Europe must face up to cancer drugs prices, say oncologists

Faced with rising cancer drug prices and fragmented payer decision-making, Europe’s oncologists are joining US counterparts in taking cost effectiveness reviews into their own hands. Pharma will need to sit up and listen, says Andrew McConaghie.

A group of leading oncologists has issued a stark warning that Europe has to make tough decisions on what cancer drugs it can and cannot afford.

The calls for debate about the cost of cancer treatment mirror those in the US, which has seen the steepest rise in drug costs, but Europe is facing huge funding dilemmas in cancer as well.

The executive board of the European Society of Medical Oncologists (ESMO) has outlined its concerns about how the continent can meet the rising demand for cancer treatment, and pay for increasingly costly drugs.

Writing in the Annals of Oncology on behalf of the ESMO board, leading cancer specialist Josep Tabernero of Barcelona’s Vall D’Hebron Institute of Oncology says debate is urgently needed.

Tabernero states: “We must act now to reach consensus among our medical colleagues, funding agencies, legislative bodies, patient groups, and other key stakeholders, or we cannot hope to sustain the progress we have made thus far against this looming challenge.”

ESMO has taken direct action by developing its Magnitude of Clinical Benefit Scale (ESMO-MCBS), a new simple way of rating the value of cancer treatments.

The European doctors believe this provides a ‘rational, consistent’ approach to gauging clinical benefit of new drugs, which they say often come laden with hype and high expectations.

The ESMO-MCBS has parallels with cost effectiveness models being developed in the US, where oncologists are becoming increasingly vocal in their criticism of high drug costs.

This do-it-yourself approach to cost effectiveness is putting pressure on pharma to lower prices, and will add momentum to wider healthcare system cost-effectiveness reforms.

No ‘sweetheart’ solution

Cancer drug prices are generally much lower in Europe than the US, but ESMO says the situation is, nevertheless, reaching crisis point.

Tabernero says there can be no ‘sweetheart’ solution to the problem: drugs must be prioritised, which means some will not be funded, and not everyone will be pleased by the decision. To illustrate his point, he refers to the rejection of Zytiga (abiraterone) for earlier use in prostate cancer by the UK’s NICE.

“Regardless of the popularity of such an outcome, decisions based on cost–value relationships must be made and upheld,” he comments.

This pressure is mounting in England, where plans are now underway to tame the Cancer Drugs Fund, which has, until now, been a means of bypassing NICE’s strict cost controls.

Pharma can certainly claim some major advances in cancer care in recent years, not least the new immunotherapy treatments, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda. But these new, more effective drugs carry a huge price tag in the US – $12,500 a month or $150,000 for a year’s treatment.

The drugs are expected to be frequently used in combination with other high priced treatments (e.g. Opdivo + Yervoy), which will push costs even higher.

Opdivo and Keytruda have both hit European markets in the last few weeks, and prices here are significantly lower – the UK monthly price of Opdivo is around £5,700 (£8,800) – a third cheaper.

Dr Tabernero thinks the ESMO-MCBS scoring system will help control expectations, and separate the true breakthroughs from the hyped drugs.

He states that it will: “not only benefit the credibility of drugs or treatment interventions with the highest scores…but also help us to better manage the hype and inflated expectations that are by-products of clinical findings being wrongly (or prematurely) positioned as breakthroughs.”

Clearer ranking – but price not included

So how does the MCBS work? Drugs which aim to be curative are rated from A (top) to C and non-curative treatments are rated from 1 to 5, with 5 being the top score in this ranking. ESMO says it will highlight any drug or combinations of drugs which achieve scores of A and B or 4 and 5, and urges European payers to accelerate their value and cost-effectiveness assessments.

However the MCBS stops short of addressing price: the scale looks at magnitude of clinical benefit and the quality of supporting evidence, but doesn’t factor in cost. One reason for this is because drug prices differ greatly from country to country in Europe.

So what results has the first iteration produced?

