Assessing the economic impact of Rx-to-OTC switches: systematic review and guidelines for future development

Figures & data

Table 1. Rx-to-OTC switches since 2000 in the US, the UK, France, and The Netherlands.

Drug	US	UK	France	Netherlands
Adenosine		2004
Alclometasone		2009
Ambroxol				2004
Amorolfine		2006	2010
Azelastine			2005
Azithromycin		2008
Beclometasone			2002
Cetirizine	2007
Chloramphenicol		2005
Clobetasone		2001
Docosanol	2000			2008
Fenticonazole		2001
Fexofenadine				2008
Flurbiprofen		2001	2005
Fluticasone		2002
Ketotifen	2006
Ipratropium bromide				2009
Levocabastine			2009
Levonorgestrel	2006	2001		2005
Loratadine	2002		2006
Naproxen		2007
Omeprazole	2003	2004	2010	2008
Orlistat	2007	2009*	2009*	2009*
Nicotine	2002	2001		2000
Nizatidine	2009
Pantoprazole		2009*	2009*	2009*
Penciclovir		2006	2000
Polyethylene glycol	2006
Prochlorperazine		2001
Simvastatin		2004
Sumatriptan		2006
Tamsulosin		2009
Terbinafine		2001	2002
Tranexamic acid		2010

*EU centralized switch, applicable to all 27 EU members. Only two successful pan-European regulatory approvals using the centralized process.

Table 2. Search strategy.

Database	Search terms
Embase	([english]/lim OR [french]/lim) AND [2000–2011]/py) AND (‘switch’ OR ‘move’ OR ‘moving’ OR ‘changing’ OR ‘status’ OR ‘changes’) AND (‘otc’ OR ‘over-the-counter’ OR ‘counter’ OR ‘nonprescription’ OR ‘non-prescription’ OR ‘self medication’/exp OR ‘self medication’ OR ‘self care’/exp OR ‘self care’) AND (rx OR ‘prescriptions’/exp OR ‘prescriptions’ OR prescribed) AND (‘economics’/exp OR ‘economics’ OR ‘health economic evaluation’ OR ‘costs’ OR ‘cost’ OR ‘cost’/exp OR cost OR ‘analysis’ OR ‘analysis’/exp OR analysis OR costing OR costly OR ‘budget impact’ OR ‘decision making’/exp OR ‘decision making’ OR ‘cost-benefit’/exp OR ‘cost-benefit’ OR ‘managed care’/exp OR ‘managed care’ OR ‘managed care programs’/exp OR ‘managed care programs’ OR ‘cost-of-illness’/exp OR ‘cost-of-illness’ OR ‘payers’ OR ‘impact’ OR ‘out-of-pocket’ OR ‘co-payment’)
Medline	(Limits: English, French, published in the last 10 years) AND (Economics OR costs OR cost OR costing OR costly OR ‘budget impact’ OR ‘Decision Making’ OR ‘comparative study’ OR ‘cost-benefit analysis’ OR ‘cost-minimization analysis’ OR ‘Cost’ OR ‘managed care’ OR ‘Managed Care Programs’ OR ‘Decision Support Techniques’ OR ‘Cost-of-Illness’) AND (Rx OR prescriptions OR prescribed OR prescription) AND (‘OTC’ OR ‘over-the-counter’ OR ‘counter’ OR ‘nonprescription’ OR ‘non-prescription’ OR ‘self medication’ OR ‘self care’)
ISPOR	‘OTC’, ‘Over the counter’, ‘Non prescription’ [abstract]
Google Scholar	(OTC or ‘over the counter’ or ‘non prescription’ or ‘self medication’) and (prescription or prescribed or Rx) and (switch or move or change) (date 2000–2010)

Table 3. General characteristics of studies included in the review.

