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The Value of OTC Products and Consumer Self-Care

Lauren Lee, PharmD, MSDirector, Health Economics and Outcomes Research, Pfizer, Inc. June 1,2018

What is self-care?

According to the Association of the European Self-Medication Industry (AESGP):1

• Self-care includes actions and measures individuals take to improve their health and well-being, to prevent and decrease the likelihood of disease and to restore health after illness or injury.1

• Daily lifestyle choices and self-medication are the two main aspects of self-care.1

Preventive methods

Healthy eating

Treatment of certain chronic conditions

Exercise

Dietary supplements

OTC medicines

1. AESGP. About Self-Care. 2018; http://www.aesgp.eu/self-care/about-self-care/. Accessed 24 May, 2018.

2. Scorza. Is self-care the new health care? Society for Human Resource Management, Oct 26, 2015. https://www.shrm.org/hrdisciplines/benefits/articles/pages/self-care-healthcare.aspx. Accessed June 27, 2016.

Source: Scorza 2016.2

What is the Value of Self-Care?

• Self-care is becoming a vital part of the management and prevention of minor ailments and certain chronic conditions

• Over-utilization of valuable healthcare resources for self-treatable conditions reduces primary care access and contributes to rising healthcare costs

• OTC medicines for common minor ailments reduce costs spent on prescription drugs and physician/ER visits

• Expanding OTC access could lower system costs, reduce avoidable physician visits, and improve worker productivity

Valuable healthcare resources are over-utilized for self-treatable conditions, reducing primary care access and contributing to rising healthcare costs

• Use of emergency rooms for self-treatable conditions incurs avoidable costs for direct healthcare and lost productivity1

• A cost analysis study in Brazil estimated that 8% of all ER visits in 2013 resulted in prescriptions for minor ailments (colds, pain, and allergies)1

• Estimated cost of these unnecessary visits:BRL 56.12 million1

• Estimated additional costs for absenteeism due to ER visits: BRL 369 million1

BRL=Brazilian Real; ER=emergency room

Data sources: DATASUS and SIGTAP systems, US CHPA research (January 2012), IMS Health 2013 data, and Brazilian Ministry of Work IBGE data.

1. Ferreira CN, Santana CF, Rufino CS. The value of over the counter medicines in Brazilian public health system (SUS). ISPOR 20th Annual International Meeting, Philadelphia PA, May; 2015.

Every BRL 1 spent by consumers on OTC medicines saves BRL 7 by reducing ER visits and absenteeism1

Over-utilization of healthcare resources for self-treatable conditions reduces primary care access and contributes to rising healthcare costs

• 88% of 57 million GP consultations for minor ailments in the UK in 2007 were suitable for self-care1

• 90% of these visits included a prescription, accounting for £371 million of an estimated £2 billion in NHS annual spending on GP consults for minor ailments1

A&E=accident and emergency; GP=general practitioner; HB=heartburn; NHS=National Health Service; Rx=prescription given during consult.

Data source: Disease Analyzer (formerly MediPlus) from 4 million patients (2007). Costs assessed: GP consultations (n=57 million).

1. Pillay N, Tisman A, Kent T, Gregson J. The economic burden of minor ailments on the National Health Service in the UK. Self Care. 2010;1(3):105-116.2. IMS Health Ltd. Presentation of self treatable conditions (STCs) in A&E units in England – Executive Summary. 2015. http://www.pagb.co.uk/publications/pdfs/PAGB_A&E_Executive_Summary_June%202015_Final.pdf.

About 19% of visits to A&Es in England in 2014 were for self-treatable conditions, at an annual cost of £290 million2

Minor ailments result in productivity losses when employees take time off to see a physician or go to work sick

• In the US, 27 of the most common chronic conditions cost $165 billion annually in lost productivity1

• Of the 12 of these conditions that have OTC treatments, self-medication is reported at only 15% to 39%; net annual lost productivity for these 12 conditions range from $3 billion to $45 billion1

CHWP=Center for Workforce Health and Performance; GERD=gastro-esophageal reflux disorder

Costs were estimated using the Integrated Benefits Institute (IBI) Full Cost Estimator (FCE) modeling tool.Data source: Self-reported prevalence and treatment rates from the Health and Work Performance (HPQ) Select database.

