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Merck Serono Survey Finds Limited Test Access, High Costs a Barrier to Personalized Rx Adoption in UK

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After a survey of UK oncologists revealed that access hurdles and high costs associated with biomarker testing are limiting their ability to prescribe personalized treatments, Merck Serono has issued a "call to action" for the government and pharmaceutical industry to work together to identify and lift these adoption barriers.

In a survey of 100 UK oncologists conducted by the drug developer, 75 percent said that there are barriers that limit their ability to prescribe personalized cancer drugs to patients who would benefit from them. Specifically, 55 percent of doctors cited test access issues as their main hurdle to prescribing personalized drugs, while 71 percent found the cost of the diagnostics prohibitive.

Moreover, around 22 percent of surveyed oncologists said they were more likely to offer personalized drugs to patients who were covered by private insurance as opposed to those who were insured by the UK's government payor, the National Health Service. "The main reasons given for this private/NHS disparity were problems with funding for personalized medicines and funding for biomarker tests," Merck Serono reflected in a briefing paper discussing the survey finding.

According to Merck Serono, the report represents a "call to action" for UK parliamentarians, government officials, and the drug industry.

The company recommends that parliamentarians engage with their local NHS trusts to ensure there is a plan to provide equitable access to personalized cancer treatments. The report also asks government officials to review implementation plans to identify adoption barriers and train health service staff in bioinformatics. Meanwhile, pharmaceutical companies should partner with the NHS to advance strategies that will increase access to diagnostics that can help doctors prescribe treatments that their patients are most likely to respond to, Merck Serono advises.

The UK government has begun some efforts to tackle access issues to biomarker-based tests. For example, in 2010, the Department of Health asked the National Institute for Health and Clinical Excellence to establish a pathway for evaluating medical devices and diagnostics and develop a strategy for accelerating access to these technologies across the country. NICE conducts cost-effectiveness analysis for innovative medical interventions and recommends which treatments the NHS should pay for.

Additionally, last year the charity organization Cancer Research UK launched the Stratified Medicines Program, which joins hospitals, drug companies, and labs in an effort to establish a national service for cost-effective genetic testing and a national database of patients' genetic information and outcomes that can be used to advance personalized treatment strategies. The program has £16.7 million ($26.5 million) in total funding, including £5.6 million from the government.

The drug industry, for its part, has selectively engaged in cost-sharing strategies in various European countries to pay for pharmacogenetic tests that facilitate sales of their drugs. For example, Merck Serono has launched a cost-sharing program in the UK around KRAS testing to ensure that the patients most likely to respond to its metastatic colorectal cancer drug Erbitux will get the treatment.

However, these cost-sharing schemes for relatively simple genetic tests may be unsustainable in the long term as more complex pharmacogenetic treatment strategies and multi-marker tests come to market. For the long term, industry observers feel that drug developers need to form collaborations with each other to find precompetitive solutions that will advance personalized medicine on the whole.

Paying for Testing to Drive Drug Sales

Merck Serono initiated a program in 2008 to fund KRAS testing for metastatic colorectal cancer patients in the UK and in Ireland. The company markets the drug Erbitux (cetuximab) in these countries as a treatment for patients who have metastatic colorectal cancer with tumors that express EGFR and have the wild-type KRAS gene.

According to the published literature, around 60 percent of metastatic colorectal cancer patients have tumors that harbor the wild-type KRAS gene, and therefore will benefit from Erbitux. Meanwhile, 40 percent of metastatic colorectal cancer patients with certain mutations in KRAS will not benefit from Erbitux and other anti-EGFR monoclonal antibodies.

In September 2011, noting access issues with testing, Merck Serono decided to expand its KRAS testing access program and began paying for testing for all colorectal cancer patients diagnosed with bowel cancer.

Under the expanded access program, Merck Serono is collaborating with 21 NHS labs and three commercial labs to provide KRAS testing to patients throughout the UK. The labs in the KRAS testing access program have agreed to provide results within seven working days. A spokesperson for the company told PGx Reporter that it is paying approximately $195 (£120) per KRAS test, which could amount to a $1.6 billion (£1 billion) total investment.

