tag:theconversation.com,2011:/nz/topics/cost-of-cancer-drugs-40010/articlesCost of cancer drugs – The Conversation2019-09-24T05:02:47Ztag:theconversation.com,2011:article/1237682019-09-24T05:02:47Z2019-09-24T05:02:47ZDo new cancer drugs work? Too often we don’t really know (and neither does your doctor)<figure><img src="https://images.theconversation.com/files/293510/original/file-20190923-23822-1kn8g6y.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4294%2C3027&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The effectiveness of a drug may be evaluated based on its potential to shrink tumours – but this doesn't necessarily equate to improved survival rates.</span> <span class="attribution"><span class="source">From shutterstock.com</span></span></figcaption></figure><p>It’s hard to find anyone who hasn’t been touched by cancer. People who haven’t had cancer themselves will likely have a close friend or family member who has been diagnosed with the disease. </p>
<p>If the cancer has already spread, the diagnosis may feel like a death sentence. News that a new drug is available can be a big relief. </p>
<p>But imagine a cancer patient asks their doctor: “Can this drug help me stay alive longer?” And in all honesty the doctor answers: “I don’t know. There’s one study that says the drug works, but it didn’t show whether patients lived longer, or even if they felt any better.”</p>
<p>This might sound like an unlikely scenario, but it’s precisely what a team of <a href="https://www.bmj.com/content/366/bmj.l5221">UK researchers</a> found to be the case when it comes to many new cancer drugs. </p>
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Read more:
<a href="https://theconversation.com/we-dont-need-to-change-how-we-subsidise-breakthrough-cancer-treatments-87185">We don't need to change how we subsidise 'breakthrough' cancer treatments</a>
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<h2>A look at the research</h2>
<p>A study published last week in the <a href="https://www.bmj.com/content/366/bmj.l5221">British Medical Journal</a> reviewed 39 clinical trials supporting approval of all new cancer drugs in Europe from 2014 to 2016.</p>
<p>The researchers found more than half of these trials had serious flaws likely to exaggerate treatment benefits. Only one-quarter measured survival as a key outcome, and fewer than half reported on patients’ quality of life.</p>
<p>Of 32 new cancer drugs examined in the study, only nine had at least one study without seriously flawed methods. </p>
<p>The researchers evaluated methods in two ways. First, they used a standard “risk of bias” scale that measures shortcomings shown to lead to biased results, such as if doctors knew which drug patients were taking, or if too many people dropped out of the trial early. </p>
<p>Second, they looked at whether the European Medicines Agency (EMA) had identified serious flaws, such as a study being stopped early, or if the drug was compared to substandard treatment. The EMA identified serious flaws in trials for ten of the 32 drugs. These flaws were rarely mentioned in the trials’ published reports.</p>
<h2>From clinical trials to treatment – faster isn’t always better</h2>
<p>Before a medicine is approved for marketing, the manufacturer must carry out studies to show it’s effective. Regulators such as the EMA, the US Food and Drug Administration (FDA) or Australia’s Therapeutic Goods Administration (TGA) then judge whether to allow it to be marketed to doctors. </p>
<p>National regulators mainly examine the same clinical trials, so the findings from this research are relevant internationally, including in Australia.</p>
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Read more:
<a href="https://theconversation.com/spot-the-snake-oil-telling-good-cancer-research-from-bad-36344">Spot the snake oil: telling good cancer research from bad</a>
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<p>There’s strong public pressure on regulators to approve new cancer drugs more quickly, based on less evidence, especially for poorly treated cancers. The aim is to get treatments to patients more quickly by allowing medicines to be marketed <a href="https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.59">at an earlier stage</a>. The downside of faster approval, however, is more uncertainty about treatment effects. </p>
<p>One of the arguments for earlier approvals is the required studies can be carried out later on, and sick patients can be given an increased chance of survival before it’s too late. However, <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2733561">a US study</a> concluded that post-approval studies found a survival advantage for only 19 of 93 new cancer drugs approved from 1992 to 2017.</p>
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<img alt="" src="https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/293512/original/file-20190923-23822-zn3gbl.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">If the evidence for a new cancer drug is flawed, this leaves patients vulnerable to false hope.</span>
