Inhaled Respiratory Medications: Where are the Generic Substitutes?

Inhaled respiratory medications have been the standard of care for patients with respiratory disease such as asthma and COPD.  The cost of asthma has grown from $53 billion in 2002, growing to $56 billion in 2007, just over 6% per year. ¹ In addition, the cost of medication has also increased. Over the past 10 years there has been more than 15 different medications approved which include an array of beta-agonists, anticholinergics, corticosteroids, and combination products.

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The challenge with all these medications has been the financial burden passed on to patients due to their cost. Since 2009, the cost of inhaled asthma medications have increased by an average of 50%. ² Many of the brand inhalers cost over $200, which can be an extraordinary cost if patients require two or more devices or have limited or no insurance coverage. 

At this time, there are no generic alternatives for the orally inhaled respiratory medications commonly prescribed for asthma and COPD. ³ Since the FDA approved an outright ban on CFC based inhalers in 2009, due to its impact on the environment; HFA based propellants are now the standard. Based upon this change, pharmaceutical companies have developed brand products with new delivery systems driving up costs tremendously.  Recently, in AnnalsATS, Longphre and colleagues report the pharmacodynamics bioequivalence of a generic substitute for Advair (fluticasone propionate/ salmeterol). ⁴ Since Advair was FDA approved in 2000, why has it taken more than 15 years for a generic substitute to be evaluated?

Generic substitutes are vital for our patients to maintain medication compliance to improve their quality of life. I am concerned that it may take years for a generic alternative for a brand product to make it to market. Many patients will end up absorbing the exorbitant cost of their medications or will simply not take them at all. I would welcome comments from pharmacists including experience you have had about this issue. We can do better than this for the patients we serve.  

References

1. Asthma and Allergy Foundation of America. Cost of asthma on society. https://www.aafa.org/page/cost-of-asthma-on-society.aspx. Accessed Feb 6, 2017
2. Consumer Reports. Evaluating inhaled steroids used to treat asthma. consumerreports.org/health/resources/pdf/best-buy-drugs/InhaledSteroidsFINAL.pdf. Accessed Feb 11, 2017.
3. Gerald JK. Generic competition for orally inhaled respiratory medications. Two steps forward, one step back. Ann Am Thorac Soc 2017; 14(2); 165-167.
4. Annals of the American Thoracic Society. Clinical bioequivalence of OT329 SOLIS and ADVAIR DISKUS in Adults with Asthma. https://www.atsjournals.org/doi/full/10.1513/AnnalsATS.201606-436OC. Accessed Feb 11, 2017