How Much Do Drugs Actually Cost?

Factors Influencing Drug Pricing

Understanding the cost of drugs is a complex issue, with several factors contributing to the final price tag. Research and studies have examined this topic in depth, looking at various elements that influence the pharmaceutical pricing landscape.

Pharmaceutical Pricing Studies

Pharmaceutical pricing studies offer a comprehensive view of the factors affecting drug costs. According to a scoping study by the Journal of Pharmaceutical Policy and Practice, 204 articles were published in peer-reviewed journals between 1981 and 2016, focusing on aspects influencing pharmaceutical pricing. These studies have become more prevalent in recent years, with over half of the literature produced after 2010.

These research endeavors have shed light on several key topics, including the role of trading strategies, regulatory approaches, and market dynamics. Additionally, they've delved into the impact of product-related and demand-related market dynamics, all of which can significantly influence drug pricing.

Despite the extensive research, there remains a significant gap in understanding why prescription drugs in the US cost about 2.5 times more than in other countries. This high cost has led to a challenging situation, where approximately a quarter of Americans struggle to afford these drugs, as reported by WIRED.

Dominant Themes in Literature

The dominant themes in the literature regarding drug pricing are trading strategies and regulatory approaches. Trading strategies refer to the methods and tactics pharmaceutical companies use to position their products in the market. This includes strategies related to pricing, distribution, and marketing.

Regulatory approaches, on the other hand, pertain to the legal and policy measures put in place to control drug pricing. These can include laws related to patent protection, pricing controls, and guidelines for market competition.

Another recurring theme in the literature is the argument put forth by pharmaceutical companies in the US that high drug prices are necessary to recoup investments in research and development (R&D). However, as cited by WIRED, a study published in JAMA found no correlation between R&D spending and drug pricing for 60 drugs approved by the FDA between 2009 and 2018.

In conclusion, while various factors influence drug pricing, the role of trading strategies, regulatory approaches, and R&D costs remain dominant themes in the literature. Further research is required to fully understand the interplay of these elements and their impact on the question of 'how much do drugs cost?'.

Pricing of Specific Drugs

An understanding of the costs associated with specific drugs can provide a clearer picture of the pharmaceutical market and its impact on healthcare accessibility. The prices of drugs vary widely, and a closer look at specific examples can help illustrate these disparities.

Example: Relyvrio for ALS

One recent example of a high-cost drug is Relyvrio, a treatment for ALS. The price of Relyvrio was revealed to be $158,000 a year, significantly higher than the estimated reasonable price range of $9,100 to $30,700 as determined by the Institute for Clinical and Economic Review [1].

Drug Pricing Discrepancies

Drug pricing discrepancies are not uncommon in the pharmaceutical industry. These discrepancies can sometimes contradict the claim that high drug prices are solely influenced by the need to recoup research and development costs. For example, a study published in JAMA found no correlation between R&D spending and drug pricing for 60 drugs approved by the FDA between 2009 and 2018 [1].

Pricing Trends in Cancer Drugs

When it comes to cancer drugs, a concerning trend has been observed. Every new cancer drug in the US starts at over $100,000 a year, and on average, the price of newly released drugs increases by 20% annually [1]. This trend illustrates the growing challenge of accessing life-saving treatments for many patients.

While these examples provide a snapshot into the world of drug pricing, they represent just a small fraction of the vast and complex pharmaceutical market. The costs associated with specific drugs can be influenced by a range of factors, from R&D costs to market competition, highlighting the need for transparency and regulation in drug pricing.

Pharmaceutical Companies and Pricing

The pricing strategies of pharmaceutical companies play a crucial role in determining how much drugs cost. One significant factor often cited by these companies to justify drug prices is the investment in Research and Development (R&D).

R&D Investment Justification

Pharmaceutical companies in the US rationalize high drug prices by citing the need to recoup investments in R&D. They argue that the process of developing new drugs is expensive, fraught with failures, and requires substantial financial resources. According to CBO, estimates of average R&D expenditures per new drug range from less than $1 billion to more than $2 billion.

In 2019, the pharmaceutical industry devoted $83 billion to R&D expenditures, which is about 10 times what the industry spent per year in the 1980s, after adjusting for the effects of inflation. The share of revenues that drug companies devote to R&D has also grown, with pharmaceutical companies spending about one-quarter of their revenues on R&D expenses in 2019, almost twice as large a share as they spent in 2000. Revenue share devoted to R&D in the pharmaceutical industry is larger than in other knowledge-based industries such as semiconductors, technology hardware, and software.

Moreover, a significant portion of R&D spending of larger drug companies is allocated to conducting clinical trials, developing incremental improvements, and conducting postapproval testing.

The federal government also affects R&D decisions by increasing demand for prescription drugs through federal programs such as Medicare and Medicaid, funding basic biomedical research, providing tax credits and deductions for R&D investment, and implementing regulatory policies that influence the supply and demand for new drugs.

Correlation Between R&D Spending and Prices

Despite the high investment in R&D, a study published in JAMA found no correlation between R&D spending and drug pricing for 60 drugs approved by the FDA between 2009 and 2018 [1]. This suggests that while R&D investments are substantial, they do not directly dictate drug prices.

This lack of correlation raises questions about the justification of high drug prices based on R&D expenditures. It further underscores the complexity of drug pricing mechanisms and the need for greater transparency and regulation in this sector.

In understanding the cost of drugs, it is crucial to take into account these factors, along with the role of other key players such as Pharmacy Benefit Managers (PBMs) and insurance companies. The interplay of these factors gives us a more comprehensive view of how drug prices are determined.