<span class="attribution"><span class="source">From shutterstock.com</span></span>
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<h2>So how is effectiveness measured currently?</h2>
<p>Approval of new cancer drugs is often based on short-term health outcomes, referred to as “surrogate outcomes”, such as shrinking or slower growth of tumours. The hope is these surrogate outcomes predict longer-term benefits. For many cancers, however, they have been found to do a poor job of <a href="https://www.sciencedirect.com/science/article/pii/S095980491831476X?via%3Dihub">predicting improved survival</a>. </p>
<p><a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2729389">A study of cancer trials</a> for more than 100 medicines found on average, clinical trials that measure whether patients stay alive for longer take an extra year to complete, compared to trials based on the most commonly used surrogate outcome, called “progression free survival”. This <a href="https://ascopubs.org/doi/10.1200/JCO.2011.38.7571">measure</a> describes the amount of time a person lives with a cancer without tumours getting larger or spreading further. It’s often poorly correlated with overall survival.</p>
<p>A year may seem like a long wait for someone with a grim diagnosis. But there are policies to help patients access experimental treatments, such as participating in clinical trials or compassionate access programmes. If that year means certainty about survival benefits, it’s worth waiting for. </p>
<h2>Approving drugs without enough evidence can cause harm</h2>
<p>In an <a href="https://www.bmj.com/content/366/bmj.l5399">editorial</a> accompanying this study, we argue that exaggeration and uncertainty about treatment benefits cause direct harm to patients, if they risk severe or life-threatening harm without likely benefit, or if they forgo more effective and safer treatments. </p>
<p>For example, the drug <a href="https://english.prescrire.org/en/81/168/57219/0/NewsDetails.aspx">panobinostat</a>, which is used for multiple myeloma patients who have not responded to other treatments, has not been shown to help patients live longer, and can lead to serious infections and bleeding.</p>
<p>Inaccurate information can also encourage false hope and create a distraction from needed palliative care. </p>
<p>And importantly, the ideal of shared informed decision-making based on patients’ values and preferences falls apart if neither the doctor nor the patient has accurate evidence to inform decisions.</p>
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Read more:
<a href="https://theconversation.com/if-we-dont-talk-about-value-cancer-drugs-will-become-terminal-for-health-systems-44072">If we don't talk about value, cancer drugs will become terminal for health systems</a>
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<p>In countries with public health insurance, such as Australia’s Pharmaceutical Benefits Scheme (PBS), patients’ access to new cancer drugs depends not just on market approval but also on payment decisions. The PBS often refuses the pay for new cancer drugs because of <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/imj.13350">uncertain clinical evidence</a>. In the cases of the drugs in this research, some are available on the PBS, while others are not.</p>
<p>New cancer drugs are often very expensive. On average in the US, a course of treatment with a new cancer drug costs more than US$100,000 (A$148,000).</p>
<p>Cancer patients need treatments that help them to live longer, or at the very least to have a better quality of life during the time that they have left. In this light, we need stronger evidence standards, to be sure there are real health benefits when new cancer drugs are approved for use. </p>
<p><em>The article has been updated to reflect Agnes Vitry’s current role at the University of South Australia.</em></p><img src="https://counter.theconversation.com/content/123768/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Barbara Mintzes receives funding from the National Health and Medical Research Council (NHMRC) for a research project on post-market regulatory safety advisories on medicines. She is also a member of Health Action International (HAI-Europe), a network of health and consumer organisations that promotes access to essential medicines and quality use of medicines. </span></em></p><p class="fine-print"><em><span>Agnes Vitry is affiliated with Cancer Voices, SA.</span></em></p>National drug regulators use evidence from clinical trials to decide whether new cancer drugs will be approved for use. But these studies are often flawed.Barbara Mintzes, Senior Lecturer, Faculty of Pharmacy, University of SydneyAgnes Vitry, Senior lecturer, University of South AustraliaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/871852017-11-27T05:04:15Z2017-11-27T05:04:15ZWe don’t need to change how we subsidise ‘breakthrough’ cancer treatments<figure><img src="https://images.theconversation.com/files/194963/original/file-20171116-17109-odtazf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Applications to list drugs on the PBS are usually submitted by the manufacturers of those drugs.</span> <span class="attribution"><span class="source">from shutterstock.com</span></span></figcaption></figure><p>New therapies that arm the immune system to fight cancer, such as Keytruda (pembrolizumab) and Yervoy (ipilimumab), have offered patients with advanced melanoma real hope of effective treatment. </p>
