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3 posts from December 2014

12/18/2014

Is Gilead’s Pricing of Breakthrough Hepatitis C Drugs Justified?

RowanBackground: A previous blog post elaborated on the time and costs associated with bringing a single drug to market in the pharmaceutical industry. If a company could not recoup its investment costs, in addition to making a profit, the incentive to innovate quickly disappears. This is seen in the lack of research being done to develop new antibiotics even though there is a great need (Herper, 2014). On the other hand, more research is being put into oncology drugs than treatment for any other disease (Herper, 2014). Antibiotics are cheap; cancer drugs are not. For drug markets on the more expensive side, the burden is much greater for Medicare, insurance companies, and patients (payers). Some drugs can justify the high prices better than others, but this is certainly a controversial issue that continues to receive attention. The dilemma revolves around how ethical it is to market a drug at so high a price that it cannot benefit the very people who need it.

To provide a reference point for drug pricing, one can look to the market differences between prevalent diseases and orphan diseases (rare diseases that affect smaller numbers of people). The Orphan Drug Act of 1983 was passed exactly because of the reasoning stated above. Due to the small amount of people affected by orphan diseases, a pharmaceutical company may conclude that it would not be able to earn back the money that was spent developing the drug (Food and Drug Administration, 2014). In order to facilitate research for such diseases, the federal government of the United States (US) passed the Orphan Drug Act to provide pharmaceutical companies who invest in orphan drugs certain benefits. These benefits include a 7 year exclusivity period after FDA approval (independent of current patent status, certain tax credits), and federal grants (Waxman). Orphan drugs costs much more than drugs for other disease (including the aforementioned pricy cancer drugs), but this is usually justified in light of the smaller proportions of people affected by any given orphan disease (Miller, Oct 2014).

Introduction: About 3.2 million people in the US (Miller, Sep 2014) and about 170 million people in the world (Saab et al., 2014) are infected with hepatitis C. Gilead Science’s Sovaldi (sofosbuvir) was the first drug of a new class of oral treatments. The cost for 12 weeks of treatment is $84,000 or $1,000 per pill (Staton, Oct 2014). Despite being a breakthrough drug in the treatment of Hepatitis C with an impressive cure rate (>90% [Miller, Sep 2014]), it is well known that Gilead has come under fire for the hefty price tag it has placed on Sovaldi. To add fuel to the flame, Gilead has also rolled out Harvoni (sofosbuvir and ledipasvir), its next blockbuster drug for the treatment of Hepatitis C genotype 1 (Miller, Oct 2014), with at an even greater price. About 2.4 million people in the US have genotype 1 (Miller, Oct 2014), and the cost for 12 weeks of Harvoni treatment is $94,500 or $1,125 per pill (Staton, Oct 2014). However, Harvoni represents another undeniable, true improvement as far as treatment goes, with some patients being cured in 8 or 4 weeks (Staton, Oct 2014).

Steve Miller, MD is the CMO of Express Scripts, and has been a strong voice of disapproval over Gilead’s pricing of Sovaldi. His objections over Harvoni follow suit. Dr. Miller’s primary argument is that Gilead is charging orphan drug prices for drugs that do not treat orphan diseases, and with so many people infected with hepatitis C, the high drug costs are not sustainable (Miller, Oct 2014). To make his point, Dr. Miller compiled a list of the most expensive drugs in the US (cost per 30 days of treatment), and even though Sovaldi and Harvoni rank at number 26 and number 18, the hepatitis C population is a staggering 48 times larger than the second most prevalent indication listed (Miller, Oct 2014). Gilead, however, insists that its breakthrough medications will prevent hepatitis C complications down the road, which will save the healthcare system more money in the long run (Staton, Oct 2014).

Issue: Is Gilead’s pricing of Sovaldi and Harvoni justified?

