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PubMed1999

Formulary management of proton pump inhibitors.

The management of dyspepsia has been radically altered by the discovery of the role of Helicobacter pylori and the advent of proton pump inhibitors (PPIs). The use of PPIs alone as antisecretory agents and as part of triple therapy regimens for H. pylori eradication accounts for a significant percentage of any healthcare system's drug budget. Thus, it is important to take into account a variety of factors when devising a formulary and considering which PPIs to include. Consideration of 3 factors are particularly crucial in this process, namely therapeutic efficacy, tolerability and cost but several other clinical and economic parameters should also be considered. The mechanisms of action of all 4 PPIs currently available (omeprazole, lansoprazole, pantoprazole and rabeprazole) are very similar, with any small differences in pharmacological properties unlikely to be of clinical significance. Therapeutic efficacy in patients with acute reflux oesophagitis is again very similar for all 4 PPIs at their standard dosages; all agents are superior to H2-antagonists. Data on maintenance therapy for reflux oesophagitis also suggest similar efficacy for omeprazole and lansoprazole; data on pantoprazole and rabeprazole are awaited. For the treatment of H. pylori-related ulcers, the consensus at present is for PPI-based triple therapy. Again, all PPIs seem equally efficacious for this indication but pantoprazole and rabeprazole have yet to receive licences for H. pylori eradication therapy (HPET) in most countries. Drug tolerability is another critical issue to consider in formulary inclusion decisions. As a class, the PPIs are well tolerated. Minor drug interactions are reported for omeprazole, lansoprazole and rabeprazole but not for pantoprazole. However, whether or not this is significant in clinical practice is open to debate. Most of the pharmacoeconomic data in these indicators, to date, relate to omeprazole and, to a lesser extent, lansoprazole. Certainly, the studies on these 2 drugs confirm the superior cost effectiveness of PPIs over H2-antagonists in the treatment of reflux oesophagitis and peptic ulceration in both the short and long-terms. Although data are awaited, there is no reason to suggest that this will be any different for pantoprazole and rabeprazole. PPI-based triple therapy for H. pylori eradication appears to be the most cost-effective treatment option for H. pylori-related peptic ulcer disease. It is clear that PPIs are superior in several regards to previously used medications in the treatment of dyspepsia. Which PPI(s) to include in a particular formulary is a more difficult decision. On review of many criteria involved in formulary decisions, differences between the individual PPIs appear minimal. The relative acquisition costs of the PPIs vary nationally and internationally and this may be a critical factor in formulary inclusion decisions. However, one should not ignore non-economic factors, as these should form the basis of any sound drug policies.

Anti-Ulcer Agents↗
PubMed2000

Formulary management of low molecular weight heparins.

Low molecular weight heparins (LMWHs) are increasingly being utilised as anticoagulants in healthcare settings. These agents offer several advantages over standard unfractionated heparin. Indications for LMWHs include deep vein thrombosis and pulmonary embolism prophylaxis, deep vein thrombosis treatment, use in coronary procedures associated with a high risk for bleeding, and in acute coronary syndromes. Prior to being added to formularies, LMWHs should be evaluated for efficacy, safety and economic benefits over other anticoagulants. Institutions should be prepared to conduct their own economic assessments in the absence of readily available studies. There is clear evidence that LMWHs are cost saving or are at least cost effective as thromboprophylactic agents in major orthopaedic surgery. The economic benefits of LMWHs in other surgical situations is less clear. Consistent evidence from several countries indicate that LMWHs are cost saving as anticoagulants for the initial treatment of DVT. Further studies are needed to evaluate the efficacy, safety and economics of LMWHs in other conditions besides hip and knee arthroplasty and general surgery.

Cost-Benefit Analysis↗
PubMed2000

Using economic evaluations to make formulary coverage decisions. So much for guidelines.