<p>But until these drugs, known as immunotherapies, were publicly subsidised, they were prohibitively expensive for Australian patients. A patient using Keytruda, for example, would be out of pocket an estimated <a href="http://www.abc.net.au/news/2015-06-28/melanoma-drug-listed-on-pbs-saving-patients-thousands/6578554">A$150,000</a> per year of treatment.</p>
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Read more:
<a href="https://theconversation.com/explainer-how-does-keytruda-treat-melanoma-and-why-is-it-so-costly-40558">Explainer: how does Keytruda treat melanoma and why is it so costly?</a>
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<p>The <a href="http://www.pbs.gov.au/info/industry/listing/participants/pbac">Pharmaceutical Benefits Advisory Committee</a> (PBAC) recommends which drugs to subsidise and list on the Pharmaceutical Benefits Scheme (PBS). The PBAC uses the same <a href="http://www.pbs.gov.au/info/industry/listing/listing-steps">process</a> for all drugs, regardless of the health condition the drug will treat. </p>
<p><a href="https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Cancer_Drugs">Some argue</a> considerations of cost-effectiveness that have been used for years are not a good fit for new cancer therapies, particularly immunotherapies. The argument is that these considerations overlook some unique benefits new drugs offer that aren’t relevant to old medications, and that we should <a href="https://jitc.biomedcentral.com/articles/10.1186/s40425-017-0241-6">review how</a> we consider such drugs for funding.</p>
<p>But looking at the processes that led to Keytruda and Yervoy being listed on the PBS, we argue the way PBAC currently works serves us well.</p>
<h2>How the PBAC makes decisions</h2>
<p>The health minister can’t list a drug on the PBS without a PBAC recommendation to do so. For the PBAC to consider a drug, it has to receive an application. Generally, the manufacturer of the drug submits the application.</p>
<p>The process has a fixed 17-week period from submission of the application to the PBAC meeting. During this time, applicants can provide evidence for the committee to consider. A list of all submissions being considered by the PBAC is published prior to the meeting so members of the community can provide their views. </p>
<p>More recently, the PBAC has invited patient groups to attend hearings and provide evidence. </p>
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<a href="https://images.theconversation.com/files/194981/original/file-20171116-8015-3jxgqm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/194981/original/file-20171116-8015-3jxgqm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/194981/original/file-20171116-8015-3jxgqm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/194981/original/file-20171116-8015-3jxgqm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/194981/original/file-20171116-8015-3jxgqm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/194981/original/file-20171116-8015-3jxgqm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/194981/original/file-20171116-8015-3jxgqm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/194981/original/file-20171116-8015-3jxgqm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">A drug needs to be recommended by the Pharmaceutical Benefits Advisory Committee to be listed on the PBS.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
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<p>Since 1993, <a href="https://www.legislation.gov.au/Details/C2017C00250">legislation</a> has required the PBAC to consider the health outcomes and costs of a new medicine relative to currently available treatments. Typically, the PBAC assesses the effectiveness of a drug according to its impact on the length and quality of life of the patient taking it. This is expressed in a measure called the quality adjusted life year (QALY). </p>
<p>The committee then judges whether each cost per QALY represents value for money for society, and whether it has confidence in those values given the data available. The PBAC also considers other factors, including equity of access and the availability of alternatives.</p>
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Read more:
<a href="https://theconversation.com/new-cancer-drugs-are-very-expensive-heres-how-we-work-out-value-for-our-money-44014">New cancer drugs are very expensive - here's how we work out value for our money</a>
