Prescription costs

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Prescription costs are a common health care cost for many people. Prescription costs are influenced by multiple factors such as patents, stakeholder influence, and marketing expenses. A number of countries including Canada, parts of Europe, and Brasil use external reference pricing as a means to compare drug prices and to determine a base price for a particular medication.[1]

Definition[edit]

Prescription cost is defined as a cost which the patient has to pay to get medicines or treatments which are written as directions on prescription by a prescribers.[2] The cost is generally influenced by a financial relationship between pharmaceutical manufacturers, wholesale distributors and pharmacies.[3] In addition to the financial relationship, each nation has different systems to control the cost of prescriptions. In the United States, a pharmacy benefit manager, a third-party organization, such as private insurances or government-run health insurances will implement cost containment programs, such as establishing a formulary, to contain the cost.[3][4]  In the United Kingdom, a government agency, the National Institute of Health and Care Excellence (NICE), will negotiate with pharmaceutical companies to contain cost of prescription drug.[5] Prescription costs are a regular health care cost for the sick and may mean economic hardship for the underprivileged.[6] With healthcare insurance, the patient in the U.S. pays a co-pay (the amount the patient must pay for each drug or medical visit), a deductible (the amount the patient has to pay before the insurance starts sharing the cost) and co-insurance (the amount the patient has to pay after deductible) for prescription costs.[7] After reaching the out of pocket maximum, the insurance company will pay 100% of the prescription cost.[7] The amount the patient has to pay depends on the healthcare insurance plan the patient has.[7]

As of 2017, prescription costs range from just more than 15% in high income countries to 25% in lower-middle income countries and low income countries.[8]:418

Drug pricing factors[edit]

Drug costs in different countries[9]
Drug US Canada UK Spain Netherlands
Enbrel $2,225 $1,646 $1,117 $1,386 $1,509
Celebrex $225 $51 $112 $164 $112
Copaxone $3,903 $1,400 $862 $1,191 $1,190
Cymbalta $194 $110 $46 $71 $52
Humira $2,246 $1,950 $1,102 $1,498 $1,498
Nexium $215 $30 $42 $58 $23

Pricing any pharmaceutical drug for sale to the general public is daunting. Per Forbes, setting a high ceiling price for a new drug could be problematic as physicians could shy away from prescribing the drug, because the cost could be too great for the benefit.[10] Setting too low of a price could imply inferiority, that the drug is too "weak" for the market.[10] There are many different pricing strategies and factors that go into the research and evaluation of a future drug’s price with whole departments within US pharmaceutical companies like Pfizer devoted to cost analysis. Regardless of the pricing strategy the common theme within all factors is to maximize profits.

This chart shows discrepancies in drug pricing in different countries, which indicates differences in both market conditions and government regulation. For instance, Canada has federal Patented Medicine Prices Review Board (PMPRB), which does not set prices of drugs, but it reviews to determine if the prices are not excessive.[11]

Marketing expenses[edit]

A study has placed the amount spent on drug marketing at 2-19 times that on drug research.[12]

Research and development[edit]

The table shows research and development statistics for pharmaceutical companies as of 2013 per Astra Zeneca.[13][page needed]

Pharmaceutical company Number of drugs approved Average R&D spending per drug (in $ Millions) Total R&D spending from 1997-2011 (in $ Millions)
AstraZeneca 5 $11,790.93 $58,955
GlaxoSmithKline 10 $8,170.81 $81,708
Sanofi 8 $7,909.26 $63,274
Roche Holding 11 $7,803.77 $85,841
Pfizer 14 $7,727.03 $108,178
Johnson & Johnson 15 $5,885.65 $88,285
Eli Lilly & Co. 11 $4,577.04 $50,347
Abbott Laboratories 8 $4,496.21 $35,970
Merck & Co Inc. 16 $4,209.99 $67,360
Bristol-Meyers Squibb Co. 11 $4,152.26 $45,675
Novartis 21 $3,983.13 $83,646
Amgen Inc. 9 $3,692.14 $33,229

Severin Schwan, the CEO of the Swiss company Roche, reported in 2012 that Roche’s research and development costs in 2014 amounted to $8.4 billion, a quarter of the entire National Institutes of Health budget.[10] Given the profit-driven nature of pharmaceutical companies and their research and development expenses, companies use their research and development expenses as a starting point to determine appropriate yet profitable prices.[14]