BACKGROUND: It is mandatory for drug manufacturers requesting formulary inclusion under the British Columbia (BC) provincial drug plan to submit a pharmacoeconomic analysis according to published guidelines. These submissions are reviewed by the Pharmacoeconomic Initiative (PI) of BC. OBJECTIVE: To assess the compliance of submitted studies with specific criteria outlined in the guidelines, to assess the methodological quality of individual submissions, and to demonstrate the importance of submitting guidelines-compliant pharmacoeconomic analyses. DATA AND METHODS: All submissions between January 1996 and April 1999 assessed by the PI of BC were included. Submissions were reviewed according to a checklist to establish compliance with respect to choice of comparator drug, study perspective, sensitivity analysis, analytical horizon and discounting. Submissions were examined for association between analytical technique and author, and between source of submission and compliance. Association between compliance and recommendation for approval was also examined. RESULTS: 95 applications were reviewed. Seven submitted no analyses. There were 25 cost-comparison/consequence, 14 cost-effectiveness, 11 cost-minimisation, 9 cost-utility/benefit and 29 budget-impact analyses. 65 of these 88 submissions failed to comply with guidelines. Of these, 45% used an inappropriate comparator drug, 61% lacked a sensitivity analysis, 73% used a third-party payer and excluded a societal perspective, 66% did not provide a long term evaluation and 25% did not specify any time horizon. 80% of noncompliant studies were cost-comparison/consequence or budget-impact analyses (p < 0.001, Fisher's Exact). Of 25 cost-comparison/consequence and 29 budget-impact analyses, 19 (76%) and 24 (83%), respectively, were industry-conducted, whereas cost-effectiveness (11 of 14) and cost-utility/benefit (6 of 9) analyses were mostly subcontracted to private consultants or academics (p < 0.001, Fisher's Exact). 74% of all submissions (compliant and noncompliant) were not recommended by the PI for listing as a provincial drug plan benefit, 16% received approval for restricted benefit and 9% were recommended as full benefit. 80% of the noncompliant submissions were not recommended (p = 0.06, Fisher's Exact test). Moreover, a strong association between type of analysis and type of recommendation was found (p = 0.03, Fisher's Exact test). Cost-comparison/consequence and budget-impact analyses were less likely to be recommended. IMPLICATIONS OF FINDINGS: Our findings show poor compliance with guidelines, especially among industry-conducted studies. Possible explanations are lack of expertise in pharmacoeconomics and/or scepticism regarding the importance of guidelines and submission quality in decision making. As corroborated by the strong associations between type of recommendation and compliance, and between type of recommendation and type of analysis, these 2 characteristics have a significant impact on decision making.

British Columbia↗
PubMed2001

Formulary restriction of selective serotonin reuptake inhibitors for depression: potential pitfalls.

The American healthcare market is currently estimated at more than 900 billion US dollars with double digit rising costs per year. Psychotropic agent costs have more than kept pace with market increases. Medication acquisition costs are an obvious focus for limiting costs in various care systems. Restrictive formularies are a common method of attempting to limit costs. To support our opinion that a single agent is ill advised, we explored the available evidence on the intended and unintended consequences of having a single or exclusive selective serotonin reuptake inhibitor (SSRI) on a formulary. Central to this position is an assumption of the interchangeability of SSRIs; we examined the evidence for and against this through a model to determine the probability of interchangeability. We conclude that the practice of having a single SSRI on the formulary for a healthcare plan seems ill founded. Patients who switch antidepressants remain in treatment 50% longer and cost approximately 50% more to treat in a more costly treatment setting. Giving the primary care physician several antidepressant choices can provide more options to continue treatment of his or her patient in the less expensive primary care setting. In terms of cost containment, formulary restrictions are far more likely to have the opposite effect.

Depressive Disorder↗
PubMed2002

Pharmacy benefit management: enhancing the applicability of pharmacoeconomics for optimal decision making.