Rule: Gilead’s pricing of Sovaldi and Harvoni are justified if:

  • the benefit to patients is significantly improved from prior standard therapies
  • the drugs will contribute significantly to a reduction in healthcare costs over time due to the decrease in costly hepatitis C complications
  • the majority of patients can reasonably afford it

Analysis: The advent of Sovaldi and Harvoni ushered in a new age of treatments for hepatitis C. Just 4 years ago, the standard therapy cost up to $34,000, lasted up to 48 weeks, had lasting, severe side effects, and cured less than 50% of patients (Miller, Sep 2014). Sovaldi and Harvoni exhibited a game-changing increase in safety and efficacy. Today, therapy with drugs like these can cost more than $100,000 but lasts up to only 12 weeks, has short-term, well-tolerated side effects, and cures more than 90% of patients (Miller, Sep 2014). Going back to Dr. Miller’s list, it should be pointed out that Sovaldi and Harvoni will cure a high percentage of patients in 12 weeks or less, while most of the other drugs on the list need to be taken for life. Quick calculations would reveal, though, that this still does not quite balance the scales. Nevertheless, it is without question that the benefit of Sovaldi and Harvoni to patients with hepatitis C is significantly improved as compared with prior standard therapy.

According to Younossi et al. (2014), hepatitis C “has been associated with tremendous clinical, economic and quality of life burden” (p. 518), and “chronic [hepatitis C virus] independently and significantly increases health care costs” (p. 526). Complications of hepatitis C include liver cirrhosis, hepatocellular carcinoma, and liver transplantation (Younossi, 2014). A review paper by Gordon et al. (2013) concluded that “[a]nti-[hepatitis C virus] therapy was associated with lower follow-up US health care costs, and these savings were independent of baseline patient comorbidities and stage of disease” (p. 784). It appears that Gilead’s claim of saving the healthcare system more money in the long run has legitimate substance to it. This is a very compelling argument on behalf of Gilead, and may appear to close this case, but one would not have to look very deeply in order to realize that this does not mean that the high prices for Sovaldi and Harvoni are sustainable.

The data on the population of Americans that need hepatitis C treatment is also compelling. Since hepatitis C progresses slowly and older drugs were difficult to tolerate, physicians had been “warehousing” patients, advising them to wait for breakthrough drugs like Sovaldi and Harvoni (Miller, Sep 2014). A study by Express Scripts revealed that in 2013, only 8% of the 3.2 million hepatitis C patients who saw a physician were taking hepatitis C drugs (Miller, Sep 2014). Furthermore, even prior to the introduction of Sovaldi, the total prescription drug expense was half the total medical and pharmacy cost to treat hepatitis C patients (Miller, Sep 2014). Again, that’s prescription drugs taking up 50% of the total treatment costs when only 8% of patients were actually taking prescription drugs, and before Sovaldi even hit the market! A lot of people need access to Sovaldi and Harvoni.

The price tag of Sovaldi and Harvoni indicate that only the wealthiest or best insure patients will have access (Wapner, 2014). Many Americans who have hepatitis C are poor or incarcerated (Wapner, 2014), and Dr. Miller says that the cost “forces patients to decide between medications and other staples like food or rent” (Miller, Oct 2014). Physicians, insurance companies, and Medicare groups have all expressed outrage over Gilead’s pricing. The latest data to be analyzed were by CVS Health, showing that in comparison to patients in clinical trials, 4 times as many patients in the real world are coming off hepatitis C treatments due to the high costs (Staton, Sep 2014). If each pill costs $1,000 and patients do not finish therapy because they cannot afford it, they lose the clinical benefit and waste a substantial amount of money (Staton, Sep 2014). Payer groups have managed the high costs thus far by giving the drugs only to the sickest patients, advocating for financial assistance from state health agencies, and even appealing to Congress (Helfand, 2014). It is difficult to deny the reality that most patients will not be able to afford these new hepatitis C drugs. It has further been noted that the high costs of Sovaldi and Harvoni will actually cause an increase in immediate healthcare costs, particularly driving up health plan hepatitis C cost burdens by 40% in 2015 (on top of an already record-breaking increase in costs seen this year) (Helfand, 2014). One thing payers are hoping for is that other pharmaceutical companies, such as AbbVie and Merck, will be able to help drive prices down by marketing their own hepatitis C drugs and creating more competition (Staton, Oct 2014).