Ref	Type	Authors	Year	Country	Sponsor	Therapeutic area	Objective	Type of analysis	Type of model
[10]	Full paper	Cohen and DiMasi	2001	US	Independent	Allergy	To estimate the impact of a loratadine switch by using an economic model to compare two treatment pathways (pre- and post-switch) in term of cost, effectiveness, and safety	BIA	Decision tree
[11]	Full paper	Sullivan et al.	2003	US	Independent	Allergy	To assess the cost-effectiveness of switching loratadine from Rx-To-OTC status	BIA + CEA	Decision tree
[12]	Full paper	Sullivan and Nichol	2004	US	Independent	Allergy	To assess the economic impact of payer policies following an Rx-to-OTC switch of loratadine	BIA + CUA	Decision tree
[13]	ISPOR poster	Amirsadri-Naeini and Jackson	2008	UK	Independent	Dyslipidemia	To consider the cost-effectiveness of POM statins, OTC statin, and plant sterol/stanol products from the perspective of middle-aged males at moderate CVD risk when used according to current UK guidance for the primary prevention of CVD	CUA	Markov model
[14]	ISPOR abstract	Gandhi et al.	2006	US	Independent	Dyslipidemia	To compare the cost-utility of statins available via prescription vs hypothetical OTC status in the US	CUA	NA
[15]	ISPOR abstract	Gandhi et al.	2006	US	Independent	Dyslipidemia	To evaluate the cost-effectiveness of statins available by prescription vs OTC from a societal perspective	CEA + BIA	NA
[16]	Full paper	Kalish	1997	US	Johnson & Johnson Merck Consumer Pharmaceuticals	Gastro-enterology	To assess the societal costs of the treatment of dyspepsia prior to and after to OTC availability of the H2RAs	BIA	Decision tree
[17]	Full paper	Kunz et al.	1996	US	Johnson & Johnson Merck Consumer Pharmaceuticals	Gastro-enterology	To calculate the potential cost savings for a managed care organization (MCO) after switching appropriate patient from a prescription to OTC treatment of heartburn/non-ulcer dyspepsia	BIA	Decision tree
[18]	Full paper	Zhu et al.	2001	US	Independent	Contraception	To assess the economic value of moving oral contraceptives to OTC status	BIA	Decision tree
[19]	Full paper	Keeler et al.	2002	US	Pfizer	Smoking cessation	To assess the social benefit from the RX-to-OTC switch of nicotine replacement drugs (nicotine patches and gum) based on available data from the literature and estimations methods	BIA	Micro-simulation
[20]	ISPOR poster	Chang and Nichol	2009	US	Independent	Virology	To assess the cost implications of transitioning valacyclovir to OTC status and examine episodic and suppressive treatment models for genital herpes	BIA	Decision tree
[21]	Report	AESGP	2004	Austria, France, Germany, Italy, Portugal, Spain, UK	Independent	General	To develop a model assessing the economic impact of an Rx-to-OTC switch for European health care systems as well as the effects on public health	BIA	NA

AESGP, Association of the European Self-Medication Industry.

Table 4. Economic impact associated with Rx-to-OTC switches.

