Elsevier

Health Policy

Volume 102, Issues 2–3, October 2011, Pages 159-169
Health Policy

Analysis of the impact of removing mucolytics and expectorants from the list of reimbursable drugs on prescription rates: A time-series analysis for France 1998–2010

https://doi.org/10.1016/j.healthpol.2011.07.001Get rights and content

Abstract

Objectives

After a comprehensive review of the therapeutic advantage of all drugs reimbursed by the French Public Health Insurance, a large number of drugs were removed from the list of reimbursable drugs, among them mucolytics and expectorants (ATC Class R05C) in March 2006. The aim of this study is to evaluate the impact of this measure on the mucolytic and expectorant class, on the prescription of possible substitute drugs (other bronchodilators, antitussives and antibacterials) and on the costs for Public Health Insurance.

Methods

Prescription data were taken from a 850 French physicians sample surveyed by the IMS-Health Permanent Survey on Medical Prescription from 1998 to 2010. We performed linear segmented regression to determine changes in the level and slope of the prescription rates and to estimate the budget impact.

Results

Following their removal from the list of reimbursable drugs, the prescription rate for mucolytics declined significantly and we recorded an increase in the prescription rates for antitussives and bronchodilators. The medically unexpected increase in antitussives can be viewed as a negative side-effect of the policy. Four years after the reform, total savings for Public Health Insurance were estimated at EUR 32.1 million.

Conclusions

Further removals from the list of reimbursable drugs should take into account the possibility of negative impact on public health and potential savings.

Introduction

Pharmaceutical expenditures are growing significantly in most western countries and France is no exception. Most of the growth may be explained by changes in practices for a given morbidity, driven by the prescription of more innovative drugs [1]. This rise in expenditures has resulted in policies aimed at either reducing the use of pharmaceuticals or steering patients to using less expensive alternatives [2], [3], [4], [5]. Increasing the patient's out-of-pocket payment is commonly used to contain pharmaceutical spending. This can be achieved in a number of ways such as introducing or increasing co-payments, removing drugs from the reimbursement schedule or introducing new reimbursement rules (prior-authorization policy, for example, which restricts the use of medications by requiring prior approval from an insurer, has become in recent years a very popular method to contain costs in the USA and Canada), and restricting the volume of drugs subsidised.

Many studies have analysed how access to prescription drugs, medical spending and health outcomes may be affected by cost-sharing [6], [7]. They found that increased cost-sharing is associated with lower rates of drug treatment, less adherence, and more frequent discontinuation of therapy. Depending on the class of drug and the patient's health status, every 10% increase in cost sharing decreases prescription drug spending by 2–6% [6]. In addition, increased patient cost-sharing for prescription drugs is associated with an increase in the use of other medical services, such as hospital services and emergency department visits [8]. In a study on chronic venous insufficiency in Italy, removing drugs from the reimbursement schedule reduced drug costs and the number of visits to the GP in the short term, but in the long term resulted in an increase in disease-related hospitalisations [9]. The majority of studies reveal that the use of potential drug substitutes increased as cost-sharing rose [7]. When health plans introduce differential co-payments for preferred (on the formularies) or non-preferred drugs, evidence shows that substitution from non-preferred to preferred brand-name drugs occurs but there is no evidence for substitution from brand-name to generic drugs. Studies on the substitution of prescription drugs by over the counter drugs are inconclusive [7], [10].

Whereas studies evaluating the impact of prior authorization policy implementation [11] or the increase of co-payments are becoming very popular [7], studies focussing specifically on the impact of removing drugs from reimbursement are scarce. Although a reduction in pharmaceutical expenditures on the targeted class of drug has been observed in most of these studies, the risk of increasing the cost of the disease by shifting the prescription to more costly drugs or treatments is also underlined [9]. As suggested by the response to a survey using vignettes, physicians are more likely to change to a medication that is still listed on the formulary [12] in a situation where a patient's drug has been delisted. Meissner et al. found that the decrease in total expenditures on drugs and medical management costs was lessened by a shift from the delisted Atorvastatin to the still listed Pravastatin, the most expensive statin among the proposed substitutes [13]. A recent study analyses the consequences of removing 64 drugs from reimbursement, distributed into four ATC groups (R05 Cough and Cold Preparations, A11 vitamins, A12 mineral supplements and R02 Pharyngeal Preparations), from the list of reimbursable drugs in Turkey [14]. The results show that expenditures for the removed drugs decreased rapidly after the introduction of the policy change in July 2006. However, removing these drugs from the reimbursement list has led to a strong increase in expenditures for reimbursable drug alternatives to the delisted drugs. Finally, the policy was found to be associated with a decrease in pharmaceutical expenditures in two of the four ATC groups – Vitamins and Minerals – and an increase in pharmaceutical expenditures for the Cough and Cold Preparations and Pharyngeal Preparations ATC groups. The total net impact on the pharmaceutical expenditures in the four ATC groups was almost zero.