Role of Pharmacy Benefit Managers (PBMs)

In the complex web of pharmaceutical pricing, Pharmacy Benefit Managers (PBMs) play a significant role. They operate behind-the-scenes to influence total drug costs, shape patients' access to medications, and determine pharmacies' pay. Let's examine this impact further and understand the dynamics of manufacturer rebates and list prices.

Impact on Total Drug Costs

PBMs have a considerable effect on total drug costs for insurers, which in turn reflects in the cost of medications for patients. They negotiate on behalf of insurance companies to secure price reductions from drug manufacturers and pharmacies. This involves complex dealings that include rebates from manufacturers and agreements on dispensing fees and drug markups with pharmacies [2].

The table above shows that the share of rebates PBMs passed through to insurers and payers increased from 78 percent in 2012 to 91 percent in 2016.

Manufacturer Rebates and List Prices

Manufacturer rebates to PBMs increased from $39.7 billion in 2012 to $89.5 billion in 2016, helping to partially offset list price increases. Despite this, there is ongoing debate about the distribution of these savings. While PBMs have been passing along a larger share of the rebates to insurers, many small insurers and employers claim they do not receive this share of savings [2].

This has led to calls for PBMs to "pass through" all or a larger portion of savings from rebates to health insurers and other payers. Advocates argue that this could help reduce people's premiums and cost-sharing payments, making medications more affordable for patients.

Understanding the role of PBMs in drug pricing is a crucial part of deciphering the question of "how much do drugs cost?". Their influence extends across manufacturers, insurers, pharmacies, and ultimately, patients, underlining the complexity of medication pricing in the healthcare system.

Generic vs. Brand-Name Drugs

A significant aspect that affects how much drugs cost is whether they are generic or brand-name. Both types play important roles in the pharmaceutical industry, with each having distinct considerations regarding cost and safety.

Cost Disparities and Usage

Generic drugs, on average, cost 80% to 85% less than brand-name drugs in the U.S [3]. Despite the cost-saving potential, brand-name drugs still account for nearly 75% of the total cost of prescriptions. This disparity can be attributed to various factors, including marketing strategies, patent rights, and the perception of efficacy associated with brand-name drugs.

Generic drugs can be brought to market quicker and sold much cheaper than brand-name drugs because they do not require as much time and research into development. They leverage the FDA testing and approval already done on the brand-name drug's active ingredients, reducing the cost and timeline of bringing the drug to market.

Safety Considerations

While generics must meet the same standards for safety, quality, strength, purity, and efficacy as brand-name drugs, there may still be differences. However, these differences are often minor and do not affect the drug's therapeutic effect. Generics are considered to offer the same benefits and generally have the same side effects and adverse reactions as brand-name drugs [3].

Generics are recommended as a more affordable option when cost is a priority and there are no adverse reactions or side effects. However, it's crucial for patients to consult with their healthcare provider before switching from a brand-name drug to a generic version to ensure that it is a suitable alternative.

Overall, the introduction of generic drugs into the market has allowed for more accessible and affordable medication options. However, it's crucial to balance cost savings with efficacy and safety considerations when choosing between generic and brand-name drugs.

Insurers' Influence on Drug Prices

When examining the question, 'how much do drugs cost?', it's crucial to consider the role insurance companies play. Insurers' bargaining power and enrollment numbers significantly impact drug pricing.

Bargaining Power Effects

Insurance companies use their bargaining power to negotiate drug prices with pharmacies. This increased bargaining power allows insurers to secure lower prices, especially for competitively supplied drugs. Consequently, this leads to reduced prices for their members. Interestingly, the profits and markups of pharmacies and drug manufacturers tend to move in the same direction with greater insurer bargaining power. This shows that a powerful insurer can influence not only drug prices but also the profit margins of pharmacies and drug manufacturers.

Enrollment Impact on Pricing

The number of members enrolled in an insurance plan also has a significant impact on drug pricing. Insurers that experience larger enrollment increases, such as due to Medicare Part D implementation, can negotiate lower drug prices. Specifically, enrolling 100,000 additional members is associated with a 2.5 percent decrease in drug prices and a 5 percent decrease in pharmacy profits earned on prescriptions filled by enrollees of that insurer.

For both generic drugs and branded drugs with therapeutic substitutes, enrollment increases lead to larger declines in prices and profits. There's a 7 to 9 percent drop in profits for generic drugs and branded drugs with substitutes, compared to a 5 percent average drop in profits from all drugs [4].

However, the effect on non-competitively supplied branded drugs, which account for roughly half of all drug expenditures in the U.S., is close to zero. This suggests that insurers have little ability to leverage additional enrollments into lower prices for drugs with few substitutes [4].

Additionally, a Part D enrollment increase of 100,000 reduces prices by 2 percent for non-Part D members. These external effects may rival the direct benefits of Part D to the population of now-insured seniors who lacked drug coverage prior to Part D [4].

In conclusion, the influence of insurers on drug pricing is significant and multifaceted. Both their bargaining power and the size of their membership play major roles in determining the cost of drugs.

References

[1]: https://www.wired.com/story/drug-research-pricing/

‍[2]: https://www.commonwealthfund.org/publications/explainer/2019/apr/pharmacy-benefit-managers-and-their-role-drug-spending

‍[3]: https://www.uhhospitals.org/blog/articles/2022/07/generic-vs-brand-name-drugs-is-there-a-difference

‍[4]: https://www.nber.org/bah/2009no4/how-insurers-bargaining-power-affects-drug-prices-medicare-part-d

‍[5]: https://www.addictioncenter.com/drugs/how-much-do-drugs-cost/