Conclusion: Gilead should seriously consider reducing the price of Sovaldi and Harvoni. These have already proven to be the unrivaled best therapies on the market, so even if the prices were significantly reduced, Gilead would not even have to worry about major competition at this point. In addition, if substantially more patients are able to afford these drugs, Gilead’s profits may be minimally affected. Most importantly, Gilead would be making good on its ethical responsibility of making these groundbreaking hepatitis C treatments available to more patients, for what good are these miracle drugs if they are being kept out of the hands of the very people they were meant to help? Sovaldi and Harvoni have left little doubt that they are significant improvements to the prior hepatitis C standard therapies, or that they will contribute significantly to a reduction in healthcare costs over time due to the decrease in costly hepatitis C complications. The problem is the economic burden they present to patients in the present, and how it severely restricts patient access to these life-saving drugs.

References

  1. Herper, M. (2014). '60 Minutes' Just Attacked High Drug Prices. Here's What You Should Know. Retrieved from http://www.forbes.com/sites/matthewherper/2014/10/05/60-minutes-just-attacked-high-drug-prices-heres-what-you-should-know/
  2. Food and Drug Administration. (2013). Orphan Drug Act. Retrieved from http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/orphandrugact/default.htm
  3. Waxman, H. Orphan Drugs. Retrieved from http://waxman.house.gov/orphan-drugs
  4. Miller, S. (Oct 2014). Harvoni: Orphan-Drug Pricing for a Non-Orphan Drug. Retrieved from http://lab.express-scripts.com/insights/specialty-medications/harvoni-orphan-drug-pricing-for-a-nonorphan-drug
  5. Miller, S. (Sep 2014). New Data Warns of Looming Hepatitis C Medication Costs. Retrieved from http://lab.express-scripts.com/insights/specialty-medications/new-data-warns-of-looming-hepatitis-c-medication-costs
  6. Saab, S., Gordon, S. C., Park, H., Sulkowski, M., Ahmed, A., & Younossi, Z. (2014). Cost-effectiveness analysis of sofosbuvir plus peginterferon/ribavirin in the treatment of chronic hepatitis C virus genotype 1 infection. Alimentary Pharmacology & Therapeutics, 40(6), 657-675.
  7. Staton, T. (Oct 2014). Orphan drug pricing for non-orphan meds? Express Scripts is looking at you, Gilead. Retrieved from http://www.fiercepharmamarketing.com/story/orphan-drug-pricing-non-orphan-meds-express-scripts-looking-you-gilead/2014-10-28
  8. Younossi, Z. M., Kanwal, F., Saab, S., Brown, K. A., El-Serag, H. B., Kim, W. R., … Gordon, S.C. (2014). The impact of hepatitis C burden: an evidence-based approach. Alimentary Pharmacology & Therapeutics, 39(5), 518-531.
  9. Wapner, J. (2014). The Solid-Gold Wonder Drug. Scientific American, 311(3), 32-34.
  10. Staton, T. (Sep 2014). Real-world hep C patients drop off pricey Sovaldi, CVS study finds. Retrieved from http://www.fiercepharma.com/story/real-world-hep-c-patients-drop-pricey-sovaldi-cvs-study-finds/2014-09-18
  11. Helfand, C. (2014). Payers hit back at Gilead for $94,500 price tag on brand-new hep C combo pill. Retrieved from http://www.fiercepharma.com/story/payers-hit-back-gilead-94500-price-tag-brand-new-hep-c-combo-pill/2014-10-13?utm_medium=nl&utm_source=internal

Rowan Valenzuela is a regulatory medical writer for a contract research organization based in New Jersey. He earned a bachelor of arts in biology from Rutgers University and is currently a graduate student in the Biomedical Writing program at the University of the Sciences in Philadelphia. Rowan’s professional career allows him to combine his passions for both healthcare and writing. He is also involved with different aspects of the arts and religion, being a strong advocate of creative expression and critical thinking.

12/16/2014

Should Federal Law Classify Cannabis As One of the Nation’s Most Dangerous Drugs?