Pharmaceutical companies spend a large amount on research and development before a drug is released to the market and costs can be further divided into three major fields: the discovery into the drug’s specific medical field, clinical trials, and failed drugs.[15]

Discovery[edit]

The process of drug discovery can involve scientists determining the germs, viruses, and bacteria that cause a specific disease or illness.[16] The time frame can range from 3–20 years and costs can range between several million to tens of millions of dollars. Research teams attempt to break down disease components to find abnormal events/processes taking place in the body.[16] Only then do scientists work on developing chemical compounds to treat these abnormalities with the aid of computer models.[16]

After "discovery" and a creation of a chemical compound, pharmaceutical companies move forward with the Investigational New Drug (IND) Application from the FDA.[16] After the investigation into the drug and given approval, pharmaceutical companies can move into pre-clinical trials and clinical trials.[16]

Trials[edit]

Drug development and pre-clinical trials focus on non-human subjects and work on animals such as rats.

The Food and Drug Administration requires at least 3 phases of clinical trials that assess the side effects and the effectiveness of the drug. An analysis of trial costs of approved drugs by the FDA from 2015-2016 found that out of 138 clinical trials, 59 new therapeutic agents were approved by the FDA. These trials have a medium estimated cost of $19 million US dollars.[17]

  • Phase 1 lasts several months and aims to assess the safety and dosage of the drug. The purpose is to determine how the drug affects the body.[18]
  • Phase 2 lasts several months to two years and aims to assess the efficacy and side effect profile of the drug.[18]
  • Phase 3 lasts 1 to 4 years and aims to continue assessing and monitoring the efficacy and side effects of the drug. Phase 3 aims to determine the risks and benefits of a drug to its intended patient population.[18]
  • Phase 4 trials occur after the drug is approved by the FDA and aims to continue monitoring safety and efficacy of the drug.[18]

Of these phases, the phase 3 is the most costly process of drug development. [19] A single phase 3 trial can cost upwards of $100 million.[20] It accounts for about 90 percent of the cost to pharmaceutical companies to develop a medication.[21]

Failed drugs[edit]

The processes of "discovery" and clinical trials amounts to approximately 12 years from research lab to the patient, in which about 10% of all drugs that start pre-clinical trials ever make it to actual human testing.[16] Each pharmaceutical company (who have hundreds of drugs moving in and out of these phases) will never recuperate the costs of "failed drugs". Thus, profits made from one drug need to cover the costs of previous "failed drugs".

Relationship[edit]

Overall, research and development expenses relating to a pharmaceutical drug amount to the billions. For example, it was reported that AstraZeneca spent upwards on average of $11 billion per drug for research and developmental purposes.[20] The average of $11 billion only comprises the "discovery" costs, pre-clinical and clinical trial costs, and other expenses.[citation needed] With the addition of "failed drug" costs, the $11 billion easily amounts to over $20 billion in expenses.[citation needed] Therefore, an appropriate figure like $60 billion would be approximate sales figure that a pharmaceutical company like AstraZeneca would aim to generate to cover these costs and make a profit at the same time.[citation needed]

Total research and development costs provide pharmaceutical companies a ballpark estimation of total expenses. This is important in setting projected profit goals for a particular drug and thus, is one of the most necessary steps pharmaceutical companies take in pricing a particular drug.[citation needed]

Stakeholders[edit]

Patients and doctors can also have some input in pricing, though indirectly. Customers in the United States have been protesting the high prices for recent "miracle" drugs like Daraprim and Harvoni, both of which attempt to cure or treat major diseases (HIV/AIDS and hepatitis C).[22] Public outcry has worked in many cases to control and even decide the pricing for some drugs. For example, there was severe backlash over Daraprim, a drug that treats toxoplasmosis.[23] Turing Pharmaceuticals under the leadership of Martin Shkreli raised the price of the drug 5,500% from $13.50 to $750 per pill.[23] After denouncement from 2016 presidential candidates Hillary Clinton and Bernie Sanders, Turing Pharmaceuticals decided to reduce the price.[23]

With the recent trend of price gouging, legislators have introduced reform to curb these hikes, effectively controlling the pricing of drugs in the United States. Hillary Clinton announced a proposal to help patients with chronic and severe health conditions by placing a nationwide monthly cap of $250 on prescription out-of-pocket drugs.[23]