Previous research indicates that in order to make pharmacoeconomic information applicable and useful for pharmaceutical benefit management (PBM) companies, several aspects need to be considered and improved. These include: timely availability of information, head-to-head comparators, peer-reviewed publications, independent sponsorship of pharmacoeconomic studies, use of relevant populations in research and published pharmacoeconomic models, and pharmacoeconomics training for pharmaceutical companies' sales personnel. In addition to these measures, guidelines have been playing an important role in improving the applicability of pharmacoeconomic information. This paper examines the progress to date in enhancing the applicability of pharmacoeconomics for optimal PBM decision making. The greatest improvements have been made in enhancing the quality of pharmacoeconomic research and the quality of peer-reviewed publications. Direct comparator studies are starting to emerge, but in limited numbers. The need for additional training of pharmaceutical representatives and PBM staff members remains a critical issue.

Cost-Benefit Analysis↗
PubMed2003

European healthcare policies for controlling drug expenditure.

In the last 20 years, expenditures on pharmaceuticals - as well as total health expenditures - have grown faster than the gross national product in all European countries. The aim of this paper was to review policies that European governments apply to reduce or at least slow down public expenditure on pharmaceutical products. Such policies can target the industry, the wholesalers and retailers, prescribers, and patients. The objectives of pharmaceutical policies are multidimensional and must take into account issues relating to public health, public expenditure and industrial incentives. Both price levels and consumption patterns determine the level of total drug expenditure in a particular country, and both factors vary greatly across countries. Licensing and pricing policies intend to influence the supply side. Three types of pricing policies can be recognised: product price control, reference pricing and profit control. Profit control is mainly used in the UK. Reference pricing systems were first used in Germany and The Netherlands and are being considered in other countries. Product price control is still the most common method for establishing the price of drugs. For the aim of fiscal consolidation, price-freeze and price-cut measures have been frequently used in the 1980s and 1990s. They have affected all types of schemes. For drug wholesalers and retailers, most governments have defined profit margins. The differences in price levels as well as the introduction of a Single European Pharmaceutical Market has led to the phenomenon of parallel imports among member countries of the European Union. This may be facilitated by larger and more powerful wholesalers and the vertical integration between wholesalers and retailers. To control costs, the use of generic drugs is encouraged in most countries, but only few countries allow pharmacists to substitute generic drugs for proprietary brands. Various interventions are used to reduce the patients' demand for drugs by either denying or limiting reimbursement of products and providing an incentive for patients to reduce their consumption of drugs. These interventions include defining a list either of drugs reimbursed (positive list) or one of drugs not reimbursed (negative list), and patient co-payments, which require patients to pay a proportion of the cost of a prescribed product or a fixed charge. Policies intended to affect physicians' prescribing behaviour include guidelines, information (about price and less expensive alternatives) and feedback, and the use of budgetary restrictions.

Cost Control↗
PubMed2003

Ontario's formulary committee: how recommendations are made.

BACKGROUND: In 1996, the provincial government in Ontario, Canada required pharmaceutical manufacturers seeking to list their products on the provincial formulary to provide a formal economic analysis documenting the products' cost effectiveness. The provincial formulary lists pharmaceutical products for which reimbursement is provided for residents on the Ontario Drug Benefit Program (ODB). OBJECTIVE: To describe how listing decisions are made, and specifically the role of economic analysis in this process. DESIGN: A qualitative case study approach was taken. Data were analysed using the pattern-matching technique. Data consisted of meeting transcripts and interviews with committee members, which were coded and weighted for analysis using the pattern-matching technique. SETTING: Nine meetings of the Drug Quality and Therapeutics Committee (DQTC), which makes listing recommendations to the ODB, were observed. PARTICIPANTS: Seven individual committee members were interviewed. RESULTS: Complex economic analyses (i.e. analyses more involved than a simple cost-consequence analysis) played a limited role. The clinical factor dominated the perception of costs. Generic and 'me-too' products with no price premium did not require complex economic analyses. Poor quality analyses were not useful and the DQTC members' lack of in-depth knowledge of health economics influenced the extent to which analyses were discussed. The DQTC did discuss economic issues however, and often performed informal economic analyses to guide decisions. CONCLUSIONS: Complex economic analyses had an impact on provincial drug benefit decisions in a limited number of circumstances, principally for expensive innovative products. However, the committee did use some form of economic analysis to guide decisions in almost all cases, and therefore requesting economic analyses, even simple ones, from manufacturers seeking formulary listing is a useful healthcare policy.

