DA - Drug Prices - JDI 2024

Negative
Note
Super straight forward DA – extending drug patents and blocking generics from entering the market cause drug prices to spike, which kills tons of people due to lack of access. The DA is intentionally designed to have a small terminal impact to encourage the negative to find ways to nullify aff offense (such as through turns case arguments) rather than relying on an extremely high magnitude impact.
If there are any issues with evidence in this file, please tell your lab leaders which piece(s) of evidence have issues, what those issues are, and ask them to tell me (jam) about those issues
1nc
Drug price increases are managed and steady now
Commins and Tichy, 12/21
John Commins, Senior Editor at HealthLeaders Media, interviewing Eric Tichy, Pharm.D., MBA, vice chair of pharmacy formulary at the Mayo Clinic, 12/21/23, “Modest Drug Costs Hikes Predicted for 2024. Drug Expenditures Are a Different Story.” Dummy Head | HealthLeaders Media, www.healthleadersmedia.com/pharma/modest-drug-costs-hikes-predicted-2024-drug-expenditures-are-different-story. Accessed 28 June 2024. ES - HW
The pharmaceutical sector is a hive of activity these days, buzzing with breakthrough treatments for stubborn diseases such as Alzheimer's and obesity, and with sickle cell anemia, an outfight cure.
These drugs can be very expensive. The gene therapy needed to cure sickle cell anemia, for example, costs almost $3 million per patient. By comparison, the Alzheimer's drug Leqembi, at almost $25,500 per patient, per year, seems like a bargain. The wildly popular weight-loss drug Ozempic, with a cost of merely $900 to $1,300 per month, sounds like a giveaway.
Despite the headlines that conflate expensive new drug treatments with rising drug costs, Eric Tichy, Pharm.D., MBA, vice chair of pharmacy formulary at the Mayo ClinicMayo Clinic, says it's important to make the distinctions between drug costs and drug expenditures.
He offers his thoughts on the topic, and other issues that are expected to confront providers in 2024 in this interview, which has been edited for brevity and clarity.
HL: Do you anticipate big drug price hikes in 2024?
Tichy: There are several things that are going to prevent inflation of drug prices. One of those is the Inflation Reduction Act, which has caps on how much a drug price can be raised year-over-year based on the Consumer Price Index for that given year.
Where we've seen a lot of spend increase over the last couple of years is where there's new drugs developed to treat things that didn't exist before. Think about Alzheimer's disease, where there haven't been effective medications in the marketplace in the last two or three decades. There are some new medications that have been approved to treat Alzheimer's and they're modestly expensive. However, the population of how many people can be treated is very high. That's something that could increase expenditures.
Also, we haven't had effective weight-loss medications until very recently. When you have a therapy that meets an unmet need, there can be huge demand. That's why there's so much uptake of those medications. Those are our biggest drug spends now. Weight-loss drugs will be the No. 1 spend in 2023 once we have all the data.
There's potentially huge downstream savings. We're learning, for example, that some of these medications prevent heart attacks and things like that. But we need time. With some of these savings, we won't see it for 10, 15, 20 years. As we have more of that information over time, it will support the prices of these medications and make the case for why payers should cover them.
HL: What is driving high drug costs?
Tichy: Some of these new drugs treat very rare conditions affecting small populations, and they’re priced to maintain profitability for the manufacturers, despite a low treatment population. If you didn't have these prices, there would not be incentives for manufacturers to develop these products.
The Orphan Drug Act was developed to incentivize production of these rare medications that treat rare conditions, and new developments in medicine have allowed us to get more precise with how we treat these conditions. It's this confluence that's leading to a larger number of high-cost products hitting the marketplace.
There's also an important nuance between drug prices and drug expenditures. I expect the price growth will be close to inflation, maybe even less than inflation. It has been less than inflation for the last couple of years.
People conflate expenditures with prices, and we expect drug expenditures will keep going up. A lot of that's because there are new drugs for things that as of yet don't have treatments, or there are drugs being developed where the current treatment is cheap but ineffective.
