Many patients are not compliance with their prescribed medication, and estimates of the total cost to the system range up to nearly $300 billion annually. How much money could be saved if patients were compliant with their inhaled medications, and what are developers doing to improve compliance?

Compliance with medication is an ongoing concern for physicians across all specialty types and is beginning to attract attention from policy makers and payers. Non-compliance is a particular concern in chronic conditions like asthma and COPD, where patients often continue to decline unless their disease is brought under control using a daily medication. When asked, patients offer a variety of reasons for not adhering to their prescribed mediation, including a perception that daily medication is not required because they currently do not feel sick (COPD: Current Treatment: EU5, brochure available upon request). Additionally, for asthma and COPD, which are often managed using inhaled medication, difficulty in taking the dose correctly can discourage patients and lead to non-compliance. However, in the United States, cost is often a major concern; many patients experience high out-of-pocket costs for their medication, and this becomes especially burdensome when managing chronic disease. Overall, the cost of non-adherence in the U.S. healthcare system is estimated to be between $100 and $290 billion annually; however, this estimate has not been updated to reflect the current state of the healthcare system (Viswanathan M et al., Annals of Internal Medicine 2012;157(11):785-795). Here, I estimate the cost to the healthcare system due to non-compliance to asthma and COPD medication, using data from DRG’s Epidemiology reports and market forecast, along with some cost assumptions and clinical trial data.

For both asthma and COPD, physicians are concerned with both day to day control of symptoms to improve patient’s quality of life and preventing exacerbations. In both diseases, exacerbations are severe events in which a patient experiences a sudden worsening of symptoms; in asthma, these events can lead to ER visits and hospitalization. For COPD, exacerbations often correspond with an acute infection and frequently trigger an increase in medication. For both diseases, these represent significant costs to the healthcare system, and in this piece, the cost of treating exacerbations will be used as an estimate of the long-term costs of the disease.

Using a combination of DRG’s epidemiology reports for asthma and COPD, along with data from our market forecast reports for both diseases, I estimate that just over 1.75 million of the United States’s moderate to severe asthma patients are not receiving optimal treatment to prevent exacerbations, along with just over 1 million COPD patients. As a note of caution, I used our estimates of compliance in this calculation; DRG estimates patient compliance using a combination of real-world evidence, primary market research, and interviews with key thought leaders, and as such represents a relatively robust estimate of compliance. In COPD and asthma, it can be used as a proxy for the number of missed doses, but here I applied it to the total population as if some patients were taking all of their doses and some were taking none. This simplifies my calculations by giving a concrete number of patients for further calculations, but in reality, it is more likely that an individual patient is partially compliant, rather than either wholly compliant or completely noncompliant.

Using these estimated numbers of non-compliant patients along with the price per treated day for maintenance therapies, the cost of bringing all of these asthma and COPD patients completely in line with their prescribed treatment would be slightly over $3 billion for COPD and over $8 billion in asthma, making up about 20% of the COPD market and near half of the 2015 asthma market! Estimations of exacerbation frequency and severity vary, but evidence suggests that the severe to very severe COPD population experiences 1-2 exacerbations per year. I assume a cost of $10,000 per exacerbation and using a conservative estimate of the number of exacerbations (about 2.8 million per year), estimate a total cost of $28 billion per year to the US health system (Perera P et al., COPD: Journal of COPD. 2012;9(2):131-141). Current therapies available for COPD have demonstrated an ability to reduce exacerbations from about 25-30% per year, resulting in a savings of at least $7.125 billion. Therefore, the cost savings would be over $4 billion per year if all patients were completely compliant with their prescribed COPD medication, accounting for the cost of medication.

In asthma, exacerbations resulting in critical care or hospitalization are less frequent, with an average severe patient experiencing one only every 2 years, rather than 2 per year, and are somewhat less costly, possibly because asthma is characterized by reversible airflow obstruction, while COPD is typically irreversible; using DRG’s epidemiology, I estimate 1.6 million total exacerbations per year. Previous research has estimated a total cost of $2.2 billion to the healthcare system for treated acute asthma episodes (Suruki R et al. BMC Pulmonary Medicine. 2017;17(74):1-1, Zein J et al., PLOS One. 2016;11(6):e0157301., Altawalbeh S et al., Value in Health. 2016;19(5):537-543). Current inhaled treatments can offer a 20% reduction in exacerbations; biologic therapies offer a larger reduction, up to 60%. Using DRG’s market forecast drug share values to calculate the number of exacerbations that could be prevented, I estimate a savings of only $748 million if all patients were perfectly compliant, which is blown away by the medication cost of $8 billion; however, the launch of generic LABA/ICS FDCs could make significant inroads on these medication costs, especially if uptake is high.

However, it is important to note that exacerbation frequency is only a rough proxy of the cost of undertreating respiratory disease. On top of the direct cost of exacerbations, there is evidence that patients who have experienced multiple COPD exacerbations, usually those with more severe disease and with complicating comorbidities, have higher (as much as double) all-cause costs to the healthcare system (Dhamane D et al., Int J Chron Obstruct Pulmon Dis. 2015;10:2609-2618, Pasquale M et al., Int J Chron Obstruct Pulmon Dis. 2012;7:757-764). The same is true for asthma (Ivanova J et al., J Allergy Clin Immunol. 2012;129(5):1229-1235). Additionally, more sophisticated analysis takes into account the improved quality of life for patients along with both direct and indirect costs to the system.

Additional biologic therapies are anticipated to launch for both asthma and COPD in the coming years, and these drugs are forecast to be substantially more expensive than inhaled therapies. However, these will likely be reserved for the most severe, and most costly, patients, and market access for these therapies will likely rely on sophisticated cost-effectiveness calculations. As generic inhaled therapies are entering the market, current marketers are anticipating this competition by launching once-daily therapies and fixed-dose combinations that are intended to improve compliance, thereby delivering cost offsets. Additionally, inhalers are becoming increasingly sophisticated, and many of the emerging technologies will emphasize an ability to increase compliance by adding smart features to the device. However, it remains to be seen if physicians will find these changes sufficient reason to pay extra for them, but again, possible cost offsets to the healthcare system will be a compelling reason to prescribe (see upcoming Special Topics: Devices in COPD and Asthma; brochure available upon request).

Although my “back of the envelope” calculation for asthma did not reveal any cost savings due to preventing exacerbations, it did estimate a savings of $4 billion for COPD. As healthcare costs continue to rise in the United States and globally, patient adherence will likely remain the low hanging fruit to control long-term spending in many diseases. Additionally, improvements in quality of life can be significant, especially for chronic conditions like asthma and COPD, and increased QOL can also feed back into the economy by improving school attendance and decreasing missed days of work, so concerns about the relationship between cost and compliance will go far beyond the simple direct costs estimated here.

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