1. Jinett K. The Center for Workforce Health and Performance; 2016. Consumerism, Self-Care Trends and the Broader Value of Employee Health.

OTC medicines are an essential part of healthcare worldwide• Self-care is increasingly becoming a vital part of the management and prevention

of minor ailments and chronic conditions

• In a global online survey of more than 25,000 adults in 50 countries by Nielsen in 2009:1

• 33% reported taking an OTC medicine either “always” or “usually” at the first sign of a minor ailment1

• 95% were at least open to taking OTCs for minor ailments1

• In a population-based UK survey (n=2,474 adults), the most common action to relieve symptoms of minor ailments in the prior 2 weeks:2

• Lay care:* 35% (OTC was most common at 25%)2

• Consult a primary care health professional (usually GP): 12%2

• Did nothing: 49%2

1. The Nielsen Company. The Changing Landscape – A Multi-Country Study Undertaken with AESGP. 2009. http://www.pagb.co.uk/publications/pdfs/AESGPResearchJun09.pdf.2. Elliott AM, McAteer A, Hannaford PC. Revisiting the symptom iceberg in today's primary care: results from a UK population survey. BMC Fam Pract. 2011;12:16.

* Lay care=OTC, looked for information, discussed with family/friends, or other. Note: individuals could report more than one action.

Many people in Latin American countries are using OTC medicines to treat minor ailments

• About 15% to 18% of Brazilians self-medicate with common OTC medicines that treat minor ailments

• In a survey of >30,000 adult residents of urban areas of Brazil (2013-2014), 18% reported self-medicating (ie, took a medication in the prior 15 days without a physician recommendation)1

• Non-prescription medicine already stocked at home: 74%1

• Previous use of the same medicine: 74%1

• In a survey of 1,800 adults living in the Federal District of Brazil in 2012, 15% reported self-medicating in prior week2

• Most common medicines: analgesics (39%) and anti-inflammatories/anti-rheumatics (10%)2

1. Pons EDS, Knauth DR, Vigo A, Group PR, Mengue SS. Predisposing factors to the practice of self-medication in Brazil: Results from the National Survey on Access, Use and Promotion of Rational Use of Medicines (PNAUM). PLoS One. 2017;12(12):e0189098.

2. Domingues PHF, Galvao TF, Andrade KRC, Araujo PC, Silva MT, Pereira MG. Prevalence and associated factors of self-medication in adults living in the Federal District, Brazil: a cross-sectional, population-based study. Epidemiol Serv Saude. 2017;26(2):319-33.

Brazilians across the country self-medicate for minor ailments, and many consult community pharmacists for advice

• According to a cross-sectional survey of >40,000 individuals in Brazil in 2014, 16% reported self-medicating during prior 15 days1

• Highest rate was 24% in the Northeast region1

• Most used non-prescription medications for self-limited, acute conditions: analgesics (33%), muscle relaxers (15%), anti-inflammatories (12%), and cough and cold remedies (6%)1

• According to 533 community pharmacists surveyed in the state of Parana, Brazil in 2013-2014, 33% of their medication counseling on a daily basis is related to advice about OTC products2

1. Arrais PS, Fernandes ME, Pizzol TD, et al. Prevalence of self-medication in Brazil and associated factors. Rev Saude Publica. 2016;50(suppl 2):13s.

2. Halila GC, Junior EH, Otuki MF, Correr CJ. The practice of OTC counseling by community pharmacists in Parana, Brazil. Pharm Pract (Granada). 2015;13(4):597.