Longer exclusivity periods lead to increased drug prices and decreased pharma innovation
Nega ‘23
(Michael Nega, attended Chicago Kent College of Law – majored in Economics – minored in Philosophy at the University of Chicago, The Chicago-Kent Journal of Intellectual Property welcomes academic and professional author submissions on topics in all areas of intellectual property law including patents, copyrights, trade secrets, and trademarks, 02/19/2023, How Do Patents Impact Drug Prices?, Chicago Kent Journal of Intellectual Property, https://studentorgs.kentlaw.iit.edu/ckjip/how-do-patents-impact-drug-prices/, Accessed 6/29/2024) Blaine -- WH
Patent law gives inventors the right to exclude others from using and benefitting from their invention for a specified period. “During patent exclusivity, prices of products are typically set higher that permit patent holders to realize greater profits that would be achievable in a competitive marketplace.”[24] Pharmaceutical patents are typically “composition of matter” patents that cover specific molecules or combinations of molecules. [25] Many of the patents that pharmaceutical companies obtain cover either the tangible item (i.e., the composition of matter itself) or specific production processes to make the said composition. [26] “During the span of the patent, no other entity is allowed to sell a generic version of the drug, which keeps competition and lower prices at bay.” [27] When the patent system was first developed, its goal was to encourage innovation by giving certain protections to inventions. However, today’s pharmaceutical companies no longer operate primarily to innovate new medication but to monopolize existing ones. [28] It is estimated that about 80% of new patent applications are not for new medicines. [29] About 70% of the most popular drugs on the market have had an additional patent filed for them or have had their existing patent terms extended to further monopolize the market for that drug. [30] “An analysis of the ten best-selling drugs of 2019 found that, on average, these drugs held more than 69 patents with 37.5 years of patent protection, well past the 20 years of patent life intended by Congress. Furthermore, the prices for these drugs increased 71% over the previous five years.” [31]
Price hikes kill millions
CIDSA 20
(Council for Informed Drug Spending Analysis, “High Drug Prices and Patient Costs: Millions of Lives and Billions of Dollars Lost,” CIDSA, https://www.cidsa.org/publications/xcenda-summary#:~:text=When%20patients%20are%20unable%20to,health%20outcomes%20and%20premature%20death., Shah – WH)
Existing Problem
Medication adherence refers to how well patients follow the instructions given by their healthcare providers for taking a medication regimen. While nonadherence can be a result of many factors, unaffordable drug prices can significantly impair medication adherence (we call this “cost-related nonadherence”). When patients are unable to adhere to their medications because of high prices, medical spending significantly increases to treat patients’ conditions; over time, these complications can lead to worse health outcomes and premature death.
The benefit design structure of the Medicare Part D program leaves many beneficiaries particularly vulnerable to complications from cost-related nonadherence. Under the standard benefit design, Medicare beneficiaries are responsible for 25% of a drug’s cost until they hit the out-of-pocket maximum. This means that even with Medicare insurance, what seniors pay is linked to a drug’s price. This linkage allows us to model how cost-related nonadherence would change under policies that would reduce drug prices, such as Medicare negotiation, and to simultaneously model changes in mortality and avoidable medical spending that would follow from lower drug prices.
Existing publications on the impact of medication adherence are dated, using models from the 1990s that do not reflect the efficacy, safety, and pricing of current treatments. The West Health Policy Center commissioned Xcenda, the research arm of drug distributor AmerisourceBergen, to model the current relationship between cost-related nonadherence and mortality and cost outcomes in the Medicare program. This analysis considers the impact of cost-related nonadherence on the general Medicare population, and on five individual conditions – Atrial Fibrillation, Chronic Kidney Disease, Chronic Obstructive Pulmonary Disorder, Type 2 Diabetes, and Ischemic Heart Disease –that significantly affect seniors and for which effective pharmaceutical treatments are available. Xcenda modeled the impact of cost-related nonadherence on a ten-year period, from 2021-2031.
Analysis of Results
Over the ten-year period, high out-of-pocket costs for drugs are estimated to cause 1.1 million premature deaths of seniors in the Medicare program and lead to an additional $177.4 billion in avoidable Medicare medical costs. The plurality of premature deaths is due to cardiac conditions (atrial fibrillation and ischemic heart disease), causing 354,800 seniors to die prematurely over the ten-year period. High drug prices are estimated to contribute to 70,400 premature deaths from chronic kidney disease, 69,300 premature deaths from chronic obstructive pulmonary disease, and 62,700 premature deaths from diabetes among seniors by 2031.
