

The global cancer experts warn that the whole system for drug discovery and development is flawed, because pharmaceutical companies are not incentivised to take the risks they need to create innovative and exciting treatments that work in new ways.

Their statement calls for governments to incentivise companies to take greater risks in drug development – encouraging them to produce innovative new drugs that deliver big steps forward in survival, and speeding up progress towards cures.

Targeted drugs exist for only around 5 per cent of the 500 known cancer-causing proteins, in part because companies prioritise ‘me-too’ drugs that mimic existing options ahead of innovative new ideas.

Incentives for innovation could include earlier drug licensing to reduce development costs for companies, tax breaks for companies that work in partnership with universities or charities to share risk, or extensions to the periods of market exclusivity granted as part of drug patents.

But members of the World Oncology Forum warn that in return pharmaceutical companies must drop the prices of drugs to reflect reduced development costs, particularly when publicly funded research has played a key role in a drug’s development.

Their statement argues that governments should ensure the amount they pay for drugs reflects the size of the benefit they deliver – something that is not possible at present because of a lack of transparency in the process for setting prices.

Members of the World Oncology Forum made a range of recommendations to accelerate improvements in cancer treatment following a keynote lecture by Professor Workman at its summit in October. Other suggestions include:

  • Requiring clinical trials to satisfy public interest criteria to ensure they are answering important scientific and medical questions, rather than simply aiding the licensing process – for example to find new drugs in rarer cancers
  • More public funding for drug discovery and early development in the public and not-for-profit sector – to encourage public-private partnership
  • Changes to the way academic research is rewarded to incentivise collaboration and team building, gearing research towards clinical application. 

Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said: “The current system for drug discovery and development is failing to deliver enough genuinely innovative advances in treatment, or to produce new drugs at a cost that is affordable for taxpayers.

“We need to streamline the process of trialling and licensing drugs, to bring down the costs of development and get drugs into the NHS as early as possible. Earlier access to new medicines is what everyone wants – doctors, patients, university researchers and drug companies.

“We should be licensing promising cancer drugs on small trials of a hundred or so selected patients, rather than waiting until results are replicated in much larger numbers, hence delaying patient access. And it is essential that companies pass on the cuts in the cost of drug development through reductions in the prices of new medicines, and for that to happen we need a more transparent system for agreeing prices.

“We also need to incentivise drug companies to take the risks that are vital to produce genuinely game-changing cancer medicines – by encouraging them to work in partnership with universities and charities, and rewarding those that produce highly innovative and effective drugs through prices that rise over time as their benefits become clear.”

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