In breast cancer, Roche’s Herceptin combined with chemotherapy is given an ‘A’ rating (signifying a curative aim) for (neo)adjuvant treatment for HER-2+ tumours. Its follow-up Kadcyla is given a ‘5’ rating (ie non-curative) in second line metastatic use after failure of Herceptin.

In truth, this won’t help Europe’s health technology assessment bodies (NICE in the UK, Germany’s IQWiG and France’s HAS) very much. NICE has been locked in a stalemate with Roche on Kadcyla for a whole year, and the (very public) disagreement has been solely on the drug’s price.

A showdown on value and prices?

But meanwhile, across the Atlantic, ESMO’s US counterpart the American Society of Clinical Oncology (ASCO) is finalising the ASCO Value Framework – and this will include a rating of cost effectiveness.

This is a hugely significant development for the US, which has so far resisted the move towards government bodies undertaking cost effectiveness analysis, as seen in Europe, Canada and Australia.

ASCO is currently finalising its methodology, which would consider relative clinical benefits, side effects and cost of treatment regimens that have been tested in head-to-head clinical trials. This would be combined in a ‘Net Health Benefit’ score (NHB), comparing benefits of the new drug to current standard care.

The Value Framework scores treatment regimens on a 0-100 scale (and in some cases up to 130), creating a much simplified assessment of a drug’s value to patients.

The first review suggests the system is no pushover, with no drug scoring above 50 points.

Two different regimens including Herceptin were reviewed, producing some of the best scores in the survey. Herceptin scored 48 and cost over $73,165 when combined with doxorubicin, cyclophosphamide and paclitaxel, and scored 32 and cost $65,707 when used with carboplatin and docetaxel.

Other drugs didn’t fare so well, however. A prostate cancer regimen including Sanofi’s Jevtana achieved just 16 points, while a lung cancer combination therapy with Alimta scored zero. Low rankings for these drugs weren’t a surprise, as these drugs had already been identified as also-rans in the market, while rival treatments scored well.

But the bigger message is clear: cost effectiveness reviews are coming to the US, and oncologists are becoming far less shy about discussing cost versus clinical benefit with patients.

ASCO has opened up its model to consultation, which closes on 21 August, and is sure to face determined opposition from US industry lobby group PhRMA.

US oncologists are speaking out because patients frequently have to pay a large share of the drug costs. Most recently, last month 118 US oncologists signed a petition demanding action on rising drug prices, which they say are not linked to benefits added. The petition included seven solutions to the problem, including the creation of an independent agency to review drugs and ‘propose a fair price for new treatments, based on value to patients and health care’.

Forbes columnist Matthew Herper asked Novartis chief executive Joe Jimenez for his response to this wave of protest. Jimenez agreed that the price of treating cancer “has reached a level that is concerning and we must find a solution,” but warned of anything that would disincentivise new drug discovery.

Most big pharma companies share Jimenez’s line that high prices are worth paying for progress in cancer. However there is one dissenting voice – GlaxoSmithKline’s chief executive Andrew Witty – who says ever-increasing prices are unsustainable, and has swapped his company’s oncology portfolio for Novartis’ vaccines business.

Other changes may well change the US market balance of power: its health insurance companies are in the midst of their own merger mania. The current big five are set to become just three giant firms, which are likely to give them more power to drive down pharma prices (though this may not be passed on to patients).

Meanwhile, in Europe, one of ESMO’s biggest concerns is inequality of access. Richer nations are able to invest more in health, but patients in poorer nations could lose out.

One of Tabernero’s most eye-catching observations is that there is no single European approach to pricing or assessing cancer drugs, presenting a major payer-side barrier to change.

“Public policy and health care models across Europe are arguably as heterogeneous as cancer itself,” he notes.

He nevertheless concludes that “leaving the pricing efficacy of cancer drugs out of the equation is no longer an option,” and says solutions need to be found and agreed on.

Links

Read the full ESMO article Proven efficacy, equitable access, and adjusted pricing of anti-cancer therapies: no ‘sweetheart’ solution

Read about ASCO’s proposed Value Framework here.

Read the Mayo Clinic article: In Support of a Patient-Driven Initiative and Petition to Lower the High Price of Cancer Drugs