Cost-Benefit Analysis↗
PubMed2006

Economic evaluations in the canadian common drug review.

The Canadian Common Drug Review (CDR) was established in 2003 to provide a single process for making formulary recommendations to most Canadian publicly funded drug plans. This paper considers the most common challenges faced by the CDR: (a) determining the effectiveness of a drug (particularly interpreting the importance of surrogate markers and changes in QOL measures); (b) the massive rise in the cost of new drugs, which, in general, does not seem to accompanied by a massive increase in effectiveness; (c) interpreting complex pharmacoeconomic evaluations which often do not provide straightforward answers about the cost effectiveness of a drug; (d) prescription creep (the tendency for drugs in the real world to be used in patients who were not studied in clinical trials, thus raising concerns about a drug's real-world cost effectiveness; and (e) ethical and societal issues, particularly the reimbursement of expensive drugs for rare diseases.

Canada↗
PubMed2006

Centralising drug review to improve coverage decisions: economic lessons from (and for) Canada.

Drug coverage decisions require information about clinically relevant benefits and risks, as well as economic information about direct and indirect costs, in comparison with relevant treatment alternatives. A recent Canadian initiative aims to improve the evidentiary basis for drug coverage decisions through centralised evaluation of the clinical and economic value of new drug products. Centralised review can make important, 'positive' contributions to decision making by raising the evidentiary basis for decisions. Even in the absence of a single-payer for medicines, such information can directly inform decisions focussed on matters of technical efficiency. Centralised review also provides necessary but not sufficient information for the many decisions in this sector that concern allocative efficiency and therefore have 'normative' implications. Thus, in addition to processes for collecting and critically assessing clinical and economic data, effective priority setting requires processes at a local level for engaging affected populations in the consideration of the trade-offs inherent in coverage decisions.

Canada↗
PubMed2006

Comparing patient access to pharmaceuticals in the UK and US.

BACKGROUND: The debate on access to new drugs has focused on the time lag between applications for approval and granting of marketing authorisation. This delay was identified as the first barrier with respect to patient access to new drugs, encompassing the hurdles of safety, efficacy and quality. Additional barriers have since been identified. These pertain to reimbursement and pricing of approved drugs, the so-called fourth and fifth hurdles. METHODS: We reviewed 38 National Institute for Health and Clinical Excellence (NICE) guidance appraisals carried out between April 1999 and April 2005. These appraisals included 71 recently approved drugs considered to have either high clinical or cost impact. For each drug we first determined its marketing approval date by the British Medicines Healthcare Products Agency (MHRA) or European Medicines Evaluation Agency (EMEA). Secondly, we determined if each drug was approved by the US FDA for marketing and, if so, the date when it was approved. Thirdly, we considered whether and when each drug was recommended for reimbursement and use by NICE, and whether conditions of reimbursement applied. Fourthly, for the subset of FDA-approved drugs, we examined formulary placement, cost sharing and conditions of reimbursement on three-tier formularies used by seven leading US third-party payers serving Medicare beneficiaries. Fifthly, we reviewed each NICE recommendation to determine if cost-effectiveness data were referred to either in the appraisal documentation or in the final recommendation. Sixthly, we asked a spokesperson from each US payer whether cost-effectiveness assessments or rebates played a role in determining formulary placement of drugs in our sample, and whether there was a lag between marketing approval and reimbursement for any of the covered drugs. RESULTS: Of the 71 drugs contained in 38 NICE guidance appraisals, the US FDA approved 64. On average, the subset of 64 drugs received marketing authorisation in the US prior to the UK. On average, US plans covered 87% of the 64 drugs, the same percentage of drugs recommended for NHS reimbursement and use. Cost sharing in the US was significantly higher than in the UK, with wider variation across plans. On average, drugs covered in the US had fewer conditions of reimbursement (15%) than the percentage of drugs given conditions by NICE (46%). US plans were quicker to decide to reimburse drugs following marketing approval than NICE. CONCLUSIONS: The US provides faster, more flexible access to most, but not all, of the UK-approved pharmaceuticals in our sample. However, US patients have higher cost sharing than the UK and coverage is less evenly spread across the population. From a policy perspective, our study findings confirm the need to bolster the NICE fast-track initiative to decrease the amount of time it takes to appraise certain new pharmaceuticals. Also, the study findings point to the need in the US for careful monitoring of plan compliance with regulations pertaining to the Medicare drug benefit, particularly with respect to formulary restrictions and limits on cost sharing.

