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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Gupta, Ravi, Nilay D. Shah, and Joseph S. Ross. “Generic Drugs in the United States: Policies to Address Pricing and Competition.” Clinical Pharmacology & Therapeutics 105, no. 2 (January 10, 2019): 329–37. https://doi.org/10.1002/cpt.1314 . “Generic Drugs in the United States:Policies to Address Pricing and Competition” by Ravi Gupta, Nilay Shah, and Joseph Ross examine the cost of prescription drugs in the United States. The paper examines the strategies used by brand-name manufacturers to elongate their patents and make it so generic drug manufacturers are unable to create affordable drugs of the same equivalence. They discuss the role of the FDA in the approval process and patents and then suggest a couple policy solutions to address high prescription drug costs and the existing patent system. One strategy the authors suggest is to develop a nonprofit generic drug manufacturer that has the clear goal of providing a stable supply of affordable drugs. Second strategy suggested is to increase the competition for off-patent drugs by importing additional generic versions that have been approved by countries that have comparable approval standards and requirements to that of the FDA. A way this could be streamlined is through reciprocal approval, where the FDA would issue its approval based on the evidence of the drugs prior approval in another country. Overall the authors argue that there needs to be a greater understanding of the strategies that name-brand companies are using to undermine generic manufacturers. Kesselheim, Aaron S., Jerry Avorn, and Ameet Sarpatwari. “The High Cost of Prescription Drugs in the United States.” JAMA 316, no. 8 (August 23, 2016): 858. https://doi.org/10.1001/jama.2016.11237 . The rising costs of prescription drugs in the U.S. is of growing concern for patients and policymakers, the authors of this paper sought out to review the origins of high prescription costs in the U.S. and look at possible policy options to combat the rising

prescription drug costs. To do this the authors looked at medical and health policy literature from January of 2005 to July 2016, specifically looking at articles addressing drug prices in the U.S, why it is occurring, its consequences, and possible alternative policy options. The possible solutions examined in this paper include improving competition in the marketplace, enhancing government involvement in negotiating prices, and providing further guidance for physicians and consumers in making decisions regarding medication usage. Proposed strategies to address high drug prices include enhanced oversight of tactics to extend market exclusivity, stronger enforcement of existing laws, and increased scrutiny of antitrust measures. Cost-cutting strategies involve limiting direct-to-consumer drug advertising and emphasizing the generic drug market. Government efforts to reduce high prescription prices include promoting better information on the clinical and economic value of drugs and allowing Medicare to negotiate drug prices covered in Medicare Part D. Physicians level solutions include increasing education on drug costs and integrating value-based prescribing into physicians training and payment methods. Summary Collectively these articles tackle the issue of high pharmaceutical costs in the U.S., examining what had led to the high costs, the rationale behind the costs, its consequences, and possibly policy alternatives to tackle the high drug prices seen in the U.S. The review focusing on specialty drugs, “ Policy Options for Addressing the High Cost of Specialty Pharmaceuticals” suggest six long-term policy options that emphasize transparency and value-based pricing. The analysis of branded prescription drug prices “ Reducing Branded Prescription Drug Prices: A Review of Policy Options” explores solutions within five categories recognizing implementation challenges. The examination of the patent-based development process “The Patents-Based

Pharmaceutical Development Process” advocates for reforms like tiered pricing. The discussion on generic drugs “Generic Drugs in the United States: Policies to Address Pricing and Competition” suggests strategies to counter brand-name manufacturers and enhance competition. Finally, the assessment of high prescription drug costs “The High Cost of Prescription Drugs in the United States” proposes solutions like improved competition and increased oversight.

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Annotated Bibliography 8

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