PoliticalSpeak: High-cost drugs NICE or not so NICE

How long can we continue to ignore the impact high-cost drugs are having on the treatment of MS? #PoliticalSpeak #MSBlog

"I note my post on the Norwegian health technology appraisal on the cost-effectiveness of DMTs in Norway generated a relative muted response. I am surprised considering how hot the topic of high-cost drugs is at the moment, particularly in the USA. An online BMJ article by Narcyz Ghinea and Wendy Lipworth discuss the issue and cover many of the points we have highlighted many times on the blog in the past."


"What surprises me, and upsets me, is how passive the MS community seems to be about the issue of high-cost drugs when you compare it to communities in other disease areas. Why? To me the cost of MS DMTs is one of the main reason why we are not managing MS actively, or aggressively, enough. The price of DMTs forces healthcare systems to rank DMTs as first, second and third-line and to impose a whole raft of restrictions to prescribing. More importantly the price of these drugs means that the majority of pwMS in resource poor environments have no access to treatment. In my opinion this is a scandal. High-cost drugs are responsible for a new form of therapeutic nihilism; dare I call it nihilism?"


"I am aware that many of you disagree with me on this issue, but seeing patients with highly-active MS on no DMTs, in South Africa and India, when I was on my sabbatical still haunts me. They weren't on DMTs because their respective healthcare systems couldn't afford the price of licensed DMTs and they couldn't afford to pay for it privately. In response to this dilemma I generated our Barts-MS Essential Off-label DMT List that has drawn criticism, some of it very vocal, from many quarters. To be honest I don't care; at the end of the day I am a clinician and if faced with the option of not-to-treat, or to-treat with an off-label drug, I will always put my patient's interest first and offer them an off-label drug. I know enough about MS that if it was left to its own devices, and given sufficient time, it will cause the majority of people with the disease to become disabled. Since promoting off-label DMTs in resource poor settings it has become clear that these drugs need to be prescribed in a safe and appropriate way. This has highlighted the need for education of neurologists in these environments and for improving MS services in these environments so that the drugs can be prescribed safely. To do this we are starting an initiative to raise awareness of the issues faced by patients and clinicians in resource poor environments. What I have learnt from our 'Brain Health: time matters' policy initiative, is that simply standing on a soap box and shouting makes little difference and simply adds to the noise; in short nobody listens. This is why we need discussion forums, lobby groups and policy initiatives to address the issue of high-cost DMTs; if we don't we would be letting these people down." 


"I am pleased to see that the high-cost drug debate, and what is cost-effective, is still very active and ongoing. Have you ever considered why NICE, health economists and payers set the cost per QALY (quality adjusted life year) at a particular level and then base their cost-effectiveness, or rationing, decisions on this level? Last week's BMJ highlights this issue and gives the rationale for why NICE has set the cost per QALY between £20,000 and £30,000 (see Timmins' & Appleby's articles below). In relation to DMTs for people with MS we think the threshold has been set slightly higher at ~£36,000. Why? This level was set more than a decade ago when they assessed the cost-effectiveness of interferon-beta and glatiramer acetate. The threshold was set to cover direct medical costs and does not include societal, or indirect costs, and the threshold is not index linked. So overtime DMTs are getting relatively cheaper and hence more cost-effective. Please note this statement refers to the NHS and does not apply to other countries, for example, in the USA the real cost of MS DMTs have soared well above the price of inflation, including drug-price inflation."



Article 1: Narcyz Ghinea & Wendy Lipworth. Propaganda or the cost of innovation? Challenging the high price of new drugs. BMJ 2016;352:i1284

Key messages: 


Article 2: Nicholas Timmins. At last, NICE to take over the Cancer Drugs Fund. BMJ 2016;352:i1324.

Excerpts


..... The National Institute for Health and Care Excellence (NICE) celebrates its 17th birthday in April. By any standards it must be judged to have been one of the more successful pieces of public policy in the past couple of decades.....

...... It has shielded politicians from many of the really difficult decisions about what the NHS should and should not provide. It has made cost effectiveness, as opposed to purely clinical effectiveness, a key part of that. And—amid repeated controversies—it has sought with considerable success to balance an essentially unequal equation. One between the interests of the taxpayer in cost effectiveness; the interests of individual patients, who when they are not paying simply want the treatment whatever it costs; the interests of clinicians who, by and large, welcome guidance but detest instruction; and the interests of the life sciences industry, which needs a market for its products and ideally wants one that encourages the best sort of innovation while delivering the best possible price. Navigating that equation—seeking to balance it—has never been easy and has often been controversial......

....... However, by applying a set of social values to its judgments and seeking to operate to a set of principles—that it will be robust, inclusive, transparent, independent and contestable—it has done a pretty good job. One that other countries have sought to emulate...... 

Article 3: John Appleby. Crossing the line: NICE’s value for money threshold. BMJ 2016;352:i1336.

Excerpts: 

..... For a publicly funded health service, deciding what services and treatments should be available to patients is not just a matter of getting the best value for every (scarce) pound spent but an ethical duty too.... 

..... Choosing “what’s in and what’s out” quite literally involves decisions about life and death; the cost of getting a decision wrong can be measured not just in wasted resources but in avoidable deaths and lower quality of life. In this respect, the creation of the National Institute for Health and Clinical Excellence (NICE) 17 years ago was a watershed moment. For the first time there was an organisation required to advise the NHS explicitly on what it should offer to patients, drawing on evidence of the clinical benefits and the cost of obtaining those benefits......

...... For some obvious practical reasons, this is not how NICE arrived at its threshold range of £20 000 to £30 000. (It chose a range rather than a single number to allow some flexibility in decision making to reflect uncertainties in cost and effectiveness data and the use of criteria other than cost effectiveness in making decisions....

...... The exact origin of this range remains somewhat shady, emerging as a reasonable benchmark from NICE’s early evaluations of various healthcare interventions. Compared with the World Health Organization’s suggested cost effectiveness range based on gross domestic product (GDP) per capita of a country (“very cost effective”) to three times GDP per capita (“cost effective”), NICE’s threshold is much less generous (fig 2). On the other hand, recent analysis by Claxton and colleagues suggests NICE’s threshold is too generous relative to the cost effectiveness of treatments and services currently provided by the NHS....

.... Whatever the starting point for NICE’s threshold, because the NHS budget has roughly doubled in real terms since NICE started using its threshold range and the NHS has also increased outputs relative to inputs (that is, increased its productivity) over time, the threshold should have more than doubled over the past 15 years—becoming more generous to less cost effective treatments (fig 3). To the possible chagrin of drug manufacturers, this hasn’t happened—not least because moving the threshold goal posts would create problems. Previously rejected treatments could become cost effective as the threshold moves; what does NICE do then, and what incentives does this create for drug manufacturers? But we shouldn’t get too fixated by the cliff edge nature of thresholds. As Helen Dakin and colleagues have shown, while cost effectiveness explains most of the decisions made by NICE, other criteria play a part, and there is little indication of a sharp accept-reject divide at the supposed fixed threshold of £20 000 to £30 000 per QALY......

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