Consumers in Colombia commonly self-medicate for minor ailments, such as headaches and colds

• A cross-sectional survey of 414 adults in Pereira, Colombia in 2013 reported the following:1

• Any self-medication ever: 78%1

• Self-medication in the prior month: 32%1

1. Machado-Alba JE, Echeverri-Catano LF, Londono-Builes MJ, Moreno-Gutierrez PA, Ochoa-Orozco SA, Ruiz-Villa JO. Social, cultural and economic factors associated with self-medication. Biomedica. 2014;34(4):580-588.

Most common ailments1 Most common medicines used

Headache: 56% Analgesics and antipyretics: 44%

Common cold: 16% NSAIDs: 36%

Muscle pain: 13% Antihistamines: 9%

OTC medicines are commonly used to treat nasal allergies across Latin American countries

• A survey of 1,088 adults and 457 children and adolescents (aged 4 to 17 years) with nasal allergies or allergic rhinitis included 8 Latin American countries: Argentina, Brazil, Mexico, Chile, Colombia, Ecuador, Pero, and Venezuela1

• Across the 8 countries, use of OTC medicines within the prior 4 weeks to treat nasal allergy symptoms:1

• Adults: 42%1

• Children/adolescents: 25%1

1. Neffen H, Mello JF, Jr., Sole D, et al. Nasal allergies in the Latin American population: results from the Allergies in Latin America survey. Allergy Asthma Proc. 2010;31 Suppl 1:S9-27.

OTC medicines avert productivity loss incurred when employees go to work sick (presenteeism) and take time off for doctor’s visits (absenteeism)

Estimated US savings from employee use of OTC drugs

• At least US $23 billion annually in avoidance of productivity losses due to physician visits (Booz & Co. study)1

• $250‒$296 billion total savings from reducing presenteeism and regaining worker productivity (based on data from studies of Dow Chemical Company and JP Morgan Chase Banking Corp)2

Navistar International2

• Used employee manuals to encourage self-care and use of OTC drugs2

• Savings from employee use of OTC products estimated at US $1‒$2 million annually over 10+ years through avoidance of Rx drug costs, physician visit payments, and associated absenteeism2

1. Booz & Co. and the Consumer Healthcare Products Association. The Value of OTC Medicine to the United States. 2012. 2. Institute for Health and Productivity Management. 2015. https://www.ihpm.org/pdf/IHPM_self-care_lores.pdf.

Managing commonly occurring minor ailments with OTC products reduces costs for prescription drugs and physician visits

OTC medicines for migraine and headaches save the German healthcare system an estimated €965 million to €1,101 million annually by reducing Rx and physician visit costs1

1. Göbel H, Braun J, Petersen-Braun M, Gessner U. Pharmacoeconomical benefit of OTC-medicines in Germany – empirical study on migraine and headaches. Gesundh ökonQual manag. 2015;55(2):e183-e184.

• Incremental costs for eliminating OTC for migraine/headache:1

– Physician visits: €707.8 million net extra (€696.8 to €832.9 million for added consultations minus eliminated costs)1

– Rx: €393.2 million1

Study: Economic model based on representative population survey of individual insured through the GKV, which covers the majority of German citizens.

Data source: 2013/2104 physicians fees and prescribed medicinal products.

OTC products and self-care provide economic benefits in managing many commonly occurring conditions

1. Booz & Co. and the Consumer Healthcare Products Association. The Value of OTC Medicine to the United States. 2012.

2. Klepser ME. Socioeconomic impact of seasonal (epidemic) influenza and the role of over-the-counter medicines. Drugs. 2014;74(13):1467-1479.

