Academia and Generics: Can They Reduce Cancer Drug Costs?

Roxanne Nelson, BSN, RN

February 27, 2017

The ever-rising cost of prescription drugs, and in particular cancer drugs, has become a focal point of concern for patients, healthcare providers, payers, and policymakers alike, and several strategies have been offered to address the issue.

But the authors of a new paper, led by Paul Workman, FMedSci, FRS, chief executive and president of the Institute of Cancer Research, say that a "fundamentally different approach" has to be taken.

This new approach, they write, would be the "formation of new relationships between academic drug discovery centers and commercial partners, which can accelerate the development of truly transformative drugs at sustainable prices."

Their proposals are outlined in a paper published online in Cell.

However, the proposals were dismissed as "short-sighted" by a spokesperson for the pharmaceutical industry.

Overall Inefficiency of Commercial Enterprise

While recently developed targeted drugs and immunotherapies can greatly benefit patients with cancer, the costs of these drugs "threaten the financial sustainability of cancer treatment," Dr Workman and colleagues write. Nearly all of the newly approved cancer drugs emerging from the research pipeline have price tags above $100,000, and the trend shows no signs of slowing.

Urgently needed are methods of encouraging innovation that will in turn improve access to new therapies, and at prices that patients can afford, they argue.

Many factors contribute to the high cost of drugs, but one significant component is the overall inefficiency of "commercial enterprise." As an example, they point out that at the current time, 803 clinical trials are evaluating checkpoint immune therapeutic agents, with at least 12 antibodies from as many different companies. Taken together, these trials intend on enrolling more than 166,000 patients.

The redundancy in these trials is enormous, as many of the pharmaceutical companies are conducting very similar trials with comparable compounds, but the data are not shared. Over the long term, it is the patients who end up paying the price for this inefficiency and duplication.

Another important factor, the authors note, is the frequent absence of a rigorous biomarker program that will identify the population who may derive the most benefit from a specific compound. However, the "primary incentive of the pharma industry is to increase sales, which are restricted by identifying drug-responsive subpopulations."

To overcome these challenges and others, a whole new strategy is needed if drug costs are to become more manageable.

Honing in on Academia

The authors propose that efforts should be directed to further develop discoveries that are made in the academic community. Many of the fundamental discoveries that have set the foundation for new categories of oncologic agents originated in academia, they point out. Examples include the brain tumor DNA alkylating drug temozolomide and the prostate cancer CYP17 inhibitor agent abiraterone, as well as the biomarker strategy for the poly-(adenosine diphosphate-ribose) polymerase inhibitor olaparib in BRCA-mutant ovarian cancer.

A major advantage of discovering new compounds in the academic world, Dr Workman and his colleagues write, is the freedom and "indeed incentivization to tackle major challenges that would be viewed as too risky by big pharma and even by many biotech companies."

In principle, academia has all the tools and skill sets that are needed to discover new drug targets, to convert them into candidates for clinical use, and to conduct clinical trials to evaluate them. Nevertheless, academics tend to be "driven into the arms of big pharma after initial proof of concept clinical trials" for three main reasons.

The first, the authors write, is that the stringent quality control needed for large-scale manufacturing of clinical grade drugs, along with their formulation, is not a routine skill for academic teams.

Second is that taking a drug through the steps needed to bring it to fruition is costly. Funding is essential to pay for the high cost of performing nonclinical regulatory toxicology studies and clinical trials, and sufficient amounts are difficult for nonprofit organizations to raise.

Finally, even if the first two challenges can be overcome, academic drug discovery and development units are generally not well equipped to handle subsequent marketing and sales of approved drugs.

"Yet, it is at the level of commercialization that the interests of large pharma to maximize return on investment are diagonally disparate from the typically idealistic motivation that drives most academics to spend countless hours at modest compensation to solve important problems in oncology," they write.

Therein lies the problem: how to break free of this Catch-22 situation in academic drug development?

Teaming Up With Generics

One potential solution may lie with generic drug manufacturers.

Generic drugs that enter the marketplace after the expiration of a patent are most often less expensive and often sell at a greatly reduced price. Companies can charge lower prices because they are not financing research and development. And because they are used to having lower profit margins for their products, they could potentially partner with academic-based drug discovery and research.

However, the authors emphasize that "two elements will be mission critical for this model to succeed."

The first is the necessity for academic organizations to abide by their societal responsibility and resist the temptation to sell their product to the highest bidder. Second, agreements on price caps must be part of the negotiations with any potential investor or a company interested in taking the drug forward.

This approach should ideally be accompanied by pricing strategies that would make these new drugs affordable to middle- and low-income countries, which can help decrease the current inequality in global cancer therapy.

The authors acknowledge that their proposed strategy of building up a collection of academic centers that will be able to eventually develop significant numbers of drug candidates is not an overnight solution to the problem of cost. It will take time and money but it is "a move in the right direction," they argue.

"Moreover, the creation of such groups alongside generics partners or newly created commercial entities will create competition and drive down prices in conventional pharma and biotech," they note.

Chilling Collaborations

However, the Pharmaceutical Research and Manufacturers of America (PhRMA), the trade organization of the industry, sees problems with this concept.

"Short-sighted policies like these would chill critically important public-private sector collaborations," said Holly Campbell, a spokesperson for PhRMA. "Instead, we need to ensure we have a health care system that recognizes the value of these medicines and the offsets that occur elsewhere in the health care system."

The cancer death rate in the United States has fallen 25% since its peak, and two in three patients diagnosed with cancer are living at least 5 years after diagnosis, Campbell noted in an interview with Medscape Medical News.

"The increase in life expectancy is a testament to new treatment options and improvements on existing therapies," she said. "Innovations such as improved biomarker data, combination therapies and new immunotherapies are leading to more effective treatments for cancer."

She emphasized that while government and academia both support basic research, the US biopharmaceutical companies "assume the full risk of development and costs for commercializing a drug candidate that eventually may prove to be scientifically and economically viable products."

Campbell also pointed out that the proposal in the article ignores the Bayh-Dole Act. "Under Bayh-Dole, universities and other institutions own title to the patents arising directly from their federal government-funded research activities," she explained. "With these clear patent rights, universities are then free to license to use under terms they find acceptable."

No funding source was reported. The authors are involved in multiple drug discovery and development projects with actual or potential commercial revenues and act as advisers to several companies.

Cell. 2017;168:579-583. Full text

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