Research for a drug that is curing something no one has ever cured before will cost much more than research for the medicine of a very common disease that has known treatments.[citation needed] Also, there would be more patients for a more common ailment so that prices would be lower.[citation needed] Soliris only treats two extremely rare diseases, so the number of consumers is low, making it an orphan drug. Soliris still makes money because of its high price of over $400,000 per year per patient.[10] The benefit of this drug is immense because it cures very rare diseases that would cost much more money to treat otherwise, which saves insurance companies and health agencies millions of dollars. Hence, insurance companies and health agencies are willing to pay these prices.[citation needed]

Public policy[edit]

Policy makers in some countries have placed controls on the amount pharmaceutical companies can raise the price of drugs. In 2017, Democratic party leaders proposed the creation of a new federal agency to investigate and perhaps fine drug manufacturers who make unjustified price increases. Pharmaceutical companies would be required to submit a justification for a drug with a “significant price increase” within at least 30 days of implementation. Under the terms of the proposal, Mylan’s well-publicized price increase for its EpiPen product would fall below the criteria for a significant price increase, while the 5000% overnight increase of Turing Pharmaceuticals Daraprim (pyrimethamine) would be subject to regulatory action.[24]

Patents[edit]

Drug developers are able to gain Patent rights to their particular product. Two patents that are commonly used are process patents and product patents.[25] These patents contribute to fluctuations in drug pricing. Process patents only provide developers intellectual claim to the methods in which the product was manufactured. Comparatively, product patents give the developer prime control as the "single innovating firm" of that product.[25] Product patents allow developers to maintain exclusivity of their product for up to a decade.[26] With this exclusivity, the developer can establish a monopoly and determine what they deem as an appropriate price for their product.[26]

Effect of cost on consumers[edit]

When the price of medicine goes up the quality of life of consumers who need the medicine decreases.[27][28] Consumers who have increased costs for medicine are more likely to change their lifestyle to spend less money on groceries, entertainment, and routine family needs.[27] They are more likely to go into debt or postpone paying their existing debts.[27] High drug prices can prevent people from saving for retirement.[27] It is not uncommon for typical people to have challenges paying medical bills.[27] Some people fail to get the medical care they need due to lack of money to pay for it.[27]

Consumers respond to higher drug prices by doing what they can to save drug costs. The most commonly recommended course of action for consumers who seek to lower their drug costs is for them to tell their own doctor and pharmacist that they need to save money and then ask for advice.[29] Doctors and pharmacists are professionals who know their fields and are the most likely source of information about options for reducing cost.[29]

Depending on the country and health policies implemented, there are also options to search for the most convenient and affordable health insurance plans without having to consult a healthcare provider or obtain insurance through the employer. However, those who seek to purchase insurance individually through the individual market are most likely to be underinsured and therefore could potentially have a higher prescription cost.[30]

There can be significant variation of prices for drugs in different pharmacies, even within a single geographical area.[31] Because of this, some people check prices at multiple pharmacies to seek lower prices.[31] Online pharmacies can offer low prices but many consumers using online services have experienced Internet fraud and other problems.[32]

Some consumers lower costs by asking their doctor for generic drugs when available.[33] Because pharmaceutical companies often set prices by pills rather than by dose, consumers can sometimes buy double-dose pills, split the pills themselves with their doctor's permission, and save money in the process[34]

By region[edit]

United States[edit]

Prescription drug prices in the United States have been among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the new millennium, leading up to the U.S. health care reform debate of 2009, and received renewed attention in 2015. High prices have been attributed to monopolies given to manufacturers by the government and a lack of ability for organizations to negotiate prices.[35]

Individuals are able to enroll in health insurance plans, which often include prescription medication coverage. However, insurance companies decide which drugs they will cover by creating a formulary. If a medication is not on this list, the insurance company may require people to pay more money out-of-pocket compared to other medications that are on the formulary. There are also often tiers within this approved drug list, as the insurance company may be willing to cover a portion of one drug but prefer and completely cover a cheaper alternative.[36]

Medicare Part D is a branch of Medicare that helps to cover costs of prescription medications for patients aged 65 and up. From 2010 to 2018, the Part D plan "nearly quadrupled" its spending on the catastrophic coverage phase. [37]This increase in spending is attributed to the rising pricing of prescription medications.