• US annual spending on influenza: $87.1 billion (2003 USD)1

• OTC saves the US $102 billion annually, nearly one-third of which comes from products for cough, cold, and flu, with savings primarily from 2 cost categories:2

– Rx drug cost savings: $25 billion2

– Avoided clinical visits: $66 billion2

OTC medicines for common minor ailments provide substantial saving for both consumers and health systems

In a 2008 Nielsen survey of >17,000 US adults with heartburn:1

• 55% used only OTC heartburn medicines to relieve their symptoms1

• Estimated annual health system savings through reduced physician office visits for heartburn: US $757 million1

• Estimated annual savings to consumer in physician visits and medications: US $1741

A Canadian model estimated that switching a histamin-2 receptor antagonist medicine used for heartburn from Rx to OTC provided the following over 16 weeks of treatment:2

• Reduced costs by CAN $6 per patient (1993 cost basis) for the provincial third–party payer2

• No increase in total costs for patients2

1. Mansfield JE, Callahan D. Benefits of over-the-counter heartburn medication to consumers and the healthcare system. NielsenHealth, The Nielsen Company; December 7, 2008.

2. Tasch RF, Goeree R, Henke CJ, O'Brien BJ. Switching the histamine H2 receptor antagonist famotidine to nonprescription status in Canada. An economic evaluation. Pharmacoeconomics. 1996;9(1):61-75.

OTC with or without Rx pain medication in pain management provides substantial incremental economic benefits• OTC pain medications in the US significantly reduce presenteeism, overall work impairment,

and activity impairment1

• OTC + Rx also significantly reduces activity impairment vs Rx alone1

1. Lee LJ, DiBonaventura M, Kudel I, Schepart A, Kellstein D. The incremental effect of over-the-counter medications on work productivity and healthcare resource utilization among adults with pain in the United States. Presented at the ISPOR 21st Annual International Meeting, May 21–25. 2016; Washington, DC.

P values for untreated vs OTC only and Rx only vs OTC+Rx are displayed. Additional significant between-group differences favored untreated vs Rx only; untreated vs OTC+Rx; OTC only vs Rx only; and OTC only vs OTC+Rx for all 4 domains of the WPAI-GH (P<0.0001 for each comparison for each respective domain).

WPAI-GH=Work Productivity and Activity Impairment–General Health.

Study was a non-interventional, cross-sectional study; data source: 2013 US National Health and Wellness Survey (NHWS; n=75,000).

Rx-to-OTC switch provide economic benefits in managing many minor health conditions that can be self-treated

• Allergic rhinitis: A US model predicted that reclassifying non-sedating second-generation antihistamines to OTC availability would result in:1

• Annual direct cost savings of US $100 per patient, or about US $4 billion total (2001 cost basis) or about US $4.9 billion when productivity cost is included1

• Savings includes reduction in costs due to accidents/injuries caused by sedating effects of currently available OTC first-generation antihistamines1

• Vaginitis: An analysis following the reclassification of vaginal fungal products from Rx to OTC at one US healthcare plan over 1 year showed:2

• Medication cost savings: US $42,528 (1991 cost basis)2

• Physician visit cost savings: US $12,768 to $25,729 (depending on use of laboratory testing)2

• Common cold: A US cost-minimization analysis estimated that if the cough medicine dextromethorphan was available only by prescription rather than OTC:3

• Incremental cost increase (physician office cost, missed work for visit, and medication):US $22-31 billion over 2016-20253

1. Sullivan PW, Follin SL, Nichol MB. Transitioning the second-generation antihistamines to over-the-counter status: a cost-effectiveness analysis. Med Care. 2003;41(12):1382-1395.

2. Gurwitz JH, McLaughlin TJ, Fish LS. The effect of an Rx-to-OTC switch on medication prescribing patterns and utilization of physician services: the case of vaginal antifungal products. Health Serv Res. 1995;30(5):672-685.

3. Rankin PJ, Tsvetkova IV, Estus M, Nah N, Senne B. Managing Access to Dextromethorphan: Cost Implications of a Potential Over-the-Counter to Prescription-Only Conversion. Boston, MA: Charles River Associates; 2016.