Several studies suggest that the impact of cost sharing depends on a drug's therapeutic class and its “essential” or “non-essential” feature [7]. A time-series analysis measuring the effect of withdrawing reimbursement for twelve categories of older, questionably effective drugs has shown an increase in the use of newer, more costly drugs, but only two of the ten substitute categories of drugs represented a probable therapeutic improvement [15]. Conversely, de-insuring such essential drugs as Chlorpropamide in diabetes resulted in a change to more appropriate antihyperglycemic agents [16].

In France, most pharmaceutical treatments are partially or entirely covered by the public health insurance scheme. In order to be reimbursed, drugs have to be registered on the ‘Liste des spécialités remboursables’, i.e. List of Reimbursable Drugs. The applied reimbursement rate (100%, 65% or 35%) depends on the drug effectiveness and the severity of the disease. But as drug effectiveness can be reassessed over time, the reimbursement rate can also be reconsidered. Prices for reimbursed drugs are strictly controlled and fixed according to an agreement between the pharmaceutical firms and the Healthcare Products Pricing Committee, which is an interministerial committee. By contrast, prices for non-reimbursable drugs and OTC drugs are unregulated and pharmaceutical firms can freely fix them. In 1999, for the purpose of improving quality of care and reducing health insurance expenditure for marginally effective drugs, the French Transparency Committee, responsible for listing reimbursable drugs, initiated a comprehensive review of the therapeutic advantage of all the drugs reimbursed by the French Public Health Insurance. Following this review, the Committee recommended the removal of a large number of drugs from the reimbursement scheme because of their insufficient therapeutic advantage. Existence of alternative drugs was not taken into account in France in the delisting decision process which was only based on the intrinsic value of the drug. According to this review, mucolytics and expectorants were removed from the list of reimbursable drugs on March the 1st 2006 and were therefore no longer covered by the National Health Insurance. Before they were removed from the list of reimbursable drugs, mucolytics and expectorants were both available over-the-counter and delivered by the pharmacist on prescription. But only the latter were reimbursed by Public Health Insurance. In 2005 the National Health Insurance reimbursed EUR 50 million for mucolytics and expectorants [17]. After March 2006, those drugs were still available over-the-counter but were not eligible for reimbursement even if prescribed, except for cystic fibrosis. Furthermore, as prices for OTC drugs are unregulated in France, pharmaceutical firms increased the prices of mucolytics and expectorants after they were removed from reimbursement.

Mucolytics and expectorants are designed to dissolve mucus and facilitate expectoration in patients suffering from respiratory diseases. They make coughing up mucus easier and less irritating. The major active ingredients are carbocysteine, acetylcysteine and ambroxol. No perfect substitute exists and few alternatives with comparable indications are available. Fenspiride for instance acts as an antitussive and bronchodilator agent and could be a possible substitute for expectorants.

Eliminating drugs that are judged to be ineffective from reimbursement theoretically enables the regulator to rationalize physicians’ prescriptions and contain Public Health Insurance costs. Even if removing a drug from the list of reimbursable drugs is generally associated with a strong decrease in prescription rates for the concerned drug (intended impact) it can also, however, be associated with an increase in prescription rates for reimbursed substitutes (unintended impact) which can completely offset any cost savings that might have been achieved by the policy. An evaluation of the impact of those measures on public health insurance costs therefore requires a global approach taking into account their impact not only on a drug removed from the reimbursement list but also on the level of its substitutes [15].

In this paper, we look at the evolution of the prescription rate and the cost of four therapeutic classes in France over a 10 year period and more specifically before and after March 2006 when 128 mucolytics and expectorants (R05C class in the EPhMRA1 classification) were removed from the list of reimbursable drugs. The aim of this study is to evaluate the impact of this measure on the prescription of mucolytics and expectorants, on the prescription of possible substitute drugs and the corresponding impact on Health Insurance costs. As we are focussing on the impact of this policy on public health expenditure, we do not take into account the cost for the patient.