Cost-Benefit Analysis↗
PubMed1992

Prescribing and drug costs in the province of Ontario.

The Report of the Pharmaceutical Inquiry of Ontario documented dramatic increases in the cost of the Ontario Drug Benefit (ODB) program. This article demonstrates that the rise in ODB costs for those 65 and over is due to two factors: more intensive prescribing--physicians prescribing to the elderly more often and writing more prescriptions each time they see an elderly patient--and physicians writing prescriptions for more expensive drugs. Neither of these two changes in prescribing behavior has resulted in any demonstrable improvement in the health of the elderly. Efforts to control costs through some form of copayment or by eliminating some drugs from the ODB formulary should not be undertaken since they probably will result in a reduction in the use of medically necessary drugs. Ultimately, drug costs will only be controlled by improving the appropriateness of physicians' prescribing.

Aged↗
PubMed2000

Pharmaceutical expenditure in Spain: cost and control.

In recent years, the Spanish government has been battling to keep pharmaceutical expenditures under control. Its measures include control of prices, introduction of a "negative list" of drugs no longer reimbursed, increased cost-sharing, and introduction of overall budgets for pharmaceutical expenditures. Although the average prices of old pharmaceutical products declined by 39 percent over the last 15 years and consumption in value increased by only 10 percent, real pharmaceutical expenditures in Spain increased by 264 percent over that period. The main reason for the continuing rise in these expenditures and the failure of cost-containment measures is the introduction of new, more expensive drugs, which often fail to offer any real therapeutic advantages over products already on the market. This situation is exacerbated by a lack of effective demand-side measures such as budgets for doctors and lack of a generics market.

Cost Control↗
PubMed1988

Medicaid formularies: a critical review of the literature.

Studies on the impact of restricted Medicaid formularies were reviewed to assess whether other drugs on the formulary were substituted for restricted drugs, the cost of the substitutes, whether the substitutes were therapeutically appropriate, whether restricted drugs continued to be prescribed, what incremental administrative costs accompanied restrictions, what indirect costs occurred and how the cost-effectiveness of pharmaceuticals impinged on the total cost of illness. The assumption that restriction of specific drugs results in savings in the drug costs proportional to prior usage was shown to be questionable, numerous studies found alternate formulary drugs to the restricted drugs being prescribed, or patients were paying out-of-pocket for denied drugs. There was a tendency for alternate drugs to be more expensive. Little information exists as to the incremental administrative costs of restricted formularies or the therapeutic appropriateness of substituted drugs. One study suggests that major shifts in costs occur due to restrictive formularies through substitution of more expensive services such as hospitalization in lieu of pharmaceuticals. It is concluded that restricting formularies leads to dynamic changes in the total Medicaid program of a complex and often costly nature. Plans to implement formulary restrictions require considerable careful thought.

Cost Control↗
PubMedDate not supplied

A bitter pill: formulary variability and the challenge to prescribing physicians.