United Kingdom[edit]

Most people in the countries of the United Kingdom get prescriptions partly or totally paid for by the National Health Service.

Developing world[edit]

In many developing countries[which?] the cost of proprietary drugs is beyond the reach of the majority of the population.[38] There have been attempts both by international agreements and by pharmaceutical companies to provide drugs at low cost, either supplied by manufacturers who own the drugs,[39] or manufactured locally as generic versions of drugs which are elsewhere protected by patent.[40] Countries without manufacturing capability may import such generics.

The legal framework regarding generic versions of patented drugs is formalised in the Doha Declaration on Trade-Related Aspects of Intellectual Property Rights and later agreements.[citation needed]

People and governments in developing countries have far fewer financial resources to bear high monopoly prices and drug prices even for patent-protected medicines in these countries are often considerably lower.[citation needed] Profits are often insubstantial and do not proportionally cover development costs.[citation needed] In many cases, a patent holder will license generic manufacturers to sell to low-income countries at low cost.[citation needed] India has less restrictive patent regimes which make the manufacture of generic medications possible sooner, for sale domestically or in other countries where the patent protections do not apply.[citation needed] Typically the cost of making small-molecule drugs is only a very small portion of a developed-country market monopoly price, which makes generic manufacturing very cheap.[citation needed] In contrast, some drugs are inherently expensive to produce, such as the biopharmaceutical drug Cerezyme, typically costing $200,000 per year in the United States.[citation needed]

See also[edit]

References[edit]