But access issues are still widespread, according to the company's recent survey. Among colorectal cancer oncologists who responded, 66 percent said that they "often" or "sometimes" prescribe a treatment that "is not necessarily the best choice because of lack of access to biomarker testing." Of the 100 oncologists surveyed, 40 said that due to delays in getting test results, they have prescribed a cancer treatment that isn't the optimal choice for their patients.

Labceutics, a firm that aims to help pharma and diagnostics companies tap into the vast laboratory network in Europe and improve access to personalized medicines, believes that Merck Serono's effort to fund KRAS testing is a promising start toward lifting adoption barriers to molecularly targeted cancer medicines. However, Labceutics believes that this type of effort is only a short-term solution.

"We certainly believe that this type of expanded access program is required in many European markets during the launch phase of a test. However, it is also important that Merck Serono work in parallel to achieve a more normal reimbursed market for the test in the long run," Maria Fe Paz, managing director of Labceutics, told PGx Reporter over e-mail.

According to Fe Paz, currently drug developers are reactively funding testing when they realize how critical companion testing access is to the sales of their drug. "I can tell you that there is very little precompetitive activity in this regard at the minute and test reimbursement solutions are being considered far too late as a general rule in personalized medicine planning," she said.

Long-Term Strategies Needed

Fe Paz noted that cost sharing may be an effective strategy to drive genetic testing use in the short term, but what is really needed are comparative effectiveness and cost-effectiveness studies to identify the clinical scenarios under which pharmacogenetic testing should be funded.

For the time being, drug developers seem willing to pay for PGx testing when there is a financial advantage. "We are seeing that these expanded access programs funded by pharma are on a case-by-case basis," Fe Paz said.

For example, Erbitux is currently the market leader in the UK as a treatment for colorectal cancer. NICE has recommended Erbitux as a first-line treatment for metastatic colorectal cancer, but did not find Amgen's Vectibix or Genentech's Avastin to be cost-effective in this setting.

As such, it appears that Merck Serono, by funding KRAS testing for patients at the time they are diagnosed with colorectal cancer, is avoiding treatment delays by ensuring that doctors will already have the PGx data needed to personalize treatment if their patients' cancers advance, and at the same time ensuring downstream sales of Erbitux. For the first quarter of this year, Eli Lilly, which markets Erbitux with Merck Serono and Bristol-Myers Squibb, reported worldwide revenues of $113 million for the drug. Comparatively, Amgen reported worldwide sales of $90 million for Vectibix in the first quarter.

However, it is currently unknown whether Merck Serono will continue to pay for KRAS testing if market incentives change, for instance when Erbitux goes off patent or when another drug overtakes Erbitux's position as market leader, Le Paz observed.

In a similar strategy, AstraZeneca has funded testing for EGFR mutations in France to ensure access to patients who are likely to respond to its non-small cell lung cancer drug Iressa. However, Le Paz predicted that AstraZeneca will likely not pay for testing if Genentech's Tarceva is approved as a first-line treatment for EGFR mutation-positive NSCLC patients.

Testing access challenges may be further exacerbated as the cancer diagnostics market shifts away from single-marker tests to multi-marker panels. Although Cancer Research UK's Stratified Medicine Program is exploring ways to standardize molecular testing in a cost-effective manner throughout hospitals, drug developers need to start thinking about how the emergence of such diagnostics will influence their businesses.

"As panel tests are launched … the ability to fence test cost and attribute the benefit to one drug over another will be impossible," Fe Paz observed. "Either competing pharma companies would agree to share the cost or, better still, … an investment in relevant health economic [studies] would support the typical evolution … and development of well reimbursed tests regardless of whether they are single tests or part of a test panel."

Labceutics, a subsidiary of the personalized medicine focused consultancy Diaceutics, is working to avoid these types of temporary solutions and trying to figure out ways in which drug developers can jointly invest in conducting economic studies for molecular tests or collaborate on cost-sharing schemes for diagnostics.

"Our initial view of is that in the short term pharma is likely to have to fund testing at the launch phase (first 18 months) of a test but that in the longer run we will specifically look for areas where pharma can collaborate precompetitively on health economic studies and value-based pricing schemes, which move to normalize the reimbursement market," Fe Paz said.

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