Reducing drug prices through Medicare negotiation could significantly reduce the number of premature deaths. After calibrating to the Congressional Budget Office’s score of H.R.3, the Elijah E. Cummings Lower Drug Costs Now Act, the model estimates that granting Medicare the authority to negotiate and limiting drug price increases could prevent 93,900 deaths per year. These policy changes are projected to reduce Medicare spending by $475.9 billion by 2030.
Uniqueness
1nc – price hikes managed now
Drug price increases are managed and steady now
Commins and Tichy, 12/21
John Commins, Senior Editor at HealthLeaders Media, interviewing Eric Tichy, Pharm.D., MBA, vice chair of pharmacy formulary at the Mayo Clinic, 12/21/23, “Modest Drug Costs Hikes Predicted for 2024. Drug Expenditures Are a Different Story.” Dummy Head | HealthLeaders Media, www.healthleadersmedia.com/pharma/modest-drug-costs-hikes-predicted-2024-drug-expenditures-are-different-story. Accessed 28 June 2024. ES - HW
The pharmaceutical sector is a hive of activity these days, buzzing with breakthrough treatments for stubborn diseases such as Alzheimer's and obesity, and with sickle cell anemia, an outfight cure.
These drugs can be very expensive. The gene therapy needed to cure sickle cell anemia, for example, costs almost $3 million per patient. By comparison, the Alzheimer's drug Leqembi, at almost $25,500 per patient, per year, seems like a bargain. The wildly popular weight-loss drug Ozempic, with a cost of merely $900 to $1,300 per month, sounds like a giveaway.
Despite the headlines that conflate expensive new drug treatments with rising drug costs, Eric Tichy, Pharm.D., MBA, vice chair of pharmacy formulary at the Mayo ClinicMayo Clinic, says it's important to make the distinctions between drug costs and drug expenditures.
He offers his thoughts on the topic, and other issues that are expected to confront providers in 2024 in this interview, which has been edited for brevity and clarity.
HL: Do you anticipate big drug price hikes in 2024?
Tichy: There are several things that are going to prevent inflation of drug prices. One of those is the Inflation Reduction Act, which has caps on how much a drug price can be raised year-over-year based on the Consumer Price Index for that given year.
Where we've seen a lot of spend increase over the last couple of years is where there's new drugs developed to treat things that didn't exist before. Think about Alzheimer's disease, where there haven't been effective medications in the marketplace in the last two or three decades. There are some new medications that have been approved to treat Alzheimer's and they're modestly expensive. However, the population of how many people can be treated is very high. That's something that could increase expenditures.
Also, we haven't had effective weight-loss medications until very recently. When you have a therapy that meets an unmet need, there can be huge demand. That's why there's so much uptake of those medications. Those are our biggest drug spends now. Weight-loss drugs will be the No. 1 spend in 2023 once we have all the data.
There's potentially huge downstream savings. We're learning, for example, that some of these medications prevent heart attacks and things like that. But we need time. With some of these savings, we won't see it for 10, 15, 20 years. As we have more of that information over time, it will support the prices of these medications and make the case for why payers should cover them.
HL: What is driving high drug costs?
Tichy: Some of these new drugs treat very rare conditions affecting small populations, and they’re priced to maintain profitability for the manufacturers, despite a low treatment population. If you didn't have these prices, there would not be incentives for manufacturers to develop these products.
The Orphan Drug Act was developed to incentivize production of these rare medications that treat rare conditions, and new developments in medicine have allowed us to get more precise with how we treat these conditions. It's this confluence that's leading to a larger number of high-cost products hitting the marketplace.
There's also an important nuance between drug prices and drug expenditures. I expect the price growth will be close to inflation, maybe even less than inflation. It has been less than inflation for the last couple of years.
People conflate expenditures with prices, and we expect drug expenditures will keep going up. A lot of that's because there are new drugs for things that as of yet don't have treatments, or there are drugs being developed where the current treatment is cheap but ineffective.