  1. ^ "++ Health Action International ++ [ Focus ]". www.haiweb.org. Retrieved 1 October 2019.
  2. ^ "PRESCRIPTION | definition in the Cambridge English Dictionary". dictionary.cambridge.org. Retrieved 23 October 2019.
  3. ^ a b Feb 28, Published:; 2005 (28 February 2005). "Follow The Pill: Understanding the U.S. Commercial Pharmaceutical Supply Chain". The Henry J. Kaiser Family Foundation. Retrieved 23 October 2019.CS1 maint: extra punctuation (link)
  4. ^ Gryta, Thomas (21 July 2011). "What is a 'Pharmacy Benefit Manager?'". Wall Street Journal. ISSN 0099-9660. Retrieved 23 October 2019.
  5. ^ "Cost control: drug pricing policies around the world". Retrieved 23 October 2019.
  6. ^ The Editorial Board (19 December 2015). "No Justification for High Drug Prices". New York Times. Retrieved 20 December 2015.
  7. ^ a b c Kagan, Julia. "What Is Health Insurance?". Investopedia. Retrieved 31 October 2019.
  8. ^ Wirtz VJ, Hogerzeil HV, Gray AL, Bigdeli M, de Joncheere CP, Ewen MA, et al. (January 2017). "Essential medicines for universal health coverage". Lancet. 389 (10067): 403–476. doi:10.1016/S0140-6736(16)31599-9. PMID 27832874.
  9. ^ International Federation of Health Plans.
  10. ^ a b c d LaMattina, John. "What Is The Rationale For The Pricing Of New Drugs?". Forbes. Retrieved 15 March 2016.
  11. ^ Menon, Devidas (1 May 2001). "Pharmaceutical Cost Control In Canada: Does It Work?". Health Affairs. 20 (3): 92–103. doi:10.1377/hlthaff.20.3.92. ISSN 0278-2715.
  12. ^ Pharmaceutical Companies Spent 19 Times More On Self-Promotion Than Basic Research: Report The Huffington Post, 2012
  13. ^ Al-Huniti, Nidal (20 June 2013). "Quantitative Decision-Makingin Drug Development". AstraZeneca. p. 23. Retrieved 13 March 2016.
  14. ^ Medicine, Institute of Medicine (US) Committee on Technological Innovation in; Gelijns, Annetine C.; Halm, Ethan A. (1991). The Economics of Pharmaceutical Research and Development: An Industry Perspective. National Academies Press (US).
  15. ^ Klotz, Lynn (16 January 2014). "What Is the Real Drug Development Cost for Very Small Biotech Companies?". Genetic Engineering & Biotechnology News. Retrieved 15 March 2016.
  16. ^ a b c d e f "New Drug Development Process" (PDF). California Biomedical Research Association. Retrieved 15 March 2016.
  17. ^ Moore TJ, Zhang H, Anderson G, Alexander GC (November 2018). "Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016". JAMA Internal Medicine. 178 (11): 1451–1457. doi:10.1001/jamainternmed.2018.3931. PMC 6248200. PMID 30264133.
  18. ^ a b c d Commissioner, Office of the (18 April 2019). "Step 3: Clinical Research". FDA.
  19. ^ "The Drug Development and Approval Process | FDAReview.org". Retrieved 31 October 2019.
  20. ^ a b Herper, Matthew. "The Truly Staggering Cost Of Inventing New Drugs". Forbes. Retrieved 15 March 2016.
  21. ^ "Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials". Manhattan Institute. 24 August 2015. Retrieved 7 November 2019.
  22. ^ Sanghoee, Sanjay. "The Unintended Side Effect of Lower Drug Prices". TIME.com. Retrieved 15 March 2016.
  23. ^ a b c d "CEO says he'll lower price of drug after public outcry over 5,000% price hike". www.CBC.ca. 23 September 2015. Retrieved 16 March 2016.
  24. ^ Gingery, Derrick (24 July 2017). "Dems' 'Better Deal' Would Create Drug Price Gouging 'Enforcer'". OTC Markets Group. Retrieved 27 July 2017.
  25. ^ a b Lanjouw, Jean (May 2005). "Patents, Price Controls, and Access to New Drugs: How Policy Affects Global Market Entry" (PDF). Cambridge, MA: w11321. doi:10.3386/w11321. Cite journal requires |journal= (help)
  26. ^ a b Brennan, Hannah; Kapczynski, Amy; Monahan, Christine H.; Rizvi, Zain (2 April 2017). "A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health". Yale Journal of Law and Technology. 18 (1).
  27. ^ a b c d e f Skinner, Ginger (21 June 2016). "As Drug Prices Increase, Quality of Life Goes Down". Consumer Reports. Retrieved 8 March 2017.
  28. ^ Walker, Joseph (31 December 2015). "Patients Struggle With High Drug Prices". Wall Street Journal. Retrieved 8 March 2017.
  29. ^ a b Consumer Reports (21 June 2016). "The Way To Save On Your Prescription Drugs: Speak Up". www.consumerreports.org. Retrieved 8 March 2017.
  30. ^ "Health Insurance Coverage Eight Years After the ACA — 2018 Biennial | Commonwealth Fund". www.commonwealthfund.org. Retrieved 23 October 2019.
  31. ^ a b Consumer Reports (5 January 2016). "Save Money on Meds: 6 Tips for Finding the Best Prescription Drug Prices". Consumer Reports. Retrieved 8 March 2017.
  32. ^ Consumer Reports (30 August 2015). "Is it OK to buy medicine online? - Consumer Reports". Consumer Reports. Retrieved 8 March 2017.
  33. ^ Consumer Reports (January 2012). "Generic Drugs: The Same Medicine for Less Money" (PDF). Consumer Reports. Retrieved 8 March 2017.
  34. ^ Consumer Reports (30 December 2015). "When It's Safe to Split Pills". Consumer Reports. Retrieved 8 March 2017.
  35. ^ Kesselheim AS, Avorn J, Sarpatwari A (23 August 2016). "The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform". JAMA. 316 (8): 858–71. doi:10.1001/jama.2016.11237. PMID 27552619.
  36. ^ "Prescription Drugs | Covered California™". www.coveredca.com. Retrieved 23 October 2019.
  37. ^ Dusetzina, Stacie B.; Keating, Nancy L.; Huskamp, Haiden A. (10 October 2019). "Proposals to Redesign Medicare Part D — Easing the Burden of Rising Drug Prices". New England Journal of Medicine. 381 (15): 1401–1404. doi:10.1056/NEJMp1908688. ISSN 0028-4793.
  38. ^ Angela Saini Making poor nations pay for drugs, New Scientist, 31 March 2007
  39. ^ GSK tops new ethical ranking for investors – health – 16 June 2008. New Scientist. Retrieved on 23 April 2011.
  40. ^ Drugs bust – 13 June 2001. New Scientist. Retrieved on 23 April 2011.

Further information[edit]