LaurenWhetzel1At the height of President Richard Nixon’s war against drugs in 1970, he urged Congress to pass the Controlled Substances Act to crack down on drug abuse across the United States.1 This law categorizes controlled substances into 5 schedule groups, which are determined by their medical acceptance, abuse potential, and ability to produce dependence.It also regulates the development and distribution of controlled substances, such as narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illegal production of drugs. This law classifies cannabis (marijuana) as a Schedule I drug with a “high potential for abuse” and “no accepted medical use,” right next to deadly drugs such as heroin, LSD, and ecstasy.2 Meanwhile, oxycodone and methadone – which are among the most commonly abused prescription drugs and leading causes of opioid overdose deaths – are Schedule II drugs; thus implying that these drugs are less dangerous than marijuana.2

Issue

Should Federal Law Classify Cannabis As One of the Nation’s Most Dangerous Drugs?

Analysis:

The epidemic of prescription painkiller abuse continues to take a deadly toll in the United States.4 In fact, fatal overdoses involving drugs such as OxyContin and Vicodin have tripled over the past decade, according to the Centers for Disease Control and Prevention (CDC).4 Even more alarming is the fact that the United States consumes 80 percent of the world’s supply of prescription painkillers.5 Imagine how these ever increasing statistics would change if the federal government legalized cannabis, and reclassified it alongside prescription painkillers, to provide alternatives to pain management.

The first global study6 of illicit drug abuse, recently published in the Lancet, revealed that addictions to heroin and popular painkillers, like Vicodin and OxyContin, kill the most people and cause the greatest health burden to society; unlike illicit drugs such as cannabis. While critics of cannabis point out its potential health risks, research6,7 has shown that they are inferior when compared to those of opioids. While some cannabis users do in fact become addicted, or at least dependent on this drug, it is far less addictive and deadly than prescription opioids.6

In fact, CDC officials have come forward on several occasions to say that many people find themselves addicted to painkillers before they even realize it— often after taking the prescribed drugs to recover from surgery or treat chronic pain. The common major adverse health effects of cannabis includes dependence, psychotic disorders, and other mental disorders; but contributes very little to mortality.6

According to Bachhuber, et al,7 deaths from opioid overdoses have sharply declined in states where medical marijuana is now legal. This recent study7 examined medical marijuana laws and death certificate data in all 50 states between 1999 and 2010; 13 states had medical marijuana laws in place during that time period. Bachhuber7 wrote that “there was about a 25 percent lower rate of prescription painkiller overdose deaths on average after implementation of a medical marijuana law.” More specifically, states with medical marijuana laws in place in 2010, alone, experienced 1,700 fewer overdose deaths than would have been expected before cannabis laws were implemented, according to the states’ mortality statistics.8 A senior author of the study,7 public health expert Colleen Barry,8 wrote that as awareness of prescription drug addiction and overdose risk continues to spike, and “individuals with chronic pain and their medical providers may be opting to treat pain entirely or in part with medical marijuana.”

For the past decade, patients, advocates, medical providers and lawmakers have fought to have cannabis rescheduled to reflect its accepted medical value, low abuse potential, and relative safety. However, their efforts can only do so much, since drug rescheduling can only occur through Congressional action (legislation) or the DEA’s administrative rulemaking process (petition).1

Conclusion:

Like all political debates, people continue to argue about the potential health benefits and dangers of cannabis usage; and constituents on both sides of the issue point to medical studies that reach different conclusions. Opponents of legalizing cannabis believe that it is a “gateway drug” to more dangerous drugs like heroin or cocaine. However, that is an ironic argument, since prescription painkillers – not cannabis – have been tagged as gateway drugs to heroin, and blamed for the rise in drug overdose deaths across the United States.5

At the end of the day, no matter which side of the debate people stand, there should be a mutual agreement that cannabis does not fit the description of a Schedule I drug. The focus of the marijuana debate should aim to reschedule the drug for medical purposes. With a Schedule I, II, or III classification, cannabis could be used and monitored responsibly to help relieve or manage the symptoms of patients with medical conditions such as cancer, human immunodeficiency virus, acquired immunodeficiency syndrome, hepatitis C, amyotrophic lateral sclerosis, Crohn’s disease, Parkinson’s disease, and multiple sclerosis.