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<p>But there have recently <a href="https://jitc.biomedcentral.com/articles/10.1186/s40425-017-0241-6">been suggestions</a> that some of the benefits of immunotherapies are overlooked when the focus is on the cost per QALY. These include increased durability of the response for some patients, reduced treatment costs for the future, improved productivity and the value of hope to patients.</p>
<p>But if these benefits were indeed being overlooked, we might expect immunotherapies not to be listed on the PBS, or delays in listing. This has not been the case.</p>
<h2>Immunotherapy case studies</h2>
<p>The PBS recently added two immunotherapy drugs for patients with metastatic melanoma (melanoma that has spread): Yervoy (ipilimumab) and Keytruda (pembrolizumab).</p>
<p><strong>Yervoy</strong></p>
<p>PBAC first considered an application from Yervoy’s manufacturer in July 2011. Despite the drug being seen as a <a href="http://www.abc.net.au/news/2015-04-20/doctors-hail-melanoma-breakthrough/6404426">breakthrough</a> in the treatment of metastatic melanoma, the PBAC didn’t recommended it for listing then. It only <a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2012-11/ipilimumab">did so in November 2012</a> after two <a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2012-03/ipilimumab">subsequent applications</a> from the manufacturer. Yervoy was <a href="https://www.nps.org.au/australian-prescriber/articles/medical-management-of-malignant-melanoma">added to the PBS</a> in August 2013.</p>
<p>The reason for this delay was that the PBAC was <a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2012-11/ipilimumab">initially uncertain</a> of the drug’s efficacy and cost-effectiveness, based on the evidence it was given. This was in part because the primary evidence was a <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1003466#t=article">study that compared Yervoy with a vaccine</a> not used in Australian practice. </p>
<p>In the study, 50% of patients treated with Yervoy lived 3.7 months longer than those who received just the vaccine. But these results couldn’t be directly translated to Australian practice, where treatment at that time was different. </p>
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<a href="https://images.theconversation.com/files/195153/original/file-20171117-14675-1nps0r8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/195153/original/file-20171117-14675-1nps0r8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/195153/original/file-20171117-14675-1nps0r8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/195153/original/file-20171117-14675-1nps0r8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/195153/original/file-20171117-14675-1nps0r8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/195153/original/file-20171117-14675-1nps0r8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/195153/original/file-20171117-14675-1nps0r8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/195153/original/file-20171117-14675-1nps0r8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Cancer immunotherapy drugs work by arming the immune system to fight the cancer.</span>
<span class="attribution"><span class="source">from shutterstock.com</span></span>
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<p>PBAC accepted evidence for the prolonged response and survival for people on Yervoy, as a result of the two resubmissions. But the magnitude of those gains was uncertain as they reflected the experience of around 10% of the study’s patients. The ongoing costs were also uncertain – there was no answer as to how long patients would need to remain on Yervoy, or whether they would need treatment again.</p>
<p>But, overall, the PBAC <a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2011-07/pbac-psd-ipilimumab-july11">recognised the potential benefits</a> of the drug. It was made available through the government and the manufacturer entering into a <a href="http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2012-11/ipilimumab">risk-sharing arrangement</a>. Under this agreement, the government would review what it paid for Yervoy to take account of the outcomes being achieved in patients, as well as how much the drug was being used. </p>
<p><strong>Keytruda</strong></p>
<p>Keytruda had a faster, but no less complex, passage to PBS listing. PBAC <a href="http://www.pbs.gov.au/pbs/industry/listing/elements/pbac-meetings/psd/2015-03/pembrolizumab-keytruda-psd-03-2015">considered the application</a> in March 2015 to list the drug for metastatic melanoma. This was after a series of stakeholder meetings, including representatives from government, patients, clinicians and the manufacturers, as well as a rolling submission of evidence during the 17-week PBAC evaluation process.</p>
<p>Initially, no evidence was available of a direct comparison between Keytuda and the relevant comparator, which was the previously listed Yervoy. But a randomised <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1503093">controlled trial</a> became available as evidence during the evaluation.</p>
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Read more:
<a href="https://theconversation.com/cancer-immunotherapy-drugs-like-keytruda-and-opdivo-hold-hope-for-some-but-theres-still-a-way-to-go-81320">Cancer immunotherapy drugs like Keytruda and Opdivo hold hope for some, but there's still a way to go</a>
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<p>These data showed Keytruda was likely to be at least as beneficial as Yervoy, with the potential for better long-term survival. This, together with a risk-sharing arrangement similar to the one applied to Yervoy, was sufficient for the PBAC to recommend PBS listing from the first submission.</p>
<p>Keytruda became available as a PBS-listed item for melanoma in September 2015. This provided access to an additional care option for around <a href="http://www.abc.net.au/news/2015-06-28/melanoma-drug-listed-on-pbs-saving-patients-thousands/6578554">1,100</a> patients. </p>
<p>In both cases, the process was sufficiently flexible in response to the available data to make a positive recommendation for listing. It is unclear how changing requirements for evidence for these or other cancer drugs, or introducing different <a href="http://www.smh.com.au/national/health/new-report-proposes-radical-reforms-for-rare-cancer-regulation-20170808-gxrh02.html">reimbursement models</a>, would have better served these drugs or the patients who use them.</p><img src="https://counter.theconversation.com/content/87185/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Richard De Abreu Lourenco receives funding from NHMRC, Cancer Australia, the Victorian Cancer Agency and the Department of Health. None of the views expressed in the piece relfect the views of those agencies.</span></em></p><p class="fine-print"><em><span>Marion Haas receives funding from the NHMRC and Cancer Australia. She is a member of the CanTeen Strategic Advisory Committee. None of the opinions expressed in this article reflect the views of these organisations. </span></em></p><p class="fine-print"><em><span>Rosalie Viney was previously a member of the Pharmaceutical Benefits Advisory Committee. She receives funding from Cancer Australia and the NHMRC. </span></em></p>Some argue the current system of subsidising drugs in Australia needs changing to accommodate new cancer therapies. But two recent drug listings show the current system is working perfectly well.Richard De Abreu Lourenco, Senior Research Fellow, University of Technology SydneyMarion Haas, Professor of Health Economics, Deputy Director of CHERE, University of Technology SydneyRosalie Viney, Professor of Health Economics, University of Technology SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/797682017-06-22T15:04:41Z2017-06-22T15:04:41ZWhy competition is key to cutting the cost of cancer drugs in South Africa<figure><img src="https://images.theconversation.com/files/175155/original/file-20170622-11971-1xbml5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Shutterstock</span> </figcaption></figure><p>South Africa’s Competition Commission has launched an <a href="http://www.gov.za/speeches/media-statement-commissioner-investigation-manufacturers-cancer-drugs-13-jun-2017-0000">investigation</a> into excessive pricing by three major pharmaceutical companies that have the sole rights to distribute cancer drugs in the country. </p>
<p>The commission’s job is to protect ordinary South Africans from abuse by dominant players. It has <a href="http://www.compcom.co.za/">powers</a> to investigate and evaluate restrictive business practices, abuse of dominant positions and mergers. </p>
<p>Its investigation into the drug companies is vital as cancer treatment is <a href="http://www.cansa.org.za/competition-commission-investigating-pharmaceutical-companies-for-cancer-medicine-prices/">unaffordable for most South Africans</a>. Many medical schemes – which offer medical cover to 16% of the population or 7 million people – refuse to pay for the medication because of the cost. </p>
<p>In South Africa all drug prices are approved and signed off by the medicines pricing committee in the National Department of Health. But our hope is that the commission’s investigation could still drive competition among suppliers, and in turn more affordable prices for cancer treatment. This should result in better access to affordable drugs, particularly for poor people.</p>
<h2>The drugs in question</h2>
<p>Three companies are being probed: Swiss-based <a href="http://www.roche.co.za/home/about-roche/companyprofile.html">Roche</a>, US-based Pfizer and South African company Aspen Pharmacare.</p>
<p>The cancer drugs in the spotlight are used mainly to treat lung and breast cancer but they can also be used in the treatment for other types of cancers.</p>
<p>One of the drugs is trastuzumab which is supplied by Roche and <a href="http://www.who.int/bulletin/volumes/94/10/15-163998/en/">recommended</a> by the World Health Organisation to treat breast cancer and can be used in combination with other drugs for some types of stomach cancer. Roche’s branded versions of the medication is Herceptin. This is the only trastuzumab product currently available in South Africa.</p>
