Annotated Bibliography 8

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Annotated Bibliography 8 Brielle West Abbott, Kristi, Hui Shao, and Lizheng Shi. “Policy Options for Addressing the High Cost of Specialty Pharmaceuticals.” Global Health Journal 3, no. 4 (December 1, 2019): 79–83. https://doi.org/10.1016/j.glohj.2019.11.005 This review looks at the current state of the specialty drug market in the U.S. and recommends six policy options to decrease the out-of-pocket costs to consumers. The authors recognize that while specialty drugs only account for roughly 2% of prescriptions written in the U.S., in 2018, specialty drugs accounted for roughly 45% of drug spending. While the review does recommend policy options to tackle high out-of-pocket costs, the report also provides a literature review focusing on the factors that contribute to the high cost of specialty drugs, and the specialty drug supply chain along with policy options that were published within the U.S. from 2014 to May 2019. The six policy alternatives the authors propose to tackle high out-of-pocket costs on specialty drugs include, enhancing transparency in dealings among key players in the specialty drug supply chain, revising orphan drug eligibility criteria or implementing a sales tax on drugs if the tax surpasses a designated threshold, endorsing copay cards and patient assistance programs, align incentives throughout specialty drug supply chains through value-based pricing, imposing taxes on direct-to-consumer advertising of specialty drugs, and discouraging agreements related to “pay-for-delay” or patent evergreening. All the solutions proposed are long- term solutions as it could take years to be implemented sur to the legislative changes that would be necessary.

Alexander, G. Caleb, Jeromie Ballreich, Mariana P. Socal, Taruja Karmarkar, Antonio J. Trujillo, Jeremy A. Greene, Joshua M. Sharfstein, and Gerard F. Anderson. “Reducing Branded Prescription Drug Prices: A Review of Policy Options.” Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy 37, no. 11 (October 17, 2017): 1469–78. https://doi.org/10.1002/phar.2013 . The authors of “Reducing Branded Prescription Drug Prices: A Review of Policy Options” conducted a literature review that looked at 52 policy solutions to address high pharmaceutical drug prices in the U.S. Of the 52 solutions looked at, they were further broken up into five broad categories: encouraging research to increase development of new drugs, altering pharmaceutical regulation, decreasing market demand, developing alternative pricing policies, and revising the patent system. The beginning of the literature review answers questions regarding the cost of developing drugs, what value pharmaceuticals provide, the relationship between revenue and research and development, and if it is possible for the private market to create a reasonable price for pharmaceutical drugs. Some of the solutions include, “empowering government to purchase patents at auction and place them in public domain, or compel sale of patents based on quality and extent of use of drug” and “eliminate patent thickets by removing the exclusive right to use inventions in upstream research in favor of a system that gives the freedom to use inventions as long as the patent owners receive remuneration.” To decrease market demand some proposed solutions were to “eliminate or reduce-direct-to- consumer advertising and promote academic detailing” and “ adopt value-based insurance design that alters coverage based on price, effectiveness, safety, and other parameters.” All the options the authors discussed were wide ranging, and while the authors recognize that many of the solutions could lower drug spending, they

acknowledge that there are limitations which have prevented many of the policies from being adopted. Barton, John H., and Ezekiel J. Emanuel. “The Patents-Based Pharmaceutical Development Process.” JAMA 294, no. 16 (October 26, 2005): 2075. https://doi.org/10.1001/jama.294.16.2075 . “The Patents-Based Pharmaceutical Development Process” by John H. Barton and Ezekiel J. Emanuel discusses the rationales, problems of the current development process in the U.S. being patent based, they then put forth potential reforms to move away from patent-based pharmaceutical development. The paper begins by looking at the current criticisms and concerns of the patent system in the U.S. and its entanglement with pharmaceutical innovation, highlighting six problems with the current development system. The writers discuss seven proposals ultimately recommending four for future implementation. The seven proposals the authors discuss is price controls, tiered pricing, buy-out pricing system, public sector as research funder, disease burden incentive system, orphan drug approaches, and requiring products to demonstrate improvement. The first recommendation advocates for excluding the requirement for new products to outperform existing treatments during the FDA approval process, arguing that this would lower drug prices and diversify adverse-effect profiles. The second proposal enforces tiered pricing, mandating that minimal production costs for the poorest nations while implementing safeguards against smuggling. The third recommendation supports targeted public-sector funding coupled with buy-outs for products with restricted markets. The final proposal restricts experimentation to specific areas, such as water-borne diarrheal diseases or the development of new tuberculosis drugs.

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