Even 'Essential' Cancer Drugs Too Expensive for Many Patients

Roxanne Nelson, RN, BSN

September 05, 2019

UPDATED with comments September 6, 2019 // Even cancer drugs considered "essential" by the World Health Organization (WHO) are out of reach for many patients around the world because of their high price tag.

"When WHO labels medicines as essential, it means that they have proven their utility and should be available and affordable to all," note the authors of a recent commentary published in the Lancet Oncology

Ellen 't Hoen, LLM, PhD, of the Law and Policy and University Medical Center Groningen, Global Health Unit, the Netherlands, and colleagues comment that inclusion on the WHO's essential medicines list is "the crucial first step."

After that, effective national policies are needed to incorporate legal and regulatory frameworks that promote access to these essential drugs, but that action is slow in coming.

As a case in point, they highlight what happened in South Africa with lenalidomide (Revlimid, Celgene), which is a mainstay in the treatment of multiple myeloma.

Until 2016, lenalidomide was available as a generic in South Africa at a cost of US$2289 per patient per year. The drug was manufactured in India under a Section 21 legal authorization that allows the sale and use of unregistered products.

However, after Celgene registered its patented product in South Africa, that authorization was withdrawn.

Lenalidomide now costs $51,000 per patient per year, and it is no longer available in the public sector, which provides healthcare for 84% of the population. Even in the private sector, patients are struggling to pay the 20% copayment.

"Before registration of the originator product, patients in public and private sector were able to get the generic access through Section 21 authorization, as there were no products — originator or generics — registered," said study coauthor Salomé Meyer, MS, project manager, Access to Medicine Campaign, Cancer Alliance South Africa, Cape Town. "When the originator company registered their product, the Section 21 authorization was revoked, and you can only access the registered product."

She told Medscape Medical News that for any company that wants to register their product, the originator company needs to provide samples for bioequivalence studies. To date, the originator company has refused to provide any samples to any generic company that wants to register.

"A complaint of anticompetitive behavior has been lodged at the South Africa Competition Commission," she said.

In contrast, the generic version of lenalinomide remains available in India, where the application for a patent was rejected. There the cost is $2000 per patient per year.

Why Such High Costs?

The high cost of cancer drugs has been debated extensively, but without much resolution.

Hoen and colleagues point out that studies of the cost of producing cancer drugs suggest that a substantial reduction in price is possible. For example, a validated algorithm (BMJ Glob Health. 2018;3:e000571) for estimating the cost of production and that accounts for tax and a 10% profit margin showed that lenalidomide could be priced at $2.55 per month.

That same algorithm suggested that afatinib (Gilotrif, Boehringer Ingelheim) could be priced at $8.85 per month. This first-line tyrosine kinase inhibitor is used to treat lung cancer. In the real world, it costs much more. The authors point out that in Pakistan, afatinib costs over $1000 per month of treatment, and many patients cannot afford it.

The push to lower drug prices is often countered by the argument that doing so would decrease investment in the research and development of new drugs. However, critics of the pharmaceutical industry have pointed out that only a small portion of the drug companies' expenditures is used for research and development and that most of the money is spent in marketing and administration. The editorialists agree and say that the global sales figures for these drugs "further provide evidence that this concern is unwarranted."

A third of cancer drugs had already reached blockbuster status, with each drug bringing in annual sales in excess of $1 billion, they note.

They cite two drugs in particular, both of which were added to the WHO's essential drugs list in 2015. The cumulative sales income (as of 2017) for trastuzumab (Herceptin, Genentech/Roche) was $88.18 billion; for rituximab (Rituxan, Genentech/Roche), it was $93.74 billion.

In addition, a WHO study found that sales revenue from 99 cancer medicines that were approved by the US Food and Drug Administration from 1989 to 2017 show that the average financial return on investment was $14.50 for every $1 of spending.

The bulk of these sales are in high-income countries, the authors point out. They argue, "Therefore, making these new medicines affordable in LMICs [lower middle income countries] is not likely to impair future research and development."

Improving Access to Cancer Drugs

In their commentary, Hoen and colleagues urge countries to take measures to improve access to cancer drugs by such measures as "pooling their procurement at the regional or subregional level to create economies of scale and increase their negotiating power encouraging sustainable supply of low-cost generics and the uptake of biosimilars, and using flexibility in trade-related aspects of intellectual property rights (TRIPS) agreements to lift a patent monopoly when needed to access generics."

In addition, pharmaceutical manufacturers need to engage in public health–oriented voluntary licensing of products through the Medicines Patent Pool.

"There is ample evidence that the above mentioned options work in other fields, notably in the area of HIV and hepatitis C virus," they write.

Many of the high-income countries have healthcare systems that negotiate prices, and the drugs are then covered under health plans. "For LMICs, one option could be through the Medicine's Patent Pool [MPP], which has negotiated voluntary licenses in the past for HIV and hepatitis C drugs, thus allowing for generic competition in LMICs before patents expired," Meyer said. "In their new strategy, MPP will venture into other patented essential medicines to address specific health issues in LMICs beyond HIV and hepatitis C."

The authors have disclosed no relevant financial relationships.

Lancet Oncol. Published online July 11, 2019. Abstract

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