BACKGROUND: Multitiered, incentive-based formularies have been increasingly used as a mechanism to control prescription drug expenditures. Prescribing physicians who manage patients from multiple insurers must be familiar with the variability in their patients' formulary incentives to help patients choose therapy wisely. However, the degree of formulary variability among and within health plans over time is unclear. METHODS: In 6 major health plans in California, we evaluated formulary incentive variability in 4 of the 5 drug classes with the highest expenditures in California: proton pump inhibitors, hydroxymethylglutaryl coenzyme A reductase inhibitors ("statins"), calcium channel blockers, and angiotensin-converting enzyme inhibitors. We categorized 20 branded members of these classes into either "preferred" or nonpreferred/uncovered categories. We calculated the consistency that brands were preferred across health plans and the frequency of changes in formulary status for each drug within plans between 2000 and 2002. RESULTS: None of the branded drugs evaluated were preferred on all formularies in 2002, and 10% were not available on any of the formularies. Formulary status varied greatly across plans, and more than 60% of drugs were preferred on 2 to 4 of the 6 formularies studied. Formulary status within health plans varied between 2000 and 2002 in more than half of the plans in the drug classes evaluated. CONCLUSIONS: In the drug classes evaluated, over a 2-year period, considerable variability was seen among and within formularies over time. This variability poses a challenge to physicians who wish to reduce patients' expenditures by prescribing the least expensive among similarly effective drugs within a drug class. This variability is especially relevant because recent legislation increases the likelihood that more Medicare beneficiaries will receive their medications from private health plans.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1998

[The Baume du Chevalier de St-Victor otherwise the Baume du Commandeur de Pernes].

The Baume du Commandeur de Pernes was studied in 1929 and the Commandeur identified by M. Bouvet; the origin of its synonym introduced by N. Lemery (1715), i.e. the Baume du Chevalier de St-Victor had not been elucidated up to now. The author's proposals, based upon genealogical data, are the following: two brothers Chevalier de St-Victor were enrolled in the Order of Malta in 1624 at St Gilles (Languedoc); one of them was able to transmit the Balm's formula to N. Lemery during his stay in Montpellier between 1668 and 1671. The geographically very different origins of the Commander and the Knight should prove perhaps that a basic pharmaceutical formulary common at least to all the French Commanderies was existing at that time. In the other hand, the fluctuations of the formula since the XVIIth century have been reported.

Christianity↗
PubMed2005

[One hundred years after the Geminal law, Rene Cerbelaud publishes secret remedies].

Our colleague René Cerbelaud was an original character. He played an important part in the pharmaceutical history of the 20th century when published recipes of countless medicines and cosmetic products, incurring the hostility of their manufacturers. As a matter of fact, he contributed to the disappearance of secret remedies and therefore to the enforcement of the Germinal law more than a century after it was promulgated. In a sense he may be looked on as the inventor of generic drugs and the promoter of what has become "parapharmacie".

Cosmetics↗
PubMed2003

[A review of experimental designs of compound compatibility law of traditional Chinese medicine].

The paper discussed a variety of experimental designs of compound compatibility law of traditional Chinese medicine (TCM): study of whole formula and different ingredients of formula. The latter includes study of single ingredient, study of functional ingredient group, orthogonal design, clustering analysis, homogeneous design, factorial analysis and so on. It was proposed that experimental designs of formula should be based on the theory of TCM, and combined with modern sciences.

China↗
PubMed2006

A practical physicians' guide to the Medicare drug benefit plan.

Recent commentaries on Medicare Part D highlight both the early failings and the successes of the program. However, regardless of one's opinions about the program, Part D is a reality that millions of Medicare beneficiaries must address now and in the future. The ultimate economic, policy, and clinical success of the Medicare drug benefit plan depends on its transparency and ability to be navigated together by patients, physicians, and other parties. Although Medicare Part D is likely to evolve considerably in the future, it will continue to present elderly adults with numerous plan options and rules and therefore present persistent challenges for patients and physicians. By focusing on a few crucial aspects of Part D and taking advantage of available resources, physicians can simplify Part D for their patients, help them make informed decisions about enrollment and plan selection, and possibly help them save money with their current PDP. This may, in turn, reduce beneficiaries' out-of-pocket prescription costs, thereby improving patients' access to medications and possibly their medication adherence and health outcomes as well.

Decision Making↗