Section snippets

Data source

Data used in this study were taken from the IMS-Health Permanent Survey on Medical Prescription. This database contains information on pharmaceutical prescriptions administered by French community-based physicians and on diagnoses associated with these prescriptions. Each quarter, about 850 French general practitioners and physicians (cardiologists, dermatologists, gastroenterologists, gynecologists, neurologists, ophthalmologists, ENT, pediatricians, lung specialists, rheumatologists and

The effect of removing mucolytics and expectorants from the list of reimbursable drugs on their prescription rate

In France, in March 2006, the mucolytics and expectorants class contained 243 different drugs that can be divided into three categories. The first category was made up of 110 drugs that were no longer reimbursed before March 2006. As the drugs in this category were progressively removed from the reimbursement list over a period of two years (mainly in 2002 and in 2003) the global effect is difficult to analyse. The second category contained only five drugs that were reimbursed until January

Discussion

After March 2006, the prescription rate for mucolytics declined significantly and remained stable until 2009, while the prescription rates for cough suppressants and bronchodilators increased significantly and remained at a high level for two years. At the same time the rate for antibiotics remained the same. It would thus appear that the March 2006 policy only partially succeeded in both reducing health expenditure and improving quality of care as we observe an unwanted substitution effect

Conclusion

The aims of removing mucolytics and expectorants from the list of reimbursable drugs were primarily motivated by public health and cost containment concerns. Drugs were chosen because their use could be reduced without danger to public health and because they could be replaced by more effective ones, thus allowing a better allocation of public funds. According to the state of science and/or the existence of new alternatives, concerned drugs are no longer valid in terms of therapeutic strategy.

References (34)

  • B. Wettermark et al.

    Initial effects of a reimbursement restriction to improve the cost-effectiveness of antihypertensive treatment

    Health Policy

    (2010)
  • J. Puig-Junoy

    The impact of generic reference pricing interventions in the statin market

    Health Policy

    (2007)
  • C. Delga et al.

    A pilot study in general practice: pressure to prescribe

    Therapie

    (2003)
  • B. Dormont et al.

    Health expenditure growth: reassessing the threat of ageing

    Health Economy

    (2006)
  • M.J.C. Nuijten et al.

    Trends in decision-making process for pharmaceuticals in Western European countries

    Hepac: Health Economics in Prevention and Care

    (2001)
  • F. Rocchi et al.

    Current national initiatives about drug policies and cost control in Europe: the Italy example

    Journal of Ambulance Care Management

    (2004)
  • S.M. Ess et al.

    European healthcare policies for controlling drug expenditure

    Pharmacoeconomics

    (2003)
  • B. Godman et al.

    Comparing policies to enhance prescribing efficiency in Europe through increasing generic utilization: changes seen and global implications

    Expert Review Pharmacoeconomics Outcomes Research

    (2010)
  • D.P. Goldman et al.

    Prescription drug cost sharing: associations with medication and medical utilization and spending and health

    JAMA

    (2007)
  • T.B. Gibson et al.

    The effects of prescription drug cost sharing: a review of the evidence

    The American Journal of Managed Care

    (2005)
  • A.H. Anis et al.

    When patients have to pay a share of drug costs: effects on frequency of physician visits, hospital admissions and filling of prescriptions

    CMAJ

    (2005)
  • C. Allegra

    Chronic venous insufficiency: the effects of health-care reforms on the cost of treatment and hospitalisation—an Italian perspective

    Current Medical Research and Opinion

    (2003)
  • A. Leibowitz

    Substitution between prescribed and over-the-counter medications

    Medical Care

    (1989)
  • C.J. Green et al.

    Pharmaceutical policies: effects of restrictions on reimbursement

    Cochrane Database of Systematic Reviews

    (2010)
  • M. Godwin et al.

    Delisting of drugs in Ontario. How attitudes and prescribing strategies of family physicians in the Kingston area changed

    Canadian Family Physician

    (1996)
  • B. Meissner et al.

    Drug and medical cost effects of a drug formulary change with therapeutic interchange for statin drugs in a multistate managed Medicaid organization

    Journal of Managed Care Pharmacy

    (2006)
  • A.O. Gur et al.

    How removing prescription drugs from reimbursement lists increases the pharmaceutical expenditures for alternatives

    The European Journal of Health Economics

    (2010)
  • Cited by (11)

    View all citing articles on Scopus
    View full text