This would be a win-win for patients, medical providers, and society as a whole in the United States, because patients would have more access to pain relief drugs without resorting to potentially-dependent and deadly prescription painkillers.

References:

  1. Regulatory Information. Food and Drug Administration Web site.http://www.fda.gov/regulatoryinformation/legislation/ucm148726.htm#cntlsba. Updated July 9, 2012. Accessed July 9, 2014.
  2. Drug scheduling. Drug Enforcement Administration Web site. http://www.justice.gov/dea/druginfo/ds.shtml. Accessed July 12, 2014.
  3. US Code 801 Definitions. Cornell University Law School. http://www.law.cornell.edu/uscode/text/21/802. Accessed July 6, 2014.
  4. Drug Poisoning Deaths. CDC Web site. http://www.cdc.gov/nchs/data/hestat/drug_poisoning/drug_poisoning_deaths_1999-2012.pdf. Published December 2, 2014. Accessed December 3, 2014.
  5. Prescription Drug Epidemic Testimony. American Society of Interventional Pain Physicians Web site. http://www.asipp.org/documents/testimony-fromexecutivecommittee-respondingtotheprescriptiondrugepidemic-strategiesforreduci.pdf. Published May 24, 2011. Accessed December 4, 2014.
  6. Degenhardt L, Hall W. Extent of illicit drug use and dependence, and their contribution to the global burden of disease. Lancet. 2012;379(9810);55-70.
  7. Bachhuber MA, Saloner B, Cunningham CO, Barry CL. Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999-2010. JAMA Intern Med. 2014;174(10):1668-1673.
  8. Young S. Medical marijuana laws may reduce painkiller overdoses. CNN Health Web site. http://www.cnn.com/2014/08/25/health/medical-marijuana-overdose-deaths/. Published August 26, 2014. Accessed December 4, 2014.

Lauren Whetzel is a public relations professional and graduate student in the Biomedical Writing program at University of the Sciences in Philadelphia. Her interests in health and government issues stem from years of working as a health care reporter and government publicist in Washington, D.C., and Harrisburg, Pa. A native of Cleveland, Ohio, Lauren earned her BA in communication studies from Thiel College.

12/05/2014

Medication Adherence and Hospital Readmissions

Whether patients are getting medications, seeing a primary care provider, discharged from a hospital, or getting emergency care, they are being shifted between different health care providers. Transitions of care is an important aspect of healthcare because it allows smooth movement of patients from one setting to another.

Transitioning from the hospital to home can be difficult for patients, potentially leading to readmission if the transition is not well coordinated. Kirkham conducted a retrospective cohort study in two acute care hospitals in the United States to see the effect of a collaborative pharmacist-hospital care transition care program on the likelihood of 30-day readmission rates. The two-year study showed patients who did not receive bedside delivery of post discharge medications and follow-up telephone calls were twice as likely to be readmitted within 30 days of discharged than those who did receive these services. For patients greater than 65 years of age, the pharmacist transition of care resulted in a six-fold decrease in 30-day readmission rates. As this study shows, a transition of care program can be associated with a lower likelihood of readmission and pharmacist participation can be of significant benefit.  

A study conducted by Bellone reviewed 131 patients aged 18 to 65 on at least three prescription medications. The intervention group consisted of patients that pharmacists visited within 60 days of discharge to provide medication counseling or dosage adjustments, while the control group did not receive any intervention. The intervention group had an 18.2% hospital readmission rate compared to 43.1% in the control group (P = 0.002).  Pharmacists can optimize medication adherence during transitions of care to reduce readmission rates. The American Pharmacist Association and American Society of Health-System Pharmacists released a Medication Management in Care Transitions Project to display popular models from across the country that improve patient outcomes by involving pharmacists in medication-related transitions of care. Some of the roles and responsibilities of pharmacists in these practices include: medication reconciliation, counseling on medication therapy, contacting the patient’s home for follow-up, preparing medications etc. Through these interventions pharmacists are involved in patient care from inpatient to home settings.

Transition of care pharmacists can be a beneficial aspect in the health care system. By providing appropriate interventions, pharmacists can decrease the likelihood of hospital readmission.

Urvi Patel, PharmD ‘16

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