Rx-to-OTC switching provides quick access to safe, effective treatment for minor ailments and can help meet the healthcare needs of underserved populations

• A 10-year US study (1999 to 2010) found that overall utilization (Rx + OTC) increased by >30% after introduction of a first OTC medicine, including:2

• Weight loss drugs: 88% increase 2

• Emergency contraception: 40% increase2

• Antihistamines: 13% increase2

1. Milonas, A., C. Milonas, G. Dokios, D. Kouvelas and N. Maniadakis (2012). The benefits of using OTC: a systematic literature review. ISPOR 15th Annual European Congress, Berlin Germany, November.2. Stomberg, C., T. Philipson, M. Albaugh and N. Sood (2013). "Utilization effects of Rx-OTC switches and implications for future switches." Health 5: 1667-1680.

A systematic literature review found that OTC medicine have many benefits to patients1

ü Increased access to treatmentü Greater drug utilizationü Reduced travel cost and physician paymentsü Increased productivity

Expanding OTC access could lower system costs, reduce avoidable physician visits, and improve worker productivity

• The benefit of a hypothetical switch from publicly funded Rx drug for mild conditions to OTC in Spain was estimated at €3.125 billion1

• Improved primary care: €2.26 million1

• Avoided absenteeism: €507 million1

• Optimized patient time: €579 million1

• Reduced public spending: €979 million1

• Negative effects:1

• Increased privately funded drugs: €1.165 million1

• Cost of improving self-care: €35 million1

1. Pelise L. and Serra M. The economic impact of an hypothetical Rx-to-OTC switch in Spain. Presented at ISPOR 18th Annual European Congress, Milan Italy, November. 2015.

Expanding access to new OTC medicines and increasing options within current categories could deliver a wide range of efficiencies

Over 10 years, a Rx-to-OTC statin drug switch in the US is estimated to result in:1

• 293,492 fewer major CV events (strokes, major coronary events)1

• 135,299 fewer coronary revascularization procedures1

• 68,534 fewer deaths from CV events*1

• Healthcare cost reduction of $10.8 billion1

• Drug therapy increase of $28.3 billion1

ICER of OTC statins: $5,667 per QALY (95% CI: $1,384, $12,701)1

CV=cardiovascular; ICER=incremental cost effectiveness ratio; QALY=quality-adjusted life years.*Overall reduction in deaths estimated at 68,055, assuming 479 additional deaths due to rhabdomyolysis, a rare but severe AE associated with statins.

1. Stomberg C, Albaugh M, Shiffman S, Sood N. A Cost Effectiveness Analysis of OTC Statins. American Journal of Managed Care. 2016;22(5)e175-e184.

OTC statins were found to be cost-effective in improving population cardiovascular health in this study1

Expanding access to new types of OTC medicines and increasing options within current categories could lower system costs, reduce avoidable physician visits, and improve productivity

• The potential direct healthcare system savings for switching from Rx-to-OTC triptans for migraine treatment in 6 EU countries were estimated at as much as €75 million, or 13% of the current cost burden for migraine, according to a cost decision study1

• An additional €86 million in potential societal savings could be gained from avoidance of productivity loss due to absenteeism and presenteeism resulting from migraine attacks1

• In a systematic review of studies assessing the economic impact of Rx-to-OTC switches (US, UK, EU), 75% of the 12 studies reviewed predicted cost savings for both payers and patients2

1. Millier A, Cohen J, Toumi M. Economic impact of a triptan Rx-to-OTC switch in six EU countries. PLoS One. 2013;8(12):e84088.

2. Cohen J, Millier A, Karray S, Toumi M. Assessing the economic impact of Rx-to-OTC switches: systematic review and guidelines for future development. J Med Econ. 2013;16(6):835-844.

Summary: Key takeaways from studies presented in this slide deck

• Self-care is becoming a vital part of the management and prevention of minor ailments and certain chronic conditions

• Over-utilization of valuable healthcare resources for self-treatable conditions reduces primary care access and contributes to rising healthcare costs

• OTC medicines for common minor ailments reduce costs spent on prescription drugs and physician/ER visits

• Expanding OTC access could lower system costs, reduce avoidable physician visits, and improve worker productivity