Link
1nc – extending patents
Longer exclusivity periods lead to increased drug prices and decrease pharma innovation
Nega ‘23
(Michael Nega, attended Chicago Kent College of Law – majored in Economics – minored in Philosophy at the University of Chicago, The Chicago-Kent Journal of Intellectual Property welcomes academic and professional author submissions on topics in all areas of intellectual property law including patents, copyrights, trade secrets, and trademarks, 02/19/2023, How Do Patents Impact Drug Prices?, Chicago Kent Journal of Intellectual Property, https://studentorgs.kentlaw.iit.edu/ckjip/how-do-patents-impact-drug-prices/, Accessed 6/29/2024) Blaine -- WH
Patent law gives inventors the right to exclude others from using and benefitting from their invention for a specified period. “During patent exclusivity, prices of products are typically set higher that permit patent holders to realize greater profits that would be achievable in a competitive marketplace.”[24] Pharmaceutical patents are typically “composition of matter” patents that cover specific molecules or combinations of molecules. [25] Many of the patents that pharmaceutical companies obtain cover either the tangible item (i.e., the composition of matter itself) or specific production processes to make the said composition. [26] “During the span of the patent, no other entity is allowed to sell a generic version of the drug, which keeps competition and lower prices at bay.” [27] When the patent system was first developed, its goal was to encourage innovation by giving certain protections to inventions. However, today’s pharmaceutical companies no longer operate primarily to innovate new medication but to monopolize existing ones. [28] It is estimated that about 80% of new patent applications are not for new medicines. [29] About 70% of the most popular drugs on the market have had an additional patent filed for them or have had their existing patent terms extended to further monopolize the market for that drug. [30] “An analysis of the ten best-selling drugs of 2019 found that, on average, these drugs held more than 69 patents with 37.5 years of patent protection, well past the 20 years of patent life intended by Congress. Furthermore, the prices for these drugs increased 71% over the previous five years.” [31]
2nc – extending patents
Extending patent exclusivity directly drive up prices
Brough 2024
Wayne Brough, 5-23-2024, "Bad Patents Keep Drug Prices High," R Street Institute, https://www.rstreet.org/commentary/bad-patents-keep-drug-prices-high/ – Adi WH
Skyrocketing prescription drug prices remain a pressing political issue. Polls show that a large majority of voters in both parties support efforts to reduce drug prices, and President Joe Biden’s reelection campaign highlights his administration’s efforts to do so under the Inflation Reduction Act.
A major factor driving higher drug costs is the patent system, which grants pharmaceutical manufacturers a 20-year exclusive right to “make, use, sell, and import” their products. Although the government originally established the patent system to “promote the Progress of Science and useful Arts,” many patents are now deployed to protect and extend monopoly power. In the case of pharmaceuticals, complex patent strategies are regularly implemented to keep competitors and low-cost generics out of the market for as long as possible to maximize the profits of blockbuster drugs. Given this ongoing misuse of the patent system, any proposed changes to patent policy must be evaluated carefully to ensure that they deter, rather than reinforce, such practices.
With this need in mind, this analysis assesses recently proposed patent legislation. It explains the strategies pharmaceutical companies use to prolong their drug patents, outlines measures lawmakers and the judiciary have taken to limit such practices, and considers how proposed legislation could undermine these efforts.
“Gaming” the System
Pharmaceutical companies have become adept at “gaming” the patent system to extend exclusivity and monopoly power to maximize profits. Tactics like “evergreening” (making minor modifications to existing drugs to obtain additional patent protections), “patent thickets” (filing many different patents on different aspects of a single drug), and “product hopping” (introducing a new version of a drug as a patent is expiring and encouraging doctors, pharmacists, and patients to switch to the updated version) are commonly used to extend monopolies even after the key patent expires.
Celgene’s blockbuster cancer drug Revlimid is a prime example of this practice. Although a key patent expired in 2019, the drug will not see real competition in the marketplace until 2026. This is because Celgene, now a subsidiary of Bristol Myers Squibb, has been able to prolong the drug’s exclusivity by creating a patent thicket around it. The company filed for an additional 206 patents on the drug—117 of which were approved. The costs of such patent thickets can be substantial to consumers and the health care system: The price of Revlimid increased from $6,000 per month in 2002 to $24,000 per mo

Preview shortened. Download the file for the full document.