<p>Pfizer provides the only crizotinib product to South Africa for the treatment of lung cancer. Its product, Xalkori, is not yet registered in South Africa, and is only accessed through a special application process under the Medicines Act which enables clinicians to prescribe and use medicines not yet registered by the MCC to treat patients.</p>
<p>Aspen is being investigated for three of the oncology drugs it supplies: Chlorambucil (Leukeran), Melphalan (Alkeran) and Busulfan (Myleran). All are generic drugs but Aspen is the only pharmaceutical company in the country that’s registered with the Medicines Control Council to sell the drugs in South Africa.</p>
<p>Competition authorities in a number of European countries, including the European Union, are also <a href="http://europa.eu/rapid/press-release_MEX-17-1326_en.htm">investigating Aspen</a> for alleged excessive pricing on these and other products. </p>
<h2>Why are they so expensive?</h2>
<p>The cost of a drug is related to its development. Before a cancer drug reaches the market there is a complex clinical research process and an expensive administrative process that requires millions of dollars of investment. This includes regulatory studies and three phases of clinical trials. </p>
<p>In the pharmaceutical industry, the initial patent holder is usually the pharmaceutical company that researched and developed a drug . </p>
<p>Although the patent life from the date that it is filed is 20 years, the average time to bring a cancer drug from the start of clinical testing to regulatory approval is between eight and 12 years. </p>
<p>This means that the actual patent life of a drug from the time of initial marketing can be limited – often less than 10 years. In addition, only 16% to 19% of cancer drugs that enter clinical trials successfully make it to market.</p>
<p>There’s an added challenge in cancer treatments. Even with the arrival of “new and improved” versions of a previously approved drug, the older (and by now generic) drug tends to be viewed as substandard treatment. This perpetuates the situation. And in the last 59 years the health sector has increased its knowledge of cancer and treatment immensely. But it’s not yet at a curative phase. Faced with the seriousness of the diagnosis, patients, family and physicians are often willing to pay the high price of treatment even for marginal improvements in someone’s health.</p>
<p>Drug companies also have to go through a lengthy process before they can start selling a drug. Once a drug is approved by a regulatory authority it needs to be registered with a country’s medical control council before it can be prescribed by oncologists. This registration process can take a long time. </p>
<h2>What needs to be done</h2>
<p>The biggest problem with the price of cancer drugs is that there is no competition among truly effective cancer drugs to lower their cost. Healthy competition between different drugs would drive lower prices and keep prices reasonable for the consumer.</p>
<p>One way that competition has been achieved for other pharmaceutical drugs has been through the generic route. Once the patent expires, manufacturers of generic versions can produce more cost-effective versions. This is happening for some cancer drugs. But there are two limitations: one is that it takes a long time to develop cancer treatments. And generic versions of cancer drugs are much higher than those used to treat non-malignant (non-cancerous) diseases. </p>
<p>So what can be done? There are three options:</p>
<ul>
<li><p>encourage oncologists to prescribe drug treatment that isn’t as expensive,where possible. </p></li>
<li><p>reduce prices by introducing a form of generic price control, where predetermined pricing limits are prescribed, and </p></li>
<li><p>promoting a non-profit generics model, where certain designated generics would be made available at cost, as opposed to be sold at a profit.</p></li>
</ul>
<p>The competition case in South Africa is also an important part of the campaign to make sure that cancer drugs are more affordable. As incidence of cancer <a href="http://www.cansa.org.za/category/recent-posts/cope-with-cancer/about-cancer/statistics/">continue to rise</a>, massive resources are being poured into cutting-edge research and biotechnology to successfully treat this dread disease. But these benefits aren’t being felt by the vast majority of people in the world.</p><img src="https://counter.theconversation.com/content/79768/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Natalie Schellack does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The high cost of cancer drugs in South Africa has come under the spotlight with an investigation by the Competition Commission in the country.Natalie Schellack, Associate Professor and Course Leader: Post Graduate Programmes in Clinical Pharmacy in the Department of Pharmacy, Sefako Makgatho Health Sciences UniversityLicensed as Creative Commons – attribution, no derivatives.