Griffiths has devoted her additional years of disease-free survival to spearheading a campaign to open up access to the drug on the UK’s National Health Service (NHS). And after many years of lobbying – with lots of highs and lows along the way – all HER2+ patients in her hometown of Stoke-on-Trent can now apply to the local Primary Care Trust for Herceptin on the NHS. “I must be costing the NHS thousands,” she told delegates at the IMS meeting, “But we are highly taxed, we are a wealthy nation and we should be able to afford it.”
The physician’s view
Other speakers considered just how much Griffiths and other HER2+ breast cancer patients are costing taxpayers and how new therapies fit into the therapeutic and affordability profile of the NHS. Speaking from the prescriber’s perspective, Clare Vernon, Consultant in Clinical Oncology and Honorary Senior Lecturer at Hammersmith Hospital in London, presented the numbers. The cost of Herceptin compared with no treatment is just over £25,000 a year (US$46,000), while the cost to prevent one relapse is around £140,000.
High on Vernon’s oncology wish list would be health economic studies to evaluate the medical costs to the healthcare system of relapses. This information is currently not available in breast cancer, which makes it difficult to determine the real cost effectiveness of new medicines. Vernon would also like to see more money made available for new drugs and greater freedom to prescribe them, along with quicker processes for appraisal by the National Institute for Health and Clinical Excellence (NICE).
It is more than four years since NICE delivered its ringing endorsement of Herceptin’s use (in combination with paclitaxel) in advanced breast cancer: “Improvements in survival of this magnitude due to therapeutic intervention have rarely been recorded in women with metastatic breast cancer.” Yet uptake has been patchy at best and campaigners are hoping that NICE’s decision to recommend Herceptin in early breast cancer – announced on the same day as the IMS conference – will broaden market access.
The payer’s view
At a time when the NHS needs to find savings of £500 million in one year, Christopher McCabe, Professor of Health Economics at the University of Warwick, argued that budgets can accommodate one new oncology product a year – not the several currently hitting the market. “We’ve already had seven or eight decisions in 2006,” he continued, listing the following examples:
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Herceptin for early breast cancer
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Gliadel wafers
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Permatrexed (Alimta from Lilly) in multiple meothelioma
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Docetaxel (sanofi-aventis’ Taxotere) for advanced refractory prostate cancer
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Bortezomib (J&J and Millennium’s Velcade) for relapse refractory myeloma
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Schering-Plough’s Temodal (temozolomide) for newly-diagnosed malignant glioma
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Erythropoetin for cancer-related anaemia to increase tumour response and/or overall survival.
McCabe, previously Director of the NICE Decision Support Unit at the University of Sheffield, was critical of both the level of innovation of many new oncology products and the quality of health economic evidence to support their use. “There is an endless tide of increasingly expensive, potentially marginally better oncology therapies,” he said. “And the evidence base is routinely woeful… We need evidence of the value of the health gain attributable to the therapy. We just don’t have that in oncology.” Based on an informal survey of oncology commissioners, he came out with the following common criticisms:
- Short trials
- Surrogate outcomes
- No or inappropriate comparators – case series in ‘rare’ conditions
- Pooled populations
- Pooled outcomes
- Lack of published (peer reviewed) results
- No or irrelevant evidence on cost effectiveness of the new therapy
- Inadequate evidence on adverse events
- No or inadequate evidence on health gain
- Constraining rather than facilitating licences eg ‘52 weeks’ or ‘up to 52 weeks’
Both Vernon and McCabe shared concerns about future tensions between the costs and benefits of oncology therapies versus competing NHS priorities and financial constraints. “New, more effective cancer drugs will be more expensive than present drugs – we need to investigate cost savings and cost effectiveness,” said Vernon. Drug budgets will have to increase markedly if the oncology market is to continue expanding with new products and new indications. “This is at a time when the NHS budget is widely expected to plateau after 2007,” added McCabe, which raises the distinct possibility of market access restrictions and/or price reductions in response to growing demand.
The industry view
As Carla Niven, IMS Consulting Engagement Manager, explained, cancer has long been considered an exceptional case when it comes to funding: “To date, oncology has held special status – payers have been reluctant to push prices of drugs down in order to manage budgets.” The classic market entry strategy for a new oncological is to secure a high price for a first indication with a small target population or short treatment duration. It is then to increase volume by taking advantage of high off-label prescription use in oncology, or by securing new indications with larger patient populations.
This model has enabled the industry to secure high prices for products at launch with initial small market size and increased volume at a later stage. With potentially attractive rewards for innovation, this in turn has fuelled R&D investment. “A large number of innovative candidates make the oncology pipeline far and away the largest in the industry,” confirmed Niven, “Pharma companies are pinning a lot of hope on the market.” But recent growth in oncology spending has alarmed payers. “Oncology is beginning to appear on budget radars,” she continued, as countries begin to impose market access restrictions on new therapies.
The trend is set to continue. With the oncology market forecast to grow from US$29 billion to US$55 billion over the next five years, payers will be forced to appraise their budget priorities. The effects, thinks Niven, will be lower prices at launch and throughout the product life cycle, less funding for off-label use and increased use of restrictions such as prior authorisations. Like Christopher McCabe, Niven believes companies will need to demonstrate improvements in health related quality of life (HRQOL), remission and survival, in addition to having a good health economic story to tell.
On the upside, products will continue to expand into multiple oncology indications, oncologists will continue to support appropriate access for their patients and campaigners like Dorothy Griffiths will continue to fight for access to new treatments.
Extracted from Pharma Pricing & Reimbursement, published monthly by IMS Health. For further information, please contact Richard Mee via e-mail, or call +44 207 393 5757.