Ref	Authors	Year	Country	Therapeutic area	Drug	Perspective	Estimated savings	Observation	Strengths	Limitations
[10]	Cohen and DiMasi	2001	US	Allergy	Loratadine	Insured patient, uninsured patient, payer	Uninsured patients would save 80% following the switch; unclear impact for insured patient	Fewer physician visits, lower drug prices	Includes algorithm taking into account treatment failures due to lack of effectiveness or safety	Unclear how safety is incorporatedAssumes that each physician visit to obtain a prescription will be avoidedAssumes that untreated patients are not eligibleTheoretical model
[11]	Sullivan et al.	2003	US	Allergy	Loratadine	Societal	Estimated annual savings of $4 billion	Savings derive largely from avoiding adverse events from first-generation anti-histamine use	Includes utilization rates of first- and second-generation antihistamines before and after the switch	Only reports total savings, without a breakdown into cost components
[12]	Sullivan and Nichol	2004	US	Allergy	Loratadine	Managed care organization, employer, and Medicaid	OTC with policy change would save Medicaid $0.02 per member per month (PMPM)	By providing limited OTC coverage while retaining generous Rx coverage for other second-generation antihistamines	Shows potential impact of various payer policies on the overall budget impact of an OTC switch	Projection of potential impact in the absence of real data
[13]	Amirsadri-Naeini and Jackson	2008	UK	Hypercholesterolemia	Statins	Patient	From the patient’s perspective, the most cost-effective intervention to prevent CVD is POM statins (£1827.82/QALY)	Assumption is that lower dose OTC statin has same effectiveness as higher dose	No detailed description of the methodology to identify strengths	No detailed description of the methodology to identify limitations
[14]	Gandhi et al.	2006	USA	Hypercholesterolemia	Statins	Societal	OTC statins cost-utility of $1434/QALY compared to $1867/QALY for Rx statins	OTC statins were observed to be the optimal strategy choice.	No detailed description of the methodology to identify strengths	More costs could be included in the overall assessment such as lab monitoring costs, adverse events monitoring costs, compliance, and adherence measures
[15]	Gandhi et al.	2006	US	Hypercholesterolemia	Statins	Societal	From the patient’s perspective, the most cost-effective intervention to prevent CVD is a POM statins (£1827.82/QALY)	Assumption is that lower dose OTC statin has same effectiveness as higher dose.	Different statin agents were compared in the analysis	No detailed description of the methodology to identify limitations
[16]	Kalish SC, Bohn RL, Avorn J	1997	US	Gastro-enterology	Cimetidine, Ranitidine, Famotidine	Payer and societal	No substantial cost saving (payer and patient perspective)	The possible increase in costs following problems with OTC H2RAs use	Evaluation of possible increase in costs following the failure of OTC H2RAs use	Only considers the symptomatic population
[17]	Kunz et al.	1996	US	Gastro-enterology	Famotidine	Managed care organization	25% reduction in the overall cost	From avoiding unnecessary physician visits, laboratory tests, and prescriptions	As the model considers patients receiving chronic treatment, results were presented for 5 years that corresponded with new and continuing patients	Does not consider episodic patients
[18]	Zhu et al.	2001	US	Contraception	Oral contraceptive (OC) pills, Ethinyl Estradiol	Societal	$12.6 billion in savings annually	Savings from unintended pregnancies avoided	Analysis of costs comparing the cost impact of OTC pill availability	No detailed sensitivity analysisAll costs obtained from literatureSwitch rates may not be accurate to all geographic locations and some local differences may exist
[19]	Keeler et al.	2002	US	Pulmonology	Nicotine replacement therapy (NRT)	Societal	Estimated annual net ‘social value’ was ∼$1.8–2 billion in 1995	Calculations were made from the statistical value of a life saved	A demand function was developed for patches and gumHas to estimate the demand after the switchDemonstrated no significant price-sensitivity	No consideration of costs of misuse
[20]	Chang and Nichol	2009	US	Virology	Valacyclovir	Societal	Potential savings is $736 billion in direct medical expenditures	The savings are due to lower drug prices and a decrease in physician visits	Comparison of two treatment regimens (episodic and suppressive) both as a prescription and OTC status	No consideration of costs that could impact savings (such as herpes education, viral resistance, self-diagnosis, indirect cost, and the financial and quality-of-life impact of delayed treatment)Not all the population were included (only Rx population)
[21]	AESGP	2004	Austria, France, Germany, Italy, Portugal, Spain, UK	General	General	Societal	Saving to public funds just over €16.4 billion	The switch of 5% of Rx drugs to OTC status within Europe would result in fewer physician visits and an increase in worker productivity	Switch impact both from a local level (some EU countries) and from an EU perspective by projecting the results of the studied countries	No consideration of indirect costs due to inappropriate useNo consideration of potential adverse events

AESGP, Association of the European Self-Medication Industry.